#US Biosimilar Sector

[kenresearch1]

Biosimilars Unleashed: The Future of Healthcare in the US

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What is the Size of US Biosimilar Industry?

US Biosimilar Market is expected to grow at a CAGR of ~ % between 2017-2022 and is expected to reach ~USD Bn by 2028. Biosimilars enhance patient access to essential treatments, especially in therapies with high demand, like oncology, by providing more affordable options. Additionally, Growing evidence of biosimilars' comparable efficacy and safety fosters trust among healthcare professionals, driving adoption.

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Biosimilars offer cost savings compared to originator biologics, addressing the need for affordable healthcare solutions in the face of rising medical costs. Favorable regulatory frameworks, like the BPCIA, streamline biosimilar approval processes, encouraging manufacturers to invest in development.

Furthermore, The expiration of patents for numerous reference biologics creates opportunities for biosimilar entry, leading to increased competition and market expansion. Pharmaceutical companies are investing in biosimilar R&D and production, expanding the pipeline and market availability. Supportive healthcare policies and reimbursement models incentivize biosimilar adoption, creating a favorable environment for market growth.

US Biosimilar Market by drug class

The US Biosimilar market is segmented by Monoclonal Antibodies, Recombinant Hormones, Immunomodulators, Anti-inflammatory agents and Others. Based on drug class, Monoclonal Antibodies segment dominates the bio similar market in 2022.

Monoclonal antibodies have diverse applications across various therapeutic areas. From cancer treatment to autoimmune diseases, biosimilar Mabs addressed a wide range of medical needs, leading to a broad and growing market. Biosimilars, with their potential for cost savings while maintaining comparable efficacy and safety, gained significant attention as viable alternatives.

US Biosimilar Market by application

In US Biosimilar market, they are segmented by application into Oncology, Blood disorders, Chronic diseases and autoimmune conditions and Others. On the basis of application, Oncology segment was the dominant in 2022.

The increasing prevalence of cancer and the high cost of traditional biologics used in oncology treatment have created a strong incentive for the adoption of biosimilars. Biosimilars offer the potential to provide similar therapeutic outcomes at a lower cost, making them an attractive option for both healthcare providers and patients.

Additionally, the rigorous clinical trials and regulatory processes that biosimilars undergo to gain approval provide reassurance to healthcare professionals and patients regarding their safety and efficacy. This has led to increased acceptance and adoption of biosimilars in oncology.

US Biosimilar by Region

The US Biosimilar market is segmented by Region into North, East, West and South. In 2022, the dominance region is North region in US Biosimilar market.

The North region benefits from a concentration of healthcare providers and academic institutions that are at the forefront of adopting and integrating biosimilars into their treatment protocols. These institutions are more likely to have the expertise to evaluate and incorporate biosimilars effectively, driving their adoption among healthcare professionals and patients.

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Competition Scenario in US Biosimilar Market

The US biosimilar market has witnessed an evolving competitive landscape, with several key players competing for market share. Prominent pharmaceutical companies such as Amgen, Pfizer, Sandoz (Novartis), and Boehringer Ingelheim have been actively involved in developing and marketing biosimilar products. These established players have utilized their expertise in biologics and significant resources to navigate the regulatory landscape and compete effectively.

The competition in the US biosimilar market is characterized by a balance between established pharmaceutical giants and emerging biotech companies. While the major players possess the advantage of resources and experience, smaller biotech firms are also contributing to the market with innovative approaches and niche biosimilar offerings.

What is the Expected Future Outlook for the Overall US Biosimilar Market?

The US Biosimilar market was valued at USD ~Million in 2022 and is anticipated to reach USD ~ Billion by the end of 2028, witnessing a CAGR of ~% during the forecast period 2022- 2028. The US biosimilar market is likely to experience significant growth in the coming years, driven by several factors. Biosimilars are biologic drugs that are highly similar to already approved reference biologics. They offer potential cost savings, increased competition, and improved patient access to crucial treatments.

Firstly, the regulatory environment is becoming more favorable for biosimilars. The Biologics Price Competition and Innovation Act (BPCIA) established a pathway for biosimilar approval in the US, allowing for a smoother regulatory process. As more biosimilars receive approval, competition in the market is expected to intensify.

Secondly, patents for several blockbuster biologics are expiring or have already expired. This creates opportunities for biosimilar manufacturers to enter the market with more affordable alternatives, offering healthcare systems and patients a choice in treatment options.

Thirdly, as healthcare costs continue to rise, biosimilars present an attractive solution for reducing expenses. Their potential to offer cost savings without compromising therapeutic efficacy could lead to increased adoption by healthcare providers, insurers, and patients alike.

Physician and patient education are crucial, as misconceptions about biosimilars' safety and effectiveness might hinder their adoption. Additionally, legal and market access barriers, including patent litigation and complex distribution systems, could slow down the growth of the biosimilar market.

The biosimilar market witness consolidation as larger pharmaceutical companies acquire or partner with smaller biotech firms to bolster their biosimilar portfolios. This will lead to more resources being devoted to biosimilar development and marketing. Changes in healthcare policies, such as reimbursement models and value-based care initiatives, can influence the biosimilar market's growth. Favourable policies that incentivize biosimilar adoption drives their market growth.

[mordorintelligencemarketresearch]

The Albumin Industry: A Vital Component in Healthcare and Biopharmaceuticals 

Albumin, a vital protein found in blood plasma, has become an indispensable resource in the healthcare and biopharmaceutical industries. Known for its versatility and wide-ranging applications, albumin serves critical roles in medical treatments, drug delivery systems, and diagnostics. Its increasing demand across healthcare systems worldwide underscores its importance in addressing diverse clinical needs, from treating life-threatening conditions like hypovolemia and shock to enabling advanced drug formulations in biopharmaceuticals. 

The albumin market is projected to reach a value of USD 7.27 billion in 2024 and is anticipated to grow to USD 10.56 billion by 2029, exhibiting a compound annual growth rate (CAGR) of 7.76% over the forecast period from 2024 to 2029. 

Understanding Albumin and Its Importance 

Albumin, primarily derived from human plasma, is a key protein responsible for maintaining oncotic pressure and fluid balance in the body. It also serves as a carrier for hormones, enzymes, drugs, and other vital substances. In the medical field, albumin is used to treat various conditions, including: 

Hypovolemia: Restoring blood volume in cases of severe fluid loss. 

Hypoproteinemia: Managing low protein levels due to liver or kidney diseases. 

Burns and Trauma: Providing nutritional and osmotic support during recovery. 

Neonatal Conditions: Addressing complications in premature infants. 

Beyond its therapeutic use, albumin is widely employed in research and drug formulation as a stabilizer and carrier. Its ability to bind with various molecules makes it an ideal component for drug delivery systems, especially for targeting challenging diseases like cancer and autoimmune disorders. 

Key Drivers of Growth in the Albumin Industry 

1. Rising Incidence of Chronic Diseases and Critical Conditions 

The growing prevalence of chronic diseases such as liver cirrhosis, nephrotic syndrome, and cancer has significantly increased the demand for albumin. These conditions often lead to complications requiring albumin-based therapies. Additionally, the rising number of surgeries, trauma cases, and burn injuries has further fueled the need for albumin in critical care settings. 

2. Expansion of Biopharmaceutical Applications 

Albumin is gaining prominence in the biopharmaceutical sector as a stabilizer in drug formulations and as a carrier for targeted drug delivery. With the increasing development of biologics and biosimilars, albumin's role in enhancing the stability and efficacy of therapeutic agents is driving its adoption. Technologies like albumin-fusion platforms are enabling the creation of long-acting drugs, further expanding its applications in cutting-edge treatments. 

3. Growth in Plasma Fractionation 

Advancements in plasma fractionation technology have improved the efficiency of albumin production, allowing for greater yields and quality. Plasma fractionation remains the primary method for extracting albumin from blood plasma, and innovations in this area have made albumin more accessible to meet growing demand. 

4. Increasing Awareness and Adoption in Emerging Markets 

Developing regions, particularly in Asia-Pacific and Latin America, are witnessing increased adoption of albumin due to rising awareness about its therapeutic benefits. Governments and healthcare organizations in these regions are investing in improved healthcare infrastructure, driving demand for albumin-based treatments. 

5. Regulatory Support and Strategic Partnerships 

Government initiatives and regulatory frameworks supporting plasma-derived therapies have encouraged investments in the albumin market. Furthermore, collaborations between pharmaceutical companies and research institutions are accelerating the development of novel albumin-based products, contributing to market growth. 

Challenges in the Albumin Industry 

1. Limited Plasma Supply 

Albumin production relies heavily on human plasma donations, which are subject to strict regulations and limited availability. The supply-demand gap poses a significant challenge, particularly as global demand for plasma-derived therapies continues to rise. 

2. High Production Costs 

The extraction and purification of albumin through plasma fractionation are resource-intensive processes, contributing to high production costs. These costs can limit the affordability of albumin-based therapies, particularly in low-income regions. 

3. Competition from Synthetic Alternatives 

The development of synthetic or recombinant albumin as an alternative to plasma-derived albumin is gaining traction. While these alternatives offer advantages such as reduced dependency on plasma donations, they also introduce competition that could impact the traditional albumin market. 

4. Stringent Regulatory Requirements 

Albumin production and distribution are subject to rigorous regulatory standards to ensure safety and efficacy. Navigating these regulations can be time-consuming and costly for manufacturers, delaying product approvals and market entry. 

