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Bioprocess Validation Market by Testing Type, Stage, Mode, and by Region - Global Forecast to 2022-2033

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    Report

  • 200 Pages
  • January 2023
  • Region: Global
  • Quintana Research and Consulting
  • ID: 5717247
The bioprocess validation market size is estimated to be USD 468.52 million in 2022 and is expected to witness a CAGR of 9.57% during the forecast period 2023-2033. The U.S. FDA's strict regulations and the cGMP requirement for biopharmaceutical production, and escalating need for improved quality biopharmaceuticals for the treatment of infectious and chronic diseases are some of the factors contributing to the market growth. Furthermore, surge in research and development spending in pharmaceutical research and expanding pattern of outsourcing laboratory testing services are other factors supporting the market growth. However, high price of advanced technology and problems with extractables and leachables are expected to hinder the growth.

Surge in research and development spending in pharmaceutical research is expected to fuel the market growth during the projected period. For instance, since 2000, PhRMA member businesses have invested more than USD 1.1 Trillion in the pursuit for novel medicines and cures, including USD 102.3 Billion in 2021 alone, according to the Pharmaceutical Research and Manufacturers of America data updates from September 2021. Additionally, over the course of the prediction, these are anticipated to rise even further. Thus, it is predicted that increased R&D spending will drive the bioprocess validation market.

Expanding pattern of outsourcing laboratory testing services is predicted to propel the market growth during the forecast period. In response to the rising trend of outsourcing laboratory testing services, companies are increasing their market share by providing a range of services and solutions. Major players are focusing on diverse strategies including mergers, acquisitions, and other advances. For instance, in order to increase the testing options available to customers in Japan, Eurofins Scientific decided to purchase GeneTech Inc. from Noritsu Koki Co. Ltd. in August 2021. GeneTech Inc. is a major participant in the field of genetic analysis in Japan. It is anticipated that the market will grow significantly as bioprocess validation is essential.

Segmentation

By Testing Type

The market is categorized into bioprocess residuals testing, filtration & fermentation systems testing, extractable & leachable testing, viral clearance testing, and others. In 2022, the bioprocess residuals testing segment accounted for the highest revenue share due to the fact that the drug, vaccine, and therapeutic goods produced by the biotechnology, biopharmaceutical, and pharmaceutical sectors are in high demand because they need to be impurity-free, secure, and of high quality. Impurities including buffer contents, anti-foam agents, and upstream and downstream impurities derived from cell culture are tested for as residual impurities. The market segment with the fastest growth is extractable and leachable. The presence of the existing good manufacturing practise guidelines and US FDA rules is the reason of this. As a result, there is a market for certified high-quality bioproducts. The market is driven by the production of cGMP-certified bioproducts by the biopharmaceutical and biotechnology companies. Additionally, it is important to recognize the risks put on by packaging that ruins bioproducts products and leachable that arise from closed processing systems during the drug discovery process. This promotes industry growth on a worldwide scale.

By Stage

The market is categorized into continued process verification, process design, and process qualification. In the global market, the continued process verification segment accounted for the largest revenue share in 2022 owing to process' automation. It comprises gathering data and storage, processing, and analyzing each batch. For instance, Aventior deployed the digitization of the CPV process in May 2021 using the CPV-Auto solution, in accordance with 21 CRF Part 11, which substitutes automated digitization for the conventional batch record process and image processing. Throughout the projection period, this pattern will continue to fuel the segment's expansion. The process design segment presents the fastest rate during the anticipated period. The most important phase of bioprocess validation is process design. To run a process effectively, strict procedures with concepts and paths for the manufacture of the process are essential. The segment is increasing at the fastest rate due to strict protocol and process design that aims to produce quality products.

By Mode

The market is segmented into outsourced, and in house. In 2022, the in-house segment accounted for the largest revenue share owing to rising investment, mergers, and collaboration among market participants for the development of life science tools. Most industries and biopharmaceuticals produce the raw materials and equipment needed for the bioprocess validation step of product manufacturing. The outsourced segment is anticipated to develop at a significant CAGR during the forecast period. Testing services are in high demand from the biopharmaceutical and biotechnology companies that create bioproducts and carry out bioprocess validation. The market is driven by outsourcing services for the production of biopharmaceutical drugs and therapies. Additionally, the rise in healthcare costs and the supply of raw materials needed by the major market participants both contribute to industry growth. The industry is further boosted by the rise in CDMOs that provide manufacturing and drug development services to the pharmaceutical and biopharmaceutical sectors.

