[시장보고서]세계의 추출물 및 침출물 시험 서비스 시장 - 규모, 점유율, 동향 분석 보고서 : 제품 유형별, 용도별, 지역별 부문 예측(2025-2033년)

세계의 추출물 및 침출물 시험 서비스 시장 - 규모, 점유율, 동향 분석 보고서 : 제품 유형별, 용도별, 지역별 부문 예측(2025-2033년)

Extractable And Leachable Testing Services Market Size, Share & Trends Analysis Report By Product Type, By Application, By Region, And Segment Forecasts, 2025 - 2033

상품코드 : 1869729

리서치사 : Grand View Research

발행일 : 2025년 10월

페이지 정보 : 영문 100 Pages

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한글목차

샘플 요청 목록에 추가

추출물 및 침출물 시험 서비스 시장 요약

세계의 추출물 및 침출물 시험 서비스 시장 규모는 2024년 11억 3,000만 달러로 추정되었으며, 2033년까지 35억 7,000만 달러에 이를 것으로 예측됩니다.

2025년부터 2033년까지 연평균 복합 성장률(CAGR) 14.3%로 성장할 전망입니다. 세계적으로 확대되는 제약 및 바이오테크놀러지 분야가 추출물 및 침출물 시험 서비스 수요를 견인하고 있습니다.

또한 의료제품 품질에 대한 규제당국의 감시 강화, 생물학적 제제 및 복합제품 등의 복잡한 약제 제제 증가, 제품 안전성 중시가 시장의 성장을 더욱 촉진할 것으로 예측됩니다. COVID-19 팬데믹은 추출 및 용출 시험 서비스에 긍정적인 영향을 미쳤습니다. 팬데믹 하에서 의료 및 의약품에 대한 주목도의 높아짐에 따라 의료 제품의 안전성과 유효성을 확보하기 위한 엄격한 시험의 중요성에 대한 인식이 깊어졌습니다. 그 결과, 추출물 및 침출물 시험 서비스는 더 많은 인지와 투자를 얻고, 시험 기법, 장비, 전문 지식의 진보로 이어지고 있습니다. 제약 및 의료기기 산업은 안전과 규정 준수에 대한 강한 노력을 유지하면서 혁신적인 제품을 제공하기 위한 R&D 노력을 가속화할 수 있었습니다. WHO의 기사에 따르면 2021년에는 약 160억 회분의 백신(1,410억 달러 상당)이 공급되었으며, 이는 2019년 시장 규모(58억 회분)의 약 3배, 시장가치(380억 달러)의 약 3.5배에 해당합니다. 그러므로 팬데믹 하에서 백신 수요 증가는 추출물 및 침출물 시험 서비스 수요 증가를 뒷받침했습니다.

제약 및 바이오테크놀러지 산업은 기술의 진보, 신규 의약품에 대한 수요 증가, 만성 질환의 발생률 및 유병률 상승에 의해 최근 급속히 성장하고 있습니다. 이에 따라 신규 치료제 개발을 위한 연구개발 활동도 활발해지고 있습니다. 예를 들어 2022년 미국 식품의약국(FDA) 의약품평가연구센터(CDER)는 신규 분자실체 또는 신규 치료용 생물학적 제제로 37개의 신약을 승인했습니다. 이와 같이 제약업계에서의 활발한 제품 개발 및 상업화가 추출물 및 침출물 시험 서비스 수요 증가를 견인하고 있습니다.

또한 의료기기 및 제약 업계에서 환자 안전은 최우선 과제이며 최종 제품의 안전을 보장하기 위해 많은 노력을 기울이고 있습니다. 제약기업은 침출물 및 추출물 시험을 위한 견고한 수법개발에 다액의 투자를 실시했습니다. Merck KGaA에 따르면, 침출물 및 추출물은 용기에서 제제로 이동하여 독성 및 유해한 약물 반응과 같은 심각한 부작용을 일으킬 수 있는 화합물입니다. 이를 완화하기 위해 회사는 사전 인증된 2차 인증 표준물질(CRM)과 즉시 사용 가능한 CRM 혼합물을 개발했습니다. 이 표준은 ISO 17025 및 17034 인증을 받았습니다. 이 회사의 이 지침 물질은 추출물 및 침출물 테스트 서비스를 제공하는 분석 연구소의 표준 작업 절차(SOP) 역할을 합니다. 이로 인해 예측 기간 동안 추출물 및 침출물 테스트 서비스에 대한 수요가 증가할 것으로 예측됩니다.

게다가, FDA나 미국 약전(USP) 등 규제 당국의 존재가, 제조자에 대해 자사 제품의 추출물 및 침출물 시험을 추진하고 있습니다. 또한 공정 확대를 위한 단일 사용 기술의 활용 증가와 시장 기업의 다양한 전략적 노력이 시장에 수익성 있는 성장 기회를 창출할 가능성이 높습니다. 예를 들어, 2022년 5월에는 Pacific BioLabs가 바이오의약품, 제약, 의료기기 산업을 지원하는 'In Vitro Services'를 시작했습니다. 이 서비스는 회사의 분석 및 생물 분석 부문 및 생체 내부 부문에서의 시험 능력 확대에 기여했습니다. 따라서 위 요인은 이 국가의 시장을 지원합니다.

기업 분류
전략 매핑
기업시장 포지셔닝 분석, 2024년
기업 프로파일
Eurofins Scientific
Intertek Group plc
SGS Societe Generale de Surveillance SA
WuXi AppTec
Merck KGaA
West Pharmaceutical Services, Inc
Wickham Micro Limited(Medical Engineering Technologies Ltd.)
Pacific Biolabs
Boston Analytical
Sotera Health(Nelson Laboratories, LLC)

JHS

영문 목차

영문목차

Extractable And Leachable Testing Services Market Summary

The global extractable and leachable testing services market size was estimated at USD 1.13 billion in 2024 and is expected to reach USD 3.57 billion by 2033, growing at a CAGR of 14.3% from 2025 to 2033. The expanding pharmaceutical and biotechnology sectors across the world are fueling the demand for E&L testing services.

Moreover, increasing regulatory scrutiny on the quality of healthcare products, the rise of complex drug formulations, such as biologics and combination products, and rising emphasis on product safety are further anticipated to propel the market growth. The COVID-19 pandemic had positively impacted extractable and leachable testing services. With the heightened focus on healthcare and pharmaceuticals during the pandemic, there has been an increased awareness of the importance of rigorous testing to ensure the safety and efficacy of medical products. As a result, extractable and leachable testing services have gained more recognition and investment, leading to advancements in testing methodologies, equipment, and expertise. The pharmaceutical and medical device industries have been able to accelerate their research and development efforts to deliver innovative products while maintaining a strong commitment to safety and compliance. According to a WHO article, nearly 16 billion vaccine doses worth USD 141 billion were supplied in 2021, nearly thrice the market volume of 2019 (5.8 billion) and nearly three-and-a-half times the market value of 2019 (USD 38 billion). Thus, the increased demand for vaccines during the pandemic boosted the demand for extractable and leachable testing services.

The pharmaceutical and biotechnology industry has been rapidly growing in recent years due to advancements in technology, increased demand for novel drugs, and a growing incidence & prevalence of chronic diseases. This has also led to increased R&D activities for the creation of novel therapeutics. For instance, in 2022, the U.S. FDA's Center for Drug Evaluation and Research (CDER) approved 37 new drugs, either as new molecular entities or as new therapeutic biological products. Thus, high product development and commercialization by pharmaceutical industries created a higher demand for extractable and leachable testing services.

Furthermore, patient safety is the top priority for medical devices and pharmaceutical industries and they are making significant efforts to safeguard the final product. Pharmaceutical companies are investing largely to develop robust methods for leachable and extractable testing. According to Merck KGaA, leachable and extractable are compounds that can migrate from the container to the formulation and can produce serious adverse effects such as toxicity and adverse drug reactions. To mitigate this, the company developed its pre-qualified secondary Certified Reference Materials (CRMs) and ready-to-use CRM mixtures. This reference material is certified ISO 17025 and 17034. This guidance material from the company can act as SOP for analytical laboratories providing extractable & leachable testing services. Thereby increasing the demand for extractable and leachable testing services over the forecast period.

Moreover, the presence of regulatory authorities, such as the FDA and the U.S. Pharmacopeia (USP), is pushing manufacturers to test their products for E&L substances. In addition, the rising use of single-use technologies for scaling up the process and various strategic initiatives undertaken by market players will likely create lucrative growth opportunities for the market. For instance, in May 2022, Pacific BioLabs launched In Vitro Services to support the biopharma, pharmaceuticals, and medical device industries. This service aided in the expansion of the company's testing capabilities in analytical/bioanalytical and in vivo departments. Hence, the above-mentioned factors support the country's market.

Global Extractable And Leachable Testing Services Market Report Segmentation

This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global extractable and leachable testing services market based on product type, application, and region:

Product Type Outlook (Revenue, USD Million, 2021 - 2033)
Container Closure Systems
Single-use Systems
Drug Delivery Systems
Others
Application Outlook (Revenue, USD Million, 2021 - 2033)
Parenteral Drug Products
Orally Inhaled and Nasal Drug Products (OINDP)
Ophthalmic
Regional Outlook (Revenue, USD Million, 2021 - 2033)
North America
- U.S.
- Canada
- Mexico
Europe
- UK
- Germany
- France
- Italy
- Spain
- Denmark
- Sweden
- Norway
Asia Pacific
- Japan
- China
- India
- Australia
- South Korea
- Thailand
Latin America
- Brazil
- Argentina
MEA
- South Africa
- Saudi Arabia
- UAE
- Kuwait

Chapter 1. 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. Executive Summary

2.1. Market Outlook
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
- 3.2.1. Market Drivers Analysis
  - 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. Market Restraint Analysis
  - 3.2.2.1. Complexity associated with extractable and leachable testing
3.3. Porter's Five Forces Analysis
3.4. PESTLE Analysis

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

4.1. Product Type Segment Dashboard
4.2. Extractable and Leachable Testing Services Market Product Type Movement Analysis
4.3. Extractable and Leachable Testing Services Market Size & Trend Analysis, by Product Type, 2021 to 2033 (USD Million)
4.4. Container Closure Systems
- 4.4.1. Container Closure Systems Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.5. Single-use Systems
- 4.5.1. Single-use Systems Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.6. Drug Delivery Systems
- 4.6.1. Drug Delivery Systems Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.7. Others
- 4.7.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

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

5.1. Application Segment Dashboard
5.2. Extractable and Leachable Testing Services Market Application Movement Analysis
5.3. Extractable and Leachable Testing Services Market Size & Trend Analysis, by Application, 2021 to 2033 (USD Million)
5.4. Parenteral Drug Products
- 5.4.1. Parenteral Drug Products Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.5. Orally Inhaled and Nasal Drug Products
- 5.5.1. Orally Inhaled and Nasal Drug Products Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.6. Ophthalmic
- 5.6.1. Ophthalmic Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)

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

6.1. Regional Dashboard
6.2. Market Size & Forecast and Trend Analysis, 2024 & 2033
6.3. North America
- 6.3.1. North America Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
- 6.3.2. U.S.
  - 6.3.2.1. Key Country Dynamics
  - 6.3.2.2. Competitive Scenario
  - 6.3.2.3. Regulatory Framework
  - 6.3.2.4. U.S. Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
- 6.3.3. Canada
  - 6.3.3.1. Key Country Dynamics
  - 6.3.3.2. Competitive Scenario
  - 6.3.3.3. Regulatory Framework
  - 6.3.3.4. Canada Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
- 6.3.4. Mexico
  - 6.3.4.1. Key Country Dynamics
  - 6.3.4.2. Competitive Scenario
  - 6.3.4.3. Regulatory Framework
  - 6.3.4.4. Mexico Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
6.4. Europe
- 6.4.1. Europe Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
- 6.4.2. UK
  - 6.4.2.1. Key Country Dynamics
  - 6.4.2.2. Competitive Scenario
  - 6.4.2.3. Regulatory Framework
  - 6.4.2.4. UK Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
- 6.4.3. Germany
  - 6.4.3.1. Key Country Dynamics
  - 6.4.3.2. Competitive Scenario
  - 6.4.3.3. Regulatory Framework
  - 6.4.3.4. Germany Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
- 6.4.4. France
  - 6.4.4.1. Key Country Dynamics
  - 6.4.4.2. Competitive Scenario
  - 6.4.4.3. Regulatory Framework
  - 6.4.4.4. France Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
- 6.4.5. Italy
  - 6.4.5.1. Key Country Dynamics
  - 6.4.5.2. Competitive Scenario
  - 6.4.5.3. Regulatory Framework
  - 6.4.5.4. Italy Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
- 6.4.6. Spain
  - 6.4.6.1. Key Country Dynamics
  - 6.4.6.2. Competitive Scenario
  - 6.4.6.3. Regulatory Framework
  - 6.4.6.4. Spain Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
- 6.4.7. Denmark
  - 6.4.7.1. Key Country Dynamics
  - 6.4.7.2. Competitive Scenario
  - 6.4.7.3. Denmark Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
- 6.4.8. Sweden
  - 6.4.8.1. Key Country Dynamics
  - 6.4.8.2. Competitive Scenario
  - 6.4.8.3. Regulatory Framework
  - 6.4.8.4. Sweden Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
- 6.4.9. Norway
  - 6.4.9.1. Key Country Dynamics
  - 6.4.9.2. Competitive Scenario
  - 6.4.9.3. Regulatory Framework
  - 6.4.9.4. Norway Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
6.5. Asia Pacific
- 6.5.1. Asia Pacific Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
- 6.5.2. Japan
  - 6.5.2.1. Key Country Dynamics
  - 6.5.2.2. Competitive Scenario
  - 6.5.2.3. Japan Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
- 6.5.3. China
  - 6.5.3.1. Key Country Dynamics
  - 6.5.3.2. Competitive Scenario
  - 6.5.3.3. China Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
- 6.5.4. India
  - 6.5.4.1. Key Country Dynamics
  - 6.5.4.2. Competitive Scenario
  - 6.5.4.3. Regulatory Framework
  - 6.5.4.4. India Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
- 6.5.5. Australia
  - 6.5.5.1. Key Country Dynamics
  - 6.5.5.2. Competitive Scenario
  - 6.5.5.3. Regulatory Framework
  - 6.5.5.4. Australia Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
- 6.5.6. Thailand
  - 6.5.6.1. Key Country Dynamics
  - 6.5.6.2. Competitive Scenario
  - 6.5.6.3. Regulatory Framework
  - 6.5.6.4. Thailand Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
- 6.5.7. South Korea
  - 6.5.7.1. Key Country Dynamics
  - 6.5.7.2. Competitive Scenario
  - 6.5.7.3. Regulatory Framework
  - 6.5.7.4. South Korea Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
6.6. Latin America
- 6.6.1. Latin America Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
- 6.6.2. Brazil
  - 6.6.2.1. Key Country Dynamics
  - 6.6.2.2. Competitive Scenario
  - 6.6.2.3. Regulatory Framework
  - 6.6.2.4. Brazil Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
- 6.6.3. Argentina
  - 6.6.3.1. Key Country Dynamics
  - 6.6.3.2. Competitive Scenario
  - 6.6.3.3. Regulatory Framework
  - 6.6.3.4. Argentina Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
6.7. MEA
- 6.7.1. MEA Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
- 6.7.2. South Africa
  - 6.7.2.1. Key Country Dynamics
  - 6.7.2.2. Competitive Scenario
  - 6.7.2.3. Regulatory Framework
  - 6.7.2.4. South Africa Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
- 6.7.3. Saudi Arabia
  - 6.7.3.1. Key Country Dynamics
  - 6.7.3.2. Competitive Scenario
  - 6.7.3.3. Regulatory Framework
  - 6.7.3.4. Saudi Arabia Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
- 6.7.4. UAE
  - 6.7.4.1. Key Country Dynamics
  - 6.7.4.2. Competitive Scenario
  - 6.7.4.3. Regulatory Framework
  - 6.7.4.4. UAE Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)
- 6.7.5. Kuwait
  - 6.7.5.1. Key Country Dynamics
  - 6.7.5.2. Competitive Scenario
  - 6.7.5.3. Regulatory Framework
  - 6.7.5.4. Kuwait Extractable and Leachable Testing Services Market, 2021 - 2033 (USD Million)

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

7.1. Company Categorization
7.2. Strategy Mapping
7.3. Company Market Position Analysis, 2024
7.4. Company Profiles/Listing
- 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

한글목차

추출물 및 침출물 시험 서비스 시장 요약

목차

제1장 조사 방법과 범위

제2장 주요 요약

제3장 세계 추출물 및 침출물 시험 서비스 시장의 변수, 동향, 범위

제4장 세계의 추출물 및 침출물 시험 서비스 시장 : 제품 유형별 추정 및 동향 분석

제5장 세계의 추출물 및 침출물 시험 서비스 시장 : 용도별 추정 및 동향 분석

제6장 세계의 추출물 및 침출물 시험 서비스 시장 : 지역별 비즈니스 분석

제7장 세계의 추출물 및 침출물 시험 서비스 시장 : 경쟁 구도