Bioprocess Validation Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

The bioprocess validation market is segmented by Test Type (Extractables Testing Services, Microbiological Testing Services, Physiochemical Testing Services, Integrity Testing Services, Compatibility Testing Services, Other), Process Component (Filter Elements, Media containers and bags, Freezing And Thawing Process Bags, Mixing Systems, Bioreactors, Transfer Systems, Others), End-User (Pharmaceutical & Biotechnology Companies, Contract Development & Manufacturing Organizations, Other), and Geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The report offers the value (in USD million) for the above segments.

Market Snapshot

Bioprocess Validation Market Overview
Study Period: 2019-2027
Base Year: 2021
Fastest Growing Market: North America
Largest Market: Asia-Pacific
CAGR: 9.5 %

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Market Overview

Bioprocess Validation Market is expected to witness a healthy CAGR of 9.5% during the forecast period, 2022-2027.

The bioprocess validation market is significantly impacted by COVID-19. This can be attributed to significant disruptions in their respective manufacturing and supply-chain operations as a result of various precautionary lockdowns and other restrictions imposed by governments all over the world. The demand for bioprocess validation increased during the pandemic because validation is required at all phases of drug development to monitor accuracy, efficiency, and safety. Due to the uncontrolled and sudden increase in covid-19 cases, the development of biosimilars, combination molecules, and other innovative vaccines and medicines has grown, which has resulted in an increased demand for significant bioprocess validation. Companies such as SGS offer a full range of bioprocess validation for both small molecules and biologics. In November 2020, SGS, the world's leading inspection, verification, testing, and certification company, invested in its Biosafety Center of Excellence in Glasgow, boosting its capacity to support scientists and manufacturers in the development of effective vaccines, cell and gene therapies, and other biological medicines.

The market's growth is being driven by the high demand for bioprocess validation services, as well as stringent safety and quality regulations governing product certifications and testing beyond the biopharmaceutical and pharmaceutical industries, and increasing demand for outsourcing bioprocess validation coupled with rising R&D expenditure.

According to the FDA Drug Recall Statistics published in July 2021, approximately 1,279 drugs are recalled each year globally, with 94 percent of FDA drug recalls occurring in the United States, followed by 4% in Canada. The FDA issued 12,028 drug recalls in the United States between 2012 and 2021. This necessitates the validation of products and the assurance of public safety before they are marketed. Medicines are designed to improve outcomes in humans and animals, as low-quality medicines have a negative impact on patient health and funding systems. As a result, bioprocess validation is critical in ensuring the safety and efficacy data of drugs.

The increased need for specific types of tests in R&D activities, as well as the growing trend of outsourcing laboratory testing services, are two major factors driving the market's growth. Companies are expanding their market share by offering a variety of services and solutions in response to the growing trend of outsourcing laboratory testing services. Major players are also concentrating on various strategies such as mergers, acquisitions, and other developments. For example, in August 2021, Eurofins Scientific agreed to buy GeneTech Inc., a leading Japanese player in genetic analysis, from Noritsu Koki Co. Ltd, in order to expand Eurofins' testing portfolio in Japan. Because bioprocess validation plays such an important role, the market is expected to expand significantly.

Furthermore, according to the Global Research and Development Expenditures: Fact Sheet by Congressional Research Services in September 2021, since 2000, total global R&D expenditures have more than tripled in current dollars, from USD 677 billion to USD 2.2 trillion in 2019. However, The United States continued to fund more R&D than any other country. China ranked second in 2019 and funded more R&D than the next four highest countries, Japan, Germany, South Korea, and France. Thus, the rising research and development expenditure is expected to boost the bioprocess validation market.

Scope of the Report

Precisely, data are collected, evaluated, and documented from every stage of a specific project at all desired levels. In this way, bioprocess validation establishes the scientific evidence that a process is capable of consistently delivering quality products. The bioprocess validation market is segmented by Test Type (Extractables Testing Services, Microbiological Testing Services, Physiochemical Testing Services, Integrity Testing Services, Compatibility Testing Services, Other), Process Component (Filter Elements, Media containers and bags, Freezing And Thawing Process Bags, Mixing Systems, Bioreactors, Transfer Systems, Others), End User (Pharmaceutical & Biotechnology Companies, Contract Development & Manufacturing Organizations, Other), and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions, globally. The report offers the value (in USD million) for the above segments.

