바이오프로세스 밸리데이션 시장 : 세계 산업 규모, 점유율, 동향, 기회, 예측 - 시험 유형별, 단계별, 모드별, 지역별, 경쟁별(2020-2030년)
Bioprocess Validation Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Testing Type, By Stage, By Mode, By Region and Competition, 2020-2030F
상품코드:1878921
리서치사:TechSci Research
발행일:2025년 11월
페이지 정보:영문 180 Pages
라이선스 & 가격 (부가세 별도)
ㅁ Add-on 가능: 고객의 요청에 따라 일정한 범위 내에서 Customization이 가능합니다. 자세한 사항은 문의해 주시기 바랍니다.
한글목차
세계의 바이오프로세스 밸리데이션 시장은 2024년에 3억 3,892만 달러로 평가되었으며, 2030년까지 CAGR 13.80%로 성장하여 7억 3,612만 달러에 달할 것으로 예측됩니다.
바이오프로세스 밸리데이션은 바이오의약품 제조 공정이 미리 정해진 품질 특성 및 규제 기준을 충족하는 제품을 일관되게 생산하고 있음을 과학적으로 입증하는 면밀하게 문서화된 프로세스를 말합니다. 이를 통해 의약품의 안전성, 유효성 및 종합적인 품질을 보장합니다. 시장 확대는 생물의약품 및 바이오시밀러를 포함한 복잡한 바이오의약품에 대한 세계 수요 증가와 품질 및 안전 프로토콜을 엄격하게 준수해야 하는 전 세계 보건 당국의 강화된 규제 요건에 의해 근본적으로 촉진되고 있습니다.
시장 개요
예측 기간
2026-2030년
시장 규모 : 2024년
3억 3,892만 달러
시장 규모 : 2030년
7억 3,612만 달러
CAGR : 2025-2030년
13.8%
가장 빠르게 성장하는 부문
추출물·용출물 시험
최대 시장
북미
주요 시장 촉진요인
주요 시장 과제
이러한 높은 시술비용은 신규 바이오의약품의 개발 및 시장 출시를 지연시킬 수 있으며, 시장 성장을 직접적으로 저해할 수 있습니다.
주요 시장 동향
목차
제1장 개요
제2장 조사 방법
제3장 주요 요약
제4장 고객의 소리
제5장 세계의 바이오프로세스 밸리데이션 시장 전망
시장 규모 및 예측
금액별
시장 점유율과 예측
시험 유형별(추출물·용출물 시험, 바이오프로세스 잔류물 시험, 바이러스 제거 시험, 여과·발효 시스템 시험, 기타)
공정 단계별(프로세스 설계, 프로세스 적격성 확인, 지속적 프로세스 검증)
실시 형태별(사내 실시, 외부 위탁)
지역별
기업별(2024)
시장 맵
제6장 북미의 바이오프로세스 밸리데이션 시장 전망
시장 규모 및 예측
시장 점유율과 예측
북미 : 국가별 분석
미국
캐나다
멕시코
제7장 유럽의 바이오프로세스 밸리데이션 시장 전망
시장 규모 및 예측
시장 점유율과 예측
유럽 : 국가별 분석
독일
프랑스
영국
이탈리아
스페인
제8장 아시아태평양의 바이오프로세스 밸리데이션 시장 전망
시장 규모 및 예측
시장 점유율과 예측
아시아태평양 : 국가별 분석
중국
인도
일본
한국
호주
제9장 중동 및 아프리카의 바이오프로세스 밸리데이션 시장 전망
시장 규모 및 예측
시장 점유율과 예측
중동 및 아프리카 : 국가별 분석
사우디아라비아
아랍에미리트
남아프리카공화국
제10장 남미의 바이오프로세스 밸리데이션 시장 전망
시장 규모 및 예측
시장 점유율과 예측
남미 : 국가별 분석
브라질
콜롬비아
아르헨티나
제11장 시장 역학
성장 촉진요인
과제
제12장 시장 동향과 발전
인수합병
제품 출시
최근 동향
제13장 세계의 바이오프로세스 밸리데이션 시장 : SWOT 분석
제14장 Porter's Five Forces 분석
업계내 경쟁
신규 참여의 가능성
공급업체의 능력
고객의 능력
대체품의 위협
제15장 경쟁 구도
Merck KGaA
SGS S.A.
