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Bioprocess Validation - Global Strategic Business Report

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    Report

  • 385 Pages
  • December 2024
  • Region: Global
  • Global Industry Analysts, Inc
  • ID: 5303104
The global market for Bioprocess Validation is estimated at US$370.1 Million in 2023 and is projected to reach US$622.6 Million by 2030, growing at a CAGR of 7.7% from 2023 to 2030. This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions.

The growth in the bioprocess validation market is driven by several factors. One of the primary drivers is the increasing complexity of biopharmaceutical products, such as biologics and biosimilars, which require more sophisticated validation processes to ensure their quality and safety. Advances in bioprocessing technologies, including the rise of personalized medicine and gene therapies, are also expanding the scope and demand for validation services. Furthermore, stringent regulatory standards imposed by agencies like the FDA and EMA are compelling biopharmaceutical companies to invest heavily in comprehensive validation protocols. The growing biopharmaceutical industry, coupled with the increasing focus on quality assurance and risk management, is further fueling the demand for bioprocess validation. Additionally, the global expansion of biopharmaceutical manufacturing capabilities, especially in emerging markets, is contributing to the robust growth of the bioprocess validation market.

Key Insights:

  • Market Growth: Understand the significant growth trajectory of the Pharmaceutical Companies End-Use segment, which is expected to reach US$259.6 Million by 2030 with a CAGR of a 8.1%. The Biotechnology Companies End-Use segment is also set to grow at 7.8% CAGR over the analysis period.
  • Regional Analysis: Gain insights into the U.S. market, estimated at $135.8 Million in 2023, and China, forecasted to grow at an impressive 10.8% CAGR to reach $80.8 Million by 2030. Discover growth trends in other key regions, including Japan, Canada, Germany, and the Asia-Pacific.

Why You Should Buy This Report:

  • Detailed Market Analysis: Access a thorough analysis of the Global Bioprocess Validation Market, covering all major geographic regions and market segments.
  • Competitive Insights: Get an overview of the competitive landscape, including the market presence of major players across different geographies.
  • Future Trends and Drivers: Understand the key trends and drivers shaping the future of the Global Bioprocess Validation Market.
  • Actionable Insights: Benefit from actionable insights that can help you identify new revenue opportunities and make strategic business decisions.

Key Questions Answered:

  • How is the Global Bioprocess Validation Market expected to evolve by 2030?
  • What are the main drivers and restraints affecting the market?
  • Which market segments will grow the most over the forecast period?
  • How will market shares for different regions and segments change by 2030?
  • Who are the leading players in the market, and what are their prospects?

Report Features:

  • Comprehensive Market Data: Independent analysis of annual sales and market forecasts in US$ Million from 2023 to 2030.
  • In-Depth Regional Analysis: Detailed insights into key markets, including the U.S., China, Japan, Canada, Europe, Asia-Pacific, Latin America, Middle East, and Africa.
  • Company Profiles: Coverage of major players such as Almac Group, Bangalore Biotech Labs Pvt Ltd (Biozeen), DOC S.r.l, and more.
  • Complimentary Updates: Receive free report updates for one year to keep you informed of the latest market developments.

Select Competitors (Total 50 Featured):

  • Almac Group
  • Bangalore Biotech Labs Pvt Ltd (Biozeen)
  • DOC S.r.l
  • Eurofins Scientific SE
  • Hangzhou Cobetter Filtration Equipment Co. Ltd.
  • Lonza Group AG
  • Meissner Filtration Products, Inc.
  • Merck KGaA
  • Pall Corporation, a subsidiary of Danaher Corporation
  • Porvair Plc
  • Sartorius AG
  • SGS S.A.
  • Thermo Fisher Scientific, Inc.

