首頁 > 市場調查報告書 > 製藥

生技設備生物工藝

市場調查報告書

商品編碼

1638875

生物製程驗證市場機會、成長促進因素、產業趨勢分析與預測 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個工作天內

價格

簡介目錄

全球生物製程驗證市場在2023 年達到4.165 億美元，預計2024 年至2032 年複合年成長率為10.7%。。它涉及系統測試和分析，以驗證從原料使用到最終產品輸出的每個階段都滿足嚴格的法規和品質要求。

市場擴張主要是由嚴格的監管要求、生物製劑的不斷採用以及驗證技術的進步所推動的。隨著生物製藥產業在生產能力和外包方面的發展，對全面驗證協議以維持合規性和維護產品標準的需求不斷增加。對單株抗體、疫苗和基因療法等生物製劑的需求不斷成長，進一步增強了穩健驗證流程的必要性，因為這些療法必須滿足嚴格的品質、安全性和有效性標準。

按測試類型細分，市場涵蓋可萃取物和可浸出物測試、微生物測試、完整性測試和病毒清除測試等領域。 2023 年，微生物檢測成為主導領域，產生 1.262 億美元的收入。監管機構強調微生物測試對於確保整個製造過程的無菌和品質的重要性。遵守良好生產規範 (GMP) 和日常環境監測對於維護生物製藥產品的完整性至關重要，這凸顯了此測試類別的重要性。

市場範圍
開始年份	2023年
預測年份	2024-2032
起始值	4.165 億美元
預測值	10.3 億美元
複合年成長率	10.7%

依階段分類，生物製程驗證市場分為製程設計、製程鑑定及持續製程驗證。 2023年製程認證佔最大佔有率，佔市佔率46.8%。此階段對於確認製造流程始終在既定參數內生產產品至關重要。透過模擬真實的操作條件，製程鑑定可確保生物製造方案、橋接製程設計和持續驗證階段的可靠性和可重複性。

2023 年美國市場規模達 1.745 億美元，預計在預測期內複合年成長率為 10.8%。美國的監管環境要求 FDA 等機構推動嚴格的驗證實踐。遵守 GMP 標準需要對所有製造階段進行徹底驗證，促使增加對創新驗證技術的投資。

不斷發展的生物製藥產業，加上監管壓力和生物製劑的日益普及，使生物製程驗證成為現代醫療保健製造的基石。

產業生態系統分析
產業影響力
- 成長動力
  - 有關安全和品質的嚴格規定
  - 對生物製藥的需求不斷增加
  - 生命科學領域研發支出不斷增加
  - 生物製程驗證外包的需求不斷增加
- 產業陷阱與挑戰
  - 驗證的複雜性和時間密集性
  - 與驗證過程相關的高成本
成長潛力分析
監管環境
技術景觀
未來市場趨勢
差距分析
波特的分析
PESTEL分析

第 4 章：競爭格局

介紹
公司市佔率分析
公司矩陣分析
主要市場參與者的競爭分析
競爭定位矩陣
戰略儀表板

第 5 章：市場估計與預測：按測試類型，2021 - 2032 年

主要趨勢
可萃取物/可浸出物測試
微生物檢測
完整性測試
病毒清除測試
外源因子測試
支原體檢測
理化測試
相容性測試
其他測試類型

第 6 章：市場估計與預測：按階段，2021 - 2032

主要趨勢
工藝設計
工藝鑑定
持續過程驗證

第 7 章：市場估計與預測：按模式，2021 - 2032

主要趨勢
內部
外包

第 8 章：市場估計與預測：按應用分類，2021 - 2032

主要趨勢
生物製藥
基因和細胞治療
疫苗
其他應用

第 9 章：市場估計與預測：按最終用途，2021 - 2032 年

主要趨勢
製藥公司
生技公司
CRO 和 CDMO
學術及研究機構

第 10 章：市場估計與預測：按地區分類，2021 - 2032 年

主要趨勢
北美洲
- 美國
- 加拿大
歐洲
- 德國
- 英國
- 法國
- 西班牙
- 義大利
- 荷蘭
亞太地區
- 中國
- 日本
- 印度
- 澳洲
- 韓國
拉丁美洲
- 巴西
- 墨西哥
- 阿根廷
中東和非洲
- 南非
- 沙烏地阿拉伯
- 阿拉伯聯合大公國

第 11 章：公司簡介

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

簡介目錄

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