查看购物车
  • Traditional Chinese
  • English
  • Japanese
  • Korean
封面
市场调查报告书
商品编码
1703328

药品验证服务市场－全球产业规模、份额、趋势、机会和预测（按类型、应用、地区和竞争细分，2020-2030 年）

Pharmaceutical Validation Services Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type, By Application, By Region and Competition, 2020-2030F
出版日期: | 出版商: TechSci Research | 英文 187 Pages | 商品交期: 2-3个工作天内

价格

We offer 8 hour analyst time for an additional research. Please contact us for the details.

简介目录

2024 年全球药品验证服务市场价值为 82.1 亿美元，预计到 2030 年将达到 115.2 亿美元，复合年增长率为 5.78%。全球药品验证服务市场是更广泛的製药业中一个充满活力且至关重要的部门，致力于确保药品和製程的安全性、品质和合规性。药品验证服务涵盖一系列活动和程序，旨在满足严格的监管要求、维护产品完整性并提高营运效率。随着製药业日益复杂以及药品生产和分销监管的日益严格，近年来对验证服务的需求大幅增加。该市场的成长可归因于几个关键因素。

市场概览
预测期 2026-2030
2024年市场规模 82.1亿美元
2030年市场规模 115.2亿美元
2025-2030 年复合年增长率 5.78%
成长最快的领域 製药设备验证服务
最大的市场 北美洲

关键市场驱动因素

严格的监管要求

主要市场挑战

验证服务成本高昂

主要市场趋势

药物开发和製造的复杂性不断增加

目录

第 1 章：产品概述

第二章：研究方法

第三章：执行摘要

第四章：顾客之声

第五章：全球药品验证服务市场展望

  • 市场规模和预测
    • 按价值
  • 市场占有率和预测
    • 按类型（製药清洁验证服务、製药设备验证服务、其他）
    • 按应用（製药公司、生物技术公司、学术和研究机构）
    • 按公司分类（2024）
    • 按地区
  • 市场地图

第六章：北美药品验证服务市场展望

  • 市场规模和预测
  • 市场占有率和预测
  • 北美：国家分析
    • 美国
    • 墨西哥
    • 加拿大

第七章：欧洲药品验证服务市场展望

  • 市场规模和预测
  • 市场占有率和预测
  • 欧洲：国家分析
    • 法国
    • 德国
    • 英国
    • 义大利
    • 西班牙

第八章：亚太地区药品验证服务市场展望

  • 市场规模和预测
  • 市场占有率和预测
  • 亚太地区：国家分析
    • 中国
    • 印度
    • 韩国
    • 日本
    • 澳洲

第九章：南美洲药品验证服务市场展望

  • 市场规模和预测
  • 市场占有率和预测
  • 南美洲：国家分析
    • 巴西
    • 阿根廷
    • 哥伦比亚

第十章：中东和非洲药品验证服务市场展望

  • 市场规模和预测
  • 市场占有率和预测
  • MEA：国家分析
    • 南非
    • 沙乌地阿拉伯
    • 阿联酋

第 11 章：市场动态

  • 驱动程式
  • 挑战

第 12 章：市场趋势与发展

  • 最新动态
  • 产品发布
  • 併购

第 13 章： 大环境分析

第 14 章：波特五力分析

  • 产业竞争
  • 新进入者的潜力
  • 供应商的力量
  • 顾客的力量
  • 替代产品的威胁

第 15 章：竞争格局

  • Eucatech AG
  • MicroPort Scientific Corporation
  • Rontis Medical
  • Meril Life Sciences
  • Alvimedica Medical Technologies
  • InSitu Technologies
  • Elixir Medical
  • SINOMED Inc
  • Amaranth Medical Inc
  • Amg International

第 16 章：策略建议

第17章调查会社について・免责事项

简介目录
Product Code: 16784

Global Pharmaceutical Validation Services Market was valued at USD 8.21 Billion in 2024 and is expected to reach USD 11.52 Billion in the forecast period with a CAGR of 5.78% through 2030. The Global Pharmaceutical Validation Services Market is a dynamic and crucial sector within the broader pharmaceutical industry, dedicated to ensuring the safety, quality, and compliance of pharmaceutical products and processes. Pharmaceutical validation services encompass a range of activities and procedures designed to meet stringent regulatory requirements, maintain product integrity, and enhance operational efficiency. With the pharmaceutical industry's ever-growing complexity and the stringent regulations governing drug manufacturing and distribution, the demand for validation services has surged significantly in recent years. This market's growth can be attributed to several key factors.

