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.

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Biologics Safety Testing Market

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.

The Asia Pacific region is the fastest growing region of the Biologics safety testing market in 2020.

The Asia Pacific market is projected to witness the highest growth rate during the forecast period, primarily due to the expansion of key market players in emerging Asia Pacific countries, increasing expenditure on life science research, and the increasing trend of pharmaceutical outsourcing to Asia Pacific countries.

Prominent players in the biologics safety testing market are Charles River Laboratories, Inc. (US), Lonza (Switzerland), Thermo Fisher Scientific, Inc. (US), Merck KGaA (Germany), SGS SA (Switzerland), WuXi AppTec (China), and Eurofins Scientific (Luxembourg). The key players in this market are focusing on strategic expansions, partnerships, and product launches and approvals to expand their presence in the market.

Recent Developments

In 2021 Charles River Laboratories, Inc. (US) launched a new detection tool, EndoScan-V, a validated endotoxin detection and measurement software used to generate and report quantitative test data. The software performed the requisite measurements and calculations and created test reports with the convenience of digital signature report approval.
In 2021, Charles River Laboratories, Inc. (US) acquired Cognate BioServices to expand its offerings in cell and gene therapy development, testing, and manufacturing, providing clients with an integrated solution from basic research and discovery through CGMP production.
In 2021, Charles River Laboratories, Inc. (US) partnered with JADE Biomedical to expand its biological testing solutions capabilities geographically and cater to the increasing demand for biologics therapeutics, especially cell and gene therapies. This strategic relationship enabled JADE to expand its current global Good Manufacturing Practice (GMP) product testing operations in Shanghai into a second facility and further build upon its current offering of comprehensive biologics quality management and testing services.
In 2021, Lonza launched the PyroTec PRO Automated Robotic Solution for endotoxin testing. The new PyroWave Reader add-on has been designed specifically for use with the sustainable PyroGene Recombinant Factor C (rFC) Assay.
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Critical questions the report answers:

What is the current size of the Biologics safety testing market?

Who are the leading players in the biologics safety testing market?

What are the major drivers of the biologics safety testing market?

What is the COVID-19 impact on the biologics safety testing market?



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