한글목차

바이오프로세스 밸리데이션의 동향과 예측

세계의 바이오프로세스 밸리데이션 시장은 2024-2030년 CAGR 9.5%로 성장합니다. 이 시장의 주요 촉진요인은 안전성과 품질 기준을 확보하기 위한 엄격한 규칙의 증가, 바이오의약품 업계로부터의 수요 증가, 바이오프로세스 밸리데이션의 아웃소싱에 대한 관심의 증가입니다. 세계의 바이오프로세스 밸리데이션 시장의 미래는 제약회사, 바이오테크놀러지 기업, 개발·제조 수탁 기관 시장의 기회에 의해 유망시되고 있습니다.

바이오프로세스 밸리데이션 시장 인사이트

Lucintel은 바이오의약품 제조업체에 의한 시험 서비스의 아웃소싱이 증가하고 있는 것으로 인해 예측 기간 중 추출성/침출성 시험 서비스가 최대 부문을 유지할 것으로 예측하고 있습니다.

이 시장에서는 바이오의약품의 생산량이 증가하고 있는 것으로 인해 제약회사가 최대 부문을 유지할 것입니다.

아시아태평양은 바이오프로세스 밸리데이션 서비스의 아웃소싱 동향의 증가와 이 지역에서 정부의 적극적인 구상에 의해 예측 기간 중 가장 높은 성장이 전망됩니다.

자주 묻는 질문

Q1.시장의 성장 예측은?

A1.세계의 바이오프로세스 밸리데이션 시장은 2024-2030년 CAGR 9.5%로 성장할 것으로 예측되고 있습니다.

Q2.시장의 성장에 영향을 미치는 주요 촉진요인은?

A2.이 시장의 주요 촉진요인은 안전성과 품질 기준을 확보하기 위한 엄격한 규칙의 증가, 바이오의약품 업계로부터의 수요 증가, 바이오프로세스 밸리데이션의 아웃소싱에 대한 관심의 증가입니다.

Q3.시장의 주요 부문은?

A3.바이오프로세스 밸리데이션 시장의 미래는 제약회사, 바이오테크놀러지 기업, 개발·제조 수탁 기관 시장에서의 기회로 유망합니다.

Q4.시장의 주요 기업은?

A4.주요 바이오프로세스 밸리데이션 기업은 다음과 같습니다.

• Merck
• SGS
• Eurofins Scientific
• Sartorius
• Pall

Q5.향후 최대가 되는 시장 부문은?

A5.Lucintel은 바이오의약품 제조업체에 의한 시험 서비스의 아웃소싱이 증가하고 있으므로 예측 기간 중 추출성/침출성 시험 서비스가 최대 부문을 유지할 것으로 예측하고 있습니다.

Q6.시장에서 향후 5년간 최대가 될 것으로 예상되는 지역은?

A6.아시아태평양은 바이오프로세스 밸리데이션 서비스의 아웃소싱 동향의 증가와 이 지역에서 정부의 적극적인 구상에 의해 예측 기간 중 가장 높은 성장이 전망됩니다.

Q7.리포트의 커스터마이즈는 가능한가?

A7.네, Lucintel은 추가 비용 없이 10%의 커스터마이즈를 제공합니다.

목차

제1장 주요 요약

제2장 세계의 바이오프로세스 밸리데이션 시장 : 시장 역학

• 서론, 배경, 분류
• 공급망
• 업계의 촉진요인과 과제

제3장 2018-2030년의 시장 동향과 예측 분석

• 거시경제 동향(2018-2023년)과 예측(2024-2030년)
• 세계의 바이오프로세스 밸리데이션 시장 동향(2018-2023)과 예측(2024-2030)
• 테스트 유형별 세계 바이오프로세스 밸리데이션 시장
  • 추출물/침출물 시험 서비스
  • 미생물 검사 서비스
  • 정합성 테스트 서비스
  • 기타
• 프로세스 컴포넌트별 세계 바이오프로세스 밸리데이션 시장
  • 필터 요소
  • 미디어 컨테이너와 미디어 백
  • 냉동과 해동 처리용 백
  • 믹싱 시스템
  • 바이오리액터
  • 이송 시스템
  • 기타
• 최종 용도별 세계 바이오프로세스 밸리데이션 시장
  • 제약회사
  • 바이오테크놀러지 기업
  • 수탁 개발과 제조 조직
  • 기타

제4장 2018-2030년의 지역별 시장 동향과 예측 분석

• 지역별 세계의 바이오프로세스 밸리데이션 시장
• 북미의 바이오프로세스 밸리데이션 시장
• 유럽의 바이오프로세스 밸리데이션 시장
• 아시아태평양의 바이오프로세스 밸리데이션 시장
• 기타 지역의 바이오프로세스 밸리데이션 시장

