可提取和可浸出測試服務市場 - 按產品類型（容器封閉系統、一次性系統、藥物輸送系統）、應用（腸胃外藥物產品、口服吸入和鼻腔藥物產品） - 全球預測 2024 - 2032

Extractable and Leachable Testing Services Market - By Product Type (Container Closure Systems, Single-use Systems, Drug Delivery Systems), Application (Parenteral Drug Products, Orally Inhaled & Nasal Drug Products) - Global Forecast 2024 - 2032

出版日期: 2024年03月11日 | 出版商:

Global Market Insights Inc. | 英文 120 Pages | 商品交期: 2-3個工作天內

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簡介目錄

可提取和可浸出測試服務市場規模預計從2024 年到2032 年將以超過13.6% 的複合年成長率擴大。以確保產品安全和合規性。人們越來越認知到可萃取物和可浸出物測試在確保產品品質和病人安全方面的重要性，這推動了它們的吸引力。

在製造過程中擴大採用一次性系統和材料，進一步需要對潛在污染物進行全面測試。分析技術和方法的快速進步正在鼓勵開發新穎的測試服務。例如，2023 年 7 月，科學諮詢和合約研究組織 (CRO) Broughton 推出了新的可萃取物和可浸出物 (E&L) 測試服務，以幫助製藥和消費者保健公司安全高效地生產其產品。醫療保健和食品產業的擴張加上全球化的快速發展也將刺激市場成長。

可萃取和可浸出測試服務業按產品類型、應用和地區分類。

根據產品類型，從2024 年到2032 年，一次性系統細分市場的市場規模預計將成長13.9%。安全。監管機構對風險緩解和產品品質的關注還需要對一次性成分進行徹底的可提取和可浸出測試。

到 2032 年，眼科藥品應用領域的可提取和可浸出測試服務市場預計將以 13% 的複合年成長率成長。監管機構對產品品質和安全的嚴格要求要求進行全面的可提取和可浸出測試。眼科藥物配方的不斷創新和發展也將推動對檢測服務的需求。

從地區來看，2024年至2032年，亞太地區可萃取物和可浸出物檢測服務市場的複合年成長率將達到14.2%。需求，以確保產品品質和合規性。加強監管審查和採用國際品質標準也需要徹底的測試。人們越來越認知到可萃取物和可浸出物測試在確保產品安全方面的重要性，這將推動區域市場的擴張。

產業生態系統分析
產業影響力
- 成長動力
  - 支持性監管框架和對病人安全的日益重視
  - 不斷發展的製藥和生技產業
  - 廣泛採用一次性技術
- 產業陷阱與挑戰
  - 測試成本高
  - 與可萃取和可浸出測試相關的複雜性
成長潛力分析
技術景觀
監管環境
波特的分析
PESTEL分析

第 4 章：競爭格局

介紹
公司市佔率分析
競爭定位矩陣
戰略展望矩陣

第 5 章：市場估計與預測：按產品類型，2018 年 - 2032 年

主要趨勢
容器封閉系統
免洗系統
藥物輸送系統
其他產品類型

第 6 章：市場估計與預測：按應用分類，2018 年 - 2032 年

主要趨勢
腸胃外藥物產品
口服吸入和鼻腔藥物產品 (OINDP)
眼科藥品

第 7 章：市場估計與預測：按地區分類，2018 年 - 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
- 歐洲其他地區
亞太地區
- 日本
- 中國
- 印度
- 澳洲
- 韓國
- 亞太地區其他地區
拉丁美洲
- 巴西
- 阿根廷
- 墨西哥
- 拉丁美洲其他地區
中東和非洲
- 南非
- 沙烏地阿拉伯
- 阿拉伯聯合大公國
- 中東和非洲其他地區

第 8 章：公司簡介

BA Sciences
Eurofins Scientific
Intertek Group plc
Limerston Capital LLP
Merck & Co., Inc.
Pacific Biolabs, Inc.
SGS Societe Generale de Surveillance SA
Sotera Health Co
West Pharmaceutical Services, Inc.
WuXi AppTec Co., Ltd.

簡介目錄

Product Code: 8466

Extractable and Leachable Testing Services Market size is projected to expand at over 13.6% CAGR from 2024 to 2032. The stringent regulatory requirements and guidelines, particularly in the pharmaceutical and biotechnology sectors are mandating thorough testing to ensure product safety and compliance. The increasing awareness of the importance of extractable and leachable testing in ensuring product quality and patient safety is driving their appeal.

