DUBLIN--(BUSINESS WIRE)--The "Bioprocess Validation Market by Test Type (Extractables and Leachables, Integrity Testing, Microbiology Testing), Process Component (Filter Element, Bioreactors), End-User (CDMO, Biotechnology & Pharmaceutical Companies) - Global Forecast to 2024" report has been added to ResearchAndMarkets.com's offering.

The bioprocess validation services market is projected to reach USD 369.9 million by 2024 from USD 186.8 million in 2019, at a CAGR of 14.6% during the forecast period.

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.

The rising R&D spending in the life science industry has contributed to this demand significantly, while the growing demand for bioprocess validation in emerging countries and patent expiries have ensured steady market growth. However, the issues related to extractable and leachable testing affect market growth to a certain extent during the forecast period.

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).

Extractables/leachables testing services segment to witness the highest growth during the forecast period

The combination systems segment is estimated to grow at the highest CAGR during the forecast period. This can primarily be attributed to increasing outsourcing of testing services by biopharmaceutical manufacturers; the presence of regulatory mandates and guidelines regarding the testing of extractables & leachables; and growing product safety, identity, purity, and quality; and the increasing risk of product adulteration related requirement.

Filter elements segment to grow at the highest CAGR in the bioprocess validation market, by process component

The major factors driving the demand for filter elements in bioprocess validation are stringent regulations and industry standards for biopharmaceutical products; increasing usage of a variety of filters in bioprocessing; and the high demand for the evaluation of specific filter elements and their impact on the final drug product owing to the factors such as safety and efficacy of biopharmaceutical products.

APAC market to witness the highest growth during the forecast period

The Asia-Pacific is estimated to be the fastest-growing regional market for bioprocess validation 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, increasing investments by pharmaceutical & biotechnology companies, raising awareness about the advantages of biopharmaceutical drugs, increasing number of CROs & CDMOs, and the favorable government initiatives to promote the growth of the pharmaceutical & biotechnology industries in several APAC countries are some of the major factors driving the growth of this market.

Key Topics Covered

1 Introduction

1.1 Objectives of the Study

1.2 Market Definition

1.3 Market Scope

1.4 Currency

1.5 Limitations

1.6 Stakeholders

2 Research Methodology

2.1 Research Data

2.2 Market Size Estimation

2.3 Market Breakdown and Data Triangulation

2.4 Assumptions for the Study

3 Executive Summary

4 Premium Insights

4.1 Bioprocess Validation Services: Market Overview

4.2 Asia Pacific: Bioprocess Validation Services Market, By End User (2018)

4.3 Geographical Snapshot of the Market

4.4 Regional Mix: Market

4.5 Bioprocess Validation Market: Developing vs Developed Countries

5 Market Overview

5.1 Introduction

5.2 Market Dynamics: Impact Analysis

5.2.1 Drivers

5.2.1.1 Stringent Safety & Quality Regulations

5.2.1.2 Increasing Demand for Biopharmaceuticals

5.2.1.3 Increasing Demand for Outsourcing Bioprocess Validation

5.2.1.4 Rising Life Science R&D Expenditure

5.2.2 Restraints

5.2.2.1 Issues Related to Extractables & Leachables

5.2.3 Opportunities

5.2.3.1 Growth Opportunities in Asia-Pacific and Latin American Countries

5.2.3.2 Patent Expiry

5.2.4 Challenges

5.2.4.1 Waste Disposal

5.2.4.2 Development of New Validation Methods for Next Generation Bioproducts

6 Industry Insights

6.1 Industry Trends

6.1.1 Automation in Bioprocess Validation Services

6.1.2 Geographic Expansions By Market Players

6.2 Regulatory Guidelines for Bioprocess Validation

7 Bioprocess Validation Market, By Test Type

7.1 Introduction

7.2 Extractables/Leachables Testing Services

7.2.1 Specifications and Guidelines for Extractables/ Leachables Testing have Ensured the Continued Demand for These Services

7.3 Microbiological Testing Services

7.3.1 Large-Scale Eukaryotic Cell Culture Testing Services

7.3.1.1 North America Shows the Highest Demand for Large-Scale Eukaryotic Cell Culture Testing Services

7.3.2 Virus Production & Purification Testing Services

7.3.2.1 Increased Concerns of Viral Contaminant Presence in Raw Materials are Driving the Adoption of Testing Services

7.3.3 Electron Microscopy Testing Services

7.3.3.1 Electron Microscopy Provides High-Resolution Images of Specimens Present in Bioprocesses

7.4 Physiochemical Testing Services

7.4.1 Need for Detection and Characterization of Impurities in the Final Product is Driving Market Growth

7.5 Integrity Testing Services

7.5.1 Integrity Testing is Vital to Detect Wear and Tear and Pressure-Caused Damage

7.6 Compatibility Testing Services

7.6.1 Demand for Evaluating Process Component-Formulation Interaction has Necessitated Compatibility Testing

7.7 Other Testing Services

8 Bioprocess Validation Market, By Process Component

8.1 Introduction

8.2 Filter Elements

8.2.1 Stringent Regulations for Biopharmaceutical Products are Driving the Growth of This Segment

8.3 Media Containers and Bags

8.3.1 Validation and Qualification of Media Containers and Bags is Necessary to Maintain the Safety of the Final Biopharmaceutical Product