제5장 경쟁의 분석

• 제품 포트폴리오 분석
• 운영상 통합
• Porter's Five Forces 분석

제6장 성장 기회와 전략적 분석

• 성장 기회 분석
  • 테스트 유형별 세계 바이오프로세스 밸리데이션 시장의 성장 기회
  • 프로세스 컴포넌트별 세계 바이오프로세스 밸리데이션 시장의 성장 기회
  • 최종 용도별 세계 바이오프로세스 밸리데이션 시장의 성장 기회
  • 지역별 세계의 바이오프로세스 밸리데이션 시장의 성장 기회
• 세계의 바이오프로세스 밸리데이션 시장에서 새로운 동향
• 전략적 분석
  • 신제품 개발
  • 세계의 바이오프로세스 밸리데이션 시장의 능력 확대
  • 세계의 바이오프로세스 밸리데이션 시장에서의 합병, 인수, 합병사업
  • 인증과 라이선싱

제7장 유력 기업의 기업 개요

• Merck
• SGS
• Eurofins Scientific
• Sartorius
• Pall

영문목차

Bioprocess Validation Trends and Forecast

The future of the global bioprocess validation market looks promising with opportunities in the pharmaceutical company, biotechnology company, and contract development & manufacturing organization markets. The global bioprocess validation market grow with a CAGR of 9.5% from 2024 to 2030. The major drivers for this market are increasing strict rules to ensure safety and quality standards, growing demand from biopharmaceutical industry, and rising interest in outsourcing the validation of bioprocesses.

A more than 150-page report is developed to help in your business decisions.

Bioprocess Validation by Segment

The study includes a forecast for the global bioprocess validation by test type, process component, end use, and region.

Bioprocess Validation Market by Test Type [Shipment Analysis by Value from 2018 to 2030]:

• Extractables/Leachables Testing Services
• Microbiological Testing Services
• Integrity Testing Services
• Others

Bioprocess Validation Market by Process Component [Shipment Analysis by Value from 2018 to 2030]:

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

Bioprocess Validation Market by End Use [Shipment Analysis by Value from 2018 to 2030]:

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

Bioprocess Validation Market by Region [Shipment Analysis by Value from 2018 to 2030]:

• North America
• Europe
• Asia Pacific
• The Rest of the World

List of Bioprocess Validation Companies

Companies in the market compete on the basis of product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leverage integration opportunities across the value chain. With these strategies bioprocess validation companies cater increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the bioprocess validation companies profiled in this report include-

• Merck
• SGS
• Eurofins Scientific
• Sartorius
• Pall

Bioprocess Validation Market Insights

Lucintel forecasts that extractable/leachable testing service will remain the largest segment over the forecast period due to rising outsourcing of testing services by biopharmaceutical manufacturers.

Within this market, pharmaceutical company will remain the largest segment due to rising production levels of biopharmaceuticals.

APAC is expected to witness highest growth over the forecast period due to growing trend toward outsourcing bioprocess validation services and favourable government intiatives in the region.

Features of the Global Bioprocess Validation Market

Market Size Estimates: Bioprocess validation market size estimation in terms of value ($B).

Trend and Forecast Analysis: Market trends (2018 to 2023) and forecast (2024 to 2030) by various segments and regions.

Segmentation Analysis: Bioprocess validation market size by test type, process component, end use, and region in terms of value ($B).

Regional Analysis: Bioprocess validation market breakdown by North America, Europe, Asia Pacific, and Rest of the World.

Growth Opportunities: Analysis of growth opportunities in different test types, process components, end uses, and regions for the bioprocess validation market.

Strategic Analysis: This includes M&A, new product development, and competitive landscape of the bioprocess validation market.

Analysis of competitive intensity of the industry based on Porter's Five Forces model.

FAQ

Q1. What is the growth forecast for bioprocess validation market?

Answer: The global bioprocess validation market is expected to grow with a CAGR of 9.5% from 2024 to 2030.

Q2. What are the major drivers influencing the growth of the bioprocess validation market?

Answer: The major drivers for this market are increasing strict rules to ensure safety and quality standards, growing demand from biopharmaceutical industry, and rising interest in outsourcing the validation of bioprocesses.

Q3. What are the major segments for bioprocess validation market?

Answer: The future of the bioprocess validation market looks promising with opportunities in the pharmaceutical company, biotechnology company, and contract development & manufacturing organization markets.

Q4. Who are the key bioprocess validation market companies?

Answer: Some of the key bioprocess validation companies are as follows.

• Merck
• SGS
• Eurofins Scientific
• Sartorius
• Pall

Q5. Which bioprocess validation market segment will be the largest in future?

Answer: Lucintel forecasts that extractable/leachable testing service will remain the largest segment over the forecast period due to rising outsourcing of testing services by biopharmaceutical manufacturers.

Q6. In bioprocess validation market, which region is expected to be the largest in next 5 years?

Answer: APAC is expected to witness highest growth over the forecast period due to growing trend toward outsourcing bioprocess validation services and favourable government intiatives in the region.

Q.7 Do we receive customization in this report?

Answer: Yes, Lucintel provides 10% customization without any additional cost.

