医薬品溶出試験サービス市場-世界の産業規模、シェア、動向、機会、予測、サービス方法別、溶出器具別、剤形別、地域別、競合別、2020年～2030年

医薬品溶出試験サービスの世界市場は、2024年に7億234万米ドルとなり、2030年までには11億3,414万米ドルに達し、予測期間中のCAGRは8.31%で成長すると予測されています。

製薬業界が医薬品の品質、規制順守、治療効果を優先するにつれ、溶出試験サービスの需要が増加しています。これらのサービスは医薬品開発と品質管理に不可欠であり、固形製剤の溶出速度、バイオアベイラビリティ、in vivo性能に関する知見を提供します。溶出試験は、体内での薬物の放出をシミュレートし、メーカーが一貫性、安全性、治療効果を確保するのに役立ちます。世界的に規制の枠組みがますます厳しくなっているため、溶出試験は必須基準となっており、市場の需要をさらに押し上げています。医薬品の溶出プロファイルを継続的にモニタリングすることで、製薬企業は製剤や製造プロセスを改良し、製品の信頼性向上に貢献することができます。より複雑で革新的な製剤が開発されるにつれ、溶出試験サービスは、規制当局への申請やバッチ間の一貫性をサポートする上で不可欠なものとなりつつあり、医薬品研究開発および品質保証の重要な要素となっています。

主要な市場促進要因

医薬品研究開発の増加

主要な市場課題

規制遵守

主要な市場動向

医薬品開発活動の増加

目次

第1章 製品概要

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 世界の医薬品溶出試験サービス市場展望

• 市場規模・予測
  • 金額別
• 市場シェア・予測
  • サービス方法別（in vitro、in vivo）
  • 溶解器具別（バスケット、パドル、その他）
  • 剤形別（カプセル、錠剤、その他）
  • 企業別（2024年）
  • 地域別
• 市場マップ

第6章 北米の医薬品溶出試験サービス市場展望

• 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 欧州の医薬品溶出試験サービス市場展望

• 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 アジア太平洋の医薬品溶出試験サービス市場展望

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

第9章 南米の医薬品溶出試験サービス市場展望

• 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・アフリカの医薬品溶出試験サービス市場展望

• 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

• Intertek Group Plc
• Avivia BV
• Almac Group
• Agilent Technologies, Inc.
• Catalent, Inc.
• Thermofisher Scientific Inc.
• Charles River Laboratories
• Cambrex
• Boston Analytical
• Pace Analytical Life Sciences

第16章 戦略的提言

第17章 調査会社について・免責事項

The Global Pharmaceutical Dissolution Testing Services Market was valued at USD 702.34 Million in 2024 and is projected to reach USD 1134.14 Million by 2030, growing at a CAGR of 8.31% during the forecast period. As the pharmaceutical industry prioritizes drug quality, regulatory adherence, and therapeutic efficacy, the demand for dissolution testing services is on the rise. These services are vital in drug development and quality control, providing insights into the dissolution rate, bioavailability, and in vivo performance of solid dosage forms. Dissolution testing simulates the release of a drug in the body, helping manufacturers ensure consistency, safety, and therapeutic effectiveness. Increasingly stringent global regulatory frameworks have made dissolution testing a mandatory standard, further driving market demand. Through continuous monitoring of drug dissolution profiles, pharmaceutical firms can refine formulations and manufacturing processes, contributing to enhanced product reliability. As more complex and innovative drug formulations enter development, dissolution testing services are becoming indispensable in supporting regulatory submissions and batch-to-batch consistency, making them a critical component of pharmaceutical R&D and quality assurance.

Key Market Drivers

Rising Pharmaceutical R&D

The growth of pharmaceutical research and development is a key factor propelling the Global Pharmaceutical Dissolution Testing Services Market. With increasing investment in novel drug development and therapeutic innovation, the role of dissolution testing has become integral to optimizing formulations, assessing drug bioavailability, and ensuring production consistency. The surge in new drug candidates across therapeutic areas demands robust testing solutions to meet regulatory and clinical standards. According to the OECD, global pharmaceutical R&D expenditure reached USD 129 billion in 2021, with the United States contributing the majority share. This upward trend is reinforced by rapid R&D expansion in countries like China, which recorded a 189% increase in pharmaceutical research spending between 2010 and 2019. As R&D activity accelerates globally, the need for specialized testing services, particularly in dissolution studies, is rising, ensuring compliance, safety, and therapeutic performance in increasingly complex drug products.

