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Cold-chain Pharma Market by Product Type (Biologics, Blood & Plasma Products, Cell & Gene Therapies), Packaging Type (Active Packaging, Passive Packaging), Temperature Range, Equipment, Service Type, Application, End User - Global Forecast 2025-2032

Publisher 360iResearch
Published Sep 30, 2025
Length 195 Pages
SKU # IRE20446175

Description

The Cold-chain Pharma Market was valued at USD 15.39 billion in 2024 and is projected to grow to USD 16.78 billion in 2025, with a CAGR of 9.34%, reaching USD 31.47 billion by 2032.

Setting the Stage for the Evolution of Cold-Chain Pharma Logistics Amid Technological Advances Regulatory Changes and Global Supply Chain Challenges

The pharmaceutical cold-chain landscape has evolved into a cornerstone of modern healthcare delivery, demanding unparalleled precision from molecule to patient. Recent technological strides, heightened regulatory scrutiny and global supply chain disruptions have converged to redefine how temperature-sensitive products are handled, stored and transported. Biologics, vaccines and advanced therapies now depend on solutions that ensure integrity throughout complex distribution networks.
Amid this evolving backdrop, stakeholders are compelled to adopt a holistic perspective that integrates real-time visibility, risk management and sustainability imperatives. From advanced sensor arrays embedded in packaging to predictive analytics platforms guiding routing decisions, innovations are reshaping traditional cold-chain frameworks. Regulatory authorities are simultaneously tightening guidelines around temperature excursions and traceability, compelling companies to invest in robust compliance mechanisms.
This introduction sets the stage for an in-depth exploration of transformative shifts in technology, the impact of recent tariff adjustments, nuanced segmentation insights, regional dynamics, leading company strategies, actionable recommendations, methodological rigor and concluding perspectives. By framing key challenges and emerging solutions, this section lays the groundwork for strategic decision makers aiming to optimize resilience and efficiency in temperature-controlled pharmaceutical logistics.

Unveiling the Transformative Technological Regulatory and Operational Shifts Reshaping the Future of Temperature-Controlled Pharmaceutical Supply Chains

In recent years, the cold-chain pharmaceutical domain has witnessed seismic shifts propelled by digital transformation, regulatory evolution and the demand for end-to-end transparency. Advanced sensor technologies now enable real-time monitoring of temperature excursions and humidity variations, allowing supply chain managers to preempt risks before products deviate from specified conditions. Moreover, the integration of blockchain platforms has introduced immutable recordkeeping that enhances both traceability and stakeholder trust.
Simultaneously, emerging regulatory frameworks in major markets have harmonized requirements for data logging and product integrity, prompting logistics providers to upgrade warehousing and transport protocols. Enhanced process standardization has been reinforced by global initiatives to reduce product spoilage and guarantee patient safety. Furthermore, the adoption of AI-driven analytics has optimized route planning and inventory forecasting, thereby minimizing transit times and reducing carbon footprints.
Collectively, these technological and operational transformations are forging a new era in cold-chain management-one characterized by dynamic risk mitigation, continuous process improvement and strategic collaboration among stakeholders. The following sections will delve into how these trends intersect with economic policy changes, segmentation nuances and regional variances to shape the future of pharmaceutical logistics.

Analyzing the Broad Cumulative Impact of Recent US Tariff Policies on Pharmaceutical Cold-Chain Logistics and Cost Structures Across Diverse Segments

The implementation of targeted US tariffs in 2025 on imported packaging materials, refrigeration equipment and related components has introduced new cost considerations for pharmaceutical shippers and service providers. As duties on specialized containers and insulating materials rise, logistics teams have had to rethink procurement strategies and diversify supplier relationships to maintain reliability and cost effectiveness. Furthermore, increased import levies on key raw inputs have pressured manufacturers to explore near-shoring or alternative sourcing models.
Consequently, many organizations have accelerated investments in modular container designs that can be customized locally, thereby reducing exposure to cross-border duties. Cold-chain operators have also reengineered route networks to leverage domestic intermodal corridors, optimizing transport modes that are less susceptible to tariff variability. In addition, collaborative initiatives between logistics partners and packaging innovators have emerged to co-develop materials that comply with trade regulations while preserving product integrity.
Through these adjustments, the industry is navigating the evolving tariff landscape without compromising on temperature control standards. By rebalancing global sourcing, embracing adaptive packaging solutions and cultivating strategic partnerships, stakeholders are mitigating the financial and operational impacts of policy shifts on pharmaceutical distribution.

