Biologics Outsourcing Market expected to reach $45.95 billion, globally, by 2030 at 12.9% CAGR- Exclusive Report by Coherent Market Insights

Burlingame, July 25, 2023 (GLOBE NEWSWIRE) -- Coherent Market Insights published a report, titled, “Biologics Outsourcing Market, By Product and Service Type (Product, (Antibodies, Recombinant Proteins, Vaccines, Others), Services, (Cell Development, Process Development, Analytical Testing, cGMP Manufacturing, Others)), By Source (Mammalian, Microbial), By Application (Oncology, Cellular and Gene Therapy, Blood & Blood-Related Products Development, Vaccine Development, Stem Cell Research, Others) By End User (Pharmaceutical Industries, Biotechnology Industries, CDMO) - Size, Share, Outlook, and Opportunity Analysis, 2023 - 2030” According to the report, Global Biologics Outsourcing Market is estimated to be valued at US$ 19.67 Billion in 2023 and is expected to exhibit a CAGR of 12.9% during the forecast period (2023-2030).

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Analysts’ Views on Global Biologics Outsourcing Market:

Global biologics outsourcing market growth can be driven by increasing manufacturing facilities by major market players for the development of biologics. For instance, in December 2022, Thermo Fisher Scientific Inc., a scientific instrumentation, reagents and consumables, and software services providing company, announced the launch of its new facility to strengthen biologics and sterile development and manufacturing capabilities in Hangzhou, China and expanded its presence in the Asia Pacific region.

Key Trends and Analysis of the Global Biologics Outsourcing Market:

Increasing inorganic activities such as acquisition by key market players is expected to drive the market growth over the forecast period. In February 1, 2022, Recipharm, a global contract development and manufacturing organization (CDMO), announced the acquisition of GenIbet, a CDMO, specializing in the manufacturing of biological clinical trial material and novel modalities such as viral vectors, RNA, and microbiome. The acquisition forms part of Recipharm’s strategy to grow in the biologics outsourcing market, with a particular focus on drug substance manufacturing of novel Advanced Therapy Medicinal Products (ATMPs).

Global Biologics Outsourcing Market - Drivers

Launch of contract development and manufacturing facility

Major companies operating in the global biologics outsourcing market are focused on growth strategies such as launch of contract development and manufacturing services facility that is expected to drive growth of the global biologics outsourcing market over the forecast period. In June 2022, KBI Biopharma SA, a biotechnology research company, and Selexis SA, a subsidiary of JSR Life Sciences companies – a biopharmaceutical company, announced the launch of its fully-integrated mammalian contract development and manufacturing services facility in Geneva, Switzerland. The mammalian contract development and manufacturing services facility has opened and operational in Geneva, Switzerland.

Increasing number of approval for new manufacturing facility by regulatory bodies

Increasing number of approval for new biopharmaceutical manufacturing facility by regulatory bodies is expected to drive the demand of Biologics Outsourcings over the forecast period. In February 2020, EirGenix, Inc., a contract development and manufacturing organization providing services to manufacture biologics, received the approval for new facility, from the Pharmaceutical and Medical Devices Agency (PMDA), under Japan's Ministry of Health, Labor, and Welfare after the on-site inspection of EirGenix's biopharmaceutical manufacturing facility from September 9 to 12, 2019. On February 3, 2020, EirGenix received the Pharmaceutical and Medical Devices Agency’s (PMDA) official approval in its issued 'GMP Compliance Inspection Result Notification', proclaiming EirGenix's compliance with relevant Japanese regulations regarding the quality, effectiveness, and safety of pharmaceutical manufacturing.

Biologics Outsourcing Market Report Coverage

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Global Biologics Outsourcing Market - Restraint

Compliance with stringent regulatory guidelines

Regulations are sets of standards and norms that manufacturers must follow to ensure maximum public protection from the developed products. Biological product regulation involves the overall management system to secure high levels of safety and quality of biological products.

Stringent regulatory guidelines mandated by different regulatory bodies for biologic products is expected to hamper the market growth over the forecast period.

Approval of biologics in the U.S. requires a Biologics License Application (BLA). Due to the nature of biologics, which are produced by living cells, the process as well as the product must be validated and strictly monitored against Critical Quality Attribute (CQAs) throughout the manufacturing process, not just at the end as for chemistry-based drugs.

Global Biologics Outsourcing Market - Opportunity

Increasing number of Government Initiatives

Increasing government initiatives for development of biologic products is expected to offer lucrative growth opportunities for players in the global biologics outsourcing market, over the forecast period. For instance, in September 2022, the U.S. FDA partnered with National Institute of Standards and Technology (NIST), an agency of the United States Department of Commerce, to develop and benchmark methods to study and predict stability of monoclonal antibodies (mAbs) and other large molecules used for vaccines and therapeutics.

Global Biologics Outsourcing Market Cross Sectional Analysis:

Among product and service type segment, services segment is dominant in North America region, due to increasing inorganic strategies such as acquisition by key market. For instance, in February 2021, Charles River Laboratories International, Inc., a pharmaceutical company, announced that it has acquired Cognate BioServices, Inc., a premier, cell and gene therapy contract development and manufacturing organization (CDMO) for cell and gene therapy development. This acquisition will help Charles River Laboratories International, Inc. to expand its manufacturing capacity and increase its product portfolio.