By Test Type
Extractables Testing Services
Microbiological Testing Services
Physiochemical Testing Services
Integrity Testing Services
Compatibility Testing Services
Other Testing Services
By Process Component
Filter Elements
Media containers and bags
Freezing And Thawing Process Bags
Mixing Systems
Bioreactors
Transfer Systems
Other
By End User
Pharmaceutical & Biotechnology Companies
Contract Development & Manufacturing Organizations
Other
Geography
North America
United States
Canada
Mexico
Europe
Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle-East and Africa
GCC
South Africa
Rest of Middle-East and Africa
South America
Brazil
Argentina
Rest of South America

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Key Market Trends

Bioreactor is Expected to Hold Significant Market Share in the Process Component Segment

The pharmaceutical sector uses bioreactors for the manufacture of medicines, vaccines, and other pharmaceutical components. Bioreactors are also used for the production of monoclonal antibodies for the treatment of cancer, rheumatoid arthritis, and other diseases. Bioreactors have been utilized in many different areas of industry and research and for the progression of in vitro models of 2D cultures and suspensions to 3D constructs, mimicking the natural physiological state in situ.

In the pharmaceutical sector, bioreactors are used to hold organisms for the purpose of harnessing their natural biochemical processes. Bioreactors are designed to allow microorganisms to thrive, causing the contents of the tank to ferment and creating a usable end product. In a batch bioreactor, everything is added at once to a controlled and sealed environment, and the biochemical reactions are allowed to run their course before the reactor is opened so that the contents can be extracted and utilized, disposed of, or further processed. Others operate on a continuous flow method, in which materials constantly flow through the bioreactor.​

In April 2020, researchers from Ology Bioservices and Univercells SA announced that they had developed a high-yield live-virus vaccine production platform by using a novel fixed-bed bioreactor in a paper published in the ‘Vaccine’ magazine. The scientists from these companies further stated that their bioreactor platform allows for a cost-effective and scalable process for viral vaccine production. Initiatives such as these are expected to boost segment growth.​

Initiatives by major companies are also boosting segment growth. For instance, in February 2020, Eppendorf introduced its latest bioreactor control system for small- and bench-scale applications called the SciVario system. The new system has been designed for academic and industrial applications.​

Therefore, the rising demand and use of bioreactors for applications in the pharmaceutical sector are expected to boost the innovation and usage of bioreactors, thus propelling the segment growth.

Bioprocess Validation Market Growth

North America Holds a Significant Share in the Market and Expected to do Same during the Forecast Period

North America is expected to be a dominant region in the bioprocess validation market owing to the increasing number of R&D activities and investments as well as rising demand for biopharmaceuticals and increasing demand for outsourcing bioprocess validation.

The increasing demand for the biopharmaceutical drug the number of pharmaceuticals working on drug development and clinical studies. According to clinicaltrials.gov, around 293,321 studies were registered at the start of 2019, and around 32,523 studies were registered at the end of 2019. According to data provided by the Food and Drug Administration's Center for Drug Evaluation and Research (CDER), approximately 48 novel drugs were approved in 2019. (FDA). According to the FDA, the majority of the 53 drugs approved worldwide in 2020 were approved in the United States before any other country.

In the United States, biopharmaceutical companies spent around USD 79.6 billion on research and development in 2019. According to a Congressional Budget Office report released in April 2021, most pharmaceutical companies spent about one-quarter of their revenues on research and development, which is near twice as much as they spent in 2000.

According to a report published in September 2021 by the Pharmaceutical Research and Manufacturers of America (PhRMA), in the last decade, biopharmaceutical companies invested more than a trillion dollars in research and development, including a record-breaking year in 2020 where PhRMA member companies invested about USD 91 billion in the research and development. Outsourcing drug development helps the biotechnology firms a proper utilization of their resources and limit the financial risks. As a result, the bioprocess validation market is anticipated to grow over the forecast period.

Bioprocess Validation Market Forecast

Competitive Landscape

The pharmaceutical analytical testing market is fragmented in nature due to the presence of a number of companies globally. The studied market consists of several international and local companies that hold the majority of the market shares and are well known, including Laboratory Testing Inc., Eurofins Scientific, SGS SA, Toxikon Inc., Sartorius AG, Pall Corporation, Cobetter Filtration Equipments Co., Ltd, and DOC S.r.l.

