한글목차

바이오프로세스 밸리데이션 시장은 2025년 5억 5,480만 달러, 2032년에는 10억 6,070만 달러에 이를 것으로 예측되며, 2025-2032년 연평균 복합 성장률(CAGR)은 9.7%를 보일 것으로 예측됩니다.

바이오프로세스 밸리데이션은 설계 단계부터 상업적 생산에 이르기까지 데이터를 수집하고 평가하여 공정이 일관되게 고품질의 제품을 제공할 수 있다는 과학적 근거를 확립하는 것입니다. 바이오 의약품 제조의 규제 요건입니다. 바이오프로세스 밸리데이션 시장은 생물학적 제제 및 단일 클론 항체 수요 증가에 힘입어 최근 몇 년 동안 괄목할 만한 성장을 이루었습니다. 생물학적 제제는 다양한 치료 영역에서 환자 치료와 치료에 혁명을 일으키고 있습니다. 생물학적 제제의 승인과 생산 증가는 이러한 복잡한 분자의 품질, 효능, 안전성을 보장하기 위한 검증 활동을 촉진하고 있습니다. 미국 식품의약국(U.S. FDA)을 포함한 다양한 규제 기관이 바이오프로세스 밸리데이션에 대한 엄격한 규제를 시행하고 있으며, 이는 이 시장의 성장을 가속하고 있습니다.

시장 역학:

바이오프로세스 밸리데이션 시장의 성장은 업계 상황을 형성하는 다양한 요인에 의해 주도되고 있습니다. 주요 요인 중 하나는 바이오 의약품에 대한 수요 증가입니다. 암, 자가면역질환과 같은 만성질환의 확산으로 인해 첨단 바이오의약품이 개발되고 있으며, 이에 따라 견고한 바이오프로세스 밸리데이션 전략의 필요성이 대두되고 있습니다.

시장 성장의 또 다른 요인은 미국 식품의약국(FDA)과 유럽의약품청(EMA)과 같은 규제 당국의 엄격한 규제입니다. 이러한 규제는 바이오의약품 제조업체에게 제조 공정의 유효성과 일관성을 입증할 것을 요구하고 있으며, 이는 바이오프로세스 밸리데이션에 대한 수요를 촉진하고 있습니다.

또한, 시장 진출기업의 인수와 같은 무기 활동의 채택이 증가함에 따라 예측 기간 동안 세계 바이오프로세스 밸리데이션 시장의 성장이 촉진될 것으로 예측됩니다. 예를 들어, 2020년 4월 세계 생명과학 및 진단 혁신 기업인 Danaher Corporation은 생물학적 제제 개발 및 제조 솔루션을 강화하기 위해 General Electric의 생명과학 사업부에서 크로마토그래피 시스템을 포함한 바이오프로세스 사업을 인수했습니다. 크로마토그래피 시스템을 포함한 바이오프로세스 사업을 인수했습니다.

그러나 시장에는 몇 가지 억제요인도 있습니다. 바이오프로세스의 복잡한 특성과 표준화된 검증 프로토콜의 부족이 문제점으로 지적되고 있습니다. 바이오프로세스의 개발 및 검증은 시간이 오래 걸리며, 자원 및 인프라 측면에서 많은 투자가 필요합니다. 또한, 바이오프로세스 밸리데이션에 정통한 숙련된 전문가가 부족하다는 점도 시장 성장에 걸림돌이 되고 있습니다.

이러한 어려움에도 불구하고, 시장에는 몇 가지 성장 기회가 있습니다. 바이오프로세스의 자동화 및 데이터 분석의 기술 발전은 검증 프로세스를 간소화하고 비용을 절감하고 효율성을 향상시킬 것으로 예측됩니다. 또한, 개인 맞춤형 의료에 대한 관심이 높아지고 바이오프로세스에서 일회용 기술의 채택이 증가함에 따라 시장 확대의 새로운 길이 열리고 있습니다.

본 조사의 주요 특징

• 세계의 바이오프로세스 밸리데이션 시장에 대해 조사 분석했으며, 2024년을 기준 연도로 하여 2025-2032년까지의 예측 기간 동안 시장 규모와 연평균 성장률(CAGR)을 조사 분석하여 전해드립니다.
• 또한, 다양한 부문에 걸친 잠재적 수익 기회를 밝히고, 이 시장의 매력적인 투자 제안 매트릭스를 설명합니다.
• 또한 시장 성장 촉진요인, 억제요인, 기회, 신제품 출시 및 승인, 시장 동향, 지역별 전망, 주요 기업의 경쟁 전략 등에 대한 중요한 고찰을 제공합니다.
• 이 보고서의 통찰력을 통해 마케팅 담당자와 기업 경영진은 향후 제품 출시, 유형화, 시장 확대, 마케팅 전술에 대한 정보에 입각한 의사결정을 내릴 수 있습니다.
• 세계 바이오프로세스 밸리데이션 시장 보고서는 투자자, 공급업체, 제품 제조업체, 유통업체, 신규 시장 진출기업, 재무 분석가 등 업계의 다양한 이해관계자를 대상으로 합니다.
• 이해관계자들은 세계 바이오프로세스 밸리데이션 시장 분석에 사용되는 다양한 전략 매트릭스를 통해 의사결정을 쉽게 내릴 수 있습니다.

