미국의 헬스케어 콜드체인 물류 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the United States healthcare cold chain logistics market size was valued at USD 44.9 billion in 2025 and is estimated to grow from USD 48.49 billion in 2026 to reach USD 70.03 billion by 2031, at a CAGR of 7.63% during the forecast period (2026-2031).

The United States healthcare cold chain logistics market is supported by a broader biologics launch base, faster commercialization of cell and gene therapies, and a replenishment cycle for GLP-1 injectables that has increased the frequency of chilled deliveries across pharmacy and specialty networks. This report is Segmented by Logistics Function (Transportation, and More), by Temperature Type (Chilled, Frozen, Ambient, Ultra-Low), by Product Type (Pharma, Biopharma, Vaccines, and More), by Destination (Domestic, International), by End User (Pharma/Biopharma Manufacturers, and More), and by Geography (Northeast, Southeast, and More). The Market Forecasts are Provided in Value (USD).

United States Healthcare Cold Chain Logistics Market Trends and Insights

Rising Biologics and Specialty-Pharma Cold-Chain Demand

The United States healthcare cold chain logistics market is absorbing a biologics pipeline that is larger and more temperature sensitive than the system built for traditional drug distribution. Cencora said in November 2025 that half of all products launched globally through 2027 would require cold-chain storage, up from 37% during 2013 to 2017, and paired that view with a USD 1 billion plan to expand its United States distribution network. That shift matters because oncology injectables, immunologics, and similar specialty products depend on validated 2 °C to 8 °C lanes with continuous monitoring, which raises the value of premium operators over general freight providers. Biosimilar approvals are also adding more handling intensity than many buyers first expected, because new parallel SKUs often need the same refrigerated treatment as the originator products they compete against. FDA storage and distribution expectations under 21 CFR Part 211 tie temperature control to product quality throughout the journey rather than only at the factory gate. In practice, that makes compliance-grade cold-chain capability a core service line in the United States healthcare cold-chain logistics market rather than a back-end support function.

Cell and Gene Therapy Commercialization

The United States healthcare cold chain logistics market is being pushed into a very different operating model by cell and gene therapies, because many of these shipments are patient-specific and time-critical. Unlike conventional batch drugs, many autologous therapies are one-of-one products that move between collection centers, manufacturers, and treatment sites, so a failed delivery can erase both clinical and commercial value. Required temperature conditions often fall between -70 °C and -150 °C, which exceed the limits of standard pharmaceutical buildings and increase demand for modular medical cryogenic setups where permanent capacity is not yet available. DHL recognized this shift in 2025 when it acquired CryoPDP, a specialist in clinical-trial and cell and gene therapy logistics, and SDS Rx, which added a large United States final-mile footprint with more than 200 locations. As treatment access spreads beyond a small set of elite academic centers, the United States healthcare cold chain logistics market must extend ultra-cold reach to hospitals that have limited cryogenic experience. That expansion remains one of the clearest operating gaps across secondary United States markets.

High Capex, Energy, and Validation Costs

The United States healthcare cold chain logistics market remains constrained by the high cost of building compliant ultra-cold capacity. Cryogenic storage that operates at -80 °C to -150 °C requires specialized mechanical systems, backup power, and continuous monitoring, and the estimates indicate that facility construction costs can run 30% to 50% above standard cold storage costs. Operating costs are also higher because deep-freezing and ultra-low zones can cost 3 to 5 times as much per pallet as refrigerated storage. Qualification expectations under FDA good manufacturing practice rules and USP General Chapter 1079.4 add another layer, since each site must complete temperature mapping and performance qualification before commercial handling begins. That often creates a 12- to 24-month gap between capital commitment and revenue generation, narrowing the field to operators with stronger balance sheets. This cost barrier keeps supply tight in the United States healthcare cold chain logistics market, even while it protects pricing power for established providers.

Other drivers and restraints analyzed in the detailed report include:

1. Outsourcing to Specialist 3PLs and Digital Visibility Stacks
2. Vaccine, Plasma, and Other High-Integrity Temperature-Sensitive Flows
3. Skilled-Labor Shortages and Temperature-Excursion Risk

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

Segment Analysis

Transportation accounted for 46.25% of the United States healthcare cold chain logistics market size by logistics function in 2025, making it the largest functional pool in the category. Road freight held the leading position within transportation because daily pharmaceutical replenishment still depends on dense truck networks and temperature-controlled lanes serving wholesalers, pharmacies, and specialty distributors. Air freight generated the highest revenue per shipment within transportation because time-sensitive biologics and cell and gene therapy movements still require premium speed and handling discipline. Sea and inland waterway transport remained a small part of healthcare cold-chain value, mostly tied to bulk plasma proteins and bulk drug substance flows moving between coastal manufacturing sites and distribution hubs. Rail also began to show practical relevance on selected corridors, especially after J.B. Hunt launched an intermodal refrigerated service in 2025 between Monterrey, Mexico, and Pennsylvania for non-inspection-required temperature-sensitive commodities.

Value-added services are forecast to expand at an 8.38% CAGR through 2031, which makes them the fastest-growing functional segment in the United States healthcare cold chain logistics market. Growth is coming from secondary packaging, kitting, serialization support, clinical hold management, and returns processing, all of which are becoming billable services rather than bundled support tasks. Warehousing and distribution remains the second-largest function because specialty drug portfolios now require refrigerated, frozen, and controlled room-temperature zones inside the same building. The more important change is qualitative, because operators are no longer selling only square footage and cooling capacity. In the United States healthcare cold chain logistics industry, warehousing is shifting toward an information-rich service where real-time inventory visibility, audit-ready records, and predictive stock management help decide pricing and customer retention.

Ambient handling held 46.62% of the United States healthcare cold chain logistics market share by temperature type in 2025, which shows that the healthcare cold chain in the United States still spans more than refrigerated biologics alone. A large share of volume includes OTC products, controlled room-temperature therapies, and oral formulations that move in tightly managed ambient settings instead of chilled environments. Chilled 0 °C to 5 °C and frozen -18 °C to 0 °C bands formed the next tier, supported by vaccines, plasma proteins, and traditional specialty-drug traffic. This mix explains why the United States healthcare cold chain logistics market continues to depend on flexible multi-temperature infrastructure rather than a single cold profile. It also shows why network design must support both high-volume replenishment and high-integrity specialty movements at the same time.

Deep-frozen and ultra-low bands below -20 °C are projected to grow at an 11.55% CAGR through 2031, the fastest pace among temperature types in the United States healthcare cold chain logistics market. That growth reflects the commercialization wave in cell and gene therapy, where product integrity often depends on conditions far below the range used for traditional biologics. Part of the acceleration comes from a low historical base, but the underlying direction is still structural because more approved advanced therapies are entering commercial distribution. Cryoport's first quarter 2026 results and its planned fourth quarter 2026 opening of a Global Supply Chain Center in Santa Ana, California, show that infrastructure providers are scaling ultra-cold capacity before demand fully lands. The United States healthcare cold chain logistics market size for ultra-low lanes remains smaller than ambient and chilled categories today, but it is becoming one of the most strategically important pockets of future expansion.

Complete Report Scope:

• By Logistics Function
  • Transportation
    • Road
    • Air
    • Sea and Inland Waterways
    • Rail
  • Warehousing and Distribution
  • Value-added Services and Others
• By Temperature Type
  • Chilled (0-5 °C)
  • Frozen (-18-0 °C)
  • Ambient
  • Deep-Frozen / Ultra-Low (less than-20 °C)
• By Product Type
  • Pharmaceuticals
    • Prescription and Specialty Drugs
    • OTC Drugs
  • Biopharmaceuticals (Biologics and Biosimilars)
  • Vaccines
  • Clinical Trial Materials
  • Cell and Gene Therapies
  • Medical Devices
  • Veterinary Medicine
  • Blood, Plasma and Blood Components
  • Diagnostic and Laboratory Products
  • Organs and Human Tissues
  • Others
• By Destination
  • Domestics
  • International
• By End User
  • Pharmaceutical Manufacturers
  • Biopharmaceutical Manufacturers
  • Hospitals and Clinics
  • Hospitals and Retail Pharmacies
  • Healthcare Distributors and Wholesalers
  • Others
• By Region
  • Northeast
  • Southeast
  • Midwest
  • Southwest
  • West

List of Companies Covered in this Report:

1. United Parcel Service of America, Inc. (UPS)
2. FedEx
3. DHL Group
4. Cencora
5. McKesson Corporation
6. Cardinal Health
7. Kuehne+Nagel
8. DSV A/S
9. CMA CGM Group (Including CEVA Logistics)
10. Cryoport, Inc.
11. Thermo Fisher Scientific
12. Americold
13. Lineage, Inc.
14. GEODIS
15. AIT Worldwide Logistics, Inc.
16. Owens and Minor
17. Catalent
18. LifeScience Logistics
19. EVERSANA
20. Knipper Health
21. SEKO Logistics

