#non-oncology biopharmaceuticals

[credenceresearchdotblog]

The Oncology Biosimilars Market is projected to grow from USD 4725 million in 2024 to an estimated USD 23341.41 million by 2032, with a compound annual growth rate (CAGR) of 22.1% from 2024 to 2032. The oncology biosimilars market is rapidly emerging as a key segment in the biopharmaceutical industry. With increasing cases of cancer globally and the rising costs of innovative biologics, oncology biosimilars offer a cost-effective alternative while ensuring similar safety and efficacy profiles. This article delves into the market dynamics, trends, challenges, and future prospects of oncology biosimilars.

Browse the full report  https://www.credenceresearch.com/report/oncology-biosimilars-market

Understanding Oncology Biosimilars

Biosimilars are biologic medical products that are highly similar to an already approved reference product, with no clinically meaningful differences in terms of safety, efficacy, or quality. In oncology, biosimilars address various cancers such as breast cancer, colorectal cancer, non-small cell lung cancer, and lymphoma. They replicate biologics like monoclonal antibodies and growth factors used in cancer treatment and supportive care.

Market Growth Drivers

1. Rising Cancer Incidence: According to the World Health Organization (WHO), cancer is a leading cause of death worldwide, with an estimated 20 million new cases in 2022 alone. This growing disease burden amplifies the demand for cost-effective treatment options, making oncology biosimilars a critical component of cancer care.

2. Cost-Effectiveness: Biosimilars are priced approximately 15-30% lower than their reference biologics, offering significant savings for healthcare systems and patients. This affordability is particularly impactful in low- and middle-income countries where access to expensive biologics is limited.

3. Patent Expirations: Several blockbuster oncology biologics, including trastuzumab (Herceptin) and bevacizumab (Avastin), have lost patent protection in recent years. This has paved the way for the entry of biosimilars, driving market competition and adoption.

4. Regulatory Support: Regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have established clear guidelines for the approval of biosimilars, encouraging pharmaceutical companies to invest in their development.

Key Market Trends

1. Expanding Product Portfolio: The oncology biosimilars market is witnessing an expansion in product offerings. Biosimilars for blockbuster drugs such as rituximab, pegfilgrastim, and cetuximab are gaining traction, with multiple players entering the space.

2. Increasing Approvals and Launches: Over the past decade, the FDA and EMA have approved numerous oncology biosimilars, including biosimilars for trastuzumab (e.g., Ogivri, Herzuma) and bevacizumab (e.g., Zirabev, Mvasi). These approvals have bolstered the market and enhanced access to affordable cancer treatments.

3. Collaborations and Partnerships: Pharmaceutical companies are increasingly entering strategic collaborations to enhance biosimilar development and commercialization. Partnerships between biotech firms, contract research organizations, and healthcare providers are streamlining market entry and expanding distribution networks.

4. Rising Acceptance Among Physicians: Initial skepticism surrounding biosimilars is gradually fading as real-world evidence demonstrates their safety and efficacy. Educational initiatives and clinical data are fostering confidence among oncologists and patients.

Challenges in the Market

1. Regulatory and Development Complexity: Developing biosimilars involves sophisticated processes and significant investment. Ensuring similarity in structure, function, and clinical outcomes with the reference biologic is challenging and time-consuming.

2. Market Competition: While competition drives innovation, it also exerts pressure on pricing and profitability. Companies must adopt innovative pricing strategies and differentiation approaches to capture market share.

3. Physician and Patient Perception: Despite increasing acceptance, some healthcare providers and patients remain cautious about switching from biologics to biosimilars. Addressing these concerns through education and robust clinical evidence is crucial.

Future Outlook

The oncology biosimilars market is poised for exponential growth, driven by factors like rising cancer prevalence, supportive regulatory frameworks, and ongoing technological advancements. By 2030, the market is expected to reach significant valuations, with Asia-Pacific and emerging markets playing a pivotal role due to their large patient populations and cost-sensitive healthcare systems.

Moreover, advancements in biosimilar manufacturing, including the use of artificial intelligence and machine learning, promise to reduce development timelines and costs. Governments and healthcare organizations worldwide are also likely to continue promoting biosimilar adoption through favorable policies and reimbursement frameworks.

Key Player Analysis:

Allergan (Ireland)

Amneal Pharmaceuticals LLC. (U.S.)

Apotex Inc. (Canada)

Aurobindo Pharma (India)

BIOCAD (Russia)

Bristol-Myers Squibb Company (U.S.)

Cipla Inc. (U.S.)

Eli Lilly and Company (U.S.)

Endo International plc (Ireland)

Hoffmann-La Roche Ltd. (Switzerland)

GlaxoSmithKline plc (U.K.)

Glenmark Pharmaceuticals Limited (India)

Lupin (India)

Mylan N.V. (U.S.)