목차

제1장 조사 목적과 전제조건

• 조사 목적
• 전제조건
• 약어

제2장 시장 전망

• 보고서 설명
  • 시장 정의와 범위
• 주요 요약
• Coherent Opportunity Map(COM)

제3장 시장 역학, 규제, 동향 분석

• 시장 역학
  • 성장 촉진요인
  • 성장 억제요인
  • 기회
• 영향 분석
• 주요 하이라이트
• 규제 시나리오
• 테스트 유형 개시/승인
• PEST 분석
• PORTER 분석
• 인수합병(M&A) 시나리오

제4장 바이오프로세스 밸리데이션 시장 - 코로나바이러스(COVID-19) 팬데믹의 영향

• COVID-19 역학
• 공급측과 수요측 분석
• 경제에 대한 영향

제5장 세계의 바이오프로세스 밸리데이션 시장, 시험 유형별, 2020년-2032년

• 추출 가능 시험 서비스
• 미생물학적 검사 서비스
• 생리화학 검사 서비스
• 완전성 시험 서비스
• 기타(호환성 테스트 서비스 등)

제6장 세계의 바이오프로세스 밸리데이션 시장, 프로세스 컴포넌트별, 2020년-2032년

• filter element
• 미디어 용기 및 백
• 동결 및 해동 처리 백
• 바이오리액터
• 이송 시스템
• 기타(혼합 시스템 등)

제7장 세계의 바이오프로세스 밸리데이션 시장, 최종사용자별, 2020-2032년

• 제약 기업 및 바이오테크놀러지 기업
• 계약 개발 및 제조 조직
• 학술연구기관
• 기타(임상연구기관 등)

제8장 세계의 바이오프로세스 밸리데이션 시장, 지역별, 2020년-2032년

• 북미
  • 미국
  • 캐나다
• 유럽
  • 독일
  • 영국
  • 스페인
  • 프랑스
  • 이탈리아
  • 러시아
  • 기타 유럽
• 아시아태평양
  • 중국
  • 인도
  • 일본
  • 호주
  • 한국
  • ASEAN
  • 기타 아시아태평양
• 라틴아메리카
  • 브라질
  • 아르헨티나
  • 멕시코
  • 기타 라틴아메리카
• 중동 및 아프리카
  • GCC 국가
  • 이스라엘
  • 남아프리카
  • 북아프리카
  • 중앙아프리카
  • 기타 중동

제9장 경쟁 구도

• Sartorius Stedim Biotech
• Merck KGaA
• Pall Corporation
• Cobetter Filtration Equipment
• Toxikon Corporation
• DOC S.r.l.
• Meissner Filtration Test Types
• Thermo Fisher Scientific
• SGS SA
• Eurofins Scientific
• Lonza Group
• ProBioGen AG
• Charles River Laboratories
• Pacific BioLabs
• Gibraltar Laboratories
• Nelson Laboratories
• BioProcess Technology Consultants
• CMIC HOLDINGS Co., Ltd
• Cytovance Biologics
• Wuxi Biologics

제10장 섹션

• 조사 방법
• 출판사에 대해

영문목차

Bioprocess Validation Market is estimated to be valued at USD 554.8 Mn in 2025 and is expected to reach USD 1,060.7 Mn by 2032, growing at a compound annual growth rate (CAGR) of 9.7% from 2025 to 2032.

Bioprocess validation is the collection and evaluation of data, from the design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. It is a regulatory requirement for biopharmaceuticals manufacturing. The bioprocess validation market has been witnessing significant growth in recent years driven by the increasing demand for biologics and monoclonal antibodies. Biologics have revolutionized patient care and treatments across various therapeutic areas. Rising biologics approvals and production have been propelling validation activities to guarantee the quality, efficacy, and safety of such complex molecules. Various regulatory agencies including the U.S. Food and Drug Administration (U.S. FDA) have stringent regulations for bioprocess validation, facilitating the growth of this market.

Market Dynamics:

The bioprocess validation market growth is driven by various factors that are shaping the industry landscape. One of the primary drivers is the increasing demand for biopharmaceutical products. The growing prevalence of chronic diseases, such as cancer and autoimmune disorders, has led to the development of advanced biologics, thereby creating a need for robust bioprocess validation strategies.

