U.S. Formulation Development Outsourcing Market Size, Share, & Trends Analysis Report By Service, By Formulation (Oral, Injectable), By Therapeutic Area (Oncology), By End Use, By Region, And Segment Forecasts, 2025 - 2030
The U.S. formulation development outsourcing market size was estimated at USD 8.87 billion in 2024 and is projected to grow at a CAGR of 8.3% from 2025 to 2030. 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, Grand View Research 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
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. GVR's 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)