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市場調查報告書
商品編碼
1391958

生物程序驗證市場：依測試類型、按工藝組件、按最終用戶、按地區

Bioprocess Validation Market, By Test Type, By Process Component, By End User, By Geography
出版日期: | 出版商: Coherent Market Insights | 英文 130 Pages | 商品交期: 2-3個工作天內

價格
簡介目錄

生物製程驗證市場規模預計將從 2023 年的 8.824 億美元增至 2030 年的 4.609 億美元，預測期內年複合成長率為 9.7%。

報告範圍 報告詳情
基準年 2022年 2023年市場規模 4.609 億美元
實績資料 2018-2021 預測期 2023-2030
預測期年複合成長率 9.70% 2030年市場規模預測 8.824 億美元
圖 1. 2023 年按地區分類的生物製程驗證全球市場佔有率(%)
生物製程驗證市場-IMG1

生物程序驗證是從設計階段到商業生產的資料收集和評估，以建立科學證據，證明工藝可以始終如一地提供高品質的產品。生物製藥生產的監管要求。近年來，在生技藥品和單株抗體需求不斷成長的推動下，生物製程驗證市場經歷了顯著成長。生技藥品正在徹底改變各個治療領域的患者治療和護理。生技藥品的核准和生產的增加正在推動驗證工作，以確保這些複雜分子的品質、功效和安全性。包括美國食品藥物管理局(US FDA) 在內的各種監管機構對生物製程驗證制定了嚴格的規定，推動了該市場的成長。

市場動態：

生物製程驗證市場的成長是由塑造產業形勢的各種因素所推動的。主要因素之一是對生物製藥的需求不斷增加。癌症和自體免疫疾病等慢性病的盛行率日益增加，導致了先進生技藥品的開發以及對穩健的生物製程驗證策略的需求。

市場成長的另一個因素是美國食品藥物管理局（FDA）和歐洲藥品管理局（EMA）等監管機構實施的嚴格監管。這些法規要求生物製藥製造商證明製造流程的有效性和一致性，從而推動了對生物製程驗證的需求。

此外，擴大採用無機活動（例如市場參與企業的收購）預計也將在預測期內推動全球生物製程驗證市場的成長。例如，2020年4月，全球生命科學和診斷創新企業丹納赫公司從通用電氣生命科學部門收購了包括層析法系統在內的生物加工業務，以增強生技藥品開發和製造解決方案。

但市場也存在一些抑制因素。挑戰包括生物過程的複雜性和缺乏標準化驗證方案。開發和驗證生物製程非常耗時，並且需要對資源和基礎設施進行大量投資。此外，生物程序驗證方面缺乏熟練的專業人員也阻礙了市場的成長。

儘管存在這些挑戰，市場上仍存在一些成長機會。生物過程自動化和資料分析的技術進步預計將簡化驗證過程，降低成本並提高效率。此外，對個人化醫療的日益關注以及生物加工中一次性技術的日益採用為市場擴張提供了新的途徑。

本研究的主要特點

  • 本報告對全球生物製程驗證市場進行了詳細分析，並列出了以2022年為基準年的預測期（2023-2030）的市場規模和年複合成長率。
  • 它還揭示了各個細分市場的潛在商機，並為該市場說明了一系列有吸引力的投資提案。
  • 它還提供了有關市場促進因素、抑制因素、機會、新產品發布和核准、市場趨勢、區域前景、主要企業採取的競爭策略等的重要考察。
  • 該報告的見解將使行銷人員和公司負責人能夠就未來的產品發布、升級、市場擴張和行銷策略做出資訊的決策。
  • 全球生物過程驗證市場報告迎合了該行業的各種相關人員，如投資者、供應商、產品製造商、經銷商、新進業者和財務分析師。
  • 透過用於分析全球生物製程驗證市場的各種策略矩陣，將有助於相關人員做出決策。