This report answers following 11 key questions:

• Q.1. What are some of the most promising, high-growth opportunities for the bioprocess validation market by test type (extractables/leachables testing services, microbiological testing services, integrity testing services, and others), process component (filter elements, media containers and bags, freezing and thawing process bags, mixing systems, bioreactors, transfer systems, and others), end use (pharmaceutical companies, biotechnology companies, contract development & manufacturing organizations, and others), and region (North America, Europe, Asia Pacific, and the Rest of the World)?
• Q.2. Which segments will grow at a faster pace and why?
• Q.3. Which region will grow at a faster pace and why?
• Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?
• Q.5. What are the business risks and competitive threats in this market?
• Q.6. What are the emerging trends in this market and the reasons behind them?
• Q.7. What are some of the changing demands of customers in the market?
• Q.8. What are the new developments in the market? Which companies are leading these developments?
• Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?
• Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or product substitution?
• Q.11. What M&A activity has occurred in the last 5 years and what has its impact been on the industry?

Table of Contents

1. Executive Summary

2. Global Bioprocess Validation Market : Market Dynamics

• 2.1: Introduction, Background, and Classifications
• 2.2: Supply Chain
• 2.3: Industry Drivers and Challenges

3. Market Trends and Forecast Analysis from 2018 to 2030

• 3.1. Macroeconomic Trends (2018-2023) and Forecast (2024-2030)
• 3.2. Global Bioprocess Validation Market Trends (2018-2023) and Forecast (2024-2030)
• 3.3: Global Bioprocess Validation Market by Test Type
  • 3.3.1: Extractables/Leachables Testing Services
  • 3.3.2: Microbiological Testing Services
  • 3.3.3: Integrity Testing Services
  • 3.3.4: Others
• 3.4: Global Bioprocess Validation Market by Process Component
  • 3.4.1: Filter Elements
  • 3.4.2: Media Containers and Bags
  • 3.4.3: Freezing and Thawing Process Bags
  • 3.4.4: Mixing Systems
  • 3.4.5: Bioreactors
  • 3.4.6: Transfer Systems
  • 3.4.7: Others
• 3.5: Global Bioprocess Validation Market by End Use
  • 3.5.1: Pharmaceutical Companies
  • 3.5.2: Biotechnology Companies
  • 3.5.3: Contract Development & Manufacturing Organizations
  • 3.5.4: Others

4. Market Trends and Forecast Analysis by Region from 2018 to 2030

• 4.1: Global Bioprocess Validation Market by Region
• 4.2: North American Bioprocess Validation Market
  • 4.2.2: North American Bioprocess Validation Market by End Use: Pharmaceutical Companies, Biotechnology Companies, Contract Development & Manufacturing Organizations, and Others
• 4.3: European Bioprocess Validation Market
  • 4.3.1: European Bioprocess Validation Market by Test Type: Extractables/Leachables Testing Services, Microbiological Testing Services, Integrity Testing Services, and Others
  • 4.3.2: European Bioprocess Validation Market by End Use: Pharmaceutical Companies, Biotechnology Companies, Contract Development & Manufacturing Organizations, and Others
• 4.4: APAC Bioprocess Validation Market
  • 4.4.1: APAC Bioprocess Validation Market by Test Type: Extractables/Leachables Testing Services, Microbiological Testing Services, Integrity Testing Services, and Others
  • 4.4.2: APAC Bioprocess Validation Market by End Use: Pharmaceutical Companies, Biotechnology Companies, Contract Development & Manufacturing Organizations, and Others
• 4.5: ROW Bioprocess Validation Market
  • 4.5.1: ROW Bioprocess Validation Market by Test Type: Extractables/Leachables Testing Services, Microbiological Testing Services, Integrity Testing Services, and Others
  • 4.5.2: ROW Bioprocess Validation Market by End Use: Pharmaceutical Companies, Biotechnology Companies, Contract Development & Manufacturing Organizations, and Others

5. Competitor Analysis

• 5.1: Product Portfolio Analysis
• 5.2: Operational Integration
• 5.3: Porter's Five Forces Analysis

6. Growth Opportunities and Strategic Analysis

• 6.1: Growth Opportunity Analysis
  • 6.1.1: Growth Opportunities for the Global Bioprocess Validation Market by Test Type
  • 6.1.2: Growth Opportunities for the Global Bioprocess Validation Market by Process Component
  • 6.1.3: Growth Opportunities for the Global Bioprocess Validation Market by End Use
  • 6.1.4: Growth Opportunities for the Global Bioprocess Validation Market by Region
• 6.2: Emerging Trends in the Global Bioprocess Validation Market
• 6.3: Strategic Analysis
  • 6.3.1: New Product Development
  • 6.3.2: Capacity Expansion of the Global Bioprocess Validation Market
  • 6.3.3: Mergers, Acquisitions, and Joint Ventures in the Global Bioprocess Validation Market
  • 6.3.4: Certification and Licensing

7. Company Profiles of Leading Players

• 7.1: Merck
• 7.2: SGS
• 7.3: Eurofins Scientific
• 7.4: Sartorius
• 7.5: Pall