5. Ethical and Supply Chain Concerns 

The ethical considerations surrounding plasma donation, coupled with complex supply chain logistics, present additional challenges. Ensuring a sustainable and ethical plasma supply chain is critical for the long-term growth of the albumin industry. 

Emerging Trends Shaping the Albumin Industry 

1. Recombinant Albumin Development 

Recombinant albumin, produced through genetic engineering, is gaining attention as a sustainable alternative to plasma-derived albumin. It offers advantages such as consistent quality, reduced risk of contamination, and scalability in production. 

2. Integration with Advanced Drug Delivery Systems 

Albumin is increasingly being integrated with nanoparticle-based drug delivery systems to enhance targeted drug delivery. This innovation is particularly relevant in oncology, where albumin-bound drugs like paclitaxel (marketed as Abraxane) have demonstrated improved efficacy and reduced side effects. 

3. Expansion of Albumin in Diagnostics 

In addition to its therapeutic applications, albumin is being explored for use in diagnostic tools, such as in vitro assays and biomarkers for detecting diseases. Its role in diagnostics is expected to expand as research uncovers new applications. 

4. Sustainability and Ethical Plasma Sourcing 

The industry is focusing on creating more sustainable plasma collection practices and ensuring ethical sourcing to meet growing demand. Initiatives to increase plasma donation awareness and streamline collection processes are gaining momentum. 

5. Personalized Medicine and Albumin Fusion Technology 

Albumin fusion technology is enabling the development of personalized therapies by extending the half-life of drugs and optimizing their pharmacokinetics. This trend aligns with the broader movement toward personalized medicine, offering tailored treatment options for patients. 

Conclusion 

The albumin industry is an essential pillar of modern healthcare, addressing critical medical needs while supporting advancements in biopharmaceuticals and diagnostics. As demand for albumin continues to grow, driven by rising chronic disease prevalence, expanding biopharmaceutical applications, and technological innovations, the industry is poised for sustained growth. 

While challenges such as plasma supply limitations and high production costs persist, emerging trends like recombinant albumin and advanced drug delivery systems offer promising solutions. With a focus on sustainability, innovation, and accessibility, the albumin industry is set to play a transformative role in shaping the future of healthcare, ensuring better outcomes for patients worldwide.    For a detailed overview and more insights, you can refer to the full market research report by Mordor Intelligence: https://www.mordorintelligence.com/industry-reports/albumin-market 

[healthcarediagnosticmarket]

Injectable Drug Delivery Market Key Player Analysis: Growth Insights and Forecasts , Business Strategies, Challenges and Future Demand 2033

Injectable Drug Delivery Market Poised to Reach USD 1,982.0 Billion by 2032 | Straits Research

Market OverviewThe global injectable drug delivery market was valued at USD 682.1 billion in 2023 and is expected to grow at a CAGR of 12.4% over the forecast period (2024–2032), reaching USD 1,982.0 billion by 2032. This rapid growth is driven by increasing demand for advanced drug delivery systems, enhanced patient compliance, and rising prevalence of chronic diseases.

Market DefinitionInjectable drug delivery refers to administering drugs directly into the body via injection, ensuring rapid absorption and enhanced bioavailability. This includes devices such as syringes, auto-injectors, and wearable injectors, catering to various end-user sectors like hospitals, home care settings, and clinics.

Latest Market Trends

Advancements in Wearable Injectors: Rising adoption of wearable injectors for continuous and accurate drug delivery.

Development of Smart Auto-Injectors: Integration of IoT and AI for enhanced drug administration and patient monitoring.

Focus on Sustainability: Key players prioritizing eco-friendly and recyclable materials for injectables.

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Key Growth Factors

Rising prevalence of chronic diseases like diabetes and cancer.

Growing demand for self-administered drug delivery systems.

Technological advancements in injectable devices.

Key Market Opportunities

Expansion in emerging economies across Asia-Pacific.

Development of biologics and biosimilars driving demand for injectables.

Increasing investment in R&D for innovative drug delivery solutions.

Market Segmentation

By Device Type

Conventional Injectable

Pre-filled Syringes

Auto-injectors

Pen-injectors

Wearable

By Application

Freeze-dried Products

Injectable Sterile Products

By End-User

Hospitals

Home Care Settings

Clinics

Access Detailed Segmentation

Key Players

BD (New Jersey, U.S)

SHL Medical AG (Switzerland, Europe)

Schott AG (Germany, Europe)

West Pharmaceutical Services, Inc. (Pennsylvania, U.S)

Pfizer Inc. (New York, U.S)

Insulet Corporation (Massachusetts, U.S)

Elcam Medical (Israel, Middle East)

Eli Lilly and Company (Indiana, U.S)

Ypsomed AG (Switzerland, Europe)

Gerresheimer AG (Germany, Europe)

Baxter International Inc (Illinois, U.S)

Regional Insights

Dominated Region: North America leads the market due to technological advancements and high healthcare expenditure.

Fastest Growing Region: Asia-Pacific is projected to witness the highest growth due to increasing healthcare investments and a large patient population.

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[willyskristina]

Erythropoietin Stimulating Agents Market

Erythropoietin Stimulating Agents Market Size, Share, Trends: Amgen Inc. Leads

Shift Towards Biosimilar Erythropoietins Gains Momentum

Market Overview:

The global erythropoietin stimulating agents market is projected to grow significantly, driven by rising prevalence of chronic kidney disease and cancer, increasing adoption of biosimilars, and advancements in drug delivery technologies. North America stands out as the dominant region, accounting for a substantial share of the global market. The market for erythropoietin stimulating drugs is steadily expanding due to an ageing population, an increase in the frequency of anemia in chronic diseases, and expanding oncological applications.

The industry is also benefiting from the development of long-acting ESAs and the launch of new formulations, which lead to better patient compliance and treatment outcomes. 

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Market Trends:

The erythropoietin stimulating agents market is shifting significantly towards biosimilar pharmaceuticals, indicating the growing need for cost-effective treatment choices and greater healthcare cost reduction initiatives. This tendency is encouraging competition and innovation in ESA development, with firms focusing on generating high-quality biosimilars that are as effective as reference drugs but at a cheaper cost. For example, the release of biosimilar epoetin alfa has gained popularity, with up to 30% cost reductions over the original medicine. Sales of biosimilar ESAs have climbed significantly year on year, demonstrating high market acceptability and penetration, especially in Europe and emerging regions.

Market Segmentation:

Epoetin Alfa dominates the market, accounting for a significant share of global sales in 2023. The Epoetin Alfa sector continues to dominate the erythropoietin stimulating agents market, owing to its well-established effectiveness profile, broad range of approved uses, and availability of biosimilar variants. Epoetin alfa, including originator and biosimilar medicines, is still the most commonly given ESA worldwide, notably for the treatment of anemia caused by chronic renal disease. Sales of epoetin alfa products have shown a consistent growth trend.

Epoetin alfa is especially common in the dialysis setting, where it has long been used to treat anemia. Recent industry figures show that a large percentage of dialysis patients globally are given epoetin alfa as their primary ESA. This tendency is backed by the drug's favorable pharmacokinetic profile, which allows for varied dosing regimens, as well as the considerable clinical expertise gained from years of use. Furthermore, the development of biosimilar epoetin alfa medicines has greatly increased market access, particularly in cost-conscious healthcare systems. The availability of these less expensive alternatives has resulted in a significant increase in epoetin alfa prescriptions in emerging nations over the last two years.

Market Key Players:

Prominent players in the erythropoietin stimulating agents market include Amgen Inc., F. Hoffmann-La Roche Ltd, Johnson & Johnson (Janssen), Kyowa Hakko Kirin Co., Ltd., Pfizer Inc., Novartis AG, Teva Pharmaceutical Industries Ltd., Hospira Inc. (now part of Pfizer), Biocon Limited, LG Life Sciences Ltd., Intas Pharmaceuticals Ltd., Celltrion, Inc., Emcure Pharmaceuticals Ltd., and Dong-A ST Co., Ltd. These companies are leading the market with their innovative approaches, extensive product portfolios, and robust distribution networks, continuously setting industry standards and driving market growth.

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[biotichealthcare]

The report published by Kearney in collaboration with the Confederation of Indian Industry titled “Taking India’s life sciences industry to the global stage”, reported that “India’s vaccines industry can grow from $2 billion to $4 billion or even $5 billion”. This has been made possible by a number of factors prominent being the inclusion of vaccines in the product portfolios of several domestic and global pharmaceutical companies. With the pandemic kicking in 2019 end, the entire world came together to build an effective vaccine to fight against the deadly coronavirus.

This report speaks a lot about the Indian biosimilars and vaccines industries and how it is competing globally and scopes for India in the global biosimilars and vaccines industry. It lays down the challenges faced by the Indian pharmaceutical industry and how we can overcome these. It lays down abundant solutions to the challenges faced and how India can ace the Global Pharma sector and command its worthy position both in terms of volume and value.

Indian Vaccine Industry 

The global Pharmaceutical industry has made vaccines their priority. India commands a massive 40% share of the global vaccine industry by volume. India has been playing a pivotal role in combating deadly diseases for years and now the coronavirus pandemic. India is all set to grow to hold a more significant place in the global pharma industry in the coming years. With the introduction of newer and better technologies such as gene therapies, Ai-based informatics, etc has opened boundless opportunities to conduct research and experimentation and develop innovative and effective medications.

