미국의 의료용 패시브 콜드체인 포장 시장 규모, 점유율, 동향 분석 보고서 : 제품별, 온도 요건별, 최종 용도별, 부문별 예측(2026-2033년)

U.S. Healthcare Passive Cold Chain Packaging Market Summary

The U.S. healthcare passive cold chain packaging market size was valued at USD 2.22 billion in 2025 and is projected to reach USD 5.45 billion by 2033, expanding at a CAGR of 11.9% from 2026 to 2033. The industry is primarily driven by the rising production and distribution of temperature-sensitive biologics, vaccines, and advanced therapies, which demand reliable, validated passive temperature control solutions.

Additionally, cost-efficiency and operational simplicity of passive systems make them widely adopted across domestic healthcare logistics, especially for last-mile and direct-to-patient shipments.

The rising demand for temperature-sensitive biologics and vaccines is one of the most significant growth drivers for the U.S. healthcare passive cold chain packaging industry. Unlike conventional pharmaceuticals, biologics such as monoclonal antibodies, cell and gene therapies, and recombinant proteins are highly vulnerable to temperature variations. Even limited exposure outside recommended ranges can compromise product efficacy, making reliable passive cold chain solutions essential for protecting drug quality during storage and distribution.

The U.S. remains a global leader in biologics development and commercialization, supported by strong pharmaceutical innovation and increasing approvals of advanced therapies. These products require distribution across hospitals, specialty pharmacies, clinical trial sites, and increasingly direct-to-patient channels. Passive cold chain packaging, including insulated shippers, phase change materials, and gel packs, offers a scalable and cost-effective approach to ensure temperature control without the operational burden of fully active refrigeration systems.

Vaccines further strengthen this demand, particularly with the expansion of immunization programs, seasonal influenza supply chains, and broader preparedness for public health emergencies. Vaccine distribution involves high shipment volumes, variable transit durations, and complex last-mile delivery requirements. Passive packaging is widely preferred due to its flexibility, lower cost structure, and validated performance across diverse climate and transportation conditions.

Moreover, the increasing adoption of e-commerce in healthcare logistics is becoming a major growth driver for the industry. Healthcare distribution is expanding beyond traditional hospital and wholesaler channels toward digital ordering platforms, specialty pharmacy networks, and direct-to-patient delivery models. For example, specialty pharmacies shipping biologics for rheumatoid arthritis or multiple sclerosis now rely heavily on insulated parcel shippers to ensure products remain within the required 2-8°C range during doorstep delivery. This structural shift is significantly increasing demand for validated passive cold chain packaging solutions.

U.S. Healthcare Passive Cold Chain Packaging Market Report Segmentation

This report forecasts revenue growth at the country level and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the U.S. healthcare passive cold chain packaging market report based on product, temperature requirement, end use, and region:

• Product Outlook (Revenue, USD Million, 2021 - 2033)
  • Insulated Containers
  • Insulated Pallet Shippers
  • Gel Packs, Dry Ice Systems, PCM
  • Others
• Temperature Requirement Outlook (Revenue, USD Million, 2021 - 2033)
  • Refrigerated / Chilled (2°C to 8°C)
  • Frozen (-20 °C to +-5 °C)
  • Cool / Controlled Chilled (8 °C to 15 °C)
  • Controlled Room Temperature (CRT)
  • Deep Frozen (-40 °C to -60 °C)
• End Use Outlook (Revenue, USD Million, 2021 - 2033)
  • Pharmaceutical & Biopharmaceutical Companies
  • Hospitals & Healthcare Providers
  • Diagnostic & Pathology Laboratories
  • Research Institutes & Academic Laboratories
  • Clinical Research Organizations (CROs)
  • Blood Banks & Plasma Collection Centers
  • Others

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Research Methodology
  • 1.1.1. Market Segmentation
  • 1.1.2. Market Definition
• 1.2. Research Scope & Assumptions
• 1.3. Information Procurement
  • 1.3.1. Purchased Database
  • 1.3.2. GVR's Internal Database
  • 1.3.3. Secondary Sources & Third-Party Perspectives
  • 1.3.4. Primary Research
• 1.4. Information Analysis
  • 1.4.1. Data Analysis Models
• 1.5. Market Formulation & Data Visualization
• 1.6. Data Validation & Publishing
• 1.7. List of Abbreviations

Chapter 2. Executive Summary

• 2.1. Market Snapshot (USD Million)
• 2.2. Segmental Snapshot
• 2.3. Competitive Landscape Snapshot

Chapter 3. U.S. Healthcare Passive Cold Chain Packaging Market Variables, Trends, and Scope

• 3.1. Market Lineage Outlook
• 3.2. Penetration & Growth Prospect Mapping
• 3.3. Industry Value Chain Analysis
  • 3.3.1. Raw Material Trends
  • 3.3.2. Manufacturing Trends
• 3.4. Sustainability and Reusability Trends
• 3.5. Regulatory Framework
• 3.6. Market Dynamics
  • 3.6.1. Market Driver Analysis
  • 3.6.2. Market Restraint Analysis
  • 3.6.3. Market Opportunity Analysis
  • 3.6.4. Market Challenge Analysis
• 3.7. Business Environment Analysis
  • 3.7.1. Porter's Five Forces Analysis
  • 3.7.2. PESTEL Analysis

Chapter 4. U.S. Healthcare Passive Cold Chain Packaging Market: Product Estimates & Trend Analysis

• 4.1. Key Takeaways
• 4.2. Products Movement Analysis & Market Share, 2025 & 2033
  • 4.2.1. Insulated Containers
    • 4.2.1.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
  • 4.2.2. Insulated Pallet Shippers
    • 4.2.2.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
  • 4.2.3. Gel Packs, Dry Ice Systems, PCM
    • 4.2.3.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
  • 4.2.4. Others
    • 4.2.4.1. Market estimates and forecasts, 2021 - 2033 (USD Million)

Chapter 5. U.S. Healthcare Passive Cold Chain Packaging Market: Temperature Requirement Estimates & Trend Analysis

• 5.1. Key Takeaways
• 5.2. Temperature Requirement Movement Analysis & Market Share, 2025 & 2033
  • 5.2.1. Refrigerated / Chilled (2°C to 8°C)
    • 5.2.1.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
  • 5.2.2. Frozen (-20 °C to +-5 °C)
    • 5.2.2.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
  • 5.2.3. Cool / Controlled Chilled (8 °C to 15 °C)
    • 5.2.3.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
  • 5.2.4. Controlled Room Temperature (CRT)
    • 5.2.4.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
  • 5.2.5. Deep Frozen (-40 °C to -60 °C)
    • 5.2.5.1. Market estimates and forecasts, 2021 - 2033 (USD Million)

Chapter 6. U.S. Healthcare Passive Cold Chain Packaging Market: End Use Estimates & Trend Analysis

• 6.1. Key Takeaways
• 6.2. End Use Movement Analysis & Market Share, 2025 & 2033
  • 6.2.1. Pharmaceutical & Biopharmaceutical Companies
    • 6.2.1.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
  • 6.2.2. Hospitals & Healthcare Providers
    • 6.2.2.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
  • 6.2.3. Diagnostic & Pathology Laboratories
    • 6.2.3.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
  • 6.2.4. Research Institutes & Academic Laboratories
    • 6.2.4.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
  • 6.2.5. Clinical Research Organizations (CROs)
    • 6.2.5.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
  • 6.2.6. Blood Banks & Plasma Collection Centers
    • 6.2.6.1. Market estimates and forecasts, 2021 - 2033 (USD Million)
  • 6.2.7. Others
    • 6.2.7.1. Market estimates and forecasts, 2021 - 2033 (USD Million)

Chapter 7. Competitive Landscape

• 7.1. Key Players & Recent Developments & Their Impact on the Industry
• 7.2. Vendor Landscape
  • 7.2.1. Company Categorization
  • 7.2.2. List of Raw Material Suppliers and Channel Partners
  • 7.2.3. List of Potential Customers
• 7.3. Competitive Dynamics
  • 7.3.1. Company Market Position Analysis
  • 7.3.2. Company Heat Map Analysis
  • 7.3.3. Strategy Mapping
    • 7.3.3.1. Expansions
    • 7.3.3.2. Mergers & Acquisitions
    • 7.3.3.3. Collaborations
    • 7.3.3.4. New Product Launches
    • 7.3.3.5. Others

Chapter 8. Company Listing (Overview, Financial Performance, Product Overview)

• 8.1. Company Overview
• 8.2. Financial Performance
• 8.3. Product Benchmarking
• 8.4. Cold Chain Technologies
• 8.5. Peli BioThermal LLC
• 8.6. Cryopak
• 8.7. CSafe
• 8.8. Intelsius
• 8.9. TemperPack
• 8.10. Coldkeepers, LLC
• 8.11. Polar Tech Industries
• 8.12. Creative Packaging Co.
• 8.13. ThermoSafe