Biopharmaceutical CMO Downstream Processing Market Size, Share, Growth, 2034

Market Overview
According to Fortune Business Insight, The global biopharmaceutical CMO downstream processing market size was valued at USD 3.83 billion in 2024. The market is projected to grow from USD 4.18 billion in 2025 to USD 13.65 billion by 2032, exhibiting a CAGR of 16.1% during the forecast period.
The market growth is attributed to the rising demand for biologics and biosimilars, expansion in contract manufacturing services, and innovation in purification technologies. Additionally, rising approvals of biosimilars and regulatory pressure for efficient manufacturing practices are compelling companies to adopt advanced downstream technologies.

Major Players Profiled in the Market Report:
• Samsung Biologics (Republic of Korea)
• Lonza (Switzerland)
• Recipharm AB (Sweden)
• WuXi Biologics (China)
• FUJIFILM (FUJIFILM Diosynth Biotechnologies) (Japan)
• Siegfried Holding AG (Switzerland)
• Cambrex Corporation (U.S.)
• Catalent, Inc. (U.S.)
• Thermo Fisher Scientific Inc. (Patheon) (U.S.)

Segments
Major Emphasis on Product Purification to Boost Segment Growth
Based on technique, the market is segmented into purification, concentration, and others. The purification segment is expected to hold the highest share, driven by its critical role in removing impurities, host cell proteins, and DNA fragments to ensure product safety and regulatory compliance.

Major Focus on Manufacturing through Mammalian Source to Accelerate Segment Growth
Based on source, the market is categorized into non-mammalian and mammalian. The mammalian segment held a significant market share in 2024 due to the high number of regulatory-approved products based on mammalian systems and their extensive usage in R&D.

High Production of Biologics to Dominate the Market During the Forecast Period
Based on product, the market is fragmented into biosimilars and biologics. The biologics segment held a dominant share in 2024 owing to the strong focus of manufacturers on developing monoclonal antibodies and vaccines. The biosimilars segment is poised to witness strong growth due to cost-effectiveness and increasing demand.

Source: https://www.fortunebusinessinsights.com/biopharmaceutical-cmo-downstream-processing-market-114912

Report Coverage
The report offers:
• Major growth drivers, restraining factors, opportunities, and potential challenges for the market.
• Comprehensive insights into regional developments and market shares.
• List of major industry players and their profiles.
• Key strategies adopted by the market players.
• The latest industry developments including product launches, partnerships, mergers, and acquisitions.
• Impact of COVID-19 and trends regarding single-use technologies.

Drivers & Restraints
Robust Pipeline and Rising Demand for Biologics to Boost Market Growth
The increasing demand for biologics to treat chronic conditions is driving the need for efficient downstream processing. As pharmaceutical companies invest heavily in drug development pipelines, the complexity of these products necessitates specialized purification and formulation steps. The rising number of FDA approvals—such as the 18 biologics approved in 2023—further accelerates the demand for contract manufacturing services.

High Cost of Equipment and Operations Deter Market Growth
The high cost associated with equipment procurement, maintenance, and operational complexities is a prominent restraining factor. The need for stringent validation, skilled workforce salaries, and the capital expense of stainless-steel manufacturing facilities (which can reach hundreds of millions of dollars) creates a financial barrier that may impact scalability.

Regional Insights
North America Dominates Market Share Due to Contract Manufacturing Presence
North America dominated the global market in 2024 with a value of USD 1.63 billion. The region’s dominance is attributed to the high concentration of contract manufacturing companies and massive investments in expanding production capabilities.

Asia Pacific to Witness Highest CAGR
Asia Pacific is expected to witness the highest CAGR during the forecast period. This growth is driven by increasing investments by leading companies, expanding healthcare infrastructure, and rising research and development activities in countries like China, Japan, and India.

Biopharmaceutical CMO Downstream Processing Market Future Growth:
The market is poised for significant expansion driven by the global growth of biosimilars, particularly in emerging markets where affordability is key. As patents for blockbuster biologics expire, manufacturers are pursuing cost-effective alternatives, creating opportunities for downstream processing providers. A major trend shaping the future is the shift toward single-use technologies. These disposable systems (filters, bioreactors) are replacing traditional stainless-steel setups due to their operational flexibility, lower capital investment, and reduced risk of cross-contamination. Additionally, the adoption of modular and scalable systems will allow manufacturers to meet diverse product demands efficiently.

Competitive Landscape
Strategic Partnerships and Introduction of Advanced Products Drive Revenue Growth
The market is highly fragmented with major players like Lonza, Catalent, and Thermo Fisher Scientific leading the way. These companies are focusing on massive investments, capacity expansion, and technological advancements to maintain market share. Strategies include robust R&D activities and partnerships to expand service portfolios, such as Samsung Biologics' collaboration with Kurma Partners.

Key Industry Development
• October 2024: LenioBio and Recipharm collaborated to boost vaccine production.
• October 2024: Recipharm AB partnered with Exela Pharma Sciences to enhance sterile manufacturing capabilities in the U.S.
• June 2024: WuXi Biologics installed three sets of 5,000L single-use bioreactors at its Hangzhou facility, increasing capacity to 23,000L.