Biosimilar Contract Manufacturing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Recombinant Non-glycosylated Proteins, Recombinant Glycosylated Proteins), By Technology (Mammalian, Non-Mammalian), By Application (Oncology, Blood Disorders, Growth Hormonal Deficiency, Chronic & Autoimmune Disorders, Rheumatoid Arthritis, Others), By Region and Competition, 2020-2030F

Market Overview

Global Biosimilar Contract Manufacturing Market was valued at USD 9.37 billion in 2024 and is expected to reach USD 23.54 billion by 2030 with a CAGR of 16.59% during the forecast period. The global market for Biosimilar Contract Manufacturing is experiencing significant growth, driven by the growing prevalence of various chronic diseases. Additionally, increasing availability of cancer biosimilars with lowered prices and affordable treatment, along with the growing adoption of cost-effective healthcare systems across the globe, have increased the demand for biosimilar contract manufacturing. Additionally, the growing geriatric population across the globe, susceptible to different kinds of chronic diseases, is further expected to increase the demand for biosimilar contract manufacturing.

Key Market Drivers

Patent Expiry of Biologics Encouraging Biosimilar Development

The expiration of patents on many blockbusters biologic drugs has created a significant opportunity for biosimilar development, directly driving the demand for contract manufacturing organizations (CMOs) that specialize in biosimilar production. Biologics such as trastuzumab, bevacizumab, and adalimumab have either lost or are nearing the expiration of their exclusivity periods in multiple regions including the U.S., Europe, and parts of Asia. This opens the door for biosimilar manufacturers to introduce more cost-effective alternatives.

CMOs play a pivotal role in facilitating this transition by providing the infrastructure, expertise, and regulatory guidance required to bring these complex products to market efficiently. According to the U.S. Food and Drug Administration (FDA), as of 2024, over 40 biosimilars have been approved in the United States, a marked increase compared to just 11 approvals five years earlier. The European Medicines Agency (EMA) also reports steady growth in biosimilar approvals since its first authorization in 2006, reflecting a regulatory climate conducive to biosimilar uptake. The challenge of producing biologics—due to their complexity, the need for sterile environments, and sophisticated analytical testing—makes contract manufacturing a strategic choice for many biosimilar developers. Rather than investing in costly facilities and process development, pharmaceutical companies are increasingly outsourcing CMOs that already possess these capabilities, thus speeding up time-to-market and reducing capital expenditure.

Growing Demand for Affordable Biologic Therapies

The rising global healthcare burden, coupled with increasing pressure on national healthcare systems to contain costs, is accelerating the demand for more affordable biologic therapies, particularly in low- and middle-income countries. Biosimilars, which are generally priced 20–30% lower than their reference biologics, offer a viable solution to expanding access to life-saving treatments for diseases like cancer, rheumatoid arthritis, and diabetes.

This has led governments and public health organizations to support biosimilar adoption. For instance, the World Health Organization (WHO) has advocated for increased global access to biosimilars through its Prequalification Program, which facilitates approval and market access in under-resourced healthcare systems. Additionally, the U.S. Centers for Medicare & Medicaid Services (CMS) has been promoting biosimilars through favorable reimbursement models, including recent revisions to Medicare Part B drug payment policies.

In this context, biosimilar developers are turning to contract manufacturers to scale up production rapidly and cost-effectively. CMOs offer flexible production capacities, specialized analytical testing, and regulatory compliance services—all crucial for developing biosimilars that meet international quality standards. Their involvement ensures that more affordable therapeutic options are consistently available, thereby driving the global expansion of the biosimilar market.

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Key Market Challenges

High Complexity and Cost of Biosimilar Manufacturing

Despite their economic appeal, biosimilars are biologically complex molecules that require sophisticated manufacturing infrastructure, highly skilled personnel, and rigorous quality control systems. Developing biosimilars involves extensive comparative analytical studies and process validation steps to ensure therapeutic equivalence to the original biologic, which significantly increases development time and cost. Even with outsourcing to CMOs, the cost of manufacturing biosimilars can be prohibitively high, particularly for smaller biotech firms or those targeting niche therapeutic areas. Governments such as the U.S. FDA and EMA require a comprehensive dossier of quality, safety, and efficacy data before approving a biosimilar, further increasing regulatory and financial burdens.

