Biosimilar Testing and Development Services Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Service Type (Analytical Testing, Clinical Testing), By Molecule Type (Monoclonal Antibodies, Recombinant Hormones, Insulin, Interferons, Enzymes, Others), By Therapeutic Area (Oncology, Autoimmune Diseases, Diabetes, Infectious Diseases, Neurology, Others), By End User (Pharmaceutical & Biotechnology Companies, Contract Research Organizations, Academic & Research Institutes, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 3.73 Billion
CAGR (2026-2031)	12.42%
Fastest Growing Segment	Autoimmune Diseases
Largest Market	North America
Market Size (2031)	USD 7.53 Billion

Market Overview

The Global Biosimilar Testing and Development Services Market will grow from USD 3.73 Billion in 2025 to USD 7.53 Billion by 2031 at a 12.42% CAGR. Global Biosimilar Testing and Development Services encompass the specialized analytical, bioanalytical, and clinical activities outsourced by pharmaceutical companies to contract research organizations to verify the safety, efficacy, and structural similarity of biosimilars to reference biologics. The primary drivers propelling this market include the impending patent expiration of major blockbuster biologics and the escalating demand for cost-effective therapeutic alternatives within global healthcare systems. These economic pressures compel pharmaceutical developers to utilize external experts to navigate complex approval pathways efficiently, thereby accelerating the time-to-market for new molecules.

Despite this expansion, the market faces a significant challenge regarding the rigorous and often divergent regulatory standards across different jurisdictions, which necessitate extensive and costly comparative studies. This regulatory complexity can delay product launches and increase financial risk for developers, though the sector continues to demonstrate robust financial impact. According to the Association for Accessible Medicines, in 2024, savings from the use of biosimilars increased to $20.2 billion, highlighting the substantial economic value that underscores the continued demand for development support services.

Key Market Drivers

Expiration of patents for major blockbuster biologics serves as the fundamental catalyst expanding the Global Biosimilar Testing and Development Services Market. As exclusive rights for high-revenue biologics conclude, biopharmaceutical developers aggressively pursue the creation of biosimilar alternatives to capture market share, necessitating comprehensive analytical characterization and clinical trials to demonstrate biosimilarity. This "patent cliff" creates an immediate surge in demand for specialized testing services to navigate regulatory requirements for new approvals, as developers must prove their molecules are highly similar to the reference product. According to the U.S. Food and Drug Administration, January 2025, in the '2024 New Drug Therapy Approvals Annual Report', the agency approved 18 biosimilars in 2024, a record number that underscores the intensifying volume of molecules requiring rigorous validation and development support.

Growth in outsourcing of biosimilar development activities allows pharmaceutical companies to leverage external expertise for complex analytical and clinical requirements, further driving market revenue. Biopharmaceutical firms are increasingly partnering with contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) to access advanced infrastructure without incurring the heavy capital costs associated with internal facility expansion. This strategic shift mitigates risks and focuses internal resources on commercialization while external partners manage the intricate bioanalytical testing phases. According to WuXi Biologics, August 2024, in the 'Interim Report 2024', revenue from non-COVID late-phase and commercial manufacturing grew by 11.7%, reflecting this sustained industry reliance on external development partners. The success of this outsourced model is evident in the commercial uptake of these rigorously tested products; according to Samsung Bioepis, October 2024, in the 'Fourth Quarter 2024 US Biosimilar Market Report', the market share for adalimumab biosimilars reached 22% in the U.S. by August 2024.

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Key Market Challenges

Rigorous and divergent regulatory standards across different jurisdictions constitute a formidable barrier restricting the scalability of the Global Biosimilar Testing and Development Services Market. While pharmaceutical developers outsource to experts to navigate approval pathways, the lack of global harmonization necessitates extensive and duplicative analytical and clinical comparative studies to satisfy differing regional requirements. This regulatory fragmentation forces contract research organizations and developers to execute redundant testing protocols for the same molecule, significantly inflating development costs and extending timelines. These financial and operational burdens act as a deterrent, discouraging pharmaceutical companies from initiating new biosimilar programs and directly reducing the volume of projects entering the outsourcing pipeline.

The direct impact of these regulatory hurdles is a constricted development funnel, which effectively caps the potential revenue stream for testing and development services. High entry barriers prevent many potential biosimilars from ever reaching the clinical phase, thereby stalling demand for bioanalytical support. According to the Association for Accessible Medicines, in 2024, more than 80 percent of brand biologics that are eligible for competition did not have a biosimilar candidate in the development pipeline. This statistic underscores how regulatory complexity and the associated resource intensity directly suppress market activity, limiting the demand for outsourced services despite the broader sector's theoretical potential.

Key Market Trends

The Adoption of Pharmacodynamic Biomarkers to Waive Comparative Efficacy Trials represents a fundamental regulatory paradigm shift designed to reduce the high capital barriers associated with biosimilar development. By validating biosimilarity through advanced analytical characterization and pharmacokinetic/pharmacodynamic (PK/PD) data rather than large-scale Phase 3 studies, regulatory bodies are enabling a more streamlined and cost-efficient approval process. This shift allows developers to reallocate resources from redundant clinical testing to manufacturing and portfolio expansion, significantly lowering the threshold for market entry. According to MedPath, September 2025, in the article 'FDA Grants First-Ever Waiver of Clinical Efficacy Studies for Monoclonal Antibody Biosimilars', the FDA’s decision to waive these clinical efficacy requirements is expected to reduce the cost of developing biosimilars by more than 90%.