Regional Markets

In 2022, North America region accounted for the highest revenue in the bioprocess validation market and is expected to maintain its dominance during the forecast period. This is attributed to the fact that the main outsourcing services are present in this region. As a result, increase in biologics manufacturing and life science research, which propels the global market. Additionally, the biopharmaceutical and biotechnology companies are prominent in North America and have FDA approval. Along with this, larger government support for clinical trials and the bioprocess validation procedure helps the market. The market is driven by the presence of most of the major companies, including Thermo Fisher Scientific Inc., Danaher Corporation, and Europhins, among others, in North America. The market for bioprocess validation will experience the fastest growth in the Asia Pacific region over the coming years. This is a due to developments, rising healthcare costs, and funding for R&D established by government organizations. The government initiatives for the expansion and development of the biopharmaceutical industries in the Asia Pacific area are further supported by the increased awareness of the advantages of vaccines and biopharmaceutical medications to treat chronic diseases.

Competitor Insights

Some of the key players operating in the bioprocess validation market are Lonza, Thermo Fisher Scientific Inc., Charles River Laboratories, SGS S.A., Merck KGaA, Eurofins Scientific, Inc., Danaher Corporation, Toxikon Corporation, Sartorius AG, and Cobetter Filtration Equipment Co., Ltd.

To achieve a competitive edge, these companies are implementing a variety of growth strategies. Strategic partnerships, alliances, and agreements with different businesses and research institutions are seen to be the main strategies used by companies in this sector.

Qosina launched its new Bioprocess Resource Center in May 2022 as a hub for knowledge on the bioprocess sector.

In order to give customers a complete freeze-thaw solution, Sartorius and HOF Sonderanlagenbau entered into a collaboration in December 2021 to integrate two HOF horizontal plate freeze-thaw units into Sartorius' portfolio. Through better validation and purchasing support from a single provider, this collaboration will make it possible to build reliable platforms for the management of frozen medicinal substances more quickly and efficiently.

This comprehensive research report focuses on the global and regional market size and forecasts of diverse segments including testing type, stage, and mode from 2023 to 2033.

Segmentation: Bioprocess Validation Market Report 2022 - 2033

Testing Type (Revenue, USD Million), 2022 - 2033

  • Bioprocess Residuals Testing
  • Filtration & Fermentation Systems Testing
  • Extractable & Leachable Testing
  • Viral Clearance Testing
  • Others

Stage (Revenue, USD Million), 2022 - 2033

  • Continued Process Verification
  • Process Design
  • Process Qualification

Mode (Revenue, USD Million), 2022 - 2033

  • Outsourced
  • In House

By Region (Revenue, USD Million), 2022 - 2033

North America

  • U.S.
  • Canada

Europe

  • Germany
  • France
  • UK
  • Spain
  • Italy
  • Rest of Europe

Asia Pacific

  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of APAC

Latin America

  • Brazil
  • Mexico
  • Argentina
  • Rest of LATAM

Middle East & Africa

  • South Africa
  • GCC
  • Rest of MEA

Table of Contents

1. Research Methodology
1.1. Study Objectives
1.2. Study Scope
1.3. Research Framework
1.3.1. Research Models
1.3.1.1. Bottom-up Approach
1.3.1.2. Top-down Approach
1.3.1.3. Data Triangulation
1.3.2. Data Analysis
1.3.2.1. Data Validation
1.3.2.2. Market Size Estimation
1.3.2.3. Market Forecast Model