Novartis AG (Switzerland)

Pfizer Inc. (U.S.)

Sanofi (France)

Sun Pharmaceutical Industries Ltd. (India)

Takeda Pharmaceutical Company Limited (Japan)

Teva Pharmaceutical Industries Ltd.(Israel)

Zydus Cadila (India)

Segmentation:

By Drug

G-CSF

Monoclonal Antibody

Hematopoietic Agents

By Disease Indication

Breast Cancer

Non-Small Cell Lung Cancer

Colorectal Cancer

Neutropenia

Blood Cancer

Leukemia

Myeloid Leukemia

Chronic Lymphocytic Leukemia (CLL)

Non-Hodgkin Lymphoma

Others

By Distribution Channel

Hospital Pharmacy

Retail Pharmacy

Online Pharmacy

By Regional

North America

U.S.

Canada

Mexico

Europe

Germany

France

U.K.

Italy

Spain

Rest of Europe

Asia Pacific

China

Japan

India

South Korea

South-east Asia

Rest of Asia Pacific

Latin America

Brazil

Argentina

Rest of Latin America

Middle East & Africa

GCC Countries

South Africa

Rest of the Middle East and Africa

Browse the full report  https://www.credenceresearch.com/report/oncology-biosimilars-market

Contact:

Credence Research

Please contact us at +91 6232 49 3207

Email: sales@credenceresearch.com

Website: www.credenceresearch.com

[industrynewsupdates]

Clinical Trial Supplies Market Size, Trends, and Business Outlook 2024 - 2030

The global clinical trial supplies market size was estimated at USD 2.58 billion in 2023 and is anticipated to grow at a compound annual growth rate (CAGR) of 6.5% from 2024 to 2030. 

Globalization, and rise in the number of biologics & biosimilar drugs in clinical trials are among the major factors expected to drive the market growth. Rapid adoption of a supply chain management system to surmount R&D expenditure pressure and increase operational efficiency, as clinical trial supplies account for a large share of the total R&D expenditure of biopharmaceutical companies, is anticipated to propel market growth in near future. There has been a significant rise in biologics and temperature-sensitive drugs in clinical trials.

Most clinical trials are currently being conducted in developing economies. The increasing cost of clinical trials and complications in the recruitment of patients have encouraged biopharmaceutical companies to outsource clinical trials to regions such as Asia Pacific, Latin America, Central & Eastern Europe, and the Middle East. Disease variation in developing economies further aids biopharmaceutical companies in performing clinical trials on rare diseases. Some regions, such as Asia Pacific, also provide greater economic benefits to biopharmaceutical companies, as governments in Singapore and China allocate funds to promote biomedical research. In Latin America, patient recruitment is easy due to reduced language barriers, which can help obtain informed consent easily, resulting in a faster clinical trial process.

Gather more insights about the market drivers, restrains and growth of the Clinical Trial Supplies Market

Clinical Trial Supplies Market Report Highlights

• Based on the clinical phase, the market is anticipated to be dominated by the Phase III trial segment with a 52.7% revenue share in 2022. The presence of a large number of molecules currently under Phase III makes it the primary factor responsible for this deduction

• Among services, the storage, and distribution segment is anticipated to witness the fastest growth at a CAGR of 6.8% during the forecast period. The rise in global biologics pipeline and temperature-sensitive drugs is expected to increase the complexities related to the logistics of clinical trial supplies

• Biologics are expected to witness the fastest growth at 6.7% CAGR during the forecast period owing to the increasing research in the field of genetics and biotechnology such as the development of nanoparticle-based drug delivery systems

• In terms of therapeutic use, oncology dominated the market with a revenue share of 38.8% in 2022. According to the United Press International, hospitals in the U.S. are disposing of billions of cancer drug vials due to improper dosage, thereby indicating the need for appropriate supply management

Browse through Grand View Research's Medical Devices Industry Research Reports.

• The 3D printed brain model market size was valued at USD 44.3 million in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 17.9% from 2024 to 2030.

• The global spinal fusion devices market size was valued at USD 7.03 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 4.9% from 2024 to 2030. 