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 Role of Cold Chain Logistics in Healthcare
• 4.2 Healthcare Spending Trends
• 4.3 Market Drivers
  • 4.3.1 Rising Biologics and Specialty-Pharma Cold-Chain Demand
  • 4.3.2 Cell and Gene Therapy Commercialization
  • 4.3.3 Outsourcing to Specialist 3PLs and Digital Visibility Stacks
  • 4.3.4 Vaccine, Plasma, and Other High-Integrity Temperature-Sensitive Flows
  • 4.3.5 Home Infusion and Specialty-Pharmacy Direct-To-Patient Fulfillment
  • 4.3.6 GLP-1 Injectable Replenishment Intensity and Tighter Cold-Chain Turns
• 4.4 Market Restraints
  • 4.4.1 High Capex, Energy, and Validation Costs
  • 4.4.2 Skilled-Labor Shortages and Temperature-Excursion Risk
  • 4.4.3 USP Route Qualification and Data-Integrity Burden
  • 4.4.4 Site-of-Care Cryogenic Readiness Gaps for Advanced Therapies
• 4.5 Regulatory Framework
• 4.6 Value Chain and Distribution Channel Architecture Analysis
• 4.7 Technology Innovations Outlook
• 4.8 Porter's Five Forces Analysis
  • 4.8.1 Threat of New Entrants
  • 4.8.2 Bargaining Power of Suppliers
  • 4.8.3 Bargaining Power of Buyers
  • 4.8.4 Threat of Substitutes
  • 4.8.5 Rivalry Among Competitors
• 4.9 Evolution of Healthcare Cold Chain Logistics Requirements
• 4.10 Impact of Geo-Political Events on Supply Chain Shifts

5 Market Size and Growth Forecasts

• 5.1 By Logistics Function
  • 5.1.1 Transportation
    • 5.1.1.1 Road
    • 5.1.1.2 Air
    • 5.1.1.3 Sea and Inland Waterways
    • 5.1.1.4 Rail
  • 5.1.2 Warehousing and Distribution
  • 5.1.3 Value-added Services and Others
• 5.2 By Temperature Type
  • 5.2.1 Chilled (0-5 °C)
  • 5.2.2 Frozen (-18-0 °C)
  • 5.2.3 Ambient
  • 5.2.4 Deep-Frozen / Ultra-Low (less than-20 °C)
• 5.3 By Product Type
  • 5.3.1 Pharmaceuticals
    • 5.3.1.1 Prescription and Specialty Drugs
    • 5.3.1.2 OTC Drugs
  • 5.3.2 Biopharmaceuticals (Biologics and Biosimilars)
  • 5.3.3 Vaccines
  • 5.3.4 Clinical Trial Materials
  • 5.3.5 Cell and Gene Therapies
  • 5.3.6 Medical Devices
  • 5.3.7 Veterinary Medicine
  • 5.3.8 Blood, Plasma and Blood Components
  • 5.3.9 Diagnostic and Laboratory Products
  • 5.3.10 Organs and Human Tissues
  • 5.3.11 Others
• 5.4 By Destination
  • 5.4.1 Domestics
  • 5.4.2 International
• 5.5 By End User
  • 5.5.1 Pharmaceutical Manufacturers
  • 5.5.2 Biopharmaceutical Manufacturers
  • 5.5.3 Hospitals and Clinics
  • 5.5.4 Hospitals and Retail Pharmacies
  • 5.5.5 Healthcare Distributors and Wholesalers
  • 5.5.6 Others
• 5.6 By Region
  • 5.6.1 Northeast
  • 5.6.2 Southeast
  • 5.6.3 Midwest
  • 5.6.4 Southwest
  • 5.6.5 West

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Key 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, Market Rank/Share for Key Companies, Products and Services, and Recent Developments)
  • 6.4.1 United Parcel Service of America, Inc. (UPS)
  • 6.4.2 FedEx
  • 6.4.3 DHL Group
  • 6.4.4 Cencora
  • 6.4.5 McKesson Corporation
  • 6.4.6 Cardinal Health
  • 6.4.7 Kuehne+Nagel
  • 6.4.8 DSV A/S
  • 6.4.9 CMA CGM Group (Including CEVA Logistics)
  • 6.4.10 Cryoport, Inc.
  • 6.4.11 Thermo Fisher Scientific
  • 6.4.12 Americold
  • 6.4.13 Lineage, Inc.
  • 6.4.14 GEODIS
  • 6.4.15 AIT Worldwide Logistics, Inc.
  • 6.4.16 Owens and Minor
  • 6.4.17 Catalent
  • 6.4.18 LifeScience Logistics
  • 6.4.19 EVERSANA
  • 6.4.20 Knipper Health
  • 6.4.21 SEKO Logistics

7 Market Opportunities and Future Outlook

• 7.1 White-space and Unmet-Need Assessment