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市場調查報告書
商品編碼
1138368

全球生物工藝驗證市場2022-2029

Global Bioprocess Validation Market - 2022-2029
出版日期: | 出版商: DataM Intelligence | 英文 180 Pages | 商品交期: 約2個工作天內

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簡介目錄

市場動態

全球對生物製藥的需求不斷增長，預計將推動生物工藝驗證市場的需求

研發相關投資的加速集中推動了對生物製藥的巨大需求。對生物過程驗證服務外包的高需求、醫療行業生物製藥和製藥行業對產品認證和測試的嚴格安全和質量法規，以及全球範圍內的生物過程驗證服務已成為推動生物過程驗證行業增長的關鍵因素。

可提取物和可浸出物問題預計將包含全球生物過程驗證市場

近年來，一次性技術已廣泛應用於生物工藝開發和生物製藥製造。儘管此類技術的好處已廣為人知，但人們對一次性系統組件中的可提取物和可浸出物存在重大擔憂，因為它們會影響產品質量和患者健康。通常需要進行風險評估，以評估可提取物和可浸出物進入產品流的可能性以及對患者的潛在風險。在預測期內，與可提取物和可浸出物相關的問題預計將抑制全球生物工藝驗證市場的增長。

進軍新興市場有望為全球生物工藝驗證市場帶來新機遇

在亞洲地區，中國是一個充滿希望的生物工藝驗證市場，其次是印度。這一市場的增長可歸因於政府的有利支持、私人投資的增加、老年人口的增長以及向新興亞洲國家外包的趨勢增加。印度、日本和巴西有望成為市場參與者的新收入來源。對生物製造基礎設施的高投資也是這些市場具有高增長潛力的一個主要因素。新興市場提供的新機遇有望推動全球市場的增長。

預計政府對生物過程驗證的嚴格規定將對全球生物過程驗證市場構成挑戰。

驗證是製藥和生物技術公司的一項監管要求，以確保他們始終如一地為公眾生產安全的藥物。公司必須能夠提供其驗證活動的證據，例如在監管審計期間。政府法規對生物過程驗證的複雜性阻礙了其在更廣泛的應用中的應用，對全球生物過程驗證市場的增長構成挑戰。

內容

第一章研究方法與範圍

  • 調查方法
  • 調查目的和範圍

第 2 章市場定義和概述

第 3 章執行摘要

  • 按測試類型劃分的市場細分
  • 按流程劃分的市場細分
  • 最終用戶的市場細分
  • 按地區劃分的市場細分

第 4 章市場動態

  • 市場影響因素
  • 驅動程序
    • 運營和流程的可行性
    • 針對生物製藥和製藥行業的產品認證和測試的嚴格安全和質量法規
  • 限制因素
    • 政府規定
  • 影響分析
  • 機會

第五章行業分析

  • 波特五力分析
  • 供應鏈分析
  • 監管分析
  • 定價分析
  • 產品分析
  • COVID-19 影響分析

第 6 章按測試類型

  • 可萃取/可浸出測試服務
  • 微生物檢測服務
  • 完整性測試服務
  • 理化測試服務
  • 一致性測試服務
  • 其他

第 7 章按流程

  • 媒體容器/袋子
  • 冷凍/解凍袋
  • 過濾器元素
  • 其他

第 8 章最終用戶

  • 製藥公司
  • 生物技術公司
  • 其他

第 9 章按地區

  • 北美
    • 美國
    • 加拿大
    • 墨西哥
  • 歐洲
    • 德國
    • 英國
    • 法國
    • 其他歐洲
  • 南美洲
    • 巴西
    • 阿根廷
    • 其他南美洲
  • 亞太地區
    • 中國
    • 印度
    • 日本
    • 澳大利亞
    • 其他亞太地區
  • 中東和非洲

第 10 章競爭格局

  • 競爭場景
  • 市場情況/份額分析
  • 併購分析

第 11 章公司簡介

  • Cobetter Filtration Equipments Co., Ltd.
    • 公司概況
    • 產品組合和描述
    • 主要發展狀況
    • 財務摘要
  • 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（*List is not exhaustive）

第12章 DataM

簡介目錄
Product Code: DMBT2681

Market Overview

Bioprocess Validation Market size was valued at USD 224,687.30 million in 2021 and is estimated to reach at a compound annual growth rate (CAGR) of 11.20% over the forecast period 2022 to 2029.

