#Small Molecule Innovator CDMO Market size

[credenceresearchdotblog]

The Sterile Injectable CDMO Market is projected to grow from USD 11,089.66 million in 2024 to USD 26,208.37 million by 2032, reflecting a compound annual growth rate (CAGR) of 11.35%.The global pharmaceutical landscape is evolving rapidly, and one of the sectors witnessing significant growth is the Sterile Injectable Contract Development and Manufacturing Organization (CDMO) market. This market plays a crucial role in the production of sterile injectables, which are vital for delivering medications directly into the bloodstream, ensuring rapid and effective treatment. The increasing demand for biologics, the rise in chronic diseases, and advancements in drug delivery systems are driving the expansion of this market. This article explores the current trends, challenges, and future prospects of the sterile injectable CDMO market.

Browse the full report at https://www.credenceresearch.com/report/sterile-injectable-cdmo-market

Current Market Trends

1. Rising Demand for Biologics: Biologics, including monoclonal antibodies, vaccines, and gene therapies, are becoming the cornerstone of modern medicine. These complex molecules require sophisticated manufacturing processes, which often necessitate sterile injectable formulations. CDMOs, equipped with the necessary expertise and technology, are increasingly partnering with pharmaceutical companies to meet this demand. The shift towards biologics is a key driver of growth in the sterile injectable CDMO market.

2. Innovation in Drug Delivery Systems: The development of novel drug delivery systems, such as prefilled syringes, autoinjectors, and lyophilized products, is revolutionizing the administration of sterile injectables. These innovations not only improve patient compliance but also enhance the stability and efficacy of the drugs. CDMOs are investing heavily in advanced manufacturing technologies to cater to the evolving needs of the pharmaceutical industry, further boosting the market.

3. Outsourcing Trends: Pharmaceutical companies are increasingly outsourcing their sterile injectable manufacturing to CDMOs. This trend is driven by the need to reduce operational costs, access specialized expertise, and focus on core competencies such as research and development. Outsourcing also provides flexibility in scaling production based on market demand, making it an attractive option for both large and small pharmaceutical firms.

Key Challenges in the Sterile Injectable CDMO Market

1. Regulatory Compliance: The production of sterile injectables is subject to stringent regulatory requirements, including Good Manufacturing Practices (GMP) and quality control standards. CDMOs must ensure compliance with these regulations across different markets, which can be complex and resource-intensive. Any lapses in regulatory adherence can lead to significant financial penalties and damage to reputation.

2. High Operational Costs: Manufacturing sterile injectables is a capital-intensive process, requiring state-of-the-art facilities, specialized equipment, and highly trained personnel. The costs associated with maintaining sterile environments, performing regular quality checks, and managing supply chains are substantial. CDMOs must strike a balance between maintaining high standards and managing operational expenses to remain competitive.

3. Supply Chain Disruptions: The COVID-19 pandemic highlighted the vulnerabilities in global supply chains, affecting the availability of raw materials, components, and finished products. For CDMOs, managing these disruptions while ensuring uninterrupted production of sterile injectables has been a major challenge. Building resilient supply chains and diversifying suppliers are critical strategies to mitigate such risks in the future.

Future Prospects and Opportunities

1. Expansion into Emerging Markets: The sterile injectable CDMO market is poised for expansion into emerging markets, particularly in Asia-Pacific and Latin America. These regions are witnessing increased healthcare spending, improved access to medical services, and a growing prevalence of chronic diseases. CDMOs that establish a presence in these markets can tap into new opportunities and drive growth.

2. Adoption of Advanced Technologies: The integration of advanced technologies, such as single-use systems, continuous manufacturing, and digitalization, is expected to enhance the efficiency and flexibility of sterile injectable production. CDMOs that embrace these innovations can improve their competitive edge, reduce time-to-market, and offer cost-effective solutions to their clients.

3. Strategic Collaborations and Partnerships: Collaboration between pharmaceutical companies and CDMOs is likely to become more strategic in the future. Partnerships that go beyond manufacturing to include co-development, risk-sharing, and joint ventures can create synergies and foster innovation. Such alliances will be instrumental in addressing the complexities of producing next-generation sterile injectables.

Key Player Analysis

TriRx Pharmaceutical Services

Tianjin Hankang Pharmaceutical Biotechnology

Astral SteriTech

Pfizer

Prague Scientific

BioTechnique

Evonik

Flagship Biotech International Pvt. Ltd

Fareva

Brooks Laboratories Limited

Famar

Curida AS

Ethypharm

Biophrama Group

Aurigene Pharmaceutical Services

Abbvie

Temad Co.

