Report Highlights

The United States' Role in the Global Organ Preservation Supply Chain

The United States occupies a dominant and structurally unique position in the global organ preservation supply chain, functioning simultaneously as the world's largest consumer market, the primary innovation hub, and a critical technology exporter. With over 46,000 organ transplants performed in 2023 — the highest annual volume ever recorded by UNOS — U.S. transplant centers generate demand that drives global product development cycles. Domestic organ procurement organizations, numbering 57 federally designated entities, form the institutional backbone of organ collection and logistics, creating a procurement network that machine perfusion vendors specifically engineer their platforms to serve. American hospitals absorb the majority of global machine perfusion system deployments, positioning the U.S. as the reference market for regulatory benchmarking by international buyers in Europe and Asia-Pacific.

On the supply side, the U.S. hosts the headquarters and primary manufacturing operations of several globally significant organ preservation technology companies. Paragonix Technologies produces its SherpaPak cardiac transport system in Massachusetts, while TransMedics manufactures OCS components domestically before integrating imported medical-grade tubing and oxygenator subassemblies sourced from Germany and Japan. Preservation Solutions Inc., based in Wisconsin, supplies its University of Wisconsin (UW) cold storage solution — the global gold standard for kidney and liver preservation — to transplant programs across North America and exports to regulated markets in Canada, Australia, and the United Kingdom. This dual role as both the world's largest buyer and a significant exporter of preservation technology gives U.S. market dynamics an outsized influence on global pricing, clinical protocol adoption, and regulatory standard-setting through FDA clearance pathways that international markets routinely mirror.

Growth Drivers for U.S. Organ Preservation Trade and Production

Three supply chain forces are driving measurable expansion in U.S. organ preservation production capacity and trade volume. First, the normothermic machine perfusion (NMP) transition is compelling transplant programs to retire static cold storage protocols for hearts and livers, directly increasing per-transplant spend from roughly USD 200 for preservation solution to over USD 35,000 for a single OCS circuit. This unit economics shift is expanding the addressable market in dollar terms even without organ volume growth, incentivizing domestic manufacturers to scale production of perfusion cassettes, disposable oxygenators, and specialized perfusates. TransMedics reported a 74% revenue increase in its fiscal year 2023, reflecting this structural demand acceleration concentrated entirely within the U.S. market before international rollout.

Second, UNOS policy changes enacted in 2022 restructured organ allocation geography, eliminating distance-based allocation tiers in favor of acuity-based distribution. This reform extended average organ transport distances for livers and hearts, creating a logistics gap that only machine perfusion can reliably bridge for ischemia-sensitive organs. Longer transport logistics directly increase demand for active perfusion devices capable of maintaining organ viability for eight to twelve hours versus the four-to-six-hour window static cold storage permits. Third, federal investment through the Health Resources and Services Administration (HRSA) Modernizing OPO Regulations initiative is funding infrastructure upgrades at underperforming OPOs, injecting capital into procurement fleets and preservation equipment at organizations that previously operated with minimal technology budgets, thereby expanding the total installed base for preservation systems nationally.

Supply Chain Risks and Trade Barriers

The U.S. organ preservation supply chain faces three meaningful and interconnected risks that market participants consistently underestimate. Raw material dependency represents the most acute vulnerability: machine perfusion systems rely on medical-grade polyvinyl chloride tubing, hollow-fiber membrane oxygenators, and precision flow sensors, the majority of which are manufactured in Germany, Japan, and China. Any supply disruption — as demonstrated during the 2020–2021 medical device component shortage — cascades directly into perfusion circuit availability at a point in the transplant workflow where substitution is clinically impossible. TransMedics disclosed component lead time extensions of up to 22 weeks during that period, a risk that remains structurally unresolved given limited domestic oxygenator manufacturing capacity.

A secondary risk cluster centers on regulatory and reimbursement barriers. While FDA 510(k) and PMA pathways establish a clear but slow approval route for new preservation devices, Centers for Medicare and Medicaid Services (CMS) reimbursement coding for machine perfusion has lagged technology adoption. As of 2024, normothermic regional perfusion (NRP) for abdominal organs lacks a dedicated CMS reimbursement code, effectively transferring cost burden to transplant centers and slowing adoption outside well-capitalized academic medical centers. This reimbursement gap creates a two-tier market where high-volume academic programs accelerate machine perfusion uptake while community transplant programs remain anchored to cold storage, fragmenting the supply chain and complicating demand forecasting for preservation consumable suppliers operating on six-to-twelve-month production planning horizons.

