Product Code: PHA1286
The global Bioprocess Validation market is projected to grow at a CAGR of 10.8% by 2033.
“The Bioprocess Validation Market Report 2023-2033”: This report will prove invaluable to leading firms striving for new revenue pockets if they wish to better understand the industry and its underlying dynamics. It will be useful for companies that would like to expand into different industries or to expand their existing operations in a new region.
Rising Demand for Clinical Trials Globally
The market for biopharmaceuticals is rising, there is an increase in the need for healthcare due to an ageing population, and the biotech, pharmaceutical, and medical device industries are expanding to fulfil this demand. As a result, the demand for effective clinical studies has increased in order to ensure the efficacy and safety of products. Worldwide, there are around 266 thousand open clinical trials ongoing. More than 105,000 open clinical investigations are now being conducted just in the United States.
Biologics and other pharmacological medications are the focus of these trials. Positive market growth for clinical trial services has led to an uptick in finance and investment, M&A (merger and acquisition) activity, the use of CROs (contract research organisations), and the availability of functional service providers. Further variables that influence the expansion of the clinical trial services market include the FDA's (Food and Drug Administration) recently implemented simplification of the adoption authorization process, genomics' advancement, and the launch of medicinal products with genetic profiles that are customised to patients or diseases.
Issues Related to Extractables and Leachable
The primary objective of Extractables and Leachables (E&L) testing is to mitigate the potential safety hazards posed to consumers of various products, including pharmaceutical medications and Electronic Nicotine Delivery Systems (ENDS), by evaluating the container closure system of these products. One of the primary difficulties associated with conducting leachables studies pertains to the prevalent necessity of achieving lower detection limits. This poses a challenge for both instrument vendors and laboratory scientists.
The development of instrument methods and sample preparation techniques necessitates the involvement of proficient and knowledgeable analysts who possess advanced skills and extensive experience. This is essential in order to meet the stringent analytical evaluation thresholds. Additionally, the utilisation of cutting-edge mass spectrometry instruments and software is imperative to effectively detect these minute levels and efficiently process the resulting data.
What Questions Should You Ask before Buying a Market Research Report?
- How is the bioprocess validation market evolving?
- What is driving and restraining the bioprocess validation market?
- How will each bioprocess validation submarket segment grow over the forecast period and how much revenue will these submarkets account for in 2033?
- How will the market shares for each bioprocess validation submarket develop from 2023 to 2033?
- What will be the main driver for the overall market from 2023 to 2033?
- Will leading bioprocess validation markets broadly follow the macroeconomic dynamics, or will individual national markets outperform others?
- How will the market shares of the national markets change by 2033 and which geographical region will lead the market in 2033?
- Who are the leading players and what are their prospects over the forecast period?
- What are the bioprocess validation projects for these leading companies?
- How will the industry evolve during the period between 2023 and 2033? What are the implications of
bioprocess validation projects taking place now and over the next 10 years?
- Is there a greater need for product commercialisation to further scale the bioprocess validation market?
- Where is the bioprocess validation market heading and how can you ensure you are at the forefront of the market?
- What are the best investment options for new product and service lines?
- What are the key prospects for moving companies into a new growth path and C-suite?
You need to discover how this will impact the bioprocess validation market today, and over the next 10 years:
- Our 315-page report provides 113 tables and 169 charts/graphs exclusively to you
- The report highlights key lucrative areas in the industry so you can target them - NOW
- It contains in-depth analysis of global, regional and national sales and growth
- It highlights for you the key successful trends, changes and revenue projections made by your competitors.
This report tells you TODAY how the bioprocess validation market will develop in the next 10 years, and in line with the variations in COVID-19 economic recession and bounce. This market is more critical now than at any point over the last 10 years.
Forecasts to 2033 and other analyses reveal commercial prospects
- In addition to revenue forecasting to 2033, our new study provides you with recent results, growth rates, and market shares
- You will find original analyses, with business outlooks and developments
- Discover qualitative analyses (including market dynamics, drivers, opportunities, and restraints), Porter's Five Forces Analysis, PEST Analysis and recent developments.
