United States Cell and Gene Therapy Third-Party Logistics Market Size and Forecast 2025–2033

The United States Cell and Gene Therapy Third-Party Logistics Market is expected to reach US$ 5.88 billion by 2033, up from US$ 2.61 billion in 2024, expanding at a CAGR of 9.46% from 2025 to 2033, according to Renub Research. This rapid rise reflects a dramatic transformation in how the nation stores, transports, and delivers some of the most advanced therapeutic innovations in modern medicine.

As personalized therapies move from research labs to real-world patient care, logistics providers have become indispensable partners. From cryogenic storage to real-time tracking, the ecosystem supporting cell and gene therapies has evolved into a sophisticated, technology-driven domain—one that requires unprecedented precision, compliance, and reliability.

United States Cell and Gene Therapy Third-Party Logistics Industry Overview

The U.S. cell and gene therapy third-party logistics (3PL) market now sits at the intersection of biotechnology innovation, regulatory compliance, and advanced supply chain engineering. These therapies are living biological products, often created using a patient’s own cells. Their sensitivity and time-critical nature mean even minor temperature fluctuations or delays can render a treatment unusable.

This is where specialized 3PL providers have become vital. Their role goes far beyond simple transportation—they manage end-to-end, high-value, patient-specific supply chains, including:

Cryogenic storage infrastructure

Temperature-controlled distribution channels

IoT-enabled tracking and monitoring

Secure chain-of-custody systems

Regulatory documentation and quality assurance

Compliance with GDP and FDA guidelines

At the same time, technology adoption is reshaping the market. Logistics companies increasingly rely on AI-driven demand forecasting, blockchain-based transparency tools, and predictive cold-chain analytics to eliminate risks.

Partnerships between therapy developers, healthcare institutions, 3PL companies, and CDMOs are driving efficiency and scalability. While the infrastructure is improving, industry challenges such as high service costs and workforce skill gaps persist. Yet, as more therapies enter commercialization, reliable 3PL solutions are no longer optional—they are foundational to unlocking advanced treatment accessibility across the United States.

Key Factors Driving Market Growth

1. Expanding Cell and Gene Therapy Pipeline

The U.S. leads globally in cell and gene therapy research, with hundreds of therapies advancing through clinical development. As more products secure FDA approval, demand for specialized logistics support intensifies.

These therapies often require:

Customized, patient-specific handling

Just-in-time delivery models

Ultralow and cryogenic storage temperatures

Non-stop, secure transportation cycles

As commercialization accelerates, logistics providers are expanding infrastructure, upgrading technologies, and forging deeper partnerships with manufacturers. This momentum is expected to remain a major growth catalyst through 2033.

2. Stringent Regulatory Requirements

The market is shaped significantly by strict regulatory standards around Good Distribution Practices (GDP), temperature management, documentation, and chain-of-custody protocols.

Therapies must maintain viability through the entire supply chain. Any deviation can lead to efficacy loss—and potential patient harm.

Regulatory mandates require:

Advanced quality control systems

Documented temperature logs

Validated shipping containers

Auditable electronic trail management

Biopharmaceutical companies increasingly outsource logistics to certified 3PL specialists to ensure full compliance, reduce operational risks, and streamline workflows.

3. Rising Adoption of Cold Chain Technologies

Cell and gene therapies typically require:

Cryogenic storage below −150°C

Liquid nitrogen transport solutions

Ultra-low freezers

Real-time monitoring of temperature integrity

The increase in therapy approvals has pushed 3PL companies to invest heavily in:

Smart cold-chain containers

IoT-enabled surveillance platforms

AI-based temperature deviation alerts

Reliable cold chain infrastructure is now a non-negotiable prerequisite for therapy delivery—and a driving force behind rapid 3PL market expansion.

Challenges in the U.S. Cell and Gene Therapy Third-Party Logistics Market

1. High Cost of Specialized Logistics Services

Delivering advanced therapies is expensive. Cryogenic storage systems, validated shipping containers, regulatory compliance processes, and 24/7 monitoring all contribute to high operational costs.

Smaller biotech companies—especially those in early-stage clinical trials—struggle with these expenses. Limited economies of scale also push per-shipment costs higher.

Striking a balance between affordability and reliability remains one of the industry’s biggest challenges.

2. Limited Workforce Expertise

Cell and gene therapy logistics require professionals trained in:

Handling fragile biological materials

Operating cryogenic equipment

Managing emergency deviations

Regulatory reporting

Maintaining chain-of-identity standards

The current workforce lacks sufficient numbers of trained specialists. This talent gap increases risk and slows operational capacity, making workforce development a critical priority for the decade ahead.