Market Overview
Forecast Period2026-2030
Market Size 2024USD 8.21 Billion
Market Size 2030USD 11.52 Billion
CAGR 2025-20305.78%
Fastest Growing SegmentPharmaceutical Equipment Validation Services
Largest MarketNorth America

Key Market Drivers

Stringent Regulatory Requirements

Regulatory stringency is undeniably one of the most significant factors propelling the growth of the global pharmaceutical validation services market. In the pharmaceutical industry, adherence to stringent regulatory standards is paramount. Regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the International Council for Harmonization (ICH) have set forth comprehensive and increasingly stringent guidelines for drug manufacturing, quality control, and safety. Pharmaceutical companies must navigate a complex web of regulations to bring their products to market. Failure to comply with these rigorous standards can result in severe consequences, including product recalls, substantial fines, delays in drug approvals, and damage to a company's reputation. As a result, pharmaceutical companies are compelled to invest significantly in validation services.

Key Market Challenges

High Cost of Validation Services

Validation services in the pharmaceutical industry encompass a range of activities, including equipment validation, process validation, cleaning validation, and analytical method validation. These services are essential to ensure that pharmaceutical products are consistent, meet quality standards, and are safe for consumption. Regulatory bodies like the FDA and EMA have strict guidelines in place to ensure the quality and safety of pharmaceutical products, making validation services a non-negotiable aspect of drug manufacturing. Despite the unquestionable importance of validation services, their high cost presents a substantial barrier to both established pharmaceutical companies and emerging biotech startups. There are several reasons behind the escalating costs. Regulatory agencies continually update and tighten validation standards, leading to increased testing and documentation requirements, which drive up costs. Validation services require highly specialized knowledge and expertise, leading to a high demand for skilled professionals who often command high salaries. Validation processes can be time-consuming, as they involve extensive testing and data analysis, further adding to the costs. Rapid advancements in technology require frequent updates and upgrades to validation equipment and processes, contributing to cost inflation. The high cost of validation services is having a detrimental effect on the global pharmaceutical validation services market. It hinders the growth of small and medium-sized pharmaceutical companies and start-ups, limiting their ability to enter the market and innovate. Established companies also face financial pressures due to validation costs, which can impact their research and development efforts.

Key Market Trends

Increasing Drug Development and Manufacturing Complexity

Increasing drug development and manufacturing complexity significantly drive the growth of the global pharmaceutical validation services market. The pharmaceutical industry is witnessing a transformative shift towards more intricate drug development and manufacturing processes. This complexity arises from several sources, including the development of biotechnological products, advanced formulations, and innovative drug delivery methods. Biologics, for example, have gained prominence, necessitating stringent validation services due to their complexity and the need to ensure their safety and efficacy.

In 2023, the U.S. Food and Drug Administration (FDA) approved 34 new biologics, marking an all-time high. Furthermore, the FDA approved seven gene therapies in 2023, bringing the total number of approved gene therapies to 36 as of March 2024, with expectations of 10-20 approvals annually by 2025. These advancements not only require rigorous validation to comply with regulatory standards but also pose technical challenges that specialized validation services providers can address effectively. As pharmaceutical companies strive to bring cutting-edge therapies to market, they increasingly rely on validation services to navigate the complexities of drug development and manufacturing while ensuring the highest levels of quality, safety, and regulatory compliance. Consequently, the rising complexity in the pharmaceutical industry's products and processes serves as a catalyst for the continued expansion of the global pharmaceutical validation services market, making these services indispensable in the modern pharmaceutical landscape.

Key Market Players

  • Eucatech AG
  • MicroPort Scientific Corporation
  • Rontis Medical
  • Meril Life Sciences
  • Alvimedica Medical Technologies
  • InSitu Technologies
  • Elixir Medical
  • SINOMED Inc
  • Amaranth Medical Inc
  • Amg International

Report Scope:

In this report, the Global Pharmaceutical Validation Services Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Pharmaceutical Validation Services Market, By Type:

  • Pharmaceutical Cleaning Validation Services
  • Pharmaceutical Equipment Validation Services
  • Others

Pharmaceutical Validation Services Market, By Application:

  • Pharmaceutical Companies
  • Biotechnological Companies
  • Academic and Research Institutes

Pharmaceutical Validation Services Market, By Region:

  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • France
    • United Kingdom
    • Italy
    • Germany
    • Spain
  • Asia-Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
  • South America
    • Brazil
    • Argentina
    • Colombia
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Pharmaceutical Validation Services Market.