Table of Contents

I. METHODOLOGYII. EXECUTIVE SUMMARY
1. MARKET OVERVIEW
  • Global Economic Update
  • An Introduction to Bioprocess Validation
  • Types of Process Validation
  • Global Market Outlook
  • Extractables/Leachables Testing Services: The Largest Segment
  • Developed Regions Lead, Developing Economies Promise Future Growth
  • Competition
  • Bioprocess Validation - Global Key Competitors Percentage Market Share in 2024 (E)
  • Competitive Market Presence - Strong/Active/Niche/Trivial for Players Worldwide in 2024 (E)
  • Recent Market Activity
2. FOCUS ON SELECT PLAYERS
3. MARKET TRENDS & DRIVERS
  • Rapid Growth in Biopharmaceutical Production and Need to Prevent Product Contamination Necessitate Validation Services
  • Global Biopharmaceuticals Market in US$ Billion for the Years 2022, 2024, 2026 and 2028
  • Increasing Pharma & Biotech Investments into Drug Development Activities Fuel Need for Bioprocess Validation
  • Pharmaceutical R&D Spending Worldwide (USD Billion) for 2015-2025
  • Rise of Pharma Contract Manufacturing Present Growth Opportunities for Bioprocess Validation Outsourcing to Emerging Markets
  • Global Pharmaceutical Contract Manufacturing Market by Geographic Region for 2021 and 2027
  • Biosimilars Gain from Patent Expiry of Major Drugs, Driving Gains for Bioprocess Validation Market
  • Strict Safety & Quality Regulations and Compliance with cGMP for Biopharmaceuticals Support Market Growth
  • Bioprocessing 4.0: Implications for Bioprocess Validation
  • Validation 4.0: Essential for Sciences Industry Progresses towards Digital-First Industry
  • Growing Prominence of Paperless Validation in Pharma, Biotech & Medical Devices Industries
  • Bioprocess Innovations Direct Focus onto Effective & Clear Validations
  • Digital Twins to Support Bioprocess Validation Market Growth
  • AI-Enabled System-Led Transformations in Biomanufacturing & Bioprocess Validation
  • Artificial Intelligence and Continuous Validation
  • Single-Use Disposable Technologies Gain Attention
  • Bioprocess Data: Critical for Improving Efficiency of Pharma Developments & Manufacturing Operations
  • Advancing Process Analytical Technologies Necessitates Validation
  • Process Validation for Viral Vectors: What are the Key Challenges?
  • Aging Population & Increasing Burden of Chronic Diseases Spurs Pharma Product Sales, Driving Market Growth
  • Global Aging Population Statistics for the 65+ Age Group in Million by Geographic Region for the Years 2019, 2025, 2035 and 2050
  • Global Cancer Incidence: Number of New Cancer Cases in Million for the Years 2018, 2020, 2025, 2030, 2035 and 2040
  • World Diabetes and Population Statistics (2019, 2030 & 2045)
  • Fatalities by Heart Conditions - Estimated Percentage Breakdown for Cardiovascular Disease, Ischemic Heart Disease, Stroke, and Others
  • Challenges Confronting Bioprocess Validation
4. GLOBAL MARKET PERSPECTIVE
  • Table 1: World Bioprocess Validation Market Analysis of Annual Sales in US$ Thousand for Years 2014 through 2030
  • Table 2: World Recent Past, Current & Future Analysis for Bioprocess Validation by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Revenues in US$ Thousand for Years 2023 through 2030 and % CAGR
  • Table 3: World Historic Review for Bioprocess Validation by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Revenues in US$ Thousand for Years 2014 through 2022 and % CAGR
  • Table 4: World 16-Year Perspective for Bioprocess Validation by Geographic Region - Percentage Breakdown of Value Revenues for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets for Years 2014, 2024 & 2030
  • Table 5: World Recent Past, Current & Future Analysis for Extractables / Leachables Testing Services by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Revenues in US$ Thousand for Years 2023 through 2030 and % CAGR
  • Table 6: World Historic Review for Extractables / Leachables Testing Services by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Revenues in US$ Thousand for Years 2014 through 2022 and % CAGR
  • Table 7: World 16-Year Perspective for Extractables / Leachables Testing Services by Geographic Region - Percentage Breakdown of Value Revenues for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2014, 2024 & 2030
  • Table 8: World Recent Past, Current & Future Analysis for Integrity Testing Services by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Revenues in US$ Thousand for Years 2023 through 2030 and % CAGR
  • Table 9: World Historic Review for Integrity Testing Services by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Revenues in US$ Thousand for Years 2014 through 2022 and % CAGR
  • Table 10: World 16-Year Perspective for Integrity Testing Services by Geographic Region - Percentage Breakdown of Value Revenues for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2014, 2024 & 2030
  • Table 11: World Recent Past, Current & Future Analysis for Microbiological Testing Services by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Revenues in US$ Thousand for Years 2023 through 2030 and % CAGR
  • Table 12: World Historic Review for Microbiological Testing Services by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Revenues in US$ Thousand for Years 2014 through 2022 and % CAGR
  • Table 13: World 16-Year Perspective for Microbiological Testing Services by Geographic Region - Percentage Breakdown of Value Revenues for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2014, 2024 & 2030
