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市场调查报告书
商品编码
1842131

美国药品溶离度测试服务市场：市场规模、份额、趋势分析（按方法、剂型、溶离装置和地区划分）、细分市场预测（2025-2033 年）

U.S. Pharmaceutical Dissolution Testing Services Market Size, Share & Trends Analysis Report By Method (In Vitro, In Vivo), By Dosage Form (Capsules, Tablets), By Dissolution Apparatus (Basket, Paddle), By Region, And Segment Forecasts, 2025 - 2033
出版日期: | 出版商: Grand View Research | 英文 150 Pages | 商品交期: 2-10个工作天内

价格

市场规模与趋势：

据估计，2024 年美国药物溶离度测试服务市值为 2.2436 亿美元，预计到 2033 年将达到 4.2371 亿美元，2025 年至 2033 年的复合年增长率为 7.41%。

对学名药和生物等效性测试的需求不断增长，监管机构对药物释放规律和品管的持续关注，以及外包活动的日益增多，正在推动市场成长。

美国药品溶离度测试服务业的成长主要受日益严格的药品品质、安全性和生物有效性度监管法规的推动。包括美国FDA、EMA和CDSCO在内的卫生监管机构已将溶离度测试列为品牌药和学名药核准流程的核心要求。这导致对精密、可靠且标准化的溶出度测试的需求日益增长，以确保药物释放曲线的一致性。全球学名药核准数量的不断增加，推动了生物等效性研究中对溶离度对比测试的需求，使得企业必须将这些服务外包，以更快、更经济高效地满足监管要求。此外，现代药物製剂的复杂性，包括缓释性製剂和难溶性药物製剂，需要客製化、高精度的测试方案，因此製药公司依赖拥有专业技术知识和仪器设备的专业合约服务供应商。

此外，药物开发平臺的快速扩张，尤其是在新兴市场，推动了从研发早期到后期阶段对溶离度测试的需求。中小型製药和生物技术公司，由于内部基础设施有限，越来越多地转向第三方溶离度测试服务供应商，以加快研发进度并减轻营运负担。此外，个人化医疗和新型药物递送系统（包括奈米技术和3D列印片剂）的兴起，正在重塑溶离度测试的需求。自动化、即时分析以及溶离度测试与其他品管技术的整合方面的进步，也在简化工作流程并提高数据准确性，从而进一步推动了外包业务的发展。

目录

第一章 分析方法和范围

第二章执行摘要

第三章美国药品溶离度测试服务市场：影响因素、趋势与范围

  • 市场关联性展望
  • 美国製药溶离度测试服务市场动态
  • 技术格局
  • 定价模式分析
  • 美国药品溶离度测试服务市场：分析工具

第四章美国药品溶离度测试服务市场：依方法分類的估算与趋势分析

  • 细分仪表板
  • 美国药品溶离度测试服务市场：波动分析
  • 美国药品溶离度测试服务市场规模及趋势分析（依方法划分）（2021-2033 年）
  • 体外
  • 体内

第五章美国药品溶离度测试服务市场：按剂型分類的估算与趋势分析

  • 细分仪表板
  • 美国药品溶离度测试服务市场：波动分析
  • 美国药品溶离度测试服务市场规模及按剂型分類的趋势分析（2021-2033 年）
  • 胶囊
  • 药片
  • 其他的

第六章：美国製药溶离度测试服务市场：溶离度设备的估算与趋势分析

  • 细分仪表板
  • 美国药品溶离度测试服务市场：波动分析
  • 美国製药溶离度测试服务市场规模及趋势分析（依溶离仪分类）（2021-2033 年）
  • 篮子
  • 桨
  • 其他的

第七章 竞争情势

  • 公司分类
  • 美国药品溶离度测试服务市占率分析（2024 年）
  • 公司简介
    • Intertek Group Plc.
    • Avivia BV
    • Almac Group
    • Agilent Technologies, Inc.
    • Catalent, Inc.
    • Thermo Fisher Scientific Inc.
    • Cambrex
    • Charles River Laboratories
    • Boston Analytical
    • Pace Analytical Life Sciences
    • SOTAX
    • AMRI
    • SGS SA
Product Code: GVR-4-68040-726-7

Market Size & Trends:

The U.S. pharmaceutical dissolution testing services market size was estimated at USD 224.36 million in 2024 and is projected to reach USD 423.71 million by 2033, growing at a CAGR of 7.41% from 2025 to 2033.Rising demand for generic drugs and bioequivalence studies, constant regulatory emphasis on consistent drug release profiles and quality control, and growing outsourcing activities are driving the market growth.

