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Bioprocess Validation Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2023-2028

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    Report

  • 139 Pages
  • October 2023
  • Region: Global
  • IMARC Group
  • ID: 5700901

Quick Summary:

In the fast-paced world of the global bioprocess validation market, staying ahead of the curve is crucial. Boasting a blend of meticulous processes, innovative techniques, and cost-efficiency, bioprocess validation has quickly become commonplace among pharmaceutical, biopharmaceutical, and contract development and manufacturing organizations seeking to assure quality, safety, efficacy, and predetermined attributes of their drugs. From extractable and microbiological to compatibility, integrity, and physiochemical testing services, bioprocess validation meticulously evaluates multiple active pharmaceutical ingredients (APIs) and possible contaminants for optimal compliance each step of the way.

The resourceful application of bioprocess validation in healthcare is managed through adherence to good manufacturing practices (GMP), fostering market growth. Its adoption is supplemented by the rising prevalence of chronic ailments, demand for biopharmaceuticals and stringent quality and safety regulations. Further enhancing its appeal, the bioprocess validation market leverages technological advancements in bio-manufacturing infrastructure to ensure the scalable, cost-effective production of medications. Other factors like the outsourcing trend of laboratory testing services, rising necessity for personalized medicines, and continuous research and development activities to ascertain optimal drug quality also contribute to the positive market outlook.

The global bioprocess validation market size reached US$ 334.6 Million in 2022. Looking forward, the analyst expects the market to reach US$ 573.6 Million by 2028, exhibiting a growth rate (CAGR) of 8.78% during 2023-2028.

Bioprocess validation refers to an approach of acquiring documentary evidence by demonstrating various procedures, processes, and activities that are conducted during the production and testing of the product to maintain the desired level of compliance at all phases. It involves extractable, microbiological, compatibility, integrity, and physiochemical testing services as standard methods. These techniques help evaluate multiple active pharmaceutical ingredients (APIs) and possible contaminants, including endotoxin, mycoplasma, and bacteria, during the development of biological products and animal drugs. Apart from this, bioprocess validation is cost-effective and monitors practices and medication manufacturing procedures. As a result, it is used by pharmaceutical, biopharmaceutical, and contract development and manufacturing organization (CMO) to assure drug quality, safety, efficacy, and predetermined attributes.

Bioprocess Validation Market Trends:

The increasing need for outsourcing bioprocess validation services in hospitals and clinics to maintain compliance with good manufacturing practices (GMP) is majorly driving the market growth. This is further supported by the execution of stringent quality and product safety regulations by governments. Additionally, the rising prevalence of various chronic ailments and the escalating demand for biopharmaceuticals are supplementing the widespread adoption of bioprocess validation across the healthcare sector, thus favoring the market growth. Moreover, the extensive usage of bioprocess validation by pharmaceutical and CMO companies to monitor the accuracy, purity, efficiency, and safety of drugs while manufacturing novel vaccines and biosimilars, especially during COVID-19, is acting as another growth-inducing factor. In line with this, significant technological advancements in bio-manufacturing infrastructure and the ongoing bioprocess validation of bioreactors to ensure the cost-effective and scalable production of medications are propelling the market growth. Apart from this, the emerging trend of outsourcing laboratory testing services, the escalating need for personalized medicines, and continuous research and development (R&D) activities to ensure the optimal quality of drugs are creating a positive outlook for the market.

Key Market Segmentation

The report provides an analysis of the key trends in each sub-segment of the global bioprocess validation market report, along with forecasts at the global, regional and country level from 2023-2028. Our report has categorized the market based on test type, process component and end user.

Breakup by Test Type:

  • Extractables Testing Services
  • Microbiological Testing Services
  • Physiochemical Testing Services
  • Integrity Testing Services
  • Compatibility Testing Services
  • Others

Breakup by Process Component:

  • Filter Elements
  • Media Containers and Bags
  • Freezing And Thawing Process Bags
  • Mixing Systems
  • Bioreactors
  • Transfer Systems
  • Others

Breakup by End User:

  • Pharmaceutical and Biotechnology Companies
  • Contract Development and Manufacturing Organizations
  • Others

Breakup by Region:

  • North America
  • United States
  • Canada
  • Asia-Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Indonesia
  • Others
  • Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Russia
  • Others
  • Latin America
  • Brazil
  • Mexico
  • Others
  • Middle East and Africa

Competitive Landscape

The competitive landscape of the industry has also been examined along with the profiles of the key players being Almac Group, Biozeen, Doc S.R.L., Eurofins Scientific, Hangzhou Anow Microfiltration Co. Ltd., Hangzhou Cobetter Filtration Equipment Co. Ltd., Hangzhou Tianshan Precision Filter Material Co. Ltd., Meissner Filtration Products, Inc., Merck KGaA, Sartorius AG, SGS SA and Thermo Fisher Scientific Inc.

