Visiongain has published a new report on “Biological Drug API Manufacturing Services Market,2021-2031”. Forecasts by Manufacturing Type (Outsourced, In-house), Expression Platform (Mammalian Cell Cultures, Microbial Fermentations, Others), Application (Vaccines, MABs, Insulin Analogues, Interferon Therapies, Human Growth Hormones, Other Therapeutic Areas), Region (North America, Europe, Asia Pacific, Latin America, Middle East & Africa), PLUS COVID-19 Recovery Scenarios.
The global biological drug API manufacturing services market is segmented based on regions namely North America, Europe, Asia Pacific, Latin America, and Middle East and Africa.
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Which Factors are Fuelling Biological Drug API Manufacturing Services Industry Growth?
- Biological Patent Expirations to Fuel Market Growth
- Growing Investments in Orphan Drugs
- Outsourcing as a Driver for Market Growth
- Emerging Economies to Offer Lucrative Growth Opportunities
- Single Use Technology Will Become Essential Over the Next Decade
Which Factors Are Restraining Biological Drug API Manufacturing Services Industry Growth?
- Manufacturing APIs for Biologics to Restrain Market Growth
- Pricing Pressure to Impede Market Growth Through 2031
- Regulatory Scenarios to Restrain Market Growth
- Excessive Production is Projected to Impede Market Growth
- API Production is a Challenging Task
Emerging Economies to Fuel Biological Drug API Manufacturing Services Market Growth Through 2031
Between 2021 and 2031, the Indian biological drug API manufacturing services submarket will grow with the highest CAGR of 16.2%. However, in 2020, this submarket was valued at US$210.6 million, indicating the small number of companies participating in this market. Demand in the early years of the forecast period will come from multinational biotech looking to sign deals with Indian companies and take advantage of the cheaper costs of production for the emerging market. Biocon is an Indian biopharmaceutical manufacturer of generic APIs that are sold in the US and EU markets, and additionally sold domestically in Indian market. In June 2019, Biocon received the European drug regulatory agency's approval for its facilities in Bengaluru, enabling it to continue and enhance its biosimilar production for the European market. The company received the certificate of GMP compliance from EMA for its Biologics Drug Product and Drug Substance facilities at Biocon Park, Bengaluru post inspection in March 2019. From the middle of the forecast period, there will be greater development of novel biologics in India, although many companies developing these products will already have an established presence in the biosimilars industry and therefore will have their own manufacturing facilities. By 2031, the Indian submarket will be worth US$ 1,076.7 million.
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API Production is a Challenging Task
The process behind API production or complex as large molecules such as monoclonal antibodies are difficult to synthesize and take a lot of time and effort to produce. It often requires a multi-step process which is long and needs a lot of financial investment. However monoclonal antibodies also represent the most lucrative market as they can be used in biosimilars. Visiongain expects many of the biotech CMO currently in the market need to focus on the production and manufacturing of monoclonal antibodies for the future.
Competitive Landscape
Some of the companies profiled in the report include Bristol-Myers Squibb Co., Samsung Biologics, AbbVie, GSK Biopharmaceuticals, Lonza Group Ltd., NEKTAR THERAPEUTICS, Boehringer, Patheon N.V., Cytovance Biologics, and Fujifilm Diosynth Biotechnologies, among others.
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