This report includes data analysis and invaluable insight into how COVID-19 will affect the industry and your company. Four COVID-19 recovery patterns and their impact, namely, ""V" ", "L", "W" and "U" are discussed in this report.
Segments Covered in the Report:
Test Type
- Extractable/Leachable Testing
- Microbiological Testing
- Integrity Testing
- Physiochemical Testing
- Compatibility Testing
- Others
Component
- Filters Elements
- Media Containers and Bags
- Freezing and Thawing Process Bags
- Bioreactors
- Transfer Systems
- Others
Modality
- Cell and Gene Therapy
- Vaccines
- Blood and Plasma Products
- Tissue Engineering and Regenerative Medicine
- Others
End-users
- Pharmaceutical Companies
- Biotechnology Companies
- Others
In addition to the revenue predictions for the overall world market and segments, you will also find revenue forecasts for five regional and 22 leading national markets:
North America
Europe
- Germany
- UK
- France
- Italy
- Spain
- Russia
- Rest of Europe
Asia Pacific
- Japan
- China
- India
- Australia
- South Korea
- South-East Asia
- Rest of Asia Pacific
Latin America
- Brazil
- Mexico
- Rest of Latin America
MEA
- GCC
- South Africa
- Rest of MEA
The report also includes profiles and for some of the leading companies in the Bioprocess Validation Market, 2023 to 2033, with a focus on this segment of these companies' operations.
Leading companies and the potential for market growth:
- Almac Group
- Charles River Laboratories
- CMIC HOLDINGS Co., Ltd
- Cobetter Filtration Equipment Co., Ltd
- Cytovance Biologics
- Cytiva
- DOC S.r.l.
|
- Eurofins Scientific
- Lonza Group
- Meissner Filtration Products, Inc
- Merck KGaA
- Sartorius AG
- SGS SA
- Thermo Fisher Scientific Inc.
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Overall world revenue for Bioprocess Validation Market, 2023 to 2033 in terms of value the market will surpass US$490 million in 2023, our work calculates. We predict strong revenue growth through to 2033. Our work identifies which organizations hold the greatest potential. Discover their capabilities, progress, and commercial prospects, helping you stay ahead.
How will the “Bioprocess Validation Market, 2023 to 2033” report help you?
In summary, our 310+ page report provides you with the following knowledge:
- Revenue forecasts to 2033 for Bioprocess Validation Market 2023 to 2033, with forecasts for test type, component, modality and end-users, each forecast at a global and regional level - discover the industry's prospects, finding the most lucrative places for investments and revenues.
- Revenue forecasts to 2033 for five regional and 22 key national markets - See forecasts for the Bioprocess Validation Market, 2023 to 2033 market in North America, Europe, Asia-Pacific, Latin America, and MEA. Also forecasted is the market in the US, Canada, Mexico, Brazil, Germany, France, UK, Italy, China, India, Japan, and Australia among other prominent economies.
- Prospects for established firms and those seeking to enter the market - including company profiles for 14 of the major companies involved in the Bioprocess Validation Market, 2023 to 2033.
Find quantitative and qualitative analyses with independent predictions. Receive information that only our report contains, staying informed with invaluable business intelligence.
Information found nowhere else
With our new report, you are less likely to fall behind in knowledge or miss out on opportunities. See how our work could benefit your research, analyses, and decisions. Visiongain's study is for everybody needing commercial analyses for the Bioprocess Validation Market 2023 to 2033, market-leading companies. You will find data, trends and predictions.
Table of Contents
1 Report Overview
- 1.1 Objectives of the Study
- 1.2 Introduction to Bioprocess Validation Market
- 1.3 What This Report Delivers
- 1.4 Why You Should Read This Report
- 1.5 Key Questions Answered by This Analytical Report Include:
- 1.6 Who is This Report For?