目錄

第1章 調查目的和假設

  • 研究目標
  • 假設
  • 簡稱

第2章 市場展望

  • 報告說明
    • 市場定義和範圍
  • 執行摘要
  • Coherent Opportunity Map（COM）

第3章 市場動態、法規及趨勢分析

  • 市場動態
    • 促進因素
  • 對生物製藥產品的需求增加
    • 抑制因素
  • 生物過程的複雜性
    • 機會
  • 生物過程自動化和資料分析的技術進步
  • 影響分析
  • 主要亮點
  • 監管場景
  • 開始/核准測試類型
  • PEST分析
  • 波特的分析
  • 併購場景

第4章 生物製程驗證市場－冠狀病毒(COVID-19) 大流行的影響

  • 新型冠狀病毒感染疾病（COVID-19）的流行病學
  • 供需面分析
  • 經濟影響

第5章 全球生物製程驗證市場，依測試類型，2018-2030

  • 可提取物測試服務
  • 微生物檢測服務
  • 理化檢測服務
  • 完整性測試服務
  • 其他（相容性測試服務等）

第6章 全球生物製程驗證市場，依製程組成部分，2018-2030 年

  • 濾芯
  • 媒體容器和袋子
  • 冷凍/解凍加工袋
  • 生物反應器
  • 輸送系統
  • 其他（攪拌系統等）

第7章 全球生物製程驗證市場，按最終用戶分類，2018-2030 年

  • 製藥和生物技術公司
  • 合約開發/製造組織
  • 學術研究所
  • 其他（臨床研究機構等）

第8章 全球生物製程驗證市場（按地區），2018-2030

  • 北美洲
  • 美國
  • 加拿大
  • 歐洲
  • 德國
  • 英國
  • 西班牙
  • 法國
  • 義大利
  • 俄羅斯
  • 其他歐洲國家
  • 亞太地區
  • 中國
  • 印度
  • 日本
  • 澳洲
  • 韓國
  • ASEAN
  • 其他亞太地區
  • 拉丁美洲
  • 巴西
  • 阿根廷
  • 墨西哥
  • 其他拉丁美洲
  • 中東和非洲
  • 海灣合作理事會國家
  • 以色列
  • 南非
  • 北非
  • 中部非洲
  • 其他中東地區

第9章 競爭形勢

  • Sartorius Stedim Biotech
    • Test Type Portfolio
  • Merck KGaA
  • Pall Corporation
  • Cobetter Filtration Equipment
  • Toxikon Corporation
  • DOC Srl
  • Meissner Filtration Test Types
  • Thermo Fisher Scientific
  • SGS SA
  • Eurofins Scientific
  • Lonza Group
  • ProBioGen AG
  • Charles River Laboratories
  • Pacific BioLabs
  • Gibraltar Laboratories
  • Nelson Laboratories
  • BioProcess Technology Consultants
  • CMIC HOLDINGS Co., Ltd
  • Cytovance Biologics
  • Wuxi Biologics

第10章 章

  • 調查方法
  • 關於出版商
簡介目錄
Product Code: CMI6287

The Bioprocess Validation Market size is expected to reach US$ 460.9 million by 2030, from US$ 882.4 million in 2023, growing at a CAGR of 9.7% during the forecast period.

Report Coverage Report Details
Base Year: 2022 Market Size in 2023: US$ 460.9 Mn
Historical Data for: 2018 to 2021 Forecast Period: 2023 - 2030
Forecast Period 2023 to 2030 CAGR: 9.70% 2030 Value Projection: US$ 882.4 Mn
Figure 1. Global Bioprocess Validation Market Share (%), By Region, 2023
Bioprocess Validation Market - IMG1

Bioprocess validation is the collection and evaluation of data, from the design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. It is a regulatory requirement for biopharmaceuticals manufacturing. The bioprocess validation market has been witnessing significant growth in recent years driven by the increasing demand for biologics and monoclonal antibodies. Biologics have revolutionized patient care and treatments across various therapeutic areas. Rising biologics approvals and production have been propelling validation activities to guarantee the quality, efficacy, and safety of such complex molecules. Various regulatory agencies including the U.S. Food and Drug Administration (U.S. FDA) have stringent regulations for bioprocess validation, facilitating the growth of this market.

