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レポート概要
| グローバル調査会社のIMARC社は、2021年303.32百万ドルであった世界のバイオプロセスバリデーション市場規模が2027年には529.2百万ドルに達し、予測期間中、年平均9.10％成長すると予測しています。本調査レポートでは、バイオプロセスバリデーションの世界市場を調査・分析し、序論、範囲・調査手法、エグゼクティブサマリー、イントロダクション、試験種類別（抽出物試験サービス、微生物学的試験サービス、物理化学試験サービス、誠実度試験サービス、その他）分析、プロセスコンポーネント別（フィルタ素子、媒体コンテナ・バッグ、冷凍・解凍プロセスバッグ、混合システム、その他）分析、エンドユーザー別（製薬・バイオテクノロジー企業、受託開発・製造組織、その他）分析、地域別（北米、アジア、欧州、中南米、中東・アフリカ）分析、SWOT分析（強み・弱み・機会・脅威）、バリューチェーン分析、ファイブフォース分析、価格分析、競争状況などの項目を掲載しています。また、こちらの調査レポートに掲載されている企業情報には、Almac Group, Biozeen, Doc S.R.L., Eurofins Scientific, Hangzhou Anow Microfiltration Co. Ltd., Hangzhou Cobetter Filtration Equipment Co. Ltd., Hangzhou Tianshan Precision Filter Material Co. Ltd., Meissner Filtration Products, Inc., Merck KGaA, Sartorius AG, SGS SAなどが含まれています。 ・序論 ・範囲・調査手法 ・エグゼクティブサマリー ・イントロダクション ・世界のバイオプロセスバリデーション市場規模：試験種類別 - 抽出物試験サービスにおける市場規模 - 微生物学的試験サービスにおける市場規模 - 物理化学試験サービスにおける市場規模 - 誠実度試験サービスにおける市場規模 - その他試験種類における市場規模 ・世界のバイオプロセスバリデーション市場規模：プロセスコンポーネント別 - フィルタ素子の市場規模 - 媒体コンテナ・バッグの市場規模 - 冷凍・解凍プロセスバッグの市場規模 - 混合システムの市場規模 - その他バイオプロセスバリデーションの市場規模 ・世界のバイオプロセスバリデーション市場規模：エンドユーザー別 - 製薬・バイオテクノロジー企業における市場規模 - 受託開発・製造組織における市場規模 - その他エンドユーザーにおける市場規模 ・世界のバイオプロセスバリデーション市場規模：地域別 - 北米のバイオプロセスバリデーション市場規模 - アジアのバイオプロセスバリデーション市場規模 - 欧州のバイオプロセスバリデーション市場規模 - 中南米のバイオプロセスバリデーション市場規模 - 中東・アフリカのバイオプロセスバリデーション市場規模 ・SWOT分析（強み・弱み・機会・脅威） ・バリューチェーン分析 ・ファイブフォース分析 ・価格分析 ・競争状況 |
The global bioprocess validation market size reached US$ 303.32 Million in 2021. Looking forward, IMARC Group expects the market to reach US$ 529.2 Million by 2027, exhibiting a growth rate (CAGR) of 9.10% during 2022-2027.
Bioprocess validation refers to an approach of acquiring documentary evidence by demonstrating various procedures, processes, and activities that are conducted during the production and testing of the product to maintain the desired level of compliance at all phases. It involves extractable, microbiological, compatibility, integrity, and physiochemical testing services as standard methods. These techniques help evaluate multiple active pharmaceutical ingredients (APIs) and possible contaminants, including endotoxin, mycoplasma, and bacteria, during the development of biological products and animal drugs. Apart from this, bioprocess validation is cost-effective and monitors practices and medication manufacturing procedures. As a result, it is used by pharmaceutical, biopharmaceutical, and contract development and manufacturing organization (CMO) to assure drug quality, safety, efficacy, and predetermined attributes.
Bioprocess Validation Market Trends:
The increasing need for outsourcing bioprocess validation services in hospitals and clinics to maintain compliance with good manufacturing practices (GMP) is majorly driving the market growth. This is further supported by the execution of stringent quality and product safety regulations by governments. Additionally, the rising prevalence of various chronic ailments and the escalating demand for biopharmaceuticals are supplementing the widespread adoption of bioprocess validation across the healthcare sector, thus favoring the market growth. Moreover, the extensive usage of bioprocess validation by pharmaceutical and CMO companies to monitor the accuracy, purity, efficiency, and safety of drugs while manufacturing novel vaccines and biosimilars, especially during COVID-19, is acting as another growth-inducing factor. In line with this, significant technological advancements in bio-manufacturing infrastructure and the ongoing bioprocess validation of bioreactors to ensure the cost-effective and scalable production of medications are propelling the market growth. Apart from this, the emerging trend of outsourcing laboratory testing services, the escalating need for personalized medicines, and continuous research and development (R&D) activities to ensure the optimal quality of drugs are creating a positive outlook for the market.
