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市场调查报告书

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1638875

生物製程验证市场机会、成长驱动因素、产业趋势分析与预测 2024 - 2032 年

Bioprocess Validation Market Opportunity, Growth Drivers, Industry Trend Analysis, and Forecast 2024 - 2032

出版日期: 2024年11月07日 | 出版商:

Global Market Insights Inc. | 英文 135 Pages | 商品交期: 2-3个工作天内

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简介目录

全球生物製程验证市场在2023 年达到4.165 亿美元，预计2024 年至2032 年复合年增长率为10.7%。。它涉及系统测试和分析，以验证从原材料使用到最终产品输出的每个阶段都满足严格的法规和品质要求。

市场扩张主要是由严格的监管要求、生物製剂的不断采用以及验证技术的进步所推动的。随着生物製药产业在生产能力和外包方面的发展，对全面验证协议以维持合规性和维护产品标准的需求不断增加。对单株抗体、疫苗和基因疗法等生物製剂的需求不断增长，进一步增强了稳健验证流程的必要性，因为这些疗法必须满足严格的品质、安全性和有效性标准。

按测试类型细分，市场涵盖可萃取物和可浸出物测试、微生物测试、完整性测试和病毒清除测试等领域。 2023 年，微生物检测成为主导领域，产生 1.262 亿美元的收入。监管机构强调微生物测试对于确保整个製造过程的无菌和品质的重要性。遵守良好生产规范 (GMP) 和日常环境监测对于维护生物製药产品的完整性至关重要，这凸显了此测试类别的重要性。

市场范围
开始年份	2023年
预测年份	2024-2032
起始值	4.165 亿美元
预测值	10.3 亿美元
复合年增长率	10.7%

依阶段划分，生物製程验证市场分为製程设计、製程鑑定及持续製程验证。 2023年製程认证占最大份额，占市占率46.8%。此阶段对于确认製造流程始终在既定参数内生产产品至关重要。透过模拟真实的操作条件，製程鑑定可确保生物製造方案、桥接製程设计和持续验证阶段的可靠性和可重复性。

2023 年美国市场规模达 1.745 亿美元，预计在预测期内复合年增长率为 10.8%。美国的监管环境要求 FDA 等机构推动严格的验证实践。遵守 GMP 标准需要对所有製造阶段进行彻底验证，促使增加对创新验证技术的投资。

不断发展的生物製药产业，加上监管压力和生物製剂的日益普及，使生物製程验证成为现代医疗保健製造的基石。

产业生态系统分析
产业影响力
- 成长动力
  - 有关安全和品质的严格规定
  - 对生物製药的需求不断增加
  - 生命科学领域研发支出不断增加
  - 生物製程验证外包的需求不断增加
- 产业陷阱与挑战
  - 验证的复杂性和时间密集性
  - 与验证过程相关的高成本
成长潜力分析
监管环境
技术景观
未来市场趋势
差距分析
波特的分析
PESTEL分析

第 4 章：竞争格局

介绍
公司市占率分析
公司矩阵分析
主要市场参与者的竞争分析
竞争定位矩阵
战略仪表板

第 5 章：市场估计与预测：按测试类型，2021 - 2032 年

主要趋势
可萃取物/可浸出物测试
微生物检测
完整性测试
病毒清除测试
外源因子测试
支原体检测
理化测试
相容性测试
其他测试类型

第 6 章：市场估计与预测：按阶段，2021 - 2032

主要趋势
工艺设计
工艺鑑定
持续过程验证

第 7 章：市场估计与预测：按模式，2021 - 2032

主要趋势
内部
外包

第 8 章：市场估计与预测：按应用分类，2021 - 2032

主要趋势
生物製药
基因和细胞治疗
疫苗
其他应用

第 9 章：市场估计与预测：按最终用途，2021 - 2032 年

主要趋势
製药公司
生技公司
CRO 和 CDMO
学术及研究机构

第 10 章：市场估计与预测：按地区划分，2021 - 2032 年

主要趋势
北美洲
- 我们
- 加拿大
欧洲
- 德国
- 英国
- 法国
- 西班牙
- 义大利
- 荷兰
亚太地区
- 中国
- 日本
- 印度
- 澳洲
- 韩国
拉丁美洲
- 巴西
- 墨西哥
- 阿根廷
中东和非洲
- 南非
- 沙乌地阿拉伯
- 阿联酋

第 11 章：公司简介

Asahi Kasei Corporation
Bio-Rad Laboratories
Charles River Laboratories
Danaher Corporation
Eurofins Scientific
Lonza Group
Meissner Filtration Products
Merck KGaA
Pace Analytical Services
Repligen Corporation
Sartorius AG
SGS SA
Thermo Fisher Scientific
Tosoh Corporation
WuXi AppTec

简介目录

Product Code: 12192

The Global Bioprocess Validation Market reached USD 416.5 million in 2023 and is anticipated to grow at 10.7% CAGR from 2024 to 2032. Bioprocess validation plays a critical role in biopharmaceutical manufacturing, ensuring that processes consistently deliver products of high quality and safety. It involves systematic tests and analyses to verify that every stage, from raw material usage to final product output, meets strict regulatory and quality requirements.

The market expansion is largely driven by stringent regulatory demands, rising adoption of biologics, and advancements in validation technologies. As the biopharmaceutical sector grows, both in production capacity and outsourcing, there is an increasing need for comprehensive validation protocols to maintain compliance and uphold product standards. The surging demand for biologics, including monoclonal antibodies, vaccines, and gene therapies, further amplifies the necessity for robust validation processes, as these therapies must meet exacting standards for quality, safety, and efficacy.