Illuminating Segmentation Insights Across Packaging Types Temperature Ranges Distribution Channels Service Modalities Products and End User Perspectives

A deep examination of packaging segmentation reveals two primary categories: active and passive systems. Active packaging encompasses refrigerated containers equipped with powered cooling units and temperature-controlled pallets that maintain precise environmental parameters during transit. Passive packaging relies on phase change materials and insulating structures, including dry ice containers, gel packs and insulated shippers, to preserve temperature stability without external power sources.
Temperature-range segmentation further refines cold-chain requirements. Controlled ambient shipments maintain a steady environment above refrigeration thresholds, while refrigerated transport sustains a range typically between 2 and 8 degrees Celsius. Frozen logistics are subdivided into deep frozen conditions and ultra frozen environments, accommodating products such as advanced biologics or novel therapies with stringent thermal sensitivity.
When evaluating distribution channels, enterprises choose in-house or third-party logistics partners. In-house operations may adopt centralized distribution hubs for consolidated control or decentralized nodes to reduce transit distances. Third-party logistics providers offer contract services or dedicated cold-chain specialists, delivering scalability and industry expertise without the capital expenditures of self-owned fleets.
Service type classification groups solutions into storage, transportation and value-added offerings. Storage services span cold storage warehouses and temperature-controlled containers, providing flexible staging options. Transportation services traverse air freight, rail, road and sea, enabling global reach and multimodal optimization. Value-added services such as kitting, repacking and continuous monitoring enhance operational agility and ensure regulatory compliance through customized packaging configurations and rigorous data oversight.
Mode of transport delineation highlights air, rail, road and maritime options. Air transport includes express flights for high-value or time-critical shipments and specialized freighter aircraft. Rail movement employs dedicated cold cars and intermodal solutions that combine rail and truck segments for long-haul efficiency. Road transport ranges from full truckload services for large volumes to less-than-truckload shipments for smaller consignments. Sea transport leverages container ships and reefer vessels, supporting high-capacity, cost-efficient ocean crossings.
Product type segmentation addresses diverse pharmaceutical categories. Biologics are represented by monoclonal antibodies and therapeutic proteins with narrow thermal tolerances. Diagnostic products are delivered as PCR kits or rapid test kits, each requiring specific protection against freeze-thaw cycles. Small molecule drugs are shipped as injectable formulations or oral therapies, while vaccines include live attenuated or mRNA options, often demanding ultra-low temperature management.
Finally, end user segmentation encompasses clinics, contract research organizations, hospitals and retail pharmacies. Clinics subdivide into community and outpatient settings, each with distinct storage capabilities. Contract research organizations provide analytical and clinical trial services, necessitating bespoke logistical solutions. Hospitals are categorized as general or specialty facilities, influencing inventory velocity and staging needs. Retail pharmacies include chain and independent operators, each balancing volume requirements and geographic dispersion to meet patient demand.

Examining Vital Regional Variations and Strategic Opportunities in Cold-Chain Pharma Across the Americas Europe Middle East Africa and Asia-Pacific Markets

In the Americas, a mature cold-chain infrastructure underpins expansive trade routes between North and South regions. Advanced intermodal corridors, particularly in the United States and Canada, facilitate rapid pharmaceutical shipments inland, while Latin American hubs are investing heavily in temperature-controlled warehousing to support growing local vaccine distribution and biologics manufacturing.
The Europe, Middle East & Africa region presents a tapestry of regulatory complexities and infrastructure maturity levels. Western Europe boasts stringent pharmacovigilance standards and high-density urban networks, whereas emerging Middle Eastern and African markets are rapidly upgrading port and air freight facilities. Cross-border harmonization efforts continue to drive standardization, with particular emphasis on developing robust cold-chain corridors to combat public health challenges.
Asia-Pacific remains a focal point of industry expansion, propelled by pharmaceutical manufacturing growth and regional trade agreements. Key markets such as China, India and Southeast Asia are scaling cold-chain warehousing and port operations to serve both domestic demand and export commitments. The rise of e-commerce in the region has also accelerated last-mile cooling solutions, integrating real-time tracking and temperature breach alerts for end users.

