Organ Transplant Diagnostics Market

Market Overview

The global organ transplant diagnostics market size was valued at USD 3,814.93 million in 2022. It is estimated to reach USD 9,693.97 million by 2031, growing at a CAGR of 10.92% during the forecast period (2023–2031).

Organ transplantation is one of the most preferred treatment options for patients suffering from end-stage chronic diseases leading to organ dysfunction. A surgical technique called an organ transplant replaces a diseased organ with a healthy organ. Organ transplant diagnostics has become integral for conducting clinical assessments of various attributes associated with donor organ screening and recipient surveillance.

Organ transplant diagnostics are clinical diagnostic tools that help to improve the efficiency of transplantation procedures. Transplant diagnostics are typically performed before and after transplantations. It aids in the analysis of the patient's medical circumstances. HLA typing is of utmost importance in organ and blood stem cell transplantation applications. Organs that have been effectively transplanted include the kidneys, heart, liver, lungs, pancreas, and bone marrow transplants. Hospitals, transplant facilities, research labs, academic institutions, and commercial service providers are the primary end consumers of transplant diagnostics.

Highlights

• Services dominate the offering segment
• Diagnostics dominate the application segment
• Hospitals and transplant centers dominate the end-user segment
• North America is the highest shareholder in the global market

Market Dynamics

Market Drivers

Rising Number of Organ Transplants Procedures

Organ transplantation has increased globally during the past decade due to the increased incidence of vital organ failure, the rising success of transplants, and more significant improvement in post-transplant outcomes. For instance, according to a United Network for Organ Sharing (UNOS) 2020 study, transplant doctors in the United States carried out 39,718 transplants using organs from deceased and living donors. The rising number of organ transplant procedures is due to the increasing prevalence of chronic diseases such as cancer, cardiovascular diseases (heart failure), chronic kidney disease, and liver cirrhosis.

Additionally, the global market is expected to witness massive growth over the next decade due to an ongoing and anticipated trend of a significantly growing number of transplant procedures in significant economies across multiple regions. The use of transplant procedures is one of the well-established methods for diagnosing chronic diseases. Thus, a rise in the number of transplants is anticipated to boost the growth of the global market.

Strategic Initiatives by Key Market Players

The market of organ transplant diagnostics is gaining attention due to strategic initiatives being incorporated by emerging companies and market juggernauts. The market leaders are undertaking developments such as mergers and acquisitions, launching new products, and expanding their businesses. In addition, the launch of new products is creating dynamic competition among players in the market to sustain their position. For instance, in September 2018, CareDx, Inc. launched the Surveillance HeartCare Outcomes Registry to offer critical information about heart transplant recipient immune activity and donor graft injury, including AlloSure-Heart and AlloMap. The subsequent trend of strategic initiatives is also expected to continue in the global market over the coming years, driving the market growth over the forecast period.

Market Restraint

High Cost of Organ Transplant Procedure and Diagnostics

The high cost of organ transplant procedures and transplant diagnostics products are restraining the market. The average price associated with an autologous bone marrow transplant is approximately USD 471,600. In addition, the average cost associated with solid organ transplants, such as liver and heart, is roughly USD 878,400 and USD 1,664,800, respectively. Moreover, the high price of performing HLA matching using polymerase chain reaction (PCR) and NGS devices is also a dominating factor hindering the growth of the transplant diagnostics market in developing countries. Therefore, such factors can limit transplantation operations and create a massive difference between annual and organ donation processes, hampering the market growth.

Market Opportunities

Increasing Awareness Regarding Transplants in High Potential Market

Rising awareness regarding transplant procedures in high-potential markets among donors and the recipient is likely to create opportunities for the global market. To grow awareness among the public, the government in emerging economies is taking the initiative by organizing donation awareness events conducted every year on a particular date. For instance, according to the U.S. Department of Health & Human Services, 2020 Health Resources & Services Administration (HRSA), the country celebrates January 1st celebrate a national event known as "Donate Life Float is a part of the Rose Parade," honoring the millions of people touched by organ donation, including donors, donor families, transplant awaiting candidates and transplant recipients.