India already possesses a strong local pharma industry, fundamentally strong technical capabilities, and rich scientific acumen, that has helped us emerge as an innovational hub of the world. India is the global supplier of drugs and medicines and everybody prefers India for its low-cost manufacturing processes and affordable drugs.

However, Indian Pharmaceutical Industry still lags behind in terms of the value of our market share through being the third-largest volume producer. India faces several challenges that need to be overcome. COVID pandemic offers a great opportunity for India to take a step ahead to bag the top position both in terms of volume and value.

Massive Scope for Global Vaccine supply

There is abundant scope for the export of COVID-19 vaccines globally to countries unable to manufacture vaccines on their own. Moreover, there are several diseases globally that need vaccination, and these infectious diseases amount to more than 70% of the world population. Many countries rely on India for the supply of vaccine doses to combat various infectious diseases. Our own nation has a huge demand for vaccines owing to the huge population count and prevalence of abundant diseases such as diphtheria, tetanus, hepatitis B, measles, mumps, rubella, etc.

India has long been involved in supplying the highly required vaccines to several developing nations at the most affordable prices. So now also the world relied on India for COVID vaccine and India proved to be the biggest exporter of Covid vaccines globally. India itself faced a shortage of vaccines initially due to the heavy burden on the limited resources besides having huge commitments globally. Only two vaccine manufacturers i.e. Serum Institute of India (SII) and Bharat Biotech were operational in the beginning. With limited manufacturing resources, it became difficult to meet both domestic and global vaccine requirements.

This shows the scope for vaccine manufacturing in India provided we develop the required infrastructure and support our pharma medicine developers with the latest and advanced technologies to conduct their research. India requires a favorable statutory and political environment to lead the world with its pharmaceutical products. To be the global leader in terms of value, India needs to be more research-oriented to develop unique formulations to treat health conditions and obtaining Intellectual Property Rights. This is how India can occupy a major pharma share both in terms of volume as well as value.

[globalinsightblog]

Biosimilar Monoclonal Antibodies to Grow to $44.7B by 2033, CAGR 13.8%

Biosimilar Monoclonal Antibody Market : Biosimilar monoclonal antibodies (mAbs) are a game-changing innovation in the pharmaceutical industry, offering a cost-effective alternative to expensive biologic therapies. These highly similar versions of original monoclonal antibodies are designed to treat a wide range of conditions, including cancers, autoimmune disorders, and chronic diseases like rheumatoid arthritis. Unlike generic drugs, which are identical to their brand-name counterparts, biosimilars have slight variations due to the complex biological processes used in their production. However, extensive clinical testing ensures that these variations do not impact the safety, efficacy, or quality of the treatment, offering patients a reliable and affordable option.

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The rise of biosimilars is reshaping the global healthcare landscape, expanding access to biologic therapies for millions of patients. As regulatory bodies like the FDA and EMA approve more biosimilars, the market is growing rapidly, with leading pharmaceutical companies focusing on developing biosimilar mAbs to treat high-demand diseases. The affordability of biosimilars is expected to drive significant savings in healthcare systems worldwide, especially as the demand for biologics continues to increase. With ongoing advancements in biosimilar research and production, this sector is poised to revolutionize how biologic therapies are delivered, ultimately improving patient outcomes and making life-saving treatments more accessible.

#Biosimilars #MonoclonalAntibodies #Biologics #AffordableHealthcare #PharmaceuticalInnovation #CancerTreatment #AutoimmuneDisorders #HealthcareAccessibility #FDAApproved #BiotechAdvancements #Immunotherapy #ChronicDiseaseTreatment #AffordableMedications #RheumatoidArthritis #PharmaInnovation

[ananya5400]

Global Enzymes Market: Key Drivers, Challenges, and Future Outlook

The enzymes market size is expected to grow from USD 14.0 billion in 2024 to USD 20.4 billion by 2029, reflecting a CAGR of 7.8% during this period. This growth is driven by increasing global demand for enzymes across various industries. In the food and beverage sector, enzymes improve product quality and consistency, while in biofuels, they promote more efficient and sustainable production methods. The pharmaceutical industry leverages enzymes for drug formulation and disease treatment. Furthermore, the rising emphasis on eco-friendly and cost-effective industrial processes is boosting enzyme applications in detergents and textiles. Innovations in biotechnology are also leading to the development of specialized enzymes for targeted uses, enhancing their demand. Overall, the versatility and effectiveness of enzymes across multiple sectors are fueling their increasing global demand, with market players actively engaging in partnerships for industrial and specialty enzymes.Enzymes Market

Enzymes Market Trends

Here are some trends currently shaping the enzymes market:

Increased Demand in Food and Beverage: The rise in health-conscious consumers has led to higher demand for enzymes in food processing, enhancing flavor, texture, and nutritional content.

Biotechnology Advancements: Innovations in biotechnology are leading to more efficient enzyme production processes, improving yield and reducing costs.

Sustainable Practices: There’s a growing emphasis on sustainability, driving the use of enzymes in eco-friendly applications like biofuels, biodegradable plastics, and waste management.

Pharmaceutical Applications: The use of enzymes in drug formulation and as therapeutic agents is expanding, particularly in personalized medicine and biosimilars.

Animal Feed Enzymes: The demand for animal feed additives, particularly enzymes that improve nutrient absorption and digestion, is on the rise due to the growing livestock industry.

Personal Care Products: Enzymes are increasingly being incorporated into personal care and cosmetics for their ability to enhance product efficacy and skin benefits.

Specialty Enzymes Expected to Capture a Major Enzymes Market Share During the Forecast Period.

Specialty enzymes are crucial in the pharmaceutical and biotechnology sectors, particularly in biopharmaceutical production involving monoclonal antibodies and gene therapies, where precision and specificity are vital. For example, proteinase K is commonly used in DNA and RNA extraction for genomic research, a field that has seen heightened demand due to advancements in personalized medicine and diagnostics. This segment of specialty enzymes benefits from substantial R&D investments and innovations. Companies such as Novozymes A/S (Denmark) and dsm-firmenich (Switzerland) are focused on creating novel enzymes with enhanced stability and activity tailored for specific industrial uses. A notable example is dsm-firmenich’s launch of Maxilact Next in May 2023, which improves lactose-free dairy production efficiency by 25% without compromising taste. Additionally, supportive regulatory frameworks for biopharmaceuticals and the rising incidence of chronic diseases that require advanced treatments further drive the growth of specialty enzymes, reinforcing their market leadership.

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Plant-Derived Enzymes Capture a Major Share of the Enzymes Market.

Amylase, derived from barley and wheat, plays a vital role in the brewing industry by breaking down starches into fermentable sugars, enhancing both the efficiency and quality of beer production. In the juice and wine sectors, pectinase sourced from fruits such as apples and oranges is widely used to clarify beverages and boost juice yield. Plant enzymes are also essential in the expanding market for plant-based and vegan products. For example, transglutaminase from plant sources improves texture and binding in meat alternatives, addressing the growing consumer demand for sustainable and ethical food choices. This trend is reinforced by the increasing popularity of plant-based diets, which further drives the demand for plant-derived enzymes. Companies like Novozymes have made significant investments in developing enzyme solutions tailored to specific industry needs. In March 2020, Novozymes A/S (Denmark) launched Saphera Fiber, a plant-derived lactase enzyme aimed at increasing fiber content in dairy products while lowering sugar levels, catering to health-conscious consumers.

Enzymes Market Forecast: Asia Pacific to Experience the Highest Growth Rate

The Asia-Pacific region is poised for significant growth in the enzyme market, influenced by unique industry dynamics and regional trends. A major driver is the biopharmaceutical sector, especially in countries like South Korea and Singapore, where the demand for enzymes in drug manufacturing and bioprocessing is rising. These enzymes are vital for processes such as protein expression, purification, and modification, which are crucial for producing biologics like monoclonal antibodies and vaccines. Additionally, the burgeoning healthcare and diagnostic sectors in the region are rapidly increasing the need for specialty enzymes, particularly for diagnostic assays, genetic testing, and therapeutic applications, fueled by heightened investments in healthcare infrastructure and research. Moreover, the thriving textile and detergent industries in countries like Bangladesh and Vietnam present promising opportunities for enzyme manufacturers. Enzymes are increasingly utilized in textile processing for fabric softening, de-sizing, and denim finishing, as well as in detergent formulations for enhanced stain removal and fabric care. As these sectors evolve in response to changing consumer preferences and regulatory standards, the demand for enzymes is expected to rise sharply, establishing the Asia-Pacific region as a key driver of growth in the global enzyme market.

Top Enzymes Companies

Key players in this market include BASF SE (Germany), International Flavors & Fragrances Inc. (US), dsm-firmenich (Switzerland), Associated British Foods plc (England), Novozymes A/S (Denmark), Kerry Group plc. (Ireland), Dyadic International Inc. (US), Advanced Enzyme Technologies (India), Aumgene Biosciences (India), Amano Enzyme Inc. (Japan), F. Hoffmann-La Roche Ltd (Switzerland), Codexis, Inc. (US), Sanofi (France), Merck KGaA (Germany), Adisseo (China).

[shrirampharmacycollege]

“Shriram College: Innovating Pharmacy Education IN India”

Shriram Pharmacy College, based in Bankner, is at the forefront of pharmacy education in India. The institution emphasizes innovation and hands-on learning, with a special focus on biotechnology within the pharmaceutical sector. In this blog post, we explore how Shriram Pharmacy College harnesses cutting-edge biotechnological advancements to equip students for the challenges of modern pharmacy.

