Biosimilar Contract Manufacturing

Global Biosimilar Contract Manufacturing Market to Reach US$23.1 Billion by 2030

The global market for Biosimilar Contract Manufacturing estimated at US$9.8 Billion in the year 2024, is expected to reach US$23.1 Billion by 2030, growing at a CAGR of 15.5% over the analysis period 2024-2030. Recombinant Non-glycosylated Proteins, one of the segments analyzed in the report, is expected to record a 17.9% CAGR and reach US$15.8 Billion by the end of the analysis period. Growth in the Recombinant Glycosylated Proteins segment is estimated at 11.2% CAGR over the analysis period.

The U.S. Market is Estimated at US$2.7 Billion While China is Forecast to Grow at 21.0% CAGR

The Biosimilar Contract Manufacturing market in the U.S. is estimated at US$2.7 Billion in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$5.1 Billion by the year 2030 trailing a CAGR of 21.0% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 11.1% and 14.0% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 12.4% CAGR.

Global Biosimilar Contract Manufacturing Market – Key Trends & Drivers Summarized

Why Is Biosimilar Contract Manufacturing Becoming a Cornerstone of Biopharmaceutical Production?

The biosimilar contract manufacturing market is witnessing rapid growth as pharmaceutical companies seek cost-effective and scalable solutions to produce biologic alternatives. Biosimilars, which are biologic medicines highly similar to already approved reference drugs, offer a more affordable alternative to expensive biologics used in treating chronic diseases such as cancer, autoimmune disorders, and diabetes. However, the complex manufacturing processes involved in biosimilar production—requiring advanced biologic expertise, regulatory compliance, and specialized facilities—have led many pharmaceutical companies to partner with contract development and manufacturing organizations (CDMOs) to streamline production.

The rising demand for biosimilars, driven by patent expirations of blockbuster biologics, cost-containment measures by healthcare providers, and regulatory support for biosimilar adoption, has fueled the need for high-quality contract manufacturing services. CDMOs specializing in biosimilars provide end-to-end solutions, including cell line development, process optimization, large-scale bioprocessing, and regulatory compliance support. With the growing emphasis on biologics affordability and global market expansion, biosimilar contract manufacturing is playing a crucial role in enhancing accessibility while reducing production costs for pharmaceutical companies.

How Are Technological Advancements Enhancing Biosimilar Contract Manufacturing?

Advancements in bioprocessing technologies, including single-use systems, high-throughput cell line development, and process analytical technology (PAT), are revolutionizing biosimilar contract manufacturing. One of the most significant innovations is the adoption of single-use bioreactors, which allow flexible and scalable production while minimizing contamination risks and operational costs. These bioreactors enable CDMOs to quickly adjust production capacities based on market demand, improving efficiency and reducing manufacturing turnaround times.

Another major breakthrough in biosimilar manufacturing is the integration of artificial intelligence (AI) and machine learning (ML) in process optimization. AI-driven predictive analytics enable CDMOs to fine-tune bioprocessing conditions, enhance yield, and ensure batch-to-batch consistency. Additionally, advancements in biosimilar characterization techniques, such as high-resolution mass spectrometry and bioassays, are improving the comparability assessment between biosimilars and their reference biologics. The adoption of continuous bioprocessing is also transforming the industry, allowing for real-time monitoring and reducing production costs compared to traditional batch processing. As these technological advancements continue to enhance biosimilar manufacturing efficiency, contract manufacturers are increasingly becoming strategic partners for pharmaceutical companies looking to accelerate market entry and maintain high-quality production standards.

Which Market Trends Are Driving the Growth of Biosimilar Contract Manufacturing?

The rising demand for cost-effective biologics and the increasing acceptance of biosimilars in global healthcare markets are major trends fueling the biosimilar contract manufacturing sector. One of the most significant trends shaping the industry is the growing pipeline of biosimilar products, particularly in oncology, immunology, endocrinology, and hematology. With multiple patents on blockbuster biologics expiring, pharmaceutical companies are racing to develop biosimilar alternatives, driving the need for reliable and scalable contract manufacturing solutions.

