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生物工藝驗證的全球市場:2020-2027

Global Bioprocess Validation Market - 2020-2027

出版商 DataM Intelligence 商品編碼 962194
出版日期 按訂單生產 內容資訊 英文
商品交期: 請詢問到貨日
價格
生物工藝驗證的全球市場:2020-2027 Global Bioprocess Validation Market - 2020-2027
出版日期: 按訂單生產內容資訊: 英文
簡介

市場維持嚴格的安全和質量法規,以管理整個生物製藥和製藥行業的產品認證和測試,對生物工藝驗證市場服務的外包需求很高以及符合正確的製造標準(GMP)。在醫療保健行業的監管義務的驅使下,此外,人們越來越意識到生物製藥的好處,CRO和CDMO數量的增加,以及政府在某些國家推動製藥和生物技術行業增長的有利可圖的舉措,將在預測期內推動市場增長。我是。但是,預計政府法規和高價會在預測期內阻礙市場。

本報告調查了全球生物工藝驗證市場,並提供了系統信息,例如市場概況,按細分市場和地區劃分的市場規模預測,主要公司的概況以及競爭情況分析。

目錄

第1章全球生物過程驗證市場:調查方法/範圍

  • 調查方法
  • 調查目的/範圍

第2章全球生物過程驗證市場:市場定義/概述

第3章全球生物過程驗證市場:執行摘要

  • 市場細分:按測試類型
  • 市場細分:流程
  • 市場細分:按最終用戶
  • 市場細分:按地區

第4章全球生物過程驗證市場:市場動態

  • 市場影響因素
    • 促進因素
    • 抑製器
  • 影響分析
  • 市場機會

第5章全球生物過程驗證市場:行業因素

  • 波特的五力分析
  • 供應鏈分析
  • 監管分析
  • 價格分析
  • 產品分析
  • COVID-19影響分析

第6章全球生物過程驗證市場:按測試類型

  • 簡介
  • 市場規模分析/同比增長率分析:按測試類型
  • 市場吸引力指數:按測試類型
    • 提取/滲出測試服務
    • 微生物檢測服務
    • 完整性測試服務
    • 生理化學測試服務
    • 兼容性測試服務
    • 其他

第7章全球生物過程驗證市場:按過程

  • 簡介
  • 市場規模分析/同比增長率分析:按過程
  • 市場吸引力指數:按過程
    • 媒體容器袋
    • 冷凍/解凍工藝袋
    • 過濾器元素
    • 其他

第8章全球生物過程驗證市場:最終用戶

  • 簡介
  • 市場規模分析/同比增長率分析:按最終用戶劃分
  • 市場吸引力指數:按最終用戶劃分
    • 製藥公司
    • 生物技術公司
    • 其他

第9章生物過程驗證市場:按地區

  • 簡介
  • 市場規模分析/同比增長率分析:按地區
  • 市場吸引力指數:按地區
  • 北美
    • 簡介
    • 特定地區的主要動態
    • 市場規模分析/同比增長率分析:按測試類型
    • 市場規模分析/同比增長率分析:流程
    • 市場規模分析/同比增長率分析:按最終用戶劃分
    • 市場規模分析/同比增長率分析:按國家
  • 歐洲
  • 南美洲
  • 亞太地區
  • 中東/非洲

第10章競爭情況

  • 競爭情景
  • 市場定位/份額分析
  • 併購分析

第11章公司簡介

  • 科伯特過濾設備有限公司
    • 公司簡介
    • 投資組合/說明
    • 主要亮點
    • 財務概覽
  • SGS S.A.
  • DOC S.r.l.
  • Thermo Fisher Scientific
  • Toxikon Corporation
  • Sartorius Stedim Biotech
  • Eurofins Scientific
  • Pall Corporation
  • MEISSNER FILTRATION PRODUCTS, INC.
  • Merck KGaA

第12章全球生物過程驗證市場:重要討論

第13章全球生物過程驗證市場-DataM

  • 附錄
  • 關於我們的公司和服務
  • 聯繫我們
目錄

Market Overview

Validation is a method of building documentary evidence demonstrating a process, activity or procedure, carried out in production or testing maintains the desired level of compliance at all stages. Validation is an act of documenting and demonstrating that any process, procedure, and activity will consistently drive to the required results. It includes the qualification of equipment and systems.

A bioprocess is a specific process that uses complete living cells or their components to obtain desired products. Transport of energy and mass is fundamental to many biological and environmental processes. Bioprocess applications are diverse, and the products can be found in pharmaceutical, chemical, and nutrition industries.