Recent Developments

  • In December 2021, Sartorius and HOF Sonderanlagenbau formed a partnership to integrate two HOF horizontal plate freeze-thaw units into Sartorius' portfolio, providing customers with a complete freeze-thaw solution. Through improved validation and purchase support from a single supplier, this partnership will enable faster and easier implementation of robust frozen drug substance management platforms.
  • In September 2021, Sartorius opened a new, significantly expanded Application and Service Hub in Shanghai's Zhangjiang Science City. The Sartorius Application Center 3.0, the Confidence Validation Services Laboratory 2.0, and the APAC Service Hub are all housed in this Hub, which spans over 3,000 square meters and is equipped with cutting-edge professional expertise and cutting-edge instrumentation.
  • In April 2021, Riffyn's pioneering cloud-based process data system for Intelligent Process Development was upgraded with more powerful capabilities. The new features in Riffyn Nexus v4.2 enable customers to validate data in real-time at a large scale with the ability to trace the root cause of an anomaly.

Table of Contents

  1. 1. INTRODUCTION

    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study

  2. 2. RESEARCH METHODOLOGY

  3. 3. EXECUTIVE SUMMARY

  4. 4. MARKET DYNAMICS

    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Increasing Demand for Biopharmaceuticals

      2. 4.2.2 Increasing Demand for Outsourcing Bioprocess Validation

      3. 4.2.3 Rising Life Science R&D Expenditure

    3. 4.3 Market Restraints

      1. 4.3.1 Issues Related to Extractables & Leachables

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION (Market Size by Value – USD million)

    1. 5.1 By Test Type

      1. 5.1.1 Extractables Testing Services

      2. 5.1.2 Microbiological Testing Services

      3. 5.1.3 Physiochemical Testing Services

      4. 5.1.4 Integrity Testing Services

      5. 5.1.5 Compatibility Testing Services

      6. 5.1.6 Other Testing Services

    2. 5.2 By Process Component

      1. 5.2.1 Filter Elements

      2. 5.2.2 Media containers and bags

      3. 5.2.3 Freezing And Thawing Process Bags

      4. 5.2.4 Mixing Systems

      5. 5.2.5 Bioreactors

      6. 5.2.6 Transfer Systems

      7. 5.2.7 Other

    3. 5.3 By End User

      1. 5.3.1 Pharmaceutical & Biotechnology Companies

      2. 5.3.2 Contract Development & Manufacturing Organizations

      3. 5.3.3 Other

    4. 5.4 Geography

      1. 5.4.1 North America

        1. 5.4.1.1 United States

        2. 5.4.1.2 Canada

        3. 5.4.1.3 Mexico

      2. 5.4.2 Europe

        1. 5.4.2.1 Germany

        2. 5.4.2.2 United Kingdom

        3. 5.4.2.3 France

        4. 5.4.2.4 Italy

        5. 5.4.2.5 Spain

        6. 5.4.2.6 Rest of Europe

      3. 5.4.3 Asia-Pacific

        1. 5.4.3.1 China

        2. 5.4.3.2 Japan

        3. 5.4.3.3 India

        4. 5.4.3.4 Australia

        5. 5.4.3.5 South Korea

        6. 5.4.3.6 Rest of Asia-Pacific

      4. 5.4.4 Middle-East and Africa

        1. 5.4.4.1 GCC

        2. 5.4.4.2 South Africa

        3. 5.4.4.3 Rest of Middle-East and Africa

      5. 5.4.5 South America

        1. 5.4.5.1 Brazil

        2. 5.4.5.2 Argentina

        3. 5.4.5.3 Rest of South America

  6. 6. COMPETITIVE LANDSCAPE

    1. 6.1 Company Profiles

      1. 6.1.1 Merck KGaA

      2. 6.1.2 SGS S.A.

      3. 6.1.3 Eurofins Scientific

      4. 6.1.4 Sartorius AG

      5. 6.1.5 Pall Corporation

      6. 6.1.6 Cobetter Filtration Equipments Co., Ltd

      7. 6.1.7 Toxikon Corporation

      8. 6.1.8 DOC S.r.l

      9. 6.1.9 MEISSNER FILTRATION PRODUCTS, INC.

      10. 6.1.10 Thermo Fisher Scientific

      11. 6.1.11 Almac Group

      12. 6.1.12 Danher Corporation.

    2. *List Not Exhaustive
  7. 7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Competitive Landscape covers- Business Overview, Financials, Products and Strategies, and Recent Developments

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Frequently Asked Questions

The Global Bioprocess Validation Market market is studied from 2019 - 2027.

The Global Bioprocess Validation Market is growing at a CAGR of 9.5% over the next 5 years.

North America is growing at the highest CAGR over 2021- 2026.

Asia-Pacific holds highest share in 2021.

Merck KGaA, Eurofins Scientific, SGS S.A. , Sartorius AG , Pall Corporation are the major companies operating in Global Bioprocess Validation Market .

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