Eurofins Scientific SE
Sartorius AG
Pall Corporation
Cobetter Filtration Equipments Co., Ltd
Laboratory Corporation of America Holdings
DOC S.r.l
Meissner Corporation
Thermo Fisher Scientific, Inc.
제16장 전략적 제안
제17장 조사 회사 소개 및 면책사항
KSM
영문 목차
영문목차
The Global Bioprocess Validation Market, valued at USD 338.92 Million in 2024, is projected to experience a CAGR of 13.80% to reach USD 736.12 Million by 2030. Bioprocess validation refers to the meticulously documented process of establishing scientific evidence that a biopharmaceutical manufacturing procedure consistently produces products meeting predetermined quality attributes and regulatory standards, thereby ensuring drug safety, efficacy, and overall quality. The market's expansion is fundamentally driven by the escalating global demand for complex biopharmaceutical products, including biologics and biosimilars, alongside increasingly stringent regulatory mandates from health authorities worldwide that necessitate rigorous adherence to quality and safety protocols.
Market Overview
Forecast Period
2026-2030
Market Size 2024
USD 338.92 Million
Market Size 2030
USD 736.12 Million
CAGR 2025-2030
13.8%
Fastest Growing Segment
Extractables & Leachables Testing
Largest Market
North America
Key Market Drivers
The growing demand for biologics and biopharmaceuticals represents a primary catalyst for the bioprocess validation market. As medical advancements yield sophisticated treatments for complex diseases, the pipeline for biological drugs consistently expands, necessitating robust validation throughout their manufacturing lifecycle. These therapeutic agents, including monoclonal antibodies, vaccines, and gene therapies, require precise and consistent production to ensure safety and efficacy. According to the research article 'Food and Drug Administration (FDA) Approvals of Biological Drugs in 2023' published in Biomedicines in September 2024, the FDA authorized 17 biologics in 2023, with monoclonal antibodies accounting for 70% of these approvals. This increasing rate of new biologic approvals directly translates into a heightened need for comprehensive process validation activities.
Key Market Challenges
A significant challenge impeding the expansion of the Global Bioprocess Validation Market is the inherent complexity of advanced bioprocesses. This complexity necessitates specialized expertise and robust validation methodologies, ultimately contributing to high procedural costs. Such demands require substantial investment in highly skilled personnel, sophisticated analytical equipment, and extensive research to develop and implement rigorous validation protocols throughout the product lifecycle. These considerable requirements translate into elevated operational expenditures for biopharmaceutical companies, creating significant financial barriers to both new entrants and existing players.
These high procedural costs directly hamper market growth by potentially slowing the development and market introduction of novel biopharmaceuticals
Key Market Trends
Integration of Advanced Digital Technologies and AI is revolutionizing bioprocess validation through enhanced efficiency and data analysis. The pharmaceutical industry is significantly advancing its digital transformation; the "not started" category for Pharma 4.0 adoption dropped from 31.2% in 2021 to 15.1% in 2023, as per the 7th ISPE Pharma 4.0(TM) Survey, indicating a clear shift towards active digital implementation. Advanced digital technologies, including Artificial Intelligence, enable real-time monitoring and automated data processing, streamlining validation protocols. This integration is crucial for managing complex bioprocesses and accelerating market entry. For instance, Siemens AG acquired Dotmatics for $5.1 billion in April 2025, expanding its AI-powered product lifecycle management software, demonstrating substantial investment in these transformative technologies.
Key Market Players
Merck KGaA
SGS S.A.
Eurofins Scientific SE
Sartorius AG
Pall Corporation
Cobetter Filtration Equipments Co., Ltd
Laboratory Corporation of America Holdings
DOC S.r.l
Meissner Corporation
Thermo Fisher Scientific, Inc.
Report Scope:
In this report, the Global Bioprocess Validation Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Bioprocess Validation Market, By Testing Type:
Extractables & Leachables Testing
Bioprocess Residuals Testing
Viral Clearance Testing
Filtration & Fermentation Systems Testing
Others
Bioprocess Validation Market, By Stage:
Process Design
Process Qualification
Continued Process Verification
Bioprocess Validation Market, By Mode:
In house
Outsourced
Bioprocess Validation Market, By Region:
North America
Asia-Pacific
Europe
South America
MEA
Competitive Landscape
Company Profiles: Detailed analysis of the major companies presents in the Global Bioprocess Validation Market.
Available Customizations:
Global Bioprocess Validation Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:
Company Information
Detailed analysis and profiling of additional market players (up to five).