  • Table 14: World Recent Past, Current & Future Analysis for Compatibility Testing Services by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Revenues in US$ Thousand for Years 2023 through 2030 and % CAGR
  • Table 15: World Historic Review for Compatibility Testing Services by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Revenues in US$ Thousand for Years 2014 through 2022 and % CAGR
  • Table 16: World 16-Year Perspective for Compatibility Testing Services by Geographic Region - Percentage Breakdown of Value Revenues for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2014, 2024 & 2030
  • Table 17: World Recent Past, Current & Future Analysis for Other Test Types by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Revenues in US$ Thousand for Years 2023 through 2030 and % CAGR
  • Table 18: World Historic Review for Other Test Types by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Revenues in US$ Thousand for Years 2014 through 2022 and % CAGR
  • Table 19: World 16-Year Perspective for Other Test Types by Geographic Region - Percentage Breakdown of Value Revenues for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2014, 2024 & 2030
  • Table 20: World Recent Past, Current & Future Analysis for Pharmaceutical Companies by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Revenues in US$ Thousand for Years 2023 through 2030 and % CAGR
  • Table 21: World Historic Review for Pharmaceutical Companies by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Revenues in US$ Thousand for Years 2014 through 2022 and % CAGR
  • Table 22: World 16-Year Perspective for Pharmaceutical Companies by Geographic Region - Percentage Breakdown of Value Revenues for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2014, 2024 & 2030
  • Table 23: World Recent Past, Current & Future Analysis for Biotechnology Companies by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Revenues in US$ Thousand for Years 2023 through 2030 and % CAGR
  • Table 24: World Historic Review for Biotechnology Companies by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Revenues in US$ Thousand for Years 2014 through 2022 and % CAGR
  • Table 25: World 16-Year Perspective for Biotechnology Companies by Geographic Region - Percentage Breakdown of Value Revenues for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2014, 2024 & 2030
  • Table 26: World Recent Past, Current & Future Analysis for Contract Development & Manufacturing Organizations by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Revenues in US$ Thousand for Years 2023 through 2030 and % CAGR
  • Table 27: World Historic Review for Contract Development & Manufacturing Organizations by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Revenues in US$ Thousand for Years 2014 through 2022 and % CAGR
  • Table 28: World 16-Year Perspective for Contract Development & Manufacturing Organizations by Geographic Region - Percentage Breakdown of Value Revenues for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2014, 2024 & 2030
  • Table 29: World Recent Past, Current & Future Analysis for Other End-Uses by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Revenues in US$ Thousand for Years 2023 through 2030 and % CAGR
  • Table 30: World Historic Review for Other End-Uses by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Revenues in US$ Thousand for Years 2014 through 2022 and % CAGR
  • Table 31: World 16-Year Perspective for Other End-Uses by Geographic Region - Percentage Breakdown of Value Revenues for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2014, 2024 & 2030
III. MARKET ANALYSIS
UNITED STATES
  • Bioprocess Validation Market Presence - Strong/Active/Niche/Trivial - Key Competitors in the United States for 2024 (E)
CANADA
JAPAN
  • Bioprocess Validation Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Japan for 2024 (E)
CHINA
  • Bioprocess Validation Market Presence - Strong/Active/Niche/Trivial - Key Competitors in China for 2024 (E)
EUROPE
  • Bioprocess Validation Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Europe for 2024 (E)
FRANCE
  • Bioprocess Validation Market Presence - Strong/Active/Niche/Trivial - Key Competitors in France for 2024 (E)
GERMANY
  • Bioprocess Validation Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Germany for 2024 (E)
ITALY
UNITED KINGDOM
  • Bioprocess Validation Market Presence - Strong/Active/Niche/Trivial - Key Competitors in the United Kingdom for 2024 (E)
SPAINRUSSIAREST OF EUROPE
ASIA-PACIFIC
  • Bioprocess Validation Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Asia-Pacific for 2024 (E)
AUSTRALIA
  • Bioprocess Validation Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Australia for 2024 (E)
INDIA
  • Bioprocess Validation Market Presence - Strong/Active/Niche/Trivial - Key Competitors in India for 2024 (E)
SOUTH KOREAREST OF ASIA-PACIFIC
LATIN AMERICA
  • Bioprocess Validation Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Latin America for 2024 (E)
MIDDLE EAST
  • Bioprocess Validation Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Middle East for 2024 (E)
AFRICA
  • Bioprocess Validation Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Africa for 2024 (E)
IV. COMPETITION

Companies Mentioned

  • Almac Group
  • Bangalore Biotech Labs Pvt Ltd (Biozeen)
  • DOC S.r.l
  • Eurofins Scientific SE
  • Hangzhou Cobetter Filtration Equipment Co. Ltd.
  • Lonza Group AG
  • Meissner Filtration Products, Inc.
  • Merck KGaA
  • Pall Corporation, a subsidiary of Danaher Corporation
  • Porvair Plc
  • Sartorius AG
  • SGS S.A.
  • Thermo Fisher Scientific, Inc.

Table Information