Growth Opportunities and Trends in the Biological Safety Testing Products And Services Market: Key Insights for 2025-2034
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How has the biological safety testing products and services market grown over the years?
The biological safety testing products and services market has seen rapid growth in recent years. It will grow from $5.4 billion in 2024 to $6.14 billion in 2025, at a CAGR of 13.7%. This growth is driven by the prevalence of target diseases, increased production of next-generation biologics, rising demand for biologics, higher adoption of testing tools, the expanding pharmaceutical and biotechnology industries, and a greater focus on regulatory compliance.
What Is the forecasted market size and growth rate for the biological safety testing products and services market?
The biological safety testing products and services market is expected to grow to $10.11 billion by 2029, at a CAGR of 13.3%. Growth drivers include the need for safety and effectiveness evaluations, increasing biopharmaceutical development, interest in cell and gene therapies, rising biopharmaceutical investments, and government initiatives for biopharmaceutical safety. Key trends include technological advancements, bioburden testing demand, rising investments in biologics, regulatory compliance, and industry consolidation.
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What are the major factors driving growth in the biological safety testing products and services market?
The increasing demand for gene therapies is anticipated to drive the growth of the biological safety testing products and services market. Gene therapy, which uses genes to treat or prevent diseases by altering or replacing faulty genes, is gaining momentum due to greater investment, research in gene mutations, and favorable regulatory environments. Biological safety testing ensures that viral vectors and genetic materials are free from contaminants. For example, in January 2024, the American Society of Gene & Cell Therapy reported a 10% growth in the number of gene therapies in Phase III clinical trials during Q4 2023, marking the first such increase since Q3 2022. As a result, the demand for gene therapies is propelling the biological safety testing market.
What key areas define the segmentation of the global 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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What are the top market players propelling the growth of the biological safety testing products and services industry?
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 are the key trends shaping the future of the biological safety testing products and services market?
Companies in the biological safety testing products and services market are working on animal-free bacterial endotoxin testing to ensure patient safety and accelerate drug development. This approach eliminates the use of animal-based products, improving testing reliability and speed. For instance, in January 2024, Charles River Laboratories introduced the Endosafe Trillium cartridge, a rapid animal-free bacterial endotoxin test using recombinant technology. This method provides quicker results and eliminates animal-derived materials, promoting sustainable and ethical testing practices.
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What regions are dominating the biological safety testing products and services market growth?
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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