Clinical Trial Supplies Market Segmentation

Grand View Research has segmented the global clinical trial supplies market report based on clinical phase, product & services, therapeutic use, end-use, and region:

Clinical Phase Outlook (Revenue, USD Billion, 2018 - 2030)

• Phase I

• Phase II

• Phase III

• Other

Product & Services Outlook (Revenue, USD Billion, 2018 - 2030)

• Manufacturing

• Storage & Distribution

o Cold chain distribution

o Non-cold chain

• Supply chain management

End-use Outlook (Revenue, USD Billion, 2018 - 2030)

• Pharmaceutical

• Biologics

• Medical device

• Others

Therapeutic Use Outlook (Revenue, USD Billion, 2018 - 2030)

• Oncology

• CNS

• Cardiovascular

• Infectious disease

• Metabolic disorders

• Others

Regional Outlook (Revenue, USD Billion, 2018 - 2030)

• North America

o U.S.

o Canada

• Europe

o UK

o Germany

o France

o Italy

o Spain

o Denmark

o Sweden

o Norway

• Asia Pacific

o India

o China

o Japan

o South Korea

o Australia

o Thailand

o Singapore

• Latin America

o Brazil

o Mexico

o Argentina

• Middle East and Africa (MEA)

o South Africa

o Saudi Arabia

o UAE

o Kuwait

Order a free sample PDF of the Clinical Trial Supplies Market Intelligence Study, published by Grand View Research.

[healthcareanna]

Biosimilars Market Size, Trends, Growth Analysis 2032

Biosimilars Market Overview

An integral component of the Biosimilars Market is the emergence of follow-on biologics. These biologics, which closely resemble existing biologic drugs, offer additional options for patients and healthcare providers. Follow-on biologics undergo rigorous testing to demonstrate similarity to the reference product, ensuring interchangeability and therapeutic equivalence. With their introduction, follow-on biologics stimulate competition in the biopharmaceutical industry, driving down prices and promoting innovation. As the demand for cost-effective biologic therapies continues to grow, the Biosimilars Market stands to benefit from the availability and acceptance of follow-on biologics, expanding treatment options and improving patient outcomes.

According to Market Research Future (MRFR), the biosimilars market insights was valued at USD 29.7 billion in 2023 and is projected to grow from USD 36.79 Billion in 2024 to USD 161.95 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 20.35% during the forecast period (2024 - 2032).

Biosimilars Market: Latest News and Developments

The FDA has approved the first Humira biosimilar. Adalimumab-bwwd (Cyltezo), a Humira biosimilar, received FDA approval in January 2023 for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.

Rising use of biosimilars in the treatment of cancer. A growing number of biosimilars are being used to treat cancer. The FDA authorised filgrastim-sndz (Zarxio), pegfilgrastim-jmdb (Onpro), and trastuzumab-dkst (Herzuma) as three biosimilars for the treatment of cancer in 2022.

Market Segmentation

Biosimilars industry can be considered with respect to product, applications, and end users.

The products based on which the market has been split into are recombinant glycosylated proteins, recombinant peptides, and recombinant non-glycosylated proteins. Recombinant non-glycosylated proteins are the biggest segment in the global market, thanks to the soaring cases of chronic disorders ranging from growth hormone deficiency to diabetes. As a result, recombinant non-glycosylated proteins are therapeutically used as they are readily available and are cost-effective.

Application-wise, the biosimilars market caters to chronic diseases, oncology, blood disorders, autoimmune diseases, infectious diseases, growth hormone deficiency, and more. Blood disorders have emerged as the top segment, as a result of the rising burden of the condition worldwide and the increased use of biosimilars by virtue of their low cost and the overall reduction in the treatment cost.

Major end users in the global market are hospitals and clinics as well as research institutes. Hospital and clinics are healthcare settings where treatment options and skilled professionals are easily available, and therefore, have emerged as the leading segment in the global industry.

Regional Status

Europe, MEA or Middle East & Africa along with the Americas, APAC or Asia Pacific are the primary markets for biosimilars.

Europe has taken the lead in the global market, as the region houses a vast elderly pool, with close to one fifth of the overall EU population aged more than 65 years. This has given way to several lifestyle-related disorders such as oncology, autoimmune diseases, diabetes, to name a few. Presumably, the scenario has raised the demand for biosimilars and can mean higher market growth over the next few years. In addition to this, numerous blockbuster biologics are on track to lose patent in the coming years, which should present lucrative opportunities to the biosimilar manufacturers.

The North American market displays a bright outlook and can emerge quite lucrative in the coming years, in view of the surging burden of chronic ailments in Canada and the United States. The rising spending on research activities by the healthcare agencies also fuels the market expansion in the region. Favorable reimbursement landscape in the region, especially in the US, encourages healthy competition as it results in lower incentives for the players to compete based on price.

The APAC market is slated to witness considerable growth, with China, South Korea and India offering a host of lucrative opportunities for drug development as well as commercialization. These are generics-driven countries and are known for frequently launching new and advanced manufacturing platforms, which has brought down the costs associated with biosimilar production. In the coming few years, majority of the patent expiries is touted to be in biosimilars, which is deemed as a profitable aspect by leading manufacturers and can translate into substantial market growth.

