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U.S. Formulation Development Outsourcing Market Size, Share, & Trends Analysis Report by Service, Formulation (Oral, Injectable), Therapeutic Area (Oncology), End-use, and Region with Growth Forecasts, 2025-2030

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    Report

  • 80 Pages
  • May 2025
  • Region: United States
  • Grand View Research
  • ID: 6098045
The U.S. Formulation Development Outsourcing Market was valued at USD 8.87 billion in 2024, and is projected to reach USD 14.1 billion by 2030, rising at a CAGR of 8.30%. This growth is driven by increasing demand for innovative pharmaceutical and biotech products, rising R&D costs, and a need for specialized expertise. Outsourcing formulation development is an attractive option for companies looking to streamline their R&D processes, reduce costs, and access a wider range of resources.

The surge in R&D by pharmaceutical and biotechnology firms is a major driver propelling the demand for outsourced formulation development services. Over the past two decades, R&D spending and new drug launches have increased, leading to cost reduction and accelerated processes through outsourcing. This rising demand has prompted contract service providers to expand their capacities, fostering the growth of the U.S. formulation development outsourcing industry. Consequently, these factors substantially contribute to market expansion.

Drug formulation relies heavily on trial-and-error methods to predict optimal formulations, which can be costly, time-consuming, and labor-intensive. To address the need for reducing expenses on new Active Pharmaceutical Ingredients (APIs) and overall healthcare costs in the pharmaceuticals market, it is crucial to estimate preferred formulations. This helps the industry identify efficient drug development approaches. Consequently, the pharmaceutical and biotechnology sector extensively outsources these services to contract manufacturers to streamline costs and processes.

Advancements in technology drive innovations encourage companies to invest in discovering new compounds and developing blockbuster drugs. This leads to an increase in generic manufacturers and a growing pharmaceutical market, driven by unmet needs for various disorders and rising R&D activities for orphan therapies.

U.S. Formulation Development Outsourcing Report Segmentation

This report forecasts revenue growth at country level and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, the analyst has segmented the U.S. formulation development outsourcing market report based on service, formulation, therapeutic area, and end use:

Service Outlook (Revenue, USD Million; 2018-2030)

  • Pre-formulation
  • Formulation Development

Formulation Outlook (Revenue, USD Million; 2018-2030)

  • Oral
  • Injectable
  • Topical
  • Others

Therapeutic Area Outlook (Revenue, USD Million; 2018-2030)

  • Oncology
  • Infectious Disease
  • Neurology
  • Hematology
  • Respiratory
  • Cardiovascular
  • Dermatology
  • Others

End Use Outlook (Revenue, USD Million; 2018-2030)

  • Pharmaceutical and Biopharmaceutical Companies
  • Government and Academic Institutes
  • Others

This report addresses:

  • Market intelligence to enable effective decision-making
  • Market estimates and forecasts from 2018 to 2030
  • Growth opportunities and trend analyses
  • Segment and regional revenue forecasts for market assessment
  • Competition strategy and market share analysis
  • Product innovation listings for you to stay ahead of the curve

Why Should You Buy This Report?

  • Comprehensive Market Analysis: Gain detailed insights into the market across major regions and segments.
  • Competitive Landscape: Explore the market presence of key players.
  • Future Trends: Discover the pivotal trends and drivers shaping the future of the market.
  • Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions.

