The global perfusion system market size was valued at USD 1.062 billion in 2021 and is projected to reach USD 1.64 billion by 2030, registering a CAGR of 4.95% from 2022 to 2030.
The delivery of oxygenated blood to the various tissues throughout the body is an example of the process known as perfusion. In organ transplant procedures, perfusion systems are used extensively because they assist in temporarily replacing the function of the organ being removed by pumping blood throughout the body while the procedure is being performed. The worldwide perfusion system market has shown lucrative growth in the recent past due to the increasing number of organ transplants and the increasing number of product releases by key players in the market. For example, as of July 2017, there were over 117,000 men, women, and children on the national transplant waiting list in the United States, according to data that was published by the Organ Procurement and Transplantation Network (OPTN). Additionally, there had been 17,155 organ transplants performed up until July 2017.
In the near future, the increasing number of approvals and launches of novel perfusion systems is anticipated to have a significant impact on the growth of the perfusion system market. In 2014, the U.S. Food and Drug Administration approved Xvivo Perfusion AB's Xvivo Perfusion System (XPS) with STEEN solution, which is used to preserve initially unsuitable donor lungs while they are evaluated for their viability as transplantable organs. In Europe, the new Paragonix SherpaPak Cardiac Transport System and SherpaPerfusion Cardiac Transport System were approved in February 2018. The SherpaPak Cardiac Travel System is used for the hypothermic static preservation and transport of donor hearts, whereas the SherpaPerfusion Cardiac Transport System is a single-use, disposable device utilised for the hypothermic oxygenated perfusion preservation and transport of donor hearts. In the near future, the growth of the global perfusion system market is also anticipated to be bolstered by the rising investments of the market's major players.
Miracor Medical Systems GmbH (Miracor Austria) and Miracor Medical SA (Miracor Medical) raised approximately $26.3 million in January 2018 as part of a Series D investment deal. The funds will be utilised for the development and marketing of the PiCSO Impulse System. In addition, the rising demand for organ transplants is anticipated to enhance the demand for perfusion systems and boost their market growth in the near future. According to data given by the National Kidney Foundation in 2016, around 100,791 persons in the United States are awaiting kidney transplants.
It is anticipated that the high cost of perfusion systems will be the primary factor that will be constraining the growth of the perfusion system market on a worldwide scale. For example, the cost of a single-use Organ Care System (OCS) Heart Perfusion Set is approximately US$ 36,904.8, according to the data published by the National Institute for Health and Care Excellence in 2016. This price is extremely high and is not affordable in developing regions such as India, China, and Africa.
It is anticipated that there would be a rise in demand for dependable organ perfusion systems as a result of the growing demand for organ transplantation. In addition to this, the prevalence of cardiovascular and respiratory disorders is increasing over the world, which is another factor that is driving up the demand for organ transplantation. There were 3,408 heart transplants in 2018, according to the data that was published by the Division of Transplantation (DoT) of the Department of Health and Human Services, Health Resources and Services Administration's Healthcare Systems Bureau. As a result, due to an increase in the frequency of cardiovascular and respiratory disorders as well as an increase in the need for organ transplantation, the market is anticipated to experience significant expansion in the near future.
The cardiopulmonary perfusion system held the biggest revenue share of almost 43 percent in 2021, driven by the rising frequency of cardiovascular and respiratory disorders and the rapid increase in organ transplant procedures performed worldwide. The perfusion system market is categorised by application into cardiovascular perfusion systems, cell perfusion systems, and ex-vivo organ perfusion systems.
In 2021, the ex-vivo organ perfusion system held over 30 percent of the total market share. This is due to the fact that the ex-vivo perfusion system allows organs to survive longer outside the body, reducing the need for quick transplants. This contributes to the expansion of the number of organs accessible for transplant.
The cardiopulmonary perfusion system is subdivided into oxygenators, heart-lung machines, perfusion pumps, cannula, and other monitoring systems. In 2021, the oxygenator category had the highest revenue share because to the increasing prevalence of cardiopulmonary failure.
The cell perfusion system is subdivided into the bioreactor perfusion system, the microfluidic perfusion system, the gravity/pressure-driven perfusion system, and the small mammal organ perfusion system. In 2021, the bioreactor perfusion system held the largest market share in the cell perfusion system sector. This is due to reasons such as the increasing demand for biological products and the ongoing desire to boost product yield and decrease production costs.
The ex-vivo organ perfusion system is subdivided into hypothermic and normothermic subsystems. In 2021, the hypothermic sector held the largest market share of over 63 percent. This can be ascribed to the benefits provided by the hypothermic perfusion system, such as higher graft survival rates over the long term, the ability to give metabolic support, and less vasospasm.
In contrast, normothermic perfusion systems maintained approximately 37% of the market share in 2021. The subsegment is anticipated to develop steadily over the projected period, since it is not only advantageous for conserving extended criteria donors (ECD), but also offers the convenience of organ quality testing.
The market is split by region into North America, Europe, Asia-Pacific, and LAMEA.
It is anticipated that North America will hold a preeminent position in the global perfusion system market as a result of the high presence of important companies in the region and the growing number of partnerships among these players to increase the availability of their products in the region. For instance, in 2016, Medtronic plc., a medical device company based in the United States, entered into a strategic partnership with Spectrum Medical Ltd. for the distribution of Spectrum Medical's new Quantum Perfusion Systems in Canada and other regions. This partnership will allow Medtronic plc. to expand its market reach. In the year 2017, Paragonix Technologies, Inc. entered into a strategic distribution partnership with MBA Medical in order to distribute the SherpaPak Cardiac and Kidney Transport Systems manufactured by Paragonix Technologies in the Southern region of the United States. In addition, due to the increasing number of innovative perfusion systems being approved for use in Europe, the market for global perfusion systems is anticipated to experience considerable expansion in the region of Europe. Limflow SA was granted CE marking in 2016 for its most recent generation of the percutaneous LimFlow System, which was developed for the venous arterialization of the lower limbs of patients who were at an end-stage risk of limb amputation due to Critical Limb Ischemia.
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In March 2018, the latest automated parallel bioreactor system, the ambr 250 high throughputs (ht) perfusion, was introduced by Sartorius Stedim Biotech SA. The ambr 250ht perfusion system was created for the purpose of expediting the process development required for cell culture perfusion in order to maximize the generation of therapeutic antibodies.