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Strategic Forecast for the Biological Safety Testing Products And Services Industry: Market Outlook 2025-2034

08-04-2025 03:08 PM CET | Health & Medicine

Press release from: The Business Research Company

Biological Safety Testing Products And Services

Biological Safety Testing Products And Services

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Biological Safety Testing Products And Services Market Size Growth Forecast: What to Expect by 2025?
The market for products and services related to biological safety testing has seen a swift expansion in recent times. Estimates project a growth from $5.4 billion in 2024 to $6.14 billion in 2025, reflecting a compound annual growth rate (CAGR) of 13.7%. This growth during the historic period is attributable to factors such as, the occurrence of specific diseases, increased production of cutting-edge biologics, heightened demand for biologics, increased usage of testing tools, expansion in the pharmaceutical and biotechnology sectors, and an elevated focus on adhering to regulations.

How Will the Biological Safety Testing Products And Services Market Size Evolve and Grow by 2029?
The market for biological safety testing products and services is on track to witness a significant expansion in the coming years. It is projected to reach a valuation of $10.11 billion by 2029, expanding at a Compound Annual Growth Rate (CAGR) of 13.3%. Various factors that will fuel this boost during the anticipated timeframe include the escalating need for assessing safety and utility in addressing health conditions, the continuous creation of advanced therapeutics, the growing curiosity in establishing cell and gene therapies, increasing investment in the biopharmaceutical field, and heightened government-driven initiatives advocating for biopharmaceutical safety. The forecast period will also see key trends such as technological evolution, growing demand for bioburden testing, increasing investments in biopharmaceuticals and biologics, regulatory compliance fostering adoption and collaborations and acquisitions among prominent players.

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What Drivers Are Propelling the Growth of Biological Safety Testing Products And Services Market Forward?
The expansion of the biological safety testing products and services market is anticipated to be fueled by rising demand for gene therapies. Gene therapies, viewed as a medical strategy, utilise genes in treating or preventing diseases by substituting, altering, or supplementing defective genes. Amplified investment and research concerning gene mutation, coupled with a supportive regulatory backdrop, spur innovation and broaden the scope of gene therapeutic applications. Products and services relating to biological safety testing within gene therapy ensure that viral vectors and genetic materials are uncontaminated and safe for utilization. For example, according to a publication from the American Society of Gene & Cell Therapy, a non-profit medical and scientific organization based in the US, the count of gene therapies in Phase III clinical trials saw a 10% increase in the fourth quarter of 2023. This was the inaugural quarterly surge of its kind since the third quarter of 2022. Therefore, the escalating demand for gene therapies acts as a catalyst for the biological safety testing products and services market.

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Which Emerging Trends Are Transforming the Biological Safety Testing Products And Services Market in 2025?
Leading firms in the biological safety testing products and services market are pioneering quick bacterial endotoxin testing methods that do not rely on animal derivatives, with the goal of improving patient safety and accelerating drug discovery. This novel strategy is designed to shorten testing periods and bolster reliability without relying on materials derived from animals. For example, Charles River Laboratories International, a pharmaceutical and biotechnology company based in the US, launched the Endosafe Trillium cartridge in January 2024. This device leverages recombinant technology to identify and measure endotoxins without the need for animal-based substances. This is the first animal-free endotoxin test of its kind, boasting quicker response times and omitting the requirement for animal-sourced reagents, thereby promoting sustainability and ethical testing methods. The product's function is to deliver swift, precise outcomes while diminishing dependence on the conventional Limulus amebocyte lysate (LAL) extracted from horseshoe crabs.

What Are the Key Segments in the Biological Safety Testing Products And Services Market?
The biological safety testing products and services market covered in this report is segmented -

1) By Product: Reagents And Kits, Instruments, Services
2) By Test Type: Endotoxin Tests, Sterility Tests, Cell Line Authentication And Characterization Tests, Bioburden Tests, Adventitious Agent Detection Tests, Residual Host Contamination Detection Tests, Other Test Types
3) By Application: Vaccines And Therapeutics, Blood And Blood-Based Products, Gene Therapy, Tissue And Tissue-based Products, Stem Cell

Subsegments:
1)By Reagents And Kits: Endotoxin Testing Kits, Mycoplasma Detection Kits, Sterility Testing Kits, Microbial Detection Reagents, Cell Culture Media Reagents
2) By Instruments: PCR Instruments, Microplate Readers, Bioluminescence Detection Systems, Automated Cell Culture Systems, ELISA Readers
3) By Services: Microbial Testing Services, Biocompatibility Testing Services, Endotoxin Testing Services, Environmental Monitoring Services, Consulting And Validation Services

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Who Are the Key Players Shaping the Biological Safety Testing Products And Services Market's Competitive Landscape?
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

What Geographic Markets Are Powering Growth in the Biological Safety Testing Products And Services Market?
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.

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