Market Dynamics:

The bioprocess validation market growth is driven by various factors that are shaping the industry landscape. One of the primary drivers is the increasing demand for biopharmaceutical products. The growing prevalence of chronic diseases, such as cancer and autoimmune disorders, has led to the development of advanced biologics, thereby creating a need for robust bioprocess validation strategies.

Another factor contributing to market growth is the stringent regulations imposed by regulatory authorities, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These regulations require biopharmaceutical manufacturers to demonstrate the effectiveness and consistency of their manufacturing processes, driving the demand for bioprocess validation.

Moreover, the increasing adoption of inorganic activities such as acquisition by the market players is expected to drive the growth of the global bioprocess validation market over the forecast period. For instance, in April 2020, Danaher Corporation, a global life sciences and diagnostic innovator, acquired the bioprocessing business from General Electric's life sciences division, including chromatography systems, to enhance biologics development and manufacturing solutions.

However, the market does face some restraints. The complex nature of bioprocessing and the lack of standardized validation protocols pose challenges. The development and validation of bioprocesses are time-consuming and require substantial investments in terms of resources and infrastructure. Additionally, the scarcity of skilled professionals with expertise in bioprocess validation further impedes market growth.

Despite these challenges, the market experiences several opportunities for growth. Technological advancements in bioprocess automation and data analytics are anticipated to streamline the validation process, reducing costs and enhancing efficiency. Furthermore, the increasing focus on personalized medicine and the rising adoption of single-use technologies in bioprocessing offer new avenues for the market expansion.

Key features of the study:

  • This report provides in-depth analysis of the global bioprocess validation market, and provides market size (US$ Million) and compound annual growth rate (CAGR %) for the forecast period (2023-2030), considering 2022 as the base year
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by key players
  • Key companies covered as a part of this study include Sartorius Stedim Biotech, Merck KGaA, Pall Corporation, Cobetter Filtration Equipment, Toxikon Corporation, DOC S.r.l., MEISSNER FILTRATION PRODUCTS, Thermo Fisher Scientific, SGS SA, Eurofins Scientific, Lonza Group, ProBioGen AG, Charles River Laboratories, Pacific BioLabs, Gibraltar Laboratories, Nelson Laboratories, BioProcess Technology Consultants, CMIC HOLDINGS Co., Ltd, Cytovance Biologics, and Wuxi Biologics.
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics
  • The global bioprocess validation market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global bioprocess validation market.

Bioprocess Validation Market Segmentation:

  • By Test Type
    • Extractable Testing Services
    • Microbiological Testing Services
    • Physiochemical Testing Services
    • Integrity Testing Services
    • Others (Compatibility Testing Services and Others)
  • By Process Component
    • Filter Elements
    • Media containers and bags
    • Freezing And Thawing Process Bags
    • Bioreactors
    • Transfer Systems
    • Others (Mixing Systems and Others)
  • By End User
    • Pharmaceutical & Biotechnology Companies
    • Contract Development & Manufacturing Organizations
    • Academic and Research Institutes
    • Other (Clinical Research Organizations and Others)
  • By Region
    • North America
    • Europe
    • Asia Pacific
    • Latin America
    • Middle East & Africa
  • Top Companies in Bioprocess Validation Market:
    • Sartorius Stedim Biotech
    • Merck KGaA
    • Pall Corporation
    • Cobetter Filtration Equipment
    • Toxikon Corporation
    • DOC S.r.l.
    • MEISSNER FILTRATION PRODUCTS
    • Thermo Fisher Scientific
    • SGS SA
    • Eurofins Scientific
    • Lonza Group
    • ProBioGen AG
    • Charles River Laboratories
    • Pacific BioLabs
    • Gibraltar Laboratories
    • Nelson Laboratories
    • BioProcess Technology Consultants
    • CMIC HOLDINGS Co., Ltd
    • Cytovance Biologics
    • Wuxi Biologics