Available Customizations:

Global Pharmaceutical Validation Services market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

  • Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

  • 1.1. Market Definition
  • 1.2. Scope of the Market
    • 1.2.1. Markets Covered
    • 1.2.2. Years Considered for Study
    • 1.2.3. Key Market Segmentations

2. Research Methodology

  • 2.1. Objective of the Study
  • 2.2. Baseline Methodology
  • 2.3. Key Industry Partners
  • 2.4. Major Association and Secondary Sources
  • 2.5. Forecasting Methodology
  • 2.6. Data Triangulation & Validation
  • 2.7. Assumptions and Limitations

3. Executive Summary

  • 3.1. Overview of the Market
  • 3.2. Overview of Key Market Segmentations
  • 3.3. Overview of Key Market Players
  • 3.4. Overview of Key Regions/Countries
  • 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Pharmaceutical Validation Services Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Type (Pharmaceutical Cleaning Validation Services, Pharmaceutical Equipment Validation Services, Others)
    • 5.2.2. By Application (Pharmaceutical Companies, Biotechnological Companies, Academic and Research Institutes)
    • 5.2.3. By Company (2024)
    • 5.2.4. By Region
  • 5.3. Market Map

6. North America Pharmaceutical Validation Services Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Type
    • 6.2.2. By Application
    • 6.2.3. By Country
  • 6.3. North America: Country Analysis
    • 6.3.1. United States Pharmaceutical Validation Services Market Outlook
      • 6.3.1.1. Market Size & Forecast
        • 6.3.1.1.1. By Value
      • 6.3.1.2. Market Share & Forecast
        • 6.3.1.2.1. By Type
        • 6.3.1.2.2. By Application
    • 6.3.2. Mexico Pharmaceutical Validation Services Market Outlook
      • 6.3.2.1. Market Size & Forecast
        • 6.3.2.1.1. By Value
      • 6.3.2.2. Market Share & Forecast
        • 6.3.2.2.1. By Type
        • 6.3.2.2.2. By Application
    • 6.3.3. Canada Pharmaceutical Validation Services Market Outlook
      • 6.3.3.1. Market Size & Forecast
        • 6.3.3.1.1. By Value
      • 6.3.3.2. Market Share & Forecast
        • 6.3.3.2.1. By Type
        • 6.3.3.2.2. By Application

7. Europe Pharmaceutical Validation Services Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Type
    • 7.2.2. By Application
    • 7.2.3. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. France Pharmaceutical Validation Services Market Outlook
      • 7.3.1.1. Market Size & Forecast
        • 7.3.1.1.1. By Value
      • 7.3.1.2. Market Share & Forecast
        • 7.3.1.2.1. By Type
        • 7.3.1.2.2. By Application
    • 7.3.2. Germany Pharmaceutical Validation Services Market Outlook
      • 7.3.2.1. Market Size & Forecast
        • 7.3.2.1.1. By Value
      • 7.3.2.2. Market Share & Forecast
        • 7.3.2.2.1. By Type
        • 7.3.2.2.2. By Application
    • 7.3.3. United Kingdom Pharmaceutical Validation Services Market Outlook
      • 7.3.3.1. Market Size & Forecast
        • 7.3.3.1.1. By Value
      • 7.3.3.2. Market Share & Forecast
        • 7.3.3.2.1. By Type
        • 7.3.3.2.2. By Application
    • 7.3.4. Italy Pharmaceutical Validation Services Market Outlook
      • 7.3.4.1. Market Size & Forecast
        • 7.3.4.1.1. By Value
      • 7.3.4.2. Market Share & Forecast
        • 7.3.4.2.1. By Type
        • 7.3.4.2.2. By Application
    • 7.3.5. Spain Pharmaceutical Validation Services Market Outlook
      • 7.3.5.1. Market Size & Forecast
        • 7.3.5.1.1. By Value
      • 7.3.5.2. Market Share & Forecast
        • 7.3.5.2.1. By Type
        • 7.3.5.2.2. By Application

