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市場調查報告書
商品編碼
1842131

美國藥品溶離度測試服務市場：市場規模、佔有率、趨勢分析（按方法、劑型、溶離裝置和地區分類）、細分市場預測（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個工作天內

價格

市場規模與趨勢：

據估計，2024 年美國藥物溶離度測試服務市值為 2.2436 億美元，預計到 2033 年將達到 4.2371 億美元，2025 年至 2033 年的複合年成長率為 7.41%。

對學名藥和生物等效性測試的需求不斷成長，監管機構對藥物釋放規律和品管的持續關注，以及外包活動的日益增多，正在推動市場成長。

美國藥品溶離度測試服務業的成長主要受日益嚴格的藥品品質、安全性和生物有效性度監管法規的推動。包括美國FDA、EMA和CDSCO在內的衛生監管機構已將溶離度測試列為品牌藥和學名藥核准流程的核心要求。這導致對精密、可靠且標準化的溶出度測試的需求日益成長，以確保藥物釋放曲線的一致性。全球學名藥核准數量的不斷增加，推動了生物等效性研究中對溶離度對比測試的需求，使得企業必須將這些服務外包，以更快、更經濟高效地滿足監管要求。此外，現代藥物製劑的複雜性，包括緩釋性製劑和難溶性藥物製劑，需要客製化、高精度的測試方案，因此製藥公司依賴擁有專業技術知識和儀器設備的專業合約服務供應商。

此外，藥物開發平臺的快速擴張，尤其是在新興市場，推動了從研發早期到後期階段對溶離度測試的需求。中小型製藥和生物技術公司，由於內部基礎設施有限，擴大轉向第三方溶離度測試服務供應商，以加快研發進度並減輕營運負擔。此外，個人化醫療和新型藥物遞送系統（包括奈米技術和3D列印片劑）的興起，正在重塑溶離度測試的需求。自動化、即時分析以及溶離度測試與其他品管技術的整合方面的進步，也在簡化工作流程並提高數據準確性，從而進一步推動了外包業務的發展。

目錄

第1章 分析方法和範圍

第2章執行摘要

第3章美國藥品溶離度測試服務市場：影響因素、趨勢與範圍

  • 市場關聯性展望
  • 美國製藥溶離度測試服務市場動態
  • 技術格局
  • 定價模式分析
  • 美國藥品溶離度測試服務市場：分析工具

第4章美國藥品溶離度測試服務市場：依方法分類的估算與趨勢分析

  • 細分儀表板
  • 美國藥品溶離度測試服務市場：波動分析
  • 美國藥品溶離度測試服務市場規模及趨勢分析（依方法分類）（2021-2033 年）
  • 體外
  • 體內

第5章美國藥品溶離度測試服務市場：按劑型分類的估算與趨勢分析

  • 細分儀表板
  • 美國藥品溶離度測試服務市場：波動分析
  • 美國藥品溶離度測試服務市場規模及按劑型分類的趨勢分析（2021-2033 年）
  • 膠囊
  • 藥片
  • 其他

第6章：美國製藥溶離度測試服務市場：溶離度設備的估算與趨勢分析

  • 細分儀表板
  • 美國藥品溶離度測試服務市場：波動分析
  • 美國製藥溶離度測試服務市場規模及趨勢分析（依溶離儀分類）（2021-2033 年）
  • 籃子
  • 槳
  • 其他

第7章 競爭情勢

  • 公司分類
  • 美國藥品溶離度測試服務市佔率分析（2024 年）
  • 公司簡介
    • 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