Growth in pharmaceutical and biotechnology industry driven by government support in both industries, the positive trend of R&D investment in the life sciences industry and an increase in the number of new drug launches are the major factors driving the growth of Biologics Safety Testing Market.

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What This Report Will Provide?

The biologics safety testing industry is constantly evolving with advancements in technologies and the development of new and improved safety testing programs across various industries. Highly skilled professionals are required to keep pace with the continuing changes in analytical technologies and safety testing methodologies.

Expected Revenue Growth:

[185 Pages Report] The global biologics safety testing market is projected to reach USD 6.2 billion by 2026 from USD 3.4 billion in 2021, at a CAGR of 12.4% during the forecast period.

The overall market size was used in the top-down approach to estimate the sizes of other individual markets (mentioned in the market segmentation—by product & service, test type, application, and region) through percentage splits from secondary and primary research.

Biologics Safety Testing Market segmentation

By Product & Service
By Test Type
By Application
By Region

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The residual host-cell proteins and DNA detection tests segment accounted for the largest share of the Biologics Safety Testing market in 2020.

Based on test type, the biologics safety testing market is segmented into residual host-cell proteins and DNA detection tests, endotoxin tests, sterility tests, mycoplasma tests, bioburden tests, and virus safety tests. In 2020, the residual host-cell proteins and DNA detection tests segment accounted for the largest market share. The rising demand for residual HCP and DNA detection tests for recombinant proteins and increasing focus on the quality of drugs are the major factors driving the growth of this segment.

The monoclonal antibodies manufacturing segment accounted for the largest market share of the Biologics safety testing market in 2020.

Based on application, the biologics safety testing market is segmented into monoclonal antibodies manufacturing, vaccines manufacturing, blood and blood products manufacturing, cellular and gene therapy products manufacturing, and other applications. In 2020, the monoclonal antibodies manufacturing segment accounted for the largest market share. The large share of this segment can be attributed to the rising prevalence of diseases and increasing government initiatives for the development of monoclonal antibody drugs.

Geographical Detailed Analysis for Biologics Safety Testing Market:

By region, the global biologics safety testing market is segmented into North America, Europe, Asia, and the Rest of the World (RoW). While North America holds the largest share of the market in 2016, Asia is expected to grow at the highest CAGR during the forecast period. The presence of emerging economies like China and India; large population; growth in pharmaceutical and biotechnology industry; and growth in the outsourcing industry in this region are key factors driving the high growth of this regional segment.

The Major Players Operating in the Biologics Safety Testing Market

Key players operating in the biologics safety testing market include Lonza Group LTD. (Switzerland), Charles River Laboratories (U.S.), Merck KGaA (Germany), SGS SA (Switzerland), WuXi Apptec (China), Thermo Fisher Scientific Inc. (U.S.), Sartorius AG (Germany), Cytovance Biologics, Inc. (U.S.), Pace Analytical Services Inc. (U.S.), and Toxikon Corporation (U.S.).

Critical questions the report answers:

Where will all these developments take the industry in the long term?
What are the upcoming trends for the biologics safety testing market?
Which segment provides the most opportunity for growth?
Who are the leading vendors operating in this market?
What are the opportunities for new market entrants?

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