Eminent Vendors

Top global key players listed by biosimilars market outlook report include Stada Arzneimittel AG (Germany), Teva Pharmaceuticals (Israel), Biocon (India), Pfizer (US), Sandoz International (Germany), Eli Lily & Company (US), Actavis, Inc. (US), Dr. Reddy’s Laboratories (India), Cipla Ltd (India), Amgen, Inc. (US), Samsung Biologics (South Korea), Hospira Inc.(US), Mylan, Inc.(US), Celltrion (South Korea), to mention a few.

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[insideoutvietnam]

iTeos and GSK Initiate GALAXIES Lung-301 Phase 3 Study, Assessing Belrestotug and Dostarlimab in Previously Untreated, Unresectable Locally Advanced / Metastatic PD-L1 Selected Non-Small Cell Lung Cancer

WATERTOWN, Mass. and GOSSELIES, Belgium, June 17, 2024 (GLOBE NEWSWIRE) — iTeos Therapeutics, Inc. (Nasdaq: ITOS) (“iTeos”), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, and its development partner GSK, have initiated the first, global Phase 3 registration study of belrestotug + dostarlimab…

[precisionantibody]

Unveiling the Power of Fully Human Antibodies: Leveraging Antibody Purification Services

In the realm of biopharmaceuticals, fully human antibodies have emerged as powerful tools for targeted therapy and disease treatment. Combined with advanced antibody purification services, these antibodies offer unparalleled specificity and efficacy. In this article, we'll explore the significance of fully human antibodies and the role of antibody purification services in their development and production.

Understanding Fully Human Antibodies

Fully human antibodies, as the name suggests, are antibodies derived from human sources without any non-human components. These antibodies hold immense therapeutic potential due to their reduced immunogenicity and enhanced affinity for human targets. Fully Human Antibody are generated using advanced technologies such as phage display or transgenic mice, enabling precise targeting of disease-specific antigens.

The Importance of Antibody Purification Services

Antibody purification services are essential for isolating and purifying fully human antibodies from complex biological matrices. These services utilize a combination of chromatography, filtration, and other purification techniques to obtain highly pure and concentrated antibody preparations. By removing impurities and contaminants, antibody purification services ensure the safety, potency, and efficacy of therapeutic antibodies.

Advantages of Fully Human Antibodies

Fully human antibodies offer several advantages over traditional Antibodies Development from non-human sources, such as murine or chimeric antibodies. These advantages include lower immunogenicity, reduced risk of adverse reactions, and improved pharmacokinetics. Fully human antibodies also exhibit higher specificity and affinity for human targets, resulting in enhanced therapeutic efficacy and reduced off-target effects.

Optimizing Antibody Purification Workflows

Integration of antibody purification services into antibody development workflows streamlines the production process and maximizes efficiency. By employing customized purification protocols tailored to specific antibody characteristics, researchers can achieve high yields and purity levels while minimizing processing time and cost. Automated purification platforms further enhance workflow efficiency and reproducibility, enabling rapid scale-up for large-scale production.

Applications of Fully Human Antibodies

Fully human antibodies have broad applications across various therapeutic areas, including oncology, autoimmune diseases, and infectious diseases. These antibodies can be used as standalone therapeutics, targeted drug delivery vehicles, or diagnostic tools. Their ability to precisely target disease-specific antigens makes them valuable assets in precision medicine and personalized therapy approaches.

[infinitiresearch]

India Active Pharmaceutical Ingredient (API) Market - Forecast and Analysis, 2024-2028

Originally published on Technavio: India Active Pharmaceutical Ingredient (API) Market by Manufacturing Type, Type, and Product Type - Forecast and Analysis 2024-2028

The India Active Pharmaceutical Ingredient (API) Market is anticipated to undergo significant growth from 2024 to 2028, driven by various factors including increasing demand for generic drugs, a favorable regulatory environment, and the country's cost-effective manufacturing capabilities. This analysis focuses on different aspects of the market, including manufacturing type, type of API, and product type, to provide insights into market size, trends, and forecasts.

In terms of manufacturing type, India's API market comprises both captive manufacturing and contract manufacturing segments. Captive manufacturing refers to API production by pharmaceutical companies for their own use, while contract manufacturing involves outsourcing API production to third-party manufacturers. The country's robust contract manufacturing infrastructure, coupled with its skilled workforce and cost advantages, makes it an attractive destination for both domestic and international pharmaceutical companies seeking API manufacturing services.

The type of API encompasses various categories such as synthetic APIs, biotech APIs, and others. Synthetic APIs, which are chemically synthesized, dominate the Indian API market due to their widespread use in pharmaceutical formulations. However, there is a growing demand for biotech APIs, driven by advancements in biotechnology and the development of biopharmaceuticals. India's expertise in biotechnology and biosimilars positions it as a key player in the global biotech API market.

