세계의 바이오 프로세스 검증 시장 (2023-2030) : 시험 유형별 (추출물 및 침출물 시험, 바이오 프로세스 잔류물 시험), 스테이지별, 모드별 (사내, 위탁), 지역별

■ 영문 제목 : Bioprocess Validation Market Size, Share & Trends Analysis Report By Testing Type (Extractables & Leachables Testing, Bioprocess Residuals Testing), By Stage, By Mode (In house, Outsourced) By Region And Segment Forecasts, 2023 - 2030

Grand View Research 회사가 출판한 조사자료로, 코드는 GRV23MA021 입니다.■ 상품코드 : GRV23MA021
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Grand View Research사는 글로벌 바이오 프로세스 검증 시장 규모가 2023년부터 2030년 사이에 연평균 9.1% 성장하여, 2030년에는 842.5백만 달러에 달할 것으로 예측하고 있습니다. 본 조사 자료는 글로벌 바이오 프로세스 검증 시장을 조사대상으로 하여, 조사 방법 및 범위, 개요, 시장 변동/동향/범위, 시험 유형별 (추출물 및 침출물 시험, 바이오 프로세스 잔류물 시험, 바이러스 클리어런스 시험, 여과 및 발효 시스템 시험) 분석, 스테이지별 (프로세스 설계, 프로세스 인증, 지속적 프로세스 검증) 분석, 모드별 (사내, 위탁) 분석, 지역별 (북미, 유럽, 아시아 태평양, 중남미, 중동/아프리카) 분석, 경쟁 현황 등의 내용을 게재하고 있습니다. 또한 본 자료는 Eurofins Scientific, Inc., Sartorius Ag, Thermo Fisher Scientific Inc., Lonza, Danaher Corporation, Charles River Laboratories, Sgs S.A., Toxicon Corporation, Epigenomics Ag, Cobetter Filtration Equipment Co., Ltd. 와 같은 기업 정보를 포함하고 있습니다.
・조사 방법 및 범위
・개요
・시장 변동/동향/범위

・글로벌 바이오 프로세스 검증 시장 규모 : 시험 종류별
- 추출물 및 침출물 시험의 시장 규모
- 바이오 프로세스 잔류물 시험의 시장 규모
- 바이러스 클리어런스 시험의 시장 규모
- 여과 및 발효 시스템 의 시장 규모

・글로벌 바이오 프로세스 검증 시장 규모 : 스테이지별
- 프로세스 설계 스테이지의 시장 규모
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・글로벌 바이오 프로세스 검증 시장 규모 : 모드별
- 사내 모드의 시장 규모
- 위탁 모드의 시장 규모

・글로벌 바이오 프로세스 검증 시장 규모 : 지역별
- 북미의 바이오 프로세스 검증 시장 규모
- 유럽의 바이오 프로세스 검증 시장 규모
- 아시아 태평양의 바이오 프로세스 검증 시장 규모
- 중남미의 바이오 프로세스 검증 시장 규모
- 중동/아프리카의 바이오 프로세스 검증 시장 규모

・경쟁 현황
・기업 정보
■ 보고서 개요

Bioprocess validation Market Growth & Trends

The global bioprocess validation market size is projected to reach USD 842.5 million by 2030, at a CAGR of 9.10% from 2023 to 2030, according to a new report by Grand View Research, Inc. Bioprocess validation is the process of documentation of all the stages, activities and procedures of the bioproduct formation. This documentation complied with the EMEA and US FDA guidelines of cGMP. It aims to deliver standard, quality, and safe manufacturing of bioproducts. The process has a wide range of applications in drug discovery, therapeutics development, and biosimilar development. Precise analysis of active pharmaceutical ingredients and the removal of contaminants such as endotoxins and, bacteria during drug development are the most crucial step of bioprocess validations.

There is a surge in demand for the in-house as well as outsourcing of the validation process, which drives the global market. Trace contaminants are formed during the production and manufacturing process of bio-products. This is due to the presence of extractable and leachables, which can cause potential hazards to consumers. This can be a major restraining factor, which can hamper the market growth. Moreover, biopharmaceutical and biotechnology industries focusing on low manufacturing costs with higher yields of the products create lucrative opportunities for market growth. The major challenge faced by the key players and bio manufacturers is the approval of novel therapies to validate drug and therapeutics development by the government and regulatory agencies.