Key Market Segmentation:
IMARC Group provides an analysis of the key trends in each sub-segment of the global bioprocess validation market report, along with forecasts at the global, regional and country level from 2022-2027. Our report has categorized the market based on test type, process component and end user.
Breakup by Test Type:
Extractables Testing Services
Microbiological Testing Services
Physiochemical Testing Services
Integrity Testing Services
Compatibility Testing Services
Others
Breakup by Process Component:
Filter Elements
Media Containers and Bags
Freezing And Thawing Process Bags
Mixing Systems
Bioreactors
Transfer Systems
Others
Breakup by End User:
Pharmaceutical and Biotechnology Companies
Contract Development and Manufacturing Organizations
Others
Breakup by Region:
North America
United States
Canada
Asia-Pacific
China
Japan
India
South Korea
Australia
Indonesia
Others
Europe
Germany
France
United Kingdom
Italy
Spain
Russia
Others
Latin America
Brazil
Mexico
Others
Middle East and Africa
Competitive Landscape:
The competitive landscape of the industry has also been examined along with the profiles of the key players being Almac Group, Biozeen, Doc S.R.L., Eurofins Scientific, Hangzhou Anow Microfiltration Co. Ltd., Hangzhou Cobetter Filtration Equipment Co. Ltd., Hangzhou Tianshan Precision Filter Material Co. Ltd., Meissner Filtration Products, Inc., Merck KGaA, Sartorius AG, SGS SA and Thermo Fisher Scientific Inc.
Key Questions Answered in This Report:
How has the global bioprocess validation market performed so far and how will it perform in the coming years?
What has been the impact of COVID-19 on the global bioprocess validation market?
What are the key regional markets?
What is the breakup of the market based on the test type?
What is the breakup of the market based on the process component?
What is the breakup of the market based on the end user?
What are the various stages in the value chain of the industry?
What are the key driving factors and challenges in the industry?
What is the structure of the global bioprocess validation market and who are the key players?
What is the degree of competition in the industry?