Bioprocess Validation is a process that involves collecting documentary evidence to ensure that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. An important part of bioprocess validation requires evaluating active pharmaceutical ingredients (APIs) and possible contaminants, such as mycoplasma, bacteria, endotoxin, and others, during the development and manufacture processes of animal disinfectants or other biological products.

Market Dynamics

Increasing global demand for biopharmaceuticals is expected to boost the demand for the bioprocess validation market

The huge demand for biopharmaceuticals is facilitated by an accelerating focus on research and development-related investments. High demand for outsourcing bioprocess validation services, stringent safety and quality regulations governing product certifications and testing beyond the biopharmaceutical and pharmaceutical industries in the healthcare industry to maintain the agreement with good manufacturing practices are the important factors propelling the growth of the global bioprocess validation industry.

Issues related to extractables and leachables are expected to restrain the global bioprocess validation market

Single-use technology has been adopted widely in bioprocess development and biopharmaceutical manufacturing in recent years. While the benefits of such technologies are well recognized, there are significant concerns regarding extractable and leachable from the components of single-use systems owing to their potential effect on product quality and patient health. A risk assessment is normally required to assess the probability of extractable and leachables migrating into the product stream and their potential risk to the patient. During the forecast period, the issues related to extractables and leachables are expected to restrain the growth of the global market for bioprocess validation.

Expansion into emerging markets is expected to generate new opportunities for the global bioprocess validation market

In the Asian region, China is a high-potential market for bioprocess validation, followed by India. The growth in this market can be attributed to favorable government support, rising private investments, a growing geriatric population, and a rising trend of outsourcing to emerging Asian countries. India, Japan, and Brazil are expected to be the new revenue pockets for market players. Also, the high investment in bio-manufacturing infrastructure is a key factor responsible for the high-growth potential of these markets. The new opportunities offered by the emerging markets are expected to boost the growth of the global market.

Stringent government regulations on bioprocess validation are expected to present challenges for the global market for bioprocess validation

Validation is a regulatory requirement for pharmaceutical and biotechnology companies to confirm that they consistently manufacture safe medicines for the public. Companies must be able to provide proof of validation activities when requested, such as during an audit by regulatory agencies. The complexity of government regulations for bioprocess validation prevents its adoption for a wider range of applications and presents a challenge to the growth of the global bioprocess validation market.

Market Segmentation:

The scope of the report covers segmentation based on test type, process component, end-user and region. The global bioprocess validation market is segmented by test type into extractables/leachables testing services, microbiological testing services, integrity testing services, physiochemical testing services, compatibility testing services and others. The global market is segmented by process component into media containers and bags, freezing and thawing process bags, filter elements, bioreactors and others. The global market is segmented by end-user into pharmaceutical companies, biotechnology companies, contract development and manufacturing organizations and others. The global market is segmented by region into North America, South America, Europe, Asia-Pacific, Middle East and Africa.

Pharmaceutical Companies: Pharmaceutical companies have a large share of the end-user segment, which can majorly be attributed to the increasing production of biopharmaceuticals and the corresponding increase in the number of impurities to be checked for, the stringency of standards and regulations regarding the quality and validity of bioprocesses involved in the production

Biotechnology Companies: The biotechnology sector is experiencing rapid growth due to favorable governmental policies. Government initiatives are oriented towards modernizing the drug regulatory pathway, standardizing clinical studies, improving reimbursement policies, and speeding up the product approval process, thereby offering lucrative growth opportunities to the market.

Contract Development & Manufacturing Organizations: With developments in the pharmaceutical industry, leading contract development and manufacturing organizations (CDMOs) aim to seek and bridge capability gaps. CDMOs offering multiple services increase convenience, save time, and enhance cost efficiency as pharmaceutical companies have to only deal with a single entity. The relationship also creates opportunities for the CDMOs to sell more services to the same customer and lock in products at earlier stages of their life cycles

Others: The segment mainly includes laboratories and research institutes. Process-related cell-derived impurities such as buffer components, antibiotics, surfactants, anti-foaming agents, process enhancing agents, catalysts, or compounds that leach from contact materials can impede research projects. Therefore, process validation studies require a broad set of testing capabilities and expertise.