Another factor contributing to market growth is the stringent regulations imposed by regulatory authorities, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These regulations require biopharmaceutical manufacturers to demonstrate the effectiveness and consistency of their manufacturing processes, driving the demand for bioprocess validation.

Moreover, the increasing adoption of inorganic activities such as acquisition by the market players is expected to drive the growth of the global bioprocess validation market over the forecast period. For instance, in April 2020, Danaher Corporation, a global life sciences and diagnostic innovator, acquired the bioprocessing business from General Electric's life sciences division, including chromatography systems, to enhance biologics development and manufacturing solutions.

However, the market does face some restraints. The complex nature of bioprocessing and the lack of standardized validation protocols pose challenges. The development and validation of bioprocesses are time-consuming and require substantial investments in terms of resources and infrastructure. Additionally, the scarcity of skilled professionals with expertise in bioprocess validation further impedes market growth.

Despite these challenges, the market experiences several opportunities for growth. Technological advancements in bioprocess automation and data analytics are anticipated to streamline the validation process, reducing costs and enhancing efficiency. Furthermore, the increasing focus on personalized medicine and the rising adoption of single-use technologies in bioprocessing offer new avenues for the market expansion.

Key features of the study:

• This report provides in-depth analysis of the global bioprocess validation market, and provides market size (US$ Million) and compound annual growth rate (CAGR %) for the forecast period 2025-2032, considering 2024 as the base year
• It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
• This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by key players
• Key companies covered as a part of this study include Sartorius Stedim Biotech, Merck KGaA, Pall Corporation, Cobetter Filtration Equipment, Toxikon Corporation, DOC S.r.l., MEISSNER FILTRATION PRODUCTS, Thermo Fisher Scientific, SGS SA, Eurofins Scientific, Lonza Group, ProBioGen AG, Charles River Laboratories, Pacific BioLabs, Gibraltar Laboratories, Nelson Laboratories, BioProcess Technology Consultants, CMIC HOLDINGS Co., Ltd, Cytovance Biologics, and Wuxi Biologics.
• Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics
• The global bioprocess validation market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
• Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global bioprocess validation market.

Bioprocess Validation Market Segmentation:

• By Test Type
  • Extractable Testing Services
  • Microbiological Testing Services
  • Physiochemical Testing Services
  • Integrity Testing Services
  • Others (Compatibility Testing Services and Others)
• By Process Component
  • Filter Elements
  • Media containers and bags
  • Freezing And Thawing Process Bags
  • Bioreactors
  • Transfer Systems
  • Others (Mixing Systems and Others)
• By End User
  • Pharmaceutical & Biotechnology Companies
  • Contract Development & Manufacturing Organizations
  • Academic and Research Institutes
  • Other (Clinical Research Organizations and Others)
• By Region
  • North America
  • Latin America
  • Europe
  • Asia Pacific
  • Middle East
  • Africa
• Company Profiles
  • Sartorius Stedim Biotech
  • Merck KGaA
  • Pall Corporation
  • Cobetter Filtration Equipment
  • Toxikon Corporation
  • DOC S.r.l.
  • MEISSNER FILTRATION PRODUCTS
  • Thermo Fisher Scientific
  • SGS SA
  • Eurofins Scientific
  • Lonza Group
  • ProBioGen AG
  • Charles River Laboratories
  • Pacific BioLabs
  • Gibraltar Laboratories
  • Nelson Laboratories
  • BioProcess Technology Consultants
  • CMIC HOLDINGS Co., Ltd
  • Cytovance Biologics
  • Wuxi Biologics

Table of Contents

1. Research Objectives and Assumptions

• Research Objectives
• Assumptions
• Abbreviations

2. Market Purview

• Report Description
  • Market Definition and Scope
• Executive Summary
  • Market Bioprocess Validation, By Test Type
  • Market Bioprocess Validation, By Process Component
  • Market Bioprocess Validation, By End User
  • Market Bioprocess Validation, By Region
• Coherent Opportunity Map (COM)

3. Market Dynamics, Regulations, and Trends Analysis

• Market Dynamics
  • Drivers
• Increasing demand for biopharmaceutical products
  • Restraints
• Complex nature of bioprocessing
  • Opportunities
• Technological advancements in bioprocess automation and data analytics
• Impact Analysis
• Key Highlights
• Regulatory Scenario
• Test Type launch/Approvals
• PEST Analysis
• PORTER's Analysis
• Merger and Acquisition Scenario

4. Bioprocess Validation Market - Impact of Coronavirus (COVID-19) Pandemic

• COVID-19 Epidemiology
• Supply Side and Demand Side Analysis
• Economic Impact

5. Global Bioprocess Validation Market, By Test Type, 2020-2032, (US$ Mn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Extractable Testing Services
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
• Microbiological Testing Services
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
• Physiochemical Testing Services
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
• Integrity Testing Services
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
• Others (Compatibility Testing Services and Others)
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)

