全球生物工艺验证市场2022-2029

市场动态

全球对生物製药的需求不断增长，预计将推动生物工艺验证市场的需求

研发相关投资的加速集中推动了对生物製药的巨大需求。对生物过程验证服务外包的高需求、医疗行业生物製药和製药行业对产品认证和测试的严格安全和质量法规，以及全球范围内的生物过程验证服务已成为推动生物过程验证行业增长的关键因素。

可提取物和可浸出物问题预计将包含全球生物过程验证市场

近年来，一次性技术已广泛应用于生物工艺开发和生物製药製造。儘管此类技术的好处已广为人知，但人们对一次性系统组件中的可提取物和可浸出物存在重大担忧，因为它们会影响产品质量和患者健康。通常需要进行风险评估，以评估可提取物和可浸出物进入产品流的可能性以及对患者的潜在风险。在预测期内，与可提取物和可浸出物相关的问题预计将抑制全球生物工艺验证市场的增长。

进军新兴市场有望为全球生物工艺验证市场带来新机遇

在亚洲地区，中国是一个充满希望的生物工艺验证市场，其次是印度。这一市场的增长可归因于政府的有利支持、私人投资的增加、老年人口的增长以及向新兴亚洲国家外包的趋势增加。印度、日本和巴西有望成为市场参与者的新收入来源。对生物製造基础设施的高投资也是这些市场具有高增长潜力的一个主要因素。新兴市场提供的新机遇有望推动全球市场的增长。

预计政府对生物过程验证的严格规定将对全球生物过程验证市场构成挑战。

验证是製药和生物技术公司的一项监管要求，以确保他们始终如一地为公众生产安全的药物。公司必须能够提供其验证活动的证据，例如在监管审计期间。政府法规对生物过程验证的复杂性阻碍了其在更广泛的应用中的应用，对全球生物过程验证市场的增长构成挑战。

内容

第一章研究方法与范围

• 调查方法
• 调查目的和范围

第 2 章市场定义和概述

第 3 章执行摘要

• 按测试类型划分的市场细分
• 按流程划分的市场细分
• 最终用户的市场细分
• 按地区划分的市场细分

第 4 章市场动态

• 市场影响因素
• 驱动程序
  • 运营和流程的可行性
  • 针对生物製药和製药行业的产品认证和测试的严格安全和质量法规
• 限制因素
  • 政府规定
• 影响分析
• 机会

第五章行业分析

• 波特五力分析
• 供应链分析
• 监管分析
• 定价分析
• 产品分析
• COVID-19 影响分析

第 6 章按测试类型

• 可萃取/可浸出测试服务
• 微生物检测服务
• 完整性测试服务
• 理化测试服务
• 一致性测试服务
• 其他

第 7 章按流程

• 媒体容器/袋子
• 冷冻/解冻袋
• 过滤器元素
• 其他

第 8 章最终用户

• 製药公司
• 生物技术公司
• 其他

第 9 章按地区

• 北美
  • 美国
  • 加拿大
  • 墨西哥
• 欧洲
  • 德国
  • 英国
  • 法国
  • 其他欧洲
• 南美洲
  • 巴西
  • 阿根廷
  • 其他南美洲
• 亚太地区
  • 中国
  • 印度
  • 日本
  • 澳大利亚
  • 其他亚太地区
• 中东和非洲

第 10 章竞争格局

• 竞争场景
• 市场情况/份额分析
• 併购分析

第 11 章公司简介

• Cobetter Filtration Equipments Co., Ltd.
  • 公司概况
  • 产品组合和描述
  • 主要发展状况
  • 财务摘要
• 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

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