Furthermore, the product type segment includes various categories of APIs such as branded APIs, generic APIs, and over-the-counter (OTC) APIs. Branded APIs are proprietary molecules developed and marketed by pharmaceutical companies, while generic APIs are non-branded versions of existing drugs. India is a major supplier of generic APIs to global markets, owing to its competitive manufacturing costs and regulatory compliance. Additionally, OTC APIs, which are used in the production of over-the-counter medications, contribute to the diversity of India's API market.

Key players in the India API market include both domestic and multinational pharmaceutical companies, as well as contract manufacturing organizations (CMOs). These companies specialize in the production of a wide range of APIs catering to various therapeutic areas such as cardiovascular, oncology, central nervous system, and others. Strategic initiatives such as investments in research and development, capacity expansion, and partnerships with global pharmaceutical companies are driving market competitiveness and innovation in India's API industry.

To Learn deeper into this report , View Sample PDF

Looking ahead, the India API market is expected to witness continued growth driven by factors such as increasing demand for pharmaceuticals, patent expirations of blockbuster drugs, and the country's expanding capabilities in complex API manufacturing. Moreover, government initiatives such as the 'Make in India' campaign and regulatory reforms aimed at streamlining approval processes and ensuring quality compliance are expected to further support market growth. Overall, the forecast period presents opportunities for India to strengthen its position as a leading API manufacturer and supplier in the global pharmaceutical industry.

For more information please contact.

Technavio Research

Jesse Maida

Media & Marketing Executive

US: +1 844 364 1100

UK: +44 203 893 3200

Email: media@technavio.com

Website: www.technavio.com/

[omkarpatel]

Atezolizumab Market is Estimated to Witness High Growth Owing to Opportunity of Increasing Cancer Treatment

Atezolizumab is a type of immunotherapy drug known as a programmed death-ligand 1 (PD-L1) inhibitor. It works by blocking PD-L1 and restoring the anti-tumor immune response in patients. Atezolizumab is used to treat various forms of cancer including non-small cell lung cancer (NSCLC), urothelial carcinoma and other solid tumors. The need for effective cancer treatment options is increasing globally owing to rising cancer prevalence. The global Atezolizumab Market is estimated to be valued at US$ 308 Million in 2023 and is expected to exhibit a CAGR of 3.0% over the forecast period 2023 to 2030, as highlighted in a new report published by Coherent Market Insights. Market Opportunity: The increasing prevalence of cancer presents a major market opportunity for atezolizumab. According to WHO, cancer burden has risen to 18.1 million new cases and 9.6 million cancer deaths in 2018 globally. Lung cancer is the most common cancer worldwide. Atezolizumab is indicated for treatment of NSCLC and has potential to capture significant market share due to its efficacy and survival benefits over chemotherapy. Furthermore, ongoing clinical trials evaluating atezolizumab for new cancer indications such as breast cancer, gastric cancer provide opportunities for label expansion. This will increase the eligible patient pool and volumes, driving the atezolizumab market growth over the forecast period. Porter's Analysis Threat of new entrants: The biopharmaceutical industry requires high R&D investment and manufacturing costs which creates significant barriers for new entrants. Bargaining power of buyers: The bargaining power of buyers is moderate as major pharmaceutical companies have patent protection for their drugs. Bargaining power of suppliers: Suppliers have moderate bargaining power due to the availability of alternative suppliers in the pharmaceutical supply chain. Threat of new substitutes: The threat of new substitutes is high as newer targeted therapies are constantly emerging in the oncology segment. Competitive rivalry: The competitive rivalry is high among existing players due to frequent product launches and patent expirations. SWOT Analysis Strength: Atezolizumab has a well-established safety and efficacy profile for treating various cancers like non-small cell lung cancer and urothelial carcinoma based on positive clinical trial results. Weakness: High costs associated with immunotherapies like Atezolizumab burden the healthcare systems. Drug development also requires lengthy approval timelines. Opportunity: Increasing adoption rates of immunotherapies globally presents an opportunity to expand into new cancer indications and treatment combinations. Threats: Generic competition post patent expiration of Atezolizumab poses pricing pressures. Side effects of immunotherapies continue to be a concern. Key Takeaways The global Atezolizumab market is expected to witness high growth. Regional Analysis: North America is expected to dominate the market during the forecast period owing to rising cancer incidence and higher adoption of novel therapeutics. The Asia Pacific region is projected to grow at the fastest rate fueled by growing cancer burden, awareness, and improving access to targeted therapies. Key players operating in the Atezolizumab market are Mycovia Pharmaceuticals, Inc., Scynexis, Inc., Basilea Pharmaceutica Ltd., Astellas Pharma Inc., Grupo Ferrer Internacional, S.A., Pacgen Life Science Corporation, NovaDigm Therapeutics, Inc., Cidara Therapeutics, Inc., Amplyx Pharmaceuticals Inc., and Pfizer, Inc. Their focus is on expanding indications through ongoing clinical trials to sustain market position.