Highlighting Breakthrough Company Strategies Collaboration Models and Innovation Drivers Shaping the Future of Pharmaceutical Cold-Chain Logistics Services

Leading companies in the cold-chain pharmaceutical arena are forging strategic alliances to bolster end-to-end capabilities. Major logistics providers are partnering with packaging innovators to co-develop next-generation containers that combine real-time telemetry with enhanced insulation technologies. Simultaneously, strategic acquisitions of specialized service firms are enabling integrated offerings that span storage, transport and compliance management under a single umbrella.
Key players are also investing in digital platforms that unify shipment data across global networks, providing stakeholders with a single source of truth. Cloud-based dashboards integrate sensor feeds, carrier schedules and regulatory documentation, enabling rapid decision making in response to transit deviations or regulatory audits. Furthermore, collaborations between technology startups and established cold-chain operators are driving proof-of-concept pilots for autonomous monitoring drones and AI-driven predictive maintenance of refrigeration units.
Innovation roadmaps are increasingly embedding sustainability imperatives, with companies experimenting with low-emission vehicles, bio-derived insulation materials and optimized route planning to reduce carbon footprints. Partnerships with research institutions and regulatory bodies are advancing best-practice guidelines for energy-efficient cold storage, positioning these companies as both service providers and stewards of environmental responsibility in pharmaceutical logistics.

Crafting Strategic Actionable Recommendations to Enhance Resilience Efficiency and Compliance in Pharmaceutical Cold-Chain Operations and Supply Continuity

Industry leaders should prioritize end-to-end visibility by integrating advanced sensor networks and unified digital platforms. This approach not only mitigates the risk of temperature excursions but also streamlines regulatory reporting and enhances stakeholder trust. In addition, organizations are urged to diversify their supply base, leveraging local and regional suppliers to reduce exposure to cross-border trade fluctuations and minimize lead times.
Investment in sustainable cold-chain technologies, such as bio-based insulation and energy-efficient refrigeration units, will both reduce operational costs and align with emerging environmental regulations. Executives are encouraged to adopt multimodal routing strategies that optimize transit times and carbon footprints, balancing air, rail, road and maritime options to meet product sensitivity requirements.
Cross-functional collaboration between quality assurance, procurement and logistics teams is essential to harmonize standard operating procedures and expedite issue resolution. Furthermore, building strategic partnerships with technology developers and compliance experts can accelerate innovation cycles and ensure that next-generation solutions are both technically robust and fully compliant with evolving regulatory standards. By executing these recommendations, organizations can fortify resilience, drive efficiency and safeguard the integrity of temperature-sensitive pharmaceuticals.

Detailing the Comprehensive Research Methodology Designed to Deliver Rigorous Data-Driven Insights and Analytical Transparency in Cold-Chain Pharmaceutical Studies

The research methodology underpinning this analysis combined extensive primary interviews with senior supply chain executives, quality assurance leaders and packaging specialists, complemented by a rigorous review of published regulatory guidelines and technical white papers. Data triangulation was employed to validate insights, cross-referencing qualitative findings with operational data from leading logistics providers and real-time temperature monitoring networks.
Secondary research encompassed an exhaustive survey of industry journals, regulatory filings and patent databases to chart emerging technologies and track policy developments. An expert panel comprising scientists, engineers and logistics strategists convened to review preliminary conclusions and refine the analytical framework. The result is a robust, transparent methodology that balances depth of insight with comprehensive coverage of the global cold-chain pharmaceutical ecosystem.

Concluding Forward-Looking Perspectives on Future-Proofing Pharmaceutical Cold-Chain Logistics through Innovation Risk Management and Collaborative Partnerships

As the complexity of pharmaceutical cold-chain logistics intensifies, organizations must embrace a forward-looking approach that integrates cutting-edge technologies, risk management protocols and collaborative ecosystems. Innovation in packaging materials, sensor technologies and digital tracking platforms will drive the next wave of efficiency gains, while harmonized regulatory standards will simplify cross-border operations.
Proactive risk mitigation strategies-ranging from scenario planning for tariff impacts to redundancy in temperature-controlled transport options-will underpin resilience in volatile market conditions. Moreover, ecosystem partnerships between manufacturers, logistics providers and technology firms will be critical to scaling solutions and driving continuous improvement.
By synthesizing technological advancements with strategic collaboration and rigorous compliance, stakeholders can future-proof their cold-chain operations, ensuring that life-saving therapies reach patients in optimal condition no matter where they are in the world.