The U.S. pharmaceutical dissolution testing services industry's growth is driven by the increasing regulatory stringency surrounding drug quality, safety, and bioavailability. Health authorities such as the U.S. FDA, EMA, and CDSCO mandate dissolution testing as a core requirement in the approval process for both branded and generic pharmaceuticals. This has led to a growing need for advanced, reliable, and standardized dissolution testing to ensure consistent drug release profiles. The rising volume of generic drug approvals globally has intensified the demand for comparative dissolution testing in bioequivalence studies, making it essential for companies to outsource these services for faster and cost-effective regulatory compliance. Moreover, the complexity of modern drug formulations, such as sustained-release and poorly soluble drugs, necessitates customized and high-precision testing protocols, prompting pharma firms to rely on specialized contract service providers with technical expertise and instrumentation capabilities.

Furthermore, the rapid expansion of pharmaceutical R&D pipelines, especially in emerging markets, is creating heightened demand for dissolution testing across early- and late-phase development. Small and mid-sized pharmaceutical and biotech firms, often operating with limited in-house infrastructure, are increasingly turning to third-party service providers for dissolution testing to accelerate timelines and reduce operational burdens. Furthermore, the rise in personalized medicine and novel drug delivery systems, including nanotechnology and 3D-printed tablets, is reshaping dissolution testing needs.Advances in automation, real-time analytics, and integration of dissolution testing with other quality control technologies are also streamlining workflows and improving data accuracy, further incentivizing outsourcing.

U.S. Pharmaceutical Dissolution Testing Services Market Report Segmentation

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the U.S. pharmaceutical dissolution testing services market report based on method, dosage form, and dissolution apparatus:

  • Method Outlook (Revenue, USD Million, 2021 - 2033)
  • In Vitro
  • In Vivo
  • Dosage Form Outlook (Revenue, USD Million, 2021 - 2033)
  • Capsule
  • Tablets
  • Others
  • Dissolution Apparatus Outlook (Revenue, USD Million, 2021 - 2033)
  • Basket
  • Paddle
  • Others

Table of Contents

Chapter 1. Methodology and Scope

  • 1.1. Market Segmentation and Scope
  • 1.2. Market Definitions
  • 1.3. Research Methodology
  • 1.4. Information Procurement
    • 1.4.1. Purchased database
    • 1.4.2. GVR's internal database
    • 1.4.3. Secondary sources
    • 1.4.4. Primary research
  • 1.5. Information or Data Analysis
    • 1.5.1. Data analysis models
  • 1.6. Market Formulation & Validation
  • 1.7. Model Details
    • 1.7.1. Commodity flow analysis (Model 1)
    • 1.7.2. Value chain based analysis (Model 2)
    • 1.7.3. Multivariate Analysis (Model 3)
  • 1.8. List of Secondary Sources
  • 1.9. List of Primary Sources
  • 1.10. Objectives

Chapter 2. Executive Summary

  • 2.1. Market Outlook
  • 2.2. Segment Snapshot
  • 2.3. Competitive Landscape Snapshot

Chapter 3. U.S. Pharmaceutical Dissolution Testing Services Market: Variables, Trends, & Scope