[credenceresearchdotblog]

The Bispecific Antibodies Market is projected to grow from USD 5,740 million in 2024 to an estimated USD 106,123.6 million by 2032, with a compound annual growth rate (CAGR) of 44% from 2024 to 2032.The biopharmaceutical industry has witnessed significant advancements over the years, and bispecific antibodies (BsAbs) represent one of the most promising innovations in therapeutic development. These engineered molecules, capable of simultaneously binding to two different antigens or epitopes, have unlocked new possibilities for the treatment of complex diseases, particularly cancer, autoimmune disorders, and infectious diseases. As the global healthcare landscape continues to evolve, the bispecific antibodies market is experiencing remarkable growth.

Browse the full report https://www.credenceresearch.com/report/bispecific-antibodies-market

Market Overview

The bispecific antibodies market has grown exponentially in recent years, driven by increasing investments in research and development, breakthroughs in biotechnology, and rising prevalence of chronic diseases. According to market research, the global bispecific antibodies market is projected to expand at a compound annual growth rate (CAGR) exceeding 10% during the forecast period of 2023–2030. The market’s rapid growth is fueled by the development of innovative therapeutics and increasing adoption of precision medicine.

Key Drivers of Market Growth

1. Rising Incidence of Chronic Diseases The growing burden of cancer, autoimmune diseases, and other chronic conditions has created an urgent need for more effective and targeted therapies. Bispecific antibodies, with their unique ability to engage multiple targets simultaneously, are emerging as a powerful tool to address these challenges.

2. Advancements in Biotechnology Technological innovations such as antibody engineering, protein design, and novel manufacturing techniques have significantly enhanced the development of BsAbs. Platforms like the knob-into-hole technology and dual-variable domain immunoglobulin (DVD-Ig) are enabling the creation of bispecific antibodies with improved efficacy, stability, and manufacturability.

3. Increasing FDA Approvals and Product Launches Regulatory bodies like the U.S. Food and Drug Administration (FDA) have approved several bispecific antibody therapies in recent years, including blinatumomab (Blincyto) for leukemia and amivantamab (Rybrevant) for non-small-cell lung cancer. Such approvals not only validate the clinical potential of BsAbs but also encourage further investments in this space.

4. Rising Demand for Personalized Medicine Bispecific antibodies are at the forefront of personalized medicine, offering tailored therapeutic options based on individual patient profiles. Their ability to target specific pathways makes them particularly attractive for precision oncology.

Applications of Bispecific Antibodies

The therapeutic applications of bispecific antibodies are vast and diverse, including:

- Cancer Treatment: Bispecific T-cell engagers (BiTEs) like blinatumomab have revolutionized cancer therapy by redirecting T cells to tumor cells for targeted destruction. - Autoimmune Diseases: Bispecific antibodies are being explored for modulating immune responses, offering hope for patients with rheumatoid arthritis, psoriasis, and other autoimmune conditions. - Infectious Diseases: Novel BsAbs are being developed to neutralize viral infections by targeting both the virus and the host immune response.

Challenges in the Bispecific Antibodies Market

Despite their potential, the development and commercialization of bispecific antibodies face several hurdles:

1. Manufacturing Complexity: Producing bispecific antibodies is technically challenging due to their intricate structure and dual-targeting capabilities. Ensuring consistent quality and scalability remains a significant obstacle. 2. High Development Costs: The R&D costs for bispecific antibodies are substantially higher compared to conventional monoclonal antibodies, posing financial risks for smaller biotech firms.

3. Regulatory Challenges: The novel nature of bispecific antibodies requires tailored regulatory frameworks, which can delay approval timelines.

4. Safety Concerns: Off-target effects and immune-related adverse reactions pose risks during clinical development, necessitating rigorous safety assessments.

Future Outlook

The future of the bispecific antibodies market is bright, with a growing pipeline of innovative products and expanding therapeutic indications. Key players such as Amgen, Genentech, and Regeneron are investing heavily in the development of next-generation BsAbs with enhanced efficacy and reduced toxicity. Collaborative efforts between academia, biopharma companies, and contract research organizations are accelerating the pace of innovation.

Moreover, the integration of artificial intelligence (AI) and machine learning (ML) in drug discovery is expected to further optimize the design and development of bispecific antibodies. Emerging markets in Asia-Pacific, Latin America, and the Middle East are also providing new growth opportunities due to increasing healthcare expenditure and improving access to advanced therapies.

Key Player Analysis:

Amgen, Inc.

Bayer AG

Dow Pharmaceutical Solutions

ImmunGene, Inc.

Immunocore Limited

Merck & Co., Inc.

Novartis AG

Pfizer, Inc.

