미국의 의약품 냉장 체인 공수 물류 : 시장 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the United States pharmaceutical cold chain air logistics market size was valued at USD 10.69 billion in 2025 and estimated to grow from USD 11.54 billion in 2026 to reach USD 16.63 billion by 2031, at a CAGR of 7.57% during the forecast period (2026-2031).

The expansion reflects a larger pipeline of temperature-sensitive medicines and a distribution model that is moving closer to patients. This report is Segmented by Temperature Range (Chilled, Frozen, Ambient, Deep-Frozen/Ultra-Low), by Pharmaceutical Product Type (Small-Molecule, Biological, Specialty, Cell and Gene Therapies, Veterinary, Other), by Shipment Flow (Domestic, International), and by Region (Northeast, Southeast, Midwest, Southwest, West). The Market Forecasts are Provided in Terms of Value (USD).

United States Pharmaceutical Cold Chain Air Logistics Market Trends and Insights

Biologics and Specialty-Pharmaceutical Shipment Growth

Biologics are reshaping the cost structure of the United States pharmaceutical cold chain air logistics market because they need controlled transport and documented release procedures. CDER approved 46 novel drugs during 2025, including 12 biologics, while the combined number of novel approvals across CDER and CBER reached 58. Each launch creates transport qualification work because the product must move through a validated lane before commercial distribution begins. The United States pharmaceutical cold chain air logistics market, therefore, gains demand from both shipment movement and the qualification work that accompanies a new product. FDA approvals included 18 biosimilars for 10 reference products in 2025. Separate biosimilar manufacturers need their own qualified packaging and carrier arrangements, which increases the number of active freight relationships rather than combining freight under one originator program.

Cell and Gene Therapy Commercialization

Cell and gene therapies are moving from clinical activity into commercial distribution and have become the most demanding cargo category in the United States pharmaceutical cold chain air logistics market. Cryoport reported support for 21 commercially approved cell and gene therapies and 766 global clinical trials as of March 31, 2026. FDA approvals of GENGLYCOS in August 2026 and TREGZI in July 2026 added therapies that need specialized distribution to certified treatment centers. Autologous therapies require patient cells to travel from a hospital to a manufacturing site and then return to the same care location. That two-way movement makes identity control, timing, and temperature performance central to the shipment process. Liquid nitrogen vapor shippers operating below -150 °C are subject to IATA dangerous goods requirements for UN 1977, which limit carrier options and increase handling requirements.

High Validation, Packaging, and Temperature-Control Costs

Validation requirements establish a cost floor for pharmaceutical cold-chain air lanes, regardless of shipment volume. Under 21 CFR Part 211.142 and 211.150, manufacturers and distributors must maintain written procedures that protect a drug product's identity, strength, quality, and purity during storage and distribution. The United States pharmaceutical cold chain air logistics market must account for seasonal lane qualification, packaging performance, and documented transport procedures. USP General Chapter 1079 provides good storage and distribution practices for drug products and supports formal temperature-control processes. Active containers and qualified equipment add recurring certification and operating costs. These requirements are harder to absorb for smaller providers and sponsors managing low-volume, high-value therapy shipments.

Other drivers and restraints analyzed in the detailed report include:

1. Direct-to-Patient and Specialty-Pharmacy Fulfillment
2. Clinical-Trial Decentralization and Patient-Specific Shipments
3. Temperature Excursion, Delay, and Product-Disposal Risk

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

Segment Analysis

Ambient shipments held 46.62% of the market share in 2025, the largest position within the United States pharmaceutical cold chain air logistics market. This category includes GLP-1 injectables with controlled room-temperature requirements and oral specialty medicines with extended room-temperature profiles. Their high volume supports investment in airport cargo facilities and handling processes. That investment can also support specialized cargo moving along the same corridors. Chilled products require close handling control for many biologics and vaccines. FDA materials describe the importance of proper distribution conditions for approved drug products. Frozen products also remain important where product stability calls for lower temperature exposure.

The United States pharmaceutical cold chain air logistics market size for deep-frozen and ultra-low products is forecast to increase at an 11.55% CAGR between 2026 and 2031. This pace exceeds that of the other temperature categories. Cell and gene therapies are the main source of this demand because many require liquid nitrogen vapor shipment at temperatures below -150 °C. IATA treats UN 1977 liquid nitrogen shipments under dangerous goods rules that include specific handling controls. Growth is likely to concentrate at certified gateways with active container areas and the ability to manage cold equipment during ground dwell. Airports without these capabilities have a limited role in advanced therapy lanes. This channeling of traffic makes infrastructure quality a material factor in the United States pharmaceutical cold chain air logistics market.

Complete Report Scope:

• By Temperature Range
  • Chilled (0-5 °C)
  • Frozen (-18-0 °C)
  • Ambient
  • Deep-Frozen / Ultra-Low (More than -20 °C)
• By Pharmaceutical Product Type
  • Small-Molecule Pharmaceuticals
    • Branded Pharmaceuticals
    • Over-the-Counter (OTC) Pharmaceuticals
    • Generic Pharmaceuticals
  • Biological Pharmaceuticals (Biologics, Biosimilars, Vaccines, and Blood-Derived Medicinal Products)
  • Specialty Pharmaceuticals
  • Cell and Gene Therapies
  • Veterinary Pharmaceuticals
  • Other Pharmaceutical Products
• By Shipment Flow
  • Domestic Shipments
  • International Shipments
• By Region
  • Northeast
  • Southeast
  • Midwest
  • Southwest
  • West