## Harness Biotechnology for Drug Development

At Shriram Pharmacy College, biotechnology plays a pivotal role in drug development. The curriculum is designed to teach students how to apply biotechnological techniques to improve and create pharmaceuticals. By integrating these advanced approaches, students gain a deep understanding of the latest trends in drug design, equipping them for success in the competitive pharmaceutical industry.

## Engineer Biologics for Therapeutic Use

Biologics engineering is a key focus at Shriram Pharmacy College. Students are trained to develop biologic drugs derived from living organisms. Through hands-on lab sessions, they learn about the intricacies of biologic production and the associated quality and regulatory considerations. This expertise is invaluable in the pharmaceutical industry as biologics offer advanced treatment options for diseases like cancer and autoimmune disorders.

## Innovate Gene and Cell Therapies

The curriculum at Shriram Pharmacy College includes the study of gene and cell therapies. Students explore gene editing, cellular manipulation, and the therapeutic uses of these technologies. This cutting-edge education prepares them to work in regenerative medicine, contributing to breakthrough treatments for conditions that were once considered incurable.

## Explore Recombinant Protein Production

Students at Shriram Pharmacy College also delve into recombinant protein production, a crucial area in the development of biologics, vaccines, and enzymes. With hands-on laboratory experience, they learn to optimize production methods and ensure quality control, gaining skills that are in high demand in the biotech and pharmaceutical industries.

## Develop Biosimilars and Biologics

Shriram Pharmacy College prepares students to work on the development of biosimilars — biological products that are highly similar to an already approved reference product. By mastering biosimilar production and understanding regulatory requirements, graduates are well-positioned to contribute to this growing field, which is essential for making healthcare more accessible.

## Implement Bioprocessing for Pharmaceuticals

The college’s curriculum also emphasizes bioprocessing techniques, such as fermentation and cell culture, which are essential for pharmaceutical manufacturing. Practical lab sessions teach students how to optimize production and maintain quality standards. These skills are crucial for those pursuing careers in pharmaceutical production and quality assurance.

## Study Biotechnological Applications in Medicine

Biotechnological innovations in medicine are a core part of the education at Shriram Pharmacy College. Students learn how biotechnology is used in diagnostics, drug delivery, and therapeutic interventions. This broad understanding prepares them for careers across the pharmaceutical and healthcare sectors, equipping them to innovate in a rapidly evolving field.

## Enhance Biotech in Pharmaceutical Innovation

Shriram Pharmacy College fosters a culture of innovation. Students are encouraged to think creatively, participate in research projects, and collaborate with industry professionals. This focus on innovation ensures that graduates are prepared to address contemporary challenges in healthcare and pharmaceuticals, making a meaningful impact in the field.

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### FAQs

### 1. **How does Shriram Pharmacy College train students to monitor drug efficacy and safety?**

Shriram Pharmacy College provides students with a comprehensive education in pharmacovigilance, which involves monitoring the effects of medications to ensure they are safe and effective. Through practical lab sessions, case studies, and clinical training, students learn how to assess drug efficacy and detect adverse reactions. This knowledge is crucial for ensuring patient safety in real-world healthcare settings.

### 2. **What role do pharmacy students play in educating patients about medication management?**

Students at Shriram Pharmacy College are trained to effectively educate patients on proper medication use, including dosage, potential side effects, and drug interactions. By developing strong communication skills and learning patient counseling techniques, students help ensure that patients understand how to manage their medications safely and effectively, improving treatment outcomes.

### 3. **Does Shriram Pharmacy College offer courses on drug safety and pharmacovigilance?**

Yes, Shriram Pharmacy College integrates drug safety and pharmacovigilance into its curriculum. Students take courses that cover the monitoring of drug safety, reporting adverse drug reactions, and understanding regulatory standards for medication use. This equips them with the skills to work in healthcare roles focused on medication safety.

### 4. **How does the college ensure hands-on experience in monitoring drug efficacy?**

Shriram Pharmacy College provides hands-on training through internships and partnerships with hospitals and pharmaceutical companies. Students participate in real-world settings where they monitor drug efficacy, evaluate therapeutic outcomes, and apply their knowledge of drug safety protocols, preparing them for careers in clinical or research settings.

### 5. **What career opportunities are available for graduates skilled in medication management and drug safety?**

Graduates from Shriram Pharmacy College can pursue careers in various fields, including clinical pharmacy, drug safety monitoring, pharmacovigilance, regulatory affairs, and patient counseling. Their training in medication management and drug efficacy monitoring positions them well for roles in hospitals, pharmaceutical companies, and healthcare organizations.

## Conclusion

Shriram Pharmacy College, Bankner, is shaping the future of pharmacy education in India. By integrating biotechnology into its curriculum, the college equips students with the practical skills and knowledge necessary to excel in the dynamic pharmaceutical industry. Graduates are well-prepared to contribute to the healthcare landscape, armed with cutting-edge expertise in biotechnology, drug development, and therapeutic innovation.

### Stay Connected with Shriram Pharmacy College!

For the latest updates, educational content, and insights into the dynamic field of pharmacy, don’t miss out on the Shriram Pharmacy College YouTube channel. By liking, sharing, and subscribing, you’ll gain access to expert lectures, student testimonials, campus events, and much more. Stay informed about advancements in pharmaceutical sciences and become a part of our vibrant community. Your support helps us grow and continue providing valuable resources to students and professionals alike. Join us today and never miss an update!

[supermaxlaboratorie]

The Growth of Contract Manufacturing Companies in India: Trends and Future Outlook

India has become a major player in the global pharmaceutical industry, with contract manufacturing companies playing a key role in this growth. Contract manufacturers, or third-party manufacturing pharma companies in India, produce a wide range of medicines for companies looking to outsource production. By partnering with India’s experienced manufacturing sector, companies can meet global demand and lower costs without sacrificing quality. This blog will explore the factors driving this sector’s growth, key trends, and the future outlook for contract manufacturing companies in India.

What Are Contract Manufacturing Companies in India?

Contract manufacturing companies partner with pharmaceutical firms to produce their products, typically at a lower cost and with higher efficiency. This partnership model is especially beneficial for global pharma companies, which can focus on distribution and R&D while leaving production to specialized firms in India. Many of these companies, which serve as the Top Pharma Export Companies in India, are highly certified and able to manufacture drugs for international markets under strict regulatory guidelines.

Trends Driving the Growth of Contract Manufacturing in India

Several factors and trends have contributed to the growth of contract manufacturing in India:

1. High Global Demand for Generics and APIs

India’s contract manufacturers are highly skilled at producing generic drugs and Active Pharmaceutical Ingredients (APIs) cost-effectively. With the global demand for generics growing—especially in emerging markets—India’s contract manufacturers play a vital role in meeting this demand, while top pharma export companies in India continue to expand their reach.

2. Diverse Service Offerings

Many third-party manufacturing pharma companies in India now offer a broad range of services beyond production, including research, packaging, and distribution. This versatility allows international pharma companies to find complete solutions under one roof, reducing logistics and operational costs.

3. Cost Efficiency and Government Support

India’s relatively low costs of labor, raw materials, and infrastructure make it a preferred destination for contract manufacturing. In addition, government policies offer support for contract manufacturing through simplified regulations, investment incentives, and tax breaks. This supportive environment encourages both domestic and international companies to expand production through Indian contract manufacturers.

4. Focus on Specialized Drug Manufacturing

The demand for complex drugs, including biosimilars and high-potency formulations, is rising globally. Indian contract manufacturers are investing in the technology and expertise needed to produce these specialized drugs, making them valuable partners for companies in regulated markets like the US and Europe.

Benefits of Contract Manufacturing in India

The growth of contract manufacturing companies in India brings various benefits to the global pharmaceutical sector, including:

Quality Compliance: Many Indian contract manufacturers meet global standards with certifications from bodies like the US FDA and EU GMP, allowing them to supply to strict international markets.

High Capacity Production: Indian manufacturers can handle large-scale production, providing a reliable supply chain for companies in need of bulk medicines.

Innovation in Drug Development: With increased investment in research, contract manufacturers in India are innovating in areas like generic formulations and biosimilars.

Future Outlook for Contract Manufacturing in India

The future of contract manufacturing companies in India looks bright, with several factors expected to drive continued growth:

1. Increased Global Collaborations

With rising healthcare costs worldwide, global pharmaceutical companies are likely to continue forming partnerships with Indian manufacturers for cost-effective production. These collaborations will help India’s contract manufacturing sector reach new markets and strengthen its global presence.

2. Investment in Biologics and Biosimilars

Indian contract manufacturers are increasingly focusing on biologics and biosimilars, which have high demand in international markets. By developing specialized capabilities in these areas, India’s manufacturers can provide advanced solutions for pharmaceutical companies seeking high-quality biologic drugs.

3. Adoption of New Technologies

Many contract manufacturers are embracing automation, AI, and data analytics to improve efficiency and reduce errors in production. By integrating these technologies, companies can enhance the speed and accuracy of their processes, making Indian contract manufacturers even more competitive on the global stage.

4. Environmental Responsibility

With sustainability becoming a global priority, India’s contract manufacturers are beginning to adopt green practices, such as waste reduction and energy-efficient processes. This commitment to environmental responsibility aligns with international standards, attracting companies that prioritize sustainable practices.

Challenges in Contract Manufacturing

Despite a promising future, contract manufacturers in India face certain challenges:

Regulatory Compliance: Keeping up with the complex regulations of global markets requires constant investment in quality and compliance.