- 1.7 Methodology
- 1.7.1 Market Definitions
- 1.7.2 Market Evaluation & Forecasting Methodology
- 1.7.3 Data Validation
- 1.7.3.1 Primary Research
- 1.7.3.2 Secondary Research
- 1.8 Frequently Asked Questions (FAQs)
- 1.9 Associated Visiongain Reports
- 1.10 About Visiongain
2 Executive Summary
3 Market Overview
- 3.1 Key Findings
- 3.2 Market Dynamics
- 3.2.1 Market Driving Factors
- 3.2.1.1 Increasing Demand for Biopharmaceuticals
- 3.2.1.2 Increasing Demand for Outsourcing Bioprocess Validation
- 3.2.1.3 Rising R&D Expenditure
- 3.2.1.4 Rising Demand for Clinical Trials Globally
- 3.2.2 Market Restraining Factors
- 3.2.2.1 Issues Related to Extractables and Leachable
- 3.2.2.2 High Cost of Advanced Technology
- 3.2.2.3 Shortage of Skilled Labour Post COVID-19 Hampering Industry Growth
- 3.2.2.4 Regulatory Challenges
- 3.2.3 Market Opportunities
- 3.2.3.1 Growth Opportunities in Emerging Economies
- 3.2.3.2 Harmonized Bioanalytical Testing Opens New Opportunities
- 3.2.3.3 Data Security and Compliance in the Digital Age to Offer Lucrative Growth Prospects
- 3.2.3.4 Customised Solutions for Small and Medium Enterprises (SMEs)
- 3.2.3.5 Digital Twins for Bioprocess Validation
- 3.3 COVID-19 Impact Analysis
- 3.4 Porter's Five Forces Analysis
- 3.4.1 Supplier Power
- 3.4.2 Buyer Power
- 3.4.3 Competitive Rivalry
- 3.4.4 Threat from Substitutes
- 3.4.5 Threat of New Entrants
- 3.5 PEST Analysis
- 3.5.1 Political Factors Impacting Bioprocess Validation Market
- 3.5.2 Economic Factors Impacting Bioprocess Validation Market
- 3.5.3 Social Factors Impacting Bioprocess Validation Market
- 3.5.4 Technological Factors Impacting Bioprocess Validation Market
- 3.6 Market Overview of Single-use Technologies (Bags) and Container Closure System Validation
- 3.7 Market Limitation of Validation Services
- 3.8 Decision Making Drivers for Choosing Validation Suppliers Regionally
- 3.9 Viral Clearance Testing Market by Region, 2023-2033 (US$ Mn, AGR %)
4 Bioprocess Validation Market Analysis by Test Type
- 4.1 Key Findings
- 4.2 Test Type Segment: Market Attractiveness Index
- 4.3 Bioprocess Validation Market Size Estimation and Forecast by Test Type
- 4.4 Extractable/Leachable Testing
- 4.4.1 Market Forecast by Region, 2023-2033 (US$ Million, AGR %)
- 4.4.2 Market Share by Region, 2023 & 2033 (%)
- 4.5 Microbiological Testing
- 4.5.1 Market Forecast by Region, 2023-2033 (US$ Million, AGR %)
- 4.5.2 Market Share by Region, 2023 & 2033 (%)
- 4.6 Integrity Testing
- 4.6.1 Market Forecast by Region, 2023-2033 (US$ Million, AGR %)
- 4.6.2 Market Share by Region, 2023 & 2033 (%)
- 4.7 Physiochemical Testing
- 4.7.1 Market Forecast by Region, 2023-2033 (US$ Million, AGR %)
- 4.7.2 Market Share by Region, 2023 & 2033 (%)
- 4.8 Compatibility Testing
- 4.8.1 Market Forecast by Region, 2023-2033 (US$ Million, AGR %)
- 4.8.2 Market Share by Region, 2023 & 2033 (%)
- 4.9 Others
- 4.9.1 Market Forecast by Region, 2023-2033 (US$ Million, AGR %)
- 4.9.2 Market Share by Region, 2023 & 2033 (%)
5 Bioprocess Validation Market Analysis by Component
- 5.1 Key Findings
- 5.2 Component Segment: Market Attractiveness Index
- 5.3 Bioprocess Validation Market Size Estimation and Forecast by Component
- 5.4 Filters Elements
- 5.4.1 Market Forecast by Region, 2023-2033 (US$ Million, AGR %)