Table of Contents
1. Product Overview
1.1. Market Definition
1.2. Scope of the Market
1.2.1. Markets Covered
1.2.2. Years Considered for Study
1.2.3. Key Market Segmentations
2. Research Methodology
2.1. Objective of the Study
2.2. Baseline Methodology
2.3. Key Industry Partners
2.4. Major Association and Secondary Sources
2.5. Forecasting Methodology
2.6. Data Triangulation & Validation
2.7. Assumptions and Limitations
3. Executive Summary
3.1. Overview of the Market
3.2. Overview of Key Market Segmentations
3.3. Overview of Key Market Players
3.4. Overview of Key Regions/Countries
3.5. Overview of Market Drivers, Challenges, Trends
4. Voice of Customer
5. Global Bioprocess Validation Market Outlook
5.1. Market Size & Forecast
5.1.1. By Value
5.2. Market Share & Forecast
5.2.1. By Testing Type (Extractables & Leachables Testing, Bioprocess Residuals Testing, Viral Clearance Testing, Filtration & Fermentation Systems Testing, Others)
5.2.2. By Stage (Process Design, Process Qualification, Continued Process Verification)
5.2.3. By Mode (In house, Outsourced)
5.2.4. By Region
5.2.5. By Company (2024)
5.3. Market Map
6. North America Bioprocess Validation Market Outlook
6.1. Market Size & Forecast
6.1.1. By Value
6.2. Market Share & Forecast
6.2.1. By Testing Type
6.2.2. By Stage
6.2.3. By Mode
6.2.4. By Country
6.3. North America: Country Analysis
6.3.1. United States Bioprocess Validation Market Outlook
6.3.1.1. Market Size & Forecast
6.3.1.1.1. By Value
6.3.1.2. Market Share & Forecast
6.3.1.2.1. By Testing Type
6.3.1.2.2. By Stage
6.3.1.2.3. By Mode
6.3.2. Canada Bioprocess Validation Market Outlook
6.3.2.1. Market Size & Forecast
6.3.2.1.1. By Value
6.3.2.2. Market Share & Forecast
6.3.2.2.1. By Testing Type
6.3.2.2.2. By Stage
6.3.2.2.3. By Mode
6.3.3. Mexico Bioprocess Validation Market Outlook
6.3.3.1. Market Size & Forecast
6.3.3.1.1. By Value
6.3.3.2. Market Share & Forecast
6.3.3.2.1. By Testing Type
6.3.3.2.2. By Stage
6.3.3.2.3. By Mode
7. Europe Bioprocess Validation Market Outlook
7.1. Market Size & Forecast
7.1.1. By Value
7.2. Market Share & Forecast
7.2.1. By Testing Type
7.2.2. By Stage
7.2.3. By Mode
7.2.4. By Country
7.3. Europe: Country Analysis
7.3.1. Germany Bioprocess Validation Market Outlook
7.3.1.1. Market Size & Forecast
7.3.1.1.1. By Value
7.3.1.2. Market Share & Forecast
7.3.1.2.1. By Testing Type
7.3.1.2.2. By Stage
7.3.1.2.3. By Mode
7.3.2. France Bioprocess Validation Market Outlook
7.3.2.1. Market Size & Forecast
7.3.2.1.1. By Value
7.3.2.2. Market Share & Forecast
7.3.2.2.1. By Testing Type
7.3.2.2.2. By Stage
7.3.2.2.3. By Mode
7.3.3. United Kingdom Bioprocess Validation Market Outlook
7.3.3.1. Market Size & Forecast
7.3.3.1.1. By Value
7.3.3.2. Market Share & Forecast
7.3.3.2.1. By Testing Type
7.3.3.2.2. By Stage
7.3.3.2.3. By Mode
7.3.4. Italy Bioprocess Validation Market Outlook
7.3.4.1. Market Size & Forecast
7.3.4.1.1. By Value
7.3.4.2. Market Share & Forecast
7.3.4.2.1. By Testing Type
7.3.4.2.2. By Stage
7.3.4.2.3. By Mode
7.3.5. Spain Bioprocess Validation Market Outlook
7.3.5.1. Market Size & Forecast
7.3.5.1.1. By Value
7.3.5.2. Market Share & Forecast
7.3.5.2.1. By Testing Type
7.3.5.2.2. By Stage
7.3.5.2.3. By Mode
