Biosimilar Testing Services Market Report 2025

The biosimilar testing services market size has grown rapidly in recent years. It will grow from $1.62 billion in 2024 to $1.84 billion in 2025 at a compound annual growth rate (CAGR) of 13.3%. The growth in the historic period can be attributed to rising demand for biologics, the expanding approval of biosimilars, increasing prevalence of chronic diseases, growing focus on personalized medicine, and the expansion of clinical trial activities.

The biosimilar testing services market size is expected to see rapid growth in the next few years. It will grow to $2.99 billion in 2029 at a compound annual growth rate (CAGR) of 13%. The growth in the forecast period can be attributed to the increasing adoption of biosimilars, rising demand for cost-effective treatments, growing need for affordable biologic therapies, enhanced trust in biosimilar efficacy and safety, and greater demand for customized testing solutions. Major trends in the forecast period include advancements in analytical testing technologies, ongoing innovations in bioassay development, wider adoption of high-throughput testing platforms, increased research and development in biosimilar analytics, and the integration of artificial intelligence in data analysis.

The increasing prevalence of autoimmune diseases is expected to drive the growth of the biosimilar testing services market in the coming years. Autoimmune diseases occur when the body’s immune system mistakenly attacks its own healthy cells and tissues, causing inflammation and tissue damage. This rise is fueled by the growing need for effective biologic treatments that manage chronic symptoms, reduce flare-ups, and improve long-term patient outcomes. Biosimilar testing services support the treatment of autoimmune diseases by ensuring that biosimilars are safe, effective, and comparable to original biologics, providing affordable and accessible therapeutic options. For example, according to the Australian Institute of Health and Welfare, a government organization in Australia, an estimated 514,000 people (2%) were living with rheumatoid arthritis in 2022, with 2.5% of females and 1.6% of males affected. Consequently, the growing prevalence of autoimmune diseases is driving the expansion of the biosimilar testing services market.

Key players in the biosimilar testing services market are focusing on facility expansion to introduce new technologies and capabilities that enhance productivity and competitiveness. Facility expansion involves enlarging or upgrading existing infrastructure to accommodate growing operational needs or future growth. In October 2023, Tanvex BioPharma USA Inc., a US-based biotechnology company, launched Tanvex CDMO, a state-of-the-art contract development and manufacturing organization in San Diego. The facility offers end-to-end biologics development and manufacturing services, including cell line development, process optimization, analytical testing, and regulatory support. This expansion aims to accelerate the advancement of biopharmaceutical products from concept to commercial scale, leveraging advanced technologies and experienced teams to deliver innovative and life-changing biologics to patients worldwide.

In March 2022, Biocon Biologics Limited, an India-based biosimilars company, acquired the biosimilar portfolio of Viatris Inc. for $3.3 billion. Through this acquisition, Biocon Biologics seeks to establish a globally integrated biosimilars enterprise by combining Viatris’ biosimilar assets with its own pipeline and commercial capabilities, expanding access to affordable, high-quality biosimilar drugs worldwide. Viatris Inc. is a US-based healthcare company that provides biosimilars.

Major players in the biosimilar testing services market are Thermo Fisher Scientific Inc., IQVIA Laboratories, Laboratory Corporation of America Holdings, Fresenius SE & Co. KGaA, Eurofins Scientific SE, Intas Pharmaceuticals Ltd., SGS Société Générale de Surveillance SA, WuXi AppTec Co. Ltd., Intertek Group plc, Samsung Biologics Co. Ltd., Celltrion Inc., Almac Group Limited, Syngene International Limited, Shanghai Medicilon Inc., Kymos Group S.L., Pacific BioLabs Inc., Profacgen Inc., ExcellGene SA, BioPharmaSpec Ltd., and Sartorius Stedim Biotech Group.

North America was the largest region in the biosimilar testing services market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in biosimilar testing services market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the biosimilar testing services market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the healthcare sector, particularly in the supply of critical medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are facing higher costs for imported surgical instruments, imaging equipment, and consumables such as syringes and catheters, many of which have limited domestic alternatives. These increased costs are straining healthcare budgets, leading some providers to delay equipment upgrades or pass on expenses to patients. Additionally, tariffs on raw materials and components are disrupting the production of essential drugs and devices, causing supply chain bottlenecks. In response, the industry is diversifying sourcing strategies, boosting local manufacturing where possible, and advocating for tariff exemptions on life-saving medical products.

Biosimilar testing services refer to the scientific and analytical procedures performed to evaluate the similarity between a biosimilar and its reference biologic product. These services involve thorough assessment of structural, functional, and biological attributes to ensure consistency, quality, and safety. The primary objective is to confirm that the biosimilar demonstrates comparable efficacy and immunogenicity to the reference product while meeting regulatory requirements.

The primary types of biosimilar testing services include analytical testing, bioanalytical testing, stability testing, method development and validation, and others. Analytical testing encompasses a range of laboratory techniques used to evaluate the structural and functional similarity of biosimilars to reference biologics, ensuring product safety, quality, and effectiveness. These services utilize technologies such as cell-based assays, chromatography, mass spectrometry, and bioassays. The molecules tested include monoclonal antibodies, recombinant hormones, insulin, interferons, enzymes, and others. Applications span oncology, autoimmune diseases, blood disorders, growth hormone deficiency, and more, serving end users such as pharmaceutical and biotechnology companies, contract research organizations, academic research institutes, and government agencies.

The biosimilar testing services market research report is one of a series of new reports that provides biosimilar testing services market statistics, including the biosimilar testing services industry global market size, regional shares, competitors with the biosimilar testing services market share, detailed biosimilar testing services market segments, market trends, and opportunities, and any further data you may need to thrive in the biosimilar testing services industry. This biosimilar testing services market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

The biosimilar testing services market consists of revenues earned by entities by providing services such as comparability testing, structural characterization, functional characterization, impurity profiling, glycosylation analysis, pharmacokinetic studies, immunogenicity assessment, and regulatory compliance support. The market value includes the value of related goods sold by the service provider or included within the service offering. The biosimilar testing services market also includes sales of reference biologics, biosimilar candidates, assay kits, analytical reagents, detection reagents, and bioanalytical instruments. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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