The global market for Biosimilar Contract Manufacturing was estimated at US$9.8 Billion in 2024 and is projected to reach US$23.1 Billion by 2030, growing at a CAGR of 15.5% from 2024 to 2030. This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions. The report includes the most recent global tariff developments and how they impact the Biosimilar Contract Manufacturing market.
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.
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.
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.
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.
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.
Key Insights:
- Market Growth: Understand the significant growth trajectory of the Recombinant Non-glycosylated Proteins segment, which is expected to reach US$15.8 Billion by 2030 with a CAGR of a 17.9%. The Recombinant Glycosylated Proteins segment is also set to grow at 11.2% CAGR over the analysis period.
- Regional Analysis: Gain insights into the U.S. market, estimated at $2.7 Billion in 2024, and China, forecasted to grow at an impressive 21.0% CAGR to reach $5.1 Billion by 2030. Discover growth trends in other key regions, including Japan, Canada, Germany, and the Asia-Pacific.
Why You Should Buy This Report:
- Detailed Market Analysis: Access a thorough analysis of the Global Biosimilar Contract Manufacturing Market, covering all major geographic regions and market segments.
- Competitive Insights: Get an overview of the competitive landscape, including the market presence of major players across different geographies.
- Future Trends and Drivers: Understand the key trends and drivers shaping the future of the Global Biosimilar Contract Manufacturing Market.
- Actionable Insights: Benefit from actionable insights that can help you identify new revenue opportunities and make strategic business decisions.
Key Questions Answered:
- How is the Global Biosimilar Contract Manufacturing Market expected to evolve by 2030?
- What are the main drivers and restraints affecting the market?
- Which market segments will grow the most over the forecast period?
- How will market shares for different regions and segments change by 2030?
- Who are the leading players in the market, and what are their prospects?
Report Features:
- Comprehensive Market Data: Independent analysis of annual sales and market forecasts in US$ Million from 2024 to 2030.
- In-Depth Regional Analysis: Detailed insights into key markets, including the U.S., China, Japan, Canada, Europe, Asia-Pacific, Latin America, Middle East, and Africa.
- Company Profiles: Coverage of players such as AGC Biologics, Alcami Corporation Inc., Almac Group, Avid Bioservices, Inc., Biocon Ltd. and more.
- Complimentary Updates: Receive free report updates for one year to keep you informed of the latest market developments.
Some of the 44 companies featured in this Biosimilar Contract Manufacturing market report include:
- 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.
This edition integrates the latest global trade and economic shifts as of June 2025 into comprehensive market analysis. Key updates include:
- Tariff and Trade Impact: Insights into global tariff negotiations across 180+ countries, with analysis of supply chain turbulence, sourcing disruptions, and geographic realignment. Special focus on 2025 as a pivotal year for trade tensions, including updated perspectives on the Trump-era tariffs.
- Adjusted Forecasts and Analytics: Revised global and regional market forecasts through 2030, incorporating tariff effects, economic uncertainty, and structural changes in globalization. Includes segmentation by product, technology, type, material, distribution channel, application, and end-use, with historical analysis since 2015.
- Strategic Market Dynamics: Evaluation of revised market prospects, regional outlooks, and key economic indicators such as population and urbanization trends.
- Innovation & Technology Trends: Latest developments in product and process innovation, emerging technologies, and key industry drivers shaping the competitive landscape.
- Competitive Intelligence: Updated global market share estimates for 2025, competitive positioning of major players (Strong/Active/Niche/Trivial), and refined focus on leading global brands and core players.
- Expert Insight & Commentary: Strategic analysis from economists, trade experts, and domain specialists to contextualize market shifts and identify emerging opportunities.
- Complimentary Update: Buyers receive a free July 2025 update with finalized tariff impacts, new trade agreement effects, revised projections, and expanded country-level coverage.
Table of Contents
I. METHODOLOGYII. EXECUTIVE SUMMARY2. FOCUS ON SELECT PLAYERSIV. COMPETITION
1. MARKET OVERVIEW
3. MARKET TRENDS & DRIVERS
4. GLOBAL MARKET PERSPECTIVE
III. MARKET ANALYSIS
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- 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.
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 380 |
| Published | July 2025 |
| Forecast Period | 2024 - 2030 |
| Estimated Market Value ( USD | $ 9.8 Billion |
| Forecasted Market Value ( USD | $ 23.1 Billion |
| Compound Annual Growth Rate | 15.5% |
| Regions Covered | Global |