COVID-19 has had a positive impact on the global market as the R&D sector and the development of vaccines and therapeutics have flourished. Moreover, increasing demand for the safety and quality cGMP-approved vaccines to treat the COVID-19 virus has led to an increase in the mergers and, partnerships among the market key players for enhancing the upstream and downstream process for delivering efficient bioproducts. An effective validation process not just ensures the quality and safety but also the efficacy of the product. Moreover, during the post-COVID era, most of the biopharmaceutical industries, suppliers, and service providers have increased their pandemic-related research, development, and manufacturing of biosimilars, thus propelling the market.

The increasing CDMOs, bioprocess outsourcing services, stringent government regulations, and guidelines for developing safe and quality products propel the global bioprocess validation industry. Moreover, an increase in the number of clinical trials to deliver impurity-free biosimilars and drugs for the treatment of chronic diseases such as cancer, diabetes, and arthritis boosts the market. In addition to these leading advancements in the life sciences tools and automated systems for the bioprocess, methods boost industry growth.

Bioprocess Validation Market Report Highlights

• The bioprocess residuals testing segment dominated the market with the largest market share of 28.65% in 2022. The increases in the demand for impurity-free bio-products by pharmaceutical, biopharmaceutical, and biotechnology industries and enhancing drug discovery and therapeutics development process will drive the segment to grow in the upcoming forecast.

• By stage segment, the continued process verification segment held the largest share of 42.3% in 2022. This is due to the increasing use and availability of automation facilities for continued process verification, which drives the segment to account for the largest share.

• By mode segment, the outsourced segment dominated the market in 2022. The presence of increased bioprocess validation outsourcing testing services by the majority of the critical players propels the market to account for a large share of this segment.

• North America held the largest share of 38.93% in 2022, due to the presence of an established healthcare sector and key players such as Thermo Fisher Scientific, Inc.; Danaher Corporation; and others in the region.

