U.S. Biologics CDMO Market Size & Share Analysis - Trends, Drivers, Competitive Landscape, and Forecasts (2025

Description

The U.S. biologics contract development and manufacturing organization (CDMO) market is projected to grow from $3,810.2 million in 2024 to $9,083.4 million by 2032, at a compound annual growth rate (CAGR) of 11.7% during 2025-2032. This growth is fueled by an aging population, increasing prevalence of chronic diseases, and rising R&D expenditures by pharmaceutical and biotech companies. Biologics CDMOs play a critical role in enabling efficient drug development and manufacturing processes.

Key Insights

Drug substance development involves manufacturing active biological ingredients, while drug product services cover formulation, filling, and packaging of final biologic therapies.

Mammalian cell lines are preferred for complex protein therapeutics due to their ability to perform post-translational modifications. Microbial cell lines are suitable for simpler proteins, offering faster growth and higher yields. Viral vector and other advanced modalities are essential for gene therapies and cutting-edge biologic treatments.

Commercial services represent the largest category, focusing on large-scale manufacturing for market supply. Clinical services support drug development pipelines by producing products for clinical trial phases.

The Northeast holds the largest market share due to its concentration of biotech firms and research institutions. The Midwest is expected to experience the fastest growth, driven by increasing investments in biotech infrastructure.

An aging population and the growing prevalence of chronic conditions drive demand for biologic therapies. Pharmaceutical and biotech companies are increasing R&D expenditures to innovate and expand their biologic product portfolios.

Companies are outsourcing to CDMOs to reduce in-house development costs and accelerate time-to-market. Significant investments in capacity expansion, such as those by Fujifilm and AGC Inc., are enhancing manufacturing capabilities in the U.S.

Technological advancements are improving efficiency and scalability in biologics manufacturing, enabling companies to meet rising demand effectively.

The market is consolidated, with leading players focusing on strategic partnerships, capacity expansions, and innovation to strengthen their positions.

Product Code: 13261

Chapter 1. Research Scope

1.1. Research Objectives
1.2. Market Definition
1.3. Analysis Period
1.4. Market Size Breakdown by Segments
- 1.4.1. Market Size Breakdown, by Product Type
- 1.4.2. Market Size Breakdown, by Cell Line
- 1.4.3. Market Size Breakdown, by Service Type
1.5. Market Data Reporting Unit
- 1.5.1. Revenue
1.6. Key Stakeholders

Chapter 2. Research Methodology

2.1. Secondary Research
- 2.1.1. Paid
- 2.1.2. Unpaid
- 2.1.3. P&S Intelligence Database
2.2. Primary Research
2.3. Market Size Estimation
2.4. Data Triangulation
2.5. Currency Conversion Rates
2.6. Assumptions for the Study
2.7. Notes and Caveats

Chapter 3. Executive Summary

Chapter 4. Market Indicators

Chapter 5. Industry Outlook

5.1. Industry Background
5.2. Market Dynamics
- 5.2.1. Trends
- 5.2.2. Drivers
- 5.2.3. Restraints/Challenges
- 5.2.4. Emerging Economies and Key Opportunities
- 5.2.5. Impact Analysis of Drivers/Restraints
5.3. Impact of COVID-19
5.4. Sociopolitical Impact
5.5. Porter's Five Forces Analysis
- 5.5.1. Bargaining Power of Buyers
- 5.5.2. Bargaining Power of Suppliers
- 5.5.3. Threat of New Entrants
- 5.5.4. Intensity of Rivalry
- 5.5.5. Threat of Substitutes
5.6. Innovation and Technology Trends
5.7. Supply Chain and Value Chain Insights
5.8. Economic and Regulatory Impact
5.9. Market Entry Strategies

Chapter 6. Competitive Landscape

6.1. List of Market Players and their Offerings
6.2. Market Share of Key Players (2024)
6.3. Competitive Benchmarking of Key Players
6.4. Product Benchmarking of Key Players
6.5. Recent Strategic Developments by Key Players
6.6. Company Leadership Matrix

Chapter 7. U.S. Market

7.1. Overview
7.2. Market Revenue, by Product Type (2019-2032)
7.3. Market Revenue, by Cell Line (2019-2032)
7.4. Market Revenue, by Service Type (2019-2032)
7.5. Market Revenue, by Country (2019-2032)

Chapter 8. West Market

8.1. Overview
8.2. Economic Indicators
8.3. Demographics and Population Insights
8.4. Regional Hotspots
8.5. Growth Drivers
8.6. Challenges and Barriers
8.7. Competitive Strategies
8.8. Emerging Players
8.9. Import/Export Policies
8.10. Compliance Requirements
8.11. Emerging Investment Areas
8.12. Market Size and Forecast
- 8.12.1. Market Revenue, by Product Type (2019-2032)
- 8.12.2. Market Revenue, by Cell Line (2019-2032)
- 8.12.3. Market Revenue, by Service Type (2019-2032)

Chapter 9. Northeast Market

9.1. Overview
9.2. Economic Indicators
9.3. Demographics and Population Insights
9.4. Regional Hotspots
9.5. Growth Drivers
9.6. Challenges and Barriers
9.7. Competitive Strategies
9.8. Emerging Players
9.9. Import/Export Policies
9.10. Compliance Requirements
9.11. Emerging Investment Areas
9.12. Market Size and Forecast
- 9.12.1. Market Revenue, by Product Type (2019-2032)
- 9.12.2. Market Revenue, by Cell Line (2019-2032)
- 9.12.3. Market Revenue, by Service Type (2019-2032)

Chapter 10. Midwest Market

10.1. Overview
10.2. Economic Indicators
10.3. Demographics and Population Insights
10.4. Regional Hotspots
10.5. Growth Drivers
10.6. Challenges and Barriers
10.7. Competitive Strategies
10.8. Emerging Players
10.9. Import/Export Policies
10.10. Compliance Requirements
10.11. Emerging Investment Areas
10.12. Market Size and Forecast
- 10.12.1. Market Revenue, by Product Type (2019-2032)
- 10.12.2. Market Revenue, by Cell Line (2019-2032)
- 10.12.3. Market Revenue, by Service Type (2019-2032)

Chapter 11. South Market

11.1. Overview
11.2. Economic Indicators
11.3. Demographics and Population Insights
11.4. Regional Hotspots
11.5. Growth Drivers
11.6. Challenges and Barriers
11.7. Competitive Strategies
11.8. Emerging Players
11.9. Import/Export Policies
11.10. Compliance Requirements
11.11. Emerging Investment Areas
11.12. Market Size and Forecast
- 11.12.1. Market Revenue, by Product Type (2019-2032)
- 11.12.2. Market Revenue, by Cell Line (2019-2032)
- 11.12.3. Market Revenue, by Service Type (2019-2032)

Chapter 12. Company Profiles

Chapter 13. Appendix

13.1. Sources and References
13.2. Related Reports

U.S. Biologics CDMO Market Size & Share Analysis - Trends, Drivers, Competitive Landscape, and Forecasts (2025 - 2032)