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生技設備生物工藝

市場調查報告書

商品編碼

1596829

生物製程驗證市場規模、佔有率和成長分析：按測試類型、按製程組件、按最終用戶、按地區 - 行業預測，2024-2031 年

Bioprocess Validation Market Size, Share, Growth Analysis, By Test Type, By Process Component, By End User, By Region - Industry Forecast 2024-2031

出版日期: 2024年11月16日 | 出版商:

SkyQuest | 英文 197 Pages | 商品交期: 3-5個工作天內

價格

簡介目錄

2022年全球生物製程驗證市場規模將為4.112億美元，從2023年的4.4862億美元成長到2031年的9.0048億美元，並將從2023年的4.4862億美元成長到2031年的9.0048億美元。 2031 年複合年成長率將達9.10%）。

生物製程驗證對於確保用於生產抗體、疫苗和生物製藥等產品的程序和技術始終符合既定的品質標準至關重要。該市場受到不斷提高的監管要求、生物製品需求的激增以及生物製造技術的進步的顯著推動。此外，生物過程日益複雜和個人化醫療的興起進一步推動了市場的成長。然而，流程變化以及處理合規性和法律規範等挑戰是市場擴張的障礙。儘管存在這些障礙，在生物製藥市場開拓以及創新數位解決方案與製造實踐的整合所帶來的機會的支持下，生物製程驗證市場在不久的將來仍將出現顯著成長。隨著公司努力滿足監管期望並提高生產效率，穩健的生物製程驗證將變得越來越重要，而該市場預計將經歷動態演變和增強。

北美（測試類型、製程組件、最終用戶）
- 美國
- 加拿大
歐洲（測試類型、過程組件、最終用戶）
- 英國
- 德國
- 西班牙
- 法國
- 義大利
- 其他歐洲國家地區
亞太地區（考試類型、流程組成、最終用戶）
- 中國
- 印度
- 日本
- 韓國
- 其他亞太地區
拉丁美洲（測試類型、過程組件、最終用戶）
- 巴西
- 其他拉丁美洲地區
中東/非洲（測試類型、流程組件、最終用戶）
- 海灣合作理事會國家
- 南非
- 其他中東/非洲

競爭資訊

前5名企業對比
主要企業市場定位（2023年）
主要市場參與者所採取的策略
近期市場趨勢
公司市場佔有率分析（2023）
主要企業簡介
- 公司簡介
- 產品系列分析
- 按細分市場分類的佔有率分析
- 收益與前一年同期比較（2021-2023）

主要企業簡介

Eurofins Scientific, Inc.
Sartorius AG
Merck KGaA
Thermo Fisher Scientific Inc.
Lonza
Danaher Corporation
Charles River Laboratories
SGS SA
Toxikon Corporation
Cobetter Filtration Equipment Co., Ltd.
KDC/ONE
Ecolab Life Sciences
Celerion
Apex Bio
PAREXEL International
Pall Corporation
Porvair PLC
Biozeen
Almac Group
Pace Analytical Services

結論和建議

簡介目錄

Product Code: SQMIG35H2319

Global Bioprocess Validation Market size was valued at USD 411.20 Million in 2022 and is poised to grow from USD 448.62 Million in 2023 to USD 900.48 Million by 2031, growing at a CAGR of 9.10% in the forecast period (2024-2031).

Bioprocess validation is essential for ensuring that procedures and techniques used in the production of products such as antibodies, vaccines, and biotech drugs consistently meet established quality standards. The market is significantly driven by escalating regulatory requirements, a burgeoning demand for biological products, and advancements in biomanufacturing technologies. Additionally, the complexity of bioprocesses and the rise of personalized medicine further fuel market growth. However, challenges such as process variability and navigating compliance and regulatory frameworks present barriers to expansion. Despite these obstacles, the bioprocess validation market is poised for notable growth in the near future, supported by opportunities arising from the increasing development of biopharmaceuticals and the integration of innovative digital solutions into manufacturing practices. As companies strive to meet regulatory expectations and enhance production efficiency, the importance of robust bioprocess validation will become increasingly paramount, positioning this market for dynamic evolution and expanded capabilities.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Bioprocess Validation market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Bioprocess Validation Market Segmental Analysis

Global Bioprocess Validation Market is segmented by Test Type, Process Component, End User, and region. Based on Test Type, the market is segmented into Extractables & Leachables Testing, Microbiological Testing Services, Physiochemical Testing Services, Integrity Testing Services, Compatibility Testing Services, and Other Testing Services. Based on Process Component, the market is segmented into Filter elements, Media containers and bags, Freezing and thawing process bags, Mixing systems, Bioreactors, Transfer systems, and Other process component. Based on End User, the market is segmented into Pharmaceutical Companies, Biotechnology Companies, Contract Development & Manufacturing Organizations, Other End Users. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & and Africa.

