미국의 바이오테크놀러지 및 의약품 서비스 아웃소싱 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the US biotechnology and pharmaceutical services outsourcing market size is expected to increase from USD 11.55 billion in 2025 to USD 12.13 billion in 2026 and reach USD 15.56 billion by 2031, growing at a CAGR of 5.10% over 2026-2031.

This report is Segmented by Service Type (CRO, CDMO, Analytical, Regulatory Affairs, Pharmacovigilance, Packaging), Drug Type (Small Molecules, Large Molecules, Cell and Gene Therapies, Vaccines), Development Stage, End User, and Therapeutic Area (Oncology, Neurology, Immunology, Cardiovascular, Rare Diseases, Others). The Market Forecasts are Provided in Terms of Value (USD).

US Biotechnology And Pharmaceutical Services Outsourcing Market Trends and Insights

Rising Complexity of Biologics, Cell and Gene Therapy Pipelines

The shift towards biologics, cell therapies, and gene therapies is the primary demand driver in the United States biotechnology and pharmaceutical services outsourcing market. These programs require specialized GMP suites, modality-specific analytical methods, complex cold-chain processes, and regulatory expertise that are challenging to develop quickly. In 2024, oncology, immunology, neurology, and cardiovascular programs accounted for 71% of the 5,318 clinical trial starts, reflecting the focus on complex areas. Novel oncology modalities, including cell and gene therapies, antibody-drug conjugates, and multispecific antibodies, represented 35% of oncology trials, increasing demand for CDMOs with advanced capabilities. Autologous CAR-T programs involve multiple specialized tasks, spreading work across various vendors, which drives higher outsourcing volumes, program costs, and longer provider relationships.

Demand for Integrated End-to-End Development and Manufacturing Partners

Sponsors in the United States biotechnology and pharmaceutical services outsourcing market are reducing the number of outsourcing partners per program, favoring providers that manage end-to-end processes from development to regulatory submission. Integrated CDMO and CRO models have been shown to accelerate timelines, with adoption by over 120 biotechs across 350-plus protocols. This trend is concentrating revenue among providers with broader capabilities, while smaller specialists form partnerships to expand service offerings. Procurement teams prioritize speed and fewer handoffs, giving integrated platforms pricing leverage and stronger sponsor relationships.

Sponsor Concentration Risk and Vendor Consolidation

In the United States biotechnology and pharmaceutical services outsourcing market, vendor consolidation among major sponsors is limiting growth opportunities. Many leading pharmaceutical firms now work with a select few preferred CROs and CDMOs across service categories. While this approach streamlines oversight and cost management, it exposes providers to significant revenue risks if they lose a preferred status. Mid-tier companies face added pressure as they often invest in quality systems, staffing, and facilities before securing contracts. Smaller biotech clients provide some balance, but their demand fluctuates with financing and portfolio changes, making revenue quality sensitive to client concentration and renewal cycles.

Other drivers and restraints analyzed in the detailed report include:

1. Reshoring and North American Supply Chain Risk Diversification
2. Data-Heavy Clinical Operations Favor Scalable US-Based Technology Platforms
3. Capacity Bottlenecks in Specialized Modalities and GMP Suites

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

In 2025, Contract Research Organization (CRO) services dominated the US biotechnology and pharmaceutical services outsourcing market, accounting for 39.88% of the revenue. This dominance is largely attributed to ongoing Phase II to Phase IV activities in oncology and neurology, fields where trial execution is both data-intensive and operationally intricate. CROs are broadening their scope, moving beyond traditional monitoring and site management to include protocol design support, patient recruitment analytics, pharmacovigilance, and integrated quality oversight. This evolution is driving up average contract values, as sponsors opt for comprehensive execution packages over standalone services. The market is increasingly favoring providers that seamlessly blend clinical operations with robust regulatory and technological backing.

Services in Regulatory Affairs and Quality Assurance are thriving, thanks to heightened oversight standards across multi-site programs. Sponsors are increasingly seeking assistance in managing quality systems across vendors. As trial designs become richer in biomarkers, the demand for Analytical and Bioanalytical services is surging, especially in oncology. Pharmacovigilance and Drug Safety services are transitioning to automated models, with providers channeling investments into rapid signal detection and expansive case-processing tools. While Packaging, Labeling, and Serialization services remain niche, their significance is paramount in advanced therapy programs, where maintaining chain-of-custody control is critical.

In 2025, small molecules constituted 42.35% of the revenue, solidifying their position as the leading drug-type segment in the US biotechnology and pharmaceutical services outsourcing market. Their stronghold is bolstered by a pipeline teeming with new chemical entities and high-potency compounds. Outsourcing is already prevalent in API synthesis and oral solid dose manufacturing, particularly for programs involving controlled substances or stringent containment needs. Consequently, future growth in this segment is anticipated to stem more from an improved mix rather than a significant shift in outsourcing rates. The rising contract values, driven by higher-potency compounds and intricate synthesis routes, are evident even without a proportional increase in program counts.

Cell and gene therapies are emerging as the fastest-growing drug type, with an anticipated 8.88% CAGR through 2031 in the US biotechnology and pharmaceutical services outsourcing market. Their ascent is fueled by increasing IND activity and the scarcity of sponsors possessing in-house capabilities for vector, plasmid, cell-processing, and release-testing. Novel oncology modalities, encompassing cell and gene therapies, antibody-drug conjugates, and multispecific antibodies, now represent 35% of oncology trials, sustaining a heightened demand for specialized manufacturing and analytical support.