2. Introduction: Bioprocess Validation

3. Executive Summary

4. Market Dynamics
4.1. Market Drivers
4.1.1. Driver 1
4.1.2. Driver 2
4.1.3. Driver 3
4.1.4. Driver 4
4.2. Market Restraint
4.2.1. Restraint 1
4.2.2. Restraint 2
4.2.3. Restraint 3
4.3. Market Opportunities
4.3.1. Opportunity 1
4.3.2. Opportunity 2
4.3.3. Opportunity 3
4.4. Market Trends
4.4.1. Trend 1
4.4.2. Trend 2
4.4.3. Trend 3
4.5. Market Challenges
4.5.1. Challenge 1
4.5.2. Challenge 2
4.5.3. Challenge 3

5. Market Environment Analysis
5.1. Porter’s 5 Forces Analysis
5.2. PESTEL Analysis
5.3. SWOT Analysis

6. COVID-19 Impact Analysis: Bioprocess Validation Market

7. Market Analysis by Testing Type
7.1. Bioprocess Residuals Testing
7.1.1. Bioprocess Residuals Testing Market Forecast, 2022-2033 (USD Million)
7.2. Filtration & Fermentation Systems Testing
7.2.1. Filtration & Fermentation Systems Testing Market Forecast, 2022-2033 (USD Million)
7.3. Extractable & Leachable Testing
7.3.1. Extractable & Leachable Testing Market Forecast, 2022-2033 (USD Million)
7.4. Viral Clearance Testing
7.4.1. Viral Clearance Testing Market Forecast, 2022-2033 (USD Million)
7.5. Others
7.5.1. Others Market Forecast, 2022-2033 (USD Million)

8. Market Analysis by Stage
8.1. Continued Process Verification
8.1.1. Continued Process Verification Market Forecast, 2022-2033 (USD Million)
8.2. Process Design
8.2.1. Process Design Market Forecast, 2022-2033 (USD Million)
8.3. Process Qualification
8.3.1. Process Qualification Market Forecast, 2022-2033 (USD Million)

9. Market Analysis by Mode
9.1. Outsourced
9.1.1. Outsourced Market Forecast, 2022-2033 (USD Million)
9.2. In House
9.2.1. In House Market Forecast, 2022-2033 (USD Million)

8. Regional Market Analysis
8.1. Regional Market Trends Analysis

9. North America Bioprocess Validation Market
9.1. North America Bioprocess Validation Market
9.1.1. North America Market Size and Forecast, 2022-2033 (USD Million)
9.1.1.1. Market Size and Forecast by Testing Type, 2022-2033 (USD Million)
9.1.1.2. Market Size and Forecast by Stage, 2022-2033 (USD Million)
9.1.1.3. Market Size and Forecast by Mode, 2022-2033 (USD Million)
9.2. U.S. Bioprocess Validation Market
9.2.1. U.S. Market Size and Forecast, 2022-2033 (USD Million)
9.2.1.1. Market Size and Forecast by Testing Type, 2022-2033 (USD Million)
9.2.1.2. Market Size and Forecast by Stage, 2022-2033 (USD Million)
9.2.1.3. Market Size and Forecast by Mode, 2022-2033 (USD Million)
9.3. Canada Bioprocess Validation Market
9.3.1. Canada Market Size and Forecast, 2022-2033 (USD Million)
9.3.1.1. Market Size and Forecast by Testing Type, 2022-2033 (USD Million)
9.3.1.2. Market Size and Forecast by Stage, 2022-2033 (USD Million)
9.3.1.3. Market Size and Forecast by Mode, 2022-2033 (USD Million)

