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.
Recent Developments in the Global Industry:
# 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.
Critical questions answered in this Report:
# 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?
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Factors Influencing Global Growth:-
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.
Restraint:
# Issues Related to Extractables & Leachables
Opportunities:
# Growth Opportunities in Asia Pacific and Latin American Countries
# Patent Expiry
Challenge:
# Waste Disposal
# Development of New Validation Methods for Next Generation Bioproducts
Monetary Growth Expectations, Globally:
According to the Research Study conducted by MarketsandMarkets™: The global Bioprocess Validation Market 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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Geographical Growth Scenario:
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.
Leading Market Players:
# 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) and many more…
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.
