Biologics Testing Market Report 2026

The biologics testing market size has grown rapidly in recent years. It will grow from $6.83 billion in 2025 to $7.99 billion in 2026 at a compound annual growth rate (CAGR) of 17%. The growth in the historic period can be attributed to increasing biologics manufacturing volumes, expansion of vaccine development programs, rising regulatory expectations for product safety, wider adoption of monoclonal antibody therapies, growth of contract testing laboratories.

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.

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 market.

Major companies operating in the biological testing market are developing innovative technologies, including protein engineering approaches, to improve market profitability. Protein engineering involves the design and alteration of proteins to produce new or enhanced variants with specific desired characteristics. For example, in July 2023, Queensland University of Technology, an Australia-based university, introduced a new protein-engineering technique that enables rapid and precise development of novel diagnostic tests. This technology provides a new approach to advancing and broadening laboratory testing and is expected to deliver significant benefits to both healthcare and the economy.

In October 2024, Synexa Life Sciences, a Netherlands-based company specializing in biomarker and bioanalytical services, acquired Alderley Analytical Ltd for an undisclosed sum. Through this acquisition, Synexa seeks to expand its bioanalytical testing capabilities, diversify its service offerings across LC-MS or MS and ligand-binding platforms, and reinforce its geographic presence and scientific expertise in outsourced biologics testing services. Alderley Analytical Ltd is a UK-based firm that provides GLP- or GCP-compliant bioanalytical testing for drug development, with expertise in mass spectrometry, ligand-binding assays, and bioanalysis for both small and large molecules.

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.

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 the biologics testing market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the biologics testing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Tariffs are influencing the biologics testing market by increasing costs of imported analytical instruments, reagents, reference standards, and laboratory automation systems. Testing laboratories in North America and Europe are most affected due to reliance on imported high-end equipment, while Asia-Pacific faces consumable cost inflation. These tariffs are raising testing service prices and extending validation timelines. However, they are also encouraging domestic instrument manufacturing, regional reagent production, and expansion of local biologics testing capabilities.

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

Biologics testing involves analytical and quality control procedures conducted to assess the safety, purity, potency, and stability of biologic products, including vaccines, monoclonal antibodies, and cell or gene therapies. It is performed to ensure regulatory compliance, confirm product performance, and protect patient safety across the development and manufacturing lifecycle of biologics.

The primary products in biologics testing consist of reagents and kits, instruments, and other related products. An instrument is defined as a tool, device, or machine used to carry out experiments, analyze data, or examine biological samples. The different tests involved include endotoxin testing, sterility testing, mycoplasma testing, bioburden testing, residual host-cell protein and DNA detection testing, virus safety testing, and other test types, which are used across applications such as vaccine development and manufacturing, monoclonal antibody development and manufacturing, cellular and gene therapy product development and manufacturing, blood and blood product development and manufacturing, and other applications.

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.

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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