Hoffmann-La Roche AG

Segmentation:

Based on Type:

IgG-based Bispecific Antibodies

Non-IgG Bispecific Antibodies

Dual-target Bispecific Antibodies

Other Types

Based on Technology:

CrossMab Technology

Genetically Engineered Bispecific Antibodies

Double-targeted Single-chain Variable Fragments (scFvs)

Immune Cell-engaging Bispecifics

Other Technologies

Based on End-User:

Pharmaceutical and Biotechnology Companies

Contract Research Organizations (CROs)

Hospitals and Clinics

Research and Academic Institutions

Other End-Users

Based on Region: • North America

North America

U.S.

Canada

Mexico

Europe

Germany

France

U.K.

Italy

Spain

Rest of Europe

Asia Pacific

China

Japan

India

South Korea

South-east Asia

Rest of Asia Pacific

Latin America

Brazil

Argentina

Rest of Latin America

Middle East & Africa

GCC Countries

South Africa

Rest of the Middle East and Africa

Browse the full report https://www.credenceresearch.com/report/bispecific-antibodies-market

Contact:

Credence Research

Please contact us at +91 6232 49 3207

Email: sales@credenceresearch.com

Website: www.credenceresearch.com

[market-insider]

Biomarker Testing Services: Transforming Healthcare Delivery and Patient Outcomes

The global biomarker testing services market size is expected to reach USD 1,399.4 million by 2030. Growing investment in pharmaceutical R&D, increasing demand for the precision medicine used for cancer treatment, and growing burden of the infectious and chronic diseases facilitating the demand for the biomarker testing are some of the major factors driving the market's growth.

Gain deeper insights on the market and receive your free copy with TOC now @: Biomarker Testing Services Market Report Report

There has been a consistent rise in clinical trials during the last 5 years. For instance, according to ClinicalTrials.gov, more than 262,298 trials were registered in 2018, whereas as of September 2022, above 399,518 trials were registered. Clinical trials are expected to improve in the coming years owing to the increase in funding for clinical research. This is expected to boost demand for medicine discovery research activities and thus support demand for biomarker testing in the post-pandemic period.

The FDA approval rate for medicines through the use of biomarkers has improved, over the years. For instance, in 2016, more than 26 trials were approved by the FDA that used biomarkers for medicine testing, whereas, in 2019, 36 trials were approved by the FDA that used biomarkers for medical testing. Clinical trials now require biomarker-related data for medicine approvals, as it provides information about the action of medicine in the body and thus speeds up the medicine approval process. This is expected to improve demand for biomarker testing during the forecast period.

Various biopharmaceutical companies are taking initiatives to improve the diagnosis rate of the cancer patient through biomarker testing. For instance, in April 2021, a biopharmaceutical company, Amgen launched the Biomarker Assist Program. As per this program, patients with metastatic (stage IV) non-small cell lung cancer (NSCLC) were provided biomarker testing, to check the presence of oncogene biomarkers, which help in targeted therapies. Such initiatives by the market players are likely to support the market's growth.

According to the IQVIA, report on oncology trends, clinical trials for cancer have been increasing for the last 10 years. For instance, in 2011, 1,242 trials were registered for cancer, and as of 2021, 2,335 trials were registered for cancer. The number of clinical trials intended for cancer is expected to rise even further owing to the growing prevalence of the disease. There is an increasing demand for targeted therapies designed for cancer that use biomarkers for testing the efficacy of the drug in the research. Increased cancer research in the coming years is expected to boost demand for the biomarkers designed for cancer testing and thus support the market in the post-pandemic period.

[sriramnanda-blog]

U.S. NON-ONCOLOGY BIOPHARMACEUTICALS MARKET ANALYSIS

Biologics can be defined as molecules derived from living cells such as microorganisms, plants or animal cells and used in the treatment, diagnosis or prevention of diseases. Most of the biologic molecules are very large, complex molecules or mixture of molecules.

Biopharmaceuticals are part of a wider category of therapeutic agents called biologics. Biopharmaceuticals are the substances developed in living systems with the help of biotechnology and are used in therapeutic and diagnostic applications. Non-oncology biopharmaceuticals are the drugs that are used in the treatment of various diseases rather than cancer such as rheumatoid arthritis, psoriatic arthritis, multiple sclerosis, hemophilia, age-related macular degeneration, osteoporosis, and others.

Increasing launches, approvals, and robust pipeline of novel biopharmaceuticals for non-oncology indications .

Frequent approvals, launches, and robust pipeline of novel non-oncology biopharmaceuticals for various indications in the U.S. market is expected to significantly support the U.S. non-oncology biopharmaceuticals market growth.

For instance, in September 2018, Eli Lilly and Company received the U.S. Food and Drug Administration (FDA) approval for its Emgality (galcanezumab-gnlm) 120 mg injection, for the preventive treatment of migraine in adults.

