미국의 경구 고형 제제 CDMO 시장 규모·점유율·동향 분석 리포트 : 제품별, 메커니즘별, 약효별, 최종 용도별 및 부문 예측(2025-2033년)

U.S. Oral Solid Dosage CDMO Market Summary

The U.S. oral solid dosage CDMO market size was estimated at USD 11.62 billion in 2024 and is projected to reach USD 23.99 billion in 2033, growing at a CAGR of 8.63% from 2025 to 2033. The market growth is driven by an increasing focus on complex formulations, along with a growing emphasis on cost efficiency and speed-to-market.

In addition, increasing regulatory compliance and quality assurance standards, as well as the expansion of small and virtual pharma companies, are propelling market growth. The growing prevalence of poorly soluble APIs and advanced targeted drug delivery systems has driven significant demand for specialized expertise in oral solid dosage (OSD) formulations. U.S. contract development and manufacturing organizations (CDMOs) that can manage complex formulations such as controlled-release tablets, fixed-dose combinations, and nanotechnology in drug delivery are attracting outsourcing contracts from global pharmaceutical companies. For instance, in August 2025, Piramal Pharma Solutions inaugurated a dedicated OSD suite in Pennsylvania, investing millions to support fixed-dose combination production and enhance operational efficiency through advanced granulation, compression, tableting, and coating capabilities. Thus, by offering these sophisticated services, CDMOs help clients overcome formulation challenges, improve therapeutic efficacy, and ensure product stability, differentiating themselves, optimizing facility capacity, and building long-term partnerships with innovators seeking high-value solutions.

Further, pharmaceutical companies face pressure to reduce time-to-market, operational costs, and ensure high-quality standards for their products. Outsourcing oral solid dosage (OSD) manufacturing to U.S.-based CDMOs allows companies to utilize specialized expertise, optimize resources, and streamline supply chains, enabling faster and more efficient product development. For instance, in September 2024, Thermo Fisher Scientific invested USD 22 million to expand OSD development and manufacturing at Cincinnati, Ohio, and Bend, Oregon, enhancing early-stage R&D, formulation, and testing capabilities within its CDMO and CRO network. Furthermore, by collaborating with CDMOs, companies can avoid the costs of building and maintaining in-house facilities and regulatory capabilities. Therefore, CDMOs that provide comprehensive services, from formulation development and scale-up to commercial manufacturing and packaging, offer a strategic advantage for accelerating product launches.

Moreover, stringent FDA regulations and evolving global quality standards are major drivers for outsourcing oral solid dosage (OSD) manufacturing to U.S. CDMOs. Maintaining in-house regulatory expertise and infrastructure is expensive and complex, prompting pharmaceutical companies to rely on partners with proven compliance track records. In addition, CDMOs adhering to cGMP, FDA inspection readiness, and international quality requirements provide risk mitigation, audit preparedness, and consistent product safety. This regulatory excellence builds client trust and positions CDMOs as preferred outsourcing partners. As a result, companies gain recurring contracts, long-term collaborations, and enhanced market credibility.

U.S. Oral Solid Dosage CDMO Market Report Segmentation

This report forecasts revenue growth at the country level 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. oral solid dosage CDMO market report based on product, mechanism, technology, drug potency, and end use:

• Product Outlook (Revenue, USD Million, 2021 - 2033)
• Tablets
  • Compressed Tablets
  • Orally Disintegrating Tablets (ODT)
  • Chewable Tablets
  • Bi-layer or Tri-layer Tablets
  • Sublingual or Buccal Tablets
  • Others
• Capsules
  • Hard Gelatin Capsules
  • Soft Gelatin Capsules
• Powders
• Granules
• Others
• Mechanism Outlook (Revenue, USD Million, 2021 - 2033)
• Immediate Release
• Delayed Release
• Controlled Release
• Technology Outlook (Revenue, USD Million, 2021 - 2033)
• Granulation Technologies
• Compression Technologies
• Encapsulation Technologies
• Coating Technologies
• Continuous Manufacturing Technologies
• Others
• Drug Potency Outlook (Revenue, USD Million, 2021 - 2033)
• High Potent Drugs
• Moderate Potent Drugs
• Low Potent Drugs
• End Use Outlook (Revenue, USD Million, 2021 - 2033)
• Large Size Companies
• Medium & Small Size Companies
• Others

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation and Scope
• 1.2. Segment Definitions
  • 1.2.1. Product
  • 1.2.2. Mechanism
  • 1.2.3. Technology
  • 1.2.4. Drug Potency
  • 1.2.5. End use
• 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
  • 1.7.2. Top-Down Analysis
  • 1.7.3. Botton-Up Approach
  • 1.7.4. Multivariate Analysis
• 1.8. List of Secondary Sources
• 1.9. List of Abbreviations
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Outlook
• 2.3. Competitive Insights

