Biologics Safety Testing Market worth $6.8 billion by 2027 - Exclusive Report by MarketsandMarkets™

Biologics Safety Testing Market is projected to reach USD 6.8 billion by 2027 from USD 3.6 billion in 2022, at a CAGR of 13.3% during the forecast period according to a new report by MarketsandMarkets™. The growth of the global biologics safety testing market is driven by factors such as companies investing heavily in the development of biologics and biosimilars, strict regulatory concerns over growing cell culture contamination, and increased demand for various drugs, cell therapies, diagnostics, and active biological products.

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Biologics Safety Testing Market Scope:

The sterility tests segment accounted for the third largest share of the Biologics Safety Testing market in 2021.

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 2021, the sterility tests segment accounted for the third largest market share. Sterility testing applies to a wide range of biological medicinal products, including vaccines, blood products, biotechnology products, and cell & tissue products. Hence, its wide application and regulatory requirement are expected to drive the market growth for sterility tests in the coming years.

The cell and gene therapy development and manufacturing segment registered second highest growth rate in the Biologics safety testing market in 2021.

Based on application, the biologics safety testing market is segmented into monoclonal antibodies development and manufacturing, vaccines development and manufacturing, blood and blood products development and manufacturing, cellular and gene therapy products development and manufacturing, and other applications. In 2021, the cell and gene therapy development and manufacturing segment registered second highest growth rate. Factors such as rising investments in regenerative medicine research and the growing pipeline of regenerative medicine products are driving the growth of the cell and gene therapy market. Also, increasing adoption of cell & gene therapy products for sterility testing, mycoplasma testing, endotoxin testing, adventitious virus testing, and raw material testing is expected to drive the growth of this application segment.

The Asia Pacific region is the fastest growing region of the Biologics safety testing market in 2021.

The Asia Pacific market is projected to witness the highest growth rate during the forecast period. Rapid growth in outsourcing preclinical, clinical, and laboratory testing services to APAC countries is expected to drive market growth during the forecast period. Several companies are focusing on increasing their market shares and customer base in the region to capitalize on these opportunities in the Asia Pacific market.

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Biologics Safety Testing Market Dynamics:

Drivers:

1. Growing development of biosimilars and biologics
2. Growing concerns over cell culture contamination
3. Rising investments in biopharmaceutical R&D

Restraints:

1. Shortage of skilled professionals

Opportunities:

1. Emerging markets
2. Increasing outsourcing of biopharmaceutical activities to CROs

Challenges:

1. High cost of biologics

Key Market Players:

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), Labcorp (US) and Eurofins Scientific (Luxembourg). The key players in this market are focusing on strategic expansions, partnerships, and product & service launches to expand their presence in the market.

Recent Developments:

• In November 2022, Merck KGaA (Germany) invested in expanding its biosafety testing capacity at Rockville, Maryland, US. This site will provide biosafety testing and analytical development services in the US.
• In July 2022, Eurofins Scientific (Luxembourg) acquired Wessling Hungary, a food, environmental, and BioPharma product testing laboratory in Hungary. This acquisition helped expand Eurofins' biopharma testing business in Europe.
• In June 2022, Lonza (Switzerland) launched the PyroCell Monocyte Activation Test to detect non-endotoxin pyrogens and reduce interferences from complex drug products, such as biologics-based pharmaceuticals.
• In March 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 January 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.

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