Table of Contents

1. Research Objectives and Assumptions

  • Research Objectives
  • Assumptions
  • Abbreviations

2. Market Purview

  • Report Description
    • Market Definition and Scope
  • Executive Summary
    • Market Bioprocess Validation, By Test Type
    • Market Bioprocess Validation, By Process Component
    • Market Bioprocess Validation, By End User
    • Market Bioprocess Validation, By Region
  • Coherent Opportunity Map (COM)

3. Market Dynamics, Regulations, and Trends Analysis

  • Market Dynamics
    • Drivers
  • Increasing demand for biopharmaceutical products
    • Restraints
  • Complex nature of bioprocessing
    • Opportunities
  • Technological advancements in bioprocess automation and data analytics
  • Impact Analysis
  • Key Highlights
  • Regulatory Scenario
  • Test Type launch/Approvals
  • PEST Analysis
  • PORTER's Analysis
  • Merger and Acquisition Scenario

4. Bioprocess Validation Market - Impact of Coronavirus (COVID-19) Pandemic

  • COVID-19 Epidemiology
  • Supply Side and Demand Side Analysis
  • Economic Impact

5. Global Bioprocess Validation Market , By Test Type, 2018-2030, (US$ Mn)

  • Introduction
    • Market Share Analysis, 2023 and 2030 (%)
    • Y-o-Y Growth Analysis, 2018 - 2030
    • Segment Trends
  • Extractable Testing Services
    • Introduction
    • Market Size and Forecast, and Y-o-Y Growth, 2018-2030,(US$ Mn)
  • Microbiological Testing Services
    • Introduction
    • Market Size and Forecast, and Y-o-Y Growth, 2018-2030,(US$ Mn)
  • Physiochemical Testing Services
    • Introduction
    • Market Size and Forecast, and Y-o-Y Growth, 2018-2030,(US$ Mn)
  • Integrity Testing Services
    • Introduction
    • Market Size and Forecast, and Y-o-Y Growth, 2018-2030,(US$ Mn)
  • Others (Compatibility Testing Services and Others)
    • Introduction
    • Market Size and Forecast, and Y-o-Y Growth, 2018-2030,(US$ Mn)

6. Global Bioprocess Validation Market , By Process Component, 2018-2030, (US$ Mn)

  • Introduction
    • Market Share Analysis, 2023 and 2030 (%)
    • Y-o-Y Growth Analysis, 2018- 2030
    • Segment Trends
  • Filter Elements
    • Introduction
    • Market Size and Forecast, and Y-o-Y Growth, 2018-2030,(US$ Mn)
  • Media containers and bags
    • Introduction
    • Market Size and Forecast, and Y-o-Y Growth, 2018-2030,(US$ Mn)
  • Freezing And Thawing Process Bags
    • Introduction
    • Market Size and Forecast, and Y-o-Y Growth, 2018-2030,(US$ Mn)
  • Bioreactors
    • Introduction
    • Market Size and Forecast, and Y-o-Y Growth, 2018-2030,(US$ Mn)
  • Transfer Systems
    • Introduction
    • Market Size and Forecast, and Y-o-Y Growth, 2018-2030,(US$ Mn)
  • Others (Mixing Systems and Others)
    • Introduction
    • Market Size and Forecast, and Y-o-Y Growth, 2018-2030,(US$ Mn)

7. Global Bioprocess Validation Market , By End User, 2018-2030, (US$ Mn)

  • Introduction
    • Market Share Analysis, 2023 and 2030 (%)
    • Y-o-Y Growth Analysis, 2018- 2030
    • Segment Trends
  • Pharmaceutical & Biotechnology Companies
    • Introduction
    • Market Size and Forecast, and Y-o-Y Growth, 2018-2030,(US$ Mn)
  • Contract Development & Manufacturing Organizations
    • Introduction
    • Market Size and Forecast, and Y-o-Y Growth, 2018-2030,(US$ Mn)
  • Academic and Research Institutes
    • Introduction
    • Market Size and Forecast, and Y-o-Y Growth, 2018-2030,(US$ Mn)
  • Other (Clinical Research Organizations and Others)
    • Introduction
    • Market Size and Forecast, and Y-o-Y Growth, 2018-2030,(US$ Mn)

