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In-Depth Analysis of the Biological Safety Testing Products And Services Market: Growth Opportunities, Key Trends, and Forecast 2025-2034
Biological Safety Testing Products And Services
The increasing need for gene therapies is anticipated to drive the expansion of the biological safety testing products and services sector. Gene therapy is an innovative medical procedure that aids in disease treatment and prevention by introducing, altering, or supplementing faulty genes. Enhanced funding and research in gene mutation, coupled with a supportive regulatory environment, boost innovation and the scope of gene therapy applications. Biological safety testing products and services are critical in ensuring that viral vectors and genetic materials used in gene therapy are devoid of contaminants and safe for use. For example, as per a document released by the American Society of Gene & Cell Therapy, a non-profit medical and scientific entity based in the U.S., there was a 10% increase in Phase III clinical trials of gene therapies in the fourth quarter of 2023 - the first rise of such a kind since the third quarter of 2022. Thus, the rising need for gene therapies fuels the biological safety testing products and services market's growth.
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What is the future CAGR of the biological safety testing products and services market, and how will it impact industry expansion?
The market size for biological safety testing products and services has seen a quick rise in recent years. The market's value is set to increase from $5.4 billion in 2024 to $6.14 billion in 2025, representing a compound annual growth rate (CAGR) of 13.7%. This growth during the historic period is due to various factors including an increase in target diseases prevalence, the production of next-generation biologics, higher demand for biologics, the growing adoption of testing tools, expansion in the pharmaceutical and biotechnology sectors, and an increasing focus on regulatory compliance.
The market size for products and services related to biological safety testing is projected to witness significant growth in the forthcoming years, escalating to $10.11 billion by 2029 at a CAGR of 13.3%. The expected expansion during the forecast period can be correlated with the increasing value placed on safety evaluations and efficacy in health problem solutions, the rise in the creation of new therapeutic methods and treatments, growing interest in cell and gene therapy progressions, an increase in financial input towards biopharmaceuticals, and government-led initiatives emphasizing biopharmaceutical security. Major trends to watch over the forecast period include technological progress, a growing call for bioburden testing, intensified investments in biopharmaceuticals and biologics, regulatory compliance propelling use, and strategic merger and acquisition activities between prominent industry players.
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What are the most significant trends transforming the biological safety testing products and services market today?
Key players in the biological safety testing products and services market are pushing the boundaries by creating fast, animal-product-free methods for bacterial endotoxin testing to further safeguard patients and streamline the process of drug creation. These novel methods are targeted at decreasing the time spent on testing and enhancing the dependability without resorting to animal products. In particular, Charles River Laboratories International, an American pharmaceutical and biotechnology firm, unveiled the Endosafe Trillium cartridge in January 2024. This product uses recombinant technology to identify and calculate endotoxins without resorting to products obtained from animals. This new quick, animal-free bacterial endotoxin testing product features a quick response time and doesn't involve the usage of animal-based reagents, promoting sustainability and the ethical practices in testing. Its main goal is to offer fast and precise results whilst reducing the dependence on the classic Limulus amebocyte lysate (LAL) that is sourced from horseshoe crabs.
Which key market segments comprise the biological safety testing products and services market and drive its revenue growth?
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 regions are at the forefront of biological safety testing products and services market expansion?
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.
Who are the leading players fueling growth in 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, 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
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What Is Covered In The Biological Safety Testing Products And Services Global Market Report?
•Market Size Forecast: Examine the biological safety testing products and services market size across key regions, countries, product categories, and applications.
•Segmentation Insights: Identify and classify subsegments within the biological safety testing products and services market for a structured understanding.
•Key Players Overview: Analyze major players in the biological safety testing products and services market, including their market value, share, and competitive positioning.
•Growth Trends Exploration: Assess individual growth patterns and future opportunities in the biological safety testing products and services market.
•Segment Contributions: Evaluate how different segments drive overall growth in the biological safety testing products and services market.
•Growth Factors: Highlight key drivers and opportunities influencing the expansion of the biological safety testing products and services market.
•Industry Challenges: Identify potential risks and obstacles affecting the biological safety testing products and services market.
•Competitive Landscape: Review strategic developments in the biological safety testing products and services market, including expansions, agreements, and new product launches.
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