Market Dynamics:

The market is driven by the stringent safety and quality regulations governing product certification and testing across the biopharmaceutical and pharmaceutical industries, high demand for the outsourcing of Bioprocess Validation Market services, and regulatory mandates in the healthcare industry to maintain compliance with good manufacturing practices. Additionally, increasing awareness about the advantages of biopharmaceutical drugs, and the growing number of CROs & CDMOs, the favorable government initiatives to promote the growth of the pharmaceutical and biotechnology industries in several countries such factors are propel the market growth during forecast period.

The production process within the pharmaceutical industry undergoes a series of recalls, reworks, and product failures. This factor necessitates the presence of a system for evaluating the viability of an experiment or product development channel. The global bioprocess validation market has expanded on account of advancements in the field of pharmaceutical manufacturing. Several success factors need to be considered before employing a particular route of administration within the healthcare and pharmaceutical sectors. Hence, the global bioprocess validation market is expected to grow into a lucrative industry in the years to follow.

The need to reduce production cost across pharmaceutical and food companies necessitates the use of bioprocess validation systems. Furthermore, the Food and Drug Administration (FDA) in the U.S. has also played a key role in ascribing values for bioprocess validation. The next decade is expected to witness increased spending on development of modules for analyzing production processes. This factor, coupled with the use of sophisticated facilities in the pharmaceutical industry, shall propel market demand. Feasibility of operations and processes is amongst the most daunting concerns in the pharmaceutical industry. This factor will drive the growth of market in the forecast period.

However, government regulation and the high price is expected to hamper the market during the forecast period.

Segment Analysis

The global bioprocess validation market is segmented based on test type by extractables/leachables testing services, microbiological testing services, integrity testing services, and physiochemical testing services, compatibility testing services, and others. The extractables/leachables testing services segment held the largest market share due to presence of regulatory mandates and guidelines regarding the testing of extractables and leachables; increasing outsourcing of testing services by biopharmaceutical manufacturers; the growing requirement for product safety, identity, purity, and quality; and the increasing risk of product adulteration.

The extractables/leachables testing services is extremely important across protection of patients and majorly for regulatory documentation for establishments such as FDA and EMA. Additionally, the pharmaceutical sector has undergone a robust development for its betterment, the extractables and leachables plays a crucial role in the patient's safety and drug product interaction.

Harmful contaminants or chemicals from packaging and especially primary packaging have often shown contamination of pharmaceutical products. This may lead to create threatening and challenge to the safety for several patients using these products regularly. In 2010, one of the company McNeil Consumer Healthcare, recall more than 500 lots of Tylenol, Benadryl, Motrin, and Zyrtec. In this case, the chemical is potential carcinogen reacted with the outer packaging into the drug containers. These factors have restrained the growth of the healthcare market, however, in order to avoid these kind of mishaps, the players are adopting extractables/leachables testing services, which is likely to drive segment growth.

The microbiological testing services is expected to have positive market growth in the forecast period. Microbiology testing services are a crucial requirement across many industries worldwide where products, processes and human health are at risk of being negatively affected by the presence and breeding of micro-organisms such as specific pathogens, bacteria, yeast and moulds.

Every day, products and materials come into contact with micro-organisms. Although many are harmless, many can cause significant contamination, damage and risk to human health. Some microbes can utilize your product as a food source, breaking the material down into nutrients and irreversibly changing the product whilst other microbes can spoil food, negatively affect production environments, products and infrastructure. They can cause severe illness or contaminate sterile environments. This factor will drive the growth of market in the forecast period.

Further, the market is also classified based on process as media containers and bags, freezing and thawing process bags, filter elements, and others. The freezing and thawing process bags segment is held the largest market share. The constant evolution and betterment of the cryopreservation technique over the years has laid the foundation for the formation of these freeze and thaw process bags. More and more biotechnological and pharmaceutical companies have adopted the approach of using these systems for the storage of their medicines and drugs and thus have helped in driving the growth of the segment.

There are several advantages of using these freeze and thaw process bags. These bags are easy to use, easily transportable, and have larger storage capacity. Moreover, with the technological advancement, the freezing time of these bags has been reduced drastically due to the heath exchange plans. Such an arrangement offers efficient and effective heat transfer as well as it helps in protecting the bags. One can also keep a close eye on the progress of the freezing process in these bags. Such advantages have made these systems quite popular among the end-users and thus, helped in driving the growth of the segment.

Geographical Presentation

By region, the global bioprocess validation market is segmented into North America, South America, Europe, Asia-Pacific, Middle-East, and Africa. Among all of the regions, North America dominated the global medical coding market and is expected to grow at the highest CAGR during the forecast period due to the concentration of a large number of key service providers of bioprocess validation in the region. In addition to that, strict regulations pertaining to the production of biopharmaceutical products are adding impetus to the demand for bioprocess validation systems in the region.

