医薬品バリデーションサービス市場- 世界の産業規模、シェア、動向、機会、予測、タイプ別、用途別、地域別、競合別セグメント、2020-2030年

医薬品バリデーションサービスの世界市場規模は2024年に82億1,000万米ドルで、予測期間には115億2,000万米ドルに達し、2030年までのCAGRは5.78%になると予測されています。

医薬品バリデーションサービスの世界市場は、医薬品業界の中でもダイナミックで重要なセクターであり、医薬品およびプロセスの安全性、品質、コンプライアンスを確保することに専念しています。医薬品バリデーションサービスは、厳格な規制要件を満たし、製品の完全性を維持し、業務効率を高めるために設計された様々な活動や手順を包括しています。製薬業界は複雑化し続け、医薬品の製造と流通を管理する規制も厳しくなっているため、バリデーションサービスに対する需要は近年大幅に急増しています。この市場の成長は、いくつかの重要な要因によるものです。

市場促進要因

厳しい規制要件

主な市場課題

バリデーションサービスの高コスト

主な市場動向

医薬品開発と製造の複雑化

目次

第1章 概要

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 顧客の声

第5章 世界の医薬品バリデーションサービス市場展望

• 市場規模・予測
  • 金額別
• 市場シェア・予測
  • 種類別（医薬品洗浄バリデーションサービス、医薬品機器バリデーションサービス、その他）
  • 用途別（製薬会社、バイオテクノロジー会社、学術調査機関）
  • 企業別（2024）
  • 地域別
• 市場マップ

第6章 北米の医薬品バリデーションサービス市場展望

• 市場規模・予測
• 市場シェア・予測
• 北米：国別分析
  • 米国
  • メキシコ
  • カナダ

第7章 欧州の医薬品バリデーションサービス市場展望

• 市場規模・予測
• 市場シェア・予測
• 欧州：国別分析
  • フランス
  • ドイツ
  • 英国
  • イタリア
  • スペイン

第8章 アジア太平洋地域の医薬品バリデーションサービス市場展望

• 市場規模・予測
• 市場シェア・予測
• アジア太平洋地域：国別分析
  • 中国
  • インド
  • 韓国
  • 日本
  • オーストラリア

第9章 南米の医薬品バリデーションサービス市場展望

• 市場規模・予測
• 市場シェア・予測
• 南米：国別分析
  • ブラジル
  • アルゼンチン
  • コロンビア

第10章 中東・アフリカの医薬品バリデーションサービス市場展望

• 市場規模・予測
• 市場シェア・予測
• 中東・アフリカ：国別分析
  • 南アフリカ
  • サウジアラビア
  • アラブ首長国連邦

第11章 市場力学

• 促進要因
• 課題

第12章 市場動向と発展

• 最近の動向
• 製品上市
• 合併と買収

第13章 PESTEL分析

第14章 ポーターのファイブフォース分析

• 業界内の競合
• 新規参入の可能性
• サプライヤーの力
• 顧客の力
• 代替品の脅威

第15章 競合情勢

• 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 戦略的提言

第17章 調査会社について・免責事項

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.

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