Research Methodologies Followed for 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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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.
Pharmaceutical companies are estimated to be the largest end users of bioprocess validation in 2019
Pharmaceutical companies are expected to account for the largest share of the bioprocess validation market in 2019. The large share of this segment can majorly be attributed to increasing production of biopharmaceuticals and the corresponding increase in the number of impurities to be checked for, the stringency of standards and regulations regarding the quality and validity of bioprocesses involved in the production.
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?
Global Revenue Growth Expectations:
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.
Growth Boosting Factors:
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.
Market Size Estimation:
The market size estimates and forecasts provided in this study are derived through a mix of the bottom-up approach (revenue share analysis of leading players) and the top-down approach (assessment of utilization/adoption/penetration trends, by test type, process component, end-user, and region).
Data Triangulation:
After arriving at the market size, the total bioprocess validation market was divided into several segments and subsegments. Data triangulation and market breakdown procedures were employed, wherever applicable, to complete the overall market engineering process and arrive at the exact statistics for all segments & subsegments.
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Geographical Growth Scenario:
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.
Additionally, rising awareness about the advantages of biopharmaceutical drugs, and the growing number of CROs & CDMOs, and the favorable government initiatives to promote the growth of the pharmaceutical and biotechnology industries in several APAC countries.
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