Global Biological Safety Testing Products & Services Market Growing due to Pandemic Preparedness, Biotech Advancements

Global Biological Safety Testing Products and Services Market to Reach Valuation of US$ 9.89 Bn by 2031, at a CAGR of 12.7% (2023 – 2031); states TNR

WILMINGTON, DELAWARE, UNITED STATES, December 1, 2023 /EINPresswire.com/ -- Biological safety testing products and services encompass a suite of resources and assessments employed to evaluate the safety of biopharmaceuticals and medical equipment. These include techniques like sterility tests, endotoxin detection, cell-based assays, and viral clearance studies. They ensure that products meet stringent safety and regulatory criteria before reaching the market.

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Global Biological Safety Testing Products and Services Market Progress Drivers
Global Pandemic Preparedness: The biological safety testing products and services market is experiencing increased demand driven by global pandemic preparedness. Recent events like the COVID-19 pandemic have underscored the importance of rapid and accurate safety testing for vaccines, therapeutics, and diagnostic products. Governments and pharmaceutical companies are investing significantly in testing infrastructure. For example, with COVID-19 pandemic, the FDA authorized multiple emergency use authorizations (EUAs) for diagnostic tests. This trend emphasizes the ongoing need for robust testing capabilities to respond swiftly to emerging infectious diseases and public health crises.

Biotechnology Advancements: Advances in biotechnology, including CRISPR gene editing and bioprocessing techniques, are propelling the biological safety testing products and services market. As of recent years, gene therapies have gained prominence, with over 2,900 clinical trials in progress worldwide. This trend necessitates innovative safety testing methods to ensure the precise and safe delivery of genetic treatments. Moreover, bioprocessing technologies are evolving to produce biologics more efficiently. These developments are driving the adoption of state-of-the-art testing products and services to maintain the highest safety and quality standards in biopharmaceutical production.

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Which Test Type Will Have the Highest Share in the Global Biological Safety Testing Products and Services Market in the Upcoming Years?
The endotoxin tests segment dominated the global biological safety testing products and services market by type in 2022. The dominance is driven by its critical role in ensuring the safety of pharmaceuticals and medical devices. As of recent years, endotoxins, derived from bacterial cell walls, pose a significant risk in healthcare products. Regulatory bodies mandate stringent endotoxin testing to prevent patient harm. For instance, the European Pharmacopoeia sets limits on endotoxin levels in parenteral drugs. With the growing complexity of biopharmaceuticals and medical devices, the demand for precise endotoxin testing remains high. This dominance underscores the segment's indispensable contribution to product safety and regulatory compliance across the healthcare industry.

Based on the Application Segment, Which is the Fastest Growing Segment in the Global Biological Safety Testing Products and Services Market during the Forecast Period?
Among applications, the cellular and gene therapy product development and manufacturing segment is anticipated to be the fastest growing segment in the global biological safety testing products and services market during the forecast period. Recent years have witnessed an explosion in cellular and gene therapy research and development, with hundreds of clinical trials underway. As of 2021, there were more than 1,200 clinical trials related to gene therapies worldwide. This surge is attributed to their potential to revolutionize disease treatment. Robust safety testing, including viral and genetic vector safety assessments, is vital to mitigate risks. This segment's rapid growth mirrors the transformative potential of cellular and gene therapies in modern medicine and the essential role of safety testing in their successful development and deployment.

Based on Regions, Which Region had the Highest Share in the Biological Safety Testing Products and Services Market in 2022?
North America recorded the highest market share of 46% in the biological safety testing products and services market in 2022. The US, in particular, is a global leader in drug development and innovation. In 202, the US pharmaceutical market was valued at over $550 billion. This region is home to a multitude of pharmaceutical giants and cutting-edge biotech companies. Additionally, the stringent regulatory framework of the FDA and CDC places a strong emphasis on safety testing. North America's leadership in pharmaceutical research, production, and safety testing reaffirms its dominance in the global Biological Safety Testing market.

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Global Biological Safety Testing Products and Services Market Participants
Some of the key players operating in the global biological safety testing products and services market are
o ASSOCIATES OF CAPE COD, INC.
o BIOMERIEUX
o Charles River Laboratories
o Eurofins Scientific
o F. Hoffmann-La Roche Ltd.
o GenSscript
o Laboratory Corporation of America Holdings
o Lonza
o Merck KGaA
o Samsung Biologics
o Sartorius AG
o SGS Societe Generale de Surveillance SA
o Thermo Fisher Scientific Inc.
o WuXi AppTec
o Other market participants

Global Biological Safety Testing Products and Services Market Summary
Global Biological Safety Testing Products and Services Market
By Product
o Consumables
o Instruments
o Services

By Test Type
o Residual Host-Cell Proteins and DNA Detection Tests
o Mycoplasma Tests
o Endotoxin Tests
o Sterility Tests
o Bioburden Tests
o Virus Safety Tests
o Others

By Application
o Monoclonal Antibodies Development and Manufacturing
o Vaccine Development and Manufacturing
o Cellular and Gene Therapy Product Development and Manufacturing
o Blood and Blood Product Development and Manufacturing
o Other Applications
By End User
o Pharmaceutical and Biopharmaceutical Companies
o Contract Research Organizations and Contract Development and Manufacturing Organizations (CROs and CDMOs)
o Academic and Research Institutes

By Region
o North America (U.S., Canada, Mexico, Rest of North America)
o Europe (France, The UK, Spain, Germany, Italy, Nordic Countries (Denmark, Finland, Iceland, Sweden, Norway), Benelux Union (Belgium, The Netherlands, Luxembourg), Rest of Europe)
o Asia Pacific (China, Japan, India, New Zealand, Australia, South Korea, Southeast Asia (Indonesia, Thailand, Malaysia, Singapore, Rest of Southeast Asia), Rest of Asia Pacific)
o Middle East & Africa (Saudi Arabia, UAE, Egypt, Kuwait, South Africa, Rest of Middle East & Africa)
o Latin America (Brazil, Argentina, Rest of Latin America)

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