市場調査レポート

商品コード

1596829

バイオプロセスバリデーションの市場規模、シェア、成長分析：試験タイプ別、プロセスコンポーネント別、エンドユーザー別、地域別 - 産業予測、2024年～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: 2024年11月16日
発行: SkyQuest
ページ情報: 英文 197 Pages
納期: 3～5営業日

価格

PDF & Excel (Single User License)

USD 5,300 840,421円

レポートPDF・Excelを1 名様のみがご利用頂けるライセンスです。PDF・Excell内のテキスト等のコピーは可能です。PDF・Excelの印刷は可能ですが、印刷したもののご利用はPDF・Excelのご利用範囲に準拠します

PDF & Excel (Multiple User License)

USD 6,200 983,134円

レポートPDF・Excel2-5名様までがご利用頂けるライセンスです。PDF・Excel内のテキスト等のコピーは可能です。PDF・Excelの印刷は可能ですが、印刷したもののご利用はPDF・Excelのご利用範囲に準拠します。

PDF & Excel (Enterprise License)

USD 7,100 1,125,847円

レポートPDF・Excelを同一企業に所属の全世界の方にご使用頂けるライセンスです。PDF・Excel内のテキスト等のコピーは可能です。PDF・Excelの印刷は可能ですが、印刷したもののご利用はPDF・Excelのご利用範囲に準拠します。

価格表記: USDを日本円(税抜)に換算

本日の銀行送金レート: 1USD=158.57円

全表示
概要
目次

概要

サンプル依頼リストに入れる

世界のバイオプロセスバリデーションの市場規模は、2022年に4億1,120万米ドルとなり、2023年の4億4,862万米ドルから、2031年までには9億48万米ドルに成長し、予測期間（2024年～2031年）のCAGRは9.10%で成長する見通しです。

バイオプロセスバリデーションは、抗体、ワクチン、バイオ医薬品などの製品製造に使用される手順や技術が、確立された品質基準を常に満たすことを保証するために不可欠です。市場は、規制要件の高まり、生物学的製品に対する需要の急増、バイオ製造技術の進歩によって大きく牽引されています。さらに、バイオプロセスの複雑化と個別化医療の台頭が、市場の成長をさらに後押ししています。しかし、プロセスのばらつき、コンプライアンスや規制の枠組みへの対応といった課題が、市場拡大の障壁となっています。このような障害にもかかわらず、バイオプロセスバリデーション市場は、バイオ医薬品の市場開拓と革新的なデジタルソリューションの製造実務への統合から生じる機会に支えられ、近い将来に顕著な成長を遂げる見通しです。企業が規制の期待に応え、生産効率を向上させようと努力する中で、堅牢なバイオプロセスバリデーションの重要性はますます高まり、この市場はダイナミックな進化と機能拡張を遂げることになると考えられています。

北米（試験タイプ、プロセスコンポーネント、エンドユーザー）
- 米国
- カナダ
欧州（試験タイプ、プロセスコンポーネント、エンドユーザー）
- 英国
- ドイツ
- スペイン
- フランス
- イタリア
- その他欧州地域
アジア太平洋（試験タイプ、プロセスコンポーネント、エンドユーザー）
- 中国
- インド
- 日本
- 韓国
- その他アジア太平洋
ラテンアメリカ（試験タイプ、プロセスコンポーネント、エンドユーザー）
- ブラジル
- その他ラテンアメリカ地域
中東・アフリカ（試験タイプ、プロセスコンポーネント、エンドユーザー）
- GCC諸国
- 南アフリカ
- その他中東・アフリカ

競合情報

上位5社の比較
主要企業の市場ポジショニング（2023年）
主要な市場企業が採用した戦略
市場の最近の動向
企業の市場シェア分析（2023年）
主要企業の企業プロファイル
- 会社概要
- 製品ポートフォリオ分析
- セグメント別シェア分析
- 収益の前年比比較（2021年～2023年）

主要企業プロファイル

Eurofins Scientific, Inc.
Sartorius AG
Merck KGaA
Thermo Fisher Scientific Inc.
Lonza
Danaher Corporation
Charles River Laboratories
SGS S.A.
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

結論と提言

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

バイオプロセスバリデーションの市場規模、シェア、成長分析：試験タイプ別、プロセスコンポーネント別、エンドユーザー別、地域別 - 産業予測、2024年～2031年

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

目次

イントロダクション

調査手法

エグゼクティブサマリー

市場力学と見通し

主要な市場考察

世界のバイオプロセスバリデーション市場規模：試験タイプ別・CAGR（2024年～2031年）

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・CAGR（2024年～2031年）

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・CAGR（2024年～2031年）

バイオプロセスバリデーション市場規模・CAGR（2024年～2031年）