The global biosimilar contract manufacturing market is projected to be valued at US$ 10.70 billion in 2024. Biosimilars are biological therapeutics which are highly similar to an already approved biological reference product. Manufacturing biological drugs and biosimilars require specialized equipment and manufacturing capacities. Contract manufacturing organizations provide an effective solution for companies to develop and manufacture biosimilars without investing heavily in infrastructure development. The demand for cost-effective biologics is increasing owing to the patent expiry of major biologics and rising healthcare costs.
Global Biosimilar Contract Manufacturing Market is estimated to be valued at USD 10.70 Bn in 2024 and is expected to reach USD 30.03 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 15.9% from 2024 to 2031.
Key Takeaways
Key players operating in the biosimilar contract manufacturing are Samsung Biologics, Biocon, Amgen, copyright, Boehringer Ingelheim, Lonza, Catalent, Wuxi Biologics, AbbVie, Merck KGaA, Rentschler Biopharma, Almac Group, Fujifilm Diosynth Biotechnologies, Evonik Industries, and Avid Bioservices. These players have significant manufacturing capacities and capabilities to develop complex biosimilars.
The key opportunities Biosimilar Contract Manufacturing Market Demand include niche applications of biosimilars in the oncology segment and orphan diseases. Development of specialized formulations such as injectables and biosimilars for chronic diseases will also offer growth prospects.
North America and Europe dominate the global biosimilar contract manufacturing market. However, Asia Pacific is expected to witness the fastest growth owing to increasing investments by contract manufacturers in China, India, and South Korea. These countries offer cost advantages and favorable business environments. Several contract manufacturers are expanding their presence in emerging markets through acquisitions and partnerships.
Market drivers
The increasing demand for biosimilars due to patent expiry of major blockbuster biologics such as Humira, Herceptin, Avastin, and others is a major market driver. This provides significant opportunities for contract manufacturers. Rising R&D investments by pharmaceutical companies for biosimilar development is also propelling the market growth.
Market restraints
High capital investments required for establishing biosimilar manufacturing facilities pose significant challenges, especially for small players. Stringent regulatory requirements for biosimilar development and manufacturing also restrain the market growth. Manufacturing complexities related to maintaining product quality and consistency can hamper contract manufacturing operations.
Segment Analysis
Within the biosimilar contract manufacturing market, the cell culture segment dominates. This is because cell culture provides high product yields, allows for close monitoring and control of product quality during manufacturing, and enables production of complex therapeutic proteins. Furthermore, advancements in cell culture techniques such as fed-batch and perfusion have increased product titers, thereby driving the adoption of cell culture based production. This sub-segment within contract manufacturing handles all steps involved in cell culture operations including upstream and downstream processing.
Global Analysis
Regionally, North America commands the largest share in the Biosimilar Contract Manufacturing Market Regional Analysis owing to presence of well-established CMOs and favorable regulatory environment. However, Asia Pacific is emerging as the fastest growing regional market due to increasing biosimilar approvals, growing biopharmaceutical industry, and presence of low-cost CMOs offering end-to-end services. Countries such as China and India are attracting major investments owing to availability of skilled workforce and excipients at competitive costs. Europe follows North America in terms of market share and is expected to witness steady growth over the forecast period.
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Money Singh is a seasoned content writer with over four years of experience in the market research sector. Her expertise spans various industries, including food and beverages, biotechnology, chemical and materials, defense and aerospace, consumer goods, etc. (https://www.linkedin.com/in/money-singh-590844163)