  • 3.1. Market Lineage Outlook
    • 3.1.1. Parent Market Outlook
    • 3.1.2. Ancillary Market Outlook
  • 3.2. U.S. Pharmaceutical Dissolution Testing Services Market Dynamics
    • 3.2.1. Market Driver Impact Analysis
      • 3.2.1.1. Increasing R&D activities
      • 3.2.1.2. Rising burden of chronic and infectious diseases supporting demand for dissolution testing of drugs
      • 3.2.1.3. Rising use of generic drugs
    • 3.2.2. Market Restraint Analysis
      • 3.2.2.1. Increased effort for method validation
  • 3.3. Technological Landscape
  • 3.4. Pricing Model Analysis
  • 3.5. 3.2. U.S. Pharmaceutical Dissolution Testing Services Market: Analysis Tools
    • 3.5.1. Porter's Five Forces Analysis
    • 3.5.2. PESTEL Analysis

Chapter 4. U.S. Pharmaceutical Dissolution Testing Services Market: Method Estimates & Trend Analysis

  • 4.1. Segment Dashboard
  • 4.2. U.S. Pharmaceutical Dissolution Testing Services Market Movement Analysis
  • 4.3. U.S. Pharmaceutical Dissolution Testing Services Market Size & Trend Analysis, by Method, 2021 to 2033 (USD Million)
  • 4.4. In Vitro
    • 4.4.1. In Vitro Market Estimates and Forecasts, 2021 - 2033 (USD million)
  • 4.5. In vivo
    • 4.5.1. In Vivo Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. U.S. Pharmaceutical Dissolution Testing Services Market: Dosage Form Estimates & Trend Analysis

  • 5.1. Segment Dashboard
  • 5.2. U.S. Pharmaceutical Dissolution Testing Services Market Movement Analysis
  • 5.3. U.S. Pharmaceutical Dissolution Testing Services Market Size & Trend Analysis, by Dosage form, 2021 to 2033 (USD Million)
  • 5.4. Capsule
    • 5.4.1. Capsule Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.5. Tablets
    • 5.5.1. Tablets Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.6. Others
    • 5.6.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. U.S. Pharmaceutical Dissolution Testing Services Market: Dissolution Apparatus Estimates & Trend Analysis

  • 6.1. Segment Dashboard
  • 6.2. U.S. Pharmaceutical Dissolution Testing Services Market Movement Analysis
  • 6.3. U.S. Pharmaceutical Dissolution Testing Services Market Size & Trend Analysis, by dissolution apparatus, 2021 to 2033 (USD Million)
  • 6.4. Basket
    • 6.4.1. Basket Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.5. Paddle
    • 6.5.1. Paddle Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.6. Others
    • 6.6.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. Competitive Landscape

  • 7.1. Company Categorization
  • 7.2. U.S. Pharmaceutical Dissolution Testing Services Market Share Analysis, 2024
  • 7.3. Company Profiles
    • 7.3.1. Intertek Group Plc.
      • 7.3.1.1. Company overview
      • 7.3.1.2. Financial performance
      • 7.3.1.3. Product benchmarking
      • 7.3.1.4. Strategic initiatives
    • 7.3.2. Avivia BV
      • 7.3.2.1. Company overview
      • 7.3.2.2. Financial performance
      • 7.3.2.3. Product benchmarking
      • 7.3.2.4. Strategic initiatives
    • 7.3.3. Almac Group
      • 7.3.3.1. Company overview
      • 7.3.3.2. Financial performance
      • 7.3.3.3. Product benchmarking
      • 7.3.3.4. Strategic initiatives
    • 7.3.4. Agilent Technologies, Inc.
      • 7.3.4.1. Company overview
      • 7.3.4.2. Financial performance
      • 7.3.4.3. Product benchmarking
      • 7.3.4.4. Strategic initiatives
    • 7.3.5. Catalent, Inc.
      • 7.3.5.1. Company overview
      • 7.3.5.2. Financial performance
      • 7.3.5.3. Product benchmarking
      • 7.3.5.4. Strategic initiatives
    • 7.3.6. Thermo Fisher Scientific Inc.
      • 7.3.6.1. Company overview
      • 7.3.6.2. Financial performance
      • 7.3.6.3. Product benchmarking
      • 7.3.6.4. Strategic initiatives
    • 7.3.7. Cambrex
      • 7.3.7.1. Company overview
      • 7.3.7.2. Financial performance
      • 7.3.7.3. Product benchmarking
      • 7.3.7.4. Strategic initiatives
    • 7.3.8. Charles River Laboratories
      • 7.3.8.1. Company overview
      • 7.3.8.2. Financial performance
      • 7.3.8.3. Product benchmarking
      • 7.3.8.4. Strategic initiatives
    • 7.3.9. Boston Analytical
      • 7.3.9.1. Company overview
      • 7.3.9.2. Financial performance
      • 7.3.9.3. Product benchmarking
      • 7.3.9.4. Strategic initiatives
    • 7.3.10. Pace Analytical Life Sciences
      • 7.3.10.1. Company overview
      • 7.3.10.2. Financial performance
      • 7.3.10.3. Product benchmarking
      • 7.3.10.4. Strategic initiatives
    • 7.3.11. SOTAX
      • 7.3.11.1. Company overview
      • 7.3.11.2. Financial performance
      • 7.3.11.3. Product benchmarking
      • 7.3.11.4. Strategic initiatives
    • 7.3.12. AMRI
      • 7.3.12.1. Company overview
      • 7.3.12.2. Financial performance
      • 7.3.12.3. Product benchmarking
      • 7.3.12.4. Strategic initiatives
    • 7.3.13. SGS SA
      • 7.3.13.1. Company overview
      • 7.3.13.2. Financial performance
      • 7.3.13.3. Product benchmarking
      • 7.3.13.4. Strategic initiatives

