Bioprocess Validation - Emerging Tech Advancements | A Boon to Global Pharma Industry

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.

Objectives behind This Study:

# To define, describe, and forecast the bioprocess validation services market based on test type, process component, end-user, and region.

# To provide detailed information regarding the factors influencing market growth (such as drivers, restraints, opportunities, challenges, and industry trends)

# To analyze micromarkets1 with respect to individual growth trends, prospects, and contributions to the overall bioprocess validation services market.

# To analyze market opportunities for stakeholders and provide details of the competitive landscape for key players operating in this market.

# To strategically profile the key players in the bioprocess validation services market and comprehensively analyze their market shares and core competencies2

# To strategically analyze five different geographical regions, namely, North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

# To track and analyze competitive developments such as joint ventures & acquisitions; product developments and enhancements; agreements & partnerships; expansions; and funding activities in the bioprocess validation services market.

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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.

Key Questions Addressed by the 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?

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.

Restraints:

# Issues Related to Extractables & Leachables

Opportunities:

# Growth Opportunities in Asia Pacific and Latin American Countries

# Patent Expiry

Challenges:

# Waste Disposal

# Development of New Validation Methods for Next Generation Bioproducts

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Monetary Growth Expectations, Globally:

According to the Research Study conducted by MarketsandMarkets™: This 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.

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…

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