C. Rompharm Company SRL

Gensenta Pharmaceuticals

Polfa Tarchomin

Quotient Sciences

Sharp

Mithra CDMO

BirgiMefar Group

Segments:

Based on Manufacturing:

Preclinical Manufacturing

Clinical Manufacturing

Commercial Manufacturing

Based on Services:

Stand-alone Services

Drug Formulation and Development

Aseptic Fillings

Analytical Development

Regulatory Support

Packaging and Assembly Services

Technology Transfer

Supply Chain Management

Quality Control and Assurance

Integrated Services

Based on Drug Type:

Monoclonal Antibodies (mAbs)

Cytokines

Insulin

Peptide Hormones

Vaccines

Immunoglobulins

Blood Factors

Peptide Antibiotics

Others

Based on Organization Size:

Small

Mid-sized

Large

Very Large

Based on End-user:

Pharmaceutical Companies

Biopharmaceutical Companies

Research Institutes

Others

Based on the Geography:

North America

US

Canada

Mexico

Europe

Germany

France

UK

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 Middle East and Africa

Browse the full report at https://www.credenceresearch.com/report/sterile-injectable-cdmo-market

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[industryforecastnews]

Healthcare Contract Development And Manufacturing Organization Market To Reach USD 471.0 Billion By 2030

Healthcare Contract Development and Manufacturing Organization Market Growth & Trends

The global healthcare contract development and manufacturing organization market size is expected to reach USD 471.0 billion by 2030, growing at a CAGR of 9.68% from 2024 to 2030, according to a new report by Grand View Research, Inc. The market is expected to show lucrative growth due to rising outsourcing trends and increasing R&D expenditure.

Healthcare contract development and manufacturing organization (CDMO) provide outsourcing services to various pharmaceutical industries on a contract basis. An increase in outsourcing by pharmaceutical companies, expansions in the pharmaceutical industry, and the support of CDMOs in reducing operational and capital expenses are some of the major factors anticipated to propel the market growth in the forecast period.

In addition, growing requirement among pharmaceutical and medical device companies to follow stringent timelines has increased the demand for outsourcing development and manufacturing activities to CDMOs. Further, due to the increasing demand for medical devices in emerging countries, various companies are shifting their focus on research and development activities for medical device contract development and manufacturing. Over the past 10 years, several pharmaceutical companies have turned to CMOs, CROs, and CDMOs to assist in pre-formulation and development & manufacturing of their novel innovations. Outsourcing is a high growth market, and most spending is focused on early development.

Around 75% of new drug pipelines come from small- and midsized biopharmaceutical companies. These companies have high profit margins, which make them easy targets for healthcare providers who are trying to reduce costs. Thus, instead of investing in establishing their own infrastructure, it is profitable for these companies to outsource services to third-party organizations that have expertise and the required equipment. Several pharmaceutical companies are seeking outsourced services for optimizing the development of their molecules. Furthermore, a large number of CDMO collaborations, expansions, mergers & acquisitions, and other strategic initiatives undertaken by market players operating in the country are anticipated to boost the market. For instance, In March 2023, Remedium Bio, a U.S.-based biotechnology company, entered into a collaboration agreement with Exothera, a Belgium-based CDMO, to scale up the production of Remedium’s lead gene therapy drug candidate, AAV2-FGF18 in the treatment of osteoarthritis. Similarly, in January 2024, Enzene Biosciences, a subsidiary of Alkem Labs announced the manufacturing site in the U.S. Such innovations are anticipated to drive the market.

However, increasing logistic costs, serialization issues faced by healthcare organizations, and the threat of infringement of Intellectual Property (IP) rights are anticipated to restrain the market growth for healthcare contract development & manufacturing organization over the forecast period.

Request a free sample copy or view report summary: https://www.grandviewresearch.com/industry-analysis/healthcare-contract-development-manufacturing-organization-market

Healthcare Contract Development and Manufacturing Organization Market Report Highlights

Based on services, the contract manufacturing segment dominated the market with a revenue share of 73.50% in 2023 due to increase in the outsourcing of manufacturing services by pharmaceutical and medical device companies.In addition, cost-effectiveness, and the increasing number of CMOs are some of the key factors that are positively affecting the market growth

By small molecule contract development sub-segment, the preclinical/segment is expected to register the highest CAGR of 9.53% in the forecast period due to the rising pipeline of novel therapeutics

North America dominated the healthcare contract development and manufacturing organization industry with the largest revenue share of 40.91%in 2023. High shares of the region are majorly due to the presence of a large number of actively functioning CROs and CMOs in the region, especially across the U.S.

Healthcare Contract Development and Manufacturing Organization Market Segmentation

For this study, Grand View Research has segmented the healthcare contract development and manufacturing organization market based on services and region:

Healthcare CDMO Services Outlook (Revenue, USD Billion, 2018 - 2030)

Contract Development

Small Molecule

Preclinical

Bioanalysis and DMPK Studies

Toxicology Testing

Other Preclinical Services

Clinical

Phase I

Phase II

Phase III

Phase IV

Laboratory Services

Bioanalytical Services

Analytical Services

Large Molecule

Cell Line development

Process Development

Upstream

Microbial

Mammalian

Others

Downstream

MABs

Recombinant Proteins

Others

Others

Contract Manufacturing

Small Molecule

Large Molecule

MABs

Recombinant Proteins

Others

High Potency API

Finished Dose Formulations

Solid Dose Formulation

Liquid Dose Formulation

Injectable Dose Formulation

Medical Devices

Class I

Class II

Class III

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

North America

U.S.                

Canada

Europe

Germany

UK

France

Italy

Spain

Netherlands

Belgium

Denmark

Norway

Sweden

Asia Pacific

China

India

Japan

Australia

South Korea

Malaysia

New Zealand

Singapore

Philippines

Thailand

Latin America

Brazil

Mexico

Argentina

Colombia

Chile

Middle East & Africa

South Africa

Saudi Arabia

UAE

Israel

Kuwait

List of Key Players in the Healthcare CDMO Market

Catalent Inc.