8.4 Freezing and Thawing Process Bags

8.4.1 The High Risk of Seal Leaks in the Pre-Freezing and Thawing Stage is Driving Market Growth

8.5 Mixing Systems

8.5.1 Growing Need to Meet FDA and Other Regulatory Guidelines During the Mixing of Ingredients to Maintain Product Quality is A Key Driver

8.6 Bioreactors

8.6.1 Biopharmaceutical Companies are Increasingly Adopting Bioprocess Validation Services for Bioreactors to Lower the Risk of Cross-Contamination

8.7 Transfer Systems

8.7.1 The Necessity to Maintain Sterile Conditions During Transfer is Driving the Market

8.8 Other Process Component

9 Bioprocess Validation Market, By End User

9.1 Introduction

9.2 Pharmaceutical Companies

9.2.1 Increasing Production Volume has Enabled Pharma Companies to Dominate the End-User Market

9.3 Contract Development & Manufacturing Organizations

9.3.1 Emerging Countries have Become Key Hubs for the Outsourcing of Production and Validation Processes

9.4 Biotechnology Companies

9.4.1 Need for Regulatory Compliance has Driven the Demand for Bioprocess Validation in Biotech Companies

9.5 Other End Users

10 Bioprocess Validation Market, By Region

10.1 Introduction

10.2 North America

10.2.1 US

10.2.1.1 US Dominated the North American Bioprocess Validation Market in 2018

10.2.2 Canada

10.2.2.1 Growing Investments in the Canadian Biopharmaceuticals Sector to Support Market Growth During the Forecast Period

10.3 Europe

10.3.1 Germany

10.3.1.1 Germany Accounted for the Largest Share of the European Bioprocess Validation Market in 2018

10.3.2 France

10.3.2.1 High Demand for Biologics and Implementation of Favorable Government Initiatives to Drive the Demand for Bioprocess Validation Services in France

10.3.3 UK

10.3.3.1 Growing Demand for Outsourcing Compliance-Related Testing Services in Biopharmaceutical Production to Support Market Growth in the UK

10.3.4 Italy

10.3.4.1 Growing Biopharmaceutical Manufacturing to Drive the Adoption of Bioprocess Validation Services in Italy

10.3.5 Spain

10.3.5.1 High Consumption of Biologics to Support the Growth of The Bioprocess Validation Market in Spain

10.3.6 Rest of Europe

10.4 Asia Pacific

10.4.1 China

10.4.1.1 China is One of the Most-Preferred Destinations for Leading Biopharmaceutical Companies for Biologics Production

10.4.2 Japan

10.4.2.1 Japan is One of the Largest and Most Established Markets for Pharmaceutical Products in the Asia Pacific

10.4.3 India

10.4.3.1 Rising Volume of Biopharmaceutical Production to Drive Market Growth in India

10.4.4 Rest of Asia Pacific

10.5 Latin America

10.5.1 Brazil

10.5.1.1 Growing Investments in Biopharmaceutical Research to Drive Market Growth in Brazil

10.5.2 Mexico

10.5.2.1 Strong Presence of Global Pharmaceutical Companies in the Country to Support Market Growth

10.5.3 Rest of Latin America

10.6 Middle East & Africa

11 Competitive Landscape

11.1 Overview

11.2 Market Share Analysis

11.3 Competitive Leadership Mapping, 2018

11.4 Vendor Inclusion Criteria

11.5 Vendor Dive

11.5.1 Visionary Leaders

11.5.2 Innovators

11.5.3 Emerging Companies

11.5.4 Dynamic Differentiators

11.6 Competitive Situations and Trends

11.6.1 Acquisitions

11.6.2 Collaborations, Partnerships, and Agreements

11.6.3 Service Launches

11.7 Service Portfolio Analysis

11.7.1 Service Portfolio Analysis

12 Company Profiles

12.1 Merck KGaA

12.2 Pall Corporation (A Part of Danaher Corporation)

12.3 Sartorius Stedim Biotech S.A.

12.4 SGS S.A.

12.5 Eurofins Scientific

12.6 Cobetter Filtration Equipment Co. Ltd.

12.7 Toxikon Corporation

12.8 Doc S.R.L.

12.9 Meissner Filtration Products Inc.

12.10 Thermo Fisher Scientific Inc.

12.11 Additional Company Profiles

12.11.1 Porvair PLC

12.11.2 Biozeen

12.11.3 Tianshan (Ts Filter) Precision Filter Material Co. Ltd.

12.11.4 Hangzhou Anow Microfiltration Co. Ltd.

12.11.5 Almac Group

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