Integration of Artificial Intelligence and Machine Learning in Comparability Studies is transforming the analytical phase of biosimilar development by enhancing the precision and speed of structural characterization. AI algorithms are increasingly employed to predict molecular behavior, optimize cell line development, and analyze vast datasets to demonstrate structural similarity to reference biologics with unprecedented accuracy. This technological integration not only accelerates the identification of critical quality attributes but also mitigates the risk of failure in later development stages by ensuring higher fidelity in early comparability assessments. According to Pharmaphorum, January 2025, in the article 'Biopharma's AI rally: Readiness not hype in 2025', 67% of large biopharma companies have adopted artificial intelligence and machine learning technologies to drive operational efficiency and accelerate discovery pipelines.

Segmental Insights

The Autoimmune Diseases segment currently stands as the fastest-growing category within the Global Biosimilar Testing and Development Services Market. This rapid expansion is primarily driven by the patent expiration of blockbuster biologic therapies for conditions such as rheumatoid arthritis, necessitating rigorous comparative testing for new biosimilar candidates. Pharmaceutical companies are utilizing specialized services to ensure compliance with strict safety and efficacy guidelines established by the US Food and Drug Administration. Furthermore, the rising prevalence of chronic inflammatory disorders creates an urgent demand for cost-effective treatments, thereby accelerating investment in the development and validation of these therapeutic alternatives.

Regional Insights

North America maintains a leading position in the biosimilar testing and development services market, driven by the presence of major pharmaceutical companies and an established clinical research infrastructure. The expiration of patents for numerous blockbuster biologics has significantly increased the demand for analytical testing and characterization services in the region. Additionally, the United States Food and Drug Administration (US FDA) offers a clear and structured regulatory pathway for biosimilar approvals. This supportive framework reduces development uncertainty and fosters continuous investment in biosimilar programs, thereby securing the region's market dominance.

Recent Developments

• In October 2024, Samsung Biologics secured a major contract manufacturing deal valued at approximately USD 1.24 billion with an Asia-based pharmaceutical company. This agreement, which represents the largest single contract in the company's history, involves the provision of manufacturing services at its production facilities in Songdo, South Korea, through December 2037. The deal underscores the robust demand for contract development and manufacturing organization (CDMO) services in the biopharmaceutical sector. As a key player in the global market, this expansion of its order backlog highlights the company's growing capacity to support the development and production of biologics, which is a critical component of the biosimilar supply chain.
• In July 2024, Just - Evotec Biologics, a subsidiary of Evotec SE, expanded its multi-year strategic partnership with Sandoz to support the development and commercial manufacturing of biosimilars. Under the extended agreement, the company committed to providing long-term commercial supply of biosimilar drug substances from its J.POD biologics manufacturing facility in Toulouse, France. This collaboration leverages the company’s proprietary continuous manufacturing technology platform to enhance the efficiency and cost-effectiveness of biosimilar production. The deal ensures that the service provider will receive remuneration based on scientific validation and development milestones, reinforcing its position in the biosimilar contract development and manufacturing market.
• In July 2024, SGS North America announced a significant expansion of its biologics testing capabilities at its Center of Excellence in Lincolnshire, Illinois. The company integrated new instrumentation and scientific expertise to support the comprehensive characterization of novel biologics and biosimilars. This expansion enables the facility to provide analytical testing services across both discovery and commercial stages, including early cell bank safety assessment, method development, and raw material testing. The enhanced service offering aims to meet the growing demand from biopharmaceutical companies for streamlined and flexible testing solutions to accelerate the entry of biosimilars and other large molecule drugs into the market.
• In April 2024, Charles River Laboratories International, Inc. launched the Alternative Methods Advancement Project (AMAP), a strategic initiative designed to develop and implement alternatives to animal testing in drug discovery and development. The company committed a significant investment to drive the adoption of innovative methodologies, including digital technologies and artificial intelligence, to reduce the reliance on in vivo studies. This move is particularly relevant to the biosimilar development landscape, where regulatory bodies are increasingly encouraging the use of advanced in vitro analytical assays to demonstrate biosimilarity without extensive animal testing, thereby streamlining the development process for service providers and sponsors.

Key Market Players

• Thermo Fisher Scientific Inc.
• Charles River Laboratories, Inc.
• SGS S.A.
• Eurofins Scientific Limited
• Intertek Group plc
• Element Materials Technology
• Pacific BioLabs, Inc.
• Sartorius AG
• WuXi AppTec
• Syngene International Ltd.

By Service Type	By Molecule Type	By Therapeutic Area	By End User	By Region
Analytical Testing Clinical Testing	Monoclonal Antibodies Recombinant Hormones Insulin Interferons Enzymes Others	Oncology Autoimmune Diseases Diabetes Infectious Diseases Neurology Others	Pharmaceutical & Biotechnology Companies Contract Research Organizations Academic & Research Institutes Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

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

• Biosimilar Testing and Development Services Market, By Service Type:

• Analytical Testing
• Clinical Testing

• Biosimilar Testing and Development Services Market, By Molecule Type:

• Monoclonal Antibodies
• Recombinant Hormones
• Insulin
• Interferons
• Enzymes
• Others

• Biosimilar Testing and Development Services Market, By Therapeutic Area:

• Oncology
• Autoimmune Diseases
• Diabetes
• Infectious Diseases
• Neurology
• Others

• Biosimilar Testing and Development Services Market, By End User:

• Pharmaceutical & Biotechnology Companies
• Contract Research Organizations
• Academic & Research Institutes
• Others

• Biosimilar Testing and Development Services Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE