추출물 및 침출물(E&L) 시험 서비스 시장 규모, 점유율, 동향 분석 보고서 : 제품별, 용도별, 지역별, 부문별 예측(2023-2030년)

Extractable And Leachable Testing Services Market Growth & Trends:

The global extractable and leachable testing services market size is expected to reach a value of USD 2.57 billion by 2030, according to a new report by Grand View Research, Inc.., exhibiting a CAGR of 15.13% from 2023 to 2030. The market is expanding due to several factors, including the rising demand for biopharmaceuticals and the increasing concern about cross-contamination and patient safety. E&L testing ensures the identification of potential sources of contamination and helps in delivering safe and compatible drug products.

The significant growth in bioprocess engineering innovations has driven notable advancements in single-use systems. The increased adoption of biopharmaceuticals has further fueled progress in this field. Additionally, a growing number of studies evaluating the efficacy of single-use bioprocesses are raising awareness about these technologies. Single-use systems offer numerous advantages, including reduced risk of cross-contamination, faster turnaround times, cost-effectiveness, and greater flexibility in adjusting production volumes. Thus, the rising demand for single-use systems is anticipated to propel the growth of the market over the period of time.

Furthermore, the evolving regulatory norms have created significant demand for E&L testing capabilities to analyze healthcare products. This encouraged E&L testing service providers to develop precise and custom testing solutions. For instance, in November 2022, Smithers organized the Europe E&L conference in Germany. The company has been organizing such events past 15 years. These conferences focus on the growing importance of E&L testing and updates about dynamic regulations for E&L testing. Thus, such initiatives are anticipated to fuel the growth of the market over the forecast period.

The leachable and extractable testing services are crucial in identifying foreign substances in single-use systems and finished formulations that could potentially impact human health. However, these services are complex and subject to change due to factors like evolving regulatory requirements, diverse product types, various analytical techniques, and result variations. Service providers must navigate these variables appropriately. For instance, a wide range of analytical techniques, including UPLC, HPLC, Q-TOF, FTIR, accelerated solvent extraction, and GC-TEA, are used for extractable analysis. Selecting the right analytical techniques for specific product types can be a challenging and intricate task.

Extractable And Leachable Testing Services Market Report Highlights:

• Based on product type, the container closure systems segment dominated with a market share of 31% in 2022, primarily due to its capacity to offer long-term stability.
• On the basis of application, the orally inhaled and nasal drug products segment accounted for the highest market share of 41.88% in 2022. The large share is mainly driven by the growing demand for novel drug delivery methods.
• In 2022, North America held the leading position with a revenue share of 43.71%. A large share of the region's widespread adoption of innovative technologies and biopharmaceuticals for clinical analysis and treatment. Additionally, government initiatives aimed at boosting research and development centers are expected to further drive market growth in the region. These factors are anticipated to boost the market for extractable and leachable testing services in the region over the forecast period.
• During the forecast period, the Asia Pacific demonstrated a significant growth among regions, with a remarkable CAGR of 15.32%. The region's rapid expansion in the biopharmaceutical industry results from the increasing demand for vaccine production, which, in turn, is driving the surge in the extraction and leachable testing services for such therapies.

Table of Contents

Chapter 1. Global Extractable and Leachable Testing Services Market: Methodology and Scope

• 1.1. Market Segmentation and Scope
  • 1.1.1. Segment Definitions
    • 1.1.1.1. Product Segment
    • 1.1.1.2. Application Segment
• 1.2. Regional Scope
• 1.3. Estimates and Forecast Timeline
• 1.4. Research Methodology
• 1.5. Information Procurement
  • 1.5.1. Purchased Database
  • 1.5.2. GVR's Internal Database
  • 1.5.3. Secondary Sources
  • 1.5.4. Primary Research
• 1.6. Information or Data Analysis
• 1.7. Market Formulation & Validation
• 1.8. Market Model
  • 1.8.1. Commodity Flow Analysis
• 1.9. List of Secondary Sources
• 1.10. List of Abbreviations
• 1.11. Objectives
  • 1.11.1. Objective - 1
  • 1.11.2. Objective - 2

Chapter 2. Global Extractable and Leachable Testing Services Market: Executive Summary

• 2.1. Market Snapshot
• 2.2. Segment Snapshot
• 2.3. Competitive Landscape Snapshot

Chapter 3. Global Extractable and Leachable Testing Services Market Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent Market Outlook
  • 3.1.2. Related/Ancillary Market Outlook
• 3.2. Market Dynamics
• 3.3. Market Drivers Analysis
  • 3.3.1. Supportive regulatory framework and rising emphasis on patient safety
  • 3.3.2. Growing pharmaceutical and biotechnology industry
  • 3.3.3. Widespread adoption of single-use technology
• 3.4. Market Restraint Analysis
  • 3.4.1. Complexity associated with extractable and leachable testing
• 3.5. Industry Analysis Tools
  • 3.5.1. Porter's Five Forces Analysis
  • 3.5.2. PESTLE Analysis
  • 3.5.3. COVID-19 Impact Analysis: Global Extractable and Leachable Testing Services Market

Chapter 4. Global Extractable and Leachable Testing Services Market: Product Type Estimates & Trend Analysis

• 4.1. Global Extractable and Leachable Testing Services Market: Product Type Movement Analysis
• 4.2. Container Closure Systems
  • 4.2.1. Container Closure Systems Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.3. Single-use Systems
  • 4.3.1. Single-use Systems Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.4. Drug Delivery Systems
  • 4.4.1. Drug Delivery Systems Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.5. Others
  • 4.5.1. Others Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 5. Global Extractable and Leachable Testing Services Market: Application Estimates & Trend Analysis

• 5.1. Global Extractable and Leachable Testing Services Market: Application Movement Analysis
• 5.2. Parenteral Drug Products
  • 5.2.1. Parenteral Drug Products Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.3. Orally Inhaled and Nasal Drug Products
  • 5.3.1. Orally Inhaled and Nasal Drug Products Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.4. Ophthalmic
  • 5.4.1. Ophthalmic Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 6. Global Extractable and Leachable Testing Services Market: Regional Business Analysis

• 6.1. Regional Market Snapshot
• 6.2. North America
  • 6.2.1. North America Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
  • 6.2.2. U.S.
    • 6.2.2.1. Key Country Dynamics
    • 6.2.2.2. U.S. Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
    • 6.2.2.3. Competitive Scenario
    • 6.2.2.4. Regulatory Framework
  • 6.2.3. Canada
    • 6.2.3.1. Key Country Dynamics
    • 6.2.3.2. Canada Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
    • 6.2.3.3. Competitive Scenario
    • 6.2.3.4. Regulatory Framework
• 6.3. Europe
  • 6.3.1. Europe Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
  • 6.3.2. UK
    • 6.3.2.1. Key Country Dynamics
    • 6.3.2.2. UK Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
    • 6.3.2.3. Competitive Scenario
    • 6.3.2.4. Regulatory Framework
  • 6.3.3. Germany
    • 6.3.3.1. Key Country Dynamics
    • 6.3.3.2. Germany Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
    • 6.3.3.3. Competitive Scenario
    • 6.3.3.4. Regulatory Framework
  • 6.3.4. Spain
    • 6.3.4.1. Key Country Dynamics
    • 6.3.4.2. Spain Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
    • 6.3.4.3. Regulatory Framework
    • 6.3.4.4. Competitive Scenario
  • 6.3.5. France
    • 6.3.5.1. Key Country Dynamics
    • 6.3.5.2. France Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
    • 6.3.5.3. Competitive Scenario
    • 6.3.5.4. Regulatory Framework
  • 6.3.6. Italy
    • 6.3.6.1. Key Country Dynamics
    • 6.3.6.2. Italy Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
    • 6.3.6.3. Competitive Scenario
    • 6.3.6.4. Regulatory Framework
  • 6.3.7. Denmark
    • 6.3.7.1. Key Country Dynamics
    • 6.3.7.2. Denmark Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
    • 6.3.7.3. Competitive Scenario
    • 6.3.7.4. Regulatory Framework
  • 6.3.8. Sweden
    • 6.3.8.1. Key Country Dynamics
    • 6.3.8.2. Sweden Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
    • 6.3.8.3. Competitive Scenario
    • 6.3.8.4. Regulatory Framework
  • 6.3.9. Norway
    • 6.3.9.1. Key Country Dynamics
    • 6.3.9.2. Norway Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
    • 6.3.9.3. Competitive Scenario
    • 6.3.9.4. Regulatory Framework
• 6.4. Asia Pacific
  • 6.4.1. Asia Pacific Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
  • 6.4.2. Japan
    • 6.4.2.1. Key Country Dynamics
    • 6.4.2.2. Japan Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
    • 6.4.2.3. Competitive Scenario
    • 6.4.2.4. Regulatory Framework
  • 6.4.3. China
    • 6.4.3.1. Key Country Dynamics
    • 6.4.3.2. China Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
    • 6.4.3.3. Competitive Scenario
    • 6.4.3.4. Regulatory Framework
  • 6.4.4. India
    • 6.4.4.1. Key Country Dynamics
    • 6.4.4.2. India Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
    • 6.4.4.3. Regulatory Framework
    • 6.4.4.4. Competitive Scenario
  • 6.4.5. Australia
    • 6.4.5.1. Key Country Dynamics
    • 6.4.5.2. Australia Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
    • 6.4.5.3. Competitive Scenario
    • 6.4.5.4. Regulatory Framework
  • 6.4.6. South Korea
    • 6.4.6.1. Key Country Dynamics
    • 6.4.6.2. South Korea Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
    • 6.4.6.3. Competitive Scenario
    • 6.4.6.4. Regulatory Framework
  • 6.4.7. Thailand
    • 6.4.7.1. Key Country Dynamics
    • 6.4.7.2. Thailand Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
    • 6.4.7.3. Competitive Scenario
    • 6.4.7.4. Regulatory Framework
• 6.5. Latin America
  • 6.5.1. Latin America Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
  • 6.5.2. Brazil
    • 6.5.2.1. Key Country Dynamics
    • 6.5.2.2. Brazil Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
    • 6.5.2.3. Competitive Scenario
    • 6.5.2.4. Regulatory Framework
  • 6.5.3. Mexico
    • 6.5.3.1. Key Country Dynamics
    • 6.5.3.2. Mexico Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
    • 6.5.3.3. Competitive Scenario
    • 6.5.3.4. Regulatory Framework
  • 6.5.4. Argentina
    • 6.5.4.1. Key Country Dynamics
    • 6.5.4.2. Argentina Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
    • 6.5.4.3. Regulatory Framework
    • 6.5.4.4. Competitive Scenario
• 6.6. MEA
  • 6.6.1. MEA Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
  • 6.6.2. South Africa
    • 6.6.2.1. Key Country Dynamics
    • 6.6.2.2. South Africa Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
    • 6.6.2.3. Competitive Scenario
    • 6.6.2.4. Regulatory Framework
  • 6.6.3. Saudi Arabia
    • 6.6.3.1. Key Country Dynamics
    • 6.6.3.2. Saudi Arabia Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
    • 6.6.3.3. Competitive Scenario
    • 6.6.3.4. Regulatory Framework
  • 6.6.4. UAE
    • 6.6.4.1. Key Country Dynamics
    • 6.6.4.2. UAE Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
    • 6.6.4.3. Regulatory Framework
    • 6.6.4.4. Competitive Scenario
  • 6.6.5. Kuwait
    • 6.6.5.1. Key Country Dynamics
    • 6.6.5.2. Kuwait Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
    • 6.6.5.3. Competitive Scenario
    • 6.6.5.4. Regulatory Framework

