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Biosimilar Testing Services: Critical Driver Shaping the Growing Prevalence Of Autoimmune Diseases Is Fueling The Growth Of The Market Due To Increasing Demand For Effective And Affordable Biologic Therapies Market in 2025

09-05-2025 08:10 AM CET | Health & Medicine

Press release from: The Business Research Company

Biosimilar Testing Services

Biosimilar Testing Services

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Biosimilar Testing Services Market Size Valuation Forecast: What Will the Market Be Worth by 2025?
The size of the biosimilar testing services market has seen a swift expansion in recent years. It is projected to rise from $1.62 billion in 2024 to $1.84 billion in 2025, displaying a compound annual growth rate (CAGR) of 13.3%. The historic period growth can be traced back to factors such as the rising demand for biologics, broadened approval scope of biosimilars, soaring prevalence of chronic diseases, heightened demand for personalized medicine, and an increase in clinical trial activities.

Biosimilar Testing Services Market Size Forecast: What's the Projected Valuation by 2029?
Rapid expansion is projected for the biosimilar testing services market size in the upcoming years, with a growth trajectory aiming for $2.99 billion by 2029, at a compound annual growth rate (CAGR) of 13.0%. The growth during the forecast period will be driven by factors such as an uptick in the acceptance of biosimilars, rising consumer demand for cost-effective treatment options, increased need for affordable biologic therapies, mounting confidence in the efficacy and safety of biosimilars, and a surge in the desire for personalized testing solutions. Some key trends for the forecast period include advancements in analytical testing technologies, continuous progress in bioassay development, growing implementation of high-throughput testing platforms, heightened research and development activities in biosimilar analytics, and the introduction of artificial intelligence in data analytics.

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What Are the Drivers Transforming the Biosimilar Testing Services Market?
The continual rise in autoimmune diseases worldwide is slated to drive the expansion of the biosimilar testing services market. Autoimmune diseases occur when the body's immune system mistakenly attacks its own healthy cells and tissues, resulting in inflammation and tissue deterioration. This increasing prevalence of these diseases is due to the escalating necessity for potent biologic treatments that can control chronic symptoms, reduce flare-ups, and enhance long-term patient well-being. Biosimilar testing services play a critical part in the therapy of autoimmune diseases by verifying that biosimilars are safe, efficacious, and equivalent to original biologics, delivering affordable and accessible therapeutic alternatives. For example, statistics from the Australian Institute of Health and Welfare, a government organization based in Australia, indicated that approximately 514,000 people or 2.0% of the population in Australia were dealing with Rheumatoid arthritis in 2022, affecting 2.5% of females and 1.6% of males. Hence, the ever-increasing prevalence of autoimmune diseases is fueling the rise of the biosimilar testing services market.

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What Are the Key Trends Driving Biosimilar Testing Services Market Growth?
Leading corporations in the biosimilar testing services market are prioritizing the expansion of their facilities to incorporate new technological advancements and capabilities that will boost their efficiency and competitive edge. The action of expanding a facility involves extending or improving a currently existing physical location or infrastructure to meet the demands of escalated operations or potential growth. For example, in October 2023, Tanvex BioPharma USA Inc, a biotechnology firm from the United States, inaugurated Tanvex CDMO, an upgraded contract development and manufacturing organization located in San Diego. This organization provides comprehensive biologics development and manufacturing solutions, which include the development of cell lines, analytical testing, process optimization, and regulatory support. The target of this novel facility is to speed up the progress of biopharmaceutical products from their initial concept to commercial scale, utilizing advanced technologies and skilled personnel to produce and deliver innovative, life-altering biologics to patients across the globe.

Which Segments in the Biosimilar Testing Services Market Offer the Most Profit Potential?
The biosimilar testing services market covered in this report is segmented

1) By Service Type: Analytical Testing, Bioanalytical Testing, Stability Testing, Method Development And Validation, Other Service Types
2) By Technology: Cell-Based Assays, Chromatography Techniques, Mass Spectrometry, Bioassays
3) By Molecule Type: Monoclonal Antibodies, Recombinant Hormones, Insulin, Interferons, Enzymes, Other Molecule Types
4) By Application: Oncology, Autoimmune Diseases, Blood Disorders, Growth Hormone Deficiency, Other Applications
5) By End User: Pharmaceutical Companies, Biotechnology Companies, Contract Research Organizations, Academic Research Institutes, Government Agencies

Subsegments:
1) By Analytical Testing: Protein Characterization, Impurity Profiling, Potency Testing, Glycosylation Analysis, Structural Analysis
2) By Bioanalytical Testing: Pharmacokinetics Analysis, Immunogenicity Testing, Biomarker Analysis, Drug Concentration Measurement, Toxicokinetics Testing
3) By Stability Testing: Long-Term Stability Testing, Accelerated Stability Testing, Stress Testing, Photostability Testing, Temperature Cycling Studies
4) By Method Development And Validation: Analytical Method Development, Bioanalytical Method Development, Method Validation, Process Validation, Assay Development
5) By Other Service Types: Immunogenicity Assessment, Formulation Development, Microbial Testing, Release Testing, Regulatory Consulting

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Which Firms Dominate the Biosimilar Testing Services Market by Market Share and Revenue in 2025?
Major companies operating 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.

Which Regions Offer the Highest Growth Potential in the Biosimilar Testing Services Market?
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 the biosimilar testing services market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

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