1 Preface
2 Scope and Methodology
2.1 Objectives of the Study
2.2 Stakeholders
2.3 Data Sources
2.3.1 Primary Sources
2.3.2 Secondary Sources
2.4 Market Estimation
2.4.1 Bottom-Up Approach
2.4.2 Top-Down Approach
2.5 Forecasting Methodology
3 Executive Summary
4 Introduction
4.1 Overview
4.2 Key Industry Trends
5 Global Bioprocess Validation Market
5.1 Market Overview
5.2 Market Performance
5.3 Impact of COVID-19
5.4 Market Forecast
6 Market Breakup by Test Type
6.1 Extractables Testing Services
6.1.1 Market Trends
6.1.2 Market Forecast
6.2 Microbiological Testing Services
6.2.1 Market Trends
6.2.2 Market Forecast
6.3 Physiochemical Testing Services
6.3.1 Market Trends
6.3.2 Market Forecast
6.4 Integrity Testing Services
6.4.1 Market Trends
6.4.2 Market Forecast
6.5 Compatibility Testing Services
6.5.1 Market Trends
6.5.2 Market Forecast
6.6 Others
6.6.1 Market Trends
6.6.2 Market Forecast
7 Market Breakup by Process Component
7.1 Filter Elements
7.1.1 Market Trends
7.1.2 Market Forecast
7.2 Media Containers and Bags
7.2.1 Market Trends
7.2.2 Market Forecast
7.3 Freezing And Thawing Process Bags
7.3.1 Market Trends
7.3.2 Market Forecast
7.4 Mixing Systems
7.4.1 Market Trends
7.4.2 Market Forecast
7.5 Bioreactors
7.5.1 Market Trends
7.5.2 Market Forecast
7.6 Transfer Systems
7.6.1 Market Trends
7.6.2 Market Forecast
7.7 Others
7.7.1 Market Trends
7.7.2 Market Forecast
8 Market Breakup by End User
8.1 Pharmaceutical and Biotechnology Companies
8.1.1 Market Trends
8.1.2 Market Forecast
8.2 Contract Development and Manufacturing Organizations
8.2.1 Market Trends
8.2.2 Market Forecast
8.3 Others
8.3.1 Market Trends
8.3.2 Market Forecast
9 Market Breakup by Region
9.1 North America
9.1.1 United States
9.1.1.1 Market Trends
9.1.1.2 Market Forecast
9.1.2 Canada
9.1.2.1 Market Trends
9.1.2.2 Market Forecast
9.2 Asia-Pacific
9.2.1 China
9.2.1.1 Market Trends
9.2.1.2 Market Forecast
9.2.2 Japan
9.2.2.1 Market Trends
9.2.2.2 Market Forecast
9.2.3 India
9.2.3.1 Market Trends
9.2.3.2 Market Forecast
9.2.4 South Korea
9.2.4.1 Market Trends
9.2.4.2 Market Forecast
9.2.5 Australia
9.2.5.1 Market Trends
9.2.5.2 Market Forecast
9.2.6 Indonesia
9.2.6.1 Market Trends
9.2.6.2 Market Forecast
9.2.7 Others
9.2.7.1 Market Trends
9.2.7.2 Market Forecast
9.3 Europe
9.3.1 Germany
9.3.1.1 Market Trends
9.3.1.2 Market Forecast
9.3.2 France
9.3.2.1 Market Trends
9.3.2.2 Market Forecast
9.3.3 United Kingdom
9.3.3.1 Market Trends
9.3.3.2 Market Forecast
9.3.4 Italy
9.3.4.1 Market Trends
9.3.4.2 Market Forecast
9.3.5 Spain
9.3.5.1 Market Trends
9.3.5.2 Market Forecast
9.3.6 Russia
9.3.6.1 Market Trends
9.3.6.2 Market Forecast
9.3.7 Others
9.3.7.1 Market Trends
9.3.7.2 Market Forecast
9.4 Latin America
9.4.1 Brazil
9.4.1.1 Market Trends
9.4.1.2 Market Forecast
9.4.2 Mexico
9.4.2.1 Market Trends
9.4.2.2 Market Forecast
9.4.3 Others
9.4.3.1 Market Trends
9.4.3.2 Market Forecast
9.5 Middle East and Africa
9.5.1 Market Trends
9.5.2 Market Breakup by Country
9.5.3 Market Forecast
10 SWOT Analysis
10.1 Overview
10.2 Strengths
10.3 Weaknesses
10.4 Opportunities
10.5 Threats
11 Value Chain Analysis
12 Porters Five Forces Analysis
12.1 Overview
12.2 Bargaining Power of Buyers
12.3 Bargaining Power of Suppliers
12.4 Degree of Competition
12.5 Threat of New Entrants
12.6 Threat of Substitutes
13 Price Analysis
14 Competitive Landscape
14.1 Market Structure
14.2 Key Players
14.3 Profiles of Key Players
14.3.1 Almac Group
14.3.1.1 Company Overview
14.3.1.2 Product Portfolio
14.3.1.3 SWOT Analysis
14.3.2 Biozeen
14.3.2.1 Company Overview
14.3.2.2 Product Portfolio
14.3.3 Doc S.R.L.
14.3.3.1 Company Overview
14.3.3.2 Product Portfolio
14.3.4 Eurofins Scientific SE
14.3.4.1 Company Overview
14.3.4.2 Product Portfolio
14.3.4.3 Financials
14.3.4.4 SWOT Analysis
14.3.5 Hangzhou Anow Microfiltration Co. Ltd.
14.3.5.1 Company Overview
14.3.5.2 Product Portfolio
14.3.6 Hangzhou Cobetter Filtration Equipment Co. Ltd.
14.3.6.1 Company Overview
14.3.6.2 Product Portfolio
14.3.7 Hangzhou Tianshan Precision Filter Material Co. Ltd.
14.3.7.1 Company Overview
14.3.7.2 Product Portfolio
14.3.8 Meissner Filtration Products, Inc.
14.3.8.1 Company Overview
14.3.8.2 Product Portfolio
14.3.9 Merck KGaA
14.3.9.1 Company Overview
14.3.9.2 Product Portfolio
14.3.9.3 Financials
14.3.9.4 SWOT Analysis
14.3.10 Sartorius AG
14.3.10.1 Company Overview
14.3.10.2 Product Portfolio
14.3.10.3 Financials
14.3.10.4 SWOT Analysis
14.3.11 SGS SA
14.3.11.1 Company Overview
14.3.11.2 Product Portfolio
14.3.11.3 Financials
14.3.12 Thermo Fisher Scientific Inc.
14.3.12.1 Company Overview
14.3.12.2 Product Portfolio
14.3.12.3 Financials
14.3.12.4 SWOT Analysis
Figure 2: Global: Bioprocess Validation Market: Sales Value (in Million US$), 2016-2021
Figure 3: Global: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 4: Global: Bioprocess Validation Market: Breakup by Test Type (in %), 2021
Figure 5: Global: Bioprocess Validation Market: Breakup by Process Component (in %), 2021
Figure 6: Global: Bioprocess Validation Market: Breakup by End User (in %), 2021
Figure 7: Global: Bioprocess Validation Market: Breakup by Region (in %), 2021
Figure 8: Global: Bioprocess Validation (Extractables Testing Services) Market: Sales Value (in Million US$), 2016 & 2021
Figure 9: Global: Bioprocess Validation (Extractables Testing Services) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 10: Global: Bioprocess Validation (Microbiological Testing Services) Market: Sales Value (in Million US$), 2016 & 2021
Figure 11: Global: Bioprocess Validation (Microbiological Testing Services) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 12: Global: Bioprocess Validation (Physiochemical Testing Services) Market: Sales Value (in Million US$), 2016 & 2021
Figure 13: Global: Bioprocess Validation (Physiochemical Testing Services) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 14: Global: Bioprocess Validation (Integrity Testing Services) Market: Sales Value (in Million US$), 2016 & 2021
Figure 15: Global: Bioprocess Validation (Integrity Testing Services) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 16: Global: Bioprocess Validation (Compatibility Testing Services) Market: Sales Value (in Million US$), 2016 & 2021
