미국의 의약품 용출 시험 서비스 시장 규모, 점유율, 동향 분석 보고서 : 방법별, 제형별, 용출 장비별, 지역별, 부문별 예측(2025-2033년)

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