Human leukocyte antigens (HLA) are molecules found on the surface of the cell that regulates recognition and rejection of foreign tissue transplant by the body. Molecular profiling of HLA sequences or tissue typing is majorly performed prior to organ transplant procedures. HLA diagnostic testing is performed to determine the tissue compatibility between the donor and recipient before organ and bone marrow transplantation. It increases the probability of graft survival and minimizes severe immunologic transplant complications. Various molecular and non-molecular assays are used for pre- and post-transplantation procedures. The non-molecular assay includes serological assays and mixed lymphocyte culture (MLC) assays, whereas, molecular assay comprises of PCR-based assays, and sequencing-based assays. Independent reference laboratories, hospitals, research laboratories, transplant centers, academic institutes are the major end-users of transplant diagnostics. Rapid rise in chronic diseases have led to increased demand for early patient profiling and boosts the adoption of transplant diagnostic testing.

Molecular assays or technologies such as polymerase chain reaction (PCR)-based assays and high-throughput next-generation sequencing have led to a shift in technology platforms for transplant diagnostics. Next-generation sequencing offers precise, complete gene sequences with ultra-high base resolution, high-throughput, cost-efficient HLA DNA typing which helps to improve HLA matching for medical research and transplantation medicine. NGSgo kit by GenDx, TruSight by Illumina, Holotype HLA by Omixon are some of the commercially available NGS based HLA kits. Moreover, major industry players are focused on launch of novel products used in the field of transplantation medicine. For instance, in February 2019, Care Dx launched AlloSure Lung for lung transplants. AlloSure Lung applies next-generation sequencing (NGS) technology to measure dd-cfDNA in the blood stream emanating from the donor lung to monitor graft injury.

The global transplant diagnostics market has been segmented based on products & services, technology, application, transplant type, end-users, and region. Based on products & services, the global transplant diagnostics market is categorized into reagents & consumables, instruments, and software & services. Reagents & consumables segment held substantial share of the global market in 2018. Increase in adoption of reagents and consumables owing to rise in volume of pre-transplant diagnostics tests in reference laboratories is anticipated to propel the growth of the market over the forecast years.

Technology-wise, the global transplant diagnostics market is segmented into molecular assays and non-molecular assays. Molecular assays are segregated into PCR-based molecular assays and sequencing-based assays. Sequencing-based molecular assays are further sub-segmented into Sanger sequencing, next-generation sequencing, and others. Non-molecular assays are classified into serological assays and mixed lymphocyte culture (MLA) assays. Molecular assays segment held the majority of the market share in 2018 owing to rapid adoption of sequence-based technologies. Advantages of NGS such as higher sensitivity and specificity to detect variants, quick turnaround time for high sample volumes, and its ability to sequence hundreds to thousands of genes simultaneously are factors anticipated to drive the growth of the segment in the coming years.

On the basis of application, the global transplant diagnostics market is segmented into diagnostic applications and research applications. Diagnostic applications segment is further sub-segmented into pre-transplantation diagnostics and post-transplantation diagnostics. Diagnostic applications held majority of the market share in 2018. By type of transplantation, the global market is categorized into solid organ transplantations, stem cell transplantations and others. Solid organ transplantations are sub-categorized into kidney, liver, lung, heart, pancreas, and others.

Based on end-users, the global transplant diagnostics market is segmented into independent reference laboratories, hospitals and transplant centers, and others. Independent reference laboratories segment held the dominant share of the global market in 2018. This is attributable to surge in volume of organ transplantation procedures, increase in R&D activities outsourced by pharmaceutical & biotechnology companies to reference labs, and rapid modernization of diagnostic laboratories. Hospitals maintain high-quality transplantation products to increase the treatment efficiency and reduce the number of graft rejections.

The global transplant diagnostics market is cumulative to North America, Europe, Asia Pacific, Latin America and Middle East & Africa. North America dominated the global transplant diagnostics market in 2018, however Asia Pacific is expected to grow at a highest pace through 2025.

Wide availability of transplant diagnostics tests and increase in organ transplantation procedures, rapid adoption of stem cell therapies, and soft tissue transplantation in the U.S. are major factors expected to drive the transplant diagnostics market in the region. Furthermore, rapid adoption of advanced diagnostic tools and technologies, availability of skilled professionals and presence of well-established healthcare infrastructure are other major factors likely to boost the growth of the market in North America.

However, Asia Pacific is expected to grow at a rapid pace over the next few years. Increasing prevalence of chronic disease, large population base, increasing shift in preference from serological assays to genome-based HLA profiling, and rising market penetration in developing countries to develop transplant diagnostic assays are major factors anticipated to drive the growth of the market in the region.