추출물 및 침출물 시험 서비스 시장 : 제품 유형별, 용도별 - 세계 예측(2024-2032년)

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.

Table of Contents

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

Chapter 8 Company Profiles

• 8.1 BA Sciences
• 8.2 Eurofins Scientific
• 8.3 Intertek Group plc
• 8.4 Limerston Capital LLP
• 8.5 Merck & Co., Inc.
• 8.6 Pacific Biolabs, Inc.
• 8.7 SGS Societe Generale de Surveillance SA
• 8.8 Sotera Health Co
• 8.9 West Pharmaceutical Services, Inc.
• 8.10 WuXi AppTec Co., Ltd.