Key Questions Answered in This Report:

  • How has the global bioprocess validation market performed so far and how will it perform in the coming years?
  • What has been the impact of COVID-19 on the global bioprocess validation market?
  • What are the key regional markets?
  • What is the breakup of the market based on the test type?
  • What is the breakup of the market based on the process component?
  • What is the breakup of the market based on the end user?
  • What are the various stages in the value chain of the industry?
  • What are the key driving factors and challenges in the industry?
  • What is the structure of the global bioprocess validation market and who are the key players?
  • What is the degree of competition in the industry?
Frequently Asked Questions about the Global Bioprocess Validation Market

What is the estimated value of the Global Bioprocess Validation Market?

The Global Bioprocess Validation Market was estimated to be valued at $334.6 Million in 2022.

What is the growth rate of the Global Bioprocess Validation Market?

The growth rate of the Global Bioprocess Validation Market is 9.4%, with an estimated value of $573.6 Million by 2028.

What is the forecasted size of the Global Bioprocess Validation Market?

The Global Bioprocess Validation Market is estimated to be worth $573.6 Million by 2028.

Who are the key companies in the Global Bioprocess Validation Market?

Key companies in the Global Bioprocess Validation Market include Almac Group, Biozeen, Doc S.R.L., Eurofins Scientific, Hangzhou Anow Microfiltration Co. Ltd., Hangzhou Cobetter Filtration Equipment Co. Ltd., Hangzhou Tianshan Precision Filter Material Co. Ltd., Meissner Filtration Products Inc., Merck KGaA and Sartorius AG.

