Biologics Testing Market Report 2026

Biologics Testing Market Overview

• Biologics Testing market size has reached to $6.83 billion in 2025 • Expected to grow to $15.07 billion in 2030 at a compound annual growth rate (CAGR) of 17.2% • Growth Driver: Unleashing Potential In The Thriving Biologics Testing Market Of Pharmaceutical And Biotechnology Advancements • Market Trend: The Resonance Of Technological Advancements In Biologics Testing • North America was the largest region in 2025 and Asia-Pacific is the fastest growing region.

What Is Covered Under Biologics Testing Market?

Biologics testing refers to the analytical and quality-control processes used to evaluate the safety, purity, potency, and stability of biologic products such as vaccines, monoclonal antibodies, and cell or gene therapies. It is used for ensuring regulatory compliance, verifying product performance, and safeguarding patient safety throughout the development and manufacturing of biologics. The main products of the biologics testing include reagents and kits, instruments and other products. An instrument refers to a tool, device, or machine used to perform experiments, analyze data, or observe biological samples. The various tests included are endotoxin test, sterility test, mycoplasma tests, bioburden tests, residual host-cell proteins and DNA detection tests, virus safety test and other tests types for applications in vaccine development and manufacturing, monoclonal antibodies development and manufacturing, cellular and gene therapy products development and manufacturing, blood and blood products development and manufacturing and other applications.

What Is The Biologics Testing Market Growth Forecast?

The biologics testing market size is expected to see rapid growth in the next few years. It will grow to $15.07 billion in 2030 at a compound annual growth rate (CAGR) of 17.2%. The growth in the forecast period can be attributed to increasing demand for rapid release testing, rising adoption of automated quality control systems, expansion of cell and gene therapy testing needs, growing focus on data integrity, increasing investments in digital laboratory infrastructure. Major trends in the forecast period include increasing adoption of advanced analytical testing platforms, rising demand for comprehensive biologics quality testing, growing use of high-sensitivity assays, expansion of outsourced testing services, enhanced focus on regulatory compliance testing.

Global Biologics Testing Market Segmentation

1) By Product: Reagents And Kits, Instruments, Other Products 2) By Test Type: Endotoxin Test, Sterility Test, Mycoplasma Tests, Bioburden Tests, Residual Host-Cell Proteins And DNA Detection Tests, Virus Safety Test, Other Test Types 3) By Application: Vaccine Development And Manufacturing, Monoclonal Antibodies Development And Manufacturing, Cellular And Gene Therapy Products Development And Manufacturing, Blood And Blood Products Development And Manufacturing, Other Applications Subsegments: 1) By Reagents And Kits: ELISA Kits, PCR Kits, Cell Culture Reagents 2) By Instruments: Spectrophotometers, Chromatography Systems, Microplate Readers 3) By Other Products: Software, Consumables, Reference Standards

What Is The Driver Of The Biologics Testing Market?

The rapidly growing pharmaceutical and biotechnology industries are expected to propel the growth of the biologics testing market going forward. The pharmaceutical industry is primarily focused on developing and manufacturing medications for various diseases and medical conditions. The biotechnology industry, on the other hand, focuses on the application of technology to biology and healthcare. Biologics testing includes tests to identify and quantify impurities, assess stability, and evaluate the immune response to the drug. The growth of the pharmaceutical and biotechnology industries has also led to advances in biologics testing technology, such as the development of new analytical tools and techniques. This has allowed for more accurate and efficient testing, reducing the time and cost of bringing new biologics to market. For instance, in July 2024, according to Eurostat, a Belgium-based governing body, pharmaceutical production in the EU increased to €44 billion ($46.7 billion) in 2023, reflecting significant growth in the sector. Therefore, the rapidly growing pharmaceutical and biotechnology industries are driving the growth of the biologics testing industry.

Key Players In The Global Biologics Testing Market

Major companies operating in the biologics testing market are Charles River Laboratories Inc., Thermo Fisher Scientific Inc., Merck KGaA, SGS Société Générale de Surveillance SA, WuXi AppTec Co. Ltd., Sartorius AG, Cytovance Biologics Inc., Pace Analytical Services Inc., Avance Biosciences Inc., Biomerieux SA, Lonza Group Ltd., Genscript Biotech Corp., Bio-Rad Laboratories Inc., Accugen Laboratories Inc., Gibraltar Laboratories Inc., Jordi Labs, Bioquell Limited, Southern Research, Promega Corporation, Lancaster Laboratories Inc., Toxikon Corporation, Eurofins BioPharma Product Testing, QIAGEN N.V., Danaher Corporation, Agilent Technologies Inc., PerkinElmer Inc., Abbott Laboratories, Beckman Coulter Inc., Becton Dickinson and Company, Roche Holding AG

Global Biologics Testing Market Trends and Insights

Major companies operating in biological testing market are innovating new technologies, such as protein engineering techniques, to increase the profitability in the market. Protein engineering refers to the design and modification of proteins to create new or improved variants with desired properties. For instance, in July 2023, Queensland University of Technology, an Australia-based university, launched a novel protein-engineering technique which offers quick and accurate creation of novel diagnostic tests. The technology offers a fresh method for enhancing and expanding laboratory testing, which will have a significant positive impact on both health and the economy.

What Are Latest Mergers And Acquisitions In The Biologics Testing Market?

In October 2024, Synexa Life Sciences, a Netherlands-based provider of biomarker and bioanalytical services, acquired Alderley Analytical Ltd for an undisclosed amount. With this acquisition, Synexa aims to enhance its bioanalytical testing capabilities, broaden its service portfolio across LC-MS or MS and ligand-binding platforms, and strengthen its geographic and scientific reach in outsourced biologics testing services. Alderley Analytical Ltd is a UK-based provider of GLP- or GCP-compliant bioanalytical testing for drug development, specializing in mass spectrometry, ligand-binding assays, and bioanalysis for small and large molecules.

Regional Outlook

North America was the largest region in the biologics testing market in 2025. Asia-Pacific is expected to be the fastest-growing region in the global biologics testing market duirng the forecast period. The regions covered in this market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in this market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

What Defines the Biologics Testing Market?

The biologics testing market includes revenues earned by entities by providing services such as potency testing, purity testing, sterility testing, immunogenicity testing and others. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

How is Market Value Defined and Measured?

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.

What Key Data and Analysis Are Included in the Biologics Testing Market Report 2026?

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