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Global Bioprocess Validation Market to reach USD 756.53 million by the end of 2029

Global Bioprocess Validation Market Size study&Forecast, byTest 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 Companies, Biotechnology Companies, Contract Development & Manufacturing Organizations, Other)and Regional Analysis, 2022-2029

Product Code: HLSB-71547153
Publish Date: 20-03-2023
Page: 200

Global Bioprocess Validation Market is valued at approximately USD 376.9 million in 2021 and is anticipated to grow with a healthy growth rate of more than 9.10% over the forecast period 2022-2029. Various actions that take place during the whole manufacturing cycle of a bioproduct are included in the bioprocess validation process.To maintain the quality, safety, and effectiveness of bioproducts, precise data are gathered, reviewed, and documented for every production phase. Strict regulatory standards for the manufacturing of safe and high-quality vaccines and pharmaceutical goods are driving the industry.The industry is boosted by the growing cooperation among the major market players for product launches. COVID-19, however, has had a favourable effect on the worldwide bioprocess validation market.

The COVID-19 standard had a significant impact on the bioprocess validation market since it’s essential to validate bioprocesses at every step of medication development to check precision, effectiveness, and safety.There was an increasing need for medicines and vaccines to address the new SARS-CoV-2 virus. This prompted the major industry players to merge, work together, and make acquisitions in order to provide goods that were safe and compliant with FDA and cGMP regulations.The Food and Drug Administration (FDA) Drug Recall Statistics report from 2021 estimates that worldwide drug recalls total 1,279 each year. Another two key drivers driving the market’s expansion are the rising demand for particular types of tests in R&D activities and the expanding trend of outsourcing laboratory testing services. In response to the rising trend of outsourcing laboratory testing services, businesses are growing their market share by providing a variety of services and solutions.However, it is anticipated that problems with extractables and leachable will impede market expansion.

The key regions considered for the Global Bioprocess ValidationMarketstudy includes Asia Pacific, North America, Europe, Latin America, and Rest of the World.North America is dominating the market share with a CAGR of 4.9%. This is a result of the significant outsourcing services being present in this area.Furthermore, there are numerous biopharmaceutical and biotechnology industries in North America that have received FDA approval. The American government has also increased the amount it spends on validation services.According to the prediction, the bioprocess validation market would experience the quickest growth in the Asia Pacific region in the coming years. This is because there is more knowledge regarding the advantages of vaccines, which results in more funding, improvements, and developments.

Major market player included in this report are:
Merck KGaA
Eurofins Scientific
Sartorius Stedim biotech SA
Pall Corporation
Cobetter Filtration Equipments Co., Ltd
Toxikon Corporation
Thermo Fisher Scientific
Almac Group
Danher Corporation
Meissner Filtration Products, INC

Recent Developments in the Market:
 In May 2022, a new informational resource for the bioprocess industry, the Bioprocess Resource Center, was created by Qosina.
 In January 2022, complete acquisition of PeproTech, a pioneer in recombinant proteins, by Thermo Fisher Scientific.
 In December 2021, In order to give customers a complete freeze-thaw solution, Sartorius and HOF Sonderanlagenbau entered into cooperation in December 2021 to merge two HOF horizontal plate freeze-thaw units into Sartorius’ portfolio.

Global Bioprocess Validation Market Report Scope:
Historical Data 2019-2020-2021
Base Year for Estimation 2021
Forecast period 2022-2029
Report Coverage Revenue forecast, Company Ranking, Competitive Landscape, Growth factors, and Trends
Segments Covered Test Type, Process Component, End-user, Region
Regional Scope North America; Europe; Asia Pacific; Latin America; Rest of the World
Customization Scope Free report customization (equivalent up to 8 analyst’s working hours) with purchase. Addition or alteration to country, regional & segment scope*

The objective of the study is to define market sizes of different segments & countries in recent years and to forecast the values to the coming years. The report is designed to incorporate both qualitative and quantitative aspects of the industry within countries involved in the study.

The report also caters detailed information about the crucial aspects such as driving factors & challenges which will define the future growth of the market. Additionally, it also incorporatespotential opportunities in micro markets for stakeholders to invest along with the detailed analysis of competitive landscape and Test End-user offerings of key players. The detailed segments and sub-segment of the market are explained below:
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
Transfer Systems
By End-user:
Biotechnology Companies
Contract Development& Manufacturing Organizations
By Region:
North America
Asia Pacific
South Korea
Latin America
Rest of the World

