The global industry was valued at US$ 38.9 Bn in 2022 and is expected to register a CAGR of 7.1% from 2023 to 2031.
WILMINGTON, Del., July 29, 2024 /PRNewswire/ -- Biomanufacturing has the potential to manufacture many of the drugs we use today, particularly biologics and biosimilars. Active Pharmaceutical Ingredients (APIs) play an essential role in manufacturing biologically active substances. They serve as the active core of various drugs, including the nearly 20,000 drugs approved by the FDA.
Extensive use of biologically active substances in the development of innovative and effective pharmaceutical drugs is contributing to the global biotech API manufacturing services market size, which is expected to register a CAGR of 7.1% from 2023 to 2031 to surpass US$ 73.0 Bn by 2031, according to Transparency Market Research (TMR), a leading global market research firm.
Demand for biologics, biosimilars, and other biopharmaceuticals is growing at a rapid pace as they offer high efficacy and few side effects. Moreover, existing treatment archetypes are evolving and becoming more sophisticated all the time. Such a landscape requires a significant transformation in R&D, technology, and operations.
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Biotech API manufacturing services are playing a major role in this transformation by enabling the development of advanced pharmaceutical products and innovative treatment options. These products include complex proteins, enzymes, hormones, and other important biologically active substances.
TMR's recent Biotech API Manufacturing Services MarketReport offers in-depth insights into the drivers and restraints of the market. It also highlights various opportunities and challenges in the industry and the post-COVID-19 market scenario.
Biotech API Manufacturing Services Market Key Insights
- North America dominated the market share in 2022
- Asia Pacific is estimated to record rapid growth during the forecast period
- Based on the scale of operation, the large-scale segment accounted for the largest share in 2022
Global Biotech API Manufacturing Services Market Trends
- Contract Manufacturing is the New Growth Stimulant
Emerging economies in many regions have positioned themselves as the go-to hub for biotech API manufacturing. India and China offer potential growth opportunities for players operating in the market.
International pharmaceutical companies are looking to reduce production costs by gaining access to these growing markets. They are engaged in technology transfer to emerging economies to benefit their R&D outsourcing. These initiatives bolstered the supply of various biopharmaceutical products and essential vaccines worldwide.
A lucrative R&D outscoring sector incentivizes several regional companies to expand their API portfolio. These companies are supplying APIs to major U.S.-based companies involved in the manufacture of orphan drugs, addiction treatment, and obesity medications.
In July 2024, Rusan Pharma Private Limited was granted Good Manufacturing Practice (GMP) approval by the FDA. The approval for the company's API manufacturing facility in Gujarat, India, marks a critical step in its expansion into the North America API market.
- Fermentation Infrastructure Gaining Traction in Small-Molecule API Synthesis
Small molecule APIs have broadened their use beyond drugs in medicines and are making their way to pesticides in farming. Their low molecular weight offers some distinct advantages as therapeutics.
Most drugs manufactured from small molecule APIs can be administered orally and they can pass through cell membranes to reach intracellular targets. In novel cancer therapeutics, small molecules can be used as anticancer drugs that inhibit certain proteins in cancer cells. High prevalence of cancer has led to significant investment in biological and analytical advances in the biotech API manufacturing services market landscape.
Biological and analytical advances enable modern fermentation processes to develop safe and effective next-generation drugs. These benefits have prompted stakeholders in the overall API manufacturing sector to provide high-quality fermentation manufacturing services. This is attracting drug manufacturers to leverage fermentation sites, thereby boosting the biotech API manufacturing services market expansion.
In March 2024, Antheia, an API manufacturer, partnered with Olon Group, a developer and manufacturer of APIs for CDMO and generic markets, to leverage Olon's vast fermentation infrastructure to manufacture Antheia's early products.
Biotech API Manufacturing Services Market Report Scope:
Report Coverage | Details |
Forecast Period? | 2023-2031 |
Base Year? | 2020-2022 |
Size in 2022 | US$ 38.9 Bn |
Forecast (Value) in 2031 | US$ 73 Bn |
Growth Rate (CAGR) | 7.1 % |
No. of Pages | 105 Pages |
Segments covered | By Service Type, By Scale of Operations, By Region |
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Biotech API Manufacturing Services Market Regional Insights
The global market was valued at US$ 38.9 Bn in 2022. North America was the leading contributor to the market value in 2023. The region is expected to maintain its dominance during the forecast period.
Asia Pacific is the fastest-growing market for biotech API manufacturing services. The region is benefitting from the availability of low-cost labor and international pharma companies seeking to reduce production costs.
- R&D Next-generation Diabetes Treatment Positioning North America at the Top
Many individuals find it difficult to maintain a healthy lifestyle in our modern world. This has led to a high prevalence of lifestyle diseases, especially in North America and many developed economies.
Prevalence of type 2 diabetes mellitus is predicted to increase dramatically in the region in the near future. To counteract the resulting impact on morbidity and mortality, stakeholders in the pharma sector in North America are developing next-generation diabetes treatment solutions.
Synthetic medicine API manufacturing is likely to play a major role in North America's efforts toward effective diabetes drugs. This has prompted many companies, including Eli Lilly and Novo Nordisk, to boost their synthetic medicine API manufacturing capabilities.
Eli Lilly, in May 2024, announced plans to invest an additional US$ 5.3 Bn to build a massive manufacturing complex, 30 miles away in Lebanon, Indiana. The expenditure is expected to boost API production for Indianapolis-based drugmaker's injected tirzepatide products Mounjaro, for type 2 diabetes, and Zepbound, for obesity. With this investment, Eli Lilly aims to catch up with the diabetes drug market leader Novo Nordisk and also expand its biotech API manufacturing services market share.
Leading Players in Biotech API Manufacturing Services Industry
Lonza Group Ltd., WuXi AppTec Co., Ltd., Boehringer Ingelheim Biopharmaceuticals GmbH (Boehringer Ingelheim International GmbH), CordenPharma International, Sterling Pharma Solutions, AbbVie, Inc., Hikal Ltd., Almac Group, FUJIFILM Diosynth Biotechnologies, Abzena Ltd., Regis Technologies, Inc., Rentschler Biopharma SE, and Catalent, Inc. are the prominent players in the market.
Key Strategies by Biotech API Manufacturing Services Market Players
- Leveraging Advancements in High-Potency API
High prevalence of cancer worldwide has led to significant hustle in the field of oncology, creating a need for high-potency APIs. To better serve this growing need, Contract Development and Manufacturing Organizations (CDMOs) in developing countries are leveraging recent advancements in technology related to High-Potency API (HPAPI) manufacturing to expand their capacity to serve the diverse needs of customers.
For instance, in January 2023, Sai Life Sciences, an India-based CDMO, started a new HPAPI manufacturing facility at its Bidar Campus in the Karnataka state of India. With this facility, the company seeks to expand its expertise across HPAPI development and manufacturing.
Biotech API Manufacturing Services Market Segmentation
Service Type
- API Process Development & Manufacturing
- Analytical Testing & Quality Control
- Regulatory Support Scale-up & Commercial Manufacturing
Scale of Operation
- Small-scale
- Mid-scale
- Large-scale
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