The growing adoption of single-use systems and materials in manufacturing processes is further necessitating comprehensive testing for potential contaminants. Rapid advancements in analytical technologies and methodologies are encouraging the development novel testing services. For instance, in July 2023, Broughton, a scientific consultancy, and contract research organization (CRO), introduced a new extractables and leachables (E&L) testing service, to assist pharmaceutical and consumer healthcare companies to bring their products safely and efficiently. The expansion of the healthcare and food sectors coupled with rapid rate of globalization will also spur the market growth.

The extractable and leachable testing services industry is segregated into product type, application, and region.

Based on product type, the market size from the single-use systems segment is estimated to depict 13.9% growth rate from 2024 to 2032. The increasing adoption of single-use systems in biopharmaceutical manufacturing is spurring the demand for comprehensive testing to ensure product safety. The focus of regulatory agencies on risk mitigation and product quality is also necessitating thorough extractable and leachable testing for single-use components.

Extractable and leachable testing services market from the ophthalmic drug products application segment is estimated to rise at 13% CAGR until 2032. The sensitive nature of ophthalmic drug products is necessitating rigorous testing to ensure patient safety. The stringent requirements of regulatory agencies for product quality and safety are mandating comprehensive extractable and leachable testing. The increasing innovations and developments in ophthalmic drug formulations will also drive the demand for testing services.

Regionally, the Asia Pacific extractable and leachable testing services market will witness 14.2% CAGR from 2024 to 2032. The expanding pharmaceutical and biotechnology industries in China and India is surging the demand for testing services to ensure product quality and compliance. Increasing regulatory scrutiny and the adoption of international quality standards is also necessitating thorough testing. The rising awareness of the importance of extractable and leachable testing in ensuring product safety will fuel the regional market expansion.

Chapter 1 Methodology & Scope

1.1 Market scope & definition
1.2 Base estimates & calculations
1.3 Data collection
1.4 Forecast parameters
1.5 Data validation
1.6 Data sources
- 1.6.1 Primary
- 1.6.2 Secondary
  - 1.6.2.1 Paid sources
  - 1.6.2.2 Public sources

Chapter 2 Executive Summary

2.1 Industry 360 degree synopsis

Chapter 3 Industry Insights

3.1 Industry ecosystem analysis
3.2 Industry impact forces
- 3.2.1 Growth drivers
  - 3.2.1.1 Supportive regulatory framework and rising emphasis on patient safety
  - 3.2.1.2 Growing pharmaceutical and biotechnology industry
  - 3.2.1.3 Widespread adoption of single-use technology
- 3.2.2 Industry pitfalls & challenges
  - 3.2.2.1 High cost of testing
  - 3.2.2.2 Complexity associated with extractable and leachable testing
3.3 Growth potential analysis
3.4 Technological landscape
3.5 Regulatory landscape
3.6 Porter's analysis
- 3.6.1 Supplier power
- 3.6.2 Buyer power
- 3.6.3 Threat of new entrants
- 3.6.4 Threat of substitutes
- 3.6.5 Industry rivalry
3.7 PESTEL analysis

Chapter 4 Competitive Landscape, 2023

4.1 Introduction
4.2 Company market share analysis
4.3 Competitive positioning matrix
4.4 Strategy outlook matrix

Chapter 5 Market Estimates and Forecast, By Product Type, 2018 - 2032 ($ Mn)

5.1 Key trends
5.2 Container closure systems
5.3 Single-use systems
5.4 Drug delivery systems
5.5 Other product types

Chapter 6 Market Estimates and Forecast, By Application, 2018 - 2032 ($ Mn)

6.1 Key trends
6.2 Parenteral drug products
6.3 Orally inhaled and nasal drug products (OINDPs)
6.4 Ophthalmic drug products

Chapter 7 Market Estimates and Forecast, By Region, 2018 - 2032 ($ Mn)

7.1 Key trends
7.2 North America
- 7.2.1 U.S.
- 7.2.2 Canada
7.3 Europe
- 7.3.1 Germany
- 7.3.2 UK
- 7.3.3 France
- 7.3.4 Spain
- 7.3.5 Italy
- 7.3.6 Rest of Europe
7.4 Asia Pacific
- 7.4.1 Japan
- 7.4.2 China
- 7.4.3 India
- 7.4.4 Australia
- 7.4.5 South Korea
- 7.4.6 Rest of Asia Pacific
7.5 Latin America
- 7.5.1 Brazil
- 7.5.2 Argentina
- 7.5.3 Mexico
- 7.5.4 Rest of Latin America
7.6 Middle East and Africa
- 7.6.1 South Africa
- 7.6.2 Saudi Arabia
- 7.6.3 UAE
- 7.6.4 Rest of Middle East and Africa