HLA (Human Leukocyte Antigen) genes are carried by individuals who express the HLA molecules in almost all nucleated cells. HLA plays a crucial role in accepting and rejecting allogenic grafts by the recipient’s body. For a successful organ or graft acceptance by the recipient, the HLA genes or markers of the organ donor and receiver should be perfect or closely matched. Hence, HLA typing is crucial for a successful organ transplant. The increasing organ transplants drive the growth of the HLA typing market.
The growing prevalence of diabetes, high blood pressure, metabolic syndrome, and chronic kidney diseases is a key factor responsible for organ failure, increasing the demand for organ transplantations. For instance, as the Centers for Disease Control and Prevention (CDC) (U.S.) reported, 37 million people in the U.S. suffered from CKD in 2021, increasing the likelihood of organ failure. In addition to rising numbers of organ failures, higher success rates of organ transplants and improved post-transplant outcomes also contribute to favorable market growth.
The technological advancements in molecular assays for HLA typing are also expected to drive the adoption of HLA typing solutions. Initially, serological assays were used for HLA typing for organ transplants. However, the limitations of this technique, including low-resolution typing, the polyclonal nature of the sera, and the time taken to transport the blood samples led to cross-reactions and incorrect antigen identification. The development of PCR played a crucial role in the progress of HLA genotyping. PCR provides results with more accuracy, fewer errors, and more resolution than serotyping. However, the limitations of the PCR to distinguish between different alleles at a locus and the requirement of multiple endonucleases to break the nucleotide chain in two or more fragments led to the shift towards the sanger sequencing method for HLA typing.
The development of platforms such as Next Generation Sequencing (NGS) and third-generation sequencing brought breakthroughs in genotyping. NGS allows parallel sequencing of a DNA molecule and the characterization of an entire HLA gene. The NGS also enables the high resolution of HLA typing. Similarly, third-generation sequencing allows the production of long reads. The technology also addresses the PCR bias problem due to the intrinsic differences in amplification efficiency of the templates. Looking at the benefits of the NGS and third-generation sequencing for HLA typing, the key players operating in the market are focused on launching new solutions based on these technologies. For instance, in 2021, Thermo Fisher Scientific (U.S.) launched a rapid next-generation sequencing assay that provides high-resolution data in five hours. This assay is beneficial for characterizing HLA genes in solid organs obtained by deceased donors. Moreover, in December 2021, Genome Diagnostics B.V. (GenDx) (Netherlands) launched reagents and software named NGStrack and TRKengine, respectively. These products are used for HLA Typing with chimerism monitoring by next-generation sequencing.
HLA typing is also used for infectious disease diagnosis, immune disease testing, and cancer diagnosis and prevention. The HLA region is associated with the susceptibility to disease by the individual. Similarly, the HLA genes are also associated with autoimmune disease diagnosis. Various forms of HLA antibodies are involved in autoimmune diseases. For instance, the presence of the white blood cells with HLA-B27 antigens can lead to the diagnosis of autoimmune diseases. Some diseases associated with the HLA-B27 antigens are ankylosing spondylitis, reactive arthritis, and juvenile arthritis.
Thus, the increasing organ transplants and innovations in HLA typing techniques are some of the primary factors for the growth of the HLA typing market. The HLA Typing market is projected to grow with a CAGR of 5.6% to reach $1.90 billion by 2029, according to the Meticulous Research®.
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