- 5.4.2 Market Share by Region, 2023 & 2033 (%)
- 5.5 Media Containers and Bags
- 5.5.1 Market Forecast by Region, 2023-2033 (US$ Million, AGR %)
- 5.5.2 Market Share by Region, 2023 & 2033 (%)
- 5.6 Freezing and Thawing Process Bags
- 5.6.1 Market Forecast by Region, 2023-2033 (US$ Million, AGR %)
- 5.6.2 Market Share by Region, 2023 & 2033 (%)
- 5.7 Bioreactors
- 5.7.1 Market Forecast by Region, 2023-2033 (US$ Million, AGR %)
- 5.7.2 Market Share by Region, 2023 & 2033 (%)
- 5.8 Transfer Systems
- 5.8.1 Market Forecast by Region, 2023-2033 (US$ Million, AGR %)
- 5.8.2 Market Share by Region, 2023 & 2033 (%)
- 5.9 Others
- 5.9.1 Market Forecast by Region, 2023-2033 (US$ Million, AGR %)
- 5.9.2 Market Share by Region, 2023 & 2033 (%)
6 Bioprocess Validation Market Analysis by Modality
- 6.1 Key Findings
- 6.2 Modality Segment: Market Attractiveness Index
- 6.3 Bioprocess Validation Market Size Estimation and Forecast by Modality
- 6.4 Cell and Gene Therapy
- 6.4.1 Market Forecast by Region, 2023-2033 (US$ Million, AGR %)
- 6.4.2 Market Share by Region, 2023 & 2033 (%)
- 6.5 Vaccines
- 6.5.1 Market Forecast by Region, 2023-2033 (US$ Million, AGR %)
- 6.5.2 Market Share by Region, 2023 & 2033 (%)
- 6.6 Blood and Plasma Products
- 6.6.1 Market Forecast by Region, 2023-2033 (US$ Million, AGR %)
- 6.6.2 Market Share by Region, 2023 & 2033 (%)
- 6.7 Tissue Engineering and Regenerative Medicine
- 6.7.1 Market Forecast by Region, 2023-2033 (US$ Million, AGR %)
- 6.7.2 Market Share by Region, 2023 & 2033 (%)
- 6.8 Others
- 6.8.1 Market Forecast by Region, 2023-2033 (US$ Million, AGR %)
- 6.8.2 Market Share by Region, 2023 & 2033 (%)
7 Bioprocess Validation Market Analysis by End-users
- 7.1 Key Findings
- 7.2 End-users Segment: Market Attractiveness Index
- 7.3 Bioprocess Validation Market Size Estimation and Forecast by End-users
- 7.4 Pharmaceutical Companies
- 7.4.1 Market Forecast by Region, 2023-2033 (US$ Million, AGR %)
- 7.4.2 Market Share by Region, 2023 & 2033 (%)
- 7.5 Biotechnology Companies
- 7.5.1 Market Forecast by Region, 2023-2033 (US$ Million, AGR %)
- 7.5.2 Market Share by Region, 2023 & 2033 (%)
- 7.6 Others
- 7.6.1 Market Forecast by Region, 2023-2033 (US$ Million, AGR %)
- 7.6.2 Market Share by Region, 2023 & 2033 (%)
8 Bioprocess Validation Market Analysis by Region
- 8.1 Key Findings
- 8.2 Regional Market Size Estimation and Forecast
9 North America Bioprocess Validation Market Analysis
- 9.1 Key Findings
- 9.2 North America Bioprocess Validation Market Attractiveness Index
- 9.3 North America Bioprocess Validation Market by Country, 2023, 2028 & 2033 (US$ Million)
- 9.4 North America Bioprocess Validation Market Size Estimation and Forecast by Country
- 9.5 North America Bioprocess Validation Market Size Estimation and Forecast by Test Type
- 9.6 North America Bioprocess Validation Market Size Estimation and Forecast by Component
- 9.7 North America Bioprocess Validation Market Size Estimation and Forecast by Modality
- 9.8 North America Bioprocess Validation Market Size Estimation and Forecast by End-users
- 9.9 U.S. Bioprocess Validation Market Analysis
- 9.10 Canada Bioprocess Validation Market Analysis
10 Europe Bioprocess Validation Market Analysis
- 10.1 Key Findings
