Transplant diagnostics involves assessing compatibility between organ donor and receiver so as to predict any future organ rejection episodes and have contingencies in place. Number of tests are performed such as ABO blood group compatibility, tissue typing, cross matching, panel reactive antibody test, serology screening, and testing for infectious diseases. Increased understanding of the organ rejection phenomenon has led to identification of robust biomarkers along with development of robust biomarker identification tests. The Global Transplant Diagnostics Market was valued at US$ 544.2 million in 2016 and is expected to witness a robust CAGR of 8.4% over the forecast period (2017–2025).

Technological advancements in the molecular and non-molecular assays such as PCR, and NGS has increased the data throughput. However, high cost of transplant diagnostic products, limited medical reimbursement, and low awareness about organ transplantation in emerging economies such as Middle East and Asia Pacific is expected to be a factor hindering the transplant diagnostics market growth.

Market Dynamics

Rising prevalence of chronic diseases leading to multiple organ failures; benefits offered by transplant diagnostics, which can predict organ rejection episodes and help in preparing a contingency plan; increasing government initiatives for organ donation awareness; and research and development by leading players to enhance transplant diagnostic products is expected to boost growth of the transplant diagnostics market over the forecast period. For instance, Natera, Inc. and University of California, San Francisco (UCSF), announced a research collaboration in 2016, to study DNA markers of Kidney Transplant Rejection. Furthermore, in 2016, the U.S. government announced plans to invest US$ 200 million to shorten the waiting list of organ transplant patients. These factors are expected to aid in growth of the market over the forecast period.

Advancement in technology in diagnostics is expected to drive growth of the transplant diagnostics market

Advent of new diagnostic tests have improved medical outcomes associated with organ transplants. Organ rejection rate can be minimized by matching the donor and recipient compatibility before transplantation. Conventional techniques in transplant diagnostics include analysis of human leukocyte antigen (HLA). HLA analysis is done in high-throughput laboratories with a limited staff, which is time consuming. However, presence of molecular assay technologies, such as sequencing techniques and PCR-based assays have proved to be efficient.

Genetic information can be interpreted on a large scale by using advanced next generation sequencing (NGS) technologies at an affordable price. For instance, Illumina’s MiSeq system offers high-resolution HLA typing and uses next generation sequencing technology, which can be used by any laboratory. In December 2015, Immucor and Sirona Genomics introduced MIA FORA NGS—a high-resolution HLA typing solution—that provides accurate and detailed coverage of 11 HLA genes. Furthermore, HLA analysis at the DNA level is possible due to technologies such as PCR-RFLP, PCR-SSP, PCR-SSO, PCR-SSCP, and PCR-SNP.

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Key Companies

Some major players operating in the transplant diagnostics market are Thermo Fisher Scientific, Inc., Bio-Rad Laboratories, Inc., Qiagen N.V., F. Hoffman-La Roche Ltd., Immucor, Inc., Becton Dickinson and Company, bioMérieux S.A., Illumina, Inc., CareDx, Inc., and GenDx.

Government initiatives to promote organ transplantation along with awareness initiatives for the same is supporting growth of the transplant diagnostics market

Increasing number of transplantation is expected to increase demand for transplant diagnostics, in order to reduce episodes of organ rejection. Various organizations such as World Health Organization (WHO) and World Health Assembly have implanted action plans such as WHA57.18 to increase awareness regarding transplantation. National Health Service (NHS) Blood & Transplant funded a living transplant initiative in 2016, which was led by the National BAME Transplant Alliance, to increase the number of living transplants from black, Asian, and minority ethnic (BAME) communities. Moreover, in 2015, the Health Resources and Services Administration in the U.S. initiated the Organ Donation and Transplantation Funding program and allocated US$ 24 million for research.

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