HLA Typing Market: Growth, Size, Share, and Trends

HLA typing plays a crucial role in testing donor-recipient compatibility before transplantation, helping to prevent graft rejection caused by mismatches in blood components. This testing also reduces the risk of complications such as graft-versus-host disease (GVHD) and post-transplant lymphoproliferative disorders. Kidney transplants rose to 27,759 in 2024, reflecting a 1.6% rise from 2023. In Australia in 2023, 1,088 kidney transplants were performed, up from 938 in 2022. Despite this progress, approximately 1,800 Australians remained on the transplant waiting list as of May 2023.A key factor behind this growth is the increasing number of organ donors, with 16,988 deceased donors and 7,030 living donors contributing to these life-saving procedures. Deceased donor transplants reached 41,119 in 2024, surpassing the 40,000 mark for the first time and continuing a 12-year annual growth streak. The consistent increase in organ transplantation procedures globally accentuates the critical role of HLA typing in pre-transplant evaluations. Accurate HLA matching between donors and recipients is essential to minimize transplant rejection risk and enhance long-term graft survival. As transplantation activities expand, the demand for comprehensive HLA typing services is expected to rise correspondingly. Significantly, transplant rates among racial and ethnic minority groups also continued to rise. Hispanic/Latino recipients saw a 6.5% increase, totaling 9,097 transplants, while Black non-Hispanic recipients experienced a 1.5% rise, with 10,990 transplants performed in 2024. These trends highlight ongoing efforts to enhance outreach and improve transplant access in communities disproportionately affected by organ failure, particularly kidney disease. The ongoing increase in organ transplantation procedures underscores the critical need for accurate HLA typing to guarantee the best transplant results. With the rising global demand for organ transplants, the significance of strong HLA typing protocols is more vital than ever in facilitating successful transplantation efforts.

The high cost of HLA typing products continues to be a significant barrier to the growth of the HLA typing for transplant market. Cutting-edge HLA typing technologies—such as next-generation sequencing (NGS), real-time PCR, and sequence-specific oligonucleotide (SSO) methods—require significant upfront investment in specialized equipment, reagents, and trained personnel. These expenses are especially challenging for smaller laboratories, research institutions, and healthcare facilities in low- and middle-income countries, where financial resources are often limited. In emerging economies, limited healthcare infrastructure further compounds the cost barrier, slowing the adoption of HLA typing technologies. Even in high-income countries, the high price point of advanced sequencing platforms presents challenges. For example, in the US, Illumina’s NovaSeq X device has a list price nearing USD 1 million, compared to the more affordable MiSeq i100, priced at USD 49,000. The i100 Plus, designed for higher sample throughput, is listed at USD 109,000. Such pricing disparities illustrate the financial hurdle faced by institutions looking to scale or upgrade their HLA typing capabilities. For example, Illumina's Trusight HLA V2, an amplicon-based NGS HLA typing kit, costs approximately USD 5,000 for 11 HLA genes and 24 samples, or about USD 208 per sample. In India, the cost of HLA typing for the Molecular B51 locus ranges from INR 3,000 to INR 34,000, while the High-Resolution HLA Typing Test (A, B, C, DP, DQ, DR) costs around INR 14,980 in Mumbai. The substantial costs associated with equipment, reagents, and specialized personnel create financial barriers that can limit the widespread adoption of advanced HLA typing technologies, especially in emerging economies where healthcare budgets are constrained.

Continuous improvements in sequencing technologies are creating a favorable landscape for the adoption of HLA typing in transplantation. In particular, the increasing use of next-generation sequencing (NGS) has significantly enhanced the resolution, throughput, and accuracy of HLA typing, crucial factors for reducing graft rejection risk and improving long-term transplant success. In recent years, low-cost, scalable NGS platforms have been developed that enable high-resolution typing across multiple loci, minimizing ambiguities associated with conventional methods such as Sanger sequencing or PCR-SSP. Moreover, the introduction of fully automated HLA typing workflows has reduced manual error, turnaround times, and operational burdens on laboratories. As of 2024, transplant centers and reference labs are increasingly adopting platforms such as Illumina's Nextera Flex for Enrichment and Thermo Fisher Scientific’s Ion Torrent Genexus System to support high-throughput, cost-effective donor-recipient matching. These developments are expanding the utility of HLA typing in both routine and complex transplant cases. The increasing affordability and accessibility of NGS technologies also present an opportunity to extend advanced HLA testing capabilities to emerging markets and resource-constrained regions, thereby widening the global footprint of transplant-ready facilities.

The market for HLA typing is still struggling since different regions have different and changing regulatory frameworks. A variety of national and regional approval procedures, such as adherence to strict clinical performance standards, labeling guidelines, and post-market surveillance duties, must be negotiated by manufacturers. Agencies such as the FDA and EMA have increased monitoring of molecular diagnostic tests, particularly those that impact transplant choices, in essential markets such as the US and the EU. Demands for compliance have increased since the introduction of the IVDR (In Vitro Diagnostic Regulation) in Europe, which, even for tests that were previously self-certified, now requires third-party certification and substantial clinical evidence. These complex requirements pose notable barriers to entry for smaller manufacturers and may delay the commercialization of next-generation HLA typing solutions despite their potential to improve transplant outcomes. Furthermore, divergent regulatory expectations between regions increase the cost and time associated with multinational product rollouts, constraining broader market access. Such delays and limitations in bringing innovative HLA typing platforms to clinical use may inadvertently restrict test availability, especially in settings with time-sensitive transplant workflows. The regulatory environment, while critical for patient safety, thus remains a constraining factor for scaling up adoption and expanding access to HLA typing technologies in transplant care.