Table of Contents

1 Preface
2 Scope and Methodology
2.1 Objectives of the Study
2.2 Stakeholders
2.3 Data Sources
2.3.1 Primary Sources
2.3.2 Secondary Sources
2.4 Market Estimation
2.4.1 Bottom-Up Approach
2.4.2 Top-Down Approach
2.5 Forecasting Methodology
3 Executive Summary
4 Introduction
4.1 Overview
4.2 Key Industry Trends
5 Global Bioprocess Validation Market
5.1 Market Overview
5.2 Market Performance
5.3 Impact of COVID-19
5.4 Market Forecast
6 Market Breakup by Test Type
6.1 Extractables Testing Services
6.1.1 Market Trends
6.1.2 Market Forecast
6.2 Microbiological Testing Services
6.2.1 Market Trends
6.2.2 Market Forecast
6.3 Physiochemical Testing Services
6.3.1 Market Trends
6.3.2 Market Forecast
6.4 Integrity Testing Services
6.4.1 Market Trends
6.4.2 Market Forecast
6.5 Compatibility Testing Services
6.5.1 Market Trends
6.5.2 Market Forecast
6.6 Others
6.6.1 Market Trends
6.6.2 Market Forecast
7 Market Breakup by Process Component
7.1 Filter Elements
7.1.1 Market Trends
7.1.2 Market Forecast
7.2 Media Containers and Bags
7.2.1 Market Trends
7.2.2 Market Forecast
7.3 Freezing And Thawing Process Bags
7.3.1 Market Trends
7.3.2 Market Forecast
7.4 Mixing Systems
7.4.1 Market Trends
7.4.2 Market Forecast
7.5 Bioreactors
7.5.1 Market Trends
7.5.2 Market Forecast
7.6 Transfer Systems
7.6.1 Market Trends
7.6.2 Market Forecast
7.7 Others
7.7.1 Market Trends
7.7.2 Market Forecast
8 Market Breakup by End User
8.1 Pharmaceutical and Biotechnology Companies
8.1.1 Market Trends
8.1.2 Market Forecast
8.2 Contract Development and Manufacturing Organizations
8.2.1 Market Trends
8.2.2 Market Forecast
8.3 Others
8.3.1 Market Trends
8.3.2 Market Forecast
9 Market Breakup by Region
9.1 North America
9.1.1 United States
9.1.1.1 Market Trends
9.1.1.2 Market Forecast
9.1.2 Canada
9.1.2.1 Market Trends
9.1.2.2 Market Forecast
9.2 Asia-Pacific
9.2.1 China
9.2.1.1 Market Trends
9.2.1.2 Market Forecast
9.2.2 Japan
9.2.2.1 Market Trends
9.2.2.2 Market Forecast
9.2.3 India
9.2.3.1 Market Trends
9.2.3.2 Market Forecast
9.2.4 South Korea
9.2.4.1 Market Trends
9.2.4.2 Market Forecast
9.2.5 Australia
9.2.5.1 Market Trends
9.2.5.2 Market Forecast
9.2.6 Indonesia
9.2.6.1 Market Trends
9.2.6.2 Market Forecast
9.2.7 Others
9.2.7.1 Market Trends
9.2.7.2 Market Forecast
9.3 Europe
9.3.1 Germany
9.3.1.1 Market Trends
9.3.1.2 Market Forecast
9.3.2 France
9.3.2.1 Market Trends
9.3.2.2 Market Forecast
9.3.3 United Kingdom
9.3.3.1 Market Trends
9.3.3.2 Market Forecast
9.3.4 Italy
9.3.4.1 Market Trends
9.3.4.2 Market Forecast
9.3.5 Spain
9.3.5.1 Market Trends
9.3.5.2 Market Forecast
9.3.6 Russia
9.3.6.1 Market Trends
9.3.6.2 Market Forecast
9.3.7 Others
9.3.7.1 Market Trends
9.3.7.2 Market Forecast
9.4 Latin America
9.4.1 Brazil
9.4.1.1 Market Trends
9.4.1.2 Market Forecast
9.4.2 Mexico
9.4.2.1 Market Trends
9.4.2.2 Market Forecast
9.4.3 Others
9.4.3.1 Market Trends
9.4.3.2 Market Forecast
9.5 Middle East and Africa
9.5.1 Market Trends
9.5.2 Market Breakup by Country
9.5.3 Market Forecast
10 SWOT Analysis
10.1 Overview
10.2 Strengths
10.3 Weaknesses
10.4 Opportunities
10.5 Threats
11 Value Chain Analysis
12 Porters Five Forces Analysis
12.1 Overview
12.2 Bargaining Power of Buyers
12.3 Bargaining Power of Suppliers
12.4 Degree of Competition
12.5 Threat of New Entrants
12.6 Threat of Substitutes
13 Price Analysis
14 Competitive Landscape
14.1 Market Structure
14.2 Key Players
14.3 Profiles of Key Players
14.3.1 Almac Group
14.3.1.1 Company Overview
14.3.1.2 Product Portfolio
14.3.1.3 SWOT Analysis
14.3.2 Biozeen
14.3.2.1 Company Overview
14.3.2.2 Product Portfolio
14.3.3 Doc S.R.L.
14.3.3.1 Company Overview
14.3.3.2 Product Portfolio
14.3.4 Eurofins Scientific
14.3.4.1 Company Overview
14.3.4.2 Product Portfolio
14.3.4.3 Financials
14.3.4.4 SWOT Analysis
14.3.5 Hangzhou Anow Microfiltration Co. Ltd.
14.3.5.1 Company Overview
14.3.5.2 Product Portfolio
14.3.6 Hangzhou Cobetter Filtration Equipment Co. Ltd.
14.3.6.1 Company Overview
14.3.6.2 Product Portfolio
14.3.7 Hangzhou Tianshan Precision Filter Material Co. Ltd.
14.3.7.1 Company Overview
14.3.7.2 Product Portfolio
14.3.8 Meissner Filtration Products, Inc.
14.3.8.1 Company Overview
14.3.8.2 Product Portfolio
14.3.9 Merck KGaA
14.3.9.1 Company Overview
14.3.9.2 Product Portfolio
14.3.9.3 Financials
14.3.9.4 SWOT Analysis
14.3.10 Sartorius AG
14.3.10.1 Company Overview
14.3.10.2 Product Portfolio
14.3.10.3 Financials
14.3.10.4 SWOT Analysis
14.3.11 SGS SA
14.3.11.1 Company Overview
14.3.11.2 Product Portfolio
14.3.11.3 Financials
14.3.12 Thermo Fisher Scientific Inc.
14.3.12.1 Company Overview
14.3.12.2 Product Portfolio
14.3.12.3 Financials
14.3.12.4 SWOT Analysis
List of Figures
Figure 1: Global: Bioprocess Validation Market: Major Drivers and Challenges