Lonza

Recipharm AB

Siegfried Holding AG

Thermo Fisher Scientific, Inc.

Labcorp Drug Development

Jabil Inc

Syngene International Limited

IQVIA Inc.

Almac Group

Ajinomoto Bio-Pharma

Adare Pharma Solutions

Alcami Corporation

Vetter Pharma International

Browse Full Report: https://www.grandviewresearch.com/industry-analysis/healthcare-contract-development-manufacturing-organization-market

[tamanna31]

Small Molecule Innovator CDMO Market - The Biggest Trends to watch out for 2024-2030

Small Molecule Innovator CDMO Industry Overview

The global small molecule innovator CDMO market size was estimated at USD 48.6 billion in 2023 and is expected to expand at a compound annual growth rate (CAGR) of 6.21% from 2024 to 2030. Key drivers for this growth are increasing pharmaceutical R&D investment, growing demand for small molecules, and rising incidence of cancer & age-related disorders. Biological drugs are more expensive than small molecules. Hence, growing demand for cost-effective drugs is expected to further support market growth.

The COVID-19 pandemic significantly impacted on global economy in 2020 and caused an ongoing impact on various industries. However, the market for contract development and manufacturing organization (CDMO) witnessed a positive impact due to this pandemic. CDMOs played an important role in meeting the needs of pharmaceutical companies, biotech companies, and other end-users during this crisis. Overall, pandemic boosted market demand for small molecule innovator drugs. With the growing demand for outsourcing by pharma companies, heightened demand is observed in post-pandemic scenario.

Gather more insights about the market drivers, restrains and growth of the Small Molecule Innovator CDMO Market

Small Molecule Innovator CDMO Market Segmentation

Grand View Research has segmented the global small molecule innovator CDMO market based on product, stage type, customer type, therapeutic area, and region:

Small Molecule Innovator CDMO Product Outlook (Revenue, USD Million, 2018 - 2030)

Small Molecule API

Small Molecule Drug Product

Oral solid dose

Semi-Solid Dose

Liquid Dose

Others

Small Molecule Innovator CDMO Stage Type Outlook (Revenue, USD Million, 2018 - 2030)

Preclinical

Clinical

Phase I

Small

Medium

Large

Phase II

Small

Medium

Large

Phase III

Small

Medium

Large

Commercial

Small Molecule Innovator CDMO Customer Type Outlook (Revenue, USD Million, 2018 - 2030)

Pharmaceutical

Small

Medium

Large

Biotechnology

Small Molecule Innovator CDMO Therapeutic Area Outlook (Revenue, USD Million, 2018 - 2030)

Cardiovascular disease

Oncology

Respiratory disorders

Neurology

Metabolic disorders

Infectious disease

Others

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

The global intrauterine devices marketsize was estimated at USD 6.25 billion in 2023 and is projected to grow at a CAGR of 3.66% from 2024 to 2030.

The global dual chamber prefilled syringes marketsize was valued at USD 167.3 million in 2023 and is projected to grow at a CAGR of 5.8% from 2024 to 2030.

Key Companies & Market Share Insights

Companies are undertaking various strategic initiatives to gain a competitive advantage. Key parameters affecting the competitive nature of the market include acquisition, geographic expansion, mergers, acquisitions, and product launches.

In September 2022, WuXi STA inaugurated a new sterile lipid nanoparticle (LNP) formulation development and manufacturing facility at its Wuxi city campus. The integrated drug product platform CRDMO provides a full range of services, including solid-state development, pre-formulation, and clinical to commercial drug product manufacturing.

In June 2022, Lonza inaugurated a new clinical phase development and manufacturing facility in its small molecules site in Bend, Oregon. It is dedicated to manufacturing bioavailability-enhancing spray-dried dispersion (SDD) finished dosage forms and drug product intermediates

List of Key Players of Small Molecule Innovator CDMO Market

Piramal Pharma Solutions

CordenPharma International

Wuxi AppTec

Cambrex Corporation

Recipharm AB

Pantheon (Thermo Fisher Scientific)

Lonza

Catalent Inc.

Siegfried Holding AG

Boehringer Ingelheim

Labcorp Drug Development

Order a free sample PDF of the Small Molecule Innovator CDMO Market Intelligence Study, published by Grand View Research.

[wellnessweb]

Overview of Microbial Fermentation Techniques

The Microbial Fermentation Technology Market size was estimated at USD 30,964.20 million in 2022 and is expected to reach USD 48980.988 million by 2030 with a growing CAGR of 5.9% during the forecast period of 2023-2030.The global Microbial Fermentation Technology Market  study includes a full analysis of key driving drivers, as well as profiles of prominent firms, essential product features, sales rates, and contact information. A thorough assessment of the most important market trends is also included in the research. Information is gathered through focus groups, surveys, interviews, a geographical and national study, and a comprehensive all-dimensional examination.

