Biological Safety Testing Products and Services Market Report 2024

The biological safety testing products and services market size has grown rapidly in recent years. It will grow from $4.77 billion in 2023 to $5.4 billion in 2024 at a compound annual growth rate (CAGR) of 13.2%. The increase observed during the historic period can be attributed to the prevalence of target diseases, the rising production of next-generation biologics, the growing demand for biologics, the increased adoption of testing tools, the expansion of the pharmaceutical and biotechnology industries, and the heightened focus on regulatory compliance.

The biological safety testing products and services market size is expected to see rapid growth in the next few years. It will grow to $8.93 billion in 2028 at a compound annual growth rate (CAGR) of 13.4%. The anticipated growth during the forecast period can be attributed to the increasing importance of assessing the safety and effectiveness of treatments for health issues, the growing development of new therapeutics and treatments, heightened interest in cell and gene therapies, rising investments in the biopharmaceutical sector, and expanding government initiatives to promote biopharmaceutical safety. Major trends in the forecast period include technological advancements, a rising demand for bioburden testing, increasing investments in biopharmaceuticals and biologics, regulatory compliance driving adoption, and mergers and acquisitions among key players.

The increasing demand for gene therapies is expected to drive the growth of the biological safety testing products and services market in the future. Gene therapy is a medical approach that uses genes to treat or prevent diseases by replacing, modifying, or supplementing defective genes. Enhanced investment and research into gene mutations, along with supportive regulatory environments, further stimulate innovation and broaden the applications of gene therapies. Biological safety testing products and services in gene therapy ensure that viral vectors and genetic materials are free from contaminants and safe for use. For example, in January 2024, according to the document published by the American Society of Gene & Cell Therapy, a US-based non-profit medical and scientific organization, reported a 10% increase in the number of gene therapies in Phase III clinical trials during the fourth quarter of 2023, marking the first quarterly increase of this type since the third quarter of 2022. Thus, the rising demand for gene therapies is driving the market for biological safety testing products and services.

Leading companies in the biological safety testing products and services market are advancing rapid animal-free bacterial endotoxin testing to improve patient safety and accelerate drug development. This innovative approach aims to shorten testing time and increase reliability without using animal-based products. For example, in January 2024, Charles River Laboratories International, a US-based pharmaceutical and biotechnology company, launched the Endosafe Trillium cartridge. This product uses recombinant technology to detect and quantify endotoxins without relying on animal-derived materials. It is the first rapid animal-free bacterial endotoxin test that offers a quicker turnaround time and eliminates the need for animal-derived reagents, thereby promoting sustainability and ethical testing practices. The Endosafe Trillium cartridge provides rapid, accurate results while reducing dependence on traditional Limulus amebocyte lysate (LAL) sourced from horseshoe crabs.

In September 2023, Technical Safety Services, a US-based biotechnology company, acquired Controlled Environment Management LLC for an undisclosed amount. This acquisition is intended to boost TSS's support for pharmaceutical, biotechnology, and healthcare clients by broadening its geographic reach and service offerings. Controlled Environment Management LLC, a US-based company, provides crucial services for biological safety testing, including testing, validation, certification, and calibration of controlled environments.

Major companies operating in the biological safety testing products and services market are Merck KGaA, Thermo Fisher Scientific Inc., Quest Diagnostics Incorporated, SGS Société Générale de Surveillance SA, Eurofins Scientific, Agilent Technologies Inc., Lonza Group AG, WuXi AppTec Co. Ltd., Charles River Laboratories Inc., BioMérieux SA, Almac Group, Samsung Biologics Co. Ltd., Maravai LifeSciences Holdings Inc., Genscript Biotech Corp, Wako Pure Chemical Industries Ltd., Associates of Cape Cod Inc., InvivoGen S.A.S., Microcoat Biotechnologie GmbH, BSL BIOSERVICE Scientific Laboratories Munich GmbH, Redberry, PathoQuest.

North America was the largest region in the biological safety testing products and services market in 2023. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the biological safety testing products and services market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

The countries covered in the biological safety testing products and services market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Biological safety testing products and services encompass the equipment and methods used to verify that biological products are safe and free from harmful contaminants, ensuring their safety and efficacy for medical use. The primary goal is to detect and prevent contamination by bacteria, viruses, fungi, and other pathogens.

The main products and services in biological safety testing include reagents and kits, instruments, and services. Reagents and kits consist of various chemicals, enzymes, antibodies, and other materials used to identify and measure contaminants, pathogens, or impurities in biological products. Testing types include endotoxin tests, sterility tests, cell line authentication and characterization tests, bioburden tests, adventitious agent detection tests, residual host contamination detection tests, and others, which are applied to vaccines and therapeutics, blood and blood-based products, gene therapy, tissue and tissue-based products, and stem cells.

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

The biological safety testing product and services market consists of revenues earned by entities by providing services such as viral clearance studies, environmental monitoring, toxicology testing, and batch release testing. The market value includes the value of related goods sold by the service provider or included within the service offering. The biological safety testing market also includes sales of polymerase chain reaction (PCR) machines, biosafety cabinets, autoclaves, and centrifuges. 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 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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