10. Europe Bioprocess Validation Market
10.1. Europe Bioprocess Validation Market
10.1.1. Europe Market Size and Forecast, 2022-2033 (USD Million)
10.1.1.1. Market Size and Forecast by Testing Type, 2022-2033 (USD Million)
10.1.1.2. Market Size and Forecast by Stage, 2022-2033 (USD Million)
10.1.1.3. Market Size and Forecast by Mode, 2022-2033 (USD Million)
10.2. Germany Bioprocess Validation Market
10.2.1. Germany Market Size and Forecast, 2022-2033 (USD Million)
10.2.1.1. Market Size and Forecast by Testing Type, 2022-2033 (USD Million)
10.2.1.2. Market Size and Forecast by Stage, 2022-2033 (USD Million)
10.2.1.3. Market Size and Forecast by Mode, 2022-2033 (USD Million)
10.3. UK Bioprocess Validation Market
10.3.1. UK Market Size and Forecast, 2022-2033 (USD Million)
10.3.1.1. Market Size and Forecast by Testing Type, 2022-2033 (USD Million)
10.3.1.2. Market Size and Forecast by Stage, 2022-2033 (USD Million)
10.3.1.3. Market Size and Forecast by Mode, 2022-2033 (USD Million)
10.4. France Bioprocess Validation Market
10.4.1. France Market Size and Forecast, 2022-2033 (USD Million)
10.4.1.1. Market Size and Forecast by Testing Type, 2022-2033 (USD Million)
10.4.1.2. Market Size and Forecast by Stage, 2022-2033 (USD Million)
10.4.1.3. Market Size and Forecast by Mode, 2022-2033 (USD Million)
10.5. Spain Bioprocess Validation Market
10.5.1. Spain Market Size and Forecast, 2022-2033 (USD Million)
10.5.1.1. Market Size and Forecast by Testing Type, 2022-2033 (USD Million)
10.5.1.2. Market Size and Forecast by Stage, 2022-2033 (USD Million)
10.5.1.3. Market Size and Forecast by Mode, 2022-2033 (USD Million)
10.6. Italy Bioprocess Validation Market
10.6.1. Italy Market Size and Forecast, 2022-2033 (USD Million)
10.6.1.1. Market Size and Forecast by Testing Type, 2022-2033 (USD Million)
10.6.1.2. Market Size and Forecast by Stage, 2022-2033 (USD Million)
10.6.1.3. Market Size and Forecast by Mode, 2022-2033 (USD Million)
10.7. Rest of Europe Bioprocess Validation Market
10.7.1. Rest of Europe Market Size and Forecast, 2022-2033 (USD Million)
10.7.1.1. Market Size and Forecast by Testing Type, 2022-2033 (USD Million)
10.7.1.2. Market Size and Forecast by Stage, 2022-2033 (USD Million)
10.7.1.3. Market Size and Forecast by Mode, 2022-2033 (USD Million)

11. Asia Pacific Bioprocess Validation Market
11.1. Asia Pacific Bioprocess Validation Market
11.1.1. Asia Pacific Market Size and Forecast, 2022-2033 (USD Million)
11.1.1.1. Market Size and Forecast by Testing Type, 2022-2033 (USD Million)
11.1.1.2. Market Size and Forecast by Stage, 2022-2033 (USD Million)
11.1.1.3. Market Size and Forecast by Mode, 2022-2033 (USD Million)
11.2. Japan Bioprocess Validation Market
11.2.1. Japan Market Size and Forecast, 2022-2033 (USD Million)
11.2.1.1. Market Size and Forecast by Testing Type, 2022-2033 (USD Million)
11.2.1.2. Market Size and Forecast by Stage, 2022-2033 (USD Million)
11.2.1.3. Market Size and Forecast by Mode, 2022-2033 (USD Million)
11.3. China Bioprocess Validation Market
11.3.1. China Market Size and Forecast, 2022-2033 (USD Million)
11.3.1.1. Market Size and Forecast by Testing Type, 2022-2033 (USD Million)
11.3.1.2. Market Size and Forecast by Stage, 2022-2033 (USD Million)
11.3.1.3. Market Size and Forecast by Mode, 2022-2033 (USD Million)
11.4. India Bioprocess Validation Market
11.4.1. India Market Size and Forecast, 2022-2033 (USD Million)
11.4.1.1. Market Size and Forecast by Testing Type, 2022-2033 (USD Million)
11.4.1.2. Market Size and Forecast by Stage, 2022-2033 (USD Million)
11.4.1.3. Market Size and Forecast by Mode, 2022-2033 (USD Million)
11.5. South Korea Bioprocess Validation Market
11.5.1. South Korea Market Size and Forecast, 2022-2033 (USD Million)
11.5.1.1. Market Size and Forecast by Testing Type, 2022-2033 (USD Million)
11.5.1.2. Market Size and Forecast by Stage, 2022-2033 (USD Million)
11.5.1.3. Market Size and Forecast by Mode, 2022-2033 (USD Million)
11.6. Australia Bioprocess Validation Market
11.6.1. Australia Market Size and Forecast, 2022-2033 (USD Million)
11.6.1.1. Market Size and Forecast by Testing Type, 2022-2033 (USD Million)
11.6.1.2. Market Size and Forecast by Stage, 2022-2033 (USD Million)
11.6.1.3. Market Size and Forecast by Mode, 2022-2033 (USD Million)
11.7. Rest of Asia Pacific Bioprocess Validation Market
11.7.1. Rest of Asia Pacific Market Size and Forecast, 2022-2033 (USD Million)
11.7.1.1. Market Size and Forecast by Testing Type, 2022-2033 (USD Million)
11.7.1.2. Market Size and Forecast by Stage, 2022-2033 (USD Million)
11.7.1.3. Market Size and Forecast by Mode, 2022-2033 (USD Million)