6. Global Bioprocess Validation Market, By Process Component, 2020-2032, (US$ Mn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021- 2032
  • Segment Trends
• Filter Elements
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
• Media containers and bags
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
• Freezing And Thawing Process Bags
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
• Bioreactors
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
• Transfer Systems
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
• Others (Mixing Systems and Others)
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)

7. Global Bioprocess Validation Market, By End User, 2020-2032, (US$ Mn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021- 2032
  • Segment Trends
• Pharmaceutical & Biotechnology Companies
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
• Contract Development & Manufacturing Organizations
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
• Academic and Research Institutes
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
• Other (Clinical Research Organizations and Others)
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)

8. Global Bioprocess Validation Market, By Region, 2020-2032, (US$ Mn)

• Introduction
  • Market Share Analysis, By Country, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, For Country 2021-2032
  • Country Trends
• North America
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, By Test Type, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By Process Component, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By End User, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By Country, 2020-2032,(US$ Mn)
    • U.S.
    • Canada
• Europe
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, By Test Type, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By Process Component, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By End User, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By Country, 2020-2032,(US$ Mn)
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
• Asia Pacific
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, By Test Type, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By Process Component, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By End User, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By Country, 2020-2032,(US$ Mn)
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
• Latin America
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, By Test Type, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By Process Component, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By End User, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By Country, 2020-2032,(US$ Mn)
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
• Middle East & Africa
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, By Test Type, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By Process Component, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By End User, 2020-2032,(US$ Mn)
  • Market Size and Forecast, and Y-o-Y Growth, By Country, 2020-2032,(US$ Mn)
    • GCC Countries
    • Israel
    • South Africa
    • North Africa
    • Central Africa
    • Rest of Middle East

9. Competitive Landscape

• Sartorius Stedim Biotech
  • Company Highlights
  • Test Type Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Merck KGaA
  • Company Highlights
  • Test Type Portfolio
  • Key Highlights
  • Financial Performance
  • Strategies
• Pall Corporation
  • Company Highlights
  • Test Type Portfolio
  • Key Highlights
  • Financial Performance
  • Strategies
• Cobetter Filtration Equipment
  • Company Highlights
  • Test Type Portfolio
  • Key Highlights
  • Financial Performance
  • Strategies
• Toxikon Corporation
  • Company Highlights
  • Test Type Portfolio
  • Key Highlights
  • Financial Performance
  • Strategies
• DOC S.r.l.
  • Company Highlights
  • Test Type Portfolio
  • Key Highlights
  • Financial Performance
  • Strategies
• Meissner Filtration Test Types
  • Company Highlights
  • Test Type Portfolio
  • Key Highlights
  • Financial Performance
  • Strategies
• Thermo Fisher Scientific
  • Company Highlights
  • Test Type Portfolio
  • Key Highlights
  • Financial Performance
  • Strategies
• SGS SA
  • Company Highlights
  • Test Type Portfolio
  • Key Highlights
  • Financial Performance
  • Strategies
• Eurofins Scientific
  • Company Highlights
  • Test Type Portfolio
  • Key Highlights
  • Financial Performance
  • Strategies
• Lonza Group
  • Company Highlights
  • Test Type Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• ProBioGen AG
  • Company Highlights
  • Test Type Portfolio
  • Key Highlights
  • Financial Performance
  • Strategies
• Charles River Laboratories
  • Company Highlights
  • Test Type Portfolio
  • Key Highlights
  • Financial Performance
  • Strategies
• Pacific BioLabs
  • Company Highlights
  • Test Type Portfolio
  • Key Highlights
  • Financial Performance
  • Strategies
• Gibraltar Laboratories
  • Company Highlights
  • Test Type Portfolio
  • Key Highlights
  • Financial Performance
  • Strategies
• Nelson Laboratories
  • Company Highlights
  • Test Type Portfolio
  • Key Highlights
  • Financial Performance
  • Strategies
• BioProcess Technology Consultants
  • Company Highlights
  • Test Type Portfolio
  • Key Highlights
  • Financial Performance
  • Strategies
• CMIC HOLDINGS Co., Ltd
  • Company Highlights
  • Test Type Portfolio
  • Key Highlights
  • Financial Performance
  • Strategies
• Cytovance Biologics
  • Company Highlights
  • Test Type Portfolio
  • Key Highlights
  • Financial Performance
  • Strategies
• Wuxi Biologics
  • Company Highlights
  • Test Type Portfolio
  • Key Highlights
  • Financial Performance
  • Strategies
• Analyst Views

10. Section

• Research Methodology
• About us