8. Global Bioprocess Validation Market , By Region, 2018-2030, (US$ Mn)

  • Introduction
    • Market Share Analysis, By Country, 2023 and 2030 (%)
    • Y-o-Y Growth Analysis, For Country 2018-2030
    • Country Trends
  • North America
    • Introduction
    • Market Size and Forecast, and Y-o-Y Growth, By Test Type, 2018-2030,(US$ Mn)
    • Market Size and Forecast, and Y-o-Y Growth, By Process Component, 2018-2030,(US$ Mn)
    • Market Size and Forecast, and Y-o-Y Growth, By End User, 2018-2030,(US$ Mn)
    • Market Size and Forecast, and Y-o-Y Growth, By Country, 2018-2030,(US$ Mn)
  • U.S.
  • Canada
  • Europe
    • Introduction
    • Market Size and Forecast, and Y-o-Y Growth, By Test Type, 2018-2030,(US$ Mn)
    • Market Size and Forecast, and Y-o-Y Growth, By Process Component, 2018-2030,(US$ Mn)
    • Market Size and Forecast, and Y-o-Y Growth, By End User, 2018-2030,(US$ Mn)
    • Market Size and Forecast, and Y-o-Y Growth, By Country, 2018-2030,(US$ Mn)
  • Germany
  • U.K.
  • Spain
  • France
  • Italy
  • Russia
  • Rest of Europe
  • Asia Pacific
    • Introduction
    • Market Size and Forecast, and Y-o-Y Growth, By Test Type, 2018-2030,(US$ Mn)
    • Market Size and Forecast, and Y-o-Y Growth, By Process Component, 2018-2030,(US$ Mn)
    • Market Size and Forecast, and Y-o-Y Growth, By End User, 2018-2030,(US$ Mn)
    • Market Size and Forecast, and Y-o-Y Growth, By Country, 2018-2030,(US$ Mn)
  • China
  • India
  • Japan
  • Australia
  • South Korea
  • ASEAN
  • Rest of Asia Pacific
  • Latin America
    • Introduction
    • Market Size and Forecast, and Y-o-Y Growth, By Test Type, 2018-2030,(US$ Mn)
    • Market Size and Forecast, and Y-o-Y Growth, By Process Component, 2018-2030,(US$ Mn)
    • Market Size and Forecast, and Y-o-Y Growth, By End User, 2018-2030,(US$ Mn)
    • Market Size and Forecast, and Y-o-Y Growth, By Country, 2018-2030,(US$ Mn)
  • Brazil
  • Argentina
  • Mexico
  • Rest of Latin America
  • Middle East & Africa
    • Introduction
    • Market Size and Forecast, and Y-o-Y Growth, By Test Type, 2018-2030,(US$ Mn)
    • Market Size and Forecast, and Y-o-Y Growth, By Process Component, 2018-2030,(US$ Mn)
    • Market Size and Forecast, and Y-o-Y Growth, By End User, 2018-2030,(US$ Mn)
    • Market Size and Forecast, and Y-o-Y Growth, By Country, 2018-2030,(US$ Mn)
  • GCC Countries
  • Israel
  • South Africa
  • North Africa
  • Central Africa
  • Rest of Middle East

9. Competitive Landscape

  • Sartorius Stedim Biotech
    • Company Highlights
    • Test Type Portfolio
    • Key Developments
    • Financial Performance
    • Strategies
  • Merck KGaA
  • Pall Corporation
  • Cobetter Filtration Equipment
  • Toxikon Corporation
  • DOC S.r.l.
  • Meissner Filtration Test Types
  • Thermo Fisher Scientific
  • SGS SA
  • Eurofins Scientific
  • Lonza Group
  • ProBioGen AG
  • Charles River Laboratories
  • Pacific BioLabs
  • Gibraltar Laboratories
  • Nelson Laboratories
  • BioProcess Technology Consultants
  • CMIC HOLDINGS Co., Ltd
  • Cytovance Biologics
  • Wuxi Biologics
  • Analyst Views

10. Section

  • Research Methodology
  • About us