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2047040

藥物溶離度測試服務市場－全球產業規模、佔有率、趨勢、機會與預測：按服務方法、溶離裝置、劑型、地區和競爭格局分類，2021-2031年

Pharmaceutical Dissolution Testing Services Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Services Method, By Dissolution Apparatus, By Dosage Form, By Region & Competition, 2021-2031F
出版日期: | 出版商: TechSci Research | 英文 180 Pages | 商品交期: 2-3個工作天內

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簡介目錄

全球藥物溶離度測試服務市場預計將從 2025 年的 7.6139 億美元大幅成長至 2031 年的 12.5737 億美元，複合年成長率為 8.72%。

這些服務涉及將模擬生理條件下藥物釋放速率的分析和評估外包，其促進因素是生物等效性測試需求的不斷成長以及全球法規對品管的嚴格要求。北美龐大的藥品銷售額（預計2024年佔全球總銷售額的54.8%）表明，大量產品需要進行全面的品質檢驗。然而，市場擴張面臨的主要障礙是能夠開發和驗證複雜測試方法的專家嚴重短缺，這造成了營運瓶頸並增加了服務供應商的成本。

市場概覽
預測期 2027-2031
市場規模：2025年 7.6139億美元
市場規模：2031年 1,257,370,000 美元
複合年成長率：2026-2031年 8.72%
成長最快的細分市場 膠囊
最大的市場 北美洲

市場促進因素

該市場的主要驅動力是製藥業研發投入的增加和開發平臺的擴展，導致需要進行溶解度和釋放速率分析的化合物數量顯著增加。 2024年，美國藥品研究與製造商協會（PhRMA）成員公司在研發方面的投資約為1000億美元，促成了眾多新藥的核准，其中包括2024年獲得美國食品藥品監督管理局（FDA）核准的50種新藥。所有這些藥物都需要大量的溶離度測試數據以確保品質。此外，學名藥的激增和嚴格的生物等效性要求也是主要促進因素。這是因為溶離度測試是體內生物等效性測試的重要替代方法，可確保非專利藥製劑與原廠藥具有相同的療效。預計到2025年，學名藥和生物相似藥將占美國處方箋的90%，這將產生對比較溶出度測試的巨大且持續的需求，以支持監管申報並維持上市後批次的一致性。

市場挑戰

全球藥物溶離度測試服務市場成長的主要挑戰之一是能夠執行複雜分析程序的熟練人員嚴重短缺。溶離度測試需要訓練有素的分析人員來設計、驗證和解讀方法開發方案，這些工作無法簡單地自動化。人員短缺造成了嚴重的營運瓶頸，限制了產能，迫使服務供應商延長專案期限並拒絕新契約，最終阻礙了市場擴張。根據皮斯托亞聯盟（Pistoia Alliance）發布的2025年產業數據，34%的生命科學公司認為缺乏熟練人員是實驗室營運的一大障礙，凸顯了技術需求與可用人員之間日益擴大的差距。這也導致了營運成本的增加和利潤率的下降。

市場趨勢

溶離度測試市場的關鍵趨勢之一是自動化和機器人測試系統的日益普及，這些系統從根本上改變了實驗室的工作流程，減少了人為誤差，提高了處理能力。服務供應商正在部署全自動溶離度測試設備，用於從培養基製備到樣品分析等各種任務，這是在勞動力短缺的情況下最佳化效率的策略性舉措。據羅克韋爾自動化公司稱，50%的生命科學製造商計劃在2025年擴大自動化規模。同時，人工智慧 (AI) 和機器學習 (ML) 在預測建模中的應用正在革新溶出度測試資料的使用方式，實驗室擴大採用 AI 演算法來分析歷史資料集並預測釋放曲線。這加快了測試方法的開發，減少了物理測試的要求，從而能夠進行更精確的模擬並更快地做出決策。業界信心十足，77% 的生命科學專業人士預計在未來兩年內在實驗室中使用 AI 技術。這預示著向數據驅動型測試策略的重大模式轉移。

目錄

第1章概述

第2章：調查方法

第3章執行摘要

第4章：客戶心聲

第5章：全球藥物溶離度測試服務市場展望

  • 市場規模及預測
    • 按金額
  • 市佔率及預測
    • 服務方法（體外、體內）
    • 按類型分類的溶離度測試設備（籃式、槳式、其他）
    • 劑型（膠囊、錠劑、其他）
    • 按地區
    • 按公司（2025 年）
  • 市場地圖

第6章：北美藥品溶離度測試服務市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 北美洲：國別分析
    • 美國
    • 加拿大
    • 墨西哥

第7章：歐洲藥品溶離度測試服務市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 歐洲：國別分析
    • 德國
    • 法國
    • 英國
    • 義大利
    • 西班牙

第8章：亞太地區藥物溶離度測試服務市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 亞太地區：國別分析
    • 中國
    • 印度
    • 日本
    • 韓國
    • 澳洲

第9章：中東和非洲藥品溶離度測試服務市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 中東與非洲：國別分析
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 南非

第10章：南美洲藥物溶離度測試服務市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 南美洲：國別分析
    • 巴西
    • 哥倫比亞
    • 阿根廷