Major market factors such as drivers, constraints, opportunities, and threats are examined, as well as how they influence the market. External threats and opportunities have underlying drivers and limits in the global market. Strategic alliances, new product launches, initiatives, transactions, joint activities, and information on top market rivals are all covered by Microbial Fermentation Technology Market  research, as well as development factors, limits, and opportunities.

Get Sample Report @ https://www.snsinsider.com/sample-request/3814

Market Segmentation

By Application

Antibiotics

Probiotics Supplements

Monoclonal Antibodies

Recombinant Proteins

Biosimilars

Vaccine

Enzymes

Small Molecules

Others

By End User

Bio-Pharmaceutical Companies

Contract Research Organizations (CROs)

CMOs & CDMOs

Academic & Research Institutes

The global Microbial Fermentation Technology Market  analysis summary provides an overview of the topic, including definitions, classifications, applications, and the industrial chain structure. Global business research is offered for emerging markets, including competitive landscape studies and development trends.

Russia-Ukraine War Impact on Microbial Fermentation Technology Market

The impact of the Russia-Ukraine conflict on the worldwide market is detailed in the research paper. While tensions between Russia and Ukraine have been increasing for years, the present military action heightens fears of a long-term conflict within Ukraine, as well as market and global economic implications.

Competitive Scenario

The market report also includes a comprehensive library of future market estimates based on historical data. Customers can get quantitative industry expertise by looking at the most recent market data. The study investigates a variety of significant elements that influence firm players, including as suppliers, end-users, dealers, and others, in order to assist them in strategizing investment and pursuing various Microbial Fermentation Technology Market  growth chances. All significant competitors, prices, and positioning, as well as a thorough data collecting strategy, must operate in the same territory.

Report Highlights

Give an overview of the present situation of the target industry, including applications and innovations.

A comprehensive analysis of the Microbial Fermentation Technology Market 's situation amid COVID-19 pandemic and Russia-Ukraine War.

A detailed market analysis, including upstream raw materials, downstream output, and recent growth estimates.

Report Conclusion

The most recent Microbial Fermentation Technology Market  study looks at the target market's latest influence. The article looks at how the corporate environment is always changing, as well as the short- and long-term implications.

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SNS Insider is a market research and insights firm that has won several awards and earned a solid reputation for service and strategy. We are a strategic partner who can assist you in re framing issues and generating answers to the trickiest business difficulties. For greater consumer insight and client experiences, we leverage the power of experience and people.

When you employ our services, you will collaborate with qualified and experienced staff. We believe it is crucial to collaborate with our clients to ensure that each project is customized to meet their demands. Nobody knows your customers or community better than you do. Therefore, our team needs to ask the correct questions that appeal to your audience in order to collect the best information.

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Small Molecule Innovator CDMO Market Size, Analysis and Forecast 2031

[rene221]

Common Challenges in Developing Oral Suspensions and Solutions

Introduction: The development of oral suspensions and oral solutions in the pharmaceutical industry brings forth a multitude of advantages, but it's not without its set of challenges. In this exploration, we'll delve into the common hurdles faced during the formulation and development of these liquid dosage forms, shedding light on how the industry addresses these challenges to deliver safe and effective medications.

Stability Concerns in Liquid Formulations: One of the primary challenges in formulating oral suspensions and solutions revolves around stability. The liquid nature of these dosage forms can make them susceptible to degradation, impacting the shelf life and efficacy of the medication. This blog post will explore strategies and technologies employed to enhance the stability of oral liquid formulations.

Anchor Text: Oral Suspensions and Oral Solutions

Taste and Palatability Issues: Ensuring that oral medications are palatable is crucial, especially when it comes to pediatric and geriatric patient populations. Taste-masking presents a unique challenge in the development of oral suspensions and solutions. We'll discuss innovative approaches and formulation techniques to overcome taste and palatability issues, creating a more patient-friendly experience.

Optimizing Particle Size Distribution: The particle size of active pharmaceutical ingredients (APIs) plays a significant role in the bioavailability and effectiveness of oral suspensions. This post will explore the challenges associated with achieving and maintaining the optimal particle size distribution, ensuring uniform drug delivery and absorption.

Manufacturing Scale-Up Considerations: Taking a formulation from the laboratory to large-scale production introduces its own set of challenges. We'll examine considerations and best practices for successfully scaling up the manufacturing of oral suspensions and solutions, maintaining consistency and quality throughout the process.

Quality Control Measures: Maintaining high-quality standards is imperative in pharmaceutical manufacturing. Our guide will discuss the importance of robust quality control measures in ensuring the safety and efficacy of oral liquid medications, covering analytical techniques and testing protocols.

Anchor Text: Small Molecule CDMO

Addressing Regulatory Compliance: Meeting regulatory requirements is a critical aspect of bringing oral suspensions and solutions to market. This post will provide insights into the regulatory landscape governing these liquid dosage forms, outlining key considerations for compliance throughout the development and approval process.

Incorporating Patient Feedback: Patient-centric design is becoming increasingly crucial in pharmaceutical development. We'll explore how incorporating patient feedback into the formulation process of oral suspensions and solutions can lead to improved adherence and overall patient satisfaction.

Conclusion: Navigating the common challenges in developing oral suspensions and solutions requires a multidimensional approach. This guide aims to provide valuable insights for pharmaceutical professionals and researchers as they work towards creating effective, palatable, and stable oral liquid medications.

