可提取和可浸出测试服务市场 - 按产品类型（容器封闭系统、一次性系统、药物输送系统）、应用（肠胃外药物产品、口服吸入和鼻腔药物产品） - 全球预测 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个工作天内

价格

简介目录

可提取和可浸出测试服务市场规模预计从2024 年到2032 年将以超过13.6% 的复合年增长率扩大。以确保产品安全和合规性。人们越来越认识到可萃取物和可浸出物测试在确保产品品质和病人安全方面的重要性，这推动了它们的吸引力。

在製造过程中越来越多地采用一次性系统和材料，进一步需要对潜在污染物进行全面测试。分析技术和方法的快速进步正在鼓励开发新颖的测试服务。例如，2023 年 7 月，科学咨询和合约研究组织 (CRO) Broughton 推出了新的可萃取物和可浸出物 (E&L) 测试服务，以帮助製药和消费者保健公司安全高效地生产其产品。医疗保健和食品产业的扩张加上全球化的快速发展也将刺激市场成长。

可萃取和可浸出测试服务业按产品类型、应用和地区划分。

根据产品类型，从2024 年到2032 年，一次性系统细分市场的市场规模预计将增长13.9%。安全。监管机构对风险缓解和产品品质的关注还需要对一次性成分进行彻底的可提取和可浸出测试。

到 2032 年，眼科药品应用领域的可提取和可浸出测试服务市场预计将以 13% 的复合年增长率增长。监管机构对产品品质和安全的严格要求要求进行全面的可提取和可浸出测试。眼科药物配方的不断创新和发展也将推动对检测服务的需求。

从地区来看，2024年至2032年，亚太地区可萃取物和可浸出物检测服务市场的复合年增长率将达到14.2%。需求，以确保产品品质和合规性。加强监管审查和采用国际品质标准也需要彻底的测试。人们越来越认识到可萃取物和可浸出物测试在确保产品安全方面的重要性，这将推动区域市场的扩张。

产业生态系统分析
产业影响力
- 成长动力
  - 支持性监管框架和对病人安全的日益重视
  - 不断发展的製药和生技产业
  - 广泛采用一次性技术
- 产业陷阱与挑战
  - 测试成本高
  - 与可萃取和可浸出测试相关的复杂性
成长潜力分析
技术景观
监管环境
波特的分析
PESTEL分析

第 4 章：竞争格局

介绍
公司市占率分析
竞争定位矩阵
战略展望矩阵

第 5 章：市场估计与预测：按产品类型，2018 年 - 2032 年

主要趋势
容器封闭系统
免洗系统
药物输送系统
其他产品类型

第 6 章：市场估计与预测：按应用划分，2018 年 - 2032 年

主要趋势
肠胃外药物产品
口服吸入和鼻腔药物产品 (OINDP)
眼科药品

第 7 章：市场估计与预测：按地区划分，2018 年 - 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
- 欧洲其他地区
亚太地区
- 日本
- 中国
- 印度
- 澳洲
- 韩国
- 亚太地区其他地区
拉丁美洲
- 巴西
- 阿根廷
- 墨西哥
- 拉丁美洲其他地区
中东和非洲
- 南非
- 沙乌地阿拉伯
- 阿联酋
- 中东和非洲其他地区

第 8 章：公司简介

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.

简介目录

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