Figure 2: Global: Bioprocess Validation Market: Sales Value (in Million US$), 2017-2022
Figure 3: Global: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 4: Global: Bioprocess Validation Market: Breakup by Test Type (in %), 2022
Figure 5: Global: Bioprocess Validation Market: Breakup by Process Component (in %), 2022
Figure 6: Global: Bioprocess Validation Market: Breakup by End User (in %), 2022
Figure 7: Global: Bioprocess Validation Market: Breakup by Region (in %), 2022
Figure 8: Global: Bioprocess Validation (Extractables Testing Services) Market: Sales Value (in Million US$), 2017 & 2022
Figure 9: Global: Bioprocess Validation (Extractables Testing Services) Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 10: Global: Bioprocess Validation (Microbiological Testing Services) Market: Sales Value (in Million US$), 2017 & 2022
Figure 11: Global: Bioprocess Validation (Microbiological Testing Services) Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 12: Global: Bioprocess Validation (Physiochemical Testing Services) Market: Sales Value (in Million US$), 2017 & 2022
Figure 13: Global: Bioprocess Validation (Physiochemical Testing Services) Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 14: Global: Bioprocess Validation (Integrity Testing Services) Market: Sales Value (in Million US$), 2017 & 2022
Figure 15: Global: Bioprocess Validation (Integrity Testing Services) Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 16: Global: Bioprocess Validation (Compatibility Testing Services) Market: Sales Value (in Million US$), 2017 & 2022
Figure 17: Global: Bioprocess Validation (Compatibility Testing Services) Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 18: Global: Bioprocess Validation (Other Test Types) Market: Sales Value (in Million US$), 2017 & 2022
Figure 19: Global: Bioprocess Validation (Other Test Types) Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 20: Global: Bioprocess Validation (Filter Elements) Market: Sales Value (in Million US$), 2017 & 2022
Figure 21: Global: Bioprocess Validation (Filter Elements) Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 22: Global: Bioprocess Validation (Media Containers and Bags) Market: Sales Value (in Million US$), 2017 & 2022
Figure 23: Global: Bioprocess Validation (Media Containers and Bags) Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 24: Global: Bioprocess Validation (Freezing and Thawing Process Bags) Market: Sales Value (in Million US$), 2017 & 2022
Figure 25: Global: Bioprocess Validation (Freezing and Thawing Process Bags) Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 26: Global: Bioprocess Validation (Mixing Systems) Market: Sales Value (in Million US$), 2017 & 2022
Figure 27: Global: Bioprocess Validation (Mixing Systems) Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 28: Global: Bioprocess Validation (Bioreactors) Market: Sales Value (in Million US$), 2017 & 2022
Figure 29: Global: Bioprocess Validation (Bioreactors) Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 30: Global: Bioprocess Validation (Transfer Systems) Market: Sales Value (in Million US$), 2017 & 2022
Figure 31: Global: Bioprocess Validation (Transfer Systems) Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 32: Global: Bioprocess Validation (Other Process Components) Market: Sales Value (in Million US$), 2017 & 2022
Figure 33: Global: Bioprocess Validation (Other Process Components) Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 34: Global: Bioprocess Validation (Pharmaceutical and Biotechnology Companies) Market: Sales Value (in Million US$), 2017 & 2022
Figure 35: Global: Bioprocess Validation (Pharmaceutical and Biotechnology Companies) Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 36: Global: Bioprocess Validation (Contract Development and Manufacturing Organizations) Market: Sales Value (in Million US$), 2017 & 2022
Figure 37: Global: Bioprocess Validation (Contract Development and Manufacturing Organizations) Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 38: Global: Bioprocess Validation (Other End Users) Market: Sales Value (in Million US$), 2017 & 2022
Figure 39: Global: Bioprocess Validation (Other End Users) Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 40: North America: Bioprocess Validation Market: Sales Value (in Million US$), 2017 & 2022
Figure 41: North America: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 42: United States: Bioprocess Validation Market: Sales Value (in Million US$), 2017 & 2022
Figure 43: United States: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 44: Canada: Bioprocess Validation Market: Sales Value (in Million US$), 2017 & 2022
