(PharmaNewsWire.Com, August 06, 2021 ) 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.
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.
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 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.
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.
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.
Key Players:
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).
Merck KGaA is one of the leading providers of bioprocess validation services across the globe. It provides a comprehensive portfolio of high-quality services for biopharmaceutical manufacturing. With a strong brand name and extensive geographic coverage in more than 60 countries, Merck has a well-established presence in the bioprocess validation market. In the market, the company focuses on strategies, such as expansions to increase its presence. With regard to this, the company opened an M Lab Collaboration Center in France in March 2019. This center will provide Merck’s bioprocessing customers with a shared, exploratory environment and support pharmaceuticals to develop validation services. With regard to delivering innovative products, Merck invests a significant amount of its sales revenue in R&D. In 2018, it invested around 15% of its sales revenue in R&D activities. This allows the company to extend its technological capabilities and provide superior-quality products, thereby helping it to achieve long-term growth
Pall Corporation is another leading provider of comprehensive bioprocess validation services for the biopharmaceutical industry. The company 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. Pall’s business strategy includes selective expansion into new validation services applications. For instance, in December 2018, Pall opened its Biotech Integrated Solutions Center of Excellence (CoE) in Shanghai, China. However, the company could also focus on other strategies such as partnerships & agreements and acquisitions to further strengthen its position in the market.
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