Also the presence of the pharmaceutical and biotechnology companies are driving the growth of the market in the region. These companies are responsible for creating a solid demand for proper protein drugs and sample storage systems. In addition to this, rapidly developing domestic infrastructure coupled with the growing need for more improved and enhanced medications, therapies, and therapeutics is thus driving the demand for the bioprocess validation. This factor will drive the growth of market in the region.

The Asia-Pacific region is expected to have third-largest share due to the higher growth rate is attributed to increasing capacities of numerous biopharmaceutical manufacturers and increased spending on research and development activities in life sciences.

Competitive Analysis

The bioprocess validation market is highly competitive with the presence of several international and local markets. Product diversification, revenue generation, and opportunities intensify the market competition Cobetter Filtration Equipments Co., Ltd., SGS S.A., DOC S.r.l., Thermo Fisher Scientific, Toxikon Corporation, Sartorius Stedim Biotech, Eurofins Scientific, Pall Corporation, and MEISSNER FILTRATION PRODUCTS, INC. are the leading market players with significant market share. The major players are using product development, novel product launches, market expansion, and product diversification strategies for holding their position in the market.

The companies are entering into collaborations, mergers, strategic partnerships, and acquisitions to expand their presence and meet the rising demand for the bioprocess validation across the globe.

For instance, in August 2018, Merck KGaA launched the BioReliance Product Characterization Portfolio to enhance its service portfolio in the bioprocess validation market..

  • In March 2017, Toxikon and SG Lab (Italy) entered into a partnership, to extend its analytical and extractable & leachable testing service portfolio to determine the drug integrity in the entire life cycle.
  • In February 2018, Pall Corporation expanded its Hoegaarden office in Belgium with new R&D center, customer demonstration labs, and manufacturing space. This will help the company to establish its position in the Belgium market.
  • In March 2019, Merck KGaA opened a new M Lab Collaboration Center in France. The company has been at the forefront of innovation and strategic business growth. The company currently has a presence in over 60 countries, and this factor has helped the decision makers in introducing custom strategies. The global bioprocess validation market is projected to be dominated by Merck KGaA in the years to follow.
  • In 2019, Thermo Fisher Scientific Inc., a leading developer of biotechnology product, and Brammer Bio, famed maker of viral vectorfor cell and gene therapies, entered into a definitive agreement. Honoring the agreement, Thermo Fisher made an acquisition of Brammer Bio.

Why Purchase the Report?

  • Visualize the composition of the global bioprocess validation market products in terms of test type, process and end-user and highlighting the critical commercial assets and players.
  • Identify commercial opportunities in the global bioprocess validation market by analyzing trends and co-development deals.
  • Excel data sheet with thousands of data points of global bioprocess validation market-level 4/5 segmentation.
  • PDF report with the most relevant analysis cogently put together after exhaustive qualitative interviews and in-depth market study.
  • *The global bioprocess validation market report will provide access to approximately 61 market data tables, 59 figures, and 200 pages

Target Audience2022

  • Industry Investors/Investment Bankers
  • Suppliers/Buyers
  • Education & Research Institutes
  • Manufacturers
  • Research Professionals
  • Emerging Companies
  • Distributors

Table of Contents

1. Global Bioprocess Validation Market Methodology and Scope

  • 1.1. Research Methodology
  • 1.2. Research Objective and Scope of the Report

2. Global Bioprocess Validation Market - Market Definition and Overview

3. Global Bioprocess Validation Market - Executive Summary

  • 3.1. Market Snippet by Test Type
  • 3.2. Market Snippet by Process
  • 3.3. Market Snippet by End-User
  • 3.4. Market Snippet by Region

4. Global Bioprocess Validation Market Dynamics

  • 4.1. Market Impacting Factors
    • 4.1.1. Drivers
      • 4.1.1.1. Feasibility of operations and processes
      • 4.1.1.2. The stringent safety and quality regulations governing product certification and testing across the biopharmaceutical and pharmaceutical industries
    • 4.1.2. Restraints
      • 4.1.2.1. Government regulation
  • 4.2. Impact Analysis
  • 4.3. Opportunity

5. Global Bioprocess Validation Market - Industry Analysis

  • 5.1. Porter's Five Forces Analysis
  • 5.2. Supply Chain Analysis
  • 5.3. Regulatory Analysis
  • 5.4. Pricing Analysis
  • 5.5. Product Analysis
  • 5.6. COVID-19 Impact Analysis

