The global 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. The growth of the global biologics safety testing market is driven by factors such as the growing developments of biologics and biosimilars, increased concerns over the cell culture contamination, and rising investments in biopharmaceutical research and development. In addition, emerging markets and outsourcing to CROs are expected to provide significant growth opportunities for players in the Biologics safety testing market.
Prominent players in the biologics safety testing market are Charles River Laboratories, Inc. (US), Lonza (Switzerland), Thermo Fisher Scientific, Inc. (US), Merck KGaA (Germany), Labcorp (US), F. Hoffmann-La Roche Ltd. (Switzerland), Agilent Technologies, Inc. (US), Sartorius AG (Germany), and Lonza (Switzerland). The key players in this market are focusing on strategic expansions, partnerships, and product & service launches and approvals to expand their presence in the market.
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CHARLES RIVER LABRATORIES (US)
Charles River is one of the key players in the biologics safety testing market. It is a service and early-stage contract research organization (CRO). The company develops a diverse portfolio of discovery & safety assessment services by providing a suite of products and services to support its clients’ manufacturing activities. The company operates through three reporting segments, namely, Research Models and Services (RMS), Discovery and Safety Assessment (DSA), and Manufacturing Support (Manufacturing). The company offers biologics safety testing solutions through its Manufacturing Support segment. To further strengthen its market position, Charles River Laboratories focuses on expanding its service and product offerings in the biologics safety testing segment. The company offers customized assays to address specific concerns and needs, ensuring an appropriate testing plan is designed for biological products. Fast Track Testing is also available to quickly deliver urgently needed results. To maintain its leading position and enhance its market share, the company mainly focuses on exceeding customer expectations by maintaining the quality of its services and quickly adapting to new conditions with efficiency. The acquisitions of JADE Biomedical (China) and Cognate BioServices (US) have further strengthened the company’s portfolio and geographic presence in the market.
Lonza is a key player in the biologics safety testing market. The company has a large number of manufacturing and R&D facilities worldwide. The company's wide geographic presence and high production capacity deliver quality products worldwide. The company focuses on organic growth strategies to maintain its position in the biologics safety testing market. In line with this, in April 2021, Lonza launched the PyroTec PRO Automated Robotic Solution, designed for use with the sustainable PyroGene Recombinant Factor C (rFC) Assay for endotoxin testing. Such developments have helped the company enhance its visibility in the biologics safety testing market.
THERMO FISCHER SCIENTIFIC (US)
Thermo Fisher Scientific offers analytical instruments, equipment, reagents, and consumables for research, discovery, analysis, diagnostics, and manufacturing. The company operates through four principal product segments—Life Sciences Solutions, Analytical Instruments, Specialty Diagnostics, and Laboratory Products and Services. The company offers a wide array of biologics safety testing products through its Life Sciences Solutions segment. The company offers a wide range of biological safety testing kits for endotoxin testing, residual host-cell proteins & DNA detection tests, mycoplasma tests, and virus safety testing for biologics molecules.
Biologics Safety Testing Market by Product & Service (Instruments, Consumables, Services), Application (mAbs, Vaccine, Cell & Gene Therapy), Test Type (Sterility Test, Endotoxin, Mycoplasma, Bioburden), End User (Biopharma, CDMO) - Global Forecast to 2027
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