Chapter 3. U.S. Oral Solid Dosage CDMO Market Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent Market Outlook
  • 3.1.2. Ancillary Market Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
    • 3.2.1.1. Increasing Demand for One-Stop-Shop CMOs
    • 3.2.1.2. Growing Demand for Generic and Specialty Oral Solid Drugs
    • 3.2.1.3. Expansion of Outsourced Pharmaceutical Manufacturing
    • 3.2.1.4. Technological Advancements in Formulation and Process Development
  • 3.2.2. Market Restraint Analysis
    • 3.2.2.1. Strict Approval Criteria by Regulatory Authorities
    • 3.2.2.2. Lack of Experienced Technical Staff, Physical Capability, and Equipment Capacity
    • 3.2.2.3. Increasing Need for Biosimilars and Their Prominence in Addressing Cancer & Other Medical Conditions
• 3.3. Technology Landscape
• 3.4. Pricing Model Analysis
• 3.5. Tariff Impact Analysis
• 3.6. Value Chain Analysis
  • 3.6.1. Supply Trends
  • 3.6.2. Demand Trends
• 3.7. Market Analysis Tools
  • 3.7.1. Porter's Five Force Analysis
  • 3.7.2. PESTEL by SWOT Analysis

Chapter 4. U.S. Oral Solid Dosage CDMO Market: Product Estimates & Trend Analysis

• 4.1. U.S. Oral Solid Dosage CDMO Market Segment Dashboard
• 4.2. U.S. Oral Solid Dosage CDMO Market: Product Movement Analysis
• 4.3. U.S. Oral Solid Dosage CDMO Market Size & Trend Analysis, by Product, 2021 to 2033 (USD Million)
• 4.4. Tablets
  • 4.4.1. Tablets Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.4.2. Compressed Tablets
    • 4.4.2.1. Compressed Tablets Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.4.3. Orally Disintegrating Tablets (ODT)
    • 4.4.3.1. Orally Disintegrating Tablets (ODT) Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.4.4. Chewable Tablets
    • 4.4.4.1. Chewable Tablets Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.4.5. Bi-layer or Tri-layer Tablets
    • 4.4.5.1. Bi-layer or Tri-layer Tablets Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.4.6. Sublingual or Buccal Tablets
    • 4.4.6.1. Sublingual or Buccal Tablets Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.4.7. Others
    • 4.4.7.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.5. Capsules
  • 4.5.1. Capsules Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.5.2. Hard Gelatin Capsules
    • 4.5.2.1. Hard Gelatin Capsules Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.5.3. Soft Gelatin Capsules
    • 4.5.3.1. Soft Gelatin Capsules Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.6. Powder
  • 4.6.1. Powder Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.7. Granules
  • 4.7.1. Granules Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.8. Others
  • 4.8.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. U.S. Oral Solid Dosage CDMO Market: Mechanism Estimates & Trend Analysis

• 5.1. U.S. Oral Solid Dosage CDMO Market: Segment Dashboard
• 5.2. U.S. Oral Solid Dosage CDMO Market: Mechanism Movement Analysis
• 5.3. U.S. Oral Solid Dosage CDMO Market Size & Trend Analysis, by Mechanism, 2021 to 2033 (USD Million)
• 5.4. Immediate Release
  • 5.4.1. Immediate Release Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.5. Delayed Release
  • 5.5.1. Delayed Release Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.6. Controlled Release
  • 5.6.1. Controlled Release Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. U.S. Oral Solid Dosage CDMO Market: Technology Estimates & Trend Analysis

• 6.1. U.S. Oral Solid Dosage CDMO Market: Segment Dashboard
• 6.2. U.S. Oral Solid Dosage CDMO Market: Technology Movement Analysis
• 6.3. U.S. Oral Solid Dosage CDMO Market Size & Trend Analysis, by Technology, 2021 to 2033 (USD Million)
• 6.4. Granulation Technologies
  • 6.4.1. Granulation Technologies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.5. Compression Technologies
  • 6.5.1. Compression Technologies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.6. Encapsulation Technologies
  • 6.6.1. Encapsulation Technologies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.7. Coating Technologies
  • 6.7.1. Coating Technologies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.8. Continuous Manufacturing Technologies
  • 6.8.1. Continuous Manufacturing Technologies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.9. Others
  • 6.9.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. U.S. Oral Solid Dosage CDMO Market: Drug Potency Estimates & Trend Analysis

• 7.1. U.S. Oral Solid Dosage CDMO Market: Segment Dashboard
• 7.2. U.S. Oral Solid Dosage CDMO Market: Drug Potency Movement Analysis
• 7.3. U.S. Oral Solid Dosage CDMO Market Size & Trend Analysis, by Drug Potency, 2021 to 2033 (USD Million)
• 7.4. High Potent Drugs
  • 7.4.1. High Potent Drugs Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.5. Moderate Potent Drugs
  • 7.5.1. Moderate Potent Drugs Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.6. Low Potent Drugs
  • 7.6.1. Low Potent Drugs Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 8. U.S. Oral Solid Dosage CDMO Market: End Use Estimates & Trend Analysis