12. Latin America Bioprocess Validation Market
12.1. Latin America Bioprocess Validation Market
12.1.1. Latin America Market Size and Forecast, 2022-2033 (USD Million)
12.1.1.1. Market Size and Forecast by Testing Type, 2022-2033 (USD Million)
12.1.1.2. Market Size and Forecast by Stage, 2022-2033 (USD Million)
12.1.1.3. Market Size and Forecast by Mode, 2022-2033 (USD Million)
12.2. Brazil Bioprocess Validation Market
12.2.1. Brazil Market Size and Forecast, 2022-2033 (USD Million)
12.2.1.1. Market Size and Forecast by Testing Type, 2022-2033 (USD Million)
12.2.1.2. Market Size and Forecast by Stage, 2022-2033 (USD Million)
12.2.1.3. Market Size and Forecast by Mode, 2022-2033 (USD Million)
12.3. Mexico Bioprocess Validation Market
12.3.1. Mexico Market Size and Forecast, 2022-2033 (USD Million)
12.3.1.1. Market Size and Forecast by Testing Type, 2022-2033 (USD Million)
12.3.1.2. Market Size and Forecast by Stage, 2022-2033 (USD Million)
12.3.1.3. Market Size and Forecast by Mode, 2022-2033 (USD Million)
12.4. Argentina Bioprocess Validation Market
12.4.1. Argentina Market Size and Forecast, 2022-2033 (USD Million)
12.4.1.1. Market Size and Forecast by Testing Type, 2022-2033 (USD Million)
12.4.1.2. Market Size and Forecast by Stage, 2022-2033 (USD Million)
12.4.1.3. Market Size and Forecast by Mode, 2022-2033 (USD Million)
12.5. Rest of Latin America Bioprocess Validation Market
12.5.1. Rest of Latin America Market Size and Forecast, 2022-2033 (USD Million)
12.5.1.1. Market Size and Forecast by Testing Type, 2022-2033 (USD Million)
12.5.1.2. Market Size and Forecast by Stage, 2022-2033 (USD Million)
12.5.1.3. Market Size and Forecast by Mode, 2022-2033 (USD Million)

13. MEA Bioprocess Validation Market
13.1. MEA Bioprocess Validation Market
13.1.1. MEA Market Size and Forecast, 2022-2033 (USD Million)
13.1.1.1. Market Size and Forecast by Testing Type, 2022-2033 (USD Million)
13.1.1.2. Market Size and Forecast by Stage, 2022-2033 (USD Million)
13.1.1.3. Market Size and Forecast by Mode, 2022-2033 (USD Million)
13.2. GCC Bioprocess Validation Market
13.2.1. GCC Market Size and Forecast, 2022-2033 (USD Million)
13.2.1.1. Market Size and Forecast by Testing Type, 2022-2033 (USD Million)
13.2.1.2. Market Size and Forecast by Stage, 2022-2033 (USD Million)
13.2.1.3. Market Size and Forecast by Mode, 2022-2033 (USD Million)
13.3. South Africa Bioprocess Validation Market
13.3.1. South Africa Market Size and Forecast, 2022-2033 (USD Million)
13.3.1.1. Market Size and Forecast by Testing Type, 2022-2033 (USD Million)
13.3.1.2. Market Size and Forecast by Stage, 2022-2033 (USD Million)
13.3.1.3. Market Size and Forecast by Mode, 2022-2033 (USD Million)
13.4. Rest of MEA Bioprocess Validation Market
13.4.1. Rest of MEA Market Size and Forecast, 2022-2033 (USD Million)
13.4.1.1. Market Size and Forecast by Testing Type, 2022-2033 (USD Million)
13.4.1.2. Market Size and Forecast by Stage, 2022-2033 (USD Million)
13.4.1.3. Market Size and Forecast by Mode, 2022-2033 (USD Million)