List of Companies Covered in this Report:

1. United Parcel Service, Inc. (UPS Healthcare, including Marken)
2. FedEx Corporation
3. DHL Group
4. Kuehne+Nagel International AG
5. DSV A/S
6. CEVA Logistics (CMA CGM Group)
7. GEODIS
8. World Courier (Cencora, Inc.)
9. Cryoport, Inc.
10. AIT Worldwide Logistics, Inc.
11. JAS Worldwide
12. Biocair (Geopost)
13. Nippon Express Holdings, Inc. (NX Group)
14. Expeditors International of Washington, Inc.
15. Hellmann Worldwide Logistics SE & Co. KG
16. Yusen Logistics Co., Ltd
17. Kintetsu World Express, Inc.
18. A.P. Moller - Maersk A/S
19. Crane Worldwide Logistics
20. Rhenus Group
21. DACHSER SE
22. Scan Global Logistics A/S
23. GXO Logistics, Inc.
24. XPO, Inc.

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 and Importance of Pharmaceutical Cold Chain Air Freight Logistics
• 4.2 Market Drivers
  • 4.2.1 Biologics and Specialty-Pharmaceutical Shipment Growth
  • 4.2.2 Cell and Gene Therapy Commercialization
  • 4.2.3 Direct-to-Patient and Specialty-Pharmacy Fulfillment
  • 4.2.4 Clinical-Trial Decentralization and Patient-Specific Shipments
  • 4.2.5 Airport-Level Cold-Chain Resilience and Qualified Cross-Dock Expansion
  • 4.2.6 Digital Chain-of-Custody and Predictive Exception Management
• 4.3 Market Restraints
  • 4.3.1 High Validation, Packaging and Temperature-Control Costs
  • 4.3.2 Temperature Excursion, Delay and Product-Disposal Risk
  • 4.3.3 Dry-Ice and Cryogenic Supply Volatility at Air Hubs
  • 4.3.4 Limited GxP-Trained Labor and Site-of-Care Cryogenic Readiness
• 4.4 Value and Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Major Pharmaceutical Air Cargo Gateways and Infrastructure
• 4.8 Pharmaceutical Import Export Flows and Major Trade Corridors
• 4.9 Porter's Five Forces Analysis
  • 4.9.1 Threat of New Entrants
  • 4.9.2 Bargaining Power of Buyers and Consumers
  • 4.9.3 Bargaining Power of Suppliers
  • 4.9.4 Threat of Substitute Services
  • 4.9.5 Intensity of Competitive Rivalry

5 MARKET SIZE AND GROWTH FORECASTS

• 5.1 By Temperature Range
  • 5.1.1 Chilled (0-5 °C)
  • 5.1.2 Frozen (-18-0 °C)
  • 5.1.3 Ambient
  • 5.1.4 Deep-Frozen / Ultra-Low (More than -20 °C)
• 5.2 By Pharmaceutical Product Type
  • 5.2.1 Small-Molecule Pharmaceuticals
    • 5.2.1.1 Branded Pharmaceuticals
    • 5.2.1.2 Over-the-Counter (OTC) Pharmaceuticals
    • 5.2.1.3 Generic Pharmaceuticals
  • 5.2.2 Biological Pharmaceuticals (Biologics, Biosimilars, Vaccines, and Blood-Derived Medicinal Products)
  • 5.2.3 Specialty Pharmaceuticals
  • 5.2.4 Cell and Gene Therapies
  • 5.2.5 Veterinary Pharmaceuticals
  • 5.2.6 Other Pharmaceutical Products
• 5.3 By Shipment Flow
  • 5.3.1 Domestic Shipments
  • 5.3.2 International Shipments
• 5.4 By Region
  • 5.4.1 Northeast
  • 5.4.2 Southeast
  • 5.4.3 Midwest
  • 5.4.4 Southwest
  • 5.4.5 West

6 COMPETITIVE LANDSCAPE

• 6.1 Market Concentration
• 6.2 Strategic Moves
• 6.3 Market Share Analysis
• 6.4 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Geographic Coverage, Products and Services, Recent Developments)
  • 6.4.1 United Parcel Service, Inc. (UPS Healthcare, including Marken)
  • 6.4.2 FedEx Corporation
  • 6.4.3 DHL Group
  • 6.4.4 Kuehne+Nagel International AG
  • 6.4.5 DSV A/S
  • 6.4.6 CEVA Logistics (CMA CGM Group)
  • 6.4.7 GEODIS
  • 6.4.8 World Courier (Cencora, Inc.)
  • 6.4.9 Cryoport, Inc.
  • 6.4.10 AIT Worldwide Logistics, Inc.
  • 6.4.11 JAS Worldwide
  • 6.4.12 Biocair (Geopost)
  • 6.4.13 Nippon Express Holdings, Inc. (NX Group)
  • 6.4.14 Expeditors International of Washington, Inc.
  • 6.4.15 Hellmann Worldwide Logistics SE & Co. KG
  • 6.4.16 Yusen Logistics Co., Ltd
  • 6.4.17 Kintetsu World Express, Inc.
  • 6.4.18 A.P. Moller - Maersk A/S
  • 6.4.19 Crane Worldwide Logistics
  • 6.4.20 Rhenus Group
  • 6.4.21 DACHSER SE
  • 6.4.22 Scan Global Logistics A/S
  • 6.4.23 GXO Logistics, Inc.
  • 6.4.24 XPO, Inc.

7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK

• 7.1 White-Space and Unmet-Need Assessment

8 APPENDIX