Complete Report Scope:

• By Service Type
  • Contract Research Organization Services
  • Contract Development and Manufacturing Organization Services
  • Analytical and Bioanalytical Services
  • Regulatory Affairs and Quality Assurance Services
  • Pharmacovigilance and Drug Safety Services
  • Market Access and Medical Affairs Services
  • Packaging, Labeling and Serialization Services
• By Drug Type
  • Small Molecules
  • Large Molecules
  • Cell and Gene Therapies
  • Vaccines
  • Other Drug Types
• By Development Stage
  • Discovery and Preclinical
  • Phase I
  • Phase II
  • Phase III
  • Phase IV and Post-Marketing
• By End User
  • Pharmaceutical Companies
  • Biotechnology Companies
  • Medical Device Companies
  • Academic and Research Institutions
  • Government and Public Health Organizations
• By Therapeutic Area
  • Oncology
  • Neurology
  • Immunology
  • Infectious Diseases
  • Cardiovascular Diseases
  • Rare Diseases
  • Metabolic Disorders
  • Other Therapeutic Areas

List of Companies Covered in this Report:

1. Abbvie
2. Aenova Group GmbH
3. Alcami
4. Boehringer Ingelheim
5. Cambrex
6. Catalent
7. Charles River
8. Eurofins
9. Fortrea Holdings Inc.
10. ICON
11. IQVIA
12. Labcorp Holdings Inc.
13. Lonza Group Ltd.
14. Medpace Holdings, Inc.
15. Parexel International
16. PCI Pharma Services
17. Pfizer
18. Samsung Biologics Co., Ltd.
19. Syneos Health
20. Thermo Fisher Scientific Inc. (PPD, Inc.)
21. WuXi AppTec Co., Ltd.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 INTRODUCTION

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET LANDSCAPE

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Complexity of Biologics, Cell and Gene Therapy Pipelines
  • 4.2.2 Sponsor Push for Fixed-Cost, Variable-Capacity Operating Models
  • 4.2.3 Demand for Integrated End-to-End Development and Manufacturing Partners
  • 4.2.4 Reshoring and North American Supply Chain Risk Diversification
  • 4.2.5 Data-Heavy Clinical Operations Favor Scalable US-Based Technology Platforms
  • 4.2.6 Faster Protocol Design and Enrollment Support for Complex Trials
• 4.3 Market Restraints
  • 4.3.1 Sponsor Concentration Risk and Vendor Consolidation
  • 4.3.2 Regulatory and Quality Compliance Burden Across Multi-Site Programs
  • 4.3.3 Capacity Bottlenecks in Specialized Modalities and GMP Suites
  • 4.3.4 Margin Pressure From Bid Competition and Pricing Compression
• 4.4 Value Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Bargaining Power of Suppliers
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Threat of New Entrants
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 MARKET SIZE AND GROWTH FORECASTS (VALUE, USD)

• 5.1 By Service Type
  • 5.1.1 Contract Research Organization Services
  • 5.1.2 Contract Development and Manufacturing Organization Services
  • 5.1.3 Analytical and Bioanalytical Services
  • 5.1.4 Regulatory Affairs and Quality Assurance Services
  • 5.1.5 Pharmacovigilance and Drug Safety Services
  • 5.1.6 Market Access and Medical Affairs Services
  • 5.1.7 Packaging, Labeling and Serialization Services
• 5.2 By Drug Type
  • 5.2.1 Small Molecules
  • 5.2.2 Large Molecules
  • 5.2.3 Cell and Gene Therapies
  • 5.2.4 Vaccines
  • 5.2.5 Other Drug Types
• 5.3 By Development Stage
  • 5.3.1 Discovery and Preclinical
  • 5.3.2 Phase I
  • 5.3.3 Phase II
  • 5.3.4 Phase III
  • 5.3.5 Phase IV and Post-Marketing
• 5.4 By End User
  • 5.4.1 Pharmaceutical Companies
  • 5.4.2 Biotechnology Companies
  • 5.4.3 Medical Device Companies
  • 5.4.4 Academic and Research Institutions
  • 5.4.5 Government and Public Health Organizations
• 5.5 By Therapeutic Area
  • 5.5.1 Oncology
  • 5.5.2 Neurology
  • 5.5.3 Immunology
  • 5.5.4 Infectious Diseases
  • 5.5.5 Cardiovascular Diseases
  • 5.5.6 Rare Diseases
  • 5.5.7 Metabolic Disorders
  • 5.5.8 Other Therapeutic Areas

6 COMPETITIVE LANDSCAPE

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments)
  • 6.3.1 AbbVie
  • 6.3.2 Aenova Group GmbH
  • 6.3.3 Alcami Corporation
  • 6.3.4 Boehringer Ingelheim GmbH
  • 6.3.5 Cambrex Corporation
  • 6.3.6 Catalent, Inc.
  • 6.3.7 Charles River Laboratories International, Inc.
  • 6.3.8 Eurofins Scientific SE
  • 6.3.9 Fortrea Holdings Inc.
  • 6.3.10 ICON plc
  • 6.3.11 IQVIA Holdings Inc.
  • 6.3.12 Labcorp Holdings Inc.
  • 6.3.13 Lonza Group Ltd.
  • 6.3.14 Medpace Holdings, Inc.
  • 6.3.15 Parexel International Corporation
  • 6.3.16 PCI Pharma Services
  • 6.3.17 Pfizer
  • 6.3.18 Samsung Biologics Co., Ltd.
  • 6.3.19 Syneos Health, Inc.
  • 6.3.20 Thermo Fisher Scientific Inc. (PPD, Inc.)
  • 6.3.21 WuXi AppTec Co., Ltd.

7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK

• 7.1 White-Space and Unmet-Need Assessment