Research Methodologies Followed in this Study:

Primary Research:

In the primary research process, industry experts from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. Industry experts from the supply side include suppliers, distributors, CEOs, vice presidents, marketing and sales directors, business development managers, and technology and innovation directors of bioprocess validation providers; whereas, industry experts from the demand side include company vice presidents, c-level executives, service managers, laboratory specialists, pharmaceutical & biotechnology manufacturers, pharmaceutical firm R&D heads, research scientists, and other-related key opinion leaders.

Secondary Research:

The secondary research process involved the widespread use of secondary sources, directories, databases (such as Bloomberg Businessweek, Factiva, and D&B Hoovers), white papers, annual reports, company house documents, investor presentations, and SEC filings of companies. Secondary research was used to identify and collect information useful for the extensive, technical, market-oriented, and commercial study of the bioprocess validation market. It was also used to obtain important information about the key players and market classification & segmentation according to industry trends to the bottom-most level, and key developments related to market and technology perspectives. A database of the key industry leaders was also prepared using secondary research.

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Expected Revenue Growth:

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 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.

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.

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?

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.

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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. 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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