[desaletushki]

Small Molecule Innovator CDMO Market Size, Share, Trends And Forecast 2030

The global small molecule innovator CDMO market size is expected to reach USD 74.9 billion by 2030, according to a new report by Grand View Research, Inc. It is expected to expand at a CAGR of 6.5% from 2022 to 2030. The COVID-19 pandemic has significantly impacted market growth. During this crisis, CDMOs are playing an important role in meeting the needs of pharmaceutical companies, biotech companies, and other end users. These have been working diligently towards the development of small-molecule drugs against SARS-CoV-2 since the end of 2019.

COVID-19 has caused a significant impact on the API CDMO market where China was a key performing country in contract manufacturing of APIs. In China, due to a strict government-imposed lockdown, 44 firms became non-operational and several governments chose to boycott APIs manufactured in China. To combat this shortage, several countries have started manufacturing their own APIs. COVID-19 has changed supply chains but has also boosted the API CDMO market. With the growing demand for outsourcing by pharma companies, CDMOs are now focusing more on continuous bioprocessing and process intensification.

Small molecules continue to play an important role in the development of new treatments globally. Specialty medicines are increasingly driving the global pharmaceutical industry, particularly in developed markets with small-molecule applications accounting for over half of specialty sales. However, the main drivers of this market are increasing pharmaceutical R&D investment, growing demand, and the rising incidence of cancer and age-related disorders.

Browse Full Report: https://www.grandviewresearch.com/industry-analysis/preservatives-market-report

Small Molecule Innovator CDMO Market Report Highlights

By product, the small molecule API segment is anticipated to register the fastest growth rate over the forecast period. This growth can primarily be attributed to the high approval rate of NME small molecules during covid

The oncology therapeutic area segment dominated the market with a revenue share of over 40.0% in 2021 and is anticipated to register the fastest growth rate over the forecast period. Overall, the small molecule oncology pipeline is growing with 38% of small molecule therapeutic candidates in preclinical development

The clinical stage type segment dominated the market with a revenue share of over 50.0% in 2021. CDMOs offer specialized expertise, time-saving, and cost-efficiency, which is expected to augment the segment growth over the forecast period

Asia Pacific is anticipated to register the fastest CAGR over the forecast period due to significantly cheaper manufacturing costs than North America and Europe and the presence of favorable laws

Key Companies & Market Share Insights

Companies are undertaking various strategic initiatives to gain a competitive advantage over other players. Key parameters affecting the competitive nature of the market include acquisitions, geographic expansions, mergers and acquisitions, and product launches. For instance, in October 2020, Corden Pharma announced that its Boulder, Colorado site has accomplished the development of a new, highly powerful API laboratory. Customers can now use the new laboratory, which can handle highly strong chemicals with an OEL as low as 1 ng/m3.

In January 2020, WuXi STA opened a large-scale oligonucleotide active pharmaceutical ingredients (API) manufacturing facility in China for the manufacturing of oligonucleotide APIs for preclinical to commercial purposes. In August 2020, Piramal Pharma Solutions will partner with Epirium Bio for new orphan drugs targeting rare diseases. In December 2021, CordenPharma acquire three-drug product manufacturing facilities from Vifor Pharma Group for the manufacturing of iron therapies active pharmaceutical ingredient (API). Some prominent players in the global small molecule innovator CDMO market include: Piramal Pharma Solutions, Corden Pharma, Wuxi AppTec, Cambrex Corporation, Recipharm AB, Thermo Fisher Pantheon, Lonza Group Ltd., Catalent Inc., Siegfried Holding AG, Boehringer Ingelheim, Covance Inc.

Request Free Sample Report: https://www.grandviewresearch.com/industry-analysis/preservatives-market-report

[marketreports-blog]

The global small molecule innovator CDMO market size was valued at USD 41.1 billion in 2020, and is predicted to be worth around USD 73.9 billion by 2030, registering a CAGR of 6.4% during the forecast period 2022 to 2030.

[meditech-insights]

Cell & Gene Therapy (CGT) CDMO Market is likely to grow at a CAGR of ~25% to reach ~$5 billion by 2025

Robust CGT pipeline with rising number of product approvals, strong support from large pharma and biotech, and consistent investor enthusiasm (~$20 bn raised in 2020) is set to increase the demand for CGT services. An increasing pipeline of therapies are nearing regulatory decisions. Out of 1,220 ongoing clinical trials in 2020, 152 were in Phase 3 — FDA and EMA expect approval of 10-20 cell and gene therapies each year by 2025.

The global cell & gene therapy (CGT) CDMO market is anticipated to witness a CAGR of ~25% to reach ~$5 billion by 2025. This growth will be fueled by the rising incidence of cancer and other targeted diseases, rapidly expanding research on CGTs, substantial funding by VCs and technological innovations.

Growing Demand for Full-service/One-stop-shop CDMOs

Full-service CDMOs that can support with both development and manufacturing are in utmost demand. Recently, smaller biotech companies or research universities that rely on CDMOs for everything preclinical development to packaging have accounted for a large share of CGT development.