第11章 市場動態

  • 促進因素
  • 任務

第12章 市場趨勢與發展

  • 併購
  • 產品發布
  • 近期趨勢

第13章：全球藥物溶離度測試服務市場：SWOT分析

第14章：波特五力分析

  • 產業競爭
  • 新進入者的潛力
  • 供應商的議價能力
  • 顧客權力
  • 替代品的威脅

第15章 競爭格局

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

第16章 策略建議

第17章：關於研究公司及免責聲明

簡介目錄
Product Code: 16291

The Global Pharmaceutical Dissolution Testing Services Market is forecast to expand significantly, from USD 761.39 Million in 2025 to USD 1257.37 Million by 2031, at an 8.72% CAGR. These services involve outsourced analytical evaluations of drug release rates under simulated physiological conditions, driven by increasing demands for bioequivalence studies and stringent global regulatory quality control mandates. North America's substantial pharmaceutical sales, representing 54.8% of the global total in 2024, underscore the immense volume of products requiring comprehensive quality verification. However, a key impediment to market scalability is the acute scarcity of specialized personnel capable of managing complex method development and validation, creating operational bottlenecks and increasing costs for service providers.

Market Overview
Forecast Period2027-2031
Market Size 2025USD 761.39 Million
Market Size 2031USD 1257.37 Million
CAGR 2026-20318.72%
Fastest Growing SegmentCapsule
Largest MarketNorth America

Market Driver

The market is primarily driven by escalating pharmaceutical R&D investments and an expanding drug pipeline, which significantly increases the volume of compounds requiring solubility and release-rate profiling. In 2024, PhRMA member companies invested approximately $100 billion in R&D, contributing to a high volume of new drug approvals, such as the 50 novel drugs approved by the FDA in 2024, all necessitating extensive dissolution data for quality assurance. Furthermore, the proliferation of generic drugs and stringent bioequivalence requirements are key propellers, as dissolution testing serves as a critical surrogate for in vivo bioequivalence studies, ensuring generic formulations perform identically to innovator products. With generics and biosimilars accounting for 90% of U.S. prescriptions in 2025, there is a vast and continuous demand for comparative dissolution testing to support regulatory applications and maintain post-market batch consistency.

Market Challenge

The primary challenge impeding the Global Pharmaceutical Dissolution Testing Services Market's growth is the acute scarcity of specialized personnel capable of executing complex analytical procedures. Dissolution testing demands highly trained analysts to design, validate, and interpret method development protocols, tasks that cannot be simply automated. This talent gap creates severe operational bottlenecks, limiting production capacity and forcing service providers to extend project timelines or decline new contracts, thereby stalling market expansion. Industry data from the Pistoia Alliance in 2025 indicated that 34% of life sciences organizations identified the lack of skilled personnel as a significant barrier to laboratory operations, highlighting a widening gap between technical requirements and available talent, which also drives up operational costs and diminishes profit margins.

Market Trends

A key trend in the dissolution testing market is the increasing adoption of automated and robotic testing systems, fundamentally altering laboratory workflows to mitigate human error and improve throughput. Service providers are integrating fully automated dissolution apparatuses for tasks from media preparation to sample analysis, a strategic move to optimize efficiency amidst workforce constraints, with 50% of life sciences manufacturers planning increased automation by 2025 according to Rockwell Automation. Concurrently, the application of Artificial Intelligence (AI) and Machine Learning (ML) for predictive modeling is revolutionizing dissolution data utilization, with laboratories increasingly employing AI algorithms to analyze historical datasets and predict release profiles. This accelerates method development and reduces physical testing requirements, leading to more accurate simulations and faster decision-making. The industry's confidence is evident as 77% of life sciences professionals expect to utilize AI technologies within their laboratories over the next two years, signaling a major paradigm shift towards data-driven testing strategies.

Key Market Players

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

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 Dissolution Apparatus

  • Basket
  • Paddle
  • Others

Pharmaceutical Dissolution Testing Services Market, By Dosage Form

  • Capsule
  • Tablets
  • 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 Region
    • 5.2.5. By Company (2025)
  • 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. Canada 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. Mexico 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. Germany 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. France 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. Japan 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. South Korea 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. Middle East & Africa 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. Middle East & Africa: Country Analysis
    • 9.3.1. Saudi Arabia 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. UAE 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. South Africa 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. South America 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. South America: Country Analysis
    • 10.3.1. Brazil 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. Colombia 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. Argentina 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. Merger & Acquisition (If Any)
  • 12.2. Product Launches (If Any)
  • 12.3. Recent Developments

13. Global Pharmaceutical Dissolution Testing Services Market: SWOT 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 Products

15. Competitive Landscape

  • 15.1. Intertek Group Plc
    • 15.1.1. Business Overview
    • 15.1.2. Products & Services
    • 15.1.3. Recent Developments
    • 15.1.4. Key Personnel
    • 15.1.5. 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 International Inc.
  • 15.8. Cambrex Corp.
  • 15.9. Boston Analytical
  • 15.10. Pace Life Sciences LLC

16. Strategic Recommendations

17. About Us & Disclaimer