Another key trend shaping the market is the expansion of biosimilar adoption in emerging markets, where governments are implementing policies to improve access to affordable biologics. Countries such as China, India, and Brazil are witnessing increased biosimilar approvals and investments in local biopharmaceutical infrastructure, prompting CDMOs to establish regional production facilities. Additionally, the rise of hybrid manufacturing models—where pharmaceutical companies outsource only specific segments of biosimilar production, such as cell line development or fill-finish services—is providing flexibility in manufacturing partnerships. Regulatory agencies, including the FDA and EMA, are also supporting biosimilar adoption through streamlined approval pathways, further driving market growth.

What Are the Key Growth Drivers Shaping the Future of the Biosimilar Contract Manufacturing Market?

The growth in the biosimilar contract manufacturing market is driven by multiple factors, including increasing regulatory support, cost pressures on healthcare systems, and the expansion of biosimilar portfolios. One of the primary growth drivers is the need for pharmaceutical companies to reduce development and production costs while maintaining compliance with stringent regulatory requirements. Contract manufacturing allows biopharma firms to leverage specialized expertise, state-of-the-art infrastructure, and regulatory knowledge, minimizing the risks and expenses associated with in-house biologics production.

Another crucial driver shaping the market is the increasing role of strategic collaborations and partnerships. Large pharmaceutical companies are forming alliances with CDMOs to accelerate biosimilar commercialization while optimizing supply chain efficiency. Additionally, the growing integration of biosimilar contract manufacturing with personalized medicine and next-generation biologics is opening new opportunities for innovation. As the demand for biosimilars continues to rise and manufacturing technologies evolve, contract manufacturing organizations are poised to play an even greater role in expanding global biosimilar accessibility, ensuring high-quality production, and driving cost efficiency across the biopharmaceutical industry.

SCOPE OF STUDY:

The report analyzes the Biosimilar Contract Manufacturing market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:
Product Type (Recombinant Non-glycosylated Proteins, Recombinant Glycosylated Proteins); Production Technology (Mammalian Technology, Non-Mammalian Technology); Application (Oncology Application, Blood Disorders Application, Growth Hormonal Deficiency Application, Chronic and Autoimmune Disorders Application, Rheumatoid Arthritis Application, Other Applications)

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa.

Select Competitors (Total 44 Featured) -

• AGC Biologics
• Alcami Corporation Inc.
• Almac Group
• Avid Bioservices, Inc.
• Biocon Ltd.
• Boehringer Ingelheim International GmbH
• Catalent Inc.
• Cell Therapies Pty Ltd
• Charles River Laboratories International, Inc.
• Element Materials Technology
• FujiFilm Diosynth Biotechnologies U.S.A., Inc.
• Fujifilm Kyowa Kirin Biologics Co., Ltd.
• IQVIA, Inc.
• KBI Biopharma
• Kemwell Biopharma Pvt., Ltd.
• Miltenyi Biotec GmbH
• Minaris Regenerative Medicine
• Rentschler Biopharma SE
• Samsung BioLogics Co., Ltd.
• Thermo Fisher Scientific, Inc.

TARIFF IMPACT FACTOR

Our new release incorporates impact of tariffs on geographical markets as we predict a shift in competitiveness of companies based on HQ country, manufacturing base, exports and imports (finished goods and OEM). This intricate and multifaceted market reality will impact competitors by artificially increasing the COGS, reducing profitability, reconfiguring supply chains, amongst other micro and macro market dynamics.

We are diligently following expert opinions of leading Chief Economists (14,949), Think Tanks (62), Trade & Industry bodies (171) worldwide, as they assess impact and address new market realities for their ecosystems. Experts and economists from every major country are tracked for their opinions on tariffs and how they will impact their countries.

We expect this chaos to play out over the next 2-3 months and a new world order is established with more clarity. We are tracking these developments on a real time basis.

As we release this report, U.S. Trade Representatives are pushing their counterparts in 183 countries for an early closure to bilateral tariff negotiations. Most of the major trading partners also have initiated trade agreements with other key trading nations, outside of those in the works with the United States. We are tracking such secondary fallouts as supply chains shift.

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APRIL 2025: NEGOTIATION PHASE

Our April release addresses the impact of tariffs on the overall global market and presents market adjustments by geography. Our trajectories are based on historic data and evolving market impacting factors.

JULY 2025 FINAL TARIFF RESET

Complimentary Update: Our clients will also receive a complimentary update in July after a final reset is announced between nations. The final updated version incorporates clearly defined Tariff Impact Analyses.

Reciprocal and Bilateral Trade & Tariff Impact Analyses:

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EU
JAPAN
INDIA
176 OTHER COUNTRIES.

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