United States Cell and Gene Therapy Third-Party Logistics Market Overview by States

Regional performance varies significantly based on biopharma concentration, healthcare infrastructure, research activity, and cold-chain investments. The strongest growth is concentrated in California, Texas, New York, and Florida, all of which hold strategic importance in the cell and gene therapy supply chain.

California

California is the most influential state in the U.S. biopharmaceutical landscape and a powerhouse of cell and gene therapy activity. Its leading research hubs—San Diego, San Francisco, and Los Angeles—drive consistent demand for high-precision logistics services.

Key strengths include:

Dense clusters of biotech innovators

Heavy cold-chain infrastructure investment

Expansive clinical trial activities

Skilled workforce availability

California’s position as a global biotechnology center ensures its continued dominance in the 3PL market.

Texas

Texas is rapidly emerging as a national logistics hub thanks to:

Expanding oncology and gene therapy research

Major medical institutions in Houston and Dallas

Strong geographic connectivity across the U.S.

Growing cold-chain infrastructure investments

The state’s strategic investments in biotech innovation and transportation make it a rising force in next-generation therapy logistics.

New York

New York remains a critical node for both research and clinical deployment of cell and gene therapies. New York City, in particular, is a center of clinical adoption and innovation.

Drivers of growth include:

Renowned medical centers

Strong regulatory oversight

High demand for patient-specific therapies

Investment in IoT-enabled tracking and monitoring

New York’s advanced healthcare ecosystem ensures sustained 3PL demand.

Florida

Florida’s market strength stems from:

A large and aging patient population

Expanding specialty clinics

Growth of advanced healthcare delivery hubs (Miami, Tampa, Orlando)

Strategic proximity to Latin American markets

Investments in cryogenic logistics and real-time monitoring systems support its role as a fast-growing regional market.

Market Segmentations

By Type

Clinical

Commercial

By Product

Cell Therapies

Gene Therapies

By Therapeutic Area

Oncology

Neurology

Cardiovascular Diseases

Ophthalmology

Infectious Diseases

Others

By End Use

Biopharmaceutical Companies

CDMOs/CMOs

Others

By States

California, Texas, New York, Florida, Illinois, Pennsylvania, Ohio, Georgia, New Jersey, Washington, North Carolina, Massachusetts, Virginia, Michigan, Maryland, Colorado, Tennessee, Indiana, Arizona, Minnesota, Wisconsin, Missouri, Connecticut, South Carolina, Oregon, Louisiana, Alabama, Kentucky, and Rest of the U.S.

Key Companies Covered

Below are major players shaping the U.S. cell and gene therapy 3PL market:

Cencora Corporation

A leading supply chain and distribution provider with expanding cryogenic and cold-chain capabilities.

Cardinal Health

Strong nationwide network offering integrated logistics and healthcare supply solutions.

McKesson Corporation

Provides specialized pharmaceutical logistics and temperature-controlled distribution at national scale.

EVERSANA

Focuses on commercialization services, including end-to-end therapy logistics, patient services, and supply chain optimization.

Knipper Health

Known for tailored distribution models for highly sensitive therapies.

Arvato SE

Offers advanced cold-chain solutions, serialization, and digital logistics technologies.

DHL

Global leader with extensive life-sciences logistics capabilities, including real-time monitoring and cryogenic operations.

Kuehne+Nagel

Robust international presence with state-of-the-art temperature-controlled systems and bioservices facilities.

SWOT Analysis of the U.S. Cell and Gene Therapy 3PL Market

Strengths

Advanced cold-chain infrastructure

Strong biotech and pharma ecosystem

High regulatory compliance standards

Weaknesses

Limited trained workforce

High operational costs

Fragmented service capacity across states

Opportunities

Growing therapy pipeline

AI and IoT integration

Rise of decentralized clinical trials

Threats

Supply chain disruptions

Stringent regulatory penalties

High dependency on specialized storage equipment

Revenue Outlook and Forecast (2025–2033)

The industry will continue scaling with increased therapy approvals and commercialization. With revenues expected to climb from US$ 2.61 billion in 2024 to US$ 5.88 billion by 2033, the market is moving steadily toward becoming a core part of the national advanced-therapy infrastructure.

The demand for ultra-specialized logistics services will surge as precision medicine expands and more patient-specific therapies reach the market.

Final Thoughts

The U.S. cell and gene therapy third-party logistics market reflects the broader revolution in personalized medicine. As therapies targeting genetic disorders, cancers, and rare diseases gain momentum, the need for airtight logistics systems grows exponentially. This market is not only about transportation—it is about safeguarding treatments that can transform or even save lives.

With rising investments, stronger technological adoption, and a rapidly advancing therapy pipeline, the next decade promises exceptional growth. For stakeholders—from biopharma innovators to logistics giants—this is a defining moment to build the infrastructure that will support the next era of medical breakthroughs.