The stringent safety and quality regulations governing product certification and testing across the biopharmaceutical and pharmaceutical industries, high demand for the outsourcing of bioprocess validation services and rising R&D spending in the life science are some of the major factors that are expected to drive the growth of Bioprocess Validation Market during the forecast period.
Additionally, automation in bioprocess validation services and geographic expansions by market players are the upcoming trends in bioprocess validation, which also expected to support market growth in the coming years.
Extractables/leachables testing services segment to account for the largest share of the bioprocess validation market, by test type
The extractables/leachables testing services segment is expected to account for the largest share of the bioprocess validation market in 2019.
This attributed to the presence of regulatory mandates and guidelines regarding the testing of extractable and leachables; increasing outsourcing of testing services by biopharmaceutical manufacturers; the growing requirement for product safety, identity, purity, and quality; and the increasing risk of product adulteration is one of the major factors driving the growth of this segment.
Contract Development and Manufacturing Organizations (CDMOs) to form the fastest-growing end-user segment in the bioprocess validation market
Among all end-user segments, the demand for bioprocess validation is estimated to grow at the highest rate among CDMOs. This can majorly be attributed to the stringent FDA safety regulations and consumer lawsuits regarding testing requirement, accelerating costs of validation and quality check processes after or during drug development, increasing adoption of bioprocess validation services to keep biopharma production, and approvals in line with the regulatory requirements.
North America is estimated to be the largest regional market for bioprocess validation
North America is expected to account for the largest share of the bioprocess validation market in 2019, closely followed by Europe. Factors such as the presence of well-established biopharmaceutical industry in the region, high R&D expenditure, presence of leading bioprocess validation service providers, and stringent regulatory requirements for biopharmaceutical production are driving the growth of the bioprocess validation market in North America.
The prominent players operating in the bioprocess validation market are Merck KGaA (Germany), Sartorius Stedim Biotech (Sartorius AG) (France), Pall Corporation (US), SGS S.A. (Switzerland), Eurofins Scientific (Luxembourg), Cobetter Filtration Equipment Co., Ltd. (China), Toxikon Corporation (US), DOC S.r.l. (Italy), MEISSNER FILTRATION PRODUCTS, INC. (US), and Thermo Fisher Scientific (US).
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