8. Asia-Pacific Pharmaceutical Validation Services Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Type
    • 8.2.2. By Application
    • 8.2.3. By Country
  • 8.3. Asia-Pacific: Country Analysis
    • 8.3.1. China Pharmaceutical Validation Services Market Outlook
      • 8.3.1.1. Market Size & Forecast
        • 8.3.1.1.1. By Value
      • 8.3.1.2. Market Share & Forecast
        • 8.3.1.2.1. By Type
        • 8.3.1.2.2. By Application
    • 8.3.2. India Pharmaceutical Validation Services Market Outlook
      • 8.3.2.1. Market Size & Forecast
        • 8.3.2.1.1. By Value
      • 8.3.2.2. Market Share & Forecast
        • 8.3.2.2.1. By Type
        • 8.3.2.2.2. By Application
    • 8.3.3. South Korea Pharmaceutical Validation Services Market Outlook
      • 8.3.3.1. Market Size & Forecast
        • 8.3.3.1.1. By Value
      • 8.3.3.2. Market Share & Forecast
        • 8.3.3.2.1. By Type
        • 8.3.3.2.2. By Application
    • 8.3.4. Japan Pharmaceutical Validation Services Market Outlook
      • 8.3.4.1. Market Size & Forecast
        • 8.3.4.1.1. By Value
      • 8.3.4.2. Market Share & Forecast
        • 8.3.4.2.1. By Type
        • 8.3.4.2.2. By Application
    • 8.3.5. Australia Pharmaceutical Validation Services Market Outlook
      • 8.3.5.1. Market Size & Forecast
        • 8.3.5.1.1. By Value
      • 8.3.5.2. Market Share & Forecast
        • 8.3.5.2.1. By Type
        • 8.3.5.2.2. By Application

9. South America Pharmaceutical Validation Services Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Type
    • 9.2.2. By Application
    • 9.2.3. By Country
  • 9.3. South America: Country Analysis
    • 9.3.1. Brazil Pharmaceutical Validation Services Market Outlook
      • 9.3.1.1. Market Size & Forecast
        • 9.3.1.1.1. By Value
      • 9.3.1.2. Market Share & Forecast
        • 9.3.1.2.1. By Type
        • 9.3.1.2.2. By Application
    • 9.3.2. Argentina Pharmaceutical Validation Services Market Outlook
      • 9.3.2.1. Market Size & Forecast
        • 9.3.2.1.1. By Value
      • 9.3.2.2. Market Share & Forecast
        • 9.3.2.2.1. By Type
        • 9.3.2.2.2. By Application
    • 9.3.3. Colombia Pharmaceutical Validation Services Market Outlook
      • 9.3.3.1. Market Size & Forecast
        • 9.3.3.1.1. By Value
      • 9.3.3.2. Market Share & Forecast
        • 9.3.3.2.1. By Type
        • 9.3.3.2.2. By Application

10. Middle East and Africa Pharmaceutical Validation Services Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Type
    • 10.2.2. By Application
    • 10.2.3. By Country
  • 10.3. MEA: Country Analysis
    • 10.3.1. South Africa Pharmaceutical Validation Services Market Outlook
      • 10.3.1.1. Market Size & Forecast
        • 10.3.1.1.1. By Value
      • 10.3.1.2. Market Share & Forecast
        • 10.3.1.2.1. By Type
        • 10.3.1.2.2. By Application
    • 10.3.2. Saudi Arabia Pharmaceutical Validation Services Market Outlook
      • 10.3.2.1. Market Size & Forecast
        • 10.3.2.1.1. By Value
      • 10.3.2.2. Market Share & Forecast
        • 10.3.2.2.1. By Type
        • 10.3.2.2.2. By Application
    • 10.3.3. UAE Pharmaceutical Validation Services Market Outlook
      • 10.3.3.1. Market Size & Forecast
        • 10.3.3.1.1. By Value
      • 10.3.3.2. Market Share & Forecast
        • 10.3.3.2.1. By Type
        • 10.3.3.2.2. By Application

11. Market Dynamics

  • 11.1. Drivers
  • 11.2. Challenges

12. Market Trends & Developments

  • 12.1. Recent Developments
  • 12.2. Product Launches
  • 12.3. Mergers & Acquisitions

13. PESTLE Analysis

14. Porter's Five Forces Analysis

  • 14.1. Competition in the Industry
  • 14.2. Potential of New Entrants
  • 14.3. Power of Suppliers
  • 14.4. Power of Customers
  • 14.5. Threat of Substitute Product

15. Competitive Landscape

  • 15.1. Eucatech AG
    • 15.1.1. Business Overview
    • 15.1.2. Company Snapshot
    • 15.1.3. Products & Services
    • 15.1.4. Financials (As Reported)
    • 15.1.5. Recent Developments
    • 15.1.6. Key Personnel Details
    • 15.1.7. SWOT Analysis
  • 15.2. MicroPort Scientific Corporation
  • 15.3. Rontis Medical
  • 15.4. Meril Life Sciences
  • 15.5. Alvimedica Medical Technologies
  • 15.6. InSitu Technologies
  • 15.7. Elixir Medical
  • 15.8. SINOMED Inc
  • 15.9. Amaranth Medical Inc
  • 15.10. Amg International

16. Strategic Recommendations

17. About Us & Disclaimer