• 8.1. U.S. Oral Solid Dosage CDMO Market: Segment Dashboard
• 8.2. U.S. Oral Solid Dosage CDMO Market: End Use Movement Analysis
• 8.3. U.S. Oral Solid Dosage CDMO Market Size & Trend Analysis, by End Use, 2021 to 2033 (USD Million)
• 8.4. Large Size Companies
  • 8.4.1. Large Size Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 8.5. Medium & Small Size Companies
  • 8.5.1. Medium & Small Size Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 8.6. Others
  • 8.6.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 9. Competitive Landscape

• 9.1. Key Participant Categorization
  • 9.1.1. Market Leaders
  • 9.1.2. Emerging Players
• 9.2. Market Share/Assessment Analysis, 2024 (Heat Map Analysis)
• 9.3. Company Profiles
  • 9.3.1. Lonza
    • 9.3.1.1. Company Overview
    • 9.3.1.2. Financial Performance
    • 9.3.1.3. Service Benchmarking
    • 9.3.1.4. Strategic Initiatives
  • 9.3.2. Thermo Fisher Scientific Inc.
    • 9.3.2.1. Company Overview
    • 9.3.2.2. Financial Performance
    • 9.3.2.3. Service Benchmarking
    • 9.3.2.4. Strategic Initiatives
  • 9.3.3. Cambrex Corporation
    • 9.3.3.1. Company Overview
    • 9.3.3.2. Financial Performance
    • 9.3.3.3. Service Benchmarking
    • 9.3.3.4. Strategic Initiatives
  • 9.3.4. Catalent Inc.
    • 9.3.4.1. Company Overview
    • 9.3.4.2. Financial Performance
    • 9.3.4.3. Service Benchmarking
    • 9.3.4.4. Strategic Initiatives
  • 9.3.5. Siegfried Holding AG
    • 9.3.5.1. Company Overview
    • 9.3.5.2. Financial Performance
    • 9.3.5.3. Service Benchmarking
    • 9.3.5.4. Strategic Initiatives
  • 9.3.6. Recipharm AB
    • 9.3.6.1. Company Overview
    • 9.3.6.2. Financial Performance
    • 9.3.6.3. Service Benchmarking
    • 9.3.6.4. Strategic Initiatives
  • 9.3.7. CordenPharma International
    • 9.3.7.1. Company Overview
    • 9.3.7.2. Financial Performance
    • 9.3.7.3. Service Benchmarking
    • 9.3.7.4. Strategic Initiatives
  • 9.3.8. Boehringer Ingelheim
    • 9.3.8.1. Company Overview
    • 9.3.8.2. Financial Performance
    • 9.3.8.3. Service Benchmarking
    • 9.3.8.4. Strategic Initiatives
  • 9.3.9. Piramal Pharma Solutions
    • 9.3.9.1. Company Overview
    • 9.3.9.2. Financial Performance
    • 9.3.9.3. Service Benchmarking
    • 9.3.9.4. Strategic Initiatives
  • 9.3.10. Aenova Group
    • 9.3.10.1. Company Overview
    • 9.3.10.2. Financial Performance
    • 9.3.10.3. Service Benchmarking
    • 9.3.10.4. Strategic Initiatives
  • 9.3.11. Almac Group
    • 9.3.11.1. Company Overview
    • 9.3.11.2. Financial Performance
    • 9.3.11.3. Service Benchmarking
    • 9.3.11.4. Strategic Initiatives
  • 9.3.12. Jubilant Pharmova Limited
    • 9.3.12.1. Company Overview
    • 9.3.12.2. Financial Performance
    • 9.3.12.3. Service Benchmarking
    • 9.3.12.4. Strategic Initiatives
  • 9.3.13. AbbVie Contract Manufacturing
    • 9.3.13.1. Company Overview
    • 9.3.13.2. Financial Performance
    • 9.3.13.3. Service Benchmarking
    • 9.3.13.4. Strategic Initiatives
  • 9.3.14. Quotient Sciences
    • 9.3.14.1. Company Overview
    • 9.3.14.2. Financial Performance
    • 9.3.14.3. Service Benchmarking
    • 9.3.14.4. Strategic Initiatives
  • 9.3.15. SPI Pharma
    • 9.3.15.1. Company Overview
    • 9.3.15.2. Financial Performance
    • 9.3.15.3. Service Benchmarking
    • 9.3.15.4. Strategic Initiatives
  • 9.3.16. DPT Laboratories Ltd.
    • 9.3.16.1. Company Overview
    • 9.3.16.2. Financial Performance
    • 9.3.16.3. Service Benchmarking
    • 9.3.16.4. Strategic Initiatives
  • 9.3.17. Alcami Corporation
    • 9.3.17.1. Company Overview
    • 9.3.17.2. Financial Performance
    • 9.3.17.3. Service Benchmarking
    • 9.3.17.4. Strategic Initiatives