Transplant Diagnostics Market Size, Share & Trends Analysis Report By Technology (Molecular assay, Non-molecular assay), By Component (Instruments and equipment, Reagents and consumables, Software and services), By Transplant (Solid organ transplantation), By End-Use (Hospitals and transplant centers, Research laboratories and academic institutes, Standard reference laboratories) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2024-2032

Market Overview

The global transplant diagnostics market size was valued at USD 3,550 million in 2019 and is expected to grow with a CAGR of 7.4% during the forecast period, 2020–2029.

Organ transplantation is a surgical procedure of removing healthy organs and transplanting it to the person with a failed organ. Human Leukocyte Antigens (HLA) located on the surface of the cell is involved in the regulation of body recognition. Its vital role is to reject foreign tissue transplants. Thus, HLA testing is carried out to detect tissue compatibility between the recipient and donor. The test is performed using non-molecular and molecular assays.

Market Dynamics

Rising prevalence of chronic diseases

Globally, the rising prevalence of chronic diseases is subsequently increasing the incidence of organ failure, further surging the need for organ transplants. The Organ Donor states that over 1 million tissue transplants are performed every year. As per the statistics provided by the National Health Council, around 133 million Americans suffered from chronic diseases in 2019, and the number is expected to reach 157 million by 2020. The geriatric population is highly susceptible to chronic diseases, which further increases the need for organ transplantation. As per the World Health Organization (WHO), by 2050, the world’s population aged 60 and older is expected to reach 2 billion, from 900 million in 2015. 

Chronic kidney disease (CKD) is highly prevalent and the leading cause of kidney transplantation procedures. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) states that about 661,000 Americans have Kidney failure. About 468,000 people are on dialysis, and roughly 193,000 people live with a kidney transplant. As per the data published by the Centers for Disease Control and Pollution (CDC), around 37 million Americans have CKD. As per the Kidney Organization, in 2014, about 17,107 kidney transplants were performed in the U.S.

Technological advancement in transplant diagnostics market

The demand for organs has exceeded the supply in the last few years. The advent of personalized drugs to reduce the chances of organ failure provides impetus to market growth. For instance, Biohope, a medical foundation, is working on immunosuppressant drugs. As per the data provided by the American Transplant Foundation, currently, about 114,000 people in the U.S. are on the waiting list for organ transplants. However, the rising prevalence of chronic diseases such as diabetes is subsequently increasing the waiting list, further rising the need for technological advancements. To address the situation, the Organ Procurement and Transplantation Network (OPTN) have initiated a strategic development strategy for 2020. The OPTN has established a new liver and intestinal organ distribution system to improve the process of organ transplantation. Following are the recent developments and ongoing research in the field of organ transplantation:

Creating organs from stem cells

Stem cells can respond to the environment in which they are transplanted and continue replicating the suitable tissue.

3d printing of organs

Scientists have also designed models of many anatomical structures, including lungs, eyes, arteries, and bones, for 3D printing. This method could be used in the future to build 3D-printed soft implants where living tissue can expand to form organs. In 2017, engineers at Penn State University invented a ground-breaking way to print tissues and organs.

The advent of 3-D bioprinting technologies drives market growth. These machines can easily print real human tissue, replicas of organs, and functional organ structures. One of the recent breakthroughs in organ transportation is the TransMedics Organ Care System. The machine is designed to replicate human organs and has the potential to keep the organs alive outside the body. Additionally, these machines are reducing the waiting list for organ transplants.

Nucleic acid amplification and detection, genomic analysis, proteomics, and metabolomic techniques have enabled the development of several molecular diagnostic assays. The rising number of stem cell and soft tissue transplantation and increasing R&D funding drive the market growth. Apart from this, the application of nanomedicine in organ transplantation and regenerative surgery holds tremendous potential in regenerative organ transplantation. Nanomedicine can deliver low dose medication to the donor cells or graft tissues, while nano-imaging enables graft surveillance through non-invasive immunomonitoring of donor and recipient cells.

Regional Analysis

Transplant Diagnostics Market in North America

The U.S. and Canada are backed by the presence of robust healthcare infrastructure and government support. The regional market’s most prominent driver is the rising awareness regarding organ transplants. The market players are also actively working to raise awareness regarding organ transplants. For instance, Roche is working with hospitals and organizations such as the American Transplant Foundation, UNOS, National Kidney Foundation, and Donate Life America to bolster the rate of organ donors. Additionally, the leading players are developing novel drugs for quicker treatment of diseases pre and post transplants, further driving the transplant diagnostics market growth.

As per the American Transplant Foundation, there are over 114,000 people on the waiting list for organ transplants. In the U.S., there has been a steady rise in the number of renal donation levels accompanied by the amount of deceased donation, reflecting the need for more research programs. With a wide portion of the world's population seeking these two countries for better health care services, North America is projected to lead the transplantation diagnostics market.

Segmental Analysis

Transplant segment to dominate the transplant diagnostic market

Rising prevalence of chronic disorders, increasing frequency of vital organ loss, increasing performance, and significant advancement in post-transplant results are escalating the demand for organ transplantation in the last few years. However, lack of adequate donors has led to organ scarcity. As a result, the number of patients on the waiting lists for transplants has increased considerably.

As per the U.S. Government Information on Organ Donation and Transplantation, as of March 2020, about 112,000 people are on the national transplant waiting list in the U.S. In 2019, around 39,718 transplants were performed. Supportive reimbursement policies in developed nations for the treatment of life-threatening diseases drive the demand for organ transplantations. Thus, increasing the need for organ transplantation provides impetus to market growth.

Impact of covid-19

The COVID-19 pandemic has severely impacted organ donation. As per the Kidney organization, people with kidney disease and transplant recipients are at a higher risk for developing severe complications from COVID-19. The coronavirus majorly hits Europe. To address the issue, the governments in Europe have introduced protective screening measures for potential recipients of organs. Transplant patients take immunosuppressive medications. Thus, viruses such as cold and flu can lead to infection.

As stated by the American Society of Transplantation, ‘The risk of acquiring COVID-19 from organ donation is low. Donors are being screened for COVID-19 symptoms and exposure history. Donors diagnosed for COVID-19 infection are asked to postpone donation for 14 to 28 days after returning.’

Recent Developments

• In March 2020, CareDx, Inc. launched KIRA Immuno-Optimization to bring personalized care to transplant.
• In June2019, Eurofins Scientific acquired Transplant Genomics Inc. to improve organ transplant outcomes with non-invasive serial monitoring guided by genomics.