Rising incidences of chronic disorders, innovations in treatment and growth in number of healthcare facilities globally is expected to drive industry growth.

According to a new report by Reports and Data, the Global Biological Safety Testing Market size was valued at USD 3.59 Billion in 2020 and is forecast to exceed USD 8.92 Billion in terms of revenue, at a CAGR of 5.1% through 2028. The market growth is driven by increasing prevalence of lifestyle-associated disorders such as diabetes, and mounting demand for improving drug development and their following commercialization process.

Biologics are products manufactured from living organisms, therefore their safety and specialized evaluation is of the highest importance. The testing is performed to assure a safe quality and non-contamination of vaccines and biopharmaceuticals. Biological safety testing has become an essential step for new products launching.

 Pharmaceutical companies are taking several ensure the safety of targeted and specific therapies, circumvent probable shortcomings and evaluate their outcomes.  Surging demand for high manufacturing effectiveness is prompting pharmaceutical and biotechnology companies to include biological safety testing tools. These tools and kits offer highly accurate assessment and result for several target diseases. Increasing influence of regulatory bodies to implement safety guidelines for the biopharma companies coupled with increasing consumer awareness will reinforce biological safety testing market trends through 2028.

Top Companies Profiled in the Report Include:

Charles River Laboratories International Inc., Lonza Group, SGS SA, Sigma-Aldrich Corporation, Avance Biosciences Inc., WuXiPharmaTech Inc., BSL Bioservice, Cytovance Biologics Inc., Toxikon Corporation, and Merck KGaA, among others.

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Market Overview:

The pharma and healthcare industry has undergone a revolutionary change owing to the COVID-19 pandemic with individuals increasing their focus on health and wellness. Companies operating in the industry have invested heavily in clinical trials and research studies to develop medications to cater to the growing unmet clinical demand on a global level. Implementation of cutting-edge technology in healthcare sector and increasing investment in research and development have contributed significantly to revenue growth of the market in the recent past. In addition, availability of favorable health insurance and reimbursement policies have also positively impacted the healthcare sector with more and more individuals opting to get treatment at hospital and clinical facilities. Rapid development of novel drugs and pharmaceuticals, increasing incidence of lifestyle and chronic diseases, establishment of state-of-the-art healthcare facilities, and rising availability of over-the-counter medications have significantly contributed to the revenue growth of the market.  

The report has gather vital information about recent mergers and acquisitions, joint ventures, collaborations, partnerships, brand promotions, R&D activities, and government and corporate deals, among others through extensive primary and secondary research. The report also offers detailed analysis of each competitor along with their financial standing, global market position, product portfolio, manufacturing and production capacity, and business expansion plans.

The report offers a comprehensive overview of the regional bifurcation of the market with respect to market share, market size, revenue growth, import/export, production and consumption patterns, macro and micro economic growth factors, regulatory framework, investment and funding opportunities, and presence of key players in each region including North America, Asia Pacific, Latin America, Europe, and Middle East & Africa. The report offers a country-wise analysis to further discuss the revenue growth and lucrative growth opportunities for the Biological Safety Testing market in these key regions.

Further key findings from the report suggest

Based on product type, the reagents and kits segment is estimated to exceed USD 2.73 billion in terms of revenue at a CAGR of 12.1% through 2028. Ongoing advancements and modifications in the formulation of reagents & kits is encouraging laboratory technicians to include these products in toxicology for better assessment.

Based on application, the vaccine and therapeutic segment is forecast to contribute revenue share close to USD 2.62 billion by 2028. The increased demand vaccine and therapeutic that align with regulatory guidelines to ensure unaltered therapeutic value and decreased toxicity will favor segment’s growth.

Based on test type, the endotoxin tests type accounted for nearly 27.6% of the global biological safety testing market in 2020 and is expected to gain major traction through 2028. The robust growth can be attributed to the increasing incorporation of these tests for various drug and biopharmaceuticals manufacturing. Also, availability of various types of endotoxin tests, such as gel clot endotoxin testing, USP chromogenic endotoxin testing, and turbidimetric method, to suit different requirements is boosting segmental growth.

In the regional landscape, Asia Pacific is forecasted to observe a notable CAGR of 12.6% through 2028 on account of economic development coupled with continually increasing per capita healthcare investment in emerging countries including India, China, Singapore, and others.

North America accounted for 37.3% of the global biological safety testing market in 2020 and is expected to contribute significantly to the market revenue share during the forecast period. The market growth is driven by increasing prevalence of chronic diseases, growth in biotechnology and pharmaceutical industries, rise in number of innovative product launches, and government support for biotechnology and pharmaceutical industries in the region.

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For the purpose of this study, Reports and Data has segmented the global Biological Safety Testing Market on the basis of Product, Application, Test Type and region:

Product Outlook (Revenue, USD Million; 2020-2028)

Reagents & kits



Application Outlook (Revenue, USD Million; 2020-2028)

Vaccines & therapeutics

Stem cell

Tissue & tissue-based products

Gene therapy

Blood & blood-based therapy

Test Type Outlook (Revenue, USD Million; 2020-2028)

Endotoxin tests

Bioburden tests

Adventitious agent detection tests

Residual host contamination detection tests

Sterility tests

Cell line authentication and characterization tests


Regional Outlook (Revenue, USD Million; 2020-2028)

North America


Asia Pacific

Latin America


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Tags: Biological Safety Testing Industry, Asia-Pacific Biological Safety Testing Market, COVID-19 Effect On Industry Biological Safety Testing Market, Europe Biological Safety Testing Market, Biological Safety Testing Market 2021, Biological Safety Testing Market After COVID-19, Biological Safety Testing Market Analysis

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