- 10.2 Europe Bioprocess Validation Market Attractiveness Index
- 10.3 Europe Bioprocess Validation Market by Country, 2023, 2028 & 2033 (US$ Million)
- 10.4 Europe Bioprocess Validation Market Size Estimation and Forecast by Country
- 10.5 Europe Bioprocess Validation Market Size Estimation and Forecast by Test Type
- 10.6 Europe Bioprocess Validation Market Size Estimation and Forecast by Component
- 10.7 Europe Bioprocess Validation Market Size Estimation and Forecast by Modality
- 10.8 Europe Bioprocess Validation Market Size Estimation and Forecast by End-users
- 10.9 Germany Bioprocess Validation Market Analysis
- 10.10 UK Bioprocess Validation Market Analysis
- 10.11 France Bioprocess Validation Market Analysis
- 10.12 Italy Bioprocess Validation Market Analysis
- 10.13 Spain Bioprocess Validation Market Analysis
- 10.14 Russia Bioprocess Validation Market Analysis
- 10.15 Rest of Europe Bioprocess Validation Market Analysis
11 Asia Pacific Bioprocess Validation Market Analysis
- 11.1 Key Findings
- 11.2 Asia Pacific Bioprocess Validation Market Attractiveness Index
- 11.3 Asia Pacific Bioprocess Validation Market by Country, 2023, 2028 & 2033 (US$ Million)
- 11.4 Asia Pacific Bioprocess Validation Market Size Estimation and Forecast by Country
- 11.5 Asia Pacific Bioprocess Validation Market Size Estimation and Forecast by Test Type
- 11.6 Asia Pacific Bioprocess Validation Market Size Estimation and Forecast by Component
- 11.7 Asia Pacific Bioprocess Validation Market Size Estimation and Forecast by Modality
- 11.8 Asia Pacific Bioprocess Validation Market Size Estimation and Forecast by End-users
- 11.9 Japan Bioprocess Validation Market Analysis
- 11.10 China Bioprocess Validation Market Analysis
- 11.11 India Bioprocess Validation Market Analysis
- 11.12 Australia Bioprocess Validation Market Analysis
- 11.13 South Korea Bioprocess Validation Market Analysis
- 11.14 South-East Asia Bioprocess Validation Market Analysis
- 11.15 Rest of Asia Pacific Bioprocess Validation Market Analysis
12 Latin America Bioprocess Validation Market Analysis
- 12.1 Key Findings
- 12.2 Latin America Bioprocess Validation Market Attractiveness Index
- 12.3 Latin America Bioprocess Validation Market by Country, 2023, 2028 & 2033 (US$ Million)
- 12.4 Latin America Bioprocess Validation Market Size Estimation and Forecast by Country
- 12.5 Latin America Bioprocess Validation Market Size Estimation and Forecast by Test Type
- 12.6 Latin America Bioprocess Validation Market Size Estimation and Forecast by Component
- 12.7 Latin America Bioprocess Validation Market Size Estimation and Forecast by Modality
- 12.8 Latin America Bioprocess Validation Market Size Estimation and Forecast by End-users
- 12.9 Brazil Bioprocess Validation Market Analysis
- 12.10 Mexico Bioprocess Validation Market Analysis
- 12.11 Rest of Latin America Bioprocess Validation Market Analysis
13 MEA Bioprocess Validation Market Analysis
- 13.1 Key Findings
- 13.2 MEA Bioprocess Validation Market Attractiveness Index
- 13.3 MEA Bioprocess Validation Market by Country, 2023, 2028 & 2033 (US$ Million)
- 13.4 MEA Bioprocess Validation Market Size Estimation and Forecast by Country
- 13.5 MEA Bioprocess Validation Market Size Estimation and Forecast by Test Type
