Organ Preservation Market Assessment, By Solution [University of Wisconsin Solution, Custodial HTK, Perfadex, Other Solutions], By Technique [Static Cold Storage, Hypothermia Machine Perfusion, Normothermic Machine Perfusion], By Organ Type [Kidney, Liver

Organ Preservation Market Assessment, By Solution [University of Wisconsin Solution, Custodial HTK, Perfadex, Other Solutions], By Technique [Static Cold Storage, Hypothermia Machine Perfusion, Normothermic Machine Perfusion], By Organ Type [Kidney, Liver, Lung, Heart, Pancreas, Others], By End-user [Organ Transplant Centers, Hospitals, Specialty Clinics], By Region, Opportunities and Forecast, 2017-2031F

Global organ preservation market is projected to witness a CAGR of 6.65% during the forecast period 2024-2031, growing from USD 281.86 million in 2023 to USD 471.76 million in 2031. The organ preservation market is anticipated to thrive exponentially under the influence of driving forces like the growing number of organ transplants being performed worldwide, and technological advancements to enhance the preservation time and maintain the high viability of organs. Additionally, rising investors’ traction and healthcare spending also catalyze the market growth. Rising cases of organ failure leading to the requisite of organ transplantation further increase the demand in the organ preservation market. The increasing number of organ transplant procedures and the surging research being performed on organs have significantly increased the demand for organ preservation solutions. Increasing regulatory emphasis and various regulatory approvals for several relevant products in recent years have strengthened the market position of key players. Government support and initiatives taken by various non-profit organizations to facilitate organ transplants further enhance the demand in the market. However, the high cost associated with organ transplants and the complications associated with it are major challenges for market growth. The lacuna between the organs donated and organ transplants performed creates another barrier to market expansion.

Increasing Number of Organ Transplants

The increasing number of organ transplants is driving the demand for organ preservation products. Organ preservation solutions play a major role in safeguarding organs before transplantation, as isolated organs tend to deteriorate quickly. The reasons for increasing organ transplants include clinical advancements, high disposable income, and widespread awareness about organ donation and transplants. As per the data published by the Organ Procurement & Transplantation Network, in 2023, the number of deceased organ donors reached an unprecedented high of 16,000, marking 13 consecutive years of record-breaking donations. Moreover, the year witnessed an impressive increase in organ transplants, with over 46,000 life-saving procedures performed to overcome organ failures. Notably, liver transplants crossed the 10,000 mark for the first time, while lung transplants exceeded 3,000. Additionally, kidney and heart transplants also set new annual records, underscoring the remarkable progress in organ transplantation. Similarly, around 1589 kidney transplants, 761 liver, and 250 heart transplants were reported with India in the deceased category throughout the year 2022.

Advancements in Organ Preservation Methods

Organ preservation methods have progressively advanced throughout history, for the sake of optimizing organ transplantation outcomes. Subsequent innovations included refined formulations like the Collins, Euro-Collins, and University of Wisconsin (UW) solutions, which extended storage durations and enhanced organ viability. Presently, market players are focusing on developing products with revitalized strategies, particularly machine perfusion systems that offer a dynamic environment mimicking physiologic conditions. These systems provide opportunities for both organ repair and prolonged storage periods, reducing the chances of process failure. Ex vivo perfusion is one such extension of machine perfusion which aims to further enhance organ recovery through additional repair mechanisms and reprogramming processes.

In August 2023, TransMedics Group, Inc. announced the acquisition of assets and intellectual property from Bridge to Life Ltd., specifically the Ex-Vivo Organ Support System (EVOSS) and the LifeCradle Heart Preservation Transport System. LifeCradle is a cold perfusion technology used in heart transplantation, whereas EVOSS is a warm perfusion method used in lung and heart transplantation. As the company concentrates on expanding its product portfolio and applications in organ transplantation, TransMedics seeks to enhance these technologies.

Dominance of Static Cold Storage Technique

Static cold storage is preferred for organ preservation because it is a simple, cost-effective, and widely adopted method. It involves flushing the procured organ with preservation solution at a very low temperature and then immersing it in the same solution at the same temperature until transplantation. This technique significantly slows down cellular metabolism and maintains organ integrity, while minimizing the need for specialized equipment and reducing costs associated with alternative methods like machine perfusion. The cost-effectiveness of the static cold storage method is the major factor strengthening the lead of this technique. The hypothermic machine perfusion system segment is anticipated to grow at a relatively faster pace with the highest CAGR as market players are constantly working on it. For instance, in May 2023, Bridge to Life, Ltd. reported meeting promising standards from an interim analysis, prompting an early enrollment conclusion for its multicenter, randomized, controlled Bridge to HOPE Liver Clinical Trial (NCT05045794). This trial evaluates the clinical safety and effectiveness of the static cold storage (SCS) method, the conventional ex-vivo organ preservation technique, against a combination of SCS and hypothermic oxygenated perfusion (HOPE) using the VitaSmart Liver Machine Perfusion System. The trial is being conducted under a U.S. Food and Drug Administration (FDA)-approved investigational device exemption (IDE).

