세계의 바이오프로세스 밸리데이션 시장 보고서 : 시험 유형, 프로세스 컴포넌트, 최종 사용자, 지역별(2024-2032년)

The global bioprocess validation market size reached US$ 363.9 Million in 2023. Looking forward, IMARC Group expects the market to reach US$ 721.6 Million by 2032, exhibiting a growth rate (CAGR) of 7.66% during 2024-2032.

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:

IMARC Group 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 2024-2032. 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

• 1. How big is the global bioprocess validation market?
• 2. What is the expected growth rate of the global bioprocess validation market during 2024-2032?
• 3. What are the key factors driving the global bioprocess validation market?
• 4. What has been the impact of COVID-19 on the global bioprocess validation market?
• 5. What is the breakup of the global bioprocess validation market based on the test type?
• 6. What is the breakup of the global bioprocess validation market based on the process component?
• 7. What is the breakup of the global bioprocess validation market based on the end user?
• 8. What are the key regions in the global bioprocess validation market?
• 9. Who are the key players/companies in the global bioprocess validation market?

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