Trade and Investment Opportunities in U.S. Organ Preservation

The most commercially significant near-term opportunity lies in the lung preservation segment, where machine perfusion penetration remains below 15% of U.S. transplants despite clinical evidence supporting ex vivo lung perfusion (EVLP) for marginal donor lungs. XVIVO Perfusion, which holds FDA approval for its XPS system with STEEN Solution, is the sole approved EVLP platform in the U.S., creating a near-monopoly position in an underpenetrated segment serving 2,800 annual lung transplants. Inbound foreign direct investment targeting domestic EVLP competitors or next-generation perfusate formulations would face a clear path to market disruption, particularly from European firms already operating approved systems under CE mark that have not yet pursued FDA clearance. The lung segment represents a USD 90-plus million annual revenue opportunity at full machine perfusion penetration, currently captured at less than 20% of its potential value.

A second structural opportunity involves cold-chain logistics infrastructure serving the organ transport corridor between OPOs and transplant centers. The average U.S. organ transport now spans 480 miles and involves two or more transport mode transitions. Specialized medical logistics providers — including MedSpeed and BioMatik — have begun positioning organ transport as a distinct logistics vertical requiring temperature-controlled, GPS-tracked, aviation-integrated cold chain infrastructure. Investment in purpose-built organ transport networks, digitally integrated with OPO dispatch systems and hospital receiving protocols, represents a scalable infrastructure play with defensible contractual revenue anchored to long-term OPO service agreements. No dominant national provider has yet consolidated this fragmented logistics layer, making it an open competitive field through 2027.

Market at a Glance

Leading Market Participants

• TransMedics Group
• XVIVO Perfusion
• Paragonix Technologies
• Preservation Solutions Inc.
• Bridge to Life Ltd.
• Organ Recovery Systems
• Lifeline Scientific
• Waters Medical Systems
• Dr. Franz Köhler Chemie GmbH
• BioLife Solutions

Regulatory and Trade Policy Environment

The U.S. regulatory framework for organ preservation products is administered through the FDA's Center for Devices and Radiological Health (CDRH), with machine perfusion systems classified as Class II or Class III medical devices requiring 510(k) clearance or PMA approval depending on intended use and novelty. Preservation solutions including UW Solution and histidine-tryptophan-ketoglutarate (HTK) are regulated as drugs under the FDA's Center for Drug Evaluation and Research (CDER), creating a dual regulatory pathway that complicates single-platform perfusion systems integrating device hardware with proprietary perfusates. The FDA's Breakthrough Devices Program has been utilized by TransMedics and XVIVO to accelerate review timelines, with OCS Heart receiving Breakthrough designation and subsequent PMA approval in 2021, establishing a precedent that next-generation entrants are actively pursuing. Import tariffs on medical device components under HTS chapters 9018 and 9019 are currently set at 0% for most trading partners under the WTO Information Technology Agreement, reducing landed cost pressure on imported subassemblies.

UNOS, operating under HRSA oversight, functions as a de facto regulatory body for organ procurement and allocation protocols, and its policy decisions directly shape which preservation technologies are operationally viable in the U.S. market. The 2022 UNOS allocation policy reforms — mandating broader geographic sharing of high-quality organs — created compliance obligations for OPOs to invest in longer-range transport and superior preservation technology, effectively functioning as an indirect procurement mandate favoring machine perfusion vendors. The U.S.-EU Medical Device Regulatory Harmonization Framework discussions, ongoing since 2022, carry implications for bilateral market access: U.S. manufacturers with FDA PMA clearance seek streamlined CE mark pathways under the EU MDR, while European firms such as XVIVO and Köhler Chemie benefit from reciprocal recognition provisions that reduce their regulatory entry costs for the U.S. market.

U.S. Organ Preservation Supply Chain Outlook to 2032

By 2032, the U.S. organ preservation supply chain will have undergone a fundamental technology transition from cold storage dominance to machine perfusion as the standard of care across all four major organ categories — kidney, liver, heart, and lung. Kidney perfusion, currently the most underpenetrated segment with machine perfusion used in fewer than 30% of deceased-donor kidney transplants, will be the primary volume growth driver as clinical evidence mounts for normothermic kidney perfusion's superiority over static cold storage in reducing delayed graft function. This transition will expand domestic demand for perfusion consumables by an estimated USD 180 million annually, catalyzing investment in U.S.-based oxygenator and perfusate manufacturing to reduce the current import dependency on European components and mitigate geopolitical supply chain risk.

Trade flow dynamics will shift as U.S.-developed machine perfusion platforms achieve broader international regulatory approvals, transforming the U.S. from a net importer of preservation technology subassemblies into a net exporter of integrated machine perfusion systems to growing transplant markets in the Middle East, Southeast Asia, and Latin America. TransMedics and Paragonix are actively pursuing regulatory approvals in Saudi Arabia, Singapore, and Brazil, markets where transplant volume growth rates exceed 12% annually. Simultaneously, artificial intelligence-driven organ assessment tools — currently in clinical trials at Johns Hopkins and the University of Pennsylvania — will integrate with perfusion platforms by 2028, creating a new data services revenue layer that further differentiates U.S.-origin systems from lower-cost static preservation alternatives and consolidates American supply chain leadership in this market through the forecast period.