Figure 17: Global: Bioprocess Validation (Compatibility Testing Services) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 18: Global: Bioprocess Validation (Other Test Types) Market: Sales Value (in Million US$), 2016 & 2021
Figure 19: Global: Bioprocess Validation (Other Test Types) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 20: Global: Bioprocess Validation (Filter Elements) Market: Sales Value (in Million US$), 2016 & 2021
Figure 21: Global: Bioprocess Validation (Filter Elements) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 22: Global: Bioprocess Validation (Media Containers and Bags) Market: Sales Value (in Million US$), 2016 & 2021
Figure 23: Global: Bioprocess Validation (Media Containers and Bags) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 24: Global: Bioprocess Validation (Freezing and Thawing Process Bags) Market: Sales Value (in Million US$), 2016 & 2021
Figure 25: Global: Bioprocess Validation (Freezing and Thawing Process Bags) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 26: Global: Bioprocess Validation (Mixing Systems) Market: Sales Value (in Million US$), 2016 & 2021
Figure 27: Global: Bioprocess Validation (Mixing Systems) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 28: Global: Bioprocess Validation (Bioreactors) Market: Sales Value (in Million US$), 2016 & 2021
Figure 29: Global: Bioprocess Validation (Bioreactors) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 30: Global: Bioprocess Validation (Transfer Systems) Market: Sales Value (in Million US$), 2016 & 2021
Figure 31: Global: Bioprocess Validation (Transfer Systems) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 32: Global: Bioprocess Validation (Other Process Components) Market: Sales Value (in Million US$), 2016 & 2021
Figure 33: Global: Bioprocess Validation (Other Process Components) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 34: Global: Bioprocess Validation (Pharmaceutical and Biotechnology Companies) Market: Sales Value (in Million US$), 2016 & 2021
Figure 35: Global: Bioprocess Validation (Pharmaceutical and Biotechnology Companies) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 36: Global: Bioprocess Validation (Contract Development and Manufacturing Organizations) Market: Sales Value (in Million US$), 2016 & 2021
Figure 37: Global: Bioprocess Validation (Contract Development and Manufacturing Organizations) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 38: Global: Bioprocess Validation (Other End Users) Market: Sales Value (in Million US$), 2016 & 2021
Figure 39: Global: Bioprocess Validation (Other End Users) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 40: North America: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 41: North America: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 42: United States: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 43: United States: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 44: Canada: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 45: Canada: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 46: Asia-Pacific: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 47: Asia-Pacific: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 48: China: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 49: China: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 50: Japan: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 51: Japan: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 52: India: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 53: India: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 54: South Korea: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 55: South Korea: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 56: Australia: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 57: Australia: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 58: Indonesia: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 59: Indonesia: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 60: Others: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 61: Others: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 62: Europe: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 63: Europe: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 64: Germany: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 65: Germany: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 66: France: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 67: France: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 68: United Kingdom: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 69: United Kingdom: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 70: Italy: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 71: Italy: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 72: Spain: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 73: Spain: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 74: Russia: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 75: Russia: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 76: Others: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 77: Others: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 78: Latin America: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 79: Latin America: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 80: Brazil: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 81: Brazil: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 82: Mexico: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 83: Mexico: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 84: Others: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 85: Others: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 86: Middle East and Africa: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 87: Middle East and Africa: Bioprocess Validation Market: Breakup by Country (in %), 2021
Figure 88: Middle East and Africa: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 89: Global: Bioprocess Validation Industry: SWOT Analysis
Figure 90: Global: Bioprocess Validation Industry: Value Chain Analysis
Figure 91: Global: Bioprocess Validation Industry: Porter's Five Forces Analysis