Key Market Challenges

Regulatory Compliance

Regulatory compliance remains a significant challenge for the pharmaceutical dissolution testing services market. With evolving guidelines from global authorities such as the U.S. FDA and EMA, testing laboratories must stay updated with the latest requirements for drug evaluation. Adhering to these standards necessitates significant investment in training, advanced instrumentation, and meticulous documentation. Non-compliance can result in regulatory penalties, delays in product approvals, or product recalls, affecting a company's market standing and operational costs. As compliance expectations grow more stringent, service providers must continuously adapt their processes, ensuring accuracy, traceability, and alignment with international regulatory frameworks. The constant evolution of compliance benchmarks places a considerable operational and financial burden on testing organizations, making regulatory alignment a critical success factor in the dissolution testing services market.

Key Market Trends

Increasing Drug Development Activities

The escalating pace of drug development is driving increased demand for pharmaceutical dissolution testing services. With the pharmaceutical industry expanding its focus on targeted therapies, biologics, and controlled-release formulations, the need for precise and reliable dissolution testing is more crucial than ever. These tests play a vital role in formulation development, quality control, and regulatory approval. Modern formulations, including nanoparticles and extended-release systems, require specialized dissolution assessments to ensure accurate drug performance analysis. Regulatory agencies demand rigorous documentation of dissolution profiles during the drug approval process, reinforcing the value of expert testing services. Additionally, outsourcing testing to specialized providers offers pharmaceutical companies cost efficiency, flexibility, and access to technical expertise. This growing trend, fueled by a focus on time and resource optimization, is expected to support the sustained expansion of the dissolution testing services market.

Key Market Players

• Intertek Group Plc
• Avivia BV
• Almac Group
• Agilent Technologies, Inc.
• Catalent, Inc.
• Thermo Fisher Scientific Inc
• Charles River Laboratories
• Cambrex
• Boston Analytical
• Pace Analytical Life Sciences

Report Scope:

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

Pharmaceutical Dissolution Testing Services Market, By Services Method:

• In vitro
• In vivo

Pharmaceutical Dissolution Testing Services Market, By Dosage Form:

• Capsule
• Tablets
• Others

Pharmaceutical Dissolution Testing Services Market, By Dissolution Apparatus:

• Basket
• Paddle
• Others

Pharmaceutical Dissolution Testing 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 Dissolution Testing Services Market.

Available Customizations:

Global Pharmaceutical Dissolution Testing 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 Dissolution Testing Services Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Services Method (In vitro, In vivo)
  • 5.2.2. By Dissolution Apparatus (Basket, Paddle, Others)
  • 5.2.3. By Dosage Form (Capsule, Tablets, Others)
  • 5.2.4. By Company (2024)
  • 5.2.5. By Region
• 5.3. Market Map

6. North America Pharmaceutical Dissolution Testing Services Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Services Method
  • 6.2.2. By Dissolution Apparatus
  • 6.2.3. By Dosage Form
  • 6.2.4. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Pharmaceutical Dissolution Testing 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 Services Method
      • 6.3.1.2.2. By Dissolution Apparatus
      • 6.3.1.2.3. By Dosage Form
  • 6.3.2. Mexico Pharmaceutical Dissolution Testing 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 Services Method
      • 6.3.2.2.2. By Dissolution Apparatus
      • 6.3.2.2.3. By Dosage Form
  • 6.3.3. Canada Pharmaceutical Dissolution Testing 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 Services Method
      • 6.3.3.2.2. By Dissolution Apparatus
      • 6.3.3.2.3. By Dosage Form