Figure 45: Canada: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 46: Asia-Pacific: Bioprocess Validation Market: Sales Value (in Million US$), 2017 & 2022
Figure 47: Asia-Pacific: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 48: China: Bioprocess Validation Market: Sales Value (in Million US$), 2017 & 2022
Figure 49: China: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 50: Japan: Bioprocess Validation Market: Sales Value (in Million US$), 2017 & 2022
Figure 51: Japan: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 52: India: Bioprocess Validation Market: Sales Value (in Million US$), 2017 & 2022
Figure 53: India: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 54: South Korea: Bioprocess Validation Market: Sales Value (in Million US$), 2017 & 2022
Figure 55: South Korea: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 56: Australia: Bioprocess Validation Market: Sales Value (in Million US$), 2017 & 2022
Figure 57: Australia: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 58: Indonesia: Bioprocess Validation Market: Sales Value (in Million US$), 2017 & 2022
Figure 59: Indonesia: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 60: Others: Bioprocess Validation Market: Sales Value (in Million US$), 2017 & 2022
Figure 61: Others: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 62: Europe: Bioprocess Validation Market: Sales Value (in Million US$), 2017 & 2022
Figure 63: Europe: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 64: Germany: Bioprocess Validation Market: Sales Value (in Million US$), 2017 & 2022
Figure 65: Germany: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 66: France: Bioprocess Validation Market: Sales Value (in Million US$), 2017 & 2022
Figure 67: France: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 68: United Kingdom: Bioprocess Validation Market: Sales Value (in Million US$), 2017 & 2022
Figure 69: United Kingdom: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 70: Italy: Bioprocess Validation Market: Sales Value (in Million US$), 2017 & 2022
Figure 71: Italy: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 72: Spain: Bioprocess Validation Market: Sales Value (in Million US$), 2017 & 2022
Figure 73: Spain: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 74: Russia: Bioprocess Validation Market: Sales Value (in Million US$), 2017 & 2022
Figure 75: Russia: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 76: Others: Bioprocess Validation Market: Sales Value (in Million US$), 2017 & 2022
Figure 77: Others: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 78: Latin America: Bioprocess Validation Market: Sales Value (in Million US$), 2017 & 2022
Figure 79: Latin America: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 80: Brazil: Bioprocess Validation Market: Sales Value (in Million US$), 2017 & 2022
Figure 81: Brazil: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 82: Mexico: Bioprocess Validation Market: Sales Value (in Million US$), 2017 & 2022
Figure 83: Mexico: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 84: Others: Bioprocess Validation Market: Sales Value (in Million US$), 2017 & 2022
Figure 85: Others: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 86: Middle East and Africa: Bioprocess Validation Market: Sales Value (in Million US$), 2017 & 2022
Figure 87: Middle East and Africa: Bioprocess Validation Market: Breakup by Country (in %), 2022
Figure 88: Middle East and Africa: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 89: Global: Bioprocess Validation Industry: SWOT Analysis
Figure 90: Global: Bioprocess Validation Industry: Value Chain Analysis
Figure 91: Global: Bioprocess Validation Industry: Porter's Five Forces Analysis
List of Tables
Table 1: Global: Bioprocess Validation Market: Key Industry Highlights, 2022 and 2028
Table 2: Global: Bioprocess Validation Market Forecast: Breakup by Test Type (in Million US$), 2023-2028
Table 3: Global: Bioprocess Validation Market Forecast: Breakup by Process Component (in Million US$), 2023-2028
Table 4: Global: Bioprocess Validation Market Forecast: Breakup by End User (in Million US$), 2023-2028
Table 5: Global: Bioprocess Validation Market Forecast: Breakup by Region (in Million US$), 2023-2028
Table 6: Global: Bioprocess Validation Market: Competitive Structure
Table 7: Global: Bioprocess Validation Market: Key Players

Companies Mentioned

  • Almac Group
  • Biozeen
  • Doc S.R.L.
  • Eurofins Scientific
  • Hangzhou Anow Microfiltration Co. Ltd.
  • Hangzhou Cobetter Filtration Equipment Co. Ltd.
  • Hangzhou Tianshan Precision Filter Material Co. Ltd.
  • Meissner Filtration Products Inc.
  • Merck KGaA
  • Sartorius AG
  • SGS SA
  • Thermo Fisher Scientific Inc.

Methodology

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