Northbrook, United States, August 27,2019- This study involved the extensive use of primary and secondary sources and involved an in-depth analysis of the various factors affecting the growth of the global bioprocess validation market. Both primary and secondary research was used to identify the segmentation types, trends, key players, key market dynamics, and key player strategies as well as derive the competitive leadership mapping and competitive landscape in this market.
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 regulatory mandates in the healthcare industry to maintain compliance with Good Manufacturing Practices (GMP) are the major factors driving the growth of this market.
Major Industry Growth Restraint:
# Issues Related to Extractables & Leachables
Global Growth Opportunities:
# Growth Opportunities in Asia Pacific and Latin American Countries
# Patent Expiry
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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.
APAC market is estimated to grow at the highest CAGR during the forecast period
The bioprocess validation market in the APAC is estimated to grow at the highest CAGR during the forecast period. The growing biopharmaceutical manufacturing capabilities in Asian countries, increasing demand for outsourcing bioprocess validation, growing life science research specific to biologics and increasing investments by pharmaceutical and biotechnology companies is expected to drive market growth.
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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.
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