Intellectual Property (IP) Concerns: Handling proprietary formulations and drug patents can be complex in third-party manufacturing relationships, as companies must take extra care to protect sensitive IP.

Intense Competition: With many players in the contract manufacturing market, companies face pressure to offer high quality at competitive prices.

Conclusion

India’s contract manufacturing sector is essential in meeting the world’s demand for affordable and high-quality medicine. Supported by favorable policies, cost advantages, and high production capacity, contract manufacturing companies in India are set to maintain their role as reliable partners for the global pharmaceutical industry. As these companies continue to grow, investing in innovation, sustainability, and specialized drug development, they will further solidify India’s position as a global leader. This outlook also holds promising opportunities for third-party manufacturing pharma companies in India to reach new markets and expand their impact on global healthcare, backed by support from Top Pharma Export Companies in India that contribute to India’s success as a leading exporter of pharmaceuticals.

[kenresearch1]

Top 5 players in US Biosimilar Market

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STORY OUTLINE

Pfizer: Excelling in the line of Biosimilar drugs with an experience of more than 10 years with presence in over 180 countries.

Amgen: Making pharmaceutical products with an experience of over 40 years and presence in over 100 countries.

Viartis: Presence in over 165 countries, and making Biosimilar drugs in over 75 markets, this pharmaceutical company is another leading contributor of US Biosimilar market.

Coherus Biosciences: Increasing patient access to cost effective medicines with a Biosimilar drugs experience of 13 years.

Biogen: serving humanity through science with a experiences of more than 40 years in the field of biologics.

According to Ken Research, the US Biosimilar market is anticipated to grow at a CAGR of ~40% in the next five years which currently has a market size of ~USD 9.4 Bn.

The US Biosimilar market is rapidly growing and will be witnessing a significant growth in the next five years.

There are various reasons behind the rapid growth of US Biosimilar market. Some of the major reasons behind the growth of US Biosimilar market include the cost effective nature of Biosimilar drugs, rising geriatric population, rising prevalence of chronic diseases, and growing partnerships between companies to develop Biosimilar drugs.

Various companies and players are contributing to their best efforts in the growth of the US Biosimilar market.

This article aims to put light on the contributions done by the major players towards the growth of the US Biosimilar market.

1.Pfizer

Click to read more about Pfizer

Pfizer is a leading American pharmaceutical company which is operating in the field of generics or original drugs for more than 30 years. But did you know that this pharma not only manufactures biologics but also biosimilar drugs?

Pfizer has been in the business of biosimilar drugs for more than 10 years and have been quite successful as well. With more than 83,000 employees and presence in over 180 countries, this leading pharmaceutical company made almost USD 2 Bn. revenue only from its Biosimilar drugs sale in 2021.

Recently, this pharmaceutical company also collaborated with Samsung in two deals to produce various biosimilar drugs in South Korea. The deal size between these two companies happens to be approximately USD 900 Bn.

The major Biosimilar drugs of this pharmaceutical giant are primarily

ZIRABEV (a Biosimilar of Avastin)

TRAZIMERA (a Biosimilar of Herceptin)

RUXIENCE (a Biosimilar of Rituxan)

RITACRIT (a Biosimilar of Epogen)

NVYEPRIA (a Biosimilar of Neulasta)

NIVESTYM (a Biosimilar of Neupogen)

FILGRASTIM (a Biosimilar of Neupogen).

2.Amgen

Click here to Download a Sample Report

Amgen is another leading American pharmaceutical company which not only makes Biologics or generic drugs but also Biosimilar drugs. This pharmaceutical company has more than 40 years of experience when it comes to pharmaceutical line.

With over 25000 employees and presence in over 100 countries, this pharmaceutical company earned about USD 2 Bn. from their three biosimilar drugs which are reportedly MVASI, KANJITNTI, and AMJEVITA.

This pharma giant has also invested about USD 2 Bn. in the development of Biosimilar drugs.

This pharmaceutical company has made Biosimilar drugs primarily in 4 fields which are General Medicine, Oncology, and Hematology along with, Inflammation.

EPOTEIN ALFA

AMJEVITA

AVSOLA

KANJINTI

MVASI

RIABNI

are the various Biosimilar drugs of Amgen. And, STELARA, EYLEA, SOLIRIS are in their pipeline.

Recently Amgen revealed their Biosimilar report’s 8 version. It revealed a major information which said that the pharmaceutical company saved about USD 10 Bn. through their Biosimilar drugs in the past five years.

3.Viartis

Headquartered in Canonsburg, Pennsylvania, this American pharmaceutical company was founded only in 2020 yet they have achieved massive success in the pharmaceutical products with their revenue being USD 16 ~Bn. in 2022.

With presence in 165 countries and with over 45,000 employees worldwide, this pharmaceutical company makes pharmaceutical products in 10 areas which primarily are Cardiovascular, Dermatology, ophthalmology, Oncology, Gastroenterology, Women’s health, Infectious diseases, Diabetes & Metabolism, Immunology, CNS & Anesthesiology, Respiratory diseases and allergy.

Speaking of their first Biosimilar products, their first ever Biosimilar drug was launched in 2014. They have a variety of Biosimilar drugs which are primarily

TRASTUZUMAB

INSULIN ASPART

PEGFILGRASTIM

INSULIN GLARGINE-YFGN

ADALIMUMAB

BEVACIZUMAB

Their Biosimilar drug Insulin Glargine which is known as SEMGLEE was the first ever interchangeable Biosimilar drug in the United States which was FDA approved.

Their PEGFILGRASTIM also was the first ever FDA approved drug in the United States. They have launched their Biosimilar drugs in over 75 markets worldwide.

4.Coherus Biosciences:

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Headquartered in Redwood city, California this American pharmaceutical company earned a revenue of almost USD 211 Mn. In 2022.

With presence in over 55 countries and 300+ employees worldwide, this pharmaceutical company makes products in various areas such as solid tumors, non-small lung cancers, nasopharyngeal carcinoma, small cell lung cancer and hepatocellular carcinoma.

Speaking of their Biosimilar drugs, this pharma has been in the field of creating Biosimilar drugs since 2010 which has given them almost 13 years of experience.

This pharmaceutical company also disclosed that it plans to spend at least USD 1 Tn. on medicines worldwide, out of which at least 40% will be spent on Biosimilar drugs.

Their three major Biosimilar drugs which are also FDA approved include UDENCYA, YUSIMRY, and CIMERLI.

Udencya is a Biosimilar drug of Pegfilgrastim, Yusimry is a Biosimilar drug of Ranibizumab, and Cimerli is a Biosimilar drug of Adalimumab.

5.Biogen

Headquartered in Cambridge, Massachusetts, this American pharmaceutical company earned a revenue of around USD 10 Bn. in 2022.

This company happens to have an experience of more than 40 years when it comes to making pharmaceutical products.

With presence in over 80 countries and more than 9000 employees worldwide, this pharmaceutical company primarily deals in Neurology, Specialized Immunology, Neuropsychiatry, Ophthalmology, and Rare Diseases.

ADUCANUMAB

LECANEMAB

TOFERSEN

ZURANOLONE

LITIFILIMAB

BENAPALI

FLIXABI

IMRALDI

are some of their Biosimilar drugs.

With their Biosimilar drugs, more than 250,000 people have gone on Anti-Tumor Necrosis Factor therapy.

Recently, this pharmaceutical company also made an agreement with Bio-Thera solutions to develop a Biosimilar drug for the treatment of Rheumatoid Arthritis.

[news365timesindia]

[ad_1] Quantiphi, a global AI-first digital engineering company and DDReg, a global leader in regulatory expertise today announced a partnership that will address regulatory challenges that pharmaceutical companies, biotechnology firms, medical device and cosmetics manufacturers face by bringing innovations to market more quickly through AI.DDReg Pharma partners with Quantiphi to use power of Artificial Intelligence to datamine Regulatory Intelligence for efficient submissions, faster approvals and enhance complianceNeeti Pant - DDReg Managing Director, said, "DDReg & Quantiphi collaboration harnesses DDReg's unparalleled regulatory knowledge and Quantiphi's innovative technology, along with a deep understanding of artificial intelligence, to revolutionize regulatory processes. Together, we are transforming how the life sciences sector navigates some of its most pressing regulatory challenges, ensuring compliance, enhancing safety, and accelerating the time to market for new therapies. This collaboration will not only address current regulatory demands but also anticipate future needs, providing a solid framework for sustainable growth and innovation. By combining our strengths, we are paving the way for a more streamlined, effective, proactive & cost-efficient approach to regulatory affairs in the life sciences industry."Quantiphi Global Head of Healthcare and Life Sciences, Barinder Marhok said the partnership marries DDReg's expertise in global regulatory process management and securing and renewing government approvals for healthcare interventions with Quantiphi's expertise in AI-managed processes and documents."As the life sciences industry grapples with the ever-evolving regulation landscape, Quantiphi and DDReg have come together to help deliver cutting-edge solutions that streamline regulatory processes across both the drug development and commercialization lifecycle, ultimately helping improve more lives," Marhok said. "Leveraging cloud, data and AI technologies, our joint efforts aim to accelerate approvals, enhance compliance and optimize Life Cycle Management (LCM), ensuring a faster and more efficient path to market."About DDRegDDReg is a global Pharmaceutical Regulatory Services and Pharmacovigilance services provider company with offices in Gurgaon (India), Delaware, California (USA), Cologne (Germany), and Singapore. It is an ISO 9001:2015 & ISO 27001 TV SD certified organization that is involved in a wide variety of regulatory consulting and pharmacovigilance assignments. DDReg services span across global markets and include, European Union, the USA, UK & Australia among developed markets to Asia, Africa, Middle East & GCC, CIS, and LATAM among the emerging markets- driven by WHO.DDReg has supported its clients in ensuring compliance with worldwide regulations for a wide range of products including generics, new drug products, biologics, biosimilars, medical devices & combination products, cosmetics, and consumer products. The team has deep subject matter expertise and a knowledge base of over 120 regulatory bodies for regulatory compliance. DDReg's expansion strategy focuses on leveraging emerging technologies and expanding further into key international markets, especially those that have complex and/or ambiguous regulatory frameworks and growth of the pharmaceutical industry.Follow us on LinkedIn, X, formerly Twitter and Facebook. [ad_2] Source link