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Table of Contents

Chapter 1. Methodology and Scope
1.1. Market Segmentation & Scope
1.2. Segment Definitions
1.2.1. Service
1.2.2. Formulation
1.2.3. Therapeutic Area
1.2.4. End Use
1.3. Estimates and Forecast Timeline
1.4. Research Methodology
1.5. Information Procurement
1.5.1. Purchased Database
1.5.2. Internal Database
1.5.3. Secondary Sources
1.5.4. Primary Research
1.6. Information Analysis
1.6.1. Data Analysis Models
1.7. Market Formulation & Data Visualization
1.8. Model Details
1.8.1. Commodity Flow Analysis
1.9. List of Secondary Sources
1.10. Objectives
Chapter 2. Executive Summary
2.1. Market Snapshot
2.2. Segment Snapshot
2.3. Competitive Landscape Snapshot
Chapter 3. U.S. Formulation Development Outsourcing Market Variables, Trends, & Scope
3.1. Market Lineage Outlook
3.2. Market Dynamics
3.2.1. Market Driver Analysis
3.2.2. Market Restraint Analysis
3.3. Business Environment Analysis
3.3.1. Industry Analysis - Porter’s Five Forces Analysis
3.3.1.1. Supplier Power
3.3.1.2. Buyer Power
3.3.1.3. Substitution Threat
3.3.1.4. Threat of New Entrants
3.3.1.5. Competitive Rivalry
3.3.2. PESTLE Analysis
Chapter 4. U.S. Formulation Development Outsourcing Market: Service Business Analysis
4.1. Service Market Share, 2024 & 2030
4.2. Service Segment Dashboard
4.3. Market Size & Forecasts and Trend Analysis, by Service, 2018 to 2030 (USD Million)
4.4. Pre-formulation
4.4.1. Pre-formulation Market, 2018-2030 (USD Million)
4.5. Formulation Development
4.5.1. Formulation Development Market, 2018-2030 (USD Million)
Chapter 5. U.S. Formulation Development Outsourcing Market: Formulation Business Analysis
5.1. Formulation Market Share, 2024 & 2030
5.2. Formulation Segment Dashboard
5.3. Market Size & Forecasts and Trend Analysis, by Formulation, 2018 to 2030 (USD Million)
5.4. Oral
5.4.1. Oral Formulation Market, 2018-2030 (USD Million)
5.5. Injectable
5.5.1. Injectable Formulation Market, 2018-2030 (USD Million)
5.6. Topical
5.6.1. Topical Formulation Market, 2018-2030 (USD Million)
5.7. Others
5.7.1. Other Formulation Market, 2018-2030 (USD Million)
Chapter 6. U.S. Therapeutic Area Development Outsourcing Market: Therapeutic Area Business Analysis
6.1. Therapeutic Area Market Share, 2024 & 2030
6.2. Therapeutic Area Segment Dashboard
6.3. Market Size & Forecasts and Trend Analysis, by Therapeutic Area, 2018 to 2030 (USD Million)
6.4. Oncology
6.4.1. Formulation Development Outsourcing Market, for Oncology, 2018-2030 (USD Million)
6.5. Infectious Disease
6.5.1. Formulation Development Outsourcing Market, for Infectious Disease, 2018-2030 (USD Million)
6.6. Neurology
6.6.1. Formulation Development Outsourcing Market, for Neurology, 2018-2030 (USD Million)
6.7. Hematology
6.7.1. Formulation Development Outsourcing Market, for Hematology, 2018-2030 (USD Million)
6.8. Respiratory
6.8.1. Formulation Development Outsourcing Market, for Respiratory, 2018-2030 (USD Million)
6.9. Cardiovascular
6.9.1. Formulation Development Outsourcing Market, for Cardiovascular, 2018-2030 (USD Million)
6.10. Dermatology
6.10.1. Formulation Development Outsourcing Market, for Dermatology, 2018-2030 (USD Million)
6.11. Others
6.11.1. Formulation Development Outsourcing Market, for Others, 2018-2030 (USD Million)
Chapter 7. U.S. Formulation Development Outsourcing Market: End Use Business Analysis
7.1. End Use Market Share, 2024 & 2030
7.2. End Use Segment Dashboard
7.3. Market Size & Forecasts and Trend Analysis, by End Use, 2018 to 2030 (USD Million)
7.4. Pharmaceutical and Biopharmaceutical Companies
7.4.1. Pharmaceutical and Biopharmaceutical Companies Segment Market, 2018-2030 (USD Million)
7.5. Government and Academic Institutes
7.5.1. Government and Academic Institutes Segment Market, 2018-2030 (USD Million)
7.6. Others
7.6.1. Others Segment Market, 2018-2030 (USD Million)
Chapter 8. Competitive Landscape
8.1. Participant Overview
8.2. Company Market Position Analysis
8.3. Company Categorization
8.4. Strategy Mapping
8.5. Company Profiles/Listing
8.5.1. SGS Société Générale de Surveillance SA
8.5.1.1. Overview
8.5.1.2. Financial Performance
8.5.1.3. Product Benchmarking
8.5.1.4. Strategic Initiatives
8.5.2. Intertek Group plc
8.5.2.1. Overview
8.5.2.2. Financial Performance
8.5.2.3. Product Benchmarking
8.5.2.4. Strategic Initiatives
8.5.3. Recipharm AB
8.5.3.1. Overview
8.5.3.2. Financial Performance
8.5.3.3. Product Benchmarking
8.5.3.4. Strategic Initiatives
8.5.4. Lonza
8.5.4.1. Overview
8.5.4.2. Financial Performance
8.5.4.3. Product Benchmarking
8.5.4.4. Strategic Initiatives
8.5.5. Charles River Laboratories