Regional Classification:

According to the DataM Intelligence market research report, the global bioprocess validation market is divided into;

North America - United States, and Canada

South America - Brazil, Argentina, Peru, Chile, and Rest of the South American countries

Europe - UK, Germany, Italy, France, Spain, Russia, and the rest of the European countries

Asia-Pacific - China, India, Japan, South Korea, Singapore, Australia, Malaysia, and the Rest of the Asia Pacific countries

Middle East and Africa - UAE, KSA, Qatar, South African Countries, and the Rest of the Middle East countries

Competitive Landscape:

The global bioprocess validation market is moderately competitive with several international and regional players. The major players adopt several growth strategies such as licensing activities, collaborations, mergers and acquisitions, government tie-ups, and joint ventures, thereby contributing to the growth of the global bioprocess validation market.

Major Companies:

Some key companies contributing to the growth of the global bioprocess validation market include Cobetter Filtration Equipments Co., Ltd., SGS S.A., DOC S.r.l., Thermo Fisher Scientific, Sartorius Stedim Biotech, Merck KGaA, Meissner Filtration Products, Inc., Eurofins Scientific, Boston Analytical and Danaher Corporation (Pall Corporation), among others.

Recent Developments in the Industry:

In July 2022, Vaccizone, a vaccine manufacturer, announced a partnership with Exothera, a biotechnology research company, to use Exothera's scale-X technology to develop Vaccizone's COVID-19 vaccine with expedited bioprocess validation.

In June 2022, Alder Therapeutics announced a deal to help with the bioprocess validation for NorthX Biologics, a Swedish biotech company. The deal will enable NorthX Biologics to expand into pluripotent stem cell research.

In June 2022, the Jefferson Institute for Bioprocessing (JIB) announced the commencement of its bio technician training and validation program at the Budd Bioworks research space in Philadelphia, U.S.

COVID-19 Impact Analysis

COVID-19 had a significant impact on the market. The pandemic caused significant manufacturing and supply-chain operations disruptions due to various precautionary lockdowns and other governmental restrictions globally. Because validation is required at all stages of drug development to monitor accuracy, efficiency, and safety, demand for bioprocess validation increased during the pandemic. The pandemic has increased the demand for bioprocess validation and is expected to positively impact the bioprocess validation market growth.

Table of Contents

1. Methodology and Scope

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

2. Market Definition and Overview

3. 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. Market Dynamics

  • 4.1. Market Impacting Factors
  • 4.2. Drivers
    • 4.2.1. Feasibility of operations and processes
    • 4.2.2. The stringent safety and quality regulations governing product certification and testing across the biopharmaceutical and pharmaceutical industries
  • 4.3. Restraints
    • 4.3.1. Government regulation
  • 4.4. Impact Analysis
  • 4.5. Opportunity

5. 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. By Test Type

  • 6.1. Introduction
    • 6.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test Type
    • 6.1.2. Market Attractiveness Index, By Test Type
  • 6.2. Extractables/Leachables Testing Services *
    • 6.2.1. Introduction
    • 6.2.2. Market Size Analysis, US$ Mn, 2016-2025 and Y-o-Y Growth Analysis (%), 2019-2027
  • 6.3. Microbiological Testing Services
  • 6.4. Integrity Testing Services
  • 6.5. Physiochemical Testing Services
  • 6.6. Compatibility Testing Services
  • 6.7. Others

7. By Process

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Process
    • 7.1.2. Market Attractiveness Index, By Process
  • 7.2. Media containers and bags
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis, US$ Mn, 2016-2025 and Y-o-Y Growth Analysis (%), 2019-2027
  • 7.3. Freezing and thawing process bags
  • 7.4. Filter elements
  • 7.5. Others

8. By End-User

  • 8.1. Introduction
    • 8.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End-User
    • 8.1.2. Market Attractiveness Index, By End-User
  • 8.2. Pharmaceutical Companies
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis, US$ Mn, 2016-2025 and Y-o-Y Growth Analysis (%), 2019-2027
  • 8.3. Biotechnology Companies
  • 8.4. Others

9. 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. Competitive Landscape

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

11. 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. DataM Intelligence

  • 12.1. Appendix
  • 12.2. About Us and Services
  • 12.3. Contact Us