Global Biosimilar Testing and Development Services Market is valued approximately at USD 2.80 billion in 2023 and is anticipated to grow with a healthy growth rate of more than 12.1% over the forecast period 2023-2032. Biosimilar Testing Services and Development Services Market is set to expand significantly due to the escalating need for rigorous testing facilities to meet the growing demand for biosimilar medicines. Biosimilars offer a promising solution to reduce healthcare costs while maintaining therapeutic efficacy, making healthcare more accessible to a broader population. This demand is further amplified by the prevalence of chronic diseases such as cancer, autoimmune disorders, and diabetes, which necessitate long-term biologic treatments that can be prohibitively expensive. The market is experiencing robust growth driven by the increasing demand for biosimilars as a cost-effective alternative to biological drugs. The prevalence of chronic diseases globally further bolsters the need for biosimilar testing and development services. For instance, according to the American Cancer Society, in 2023, approximately 1,958,310 new cancer cases and 609,820 cancer deaths are projected to occur in the U.S., underscoring the critical need for effective and affordable therapeutic alternatives.

Moreover, the expiration of patents for several high-profile biologic drugs presents a lucrative opportunity for the biosimilar market. Key biologics like Keytruda, Eylea, and Stelara are nearing patent expiration, opening the market to biosimilar competition. Regulatory agencies have stringent requirements to ensure the safety and efficacy of biosimilars, necessitating comprehensive testing and development services. This rigorous regulatory landscape drives the demand for specialized testing facilities to ensure biosimilar products meet high standards of quality. The trend towards outsourcing preclinical, clinical, and laboratory testing services by pharmaceutical and biotech companies has also emerged as a significant market driver. Outsourcing allows companies to leverage specialized expertise and advanced testing facilities, which can accelerate the development timeline, reduce costs, and ensure regulatory compliance. This strategic shift towards outsourcing is expected to continue fueling the growth of the biosimilar testing and development services market. However, the market faces challenges such as stringent regulatory requirements imposed by global regulatory agencies, which can complicate the development process.

The key regions considered for the global Biosimilar Testing and Development Services market study include Asia Pacific, North America, Europe, Latin America, and Middle East and Africa. North America held the largest market share in 2022, driven by the expiration of key biologic patents and increasing demand for biosimilars. The Asia-Pacific region is expected to exhibit the fastest growth during the forecast period, attributed to high biosimilar approvals and supportive government policies for biosimilar research and development.

Major market players included in this report are:
Charles River Laboratories International, Inc.
SGS S.A.
Eurofins Scientific SE
Laboratory Corporation of America Holdings (LabCorp)
Pharmaceutical Product Development, LLC (PPD)
Intertek Group plc
Pace Analytical Services, LLC
Covance Inc.
ICON plc
Parexel International Corporation
WuXi AppTec
Syneos Health, Inc.
PPD, Inc.
BioOutsource Ltd. (a subsidiary of Sartorius AG)
Pharmalex GmbH
The detailed segments and sub-segment of the market are explained below:
By Type:
Pharmacokinetics Assay
Immunogenicity Testing
Others
By End User:
Pharmaceutical and Biopharmaceutical Companies
Contract Research Organizations
Others
By Region:
North America
U.S.
Canada
Europe
UK
Germany
France
Spain
Italy
Rest of Europe
Asia Pacific
China
India
Japan
Australia
South Korea
Rest of Asia Pacific
Latin America
Brazil
Mexico
Rest of Latin America
Middle East & Africa
Saudi Arabia
South Africa
Rest of Middle East & Africa
Years considered for the study are as follows:
Historical year - 2022
Base year - 2023
Forecast period - 2024 to 2032
Key Takeaways:
Market Estimates & Forecast for 10 years from 2022 to 2032.
Annualized revenues and regional level analysis for each market segment.
Detailed analysis of geographical landscape with Country level analysis of major regions.
Competitive landscape with information on major players in the market.
Analysis of key business strategies and recommendations on future market approach.
Analysis of competitive structure of the market.
Demand side and supply side analysis of the market.