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Bioprocess Validation - Global Strategic Business Report

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    Report

  • 385 Pages
  • April 2024
  • Region: Global
  • Global Industry Analysts, Inc
  • ID: 5303104

Global Bioprocess Validation Market to Reach $622.6 Million by 2030

The global market for Bioprocess Validation estimated at US$370.1 Million in the year 2023, is projected to reach a revised size of US$622.6 Million by 2030, growing at a CAGR of 6.7% over the analysis period 2023-2030.

Extractables / Leachables Testing Services, one of the segments analyzed in the report, is projected to record 7.3% CAGR and reach US$255.6 Million by the end of the analysis period. Growth in the Integrity Testing Services segment is estimated at 6.7% CAGR for the next 8-year period.

The U.S. Market is Estimated at $135.8 Million, While China is Forecast to Grow at 9.4% CAGR

The Bioprocess Validation market in the U.S. is estimated at US$135.8 Million in the year 2023. China, the world's second largest economy, is forecast to reach a projected market size of US$80.8 Million by the year 2030 trailing a CAGR of 9.4% over the analysis period 2023 to 2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at 5.2% and 6% respectively over the 2023-2030 period. Within Europe, Germany is forecast to grow at approximately 6.2% CAGR.

Exciting New Report Features

  • Full access to influencer engagement stats
  • Free access to digital archives & research platform. The proprietary platform is fully enabled to unlock creativity and market knowledge of domain experts worldwide in a cohesive and collaborative manner. The state-of-art tools bring world class market perspectives while protecting participants` privacy and identity. Numbers, statistics and market narrative in the report are based on fully curated insights shared by domain experts and influencers in this space.
  • Opportunity to engage with interactive questionnaires that come with real-time data simulator tools & bespoke report generation capabilities
  • Full client access to peer collaborative and interactive platform for cross-enterprise smart exchange of ideas
  • Complimentary report updates for one year
  • Competitor coverage with global market shares of major players
  • Player market presence analysis (Strong/Active/Niche/Trivial) across multiple geographies
  • Access to curated YouTube video transcripts of domain experts/influencer interviews, podcasts, press statements and event keynotes

What to Expect from the Global Economy in 2024

Edgy geopolitics, and economic instability caused by monetary policy tightening and ensuing higher interest rates will create a tumultuous landscape for 2024. Several factors will continue to exert pressure on the path to recovery including hostilities in the Middle East and increasingly common climate disasters. Among the risks, several positives are also taking shape such as growing signs of disinflation and easing of anxiety over stubborn inflation, supply chain normalization and price moderation despite volatility in energy costs. Elections across several G21 jurisdictions, notably in India and the United States, will have potential ramifications for capital flows and investment strategies. While India emerges as a compelling destination in the global investment landscape, U.S, based tech firms will continue to dominate, fueled by a dynamic ecosystem of talent and capital. Tech opportunities in Silicon Valley and beyond remain attractive for investors seeking high-growth prospects supported largely by a resilient albeit slowing domestic economy and conducive regulatory environment. Europe will continue to battle tight monetary policy and recession risks with U.K. having the most challenging outlook and running the greatest risk of recession in 2024. China remains a wild card with hope for growth in the country underpinned by government spending and improvements in consumer spending. The volatile environment will offer both opportunities and challenges for investors and businesses alike. Embracing volatility as a catalyst for growth together with agility and strategic foresight in navigating investment decisions will remain important for survival.

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 (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • 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