Market Segmentation & Coverage

This research report categorizes to forecast the revenues and analyze trends in each of the following sub-segmentations:

Product Type
Biologics
Monoclonal Antibodies
Plasma-Derived Therapeutics
Recombinant Proteins & Enzymes
Blood & Plasma Products
Coagulation Factors
Immunoglobulins
Cell & Gene Therapies
Allogeneic Cell Therapies
Autologous Cell Therapies
Gene Therapies
Clinical Trial Materials
Ancillaries & Kits
Investigational Medicinal Products
Insulins & Hormones
GLP-1 & Other Peptide Hormones
Insulin
Specialty Pharmaceuticals
Fertility & Reproductive Medicines
Specialty Injectables
Vaccines
Pandemic & Emerging Vaccines
mRNA Vaccines
Viral Vector Vaccines
Routine Immunization Vaccines
Travel & Specialty Vaccines
Packaging Type
Active Packaging
Passive Packaging
Temperature Range
Cryogenic (≤ -150 °C)
Cryo Packaging
Dry Shipper Transport
LN2 Vapor Storage
Frozen (-20 To -40 °C)
Packaging
Storage
Transportation
Refrigerated (2–8 °C)
Packaging
Storage
Transportation
Ultra-Low (-60 To -86 °C)
Packaging
Storage
Transportation
Equipment
Storage Equipment
Cold Rooms & Warehouses
Cryogenic Freezers & LN2 Tanks
Freezers (-20 °C Class)
Pharmaceutical Refrigerators (2–8 °C)
ULT Freezers (-80 °C Class)
Transport Equipment
Air Cargo Containers (ULDs)
Last-Mile Portable Coolers
Ocean Reefer Containers
Reefer Trucks & Vans
Service Type
Clinical Trial Logistics
Ancillary Management
Direct-To-Patient Services
Site Supply And Returns
Compliance & Quality
Audits & GDP Training
Lane Validation & Risk Assessment
Qualification (IQ/OQ/PQ)
Storage & Warehousing
Cryogenic Storage
Long-Term GMP Storage
Transportation
First-Mile Pickup
Last-Mile Delivery
Line-Haul Transport
Reverse Logistics & Returns
Application
Clinical Trials
Commercial Distribution
Direct-To-Patient/Home Delivery
Humanitarian & NGO Supply
Specialty Pharmacy Fulfillment
Vaccination Campaigns
End User
Blood Banks & Plasma Centers
Clinical Trial Sites & Depots
CMOs & CDMOs
CROs
Hospitals & Clinics
Pharma & Biotech Manufacturers
Emerging Biotech
Large Pharmaceutical Companies
Retail & Specialty Pharmacies
Vaccination Centers & Public Health Agencies

This research report categorizes to forecast the revenues and analyze trends in each of the following sub-regions:

Americas
North America
United States
Canada
Mexico
Latin America
Brazil
Argentina
Chile
Colombia
Peru
Europe, Middle East & Africa
Europe
United Kingdom
Germany
France
Russia
Italy
Spain
Netherlands
Sweden
Poland
Switzerland
Middle East
United Arab Emirates
Saudi Arabia
Qatar
Turkey
Israel
Africa
South Africa
Nigeria
Egypt
Kenya
Asia-Pacific
China
India
Japan
Australia
South Korea
Indonesia
Thailand
Malaysia
Singapore
Taiwan

This research report categorizes to delves into recent significant developments and analyze trends in each of the following companies:

