Recent Developments in Bioprocess Validation Market:

# 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 RD center, customer demonstration labs, and manufacturing space. This will help the company to establish its position in the Belgium market.

Global Leading Players:

The prominent players operating in the global bioprocess validation market are Merck KGaA (Germany), SGS S.A. (Switzerland), Eurofins Scientific (Luxembourg), Sartorius Stedim Biotech (France), Pall Corporation (US), Cobetter Filtration Equipments 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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Growth Strategies Opted by Them:

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.

Expected Growth in Revenue:

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 Driving Factors:

The growth of the bioprocess validation services market is driven primarily by the stringent safety and quality regulations governing product certification and testing across the biopharmaceutical and pharmaceutical industries. This has also stimulated the demand for the outsourcing of bioprocess validation services.

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. The company offers a comprehensive portfolio of high-quality services for biopharmaceutical manufacturing and has facilities in Germany, Austria, Denmark, France, the Netherlands, Russia, Switzerland, the UK, Brazil, China, India, Japan, Singapore, Thailand, Egypt, Nigeria, and South Africa. It focuses on expansions to increase its presence in the bioprocess validation services portfolio and strengthen its position in the market.

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. 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 service launches, partnerships, and agreements to further strengthen its position in the market.

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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. It focuses on organic strategies to strengthen its position in the bioprocess validation market.

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.