7. Europe Pharmaceutical Dissolution Testing Services Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Services Method
  • 7.2.2. By Dissolution Apparatus
  • 7.2.3. By Dosage Form
  • 7.2.4. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. France Pharmaceutical Dissolution Testing 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 Services Method
      • 7.3.1.2.2. By Dissolution Apparatus
      • 7.3.1.2.3. By Dosage Form
  • 7.3.2. Germany Pharmaceutical Dissolution Testing 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 Services Method
      • 7.3.2.2.2. By Dissolution Apparatus
      • 7.3.2.2.3. By Dosage Form
  • 7.3.3. United Kingdom Pharmaceutical Dissolution Testing 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 Services Method
      • 7.3.3.2.2. By Dissolution Apparatus
      • 7.3.3.2.3. By Dosage Form
  • 7.3.4. Italy Pharmaceutical Dissolution Testing 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 Services Method
      • 7.3.4.2.2. By Dissolution Apparatus
      • 7.3.4.2.3. By Dosage Form
  • 7.3.5. Spain Pharmaceutical Dissolution Testing 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 Services Method
      • 7.3.5.2.2. By Dissolution Apparatus
      • 7.3.5.2.3. By Dosage Form

8. Asia-Pacific Pharmaceutical Dissolution Testing Services Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Services Method
  • 8.2.2. By Dissolution Apparatus
  • 8.2.3. By Dosage Form
  • 8.2.4. By Country
• 8.3. Asia-Pacific: Country Analysis
  • 8.3.1. China Pharmaceutical Dissolution Testing 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 Services Method
      • 8.3.1.2.2. By Dissolution Apparatus
      • 8.3.1.2.3. By Dosage Form
  • 8.3.2. India Pharmaceutical Dissolution Testing 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 Services Method
      • 8.3.2.2.2. By Dissolution Apparatus
      • 8.3.2.2.3. By Dosage Form
  • 8.3.3. South Korea Pharmaceutical Dissolution Testing 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 Services Method
      • 8.3.3.2.2. By Dissolution Apparatus
      • 8.3.3.2.3. By Dosage Form
  • 8.3.4. Japan Pharmaceutical Dissolution Testing 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 Services Method
      • 8.3.4.2.2. By Dissolution Apparatus
      • 8.3.4.2.3. By Dosage Form
  • 8.3.5. Australia Pharmaceutical Dissolution Testing 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 Services Method
      • 8.3.5.2.2. By Dissolution Apparatus
      • 8.3.5.2.3. By Dosage Form

9. South America Pharmaceutical Dissolution Testing Services Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Services Method
  • 9.2.2. By Dissolution Apparatus
  • 9.2.3. By Dosage Form
  • 9.2.4. By Country
• 9.3. South America: Country Analysis
  • 9.3.1. Brazil Pharmaceutical Dissolution Testing 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 Services Method
      • 9.3.1.2.2. By Dissolution Apparatus
      • 9.3.1.2.3. By Dosage Form
  • 9.3.2. Argentina Pharmaceutical Dissolution Testing 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 Services Method
      • 9.3.2.2.2. By Dissolution Apparatus
      • 9.3.2.2.3. By Dosage Form
  • 9.3.3. Colombia Pharmaceutical Dissolution Testing 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 Services Method
      • 9.3.3.2.2. By Dissolution Apparatus
      • 9.3.3.2.3. By Dosage Form

10. Middle East and Africa Pharmaceutical Dissolution Testing Services Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Services Method
  • 10.2.2. By Dissolution Apparatus
  • 10.2.3. By Dosage Form
  • 10.2.4. By Country
• 10.3. MEA: Country Analysis
  • 10.3.1. South Africa Pharmaceutical Dissolution Testing 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 Services Method
      • 10.3.1.2.2. By Dissolution Apparatus
      • 10.3.1.2.3. By Dosage Form
  • 10.3.2. Saudi Arabia Pharmaceutical Dissolution Testing 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 Services Method
      • 10.3.2.2.2. By Dissolution Apparatus
      • 10.3.2.2.3. By Dosage Form
  • 10.3.3. UAE Pharmaceutical Dissolution Testing 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 Services Method
      • 10.3.3.2.2. By Dissolution Apparatus
      • 10.3.3.2.3. By Dosage Form

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. Intertek Group Plc
  • 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. Avivia BV
• 15.3. Almac Group
• 15.4. Agilent Technologies, Inc.
• 15.5. Catalent, Inc.
• 15.6. Thermofisher Scientific Inc.
• 15.7. Charles River Laboratories
• 15.8. Cambrex
• 15.9. Boston Analytical
• 15.10. Pace Analytical Life Sciences

16. Strategic Recommendations

17. About Us & Disclaimer