14. Competitor Analysis
14.1. Market Share Analysis, 2022
14.2. Major Recent Developments, 2019-2022

15. Company Profiles
15.1. Lonza
15.1.1. Company Snapshot
15.1.2. Company Overview
15.1.3. Financial Analysis
15.1.4. Product Benchmarking
15.1.5. Recent Developments
15.2. Thermo Fisher Scientific Inc.
15.2.1. Company Snapshot
15.2.2. Company Overview
15.2.3. Financial Analysis
15.2.4. Product Benchmarking
15.2.5. Recent Developments
15.3. Charles River Laboratories
15.3.1. Company Snapshot
15.3.2. Company Overview
15.3.3. Financial Analysis
15.3.4. Product Benchmarking
15.3.5. Recent Developments
15.4. SGS S. A.
15.4.1. Company Snapshot
15.4.2. Company Overview
15.4.3. Financial Analysis
15.4.4. Product Benchmarking
15.4.5. Recent Developments
15.5. Merck KGaA
15.5.1. Company Snapshot
15.5.2. Company Overview
15.5.3. Financial Analysis
15.5.4. Product Benchmarking
15.5.5. Recent Developments
15.6. Eurofins Scientific, Inc.
15.6.1. Company Snapshot
15.6.2. Company Overview
15.6.3. Financial Analysis
15.6.4. Product Benchmarking
15.6.5. Recent Developments
15.7. Danaher Corporation
15.7.1. Company Snapshot
15.7.2. Company Overview
15.7.3. Financial Analysis
15.7.4. Product Benchmarking
15.7.5. Recent Developments
15.8. Toxikon Corporation
15.8.1. Company Snapshot
15.8.2. Company Overview
15.8.3. Financial Analysis
15.8.4. Product Benchmarking
15.8.5. Recent Developments
15.9. Sartorius AG
15.9.1. Company Snapshot
15.9.2. Company Overview
15.9.3. Financial Analysis
15.9.4. Product Benchmarking
15.9.5. Recent Developments
15.10. Thermo Fisher Scientific Inc.
15.10.1. Company Snapshot
15.10.2. Company Overview
15.10.3. Financial Analysis
15.10.4. Product Benchmarking
15.10.5. Recent Developments
15.11. Cobetter Filtration Equipment Co., Ltd.
15.11.1. Company Snapshot
15.11.2. Company Overview
15.11.3. Financial Analysis
15.11.4. Product Benchmarking
15.11.5. Recent Developments
15.12. Company 12
15.12.1. Company Snapshot
15.12.2. Company Overview
15.12.3. Financial Analysis
15.12.4. Product Benchmarking
15.12.5. Recent Developments
15.13. Company 13
15.13.1. Company Snapshot
15.13.2. Company Overview
15.13.3. Financial Analysis
15.13.4. Product Benchmarking
15.13.5. Recent Developments
15.14. Company 14
15.14.1. Company Snapshot
15.14.2. Company Overview
15.14.3. Financial Analysis
15.14.4. Product Benchmarking
15.14.5. Recent Developments
15.15. Company 15
15.15.1. Company Snapshot
15.15.2. Company Overview
15.15.3. Financial Analysis
15.15.4. Product Benchmarking
15.15.5. Recent Developments

16. Conclusion

17. Recommendations

Companies Mentioned

A selection of companies mentioned in this report includes:

  • Lonza
  • Thermo Fisher Scientific Inc.
  • Charles River Laboratories
  • SGS S.A.
  • Merck KGaA
  • Eurofins Scientific Inc.
  • Danaher Corporation
  • Toxikon Corporation
  • Sartorius AG
  • Cobetter Filtration Equipment Co. Ltd.