Moreover, CMOs must make substantial upfront investments in specialized bioreactors, cell culture facilities, and cleanroom environments to accommodate biosimilar projects. These capital-intensive requirements limit the number of CMOs equipped to handle large-scale biosimilar contracts, creating a bottleneck in supply and potentially slowing market growth.

Intellectual Property and Litigation Risks

Intellectual property (IP) challenges remain a significant hurdle in the biosimilar contract manufacturing market. While the expiration of patents opens the door for biosimilars, originator companies often employ strategies such as secondary patents (covering formulations, delivery methods, or manufacturing processes) to delay or block biosimilar entry. This results in complex legal landscapes that biosimilar developers—and by extension, CMOs—must carefully navigate. For example, in the U.S., the Biologics Price Competition and Innovation Act (BPCIA) of 2009 has led to several high-profile legal battles between biologic innovators and biosimilar developers. These lawsuits can delay product launches and dissuade CMOs from entering potentially contentious manufacturing contracts. Contract manufacturers must also be cautious of inadvertently infringing IP while producing biosimilars, which can expose them to significant legal liabilities.

Additionally, varying patent laws and exclusivity periods in different countries complicate global biosimilar strategies. Contract manufacturers must stay abreast of IP landscapes in multiple jurisdictions, adding another layer of operational complexity and risk to their business.

Key Market Trends

Rise of Single-Use Bioprocessing Technologies in Biosimilar Manufacturing

One of the most prominent trends reshaping the biosimilar contract manufacturing landscape is the widespread adoption of single-use bioprocessing technologies. Single-use systems—comprising disposable bioreactors, mixing systems, and filtration units—offer significant advantages over traditional stainless-steel equipment, including reduced contamination risk, lower cleaning validation costs, and faster turnaround times between batches.

These benefits are particularly relevant in the biosimilar space, where cost efficiency and speed to market are critical. CMOs are increasingly incorporating single-use technologies to enhance their operational flexibility and meet the unique production needs of multiple clients simultaneously. According to the U.S. Department of Commerce, biopharmaceutical manufacturers who adopt single-use systems report a 30–50% reduction in production costs, making this approach especially attractive for biosimilar developers operating on tight margins.

Furthermore, these technologies support small and medium-sized batches, aligning well with the growing trend of personalized medicine and targeted biosimilars. The ability to quickly scale up or down based on demand also makes contract manufacturing more agile and responsive to fluctuating market needs.

Regulatory Harmonization Facilitating Global Market Entry

Another major trend impacting the biosimilar contract manufacturing market is the move toward greater regulatory harmonization across major pharmaceutical markets. Efforts by global regulatory bodies, such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), are making it easier for biosimilar manufacturers to navigate cross-border regulatory approvals. In 2022, the World Health Organization released updated guidance on biosimilar evaluation, emphasizing streamlined comparability exercises and reduced clinical trial requirements for well-characterized products. Meanwhile, countries such as Canada, Australia, and South Korea are aligning their biosimilar approval frameworks more closely with those of the European Union and the U.S. FDA.

This regulatory convergence benefits contract manufacturers by reducing the complexity of meeting diverse standards for each market. It also enables CMOs to optimize their production processes for global distribution, thereby attracting more clients seeking rapid international market entry. As regulatory pathways become more predictable and aligned, CMOs gain a competitive edge by offering ready-to-implement regulatory strategies, further boosting the outsourcing trend.

