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Bioprocess Validation Market - Major Growth Boosters | Future Trends

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Makarand Vaidya

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.

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).

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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.

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.

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.

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.

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Key Players:

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.

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. 

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