8. Asia Pacific Bioprocess Validation Market Outlook
8.1. Market Size & Forecast
8.1.1. By Value
8.2. Market Share & Forecast
8.2.1. By Testing Type
8.2.2. By Stage
8.2.3. By Mode
8.2.4. By Country
8.3. Asia Pacific: Country Analysis
8.3.1. China Bioprocess Validation Market Outlook
8.3.1.1. Market Size & Forecast
8.3.1.1.1. By Value
8.3.1.2. Market Share & Forecast
8.3.1.2.1. By Testing Type
8.3.1.2.2. By Stage
8.3.1.2.3. By Mode
8.3.2. India Bioprocess Validation Market Outlook
8.3.2.1. Market Size & Forecast
8.3.2.1.1. By Value
8.3.2.2. Market Share & Forecast
8.3.2.2.1. By Testing Type
8.3.2.2.2. By Stage
8.3.2.2.3. By Mode
8.3.3. Japan Bioprocess Validation Market Outlook
8.3.3.1. Market Size & Forecast
8.3.3.1.1. By Value
8.3.3.2. Market Share & Forecast
8.3.3.2.1. By Testing Type
8.3.3.2.2. By Stage
8.3.3.2.3. By Mode
8.3.4. South Korea Bioprocess Validation Market Outlook
8.3.4.1. Market Size & Forecast
8.3.4.1.1. By Value
8.3.4.2. Market Share & Forecast
8.3.4.2.1. By Testing Type
8.3.4.2.2. By Stage
8.3.4.2.3. By Mode
8.3.5. Australia Bioprocess Validation Market Outlook
8.3.5.1. Market Size & Forecast
8.3.5.1.1. By Value
8.3.5.2. Market Share & Forecast
8.3.5.2.1. By Testing Type
8.3.5.2.2. By Stage
8.3.5.2.3. By Mode
9. Middle East & Africa Bioprocess Validation Market Outlook
9.1. Market Size & Forecast
9.1.1. By Value
9.2. Market Share & Forecast
9.2.1. By Testing Type
9.2.2. By Stage
9.2.3. By Mode
9.2.4. By Country
9.3. Middle East & Africa: Country Analysis
9.3.1. Saudi Arabia Bioprocess Validation Market Outlook
9.3.1.1. Market Size & Forecast
9.3.1.1.1. By Value
9.3.1.2. Market Share & Forecast
9.3.1.2.1. By Testing Type
9.3.1.2.2. By Stage
9.3.1.2.3. By Mode
9.3.2. UAE Bioprocess Validation Market Outlook
9.3.2.1. Market Size & Forecast
9.3.2.1.1. By Value
9.3.2.2. Market Share & Forecast
9.3.2.2.1. By Testing Type
9.3.2.2.2. By Stage
9.3.2.2.3. By Mode
9.3.3. South Africa Bioprocess Validation Market Outlook
9.3.3.1. Market Size & Forecast
9.3.3.1.1. By Value
9.3.3.2. Market Share & Forecast
9.3.3.2.1. By Testing Type
9.3.3.2.2. By Stage
9.3.3.2.3. By Mode
10. South America Bioprocess Validation Market Outlook
10.1. Market Size & Forecast
10.1.1. By Value
10.2. Market Share & Forecast
10.2.1. By Testing Type
10.2.2. By Stage
10.2.3. By Mode
10.2.4. By Country
10.3. South America: Country Analysis
10.3.1. Brazil Bioprocess Validation Market Outlook
10.3.1.1. Market Size & Forecast
10.3.1.1.1. By Value
10.3.1.2. Market Share & Forecast
10.3.1.2.1. By Testing Type
10.3.1.2.2. By Stage
10.3.1.2.3. By Mode
10.3.2. Colombia Bioprocess Validation Market Outlook
10.3.2.1. Market Size & Forecast
10.3.2.1.1. By Value
10.3.2.2. Market Share & Forecast
10.3.2.2.1. By Testing Type
10.3.2.2.2. By Stage
10.3.2.2.3. By Mode
10.3.3. Argentina Bioprocess Validation Market Outlook
10.3.3.1. Market Size & Forecast
10.3.3.1.1. By Value
10.3.3.2. Market Share & Forecast
10.3.3.2.1. By Testing Type
10.3.3.2.2. By Stage
10.3.3.2.3. By Mode
11. Market Dynamics
11.1. Drivers
11.2. Challenges
12. Market Trends & Developments
12.1. Merger & Acquisition (If Any)
12.2. Product Launches (If Any)
12.3. Recent Developments
13. Global Bioprocess Validation Market: SWOT Analysis
