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).
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. Similarly, government in the U.K. allocated a budget of US$ 28 billion in FY2015, of which US$ 1.85 million was invested in medical research of HLA diagnosis conducted by universities and institutes. Furthermore, National Organ & Tissue Transplant Organization (NOTTO), India, keeps a track of transplant activities and organizes awareness activities and programs in the country.
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However, transplant diagnostic products are costly, and despite continuous efforts from government organizations to promote organ donation, there is reluctance for organ donation which is restraining the growth of the transplant diagnostics market.
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.
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.
Transplant diagnostics involves assessment of aspects associated with a transplant such as compatibility testing, safety testing, and transplant feasibility testing pre-, peri-, and post transplantation. Depending on the source of the transplant organ, they are categorized into autografts, allograft, and xenograft. Auto graft is transfer of cells, tissues, and organs within same the individual; allograft is transfer of organs or tissues from one individual to another from same species; whereas, xenograft involves transfer of tissues and organs between two different species. Allograft and xenograft transplantation involves intensive testing of donor as well as receiver, physiological parameters in order to successfully match the donor organ and receiver body and prepare contingencies for future problems. Issues associated with organ transplantation such as acute rejection can be avoided by using advanced transplant diagnostic techniques. Development of new transcriptomic, genomic, and proteomic biomarkers in molecular diagnostics can provide better personalized management for organ transplantation and can detect rejection episodes early.
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