The global biologics safety testing market is likely to boost due to the growing demand for pharmaceutical outsourcing, increased new drug launches, and reduction in cost.

The global biologics safety testing market size was valued at USD 3.04 billion in 2019 and projected to reach USD 7.14 billion by 2027, growing at a CAGR of 12.12% during the forecast period, 2020-2027. Due to the surge in demand for the increasing production of new-generation biologics by major pharmaceutical and biotechnology companies. Further, the increasing prevalence of target diseases and the large economic burden of chronic illness will augment the growth of the global biologics safety testing industry in the forecast periods. Additionally, the increasing government initiatives to promote biological safety testing products and services are expected to foster global market growth. With the development of biologics safety technology and the increase in people's medical consumption, expenditure will bolster the growth of global biologics safety testing market share in the coming years. Moreover, the government's interference in improving healthcare infrastructure and swelling investments in the R&D sector will stimulate the market share. Furthermore, the growing demand for toxicology testing, bioburden testing, and analytical testing will accelerate the growth of the global biologics safety testing industry.

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Product Overview in the Global Biologics Safety Testing Market

The global biologics safety testing market is segregated into kits & reagents, services, and instruments based on the product. The kits & reagents segment is evaluated to the highest patient over the analysis timeframe due to the Increasing usage in clinical laboratories, rising adoption of kit-based testing, and growing advancement in the formulation of reagents and kits.
The instruments will grow significantly due to the increasingly adopted pharmaceutical & biopharmaceutical industries for bioburden testing and toxicology assessment.

Test Type Overview in the Global Biologics Safety Testing Market

Based on the test type, the global biologics safety testing market is categorized into endotoxin test, sterility test, cell line authentication, and characterization test, bioburden test, residual host contaminant detection test, adventitious agent detection tests, and other tests.
The endotoxin test segment held for a significant market share in 2019 and will gain maximum market revenue by 2027. It is attributable to the increasing adoption of these tests by the pharmaceutical industries or medical device industry to test injectable pharmaceuticals or implantable medical devices and ensure product safety for patient use. In addition, several endotoxin testing methods, such as gel clot method, turbidimetric method, and kinetic/chromogenic method, are available to detect the endotoxin.

Application Overview in the Global Biologics Safety Testing Market

Based on the application, the global biologics safety testing market is classified into vaccine & therapeutics development, blood and blood-related product testing, cellular & gene therapy, tissue & tissue-related product testing, and stem cell research.
The vaccine & therapeutics development are expected to be the highest revenue share for biologics safety testing during the forecast period. The segment's patient is primarily attributed to the rising demand for vaccines to prevent infectious diseases, the presence of strict guidelines by regulatory authorities to ensure the safety of developed vaccines, and growing investments in vaccine development.
The gene therapy will witness a lucrative growth rate in the estimated period due to high infectivity potential with residual DNA. and rising prevalence of cancer, diabetes, and heart disease.

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Region Overview in the Global Biologics Safety Testing Market

By geography, the global biologics safety testing market is segmented into North America, Europe, Asia Pacific, South America, and Middle East & Africa. North America is managed to project considerable growth over 2020-2026. It is due to the growing pharmaceutical sector, increasing incidence of chronic diseases, and rising R&D activities to develop new biologics, drugs, and vaccines.
The Asia Pacific will have a prominent share of the biologics safety testing market by 2027. Due to the growing healthcare infrastructure, I am increasing the adoption of advanced technology and strict guidelines by the regulatory authorities to deliver the potential drugs or vaccines.

Global Biologics Safety Testing Market: Competitive Landscape

Companies such as Sartorius AG, Charles River Laboratories, Lonza Group LTD, Merck KGaA, SGS SA, Cytovance Biologics, Inc, Pace Toxikon Corporation, Analytical Services Inc, and WuXiApptec are the key players in the global biologics safety testing market.

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