Global Biologics Outsourcing Market Segmentation:

The global biologics outsourcing market report is segmented into product and service type, source, application, end user and region.

Based on product and service type, the market is segmented into Product and Services. Product segment is expected to dominate the biologics outsourcing market during the forecast period, due to increasing inorganic strategies such as acquisition and partnership to increase the production and manufacturing capacity.

Based on source, the market is segmented into Mammalian and Microbial. Out of which, Mammalian is expected to dominate the market over the forecast period, due to Increasing adoption of inorganic growth strategies such as acquisitions.

Based on application, the biologics outsourcing market is segmented into Oncology, Cellular and Gene Therapy, Blood & Blood-Related Products Development, Vaccine Development, Stem Cell Research, and Others. Oncology segment is expected to dominate the market over the forecast period, due to increasing number of cancer research and development.

Global Biologics Outsourcing Market: Key Developments

In January 2021, ICON plc, a global provider of outsourced drug & device development and commercialization services to the pharmaceutical companies, biotechnology, medical device industries, government, and public health organizations, announced that it has provided clinical trial services to Pfizer Inc., a multinational pharmaceutical and biotechnology corporation, and to the BioNTech SE, a Germany-based biotechnology company.

Key Market Takeaways:

Global Biologics Outsourcing Market is expected to exhibit a CAGR of 12.9% during the forecast period, due Increasing facility expansion by the key market players. For instance, in September 2022, FUJIFILM Diosynth Biotechnologies, a global contract development and manufacturing organization (CDMO) for biologics, vaccines, and advanced therapies, expanded its large scale microbial manufacturing facility at its Billingham, U.K. campus in order to accommodate increasing demand for microbial development and manufacturing services.

Among Application, Cellular and Gene Therapy segment is dominant due to increasing adaptation of inorganic growth strategies such as acquisitions by key market players, is expected to drive the segment growth over the forecast period. For instance, in July 2022, SOLVIAS AG, a company specialized in contract research, development, and manufacturing, acquired Cergentis B.V., a genomics-focused biotechnology company providing services and in-house solutions based on its proprietary genomic analysis platform. With the acquisition of Cergentis B.V., SOLVIAS AG will be able to provide an expanded platform of testing services, including customized support for distinct genetic engineering applications, including cell and gene therapy, cell line development, and genetically engineered models to pharmaceutical, biotech, and contract development and manufacturing organizations developing genetically engineered therapies.

On the basis of end user, CDMO segment is expected to grow over the forecast period, increasing adoption of strategies such as partnerships between key market players to accelerate contract development and manufacturing organization (CDMO) and clinical research services. For instance, in August 2022, Porton Advanced Solution Ltd., a Cell and Gene Therapy (CGT) CDMO, and Kun Tuo Medical Research and Development (Beijing) Co., Ltd., a full-service Contract Research Organization (CRO) based in China, entered into a strategic partnership for gene and cell therapy research and development, and manufacturing and clinical services to accelerate the development and industrialization of innovative drugs.

Competitive Landscape:

Key players operating in the Global Biologics Outsourcing Market include Thermo Fisher Scientific Inc., Abzena Ltd. Fujifilm Diosynth Biotechnologies, KBI Biopharma, EirGenix, Inc., Curia Global, Inc., Bionova Scientific, Inc., Boehringer Ingelheim International GmbH., STC Biologics., Abbvie Inc., Avid Bioservices, Inc., Catalent Inc., Emergent, Eurofins Scientific, Genentech, Inc., Genscript Biotech Corporation, Jsr Corporation, Lonza, Merck KGaA, Rentschler Biopharma SE.

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Market Segmentation:

• Global Biologics Outsourcing Market, By Product and Service Type:
  • Product
    • Antibodies
    • Recombinant Proteins
    • Vaccines
    • Others
  • Services
    • Cell Development
    • Process Development
    • Analytical Testing
    • cGMP Manufacturing
    • Others
• Global Biologics Outsourcing Market, By Source:
  • Mammalian
  • Microbial
• Global Biologics Outsourcing Market By Application:
  • Oncology
  • Cellular and Gene Therapy
  • Blood & Blood-Related Products Development
  • Vaccine Development
  • Stem Cell Research
  • Others
• Global Biologics Outsourcing Market By End User:
  • Pharmaceutical Industries
  • Biotechnology Industries
  • CDMO
• Global Biologics Outsourcing Market, By Region:
  • North America
    • By Country:
      • U.S.
      • Canada
  • Latin America
    • By Country:
      • Brazil
      • Mexico
      • Argentina
      • Rest of Latin America
  • Europe
    • By Country:
      • Germany
      • U.K.
      • France
      • Italy
      • Spain
      • Russia
      • Rest of Europe
  • Asia Pacific
    • By Country:
      • China
      • India
      • Japan
      • Australia
      • South Korea
      • ASEAN
      • Rest of Asia Pacific
  • Middle East
    • By Country:
      • GCC
      • Israel
      • Rest of Middle East
  • Africa
    • By Country/Region:
      • South Africa
      • Central Africa
      • North Africa
        
        

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