Driver of the Global Bioprocess Validation Market

The Global Bioprocess Validation market is significantly driven by the escalating demand for biopharmaceuticals and biologics, propelled by a rise in infectious diseases and chronic health conditions. This surge necessitates the development of effective and reliable biologics, including vaccines, antibodies, and gene therapies. As these biologics become more complex and produced on a larger scale, the imperative for robust validation processes intensifies, ensuring that products meet essential efficacy and safety standards. Consequently, the market for bioprocess validation is expanding rapidly to accommodate the growing need for quality assurance in the biopharmaceutical sector.

Restraints in the Global Bioprocess Validation Market

One of the primary challenges facing the global bioprocess validation market is the complexity of validation procedures. As biomanufacturing technologies evolve, introducing more effective therapies and continuous processing, new challenges emerge that can hinder validation practices. Ensuring these advanced techniques operate effectively necessitates specialized knowledge and skills. Moreover, the inherent variability in bioprocesses makes it difficult to establish consistent validation standards, particularly when working with bespoke or innovative products. This complexity can lead to increased time and resource demands, ultimately constraining the overall growth and efficiency of the bioprocess validation market.

Market Trends of the Global Bioprocess Validation Market

The Global Bioprocess Validation market is experiencing a significant trend towards the adoption of Quality by Design (QbD) methodologies, which are redefining validation protocols to ensure product quality from the outset. By integrating predefined quality attributes into bioprocess workflows, companies are enhancing their validation frameworks, ensuring compliance with regulatory standards and fostering innovation. This focus on understanding and controlling critical process parameters has led to enhanced product consistency and safety, facilitating faster market entry and reduced costs. As biopharmaceutical companies increasingly prioritize QbD approaches, the market is anticipated to expand, driven by heightened demands for efficiency and efficacy in bioprocess validation practices.

Introduction

Objectives of the Study
Scope of the Report
Definitions

Research Methodology

Information Procurement
Secondary & Primary Data Methods
Market Size Estimation
Market Assumptions & Limitations

Executive Summary

Global Market Outlook
Supply & Demand Trend Analysis
Segmental Opportunity Analysis

Market Dynamics & Outlook

Market Overview
Market Size
Market Dynamics
- Driver & Opportunities
- Restraints & Challenges
Porters Analysis & Impact
- Competitive rivalry
- Threat of substitute
- Bargaining power of buyers
- Threat of new entrants
- Bargaining power of suppliers

Key Market Insights

Key Success Factors
Degree of Competition
Top Investment Pockets
Market Ecosystem
Technological Advancement
Regulatory Landscape
Patent Analysis
Value Chain Analysis
Case Study Analysis
PESTEL Analysis
Macro-Economic Indicators
Supply Chain Analysis
Pricing Analysis

Global Bioprocess Validation Market Size by Test Type & CAGR (2024-2031)

Extractables/Leachables Testing Services
Microbiological Testing Services
- Large-Scale Eukaryotic Cell Culture
- Virus Production And Purification
- Electron Microscopy
Integrity Testing Services
Physiochemical Testing Services
Compatibility Testing Services
Others Testing Services

Global Bioprocess Validation Market Size by Process Component & CAGR (2024-2031)

Filter elements
Media containers and bags
Freezing and thawing process bags
Mixing systems
Bioreactors
Transfer Systems
Other (Tubing, Connectors, Samplers)

Global Bioprocess Validation Market Size by End User & CAGR (2024-2031)

Pharmaceutical Companies
Biotechnology Companies
Contract Development & Manufacturing Organizations
Others

Global Bioprocess Validation Market Size & CAGR (2024-2031)

North America, (Testing Type, Process Component, End User)
- US
- Canada
Europe, (Testing Type, Process Component, End User)
- UK
- Germany
- Spain
- France
- Italy
- Rest of Europe
Asia-Pacific, (Testing Type, Process Component, End User)
- China
- India
- Japan
- South Korea
- Rest of Asia Pacific
Latin America, (Testing Type, Process Component, End User)
- Brazil
- Rest of Latin America
Middle East & Africa, (Testing Type, Process Component, End User)
- GCC Countries
- South Africa
- Rest of Middle East & Africa

Competitive Intelligence

Top 5 Player Comparison
Market Positioning of Key Players, 2023
Strategies Adopted by Key Market Players
Recent Developments in the Market
Company Market Share Analysis, 2023
Company Profiles of All Key Players
- Company Details
- Product Portfolio Analysis
- Company's Segmental Share Analysis
- Revenue Y-O-Y Comparison (2021-2023)

Key Company Profiles

Eurofins Scientific, Inc.
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Sartorius AG
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Merck KGaA
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Thermo Fisher Scientific Inc.
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Lonza
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Danaher Corporation
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Charles River Laboratories
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
SGS S.A.
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Toxikon Corporation
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Cobetter Filtration Equipment Co., Ltd.
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
KDC/ONE
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Ecolab Life Sciences
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Celerion
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Apex Bio
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
PAREXEL International
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Pall Corporation
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Porvair PLC
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Biozeen
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Almac Group
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Pace Analytical Services
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments