Biological Safety Testing Products And Services Market Growth Forecast: Exploring Trends and Opportunities for the Next Decade
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What Growth Opportunities are Expected to Drive the Biological Safety Testing Products And Services Market’s CAGR Through 2034?
In recent years, there has been a swift increase in the size of the market for biological safety testing products and services. The market, which was valued at $5.4 billion in 2024, is anticipated to surge to $6.14 billion in 2025, exhibiting a compound annual growth rate (CAGR) of 13.7%. The growth during the historical period can be credited to a variety of factors such as the high occurrence of target diseases, escalating production of next-generation biologics, expanding demand for biologics, an upward trend in the adoption of testing tools, considerable growth in the pharmaceutical and biotechnology sectors, and an increasing focus on regulatory compliance.
We can anticipate a surge in the market size of biological safety testing products and services in the coming years. The projection is that it will expand to $10.11 billion by 2029, with a CAGR of 13.3%. The expansion during the predicted period can be credited to the growing emphasis on assessing the safety and effectiveness of these solutions in addressing health concerns, the ongoing development of novel therapeutics and cures, rising interest in creating cell and gene therapies, increased biopharmaceutical investments, and expanding government initiatives supporting biopharmaceutical safety. Noteworthy trends for the forecast period encompass technological innovation, heightened demand for bioburden testing, booming investments in biopharmaceuticals and biologics, regulatory compliance prompting adoption, and consolidation among significant market participants.
What Are the Primary Drivers Supporting the Growth of the Biological Safety Testing Products And Services Market?
The biological safety testing products and services market is predicted to expand due to the rising demand for gene therapies. Gene therapy, a health intervention that uses genes to avert or cure ailments through substituting, modifying, or adding inadequate genes, indirectly boosts this market. Increased focus on gene mutation research and a supportive regulatory landscape also expedite innovation and broaden the scope of gene therapeutic uses. Biological safety testing products and services play a critical role in gene therapy by ensuring the viral vectors and genetic materials are devoid of contaminants and safe for use. As per a report by the American Society of Gene & Cell Therapy, an American non-profit scientific and medical organization, there was a 10% growth in the number of gene therapies in Phase III clinical trials in the fourth quarter of 2023, marking the initial quarterly rise of this kind since the third quarter of 2022. Consequently, the escalating demand for gene therapies fuels the market for biological safety testing products and services.
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What Are the Leading Industry Players Dominating the Biological Safety Testing Products And Services Market?
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
What Are the Latest Trends Leading to Disruption in the Biological Safety Testing Products And Services Market?
Leading businesses in the market of biological safety testing products and services are creating quick, animal-free tests for bacterial endotoxins. These tests are intended to increase patient safety and speed up drug development. This breakthrough strategy aims to cut down on testing time and enhance dependability, all without animal-based products. For example, Charles River Laboratories International, an American pharmaceutical and biotechnology firm, launched the Endosafe Trillium cartridge in January 2024. This cartridge uses recombinant technology to identify and measure endotoxins without the need for substances derived from animals. It’s the first test of its kind, delivering quicker results and removing the necessity for animal-driven reagents, thereby boosting sustainability and ethical testing methods. This product is geared towards delivering swift and precise results while diminishing the dependence on the traditional Limulus amebocyte lysate (LAL) taken from horseshoe crabs.
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Which Segments of the Biological Safety Testing Products And Services Market Hold the Most Potential for Future Development?
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
Which Regions Are Significant to the Growth of 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.
What Are the Core Features That Define the Biological Safety Testing Products And Services Market?
Biological safety testing products and services refer to equipment and methods used to confirm that biological products are safe and uncontaminated by harmful agents, ensuring their safety and effectiveness for medical use. Its primary aim is to detect and prevent contamination by bacteria, viruses, fungi, and other pathogens.
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