■ 보고서 목차

Table of Contents

Chapter 1 Research Methodology
1.1 Market Segmentation & Scope
1.1.1 Estimates And Forecast Timeline
1.2 Research Methodology
1.3 Information Procurement
1.3.1 Purchased Database
1.3.2 GVR’s Internal Database
1.3.3 Secondary Sources
1.3.4 Primary Research
1.3.5 Details Of Primary Research
1.4 Information Or Data Analysis
1.4.1 Data Analysis Models
1.5 Market Formulation & Validation
1.6 Model Details
1.6.1 Commodity Flow Analysis
1.6.1.1 Approach 1: Commodity Flow Approach
1.6.1.2 Approach 2: Country-Wise Market Estimation Using Bottom-Up Approach
1.7 Global Market: CAGR Calculation
1.8 Research Assumptions
1.9 List Of Secondary Sources
1.10 List Of Primary Sources
1.11 Objectives
1.11.1 Objective 1
1.11.2 Objective 2
1.12 List Of Abbreviations
Chapter 2 Market Definitions
Chapter 3 Executive Summary
3.1 Market Summary
Chapter 4 Global Bioprocess Validation Market Variables, Trends, & Scope
4.1 Bioprocess Validation Market Lineage Outlook
4.1.1 Parent Market Outlook
4.2 Penetration And Growth Prospect Mapping
4.3 Regulatory Framework
4.4 Market Driver Analysis
4.4.1 Increase In The Number Of Clinical Trials For Vaccine Development
4.4.2 Rise In R&D Expenditure
4.5 Market Restraint Analysis
4.5.1 Issues Related To Extractables & Leachables
4.5.2 High Cost Of The Advanced Technology
4.6 Porter’s Five Forces Analysis
4.7 Swot Analysis
4.8 Covid-19 Impact Analysis
Chapter 5 Bioprocess Validation Market – Segment Analysis, By Testing Type, 2018 – 2030 (USD Million)
5.1 Global Bioprocess Validation Market: Testing Type Movement Analysis
5.2 Extractable & Leachables Testing
5.2.1 Extractables & Leachables Testing Market Estimates And Forecast, 2018 – 2030 (USD Million)
5.3 Bioprocess Residuals Testing
5.3.1 Bioprocess Residuals Testing Market Estimates And Forecast, 2018 – 2030 (USD Million)
5.4 Viral Clearance Testing
5.4.1 Viral Clearance Testing Market Estimates And Forecast, 2018 – 2030 (USD Million)
5.5 Filtration & Fermentation Systems Testing
5.5.1 Filtration & Fermentation Systems Testing Market Estimates And Forecast, 2018 – 2030 (USD Million)
Chapter 6 Bioprocess Validation Market – Segment Analysis, By Stage, 2018 – 2030 (USD Million)
6.1 Global Bioprocess Validation Market: Stage Movement Analysis
6.2 Process Design
6.2.1 Process Design Market Estimates And Forecast, 2018 – 2030 (USD Million)
6.3 Process Qualification
6.3.1 Process Qualification Market Estimates And Forecast, 2018 – 2030 (USD Million)
6.4 Continued Process Verification
6.4.1 Continued Process Verification Market Estimates And Forecast, 2018 – 2030 (USD Million)
Chapter 7 Bioprocess Validation Market- Segment Analysis, By Mode, 2018 – 2030 (USD Million)
7.1 Bioprocess Validation Market: Mode Movement Analysis
7.2 In House
7.2.1 In-House Market Estimates And Forecast, 2018 – 2030 (USD Million)
7.3 Outsourced
7.3.1 Outsourced Market Estimates And Forecast, 2018 – 2030 (USD Million)
Chapter 8 Bioprocess Validation Market: – Segment Analysis, By Region, 2018 – 2030 (USD Million)
8.1 Bioprocess Validation Market: Regional Movement Analysis
8.2 North America
8.2.1 Swot Analysis
8.2.1.1 North America Bioprocess Validation Market, 2018 – 2030 (USD Million)
8.2.2 U.S.
8.2.2.1 Key Country Dynamics
8.2.2.2 Competitive Scenario
8.2.2.3 U.S. Bioprocess Validation Market, 2018 – 2030 (USD Million)
8.2.3 Canada
8.2.3.1 Key Country Dynamics
8.2.3.2 Competitive Scenario
8.2.3.3 Canada Bioprocess Validation Market, 2018 – 2030 (USD Million)
8.3 Europe
8.3.1 Swot Analysis
8.3.1.1 Europe Bioprocess Validation Market Estimates And Forecast, 2018-2030, (USD Million)
8.3.2 Uk
8.3.2.1 Key Country Dynamics
8.3.2.2 Competitive Scenario
8.3.2.3 Germany Bioprocess Validation Market, 2018-2030, (USD Million)
8.3.3 Germany
8.3.3.1 Key Country Dynamics
8.3.3.2 Competitive Scenario
8.3.3.3 France Bioprocess Validation Market, 2018-2030, (USD Million)
8.3.4 France
8.3.4.1 Key Country Dynamics
8.3.4.2 Competitive Scenario
8.3.4.3 Uk Bioprocess Validation Market, 2018-2030, (USD Million)
8.3.5 Italy
8.3.5.1 Key Country Dynamics
8.3.5.2 Competitive Scenario
8.3.5.3 Italy Bioprocess Validation Market, 2018-2030, (USD Million)
8.3.6 Spain
8.3.6.1 Key Country Dynamics