DHL International GmbH
FedEx Corporation
Americold Realty Trust, Inc.
AmerisourceBergen Corporation
C.H. Robinson Worldwide, Inc.
Catalent, Inc.
Clinigen Group PLC
Conestoga Cold Storage Ltd.
Continental AG
CWT Ltd.
DB Schenker
DSV A/S
Emergent Cold LatAm Management LLC
HCL Technologies Limited
Helapet ltd.
Interstate Cold Storage, Inc.
JWD InfoLogistics Public Co. Ltd.
Keppel Telecommunications & Transportation Ltd,
Kerry Logistics Network Limited by SF Holding Co., Ltd.
Kuehne + Nagel Management AG
Lineage, Inc.
Mærsk A/S
NewCold Coöperatief UA
OOCL Logistics Limited by COSCO SHIPPING Holdings Co. Limited
SCG Logistics Management Co Ltd.
Tiong Nam Logistics Holdings Berhad
United Parcel Service, Inc.
Ych Group
Yusen Logistics Group
BioCold Technologies S.A.S
FreezPak Logistics

Please Note: PDF & Excel + Online Access - 1 Year

Table of Contents

195 Pages
1. Preface
1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders
2. Research Methodology
3. Executive Summary
4. Market Overview
5. Market Insights
5.1. Integration of blockchain-enabled tracking platforms for end-to-end cold-chain visibility and compliance
5.2. Adoption of IoT-enabled smart packaging solutions to monitor critical temperature deviations in real time
5.3. Scaling infrastructure for ultra-low temperature storage to support mRNA vaccine distribution at global scale
5.4. Implementation of eco-friendly biodegradable thermal insulation materials in cold-chain transport packaging
5.5. Strategic partnerships between biopharma companies and specialized 3PLs for last-mile temperature-controlled deliveries
5.6. Regulatory harmonization efforts to streamline cross-border cold-chain pharma logistics and reduce compliance delays
5.7. Acceleration of cryogenic chain-of-identity and custody for autologous cell and gene therapies from apheresis to infusion
5.8. Deployment of AI-driven lane risk scoring and predictive ETD/ETA planning to preempt delays and excursion-prone routings
5.9. Airport and airline investments in CEIV Pharma facilities and cool dollies to protect ramp integrity for pharma consignments
5.10. Use of digital twins and stability modeling to design robust cold-chain flows and proactively manage cumulative thermal exposure
6. Cumulative Impact of United States Tariffs 2025
7. Cumulative Impact of Artificial Intelligence 2025
8. Cold-chain Pharma Market, by Product Type
8.1. Biologics
8.1.1. Monoclonal Antibodies
8.1.2. Plasma-Derived Therapeutics
8.1.3. Recombinant Proteins & Enzymes
8.2. Blood & Plasma Products
8.2.1. Coagulation Factors
8.2.2. Immunoglobulins
8.3. Cell & Gene Therapies
8.3.1. Allogeneic Cell Therapies
8.3.2. Autologous Cell Therapies
8.3.3. Gene Therapies
8.4. Clinical Trial Materials
8.4.1. Ancillaries & Kits
8.4.2. Investigational Medicinal Products
8.5. Insulins & Hormones
8.5.1. GLP-1 & Other Peptide Hormones
8.5.2. Insulin
8.6. Specialty Pharmaceuticals
8.6.1. Fertility & Reproductive Medicines
8.6.2. Specialty Injectables
8.7. Vaccines
8.7.1. Pandemic & Emerging Vaccines
8.7.1.1. mRNA Vaccines
8.7.1.2. Viral Vector Vaccines
8.7.2. Routine Immunization Vaccines
8.7.3. Travel & Specialty Vaccines
9. Cold-chain Pharma Market, by Packaging Type
9.1. Active Packaging
9.2. Passive Packaging
10. Cold-chain Pharma Market, by Temperature Range
10.1. Cryogenic (≤ -150 °C)
10.1.1. Cryo Packaging
10.1.2. Dry Shipper Transport
10.1.3. LN2 Vapor Storage
10.2. Frozen (-20 To -40 °C)
10.2.1. Packaging
10.2.2. Storage
10.2.3. Transportation
