Biologics Testing Global Market Report 2024

The biologics testing market has grown rapidly in recent years. It will grow from $5.09 billion in 2023 to $5.88 billion in 2024 at a compound annual growth rate (CAGR) of 15.6%. The expansion observed during the historic period can be attributed to several factors, including the growth in biologics development, the implementation of stringent regulatory standards, a heightened focus on quality control within bioprocessing, increased investments in biopharmaceuticals, and the expansion of biomanufacturing capacity. These elements collectively contributed to the growth within the biologics industry.

The biologics testing market is expected to see rapid growth in the next few years. It will grow to $10.82 billion in 2028 at a compound annual growth rate (CAGR) of 16.5%. The anticipated growth in the forecasted period is expected to be driven by several factors, notably the emergence and adoption of advanced therapies, a rising need for contract testing services, the expansion of pipelines focusing on biologics, the globalization of biopharmaceutical manufacturing, and an increasing demand for rapid testing solutions across the industry.

The anticipated growth in the pharmaceutical and biotechnology sectors stands as a driving force propelling the expansion of the biologics testing market. This growth is primarily driven by these industries' focus on developing and manufacturing medications and leveraging technology for healthcare applications. Biologics testing encompasses crucial processes such as identifying impurities, assessing stability, and evaluating immune responses, facilitated by technological advancements. Notably, the European pharmaceutical production increased by 4.64% from €286,697 million to €300,000 million in 2021, as reported by the European Federation of Pharmaceutical Industries and Associations. Additionally, in 2020, 84 initial public offerings for biotech companies in the US raised a total of US$15 billion, as highlighted by Torys LLP. These figures underscore the substantial growth and potential of the pharmaceutical and biotech industries, driving the biologics testing market.

The projected growth of the biologics testing market is further fueled by rising government initiatives in research and development, a pivotal catalyst for advancing safety, effectiveness, and innovation in biologics. Government initiatives encompass various facets of biologics testing, ensuring safety and efficacy through robust support programs. The White House's substantial funding allocation of $204.9 billion for research and development in the President's 2023 budget reflects this commitment, representing a 28% increase from the 2021 level. These initiatives significantly contribute to the growth of the biologics testing market by nurturing innovation and advancing research.

A prominent trend in the biologics testing market is the focus on product innovations, with companies striving to introduce cutting-edge solutions to maintain their market positions. Noteworthy is Charles River Laboratories International, Inc.'s December 2022 launch of the Endosafe Nexus 200TM, a state-of-the-art instrument in their endotoxin testing line. This instrument, utilizing Endosafe Limulus Amebocyte Lysate (LAL) cartridge technology, streamlines processes for water, in-process, and final product testing, offering enhanced traceability, security, and data management.

Major companies in the biologics testing market are innovating with new technologies, such as protein engineering techniques, to enhance profitability. Queensland University of Technology's launch of a novel protein-engineering technique in July 2023 underscores this trend. This groundbreaking technology aims to expedite and refine the creation of diagnostic tests, promising significant positive impacts on both healthcare and the economy. Such innovations are instrumental in driving advancements within the biologics testing market, fostering growth and profitability.

In December 2021, Thermo Fisher Scientific, a leading biotechnology company based in the US, successfully acquired PPD Inc. for $17.4 billion. This strategic move is aimed at solidifying Thermo Fisher's position as a frontrunner in the clinical research services market while substantially broadening its service portfolio. The acquisition is set to bring forth an enhanced drug development platform, extensive expertise in patient enrollment, and robust laboratory capabilities. PPD Inc., a contract research organization headquartered in the US, specializes in offering comprehensive and integrated services across drug development, laboratory operations, and lifecycle management within the pharmaceutical industry.

Major companies operating in the biologics testing market report 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., Celgene Corporation, Biomerieux SA, Lonza Group Ltd., Genscript Biotech Corp., Bio-Rad Laboratories Inc., Accugen Laboratories Inc., Gibraltar Laboratories Inc., Jordi Labs, Gilead Sciences Inc., Bioquell Limited, Southern Research, Promega Corporation, Lancaster Laboratories Inc., Toxikon Corporation, Eurofins BioPharma Product Testing, Johnson & Johnson Inc., QIAGEN N.V., GlaxoSmithKline plc, Danaher Corporation, Agilent Technologies Inc., PerkinElmer Inc., Abbott Laboratories, Beckman Coulter Inc., Becton Dickinson and Company, Roche Holding AG, Novartis AG, Eli Lilly and Company, Pfizer Inc.

North America was the largest region in the biologics testing market in 2023. 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, 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, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Within the realm of biologics testing, the primary products include reagents, kits, instruments, and other related items. Instruments, in this context, refer to tools, devices, or machines utilized for conducting experiments, analyzing data, or observing biological samples. The suite of tests involved in biologics testing spans various assessments such as endotoxin testing, sterility testing, mycoplasma testing, bioburden testing, residual detection of host-cell proteins and DNA, virus safety testing, and other specialized tests. These tests find applications across vaccine development and manufacturing, the development and manufacturing of monoclonal antibodies, cellular and gene therapy products, blood and blood products, and various other applications within the biologics industry.

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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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