[news365times]

[ad_1] Quantiphi, a global AI-first digital engineering company and DDReg, a global leader in regulatory expertise today announced a partnership that will address regulatory challenges that pharmaceutical companies, biotechnology firms, medical device and cosmetics manufacturers face by bringing innovations to market more quickly through AI.DDReg Pharma partners with Quantiphi to use power of Artificial Intelligence to datamine Regulatory Intelligence for efficient submissions, faster approvals and enhance complianceNeeti Pant - DDReg Managing Director, said, "DDReg & Quantiphi collaboration harnesses DDReg's unparalleled regulatory knowledge and Quantiphi's innovative technology, along with a deep understanding of artificial intelligence, to revolutionize regulatory processes. Together, we are transforming how the life sciences sector navigates some of its most pressing regulatory challenges, ensuring compliance, enhancing safety, and accelerating the time to market for new therapies. This collaboration will not only address current regulatory demands but also anticipate future needs, providing a solid framework for sustainable growth and innovation. By combining our strengths, we are paving the way for a more streamlined, effective, proactive & cost-efficient approach to regulatory affairs in the life sciences industry."Quantiphi Global Head of Healthcare and Life Sciences, Barinder Marhok said the partnership marries DDReg's expertise in global regulatory process management and securing and renewing government approvals for healthcare interventions with Quantiphi's expertise in AI-managed processes and documents."As the life sciences industry grapples with the ever-evolving regulation landscape, Quantiphi and DDReg have come together to help deliver cutting-edge solutions that streamline regulatory processes across both the drug development and commercialization lifecycle, ultimately helping improve more lives," Marhok said. "Leveraging cloud, data and AI technologies, our joint efforts aim to accelerate approvals, enhance compliance and optimize Life Cycle Management (LCM), ensuring a faster and more efficient path to market."About DDRegDDReg is a global Pharmaceutical Regulatory Services and Pharmacovigilance services provider company with offices in Gurgaon (India), Delaware, California (USA), Cologne (Germany), and Singapore. It is an ISO 9001:2015 & ISO 27001 TV SD certified organization that is involved in a wide variety of regulatory consulting and pharmacovigilance assignments. DDReg services span across global markets and include, European Union, the USA, UK & Australia among developed markets to Asia, Africa, Middle East & GCC, CIS, and LATAM among the emerging markets- driven by WHO.DDReg has supported its clients in ensuring compliance with worldwide regulations for a wide range of products including generics, new drug products, biologics, biosimilars, medical devices & combination products, cosmetics, and consumer products. The team has deep subject matter expertise and a knowledge base of over 120 regulatory bodies for regulatory compliance. DDReg's expansion strategy focuses on leveraging emerging technologies and expanding further into key international markets, especially those that have complex and/or ambiguous regulatory frameworks and growth of the pharmaceutical industry.Follow us on LinkedIn, X, formerly Twitter and Facebook. [ad_2] Source link

[credenceresearchdotblog]

The MENA Biologics and Biosimilars Market is witnessing robust growth, fueled by increasing demand for innovative therapeutic solutions and the rising prevalence of chronic diseases. As of 2024, the market is valued at approximately USD 477.2 million and is projected to reach around USD 645.583 million by 2032, growing at a compound annual growth rate (CAGR) of 3.85% over the forecast period.The Middle East and North Africa (MENA) region is witnessing rapid growth in the biologics and biosimilars market, driven by increasing demand for advanced healthcare solutions, rising prevalence of chronic diseases, and evolving healthcare infrastructure. Biologics, which are complex molecules produced using living cells, offer targeted treatments for various diseases such as cancer, diabetes, autoimmune disorders, and more. Biosimilars, on the other hand, are essentially copies of biologic drugs, similar in terms of safety, efficacy, and quality but at a reduced cost, making them an appealing option in markets with budget constraints.

Browse the full report https://www.credenceresearch.com/report/mena-biologics-and-biosimilars-market

Market Drivers

1. Rising Chronic Diseases: Chronic diseases such as diabetes, cardiovascular diseases, and cancers have seen a surge across the MENA region, largely due to lifestyle changes, urbanization, and aging populations. According to the World Health Organization (WHO), the burden of non-communicable diseases (NCDs) accounts for over 75% of all deaths in the region. This increase in chronic diseases is fueling demand for biologics, which offer cutting-edge, effective treatments, particularly for conditions like rheumatoid arthritis, cancer, and diabetes.

2. Government Initiatives and Healthcare Reforms: Several MENA countries are embarking on ambitious healthcare reforms to enhance access to quality care. Countries like the UAE and Saudi Arabia have made significant investments in modernizing their healthcare sectors as part of their respective Vision 2030 agendas. Saudi Arabia, for example, is heavily investing in biotechnology and life sciences, focusing on domestic production of biologics and biosimilars. Similarly, Egypt and Morocco are seeing increased attention from international pharmaceutical companies eager to establish a foothold in these emerging markets.

Regulatory bodies in the region, such as the Saudi Food and Drug Authority (SFDA) and the Egyptian Drug Authority (EDA), are also streamlining the approval process for biosimilars, further driving the market’s growth.

3. Cost-Efficiency of Biosimilars: The high cost of biologics has been a barrier for many patients and healthcare systems in the MENA region, especially where public healthcare budgets are constrained. Biosimilars, being more affordable alternatives, provide an opportunity for governments to offer cutting-edge treatments to larger populations at reduced costs. With increasing awareness about the safety and efficacy of biosimilars, their acceptance and adoption are steadily rising.

For instance, the launch of biosimilar versions of key biologics such as adalimumab (used to treat autoimmune diseases) and trastuzumab (used in cancer treatment) has made these therapies more accessible. The affordability of biosimilars is particularly crucial in the MENA region, where insurance coverage varies greatly, and out-of-pocket healthcare costs can be prohibitive for many patients.

Key Players in the MENA Market

Several international and regional pharmaceutical companies are playing pivotal roles in the growth of the biologics and biosimilars market in the MENA region. Major global players such as Roche, Pfizer, and Amgen have long dominated the biologics market, with blockbuster drugs in oncology, immunology, and other therapeutic areas. However, the introduction of biosimilars has opened up the market for new entrants, including companies from emerging markets.

Local manufacturers, particularly in countries like Saudi Arabia, Egypt, and Jordan, are increasingly focusing on producing biosimilars to meet local demand and reduce reliance on imports. For example, the Saudi pharmaceutical company Jamjoom Pharma has made strides in the biosimilars segment, contributing to the country’s self-sufficiency in advanced biologic treatments.

Challenges and Opportunities

Despite the promising growth prospects, the MENA biologics and biosimilars market faces several challenges:

1. Regulatory Barriers: The regulatory environment across the MENA region is diverse, with some countries having well-established frameworks for biologics and biosimilars approval, while others lag behind. Harmonizing these regulations and creating a more unified system could accelerate market growth.

2. Awareness and Education: While healthcare providers are becoming increasingly aware of biosimilars, there is still a need for greater education among physicians and patients to build confidence in their use. Misconceptions about the safety and efficacy of biosimilars remain a challenge.

3. Pricing and Reimbursement: Pricing remains a significant factor, particularly in markets where government support for healthcare expenditure is limited. Biosimilars, though more affordable than biologics, still need to be priced competitively to gain widespread adoption, particularly in countries with lower healthcare budgets.

Future Outlook

The future of the MENA biologics and biosimilars market is highly optimistic. Rising healthcare demand, coupled with increasing investments in biotechnology and life sciences, will continue to drive the market forward. The adoption of biosimilars is expected to accelerate as healthcare systems seek to balance the rising cost of care with the need for innovative treatments.

Key Player Analysis:

Pfizer Inc.

Hoffmann-La Roche AG

AbbVie Inc.

Novartis AG

Merck & Co., Inc.

Bristol Myers Squibb Co.

GSK plc

AstraZeneca

Eli Lilly & Co.

Bayer AG

Gilead Sciences

Amgen Inc.

Boehringer Ingelheim International GmbH

Novo Nordisk A/S

Viatris Inc.

Johnson & Johnson (Janssen Pharmaceuticals, Inc.)