Apart from this, many emerging countries face organ donation shortages, as people need to be made aware of organ donation and transplantation procedures. Furthermore, the Donation and Transplant Institute Foundation is engaged with many diagnostic companies to carry out developments to raise awareness about donation and transplantation. Hence, the awareness among transplant physicians and patients in the high-potential markets regarding the long-term clinical outcomes of organ transplants is expected to offer lucrative opportunities for companies to launch their products in these markets.

Regional Analysis

North America Dominates the Global Market

Based on region, the global organ transplant diagnostics market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and Rest-of-the-World.

North America is the most significant global organ transplant diagnostics market shareholder and is expected to grow at a CAGR of 10.29% over the forecast period. The North American organ transplant diagnostics market is anticipated to be driven by various technological innovations to advance and enhance the overall scope of precision diagnostics. Various advanced research and development projects, mainly focused on expanding the clinical applicability of organ transplant diagnostics for donor screening and post-transplant care, have further aided in exploring new avenues to better cater to human health demands.

In addition, North America is home to many legacy companies in the organ transplant diagnostics industry that are currently updating their portfolios to offer advanced products and services. The key companies operating in the North American organ transplant diagnostics market include One Lamba, Inc. (a subsidiary of Thermo Fisher Scientific, Inc) CareDx, Inc., Abbott Laboratories, Eurofins Scientific, Quest Diagnostics Incorporated, Laboratory Corporation of America Holdings, and ARUP Laboratories, Inc. Moreover, the rising adoption of molecular assay technologies such as polymerase chain reaction (PCR) and next-generation sequencing (NGS)-based organ transplant diagnostics products and services are significantly supporting the market growth in the region.

Europe is anticipated to exhibit a CAGR of 11.19% over the forecast period. The Europe organ transplant diagnostics market has been growing since its inception. Several European countries, including Germany, France, the U.K., Italy, Spain, and Switzerland, are working persistently to enhance research initiatives in the organ transplant diagnostics market across the Europe region. The region has always been at the forefront when establishing research to advance high-fidelity transplant diagnosis globally due to high fund infusions. In addition, the area is a base of operations for most market leaders, including bioMérieux S.A., F. Hoffmann-La Roche Ltd., Novacyt Group, QIAGEN N.V., and JETA Molecular B.V., among others. Furthermore, regional standardization and harmonization of clinical review procedures for a smooth approval process by regulatory bodies fuel the market growth. Increasing approvals of organ transplant diagnostic products in European countries create opportunities for regional market growth.

Although the Asia-Pacific market is expected to remain in an intense growth phase due to the massively growing number of transplant procedures, increasing incidence of end-stage diseases, and rising purchasing power for people in the emerging economies, a significant barrier to the increasing adoption is an uneven economic balance among the countries within the region. However, growth is expected to be tremendous in the regional market due to substantial commercial growth of emerging companies, high-profile publications, and the establishment of multidisciplinary consortiums aiming to accelerate standardization and harmonization of regulatory consensus for an emerging field.

The Latin America (LATAM) organ transplant diagnostics market is still nascent, considering the rapid worldwide developments. However, several Latin American countries, including Brazil, Mexico, and Argentina, are working rigorously to enhance the adoption of organ transplant diagnostics tests across emerging economies in the Latin America region. Although sluggish growth has been observed in the region, economically developing regions in Latin America is likely to grow in organ transplant diagnostics. The market is expected to remain in a vital growth phase due to increasing health consciousness, growing prevalence of end-stage diseases, rising awareness about transplant diagnostics among physicians and patients, and rising purchasing power of people in the emerging countries of Latin America.

The Rest-of-the-World (RoW) region consists of emerging countries, including the Middle East and Africa. The growth of the RoW organ transplant diagnostics market is majorly due to the rising number of organ transplant procedures, the increasing uptake of research on transplant care, the emergence of new companies, and the increasing prominence of precision diagnostics in the field of transplant diagnostics.