8.5.5.1. Overview
8.5.5.2. Financial Performance
8.5.5.3. Product Benchmarking
8.5.5.4. Strategic Initiatives
8.5.6. Eurofins Scientific
8.5.6.1. Overview
8.5.6.2. Financial Performance
8.5.6.3. Product Benchmarking
8.5.6.4. Strategic Initiatives
8.5.7. Element
8.5.7.1. Overview
8.5.7.2. Financial Performance
8.5.7.3. Product Benchmarking
8.5.7.4. Strategic Initiatives
8.5.8. Labcorp
8.5.8.1. Overview
8.5.8.2. Financial Performance
8.5.8.3. Product Benchmarking
8.5.8.4. Strategic Initiatives
8.5.9. Thermo Fisher Scientific Inc
8.5.9.1. Overview
8.5.9.2. Financial Performance
8.5.9.3. Product Benchmarking
8.5.9.4. Strategic Initiatives
8.5.10. Catalent, Inc
8.5.10.1. Overview
8.5.10.2. Financial Performance
8.5.10.3. Product Benchmarking
8.5.10.4. Strategic Initiatives
List of Tables
Table 1. List of secondary sources
Table 2. List of abbreviations
Table 3. U.S. formulation development outsourcing market, by service, 2018-2030 (USD Million)
Table 4. U.S. formulation development outsourcing market, by formulation, 2018-2030 (USD Million)
Table 5. U.S. formulation development outsourcing market, by therapeutic area, 2018-2030 (USD Million)
Table 6. U.S. formulation development outsourcing market, by end use, 2018-2030 (USD Million)
List of Figures
Figure 1 U.S. formulation development outsourcing market segmentation
Figure 2 Market research process
Figure 3 Data triangulation techniques
Figure 4 Primary research pattern
Figure 5 Market research approaches
Figure 6 Value-chain-based sizing & forecasting
Figure 7 Market formulation & validation
Figure 8 Market snapshot
Figure 9 Service outlook (USD Million)
Figure 10 Formulation outlook (USD Million)
Figure 11 Therapeutic area outlook (USD Million)
Figure 12 End use outlook (USD Million)
Figure 13 Competitive landscape
Figure 14 U.S. formulation development outsourcing market dynamics
Figure 15 U.S. formulation development outsourcing market: Porter’s five forces analysis
Figure 16 U.S. formulation development outsourcing market: Pestle analysis
Figure 17 U.S. formulation development outsourcing market: Service segment dashboard
Figure 18 U.S. formulation development outsourcing market: Service market share analysis, 2024 & 2030
Figure 19 Pre-formulation market, 2018-2030 (USD Million)
Figure 20 Formulation development market, 2018-2030 (USD Million)
Figure 21 U.S. formulation development outsourcing market: Formulation segment dashboard
Figure 22 U.S. formulation development outsourcing market: Formulation market share analysis, 2024 & 2030
Figure 23 Oral formulation market, 2018-2030 (USD Million)
Figure 24 Injectable formulation market, 2018-2030 (USD Million)
Figure 25 Topical formulation market, 2018-2030 (USD Million)
Figure 26 Other formulation market, 2018-2030 (USD Million)
Figure 27 U.S. formulation development outsourcing market: Therapeutic area segment dashboard
Figure 28 U.S. formulation development outsourcing market: Therapeutic area market share analysis, 2024 & 2030
Figure 29 Formulation development outsourcing market, for Oncology, 2018-2030 (USD Million)
Figure 30 Formulation development outsourcing market, for Infectious Disease, 2018-2030 (USD Million)
Figure 31 Formulation development outsourcing market, for Neurology 2018-2030 (USD Million)
Figure 32 Formulation development outsourcing market, for Hematology, 2018-2030 (USD Million)
Figure 33 Formulation development outsourcing market, for Respiratory, 2018-2030 (USD Million)
Figure 34 Formulation development outsourcing market, for Cardiovascular 2018-2030 (USD Million)
Figure 35 Formulation development outsourcing market, for Dermatology, 2018-2030 (USD Million)
Figure 36 Formulation development outsourcing market, for Others, 2018-2030 (USD Million)
Figure 37 U.S. formulation development outsourcing market: End use segment dashboard
Figure 38 U.S. formulation development outsourcing market: End use market share analysis, 2024 & 2030
Figure 39 Pharmaceutical and biopharmaceutical companies segment market, 2018-2030 (USD Million)
Figure 40 Government and academic institutes segment market, 2018-2030 (USD Million)
Figure 41 Other segments market, 2018-2030 (USD Million)
Figure 42 Company categorization
Figure 43 Company market position analysis
Figure 44 Strategic framework

Companies Mentioned

The major companies featured in this U.S. Formulation Development Outsourcing market report include:
  • SGS Société Générale de Surveillance SA
  • Intertek Group plc
  • Recipharm AB
  • Lonza
  • Charles River Laboratories
  • Eurofins Scientific
  • Element
  • Labcorp
  • Thermo Fisher Scientific Inc.
  • Catalent, Inc

Table Information