Sanofi Winthrop Industries S.A

Serum Institute of India

Biocon Limited

Intas Pharmaceuticals Limited

Segmentation:

Based on Product Type:

Monoclonal Antibodies

Recombinant Proteins

Vaccines

Other Biologics

Based on Technology:

Mammalian Cell Culture

Microbial Fermentation

Plant-Based Systems

Other Production Technologies

Based on End-User:

Hospitals

Pharmaceutical Companies

Research Institutions

Biotechnology Firms

Based on Region:

Middle East (Saudi Arabia, UAE, Qatar, Kuwait, Oman, Bahrain)

North Africa (Egypt, Morocco, Algeria, Tunisia, Libya)

Gulf Cooperation Council (GCC) Countries (Saudi Arabia, UAE, Qatar, Kuwait, Oman, Bahrain)

Levant Region (Jordan, Lebanon, Syria, Palestine)

Browse the full report https://www.credenceresearch.com/report/mena-biologics-and-biosimilars-market

Contact:

Credence Research

Please contact us at +91 6232 49 3207

Email: sales@credenceresearch.com

Website: www.credenceresearch.com

[itsthesiliconreview]

Biotech Companies to Watch: Leading the Next Healthcare Breakthrough

By leading advancements that address some of the most critical medical challenges, the biotechnology sector is transforming healthcare. Biotech companies have the capacity to provide formerly unthinkable life-changing treatments due to advancements in fields like gene therapy, immunotherapy, and personalized medicine. As we look toward the future, it is certain that the biotech industry has the potential for ground-breaking discoveries that will completely transform healthcare as we look to the future.

Emerging Trends in the Biotech Industry

The biotech sector continues to evolve and several key trends are influencing the future of healthcare. Understanding these trends in the biotech industry could offer valuable insights for investors, professionals, and patients about the next phase of innovations.

Gene Therapy and Editing:

Gene therapy has become one of the industry's most promising areas. Scientists are able to fix abnormalities that lead to illnesses like hemophilia, cystic fibrosis, and muscular dystrophy by modifying a patient's genetic code. This technology has been explored by top companies, and clinical studies have generated remarkable outcomes.

Powerful gene-editing technology CRISPR-Cas9 is also gaining popularity as a means of treating hereditary diseases by fixing broken genes. These discoveries have led to an important shift in the way diseases are treated, enabling the treatment of conditions that were previously incurable.

Immunotherapy for Cancer:

In recent years, immunotherapy—a treatment that uses the body's immune system to fight cancer—has become very popular. Many biotech companies have developed treatments which activate immune cells to specifically target and eliminate cancerous cells. Patients with cancer who were previously thought to be terminally ill now have hope due to the development of novel treatments like CAR-T cell therapy.

Artificial Intelligence and Drug Discovery:

The development of new treatments is progressing faster because of the incorporation of artificial intelligence (AI) in drug discovery. Compared to traditional methods, AI systems can identify potential medication candidates more quickly by analyzing large datasets. This reduces the time it takes to produce new drugs and reduces associated expenses, which allows the entry of smaller biotech startups into the market.

Leading businesses in this field are using AI to develop new treatments for conditions like Parkinson's and Alzheimer's, for which there are currently few options.

Bio-manufacturing and Sustainability:

Sustainability is beginning to take lead role in the biotechnology industry. Bio-manufacturing helps businesses in developing more environmentally friendly solutions by using biological systems to produce items like proteins and enzymes. This includes everything, even biofuels and biodegradable plastics. Major biotech businesses are researching how their discoveries could contribute to a more sustainable future as the world struggles with environmental issues.

Biotechnology Market Growth and Investment Opportunities

The biotechnology industry is growing at a fast pace due to both public and private funding. The COVID-19 pandemic brought to light the vital role that biotechnology plays in creating vaccines and treatments, which in turn caused an increase in funding for research and development. Increasing numbers of investors are seeing the biotech industry as a promising field, and many are funding startups that are developing new treatments.

Industry reports predict that between 2023 and 2028, the global biotechnology market will expand at a compound annual growth rate (CAGR) of 7.5%. Personalized medical developments, more government financing, and increasing demand for biologics and biosimilars are some major factors contributing to this rapid development.

Top Biotech Companies Leading Healthcare Innovations

Several leading biotech firms have proven themselves as experts in the field of healthcare innovation. These firms are at the center of developing innovative therapies that have the ability to completely change the field of medicine.

Moderna

Moderna, well-known for its role in creating the mRNA COVID-19 vaccine, is a shining example of how biotechnology can transform the medical field. The company is developing medicines for a variety of diseases, such as cancer, heart disease, and rare genetic disorders, using its mRNA platform. Moderna is positioning itself as a champion in the field of personalized medicine with a network of modern therapies.

Gilead Sciences

Gilead has made major developments in antiviral therapies, particularly in the treatment of HIV and hepatitis C. Antiviral therapy has advanced significantly thanks to Gilead, especially in the treatment of hepatitis C and HIV. The company continues to innovate new ideas in the fields of immunology and cancer, concentrating on developing treatments that improve the quality of life of those who suffer from long-term illnesses. Its status as the leader in biotech advancements in healthcare has been strengthened by its acquisition of Kite Pharma, a company that specializes in CAR-T cell treatment.

Regeneron Pharmaceuticals

Regeneron is known for its groundbreaking work in monoclonal antibodies, which have been used to treat a range of diseases from macular degeneration to cancer. The company's focus on genetics-based medication discovery has led to the development of treatments that specifically target pathways involved in the progression of disease. Regeneron is in the lead for developing treatments that meet unmet medical needs

Vertex Pharmaceuticals

Vertex offers treatments that target the disease's underlying cause rather than merely its symptoms, and it has had great success treating cystic fibrosis. Additionally, the company is researching CRISPR and other gene editing methods to treat other genetic disorders.

Biotechnology Startups to Watch

While many renowned biotechnology companies are making the headlines, a number of emerging entrepreneurs are gaining attention for their creative approaches to healthcare.

Beam Therapeutics

Base editing is a new method of gene editing developed by Beam Therapeutics. Base editing allows precise modifications to individual letters of the genetic code, in contrast to conventional CRISPR that breaks the DNA strand.  This technology offers a new therapeutic alternative by correcting the mutations that cause genetic diseases.

Sana Biotechnology

Sana is focusing on developing drugs using engineered cells. With the development of therapies capable of replacing or repairing damaged tissues and organs, the company gives hope to patients suffering from ailments like diabetes and heart disease. Sana is swiftly rising to the top of the regenerative medicine field with its extensive lineup of cell-based therapies.

Verve Therapeutics

Verve is developing one-time gene-editing treatments for treating heart problems. Verve aims to provide patients at risk of heart attacks and strokes long-term remedies by treating the underlying genetic causes of high cholesterol. The treatment of cardiovascular disease could be completely transformed by this unique approach.

Companies of all sizes are pushing the limits of what is achievable in healthcare as the biotech industry undergoes an era of change. Biotech companies in the healthcare industry are at the forefront of developing medicines that can save lives, from gene editing and immunotherapy to AI-driven drug discovery.

FAQs

What are the top trends in the biotech industry? The top trends include gene therapy, immunotherapy, AI in drug discovery, and bio-manufacturing for sustainability.

Which biotech companies are leading healthcare innovations? Moderna, Gilead Sciences, Regeneron Pharmaceuticals, and Vertex Pharmaceuticals are some of the leaders.

What are some emerging biotech startups to watch? Beam Therapeutics, Sana Biotechnology, and Verve Therapeutics are notable biotech startups developing cutting-edge therapies.

How is AI impacting biotech innovation? AI is accelerating drug discovery by analyzing large datasets to identify potential drug candidates faster and more cost-effectively.

Why is the biotech sector growing so rapidly? The rapid growth is due to advancements in personalized medicine, increased funding, and a rising demand for biologics and biosimilars.

For the more information at www.thesiliconreview.com

[head-post]

Draghi report sets out new recommendations for EU pharmaceuticals and biotechnology

The European Commission’s comprehensive report on the future of European competitiveness identifies critical challenges facing the pharmaceutical industry, as well as a number of other sectors across Europe, Osborne Clarke reports.

Mario Draghi, former president of the European Central Bank and former Prime Minister of Italy, outlined in his report strategies to boost growth, innovation and regulatory compliance in the European Union.

For pharmaceutical, biotech, regulatory and legal executives, the implications of Draghi’s report are significant, particularly in the areas of innovation, compliance and market competitiveness.

Innovation gap and digital transformation

The Commission report emphasises the widening innovation gap between the EU and other global economies, notably the US and China. European pharmaceutical companies, although leaders in drug discovery and development, face structural challenges in translating innovation into commercial success.

In particular, the report notes that while European pharma and biotech companies continue to invest heavily in research and development, they are being outpaced by their US and Asian counterparts, who are adopting advanced technologies such as artificial intelligence (AI) and digital health solutions more quickly and seamlessly.

For pharmaceutical companies, this presents both a challenge and an opportunity. For example, the integration of artificial intelligence can facilitate drug discovery, optimise clinical trials and improve patient outcomes.

The report emphasises that combination products that bring together medical devices, drugs and digital technologies such as AI are a key growth area. This echoes the proposed EU legislative reform, which includes the first legal definitions of combination products in the EU, looking at complex combinations and products used exclusively with medical devices. Companies that invest in drug development using artificial intelligence and personalised medicine may have a better chance of gaining a competitive advantage over the next decade, Draghi said in the report.

Regulatory compliance and the drive for harmonisation

One of the most pressing challenges identified in the Commission’s report is the fragmentation of the regulatory framework in the EU. The lack of regulatory harmonisation across member states creates significant obstacles for pharmaceutical companies, especially those conducting clinical trials in different countries or seeking to bring new products to market across the EU.

