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.
Objectives of the Study:
# To define, describe, and forecast the bioprocess validation services market based on test type, process component, end-user, and region.
# To provide detailed information regarding the factors influencing market growth (such as drivers, restraints, opportunities, challenges, and industry trends)
# To analyze micromarkets1 with respect to individual growth trends, prospects, and contributions to the overall bioprocess validation services market.
# To analyze market opportunities for stakeholders and provide details of the competitive landscape for key players operating in this market.
# To strategically profile the key players in the bioprocess validation services market and comprehensively analyze their market shares and core competencies
# To strategically analyze five different geographical regions, namely, North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
# To track and analyze competitive developments such as joint ventures & acquisitions; product developments and enhancements; agreements & partnerships; expansions; and funding activities in the bioprocess validation services market.
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This 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.
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.
Recent Developments:
# In August 2018, Merck KGaA launched the BioReliance Product Characterization Portfolio to enhance its service portfolio in the bioprocess validation market.
# In March 2017, Toxikon and SG Lab (Italy) entered into a partnership, to extend its analytical and extractable & leachable testing service portfolio to determine the drug integrity in the entire life cycle.
# In January 2019, SGS acquired LeanSis Expertos en Productividad S.L. (Spain). This acquisition provided SGS operational and manufacturing training and capacity building services to over 200 clients across Spain.
# In February 2018, Pall Corporation expanded its Hoegaarden office in Belgium with new R&D center, customer demonstration labs, and manufacturing space. This will help the company to establish its position in the Belgium market.
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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Critical questions the report answers:
# Where will all these developments take the industry in the medium-to-long-term?
# What are the major trends in bioprocess validation?
# Who are the major end-users of bioprocess validation?
# Which test types are used mainly for bioprocess validation?
# Which process component has a higher adoption rate of bioprocess validation?
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.
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.
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.
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