“There is increasing demand for Cell and Gene Therapy CTDMOs who can offer integrated development, manufacturing, and testing services. For CGT companies, outsourcing manufacturing and testing operations to a capable CTDMO can reduce development timelines, provide supplementary capacity, and ultimately control costs.” - Senior Director, Tier 1 CGT CDMO, US

Explore Premium Report on Cell & Gene Therapy (CGT) CDMO Market @ https://meditechinsights.com/cell-and-gene-therapy-cdmo-market/

Significant Outsourcing in CGT Industry due to Lack of Internal Capabilities

The level of outsourcing in CGT now approaches 60%, which is far higher than the level observed in the entire pharma/biologics industry. A high level of expertise is necessary in the complex field of cell & gene therapy. Also, it has costly production and different manufacturing process/infrastructure requirements as compared to traditional small molecules.

Big pharma currently lacks production-ready infrastructure and are increasingly looking for CGT CDMOs to enter/expand their presence in fast-growing CGT market. Additionally, the increasing number of small biotech’s entering the market with limited manufacturing capabilities and/or lack of expertise presents CGT CDMOs with additional growth opportunities.

North America is the Largest and Fastest Growing Region for Cell & Gene Therapy (CGT) CDMO Market

North America is projected to witness fastest growth and continue its dominance in the coming 5 years owing to growing manufacturing capacity for CGTs, favorable regulatory approval process, growing CGT approvals per year, and strong product pipeline of CGTs in the U.S.

Competitive Landscape Analysis of Cell & Gene Therapy (CGT) CDMO Market

The cell & gene therapy (CGT) CDMO market is marked by presence of both established players and several small and mid-sized players. Some of the leading players include Lonza, Catalent, Patheon, Wuxi Advanced Therapies and Charles River Laboratories. Other promising players include Vive Biotech, SK Bioscience, Fujifilm, Vibalogics, Exothera, Takara, Oxford Biomedica, Viralgen and AGC Biologics, among several others.

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[altasciences]

Bioanalysis in Drug Development

One of the essential parts of the drug development process is performing bioanalysis. You will need to perform bioanalysis before your drug can go to market, and even before it is tested in humans. You will also need bioanalysis results for regulatory submissions for your drug candidates. As such, it’s best to partner with a contract research organization with plenty of experience in bioanalysis to acquire fast, accurate results. Here is everything your organization needs to know about the importance of bioanalysis.

What Is Bioanalysis? Simply put, bioanalysis is a sub-discipline of analytical chemistry. Bioanalysis is quantitative, determining pharmacokinetics, the concentration of drugs, and their metabolites. It can also determine pharmacodynamic biomarkers in biological fluids, such as blood, plasma, or urine. Analyses can also be performed in tissues, which is used to understand the elimination, activity, and toxicity of a drug. How Is Bioanalysis Performed? Before bioanalysis can be performed, your assay must be validated. This demonstrates it is suitable for its intended purpose. There are a wide variety of assays that can be used for bioanalysis, but not all will be right for your drug. Some, for example, will only work with small-molecule compounds. A Good Laboratory Practices validated bioanalytical method is required to support your drug developmental cycle, during both toxicology and first in human clinical trials. When Is Bioanalysis Performed? Bioanalysis is performed in both drug discovery and drug development. During discovery, the aim of bioanalysis is to provide reasonable values for either concentrations or exposures. This is used for lead series identification or discrimination amongst lead candidates. Bioanalysis is required before any clinical trials to determine the drug’s safety profile. Validation is formalized and mandated. Testing may be done on animals for pharmacodynamics, PK, ADME (absorption, distribution, metabolism, and elimination), and toxicity. At the clinical stage, assays for human samples need to be more rugged and robust. They should withstand future testing, as this is the longest phase of development. Keep in mind, assays might require minor modifications as the drug changes slightly. Finding the Right CRO for Bioanalytical Services Bioanalysis results must be quantitative and valid, per FDA and worldwide regulatory guidances. These results form the foundation of drug approval. It’s essential that your results are accurate. This is why you should partner with a contract research organization that boasts experienced bioanalytical services. Regulatory authorities often audit these results for accuracy before approving the drug. Outsourcing to a CRO with experience and proven results means you have a much higher chance of getting accurate results that will be approved and validated. The CRO needs to have flexible bioanalytical services in order to adapt to any changes you need to make to the drug. You might consider choosing a CRO that offers bioanalytical services as part of a full drug development package to allow for reliable communication and synergy between teams. About Altasciences Drug development can be a complex process. Altasciences, a mid-sized contract research organization, can help make it more streamlined. This integrated CRO with pharmaceutical CDMO capabilities offers partners more than 25 years of research experience performing preclinical studies and clinical trials. Pharmaceutical and biotechnology companies have come to rely on the innovative, integrated approach that Altasciences uses. Partners gain the team’s expertise in studies on a wide variety of therapeutic indications. This includes significant experience in first-in-human clinical trials and CNS clinical trials. Altasciences also gives partners access to the CRO’s various resources, including over 580 beds, experienced and highly trained staff, and a recruiting database with more than 400,000 potential participants. When you need a partner for all your early clinical development needs, trust Altasciences. Partner with Altasciences for flexible bioanalytical services at https://www.altasciences.com/ Original Source: https://bit.ly/3xzfceJ

[neha24blog]

Small Molecule Innovator CDMO Market Outlook On The Basis Of End-Use, Region And Forecast From 2022 to 2030: Grand View Research Inc.