Chapter 1. Executive Summary
1.1. Market Snapshot
1.2. Global & Segmental Market Estimates & Forecasts, 2019-2029 (USD Million)
1.2.1. Bioprocess Validation Market, by Region, 2019-2029 (USD Million)
1.2.2. Bioprocess Validation Market, by Test Type, 2019-2029 (USD Million)
1.2.3. Bioprocess Validation Market, by Process Component, 2019-2029 (USD Million)
1.2.4. Bioprocess Validation Market, by End-user, 2019-2029 (USD Million)
1.3. Key Trends
1.4. Estimation Methodology
1.5. Research Assumption
Chapter 2. Global Bioprocess Validation Market Definition and Scope
2.1. Objective of the Study
2.2. Market Definition & Scope
2.2.1. Scope of the Study
2.2.2. Industry Evolution
2.3. Years Considered for the Study
2.4. Currency Conversion Rates
Chapter 3. Global Bioprocess Validation Market Dynamics
3.1. Bioprocess Validation Market Impact Analysis (2019-2029)
3.1.1. Market Drivers Increasing Collaboration among key market players Positive Impact of COVID-19
3.1.2. Market Challenges Problems with Extractables and Leachable
3.1.3. Market Opportunities Rise in R&D Expenditure. Growing need for outsourcing bioprocess validation
Chapter 4. Global Bioprocess Validation Market Industry Analysis
4.1. Porter’s 5 Force Model
4.1.1. Bargaining Power of Suppliers
4.1.2. Bargaining Power of Buyers
4.1.3. Threat of New Entrants
4.1.4. Threat of Substitutes
4.1.5. Competitive Rivalry
4.2. Futuristic Approach to Porter’s 5 Force Model (2019-2029)
4.3. PEST Analysis
4.3.1. Political
4.3.2. Economical
4.3.3. Social
4.3.4. Technological
4.4. Investment Adoption Model
4.5. Analyst Recommendation & Conclusion
4.6. Top investment opportunity
4.7. Top winning strategies
Chapter 5. Risk Assessment: COVID-19 Impact
5.1. Assessment of the overall impact of COVID-19 on the industry
5.2. Pre COVID-19 and post COVID-19 Market scenario
Chapter 6. Global Bioprocess Validation Market, by Test Type
6.1. Market Snapshot
6.2. Global Bioprocess Validation Market by Test Type, Performance – Potential Analysis
6.3. Global Bioprocess Validation Market Estimates & Forecasts by Test Type 2019-2029 (USD Million)
6.4. Bioprocess Validation Market, Sub Segment Analysis
6.4.1. Extractables Testing Services
6.4.2. Microbiological Testing Services
6.4.3. Physiochemical Testing Services
6.4.4. Integrity Testing Services
6.4.5. Compatibility Testing Services
6.4.6. Other Testing Services
Chapter 7. Global Bioprocess Validation Market, by Process Component
7.1. Market Snapshot
7.2. Global Bioprocess Validation Market by Process Component, Performance – Potential Analysis
7.3. Global Bioprocess Validation Market Estimates & Forecasts by Process Component 2019-2029 (USD Million)
7.4. Bioprocess Validation Market, Sub Segment Analysis
7.4.1. Filter Elements
7.4.2. Media containers and bags
7.4.3. Freezing and Thawing Process Bags
7.4.4. Mixing Systems
7.4.5. Bioreactors
7.4.6. Transfer Systems
7.4.7. Other
Chapter 8. Global Bioprocess Validation Market, by End-user
8.1. Market Snapshot
8.2. Global Bioprocess Validation Market by End-user, Performance – Potential Analysis
8.3. Global Bioprocess Validation Market Estimates & Forecasts by End-user2019-2029 (USD Million)
8.4. Bioprocess Validation Market, Sub Segment Analysis
8.4.1. Pharmaceutical Companies
8.4.2. Biotechnology Companies
8.4.3. Contract Development & Manufacturing Organizations
8.4.4. Other
Chapter 9. Global Bioprocess Validation Market, Regional Analysis
9.1. Bioprocess Validation Market, Regional Market Snapshot
9.2. North America Bioprocess Validation Market
9.2.1. U.S. Bioprocess Validation Market Test Type breakdown estimates & forecasts, 2019-2029 Process Component breakdown estimates & forecasts,2019-2029 End-user breakdown estimates & forecasts, 2019-2029
9.2.2. Canada Bioprocess Validation Market
9.3. Europe Bioprocess Validation Market Snapshot
9.3.1. U.K. Bioprocess Validation Market
9.3.2. Germany Bioprocess Validation Market
9.3.3. France Bioprocess Validation Market
9.3.4. Spain Bioprocess Validation Market
9.3.5. Italy Bioprocess Validation Market
9.3.6. Rest of Europe Bioprocess Validation Market
9.4. Asia-Pacific Bioprocess Validation Market Snapshot
9.4.1. China Bioprocess Validation Market
9.4.2. India Bioprocess Validation Market
9.4.3. Japan Bioprocess Validation Market
9.4.4. Australia Bioprocess Validation Market
9.4.5. South Korea Bioprocess Validation Market
9.4.6. Rest of Asia Pacific Bioprocess Validation Market
9.5. Latin America Bioprocess Validation Market Snapshot
9.5.1. Brazil Bioprocess Validation Market
9.5.2. Mexico Bioprocess Validation Market
9.6. Rest of The World Bioprocess Validation Market

Chapter 10. Competitive Intelligence
10.1. Top Market Strategies
10.2. Company Profiles
10.2.1. Merck KGaA Key Information Overview Financial (Subject to Data Availability) Product Summary Recent Developments
10.2.2. Eurofins Scientific
10.2.3. Sartorius Stedim biotech SA
10.2.4. Pall Corporation
10.2.5. Cobetter Filtration Equipments Co., Ltd
10.2.6. Toxikon Corporation
10.2.7. Thermo Fisher Scientific
10.2.8. Almac Group
10.2.9. Danher Corporation
10.2.10. Meissner Filtration Products, INC

Chapter 11. Research Process
11.1. Research Process
11.1.1. Data Mining
11.1.2. Analysis
11.1.3. Market Estimation
11.1.4. Validation
11.1.5. Publishing
11.2. Research Attributes
11.3. Research Assumption

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Market driving trends and favorable economic conditions
Restraints and challenges that are expected to be encountered during the forecast period.
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