Pharmaceutical companies should closely monitor upcoming changes to the EU regulatory framework and be prepared for a more streamlined but stringent regulatory environment. The Commission is expected to place greater emphasis on data transparency, safety and post-marketing surveillance, which will have a direct impact on the lifecycle of pharmaceutical products from development to post-launch monitoring.

Legal and regulatory departments may want to prioritise compliance strategies that take into account the changing rules for clinical trials, drug approvals and market surveillance.

Marketing authorisations

The European Medicines Agency (EMA) is central to the approval processes for pharmaceuticals, including biosimilars, advanced therapy medicinal products (ATMPs) and generics. The report highlights that centralised marketing authorisation applications submitted through the EMA provide a simplified approach to market entry in EU member states.

For complex medicines such as ATMPs, biosimilars and other innovative therapies, it is recommended to engage with regulators at an early stage of development. This can ensure compliance with clinical trial requirements and provide opportunities for faster authorisation.

The report highlights the importance of adaptive pathways, conditional marketing approvals, and early dialogue with regulators.

Adoption of AI and digital health solutions

Artificial intelligence and digital health technologies are emerging as key drivers of innovation in the pharmaceutical industry. From optimising supply chains to improving clinical trial design and patient monitoring, AI is revolutionising the way pharmaceutical companies operate. The report highlights that despite progress, European pharmaceutical companies are lagging behind non-EU countries in incorporating AI into their core business.

Investments in digital health technologies such as AI-based research, real world evidence (RWE) integration and advanced patient engagement tools are becoming increasingly significant. These technologies have the potential to improve operational efficiency and meet regulatory demands for greater data transparency and patient-centred care.

At the same time, the categorisation of some AI systems as high risk under the new EU AI law creates significant hurdles for companies providing or implementing these systems.

Green transition in pharmaceuticals

Environmental sustainability is another area of focus in the Draghi report, especially in relation to the European Green Deal programme. The pharmaceutical and biotechnology industries, like other sectors, are expected to reduce their environmental footprint by adopting greener production processes and reducing waste. This includes using energy more efficiently in production, reducing emissions from transport and minimising the use of hazardous chemicals.

For pharmaceutical companies, these changes present both regulatory and operational challenges. Companies should anticipate stricter environmental regulations, which may include mandatory reporting of carbon emissions and sustainability practices. Those companies that invest early in green technologies and sustainable practices are more likely to benefit from government funding and regulatory incentives.

Osborne Clarke Commentary

The Draghi report provides important insights for pharmaceutical and biotech companies operating in the EU.

It highlights significant challenges such as the innovation gap with global competitors and the fragmented regulatory landscape across EU member states. The report stresses the importance of integrating advanced technologies, such as artificial intelligence and digital health solutions, to enhance drug discovery, optimise clinical trials and improve patient outcomes. It also points to the potential benefits of investing in AI-enabled drug development and personalised medicine, which can provide a competitive advantage. This comes at a time when the EU’s new AI regulation is having a huge impact on European healthcare, including where low-risk AI is concerned.

Furthermore, the report emphasises the need for companies to stay ahead of regulatory changes, especially those related to data transparency, security and post-marketing controls.

The Commission also emphasises the importance of sustainable practices in line with the European Green Deal, urging companies to adopt greener production processes and reduce their environmental impact. This includes using energy efficiently, reducing emissions and minimising the use of hazardous chemicals. Companies that actively invest in sustainable technologies can take advantage of public funding opportunities and regulatory incentives.

As the EU attempts to move towards regulatory harmonisation, it is critical for pharmaceutical and biotech companies to ensure that their compliance systems are adaptable to changing regulations. By focusing on these strategic areas, companies will be better able to navigate the challenges and capitalise on the opportunities presented by the changing European landscape.

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[shrirampharmacycollege]

“Shriram College: Innovating Pharmacy Education IN India”

Shriram Pharmacy College, based in Bankner, is at the forefront of pharmacy education in India. The institution emphasizes innovation and hands-on learning, with a special focus on biotechnology within the pharmaceutical sector. In this blog post, we explore how Shriram Pharmacy College harnesses cutting-edge biotechnological advancements to equip students for the challenges of modern pharmacy.

## Harness Biotechnology for Drug Development

At Shriram Pharmacy College, biotechnology plays a pivotal role in drug development. The curriculum is designed to teach students how to apply biotechnological techniques to improve and create pharmaceuticals. By integrating these advanced approaches, students gain a deep understanding of the latest trends in drug design, equipping them for success in the competitive pharmaceutical industry.

## Engineer Biologics for Therapeutic Use

Biologics engineering is a key focus at Shriram Pharmacy College. Students are trained to develop biologic drugs derived from living organisms. Through hands-on lab sessions, they learn about the intricacies of biologic production and the associated quality and regulatory considerations. This expertise is invaluable in the pharmaceutical industry as biologics offer advanced treatment options for diseases like cancer and autoimmune disorders.

## Innovate Gene and Cell Therapies

The curriculum at Shriram Pharmacy College includes the study of gene and cell therapies. Students explore gene editing, cellular manipulation, and the therapeutic uses of these technologies. This cutting-edge education prepares them to work in regenerative medicine, contributing to breakthrough treatments for conditions that were once considered incurable.

## Explore Recombinant Protein Production

Students at Shriram Pharmacy College also delve into recombinant protein production, a crucial area in the development of biologics, vaccines, and enzymes. With hands-on laboratory experience, they learn to optimize production methods and ensure quality control, gaining skills that are in high demand in the biotech and pharmaceutical industries.

## Develop Biosimilars and Biologics

Shriram Pharmacy College prepares students to work on the development of biosimilars — biological products that are highly similar to an already approved reference product. By mastering biosimilar production and understanding regulatory requirements, graduates are well-positioned to contribute to this growing field, which is essential for making healthcare more accessible.

## Implement Bioprocessing for Pharmaceuticals

The college’s curriculum also emphasizes bioprocessing techniques, such as fermentation and cell culture, which are essential for pharmaceutical manufacturing. Practical lab sessions teach students how to optimize production and maintain quality standards. These skills are crucial for those pursuing careers in pharmaceutical production and quality assurance.

## Study Biotechnological Applications in Medicine

Biotechnological innovations in medicine are a core part of the education at Shriram Pharmacy College. Students learn how biotechnology is used in diagnostics, drug delivery, and therapeutic interventions. This broad understanding prepares them for careers across the pharmaceutical and healthcare sectors, equipping them to innovate in a rapidly evolving field.

## Enhance Biotech in Pharmaceutical Innovation

Shriram Pharmacy College fosters a culture of innovation. Students are encouraged to think creatively, participate in research projects, and collaborate with industry professionals. This focus on innovation ensures that graduates are prepared to address contemporary challenges in healthcare and pharmaceuticals, making a meaningful impact in the field.

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### FAQs

### 1. **How does Shriram Pharmacy College train students to monitor drug efficacy and safety?**

Shriram Pharmacy College provides students with a comprehensive education in pharmacovigilance, which involves monitoring the effects of medications to ensure they are safe and effective. Through practical lab sessions, case studies, and clinical training, students learn how to assess drug efficacy and detect adverse reactions. This knowledge is crucial for ensuring patient safety in real-world healthcare settings.

### 2. **What role do pharmacy students play in educating patients about medication management?**

Students at Shriram Pharmacy College are trained to effectively educate patients on proper medication use, including dosage, potential side effects, and drug interactions. By developing strong communication skills and learning patient counseling techniques, students help ensure that patients understand how to manage their medications safely and effectively, improving treatment outcomes.

### 3. **Does Shriram Pharmacy College offer courses on drug safety and pharmacovigilance?**

Yes, Shriram Pharmacy College integrates drug safety and pharmacovigilance into its curriculum. Students take courses that cover the monitoring of drug safety, reporting adverse drug reactions, and understanding regulatory standards for medication use. This equips them with the skills to work in healthcare roles focused on medication safety.

### 4. **How does the college ensure hands-on experience in monitoring drug efficacy?**

Shriram Pharmacy College provides hands-on training through internships and partnerships with hospitals and pharmaceutical companies. Students participate in real-world settings where they monitor drug efficacy, evaluate therapeutic outcomes, and apply their knowledge of drug safety protocols, preparing them for careers in clinical or research settings.

### 5. **What career opportunities are available for graduates skilled in medication management and drug safety?**

Graduates from Shriram Pharmacy College can pursue careers in various fields, including clinical pharmacy, drug safety monitoring, pharmacovigilance, regulatory affairs, and patient counseling. Their training in medication management and drug efficacy monitoring positions them well for roles in hospitals, pharmaceutical companies, and healthcare organizations.

## Conclusion

Shriram Pharmacy College, Bankner, is shaping the future of pharmacy education in India. By integrating biotechnology into its curriculum, the college equips students with the practical skills and knowledge necessary to excel in the dynamic pharmaceutical industry. Graduates are well-prepared to contribute to the healthcare landscape, armed with cutting-edge expertise in biotechnology, drug development, and therapeutic innovation.

### Stay Connected with Shriram Pharmacy College!

For the latest updates, educational content, and insights into the dynamic field of pharmacy, don’t miss out on the Shriram Pharmacy College YouTube channel. By liking, sharing, and subscribing, you’ll gain access to expert lectures, student testimonials, campus events, and much more. Stay informed about advancements in pharmaceutical sciences and become a part of our vibrant community. Your support helps us grow and continue providing valuable resources to students and professionals alike. Join us today and never miss an update!