8.3.6.2 Competitive Scenario
8.3.6.3 Spain Bioprocess Validation Market, 2018-2030, (USD Million)
8.3.7 Denmark
8.3.7.1 Key Country Dynamics
8.3.7.2 Competitive Scenario
8.3.7.3 Denmark Bioprocess Validation Market, 2018-2030, (USD Million)
8.3.8 Sweden
8.3.8.1 Key Country Dynamics
8.3.8.2 Competitive Scenario
8.3.8.3 Sweden Bioprocess Validation Market, 2018-2030, (USD Million)
8.3.9 Norway
8.3.9.1 Key Country Dynamics
8.3.9.2 Competitive Scenario
8.3.9.3 Norway Bioprocess Validation Market, 2018-2030, (USD Million)
8.3.10 Rest Of Europe
8.3.10.1 Key Country Dynamics
8.3.10.2 Competitive Scenario
8.3.10.3 Rest Of Europe Bioprocess Validation Market Estimates And Forecast, 2018-2030 (USD Million)
8.4 Asia Pacific
8.4.1 Swot Analysis
8.4.1.1 Asia Pacific Bioprocess Validation, 2018-2030, (USD Million)
8.4.2 Japan
8.4.2.1 Key Country Dynamics
8.4.2.2 Competitive Scenario
8.4.2.3 Japan Bioprocess Validation Market, 2018-2030, (USD Million)
8.4.3 China
8.4.3.1 Key Country Dynamics
8.4.3.2 Competitive Scenario
8.4.3.3 China Bioprocess Validation Market, 2018-2030, (USD Million)
8.4.4 India
8.4.4.1 Key Country Dynamics
8.4.4.2 Competitive Scenario
8.4.4.3 India Bioprocess Validation Market, 2018-2030, (USD Million)
8.4.5 Australia
8.4.5.1 Key Country Dynamics
8.4.5.2 Competitive Scenario
8.4.5.3 Australia Bioprocess Validation Market, 2018-2030, (USD Million)
8.4.6 South Korea
8.4.6.1 Key Country Dynamics
8.4.6.2 Competitive Scenario
8.4.6.3 South Korea Bioprocess Validation Market, 2018-2030, (USD Million)
8.4.7 Thailand
8.4.7.1 Key Country Dynamics
8.4.7.2 Competitive Scenario
8.4.7.3 Thailand Bioprocess Validation Market, 2018-2030, (USD Million)
8.4.8 Rest Of Asia Pacific
8.4.8.1 Key Country Dynamics
8.4.8.2 Competitive Scenario
8.4.8.3 Rest Of Asia Pacific Bioprocess Validation Market, 2018-2030 (USD Million)
8.5 Latin America
8.5.1 Swot Analysis
8.5.1.1 Latin America Bioprocess Validation Market, 2018-2030, (USD Million)
8.5.2 Brazil
8.5.2.1 Key Country Dynamics
8.5.2.2 Competitive Scenario
8.5.2.3 Brazil Bioprocess Validation Market, 2018-2030, (USD Million)
8.5.3 Mexico
8.5.3.1 Key Country Dynamics
8.5.3.2 Competitive Scenario
8.5.3.3 Mexico Bioprocess Validation Market, 2018-2030, (USD Million)
8.5.4 Argentina
8.5.4.1 Key Country Dynamics
8.5.4.2 Competitive Scenario
8.5.4.3 Argentina Bioprocess Validation Market, 2018-2030, (USD Million)
8.5.5 Rest Of Latin America
8.5.5.1 Key Country Dynamics
8.5.5.2 Competitive Scenario
8.5.5.3 Rest Of Latin America Bioprocess Validation Market, 2018-2030 (USD Million)
8.6 Middle East & Africa (Mea)
8.6.1 Swot Analysis
8.6.1.1 Mea Bioprocess Validation Market Estimates And Forecast, 2018-2030, (USD Million)
8.6.2 South Africa
8.6.2.1 Key Country Dynamics
8.6.2.2 Competitive Scenario
8.6.2.3 South Africa Bioprocess Validation Market Estimates And Forecast, 2018-2030, (USD Million)
8.6.3 Saudi Arabia
8.6.3.1 Key Country Dynamics
8.6.3.2 Competitive Scenario
8.6.3.3 Saudi Arabia Bioprocess Validation Market Estimates And Forecast, 2018-2030 (USD Million)
8.6.4 Uae
8.6.4.1 Key Country Dynamics
8.6.4.2 Competitive Scenario
8.6.4.3 Uae Bioprocess Validation Market Estimates And Forecast, 2018-2030 (USD Million)
8.6.5 Kuwait
8.6.5.1 Key Country Dynamics
8.6.5.2 Competitive Scenario
8.6.5.3 Kuwait Bioprocess Validation Market Estimates And Forecast, 2018-2030 (USD Million)
8.6.6 Rest of MEA
8.6.6.1 Key Country Dynamics
8.6.6.2 Competitive Scenario
8.6.6.3 Rest Of Mea Bioprocess Validation Estimates And Forecast, 2018-2030 (USD Million)
Chapter 9 Competitive Landscape
9.1 Participant’s Overview
9.1.1 Eurofins Scientific, Inc.
9.1.2 Sartorius Ag
9.1.3 Thermo Fisher Scientific Inc.
9.1.4 Lonza
9.1.5 Danaher Corporation
9.1.6 Charles River Laboratories
9.1.7 Sgs S.A.
9.1.8 Toxicon Corporation
9.1.9 Epigenomics Ag
9.1.10 Cobetter Filtration Equipment Co., Ltd.
9.2 Financial Performance
9.3 Participant Categorization
9.3.1 Market Leaders
9.3.1.1 Bioprocess Validation Market Share Analysis, 2022
9.3.2 Strategy Mapping
9.3.2.1 Expansion
9.3.2.2 Acquisition
9.3.2.3 Collaborations
9.3.2.4 Stage/Service Launch
9.3.2.5 Partnerships
9.3.2.6 Others

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