Kidney is the Most Commonly Preserved Organ

Kidneys are the most transplanted organ due to several factors. Kidney transplantation has a higher success rate, offering patients a better quality of life and increased longevity compared to remaining on dialysis. Kidney transplantation does not require removing the recipient's kidneys unless they are severely damaged or causing problems like high blood pressure or infection, making it less invasive than other types of organ transplantation. Additionally, compared to other vital organs like the heart, liver, and lungs, there are relatively more suitable kidney donors available, contributing to the frequency of kidney transplantation. Due to the high number of kidney transplants, the demand for preservation products for kidneys is anticipated to be higher. For instance, in 2023, kidney transplants in the United States reached an all-time high, with 27,329 surgeries performed as reported by the Organ Procurement and Transplantation Network (OPTN). Out of these transplantations, more than 6,900 involved living donors, with kidney transplants comprising over 90% of them. Additionally, the year saw an increase in the number of organ transplants, including kidney transplants, for Black and Hispanic individuals.

North America to be the Dominating Region

North America region is expected to dominate the market with a high-value share throughout the assessment period owing to the growing public commitment to organ donation and collaboration among donor hospitals, organ procurement organizations, and transplant hospitals, as well as advancements in organ preservation techniques and scientific breakthroughs. The United States being a medically advanced nation, has crossed the milestone of 1 million organ transplants in the year 2022. The technological advancements in the region to facilitate organ transplants have further boosted the market expansion in the region. Manufacturers also keep up their position by innovating new products.

For instance, in November 2023, Paragonix Technologies unveiled an extensive network of organ procurement, preservation, and transportation services. Seven specialized hubs have been strategically positioned across the United States to streamline coordination and support. These centers operate round the clock, featuring over 50 experienced professionals like surgeons and preservation experts, demonstrating Paragonix's commitment to revolutionizing organ transplantation.

Future Market Scenario (2024 – 2031F)

Machine perfusion is a new technique to keep organs healthy for transplantation. It works by using a special liquid that flows through the organ to keep it alive. This allows the organ to be stored for longer periods and repaired if it is damaged. Researchers are working to develop even better machine perfusion techniques and solutions to make organs even healthier before transplantation. This could lead to more successful transplants and save more lives. For instance, in March 2023, The FDA granted XT-ViVo and TimeSeal a special designation called ""Breakthrough Device Designation"" because they can preserve and store kidneys for up to 120 hours. These products could be used to preserve other organs and tissues. Current methods preserve organs for only 4-16 hours, leading to waste, discarding, and countless organs not being recovered. In February 2023, LivaNova PLC unveiled the Essenz Perfusion System in Europe for cardiopulmonary bypass surgical interventions. This cutting-edge device combines a sophisticated heart-lung machine with a revolutionary patient monitor, delivering real-time critical care insights during CPB procedures.

Key Players Landscape and Outlook

XVIVO Perfusion AB, TransMedics, Inc., Preservation Solutions, Inc., Paragonix Technologies, Inc., Dr. Franz Köhler Chemie GmbH, and Waters Medical Systems LLC are some of the renowned players in the organ preservation market. These companies focus on developing and supplying organ preservation solutions, such as University of Wisconsin (UW) Solution, Custodial HTK, Perfadex, and others, while employing different preservation techniques like static cold storage, hypothermic machine perfusion, and normothermic machine perfusion. Regulatory advancements and collaboration lead the way for market expansion. The market is mainly dominated by privately held companies.

In February 2024, Bridge to Life Ltd announced that it had received ISO 13485:2016 certification. This achievement highlights the company's dedication to quality and safety in its products, including Belzer UW, EasiSlush, and VitaSmart1 Machine Perfusion System (Europe). The certification is a strategic move in preparation for the launch of the VitaSmart1 Machine Perfusion System in the US, pending FDA approval. Bridge to Life consistently strives to meet and surpass industry standards.

In February 2024, Atrium Health's Transplant Division, Carolinas Medical Center, joined forces with LifeShare Carolinas and BMI OrganBank to introduce pioneering Organ Banking technology. This advanced system will expand organ preservation and reconditioning possibilities. Atrium Health is among the top five Integrated Delivery Networks in the United States.