6. Global Bioprocess Validation Market - By Test Type

  • 6.1. Introduction
  • 6.2. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test Type
  • 6.3. Market Attractiveness Index, By Test Type
    • 6.3.1. Extractables/Leachables Testing Services *
      • 6.3.1.1. Introduction
      • 6.3.1.2. Market Size Analysis, US$ Mn, 2016-2025 and Y-o-Y Growth Analysis (%), 2019-2027
    • 6.3.2. Microbiological Testing Services
    • 6.3.3. Integrity Testing Services
    • 6.3.4. Physiochemical Testing Services
    • 6.3.5. Compatibility Testing Services
    • 6.3.6. Others

7. Global Bioprocess Validation Market - By Process

  • 7.1. Introduction
  • 7.2. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Process
  • 7.3. Market Attractiveness Index, By Process
    • 7.3.1. Media containers and bags
      • 7.3.1.1. Introduction
      • 7.3.1.2. Market Size Analysis, US$ Mn, 2016-2025 and Y-o-Y Growth Analysis (%), 2019-2027
    • 7.3.2. Freezing and thawing process bags
    • 7.3.3. Filter elements
    • 7.3.4. Others

8. Global Bioprocess Validation Market - By End-User

  • 8.1. Introduction
  • 8.2. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End-User
  • 8.3. Market Attractiveness Index, By End-User
    • 8.3.1. Pharmaceutical Companies
      • 8.3.1.1. Introduction
      • 8.3.1.2. Market Size Analysis, US$ Mn, 2016-2025 and Y-o-Y Growth Analysis (%), 2019-2027
    • 8.3.2. Biotechnology Companies
    • 8.3.3. Others

9. Global Bioprocess Validation Market - By Region

  • 9.1. Introduction
  • 9.2. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Region
  • 9.3. Market Attractiveness Index, By Region
  • 9.4. North America
    • 9.4.1. Introduction
    • 9.4.2. Key Region-Specific Dynamics
    • 9.4.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test Type
    • 9.4.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Process
    • 9.4.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End-User
    • 9.4.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
      • 9.4.6.1. U.S.
      • 9.4.6.2. Canada
      • 9.4.6.3. Mexico
  • 9.5. Europe
    • 9.5.1. Introduction
    • 9.5.2. Key Region-Specific Dynamics
    • 9.5.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test Type
    • 9.5.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Process
    • 9.5.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End-User
    • 9.5.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
      • 9.5.6.1. Germany
      • 9.5.6.2. U.K.
      • 9.5.6.3. France
      • 9.5.6.4. Rest of Europe
  • 9.6. South America
    • 9.6.1. Introduction
    • 9.6.2. Key Region-Specific Dynamics
    • 9.6.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test Type
    • 9.6.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Process
    • 9.6.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End User
    • 9.6.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
      • 9.6.6.1. Brazil
      • 9.6.6.2. Argentina
      • 9.6.6.3. Rest of South America
  • 9.7. Asia Pacific
    • 9.7.1. Introduction
    • 9.7.2. Key Region-Specific Dynamics
    • 9.7.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test Type
    • 9.7.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Process
    • 9.7.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End-User
    • 9.7.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
      • 9.7.6.1. China
      • 9.7.6.2. India
      • 9.7.6.3. Japan
      • 9.7.6.4. Australia
      • 9.7.6.5. Rest of Asia Pacific
  • 9.8. Middle East and Africa
    • 9.8.1. Introduction
    • 9.8.2. Key Region-Specific Dynamics
    • 9.8.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test Type
    • 9.8.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Process
    • 9.8.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End User

10. Global Bioprocess Validation Market Competitive Landscape

  • 10.1. Competitive Scenario
  • 10.2. Market Positioning/Share Analysis
  • 10.3. Mergers and Acquisitions Analysis

11. Global Bioprocess Validation Market Company Profiles

  • 11.1. Cobetter Filtration Equipments Co., Ltd.*
    • 11.1.1. Company Overview
    • 11.1.2. Product Portfolio and Description
    • 11.1.3. Key Developments
    • 11.1.4. Financial Overview
  • 11.2. SGS S.A.
  • 11.3. DOC S.r.l.
  • 11.4. Thermo Fisher Scientific
  • 11.5. Toxikon Corporation
  • 11.6. Sartorius Stedim Biotech
  • 11.7. Eurofins Scientific
  • 11.8. Pall Corporation
  • 11.9. MEISSNER FILTRATION PRODUCTS, INC.
  • 11.10. Merck KGaA
  • List is not exhaustive

12. Global Bioprocess Validation Market - Premium Insights

13. Global Bioprocess Validation Market - DataM

  • 13.1. Appendix
  • 13.2. About Us and Services
  • 13.3. Contact Us