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.

Bioprocess Validation Process 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 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 this 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.

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Global Industry Segmentation:

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.

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.

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 Process 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.

Global Leaders:

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.

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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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