List of Tables

  • Table 1 List of abbreviations
  • Table 2 U.S. pharmaceutical dissolution testing services market estimates and forecasts, by method, 2021 - 2033 (USD Million)
  • Table 3 U.S. pharmaceutical dissolution testing services market estimates and forecasts, by dosage form, 2021 - 2033 (USD Million)
  • Table 4 U.S. pharmaceutical dissolution testing services market estimates and forecasts, by dissolution apparatus, 2021 - 2033 (USD Million)

List of Figures

  • Fig. 1 U.S Pharmaceutical dissolution testing services market segmentation
  • Fig. 2 Market research process
  • Fig. 3 Information procurement
  • Fig. 4 Primary research pattern
  • Fig. 5 Market research approaches
  • Fig. 6 Market formulation & validation
  • Fig. 7 Commodity flow analysis
  • Fig. 8 Value-Chain-Based Sizing & Forecasting
  • Fig. 9 QFD model sizing & forecasting
  • Fig. 10 Bottom-up approach
  • Fig. 11 Market snapshot
  • Fig. 12 Segment snapshot
  • Fig. 13 Segment snapshot
  • Fig. 14 Segment snapshot
  • Fig. 15 Competitive landscape snapshot
  • Fig. 16 Parent market outlook, 2024 (USD Million)
  • Fig. 17 Ancillary market outlook, 2024 (USD Million)
  • Fig. 18 Pharmaceutical dissolution testing services market dynamics
  • Fig. 19 Total R&D drug pipeline size, 2021-2024
  • Fig. 20 Total drug pipeline by development phase, 2024
  • Fig. 21 Porter's five forces analysis
  • Fig. 22 PESTEL analysis
  • Fig. 23 U.S Pharmaceutical dissolution testing services market method outlook: Segment dashboard
  • Fig. 24 Pharmaceutical dissolution testing services market, by method segment: Market share, 2025 & 2033
  • Fig. 25 In vitro market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 26 In vivo market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 27 U.S Pharmaceutical dissolution testing services market dosage form outlook: Segment dashboard
  • Fig. 28 Pharmaceutical dissolution testing services market, by dosage form segment: Market share, 2024 & 2033
  • Fig. 29 Capsule market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 30 Tablets market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 31 Others market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 32 U.S Pharmaceutical dissolution testing services market dissolution apparatus outlook: Segment dashboard
  • Fig. 33 Pharmaceutical dissolution testing services market, by dissolution apparatus segment: Market share, 2024 & 2033
  • Fig. 34 Basket market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 35 Paddle market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 36 Market participant categorization
  • Fig. 37 Heat map analysis