The global bioprocess validation market is exceeded USD 180 million in 2019 and is projected to be valued over USD 360 million by 2024, at a CAGR of 14.6% during the forecast period. The growth of the bioprocess validation services market is driven primarily by the stringent safety and quality regulations governing product certification and testing across the biopharmaceutical and pharmaceutical industries. This has also stimulated the demand for the outsourcing of bioprocess validation services.
The rising R&D spending in the life science industry has contributed to this demand significantly, while the growing demand for bioprocess validation in emerging countries and patent expiries have ensured steady market growth. However, the issues related to extractable and leachable testing affect market growth to a certain extent during the forecast period.
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Merck KGaA (Germany), Sartorius Stedim Biotech (France), Pall Corporation (US), SGS S.A. (Switzerland), Eurofins Scientific (Luxembourg), Cobetter Filtration Equipments Co., Ltd. (China), Toxikon Corporation (US), DOC S.r.l. (Italy), MEISSNER FILTRATION PRODUCTS, INC. (US), and Thermo Fisher Scientific (US) are the leading players operating in the global bioprocess validation market. These companies are focusing on increasing their presence in high-growth markets through organic and inorganic growth strategies such as capacity expansions, service launches, agreements, partnerships, collaborations & acquisitions.
Merck KGaA (Germany) is one of the leading players in the global bioprocess validation market. The company’s leading position in this market is attributed to its extensive geographic presence across North America, Europe, Middle East & Africa, and Asia Pacific. The company offers a comprehensive portfolio of high-quality services for biopharmaceutical manufacturing and has facilities in Germany, Austria, Denmark, France, the Netherlands, Russia, Switzerland, the UK, Brazil, China, India, Japan, Singapore, Thailand, Egypt, Nigeria, and South Africa. It focuses on expansions to increase its presence in the bioprocess validation services portfolio and strengthen its position in the market.
Pall Corporation (US) accounted for the second-largest share of the bioprocess validation market in 2018. The company’s wholly-owned subsidiary offers validation services for single-use and reusable process components used in bioprocessing. The company provides validation services to the biopharmaceutical industry through its strong distribution network across the globe. Pall’s business strategy includes selective expansion into new validation services applications. For instance, in December 2018, Pall opened its Biotech Integrated Solutions Center of Excellence (CoE) in Shanghai, China. However, the company could also focus on other strategies such as service launches, partnerships, and agreements to further strengthen its position in the market.
Sartorius Stedim Biotech was the third-largest bioprocess validation company in the market in 2018. The company offers validation services; microbiological & physicochemical tests; and extractable & leachable, regulatory compliance, equipment qualification (IQ|OQ and SAT), and testing services for drug development. To build brand loyalty and enhance its brand image, Sartorius Stedim Biotech primarily focuses on supporting multiple country-specific biopharmaceutical manufacturing regulations. It focuses on organic strategies to strengthen its position in the bioprocess validation market. For instance, in January 2019, Sartorius launched NBE Product Characterization, which combines physicochemical and biological analysis for in-depth characterization studies from a single contract partner with fully compliant cGMP facilities, as audited by the FDA & MHRA. This will help the company showcase a range of company’s service lines and enhance its presence in the North American and APAC markets for bioprocess validation.
Bioprocess Validation Market by Test Type (Extractables and Leachables, Integrity Testing, Microbiology Testing), Process Component (Filter Element, Bioreactors), End-User (CDMO, Biotechnology & Pharmaceutical Companies) - Global Forecast to 2024
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