Small Molecule Innovator CDMO Market Outlook On The Basis Of End-Use, Region And Forecast From 2022 to 2030: Grand View Research Inc.

San Francisco, 25 March 2022: The Report Small Molecule Innovator CDMO Market Size, Share & Trends Analysis Report By Product (Small Molecule API, Small Molecule Drug Product), By Stage Type, By Customer Type, By Therapeutic Area, By Region, And Segment Forecasts, 2022 – 2030 The global small molecule innovator CDMO market size is expected to reach USD 74.9 billion by 2030, according to a new…

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Global Drug Discovery Outsourcing Market

Global Drug Discovery Outsourcing Market Size, Share, Growth, Industry Trends and Forecast 2020-2030

Drug discovery outsourcing is a process of inventing a new medicine in the field of pharmaceuticals, biotechnology, and pharmacology. Drug discovery is a very time consuming, complex, and expensive process and sometimes may have a low success rate. Usually, small pharmaceutical companies develop new drug molecules and sell the patent rights to big companies who can afford to conduct clinical trials and observe whether the drugs are suitable or not. Companies outsource their drug discovery process in order to focus on their core competencies like manufacturing, marketing, and product labelling. The companies providing outsourcing services for drug discovery are established companies with developed infrastructure, developed technological front, and skilled expertise. The global drug discovery outsourcing market is accounted approximate USD 2.5 billion in 2020 and it is expected to reach approximate USD 5.5 billion by 2030 with a CAGR of 8.3% during forecast period.

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Market Dynamics and Factors:

Rapid progression in technology, reduced approval time, and increasing strategic collaborations in the field of drug development are some of the major factors driving the growth of the drug discovery outsourcing market. For instance, AstraZeneca established multiple outsourcing partnerships with Cancer Research U.K, Cambridge Institute, University of Texas MD Anderson Cancer Centre, Medical Research Council Laboratory of Molecular Biology, and Academic Drug Discovery Consortium in 2014. Cost reduction, access to specialised knowledge and technology, and greater innovation are the major reasons because of which top pharmaceutical companies are opting for outsourcing their drug discovery process. Advancements in emerging technologies such as artificial intelligence and its implementation in drug discovery has also contributed towards the market growth. However, certain restraining factors like high price of drug discovery outsourcing, and increasing risk of drug failure are hindering the growth of the drug discovery outsourcing market. 

Market Segmentation:

Global Drug Discovery Outsourcing Market – By Workflow

Target Identification & Screening

Target Validation & Functional Informatics

Lead Identification & Candidate Optimization

Preclinical Development

Others

Global Drug Discovery Outsourcing Market – By Therapeutics Area

Respiratory System

Pain & Anesthesia

Oncology

Ophthalmology

Hematology

Cardiovascular

Endocrine

Gastrointestinal

Immunomodulation

Dermatology

Anti-Infective

Central Nervous System

Genitourinary System

Global Drug Discovery Outsourcing Market – By Drug Type

Small Molecules

Large Molecules

Global Drug Discovery Outsourcing Market – By Geography

North America

U.S.

Canada

Mexico

Europe

U.K.

France

Germany

Italy

Rest of Europe

Asia-Pacific

Japan

China

India

Australia

Rest of Asia Pacific

ROW

Latin America

Middle East

Africa

New Business Strategies, Challenges & Policies are mentioned in Table of Content, Request TOC at @ https://www.decisionforesight.com/toc-request/DFS020188

Geographic Analysis:

North America is expected to dominate the global drug discovery outsourcing market during the forecast period in terms of market share. The presence of a well-established research infrastructure; existence of a large pool of key players of the pharmaceutical industry; greater adoption of technological advancements; and huge investments in drug discovery research & development are some of the major factors attributing to the market dominance of the region. The Asia Pacific region is anticipated to be the fastest growing market during the forecast period. The growing number of clinical research organisations (CRO), contract manufacturing organisations (CMO), and contract development and manufacturing organisations (CDMO) in the region has resulted in huge trend of outsourcing manufacturing and R&D activities to China and India. This has fuelled the growth of the drug discovery outsourcing market in the APAC region. Government initiatives in the APAC nations to forge ties with U.S pharmaceutical companies is going to propel the market growth in the future. For instance, China launched the Market Authorisation Holder (MAH) pilot program, and as a result investments from venture capitalists increased in the nation’s biotech and pharmaceutical sector.        

Competitive Scenario:

The key players operating in the global drug discovery outsourcing market are –

Charles River Laboratories, Albany Molecular Research, Pharmaceutical Product Development LLC., Jubilant Biosys, Thermo Fisher Scientific Inc., Dalton Pharma Services, Laboratory Corporation of America Holdings, WuXi AppTec, Domainnex, Viva Biotech Ltd.

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How will this Market Intelligence Report Benefit You?

The report offers statistical data in terms of value (US$) as well as Volume (units) till 2030.

Exclusive insight into the key trends affecting the Global Drug Discovery Outsourcing industry, although key threats, opportunities and disruptive technologies that could shape the Global Drug Discovery Outsourcing Market supply and demand.