In February 2018, Novartis announced that the U.S. Food and Drug Administration (FDA) approved a label update for its Cosentyx (secukinumab), the first interleukin-17A (IL-17A) inhibitor approved to treat moderate-to-severe plaque psoriasis.

In July 2018, Amgen Inc. and UCB Inc. resubmitted the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for EVENITY (romosozumab), an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at high risk of fracture.

The U.S. non-oncology biopharmaceuticals market size was valued at US$ 116.0 Bn in 2018 and is expected to witness a CAGR of 10.2% during the forecast period (2018 – 2026).

Figure 1. U.S. Non-oncology Biopharmaceuticals Market Share (%), By Product Type, 2018-2026

Source: Coherent Market Insights Analysis (2018)

Increasing mergers and collaborations among key players for development of novel non-oncology biopharmaceuticals is expected to support the market growth

Key players in the market are involved in strategic mergers and collaborations for the development of new biopharmaceutical products and to market them in the U.S. Such strategic mergers and collaborations between key players is expected to support the development of novel products, which in turn is expected to fuel the U.S. non-oncology biopharmaceuticals market growth over the forecast period.

For instance, in 2017, Sanofi S.A. and its vaccines business unit Sanofi Pasteur collaborated with MedImmune, the global biologics research and development arm of AstraZeneca Plc., for the development and commercialization of a monoclonal antibody, namely MEDI8897, for the prevention of Respiratory Syncytial Virus (RSV) associated illness in newborns and infants.

High price of branded biologic products is expected to be a major factor negatively affecting its adoption

According to the report published by the Association for Accessible Medicines in 2018, the annual treatment with Humira comes with a list price of US$ 38,000, and according to the report published by I-Mak.org, between 2012 and 2016, the average spending on Humira per person in U.S. increased from US$ 16,000 to US$ 33,000.

Table 1. Revenue of Top Non-oncology Biopharmaceutical Brands in the U.S.

Source: Coherent Market Insights Analysis (2018)

Market Opportunity

In the recent past, various blockbuster biologics such as Humira and Remicade lost patent in the U.S. market. Furthermore, various other high revenue generating biologics are expected to lose their patents in the near future.

Loss of patent in the U.S. market offers lucrative opportunity to other players for development of its biosimilars. Hence, key players in the market are focused on launch and development of biosimilars of biologic products in the market at affordable price.

For instance, in 2017, Merck & Co., Inc. launched RENFLEXIS (infliximab-abda), a biosimilar of the originator biologic medicine Remicade (infliximab) by Janssen Biotech, Inc. As per the company, RENFLEXIS is introduced in the U.S. at a list price (wholesaler acquisition cost) of US$ 753.39, representing a 35% discount to the current list price of Remicade, which is its reference product.

Market Challenges

High R&D Investments: Developing an IV/injectable biopharmaceutical requires sophisticated infrastructure, skilled scientists, and significant resource investment. Development of a biopharmaceutical product requires extensive clinical research and multiple phases of trials, which is a lengthy and expensive process. These factors are significant barriers for the new players to enter the market.

Sales and Marketing: The U.S. non-oncology biopharmaceuticals market has established market players with strong sales and marketing team. Presence of such strong players in the country creates a big challenge for new players to enter the market and to sustain against such big players.

Physician Acceptance: Physician acceptance of substitutes for well-established products may be a challenge, particularly among indications for which numerous products are available and substitutes do not exhibit high/ better safety profile and/or lower cost.

Key players operating in the U.S. non-oncology biopharmaceuticals market include Sanofi S.A., Pfizer, Inc., Johnson & Johnson, Novartis International AG, Amgen, Inc., Eli Lilly and Company, AbbVie Inc., Bristol-Myers Squibb Company, F. Hoffmann-La Roche AG, Novo Nordisk A/S, GlaxoSmithKline plc., UCB Pharma, Teva Pharmaceutical Industries Ltd., Takeda Pharmaceutical Company Ltd, AstraZeneca Plc, Mylan N.V., LEO Pharma A/S, Boehringer Ingelheim GmbH, Alexion Pharmaceuticals Inc., Merck & Co., Inc., Elusys Therapeutics, Inc., Swedish Orphan Biovitrum AB, Samsung Bioepis NL B.V., Biogen Inc., and Theratechnologies Inc.

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[deshmukh]

The Global Non-oncology Biopharmaceuticals Market report provides information about the Global industry, including valuable facts and figures. This research study explores the Global Market in detail such as industry chain structures, raw material suppliers, with manufacturing The Non-oncology Biopharmaceuticals Sales market examines the primary segments of the scale of the market. This intelligent study provides historical data from 2015 alongside a forecast from 2020 to 2027.