- 13.6 MEA Bioprocess Validation Market Size Estimation and Forecast by Component
- 13.7 MEA Bioprocess Validation Market Size Estimation and Forecast by Modality
- 13.8 MEA Bioprocess Validation Market Size Estimation and Forecast by End-users
- 13.9 GCC Bioprocess Validation Market Analysis
- 13.10 South Africa Bioprocess Validation Market Analysis
- 13.11 Rest of MEA Bioprocess Validation Market Analysis
14 Company Profiles
- 14.1 Sartorius AG
- 14.1.1 Company Snapshot
- 14.1.2 Company Overview
- 14.1.3 Financial Analysis
- 14.1.3.1 Net Revenue, 2015-2022
- 14.1.3.2 Regional Market Shares, 2022
- 14.1.3.3 R&D, 2015-2022
- 14.1.4 Service Benchmarking
- 14.1.5 Strategic Outlook
- 14.2 Charles River Laboratories
- 14.2.1 Company Snapshot
- 14.2.2 Company Overview
- 14.2.3 Financial Analysis
- 14.2.3.1 Net Revenue, 2015-2022
- 14.2.3.2 Regional Market Shares, 2022
- 14.2.4 Service Benchmarking
- 14.2.5 Strategic Outlook
- 14.3 Merck KGaA
- 14.3.1 Company Snapshot
- 14.3.2 Company Overview
- 14.3.3 Financial Analysis
- 14.3.3.1 Net Revenue, 2015-2022
- 14.3.3.2 Regional Market Shares, 2022
- 14.3.3.3 R&D, 2015-2022
- 14.3.4 Service Benchmarking
- 14.3.5 Strategic Outlook
- 14.4 Cytiva
- 14.4.1 Company Snapshot
- 14.4.2 Company Overview
- 14.4.3 Service Benchmarking
- 14.4.4 Strategic Outlook
- 14.5 Thermo Fisher Scientific, Inc.
- 14.5.1 Company Snapshot
- 14.5.2 Company Overview
- 14.5.3 Financial Analysis
- 14.5.3.1 Net Revenue, 2015-2022
- 14.5.3.2 Regional Market Shares, 2022
- 14.5.3.3 R&D, 2015-2022
- 14.5.4 Service Benchmarking
- 14.5.5 Strategic Outlook
- 14.6 SGS SA
- 14.6.1 Company Snapshot
- 14.6.2 Company Overview
- 14.6.3 Financial Analysis
- 14.6.3.1 Net Revenue, 2015-2022
- 14.6.3.2 Regional Market Shares, 2022
- 14.6.4 Service Benchmarking
- 14.6.5 Strategic Outlook
- 14.7 Eurofins Scientific
- 14.7.1 Company Snapshot
- 14.7.2 Company Overview
- 14.7.3 Financial Analysis
- 14.7.3.1 Net Revenue, 2016-2022
- 14.7.3.2 Regional Market Shares, 2022
- 14.7.4 Service Benchmarking
- 14.7.5 Strategic Outlook
- 14.8 Lonza Group
- 14.8.1 Company Snapshot
- 14.8.2 Company Overview
- 14.8.3 Financial Analysis
- 14.8.3.1 Net Revenue, 2015-2022
- 14.8.3.2 Regional Market Shares, 2022
- 14.8.3.3 R&D, 2017-2022
- 14.8.4 Service Benchmarking
- 14.8.5 Strategic Outlook
- 14.9 Almac Group
- 14.9.1 Company Snapshot
- 14.9.2 Company Overview
- 14.9.3 Service Benchmarking
- 14.9.4 Strategic Outlook
- 14.10 Cobetter Filtration Equipment Co., Ltd.
- 14.10.1 Company Snapshot
- 14.10.2 Company Overview
- 14.10.3 Service Benchmarking
- 14.11 CMIC HOLDINGS Co., Ltd.
- 14.11.1 Company Snapshot
- 14.11.2 Company Overview
- 14.11.3 Financial Analysis
- 14.11.3.1 Net Revenue, 2015-2022
- 14.11.4 Service Benchmarking
- 14.11.5 Strategic Outlook
- 14.12 DOC S.r.l.
- 14.12.1 Company Snapshot
- 14.12.2 Company Overview
- 14.12.3 Service Benchmarking
- 14.13 Meissner Filtration Products, Inc.
- 14.13.1 Company Snapshot
- 14.13.2 Company Overview
- 14.13.3 Service Benchmarking
- 14.14 Cytovance Biologics
- 14.14.1 Company Snapshot
- 14.14.2 Company Overview
- 14.14.3 Service Benchmarking
- 14.14.4 Strategic Outlook
15 Conclusion and Recommendations
- 15.1 Concluding Remarks from Visiongain
- 15.2 Recommendations for Market Players