Chapter 7. Global Extractable and Leachable Testing Services Market: Competitive Landscape

• 7.1. Company Categorization
• 7.2. Strategy Mapping
  • 7.2.1. Service Launch
  • 7.2.2. Partnerships & Collaboration
  • 7.2.3. Expansions
  • 7.2.4. Acquisition
  • 7.2.5. Others
• 7.3. Key Company Market Share Analysis, 2022
• 7.4. Company Profiles
  • 7.4.1. Eurofins Scientific
    • 7.4.1.1. Company Overview
    • 7.4.1.2. Financial Performance
    • 7.4.1.3. Product Benchmarking
    • 7.4.1.4. Strategic Initiatives
  • 7.4.2. Intertek Group plc
    • 7.4.2.1. Company Overview
    • 7.4.2.2. Financial Performance
    • 7.4.2.3. Product Benchmarking
    • 7.4.2.4. Strategic Initiatives
  • 7.4.3. SGS Societe Generale de Surveillance SA
    • 7.4.3.1. Company Overview
    • 7.4.3.2. Financial Performance
    • 7.4.3.3. Product Benchmarking
    • 7.4.3.4. Strategic Initiatives
  • 7.4.4. WuXi AppTec
    • 7.4.4.1. Company Overview
    • 7.4.4.2. Financial Performance
    • 7.4.4.3. Product Benchmarking
    • 7.4.4.4. Strategic Initiatives
  • 7.4.5. Merck KGaA
    • 7.4.5.1. Company Overview
    • 7.4.5.2. Financial Performance
    • 7.4.5.3. Product Benchmarking
    • 7.4.5.4. Strategic Initiatives
  • 7.4.6. West Pharmaceutical Services, Inc
    • 7.4.6.1. Company Overview
    • 7.4.6.2. Financial Performance
    • 7.4.6.3. Product Benchmarking
    • 7.4.6.4. Strategic Initiatives
  • 7.4.7. Wickham Micro Limited (Medical Engineering Technologies Ltd.)
    • 7.4.7.1. Company Overview
    • 7.4.7.2. Product Benchmarking
    • 7.4.7.3. Strategic Initiatives
  • 7.4.8. Pacific Biolabs
    • 7.4.8.1. Company Overview
    • 7.4.8.2. Product Benchmarking
    • 7.4.8.3. Strategic Initiatives
  • 7.4.9. Boston Analytical
    • 7.4.9.1. Company Overview
    • 7.4.9.2. Product Benchmarking
    • 7.4.9.3. Strategic Initiatives
  • 7.4.10. Sotera Health (Nelson Laboratories, LLC)
    • 7.4.10.1. Company Overview
    • 7.4.10.2. Financial Performance
    • 7.4.10.3. Product Benchmarking
    • 7.4.10.4. Strategic Initiatives