Segmented by testing types, the market encompasses areas such as extractables and leachables testing, microbiological testing, integrity testing, and viral clearance testing, among others. In 2023, microbiological testing emerged as a dominant segment, generating USD 126.2 million in revenue. Regulatory bodies emphasize the importance of microbiological testing in ensuring sterility and quality throughout the manufacturing process. Adherence to Good Manufacturing Practices (GMP) and routine environmental monitoring are critical to safeguarding the integrity of biopharmaceutical products, underscoring the significance of this testing category.

Market Scope
Start Year	2023
Forecast Year	2024-2032
Start Value	$416.5 Million
Forecast Value	$1.03 Billion
CAGR	10.7%

By stage, the bioprocess validation market is categorized into process design, process qualification, and continued process verification. Process qualification accounted for the largest share in 2023, representing 46.8% of the market. This stage is essential in confirming that manufacturing processes consistently produce products within established parameters. By simulating real operating conditions, process qualification ensures the reliability and reproducibility of biomanufacturing protocols, bridging process design, and ongoing verification phases.

U.S. market reached USD 174.5 million in 2023 and is projected to grow at a CAGR of 10.8% during the forecast period. The regulatory landscape in the U.S. mandates rigorous validation practices driven by agencies such as the FDA. Compliance with GMP standards necessitates thorough validation of all manufacturing stages, prompting increased investments in innovative validation techniques.

The growing biopharmaceutical industry, coupled with regulatory pressures and the rising prevalence of biologics, positions bioprocess validation as a cornerstone of modern healthcare manufacturing.

Chapter 1 Methodology & Scope

1.1 Market scope & definitions
1.2 Research design
- 1.2.1 Research approach
- 1.2.2 Data collection methods
1.3 Base estimates & calculations
- 1.3.1 Base year calculation
- 1.3.2 Key trends for market estimation
1.4 Forecast model
1.5 Primary research and validation
- 1.5.1 Primary sources
- 1.5.2 Data mining sources

Chapter 2 Executive Summary

2.1 Industry 360° synopsis

Chapter 3 Industry Insights

3.1 Industry ecosystem analysis
3.2 Industry impact forces
- 3.2.1 Growth drivers
  - 3.2.1.1 Stringent regulations regarding safety and quality
  - 3.2.1.2 Increasing demand for biopharmaceuticals
  - 3.2.1.3 Rising R&D expenditure in life sciences sector
  - 3.2.1.4 Increasing demand for bioprocess validation outsourcing
- 3.2.2 Industry pitfalls & challenges
  - 3.2.2.1 Complexity and time-intensive nature of validation
  - 3.2.2.2 High costs associated with validation processes
3.3 Growth potential analysis
3.4 Regulatory landscape
3.5 Technological landscape
3.6 Future market trends
3.7 Gap analysis
3.8 Porter's analysis
3.9 PESTEL analysis

Chapter 4 Competitive Landscape, 2023

4.1 Introduction
4.2 Company market share analysis
4.3 Company matrix analysis
4.4 Competitive analysis of major market players
4.5 Competitive positioning matrix
4.6 Strategy dashboard

Chapter 5 Market Estimates and Forecast, By Testing Type, 2021 - 2032 ($ Mn)

5.1 Key trends
5.2 Extractables/leachables testing
5.3 Microbiological testing
5.4 Integrity testing
5.5 Viral clearance testing
5.6 Adventitious agent testing
5.7 Mycoplasma testing
5.8 Physicochemical testing
5.9 Compatibility testing
5.10 Other testing types

Chapter 6 Market Estimates and Forecast, By Stage, 2021 - 2032 ($ Mn)

6.1 Key trends
6.2 Process design
6.3 Process qualification
6.4 Continued process verification

Chapter 7 Market Estimates and Forecast, By Mode, 2021 - 2032 ($ Mn)

7.1 Key trends
7.2 In-house
7.3 Outsourced

Chapter 8 Market Estimates and Forecast, By Application, 2021 - 2032 ($ Mn)

8.1 Key trends
8.2 Biopharmaceuticals
8.3 Gene and cell therapy
8.4 Vaccines
8.5 Other applications

Chapter 9 Market Estimates and Forecast, By End Use, 2021 - 2032 ($ Mn)

9.1 Key trends
9.2 Pharmaceutical companies
9.3 Biotechnology companies
9.4 CROs and CDMOs
9.5 Academic and research institutes

Chapter 10 Market Estimates and Forecast, By Region, 2021 - 2032 ($ Mn)

10.1 Key trends
10.2 North America
- 10.2.1 U.S.
- 10.2.2 Canada
10.3 Europe
- 10.3.1 Germany
- 10.3.2 UK
- 10.3.3 France
- 10.3.4 Spain
- 10.3.5 Italy
- 10.3.6 Netherlands
10.4 Asia Pacific
- 10.4.1 China
- 10.4.2 Japan
- 10.4.3 India
- 10.4.4 Australia
- 10.4.5 South Korea
10.5 Latin America
- 10.5.1 Brazil
- 10.5.2 Mexico
- 10.5.3 Argentina
10.6 Middle East and Africa
- 10.6.1 South Africa
- 10.6.2 Saudi Arabia
- 10.6.3 UAE