Segmental Insights

Product Insights

Based on Product, the Recombinant Non-glycosylated Proteins Category Holds the Largest Market Share. In the Global Biosimilar Contract Manufacturing Market, the recombinant non-glycosylated proteins category holds the largest market share due to several practical, scientific, and economic reasons. Non-glycosylated proteins, such as insulin, somatropin (human growth hormone), filgrastim, and interferons, are simpler in structure compared to glycosylated proteins, as they do not require post-translational modifications involving glycosylation. This simplicity allows for easier development, production, and quality control processes, which are highly advantageous in the contract manufacturing environment. The production of these proteins typically uses prokaryotic systems such as Escherichia coli, which are cost-effective, scalable, and well-established. This leads to lower production costs and faster turnaround times, which are crucial advantages for biosimilar developers looking to gain market access quickly and at a competitive price. Additionally, regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have already approved numerous non-glycosylated biosimilars, creating a well-trodden pathway that simplifies development for contract manufacturers.

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Regional Insights

Based on the region, North America holds the largest share of the Global Biosimilar Contract Manufacturing Market. This dominance is attributed to a combination of well-established pharmaceutical infrastructure, strong regulatory frameworks, and the widespread adoption of biosimilars driven by rising healthcare costs. The region is home to several leading biopharmaceutical companies and contract development and manufacturing organizations (CDMOs) that have invested heavily in biologics and biosimilar production capabilities. In the United States, the implementation of the Biologics Price Competition and Innovation Act (BPCIA) has significantly supported the entry of biosimilars into the market by streamlining the approval process. Furthermore, government-led initiatives to improve healthcare affordability and access—such as Medicare promoting biosimilar substitution—have enhanced market uptake. The presence of robust research and development ecosystems, along with increasing public and private sector investments, has further boosted the production capabilities of biosimilar contract manufacturers in the region.

Recent Developments

• In January 2025, Lotte Biologics inaugurated a new facility in the United States to provide comprehensive, end-to-end services for antibody-drug conjugate (ADC) development and manufacturing.
• In November 2024, Chime Biologics established a manufacturing agreement with MedPacto to support the production of biologic therapies.
• In October 2024, Centivax entered a strategic collaboration with BioCina to facilitate cGMP manufacturing of its universal influenza vaccine candidate, Cent-Flu.
• In May 2024, Boehringer Ingelheim Biopharmaceuticals GmbH entered a collaboration with Quallent Pharmaceuticals. This partnership aims to expand the reach of Boehringer Ingelheim’s biosimilar products by leveraging Quallent’s distribution network and industry expertise. The agreement aligns with Boehringer Ingelheim’s overarching strategy to promote healthcare affordability and broaden patient access to high-quality biosimilar therapies.
• In May 2024, Boehringer Ingelheim, a prominent global pharmaceutical company, announced a partnership with Quallent Pharmaceuticals to improve access to its citrate-free biosimilar adalimumab-adbm, used in the treatment of chronic inflammatory conditions. The collaboration is designed to expand the biosimilar’s availability and affordability across the United States, reinforcing Boehringer Ingelheim’s dedication to enhancing healthcare access and reducing costs for both patients and the broader healthcare system.

Key Market Players

• Catalent, Inc.
• Boehringer Ingelheim GmbH
• Alcami Corporation, Inc.
• Almac Group
• Lonza Group AG
• Biocon Limited
• Avid Bioservice, Inc.
• Rentschler Biopharma SE
• Fujifilm Kyowa Kirin Biologics Co., Ltd.
• WuXi Biologics, Inc.

Report Scope:

In this report, the Global Biosimilar Contract Manufacturing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Biosimilar Contract Manufacturing Market, By Product:

o   Recombinant Non-glycosylated Proteins

o   Recombinant Glycosylated Proteins

• Biosimilar Contract Manufacturing Market, By Technology:

o   Mammalian

o   Non-Mammalian

• Biosimilar Contract Manufacturing Market, By Application:

o   Oncology

o   Blood Disorders

o   Growth Hormonal Deficiency

o   Chronic & Autoimmune Disorders

o   Rheumatoid Arthritis

o   Others

• Biosimilar Contract Manufacturing Market, By Region:

o   North America

§  United States

§  Mexico

§  Canada

o   Europe

§  France

§  Germany

§  United Kingdom

§  Italy

§  Spain

o   Asia-Pacific

§  China

§  India

§  South Korea

§  Japan

§  Australia

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East and Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Biosimilar Contract Manufacturing Market.

Available Customizations:

Global Biosimilar Contract Manufacturing Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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