Segmental Analysis

The global organ transplant diagnostics market is bifurcated into offering, transplant, technology, application, and end-user.

Based on the offering, the global market is bifurcated into products and services. 

The services segment dominates the global market and is projected to grow at a CAGR of 10.27% over the forecast period. The growth of the services segment is majorly attributed to the growing advancement in transplant diagnostics in recent years, particularly for pre-and post-transplant screening. In addition, underlying factors such as the adoption of advanced technology-based testing and the increasing number of chronic diseases impose a combinatorial effect on global organ donation, ultimately resulting in these transplant diagnostics services. Further, the favorable regulatory scenario has also allowed service providers to launch their respective tests to enhance their portfolios and enable transplant diagnostics in precision medicine.

Based on transplant, the global market is divided into solid organ transplant and stem cell transplant. 

The solid organ transplant segment is the highest contributor to the market and is estimated to exhibit a CAGR of 10.96% over the forecast period. Solid organ transplant has become a well-established medical procedure that offers a definitive treatment solution to patients suffering from end-stage organ malfunction. Rapid advancements in surgical techniques have allowed healthcare professionals to implement a more refined and efficient approach for conducting successful solid organ transplants. The solid organ transplant segment is further sub-segmented into the kidney, liver, heart, lung, pancreas, kidney-pancreas, and others.

Based on technology, the global market is divided into molecular technologies, serology, flow cytometry, and others. 

The molecular technologies segment dominates the global market and is anticipated to exhibit a CAGR of 10.89% over the forecast period. In organ transplant diagnostics, molecular technologies play an instrumental role in monitoring graft rejections, infectious disease screening, and high-resolution HLA assessments, among others. The molecular technologies in the global market typically include polymerase chain reaction (PCR), next-generation sequencing (NGS), fluorescence in situ hybridization (FISH), and other molecular technologies.

Pertaining to molecular technologies, polymerase chain reaction (PCR) dominates the global market. Molecular technologies offer high accuracy, high-resolution levels, and lower turnaround time than conventional serological methods. With the advancements in molecular technologies made by emerging and established companies, the adoption of organ transplant diagnostic products based on PCR and NGS is predicted to grow during the forecast period.

Based on application, the global market is bifurcated into diagnostics and translational research. 

The diagnostics segment owns the highest market share and is predicted to grow at a CAGR of 10.81% over the forecast period. The global market is primarily diagnostic-based, wherein major players manufacture products for use in clinical settings worldwide. These include diagnostic utilities in an organ donor and recipient testing for various applications, including infectious disease diagnosis, human leukocyte antigen (HLA) typing, ABO blood grouping, chimerism testing, and graft versus host disease (GvHD) screening, among others. It is worth mentioning here that chimerism testing and GvHD screening are only conducted in stem cell transplant patients to eliminate future medical complications.

Based on the end-user, the global  market is bifurcated into hospitals and transplant centers, reference laboratories, academic and research institutions, and others. 

The hospitals and transplant centers segment dominates the global market and is projected to exhibit a CAGR of 10.84% during the forecast period. Hospitals and transplant centers offer a wide range of expertise in pathology and advanced laboratory diagnostics for conducting screening in post-transplant and pre-transplant surgeries. These hospitals and transplant centers combine state-of-the-art testing services, which are required to assess assays, consumables, and kits in organ transplant diagnostics product types. Additionally, the hospitals and transplant centers often achieve a tight integration with local physicians, thus benefiting both specialties.

Recent Developments

• February 2023- Merck announced that the U.S. Food and Drug Administration (FDA) accepted two supplementary new drug applications (SNDA) for PREVYMIS for review (letermovir). Priority review was approved for the SNDA for PREVYMIS to prevent sytomegalovirus (CMV) illness in high-risk adult kidney transplant recipients.

• October 2022- The biotechnology company Plexision began international operations by establishing a reference laboratory in Hyderabad, India. This laboratory would provide a complete array of transplant patient diagnostics. In addition to drug-level monitoring, pharmacogenomics, and genetic testing, these tests include the company's tailored transplant diagnostic tests to detect rejection and viral infections.