10.3. Refrigerated (2–8 °C)
10.3.1. Packaging
10.3.2. Storage
10.3.3. Transportation
10.4. Ultra-Low (-60 To -86 °C)
10.4.1. Packaging
10.4.2. Storage
10.4.3. Transportation
11. Cold-chain Pharma Market, by Equipment
11.1. Storage Equipment
11.1.1. Cold Rooms & Warehouses
11.1.2. Cryogenic Freezers & LN2 Tanks
11.1.3. Freezers (-20 °C Class)
11.1.4. Pharmaceutical Refrigerators (2–8 °C)
11.1.5. ULT Freezers (-80 °C Class)
11.2. Transport Equipment
11.2.1. Air Cargo Containers (ULDs)
11.2.2. Last-Mile Portable Coolers
11.2.3. Ocean Reefer Containers
11.2.4. Reefer Trucks & Vans
12. Cold-chain Pharma Market, by Service Type
12.1. Clinical Trial Logistics
12.1.1. Ancillary Management
12.1.2. Direct-To-Patient Services
12.1.3. Site Supply And Returns
12.2. Compliance & Quality
12.2.1. Audits & GDP Training
12.2.2. Lane Validation & Risk Assessment
12.2.3. Qualification (IQ/OQ/PQ)
12.3. Storage & Warehousing
12.3.1. Cryogenic Storage
12.3.2. Long-Term GMP Storage
12.4. Transportation
12.4.1. First-Mile Pickup
12.4.2. Last-Mile Delivery
12.4.3. Line-Haul Transport
12.4.4. Reverse Logistics & Returns
13. Cold-chain Pharma Market, by Application
13.1. Clinical Trials
13.2. Commercial Distribution
13.3. Direct-To-Patient/Home Delivery
13.4. Humanitarian & NGO Supply
13.5. Specialty Pharmacy Fulfillment
13.6. Vaccination Campaigns
14. Cold-chain Pharma Market, by End User
14.1. Blood Banks & Plasma Centers
14.2. Clinical Trial Sites & Depots
14.3. CMOs & CDMOs
14.4. CROs
14.5. Hospitals & Clinics
14.6. Pharma & Biotech Manufacturers
14.6.1. Emerging Biotech
14.6.2. Large Pharmaceutical Companies
14.7. Retail & Specialty Pharmacies
14.8. Vaccination Centers & Public Health Agencies
15. Cold-chain Pharma Market, by Region
15.1. Americas
15.1.1. North America
15.1.2. Latin America
15.2. Europe, Middle East & Africa
15.2.1. Europe
15.2.2. Middle East
15.2.3. Africa
15.3. Asia-Pacific
16. Cold-chain Pharma Market, by Group
16.1. ASEAN
16.2. GCC
16.3. European Union
16.4. BRICS
16.5. G7
16.6. NATO
17. Cold-chain Pharma Market, by Country
17.1. United States
17.2. Canada
17.3. Mexico
17.4. Brazil
17.5. United Kingdom
17.6. Germany
17.7. France
17.8. Russia
17.9. Italy
17.10. Spain
17.11. China
17.12. India
17.13. Japan
17.14. Australia
17.15. South Korea
18. Competitive Landscape
18.1. Market Share Analysis, 2024
18.2. FPNV Positioning Matrix, 2024
18.3. Competitive Analysis
18.3.1. DHL International GmbH
18.3.2. FedEx Corporation
18.3.3. Americold Realty Trust, Inc.
18.3.4. AmerisourceBergen Corporation
18.3.5. C.H. Robinson Worldwide, Inc.
18.3.6. Catalent, Inc.
18.3.7. Clinigen Group PLC
18.3.8. Conestoga Cold Storage Ltd.
18.3.9. Continental AG
18.3.10. CWT Ltd.
18.3.11. DB Schenker
18.3.12. DSV A/S
18.3.13. Emergent Cold LatAm Management LLC
18.3.14. HCL Technologies Limited
18.3.15. Helapet ltd.
18.3.16. Interstate Cold Storage, Inc.
18.3.17. JWD InfoLogistics Public Co. Ltd.
18.3.18. Keppel Telecommunications & Transportation Ltd,
18.3.19. Kerry Logistics Network Limited by SF Holding Co., Ltd.
18.3.20. Kuehne + Nagel Management AG
18.3.21. Lineage, Inc.
18.3.22. Mærsk A/S
18.3.23. NewCold Coöperatief UA
18.3.24. OOCL Logistics Limited by COSCO SHIPPING Holdings Co. Limited
18.3.25. SCG Logistics Management Co Ltd.
18.3.26. Tiong Nam Logistics Holdings Berhad
18.3.27. United Parcel Service, Inc.
18.3.28. Ych Group
18.3.29. Yusen Logistics Group
18.3.30. BioCold Technologies S.A.S
18.3.31. FreezPak Logistics
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