Cell & Gene Therapy Cold Chain Logistics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global Cell & Gene Therapy Cold Chain Logistics Market is projected to expand from USD 2.02 Billion in 2025 to USD 4.47 Billion by 2031, registering a CAGR of 14.15%. This sector encompasses specialized supply chain services focused on the temperature-controlled handling, storage, and transport of therapeutic biological materials. These logistics solutions are vital for maintaining the efficacy of temperature-sensitive and time-critical cellular products, which frequently demand cryogenic conditions throughout transit. A major factor driving this market is the rapid growth of the clinical development pipeline and the resulting rise in regulatory approvals, creating a need for secure global distribution networks. As reported by the International Society for Cell & Gene Therapy, the global sector pipeline expanded to 3,063 therapies in 2024, generating significant demand for specialized logistical support for these emerging treatments.

Despite this upward trajectory, the market encounters substantial difficulties in maintaining strict temperature stability across intricate international supply chains. The necessity for ultra-low temperatures poses a high risk of product loss due to potential temperature excursions, especially during the critical last-mile delivery stage. Additionally, infrastructure deficiencies in specific geographic areas can interrupt the cold chain's continuity, complicating the distribution of these high-value therapeutics and potentially hindering the market's broader global expansion.

Market Drivers

The rise in global investments and funding for biopharmaceutical R&D drives market growth by financing expanded clinical programs and their logistical requirements. Substantial capital inflows allow developers to outsource essential, premium temperature-controlled supply chain services to protect sensitive biological assets. According to an October 2024 BioSpace article titled 'Cell and Gene Therapy Investment Ticks Up After Hard Few Years', the sector secured $10.9 billion in investment during the first half of 2024. This funding supports extensive research and drives demand for specialized handling; for instance, Cryoport, Inc. reported supporting a record 691 global clinical trials as of September 30, 2024, highlighting the intense development activity driven by this capital.

Furthermore, the accelerating commercialization and regulatory approval of cell and gene therapies are shifting the industry's focus from clinical shipments to high-volume commercial distribution. As therapies receive authorization, logistics networks must expand to guarantee global patient access while adhering to strict standards. Transitioning to commercial stages requires rigorous cold chain infrastructure to prevent temperature excursions that could compromise high-value treatments. According to World Courier's 'CGT pipeline key insights for 2024 Q3' published in October 2024, there are now 134 cell and gene therapies approved globally. This growing number of commercial products demands robust distribution networks capable of managing ultra-low temperature requirements.

Market Challenges

The primary obstacle hindering the Global Cell & Gene Therapy Cold Chain Logistics Market is the complexity of maintaining rigorous temperature stability throughout increasingly intricate international supply chains. Because these high-value therapeutics frequently demand ultra-low cryogenic temperatures, any thermal excursion or infrastructure failure during transit can lead to irreversible product loss. This fragility is especially damaging when distributing to regions with unreliable cold chain capabilities or extended last-mile delivery durations, serving as a significant barrier to market accessibility and commercial scaling.

The consequences of this logistical vulnerability are greatly intensified by the industry's global scope. According to the Alliance for Regenerative Medicine, approximately 35 percent of global revenue from cell and gene therapy in 2025 originated from markets outside the United States. This statistic highlights that a significant portion of the sector's economic value depends heavily on cross-border transport. As a result, the risk of temperature deviations across diverse geographic landscapes generates financial uncertainty for developers, compelling them to restrict market expansion strategies and directly slowing the broader growth of the global logistics sector.

Market Trends

The deployment of cloud-based cell orchestration platforms is transforming the sector by substituting manual tracking methods with integrated digital ecosystems. As autologous therapies scale, manufacturers need real-time vein-to-vein visibility to guarantee the preservation of the Chain of Identity across complex workflows. This digital transition reduces human error and streamlines the scheduling of leukapheresis and infusion, effectively connecting manufacturing sites with clinical centers. According to TrakCel's 'TrakCel Sets New Standards' announcement in November 2024, the company's orchestration platform was chosen to support five out of the seven autologous or matched allogeneic cell therapy products approved or anticipated for approval in 2024.

Additionally, strategic outsourcing to specialized niche logistics providers is becoming essential as biopharmaceutical companies aim to reduce the risks associated with distributing high-value commercial products. Unlike standard pharmaceutical shipping, CGT logistics require dedicated infrastructure, such as fleet management for cryogenic dewars and strict compliance with regenerative medicine regulatory standards. Developers are increasingly collaborating with vendors that offer purpose-built capabilities rather than generalist freight forwarders to ensure product integrity. According to Cryoport, Inc.'s 'Fourth Quarter and Full Year 2024 Financial Results' from March 2025, revenue from supporting commercially approved cell and gene therapies grew to $26 million in 2024, representing a 20 percent year-over-year increase.

Key Players Profiled in the Cell & Gene Therapy Cold Chain Logistics Market

• Cencora, Inc.
• United Parcel Service, Inc.
• Catalent, Inc.
• BioLife Solutions, Inc.
• Cryoport System LLC.
• Atelerix Ltd.
• Life Science Group Ltd.
• Yourway Biopharma Services Company
• Bertelsmann SE & Co. KGaA
• NMDP BioTherapies

Report Scope

In this report, the Global Cell & Gene Therapy Cold Chain Logistics Market has been segmented into the following categories:

Cell & Gene Therapy Cold Chain Logistics Market, by Component:

• Cryogenic Shippers
• Cryogenic Storage Freezers
• Ultra Low Freezers
• Cold Chain Management Systems
• Shipment and Storage Medium
• Cryogenic Packout Kits
• Others

Cell & Gene Therapy Cold Chain Logistics Market, by Services Offered:

• Transportation
• Storage
• Packaging

Cell & Gene Therapy Cold Chain Logistics Market, by Mode of Transportation:

• Air
• Ground
• Water

Cell & Gene Therapy Cold Chain Logistics Market, by Holding Temperature Range:

• Cryogenic
• Refrigerated
• Ambient
• Others

Cell & Gene Therapy Cold Chain Logistics Market, by End User:

• Pharmaceutical & Biotechnology Companies
• Academic & Research Institutes
• Others

Cell & Gene Therapy Cold Chain Logistics Market, by Region:

• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Cell & Gene Therapy Cold Chain Logistics Market.

Available Customization

The analyst offers customization according to your specific needs. The following customization options are available for the report:

• Detailed analysis and profiling of additional market players (up to five).

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