The report tracks the leading market players that will shape and impact the Global Drug Discovery Outsourcing Market most.

The data analysis present in the Global Drug Discovery Outsourcing Market report is based on the combination of both primary and secondary resources.

The report helps you to understand the real effects of key market drivers or retainers on Global Drug Discovery Outsourcing Market business.

The 2021 Annual Global Drug Discovery Outsourcing Market offers:

100+ charts exploring and analysing the Global Drug Discovery Outsourcing Market from critical angles including retail forecasts, consumer demand, production and more

15+ profiles of top producing states, with highlights of market conditions and retail trends

Regulatory outlook, best practices, and future considerations for manufacturers and industry players seeking to meet consumer demand

Benchmark wholesale prices, market position, plus prices for raw materials involved in Global Drug Discovery Outsourcing Market type

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Active Pharmaceutical Ingredients Market Top Companies Growth, Statistics Data, Upcoming Trends 2027

Market Overview

Active Pharmaceutical Ingredient Market size is anticipated to disclose a 4.96% CAGR and touch USD 215,125.4 Million by 2023. The active pharmaceutical ingredients share price has risen incrementally over the past few years due to medicinal properties. The drugs taken together with combined therapy have numerous active ingredients to treat a range of disorders. The various types of active pharmaceutical ingredients are prime elements in the production of drugs, and this global market is estimated to experience optimistic growth in the upcoming period.

also read @ https://www.medgadget.com/2019/12/share-valuation-of-active-pharmaceutical-ingredients-api-market-to-touch-usd-215125-4-million-during-2019-to-2023-marketresearchfuturr.html

Active Pharmaceutical Ingredients Market Segmentation

The worldwide API market has been segmented on the basis of manufacturing process, type of synthesis, API formulation, application, molecule.

In terms of manufacturing, the market can be fragmented into captive manufacturing and contract manufacturing. Out of these, the contract manufacturing segment can expect a profitable run during the review period at the highest growth rate, backed by the increasing trend of outsourcing of API manufacturing by the pharmaceutical companies, which lets them focus more on core competencies.

Depending on the synthesis, the market is considered for synthetic and biotech, wherein the synthetic API market is set to be unbeatable with the maximum share of the global market. Meanwhile, the biotech segment has displayed a considerable growth pattern in recent years, which is expected to surge further at a relatively higher CAGR owing to the reduced side effects of biotech synthesis. Furthermore, the biotech segment is split into monoclonal antibodies, recombinant proteins, vaccines, and others. At present, the monoclonal antibodies segment holds the top position, whereas the recombinant proteins segment is slated to expand at the fastest rate during the appraisal period as recombinant proteins find an increasing number of applications within the pharmaceutical industry.

With respect to the API formulation, the market is categorized as generic API and innovative API. Growing patent expirations have been responsible for the leading position of the generic API segment, at a projected CAGR of 4.62% during the conjectured time frame.

The market, application-wise, can be broken down into cardiovascular disease, oncology, neurological disorders, orthopedic disorders, respiratory, gastrointestinal, urology, and others. Here, the oncology segment is the current holder of the biggest market share, since the occurrences of cancer has surged at a substantial pace around the world. The segment is deemed to rise at a growth rate of 5.48% in the coming years.

The API market, on the basis of molecule, caters to small molecule and large molecule. Although the report identified the small molecule segment as the largest market in 2017, the large molecule segment is reckoned to cross the former’s valuation at a higher CAGR in the near future. The main reasons being the increasing focus on research and development of advanced APIs, including biologics that strive to meet with the unmet needs of patients.

Active Pharmaceutical Ingredients Market Regional Outlook

active pharmaceutical ingredients market include South America, Europe, Asia Pacific, North America, and the Middle East & Africa.

North America is spearheading the API market growth in the Americas, which in turn is leading the global market with the largest share. The crucial factors backing the said growth include the presence of a large number of prominent companies within the region. In addition, countries like the United States (U.S.) and Canada note high occurrences of chronic as well as neurological diseases, which is believed to be a prominent driver of the regional market growth.

Europe has bagged the second spot in the global API market, backed by the increasing number of initiatives within the region that support the development of generic drugs. Moreover, improving pricing, as well as reimbursement policies coupled with a huge number of manufacturing activities, is presenting multiple growth opportunities to the regional market.

As the active pharmaceutical ingredients market has reached the maturity phase in the developed countries around the globe, the market focus is shifting towards the Asia Pacific. This factor has substantiated the region as the fastest-growing market globally. The presence of a humungous patient population within countries like India and China paired with the rising incidences of chronic diseases in the region is poised to benefit the market in the subsequent years. On top of that, availability of cheap labor and need for low investments in infrastructure are encouraging several renowned pharmaceutical vendors to outsource manufacturing to Asia Pacific, opening the door for further market success.

Industry News

April 2019

OlonS.p.A., a global Active Pharmaceutical Ingredients (API) contract development and manufacturing organization (CDMO), has acquired a manufacturing facility in India. The facility’s primary product will be Rifampicin, which is used for treating a variety

Browse complete summary of this research report @ https://www.marketresearchfuture.com/reports/active-pharmaceutical-ingredients-market-1385

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