HLA Typing Market Assessment, By Products and Services [Instruments, Reagents and Consumables, Software and Services], By Technology [Molecular Assays, Non-molecular Assays], By Application [Diagnostics, Research], By End-user [Hospitals and Transplant Ce

HLA Typing Market Assessment, By Products and Services [Instruments, Reagents and Consumables, Software and Services], By Technology [Molecular Assays, Non-molecular Assays], By Application [Diagnostics, Research], By End-user [Hospitals and Transplant Centers, Commercial Service Providers, Research Labs and Academic Institutes], By Region, Opportunities and Forecast, 2017-2031F

Global HLA typing market is projected to witness a CAGR of 6.27% during the forecast period 2024-2031, growing from USD 1.31 billion in 2023 to USD 2.13 billion in 2031. The market’s growth is supported by the rising requirement for organ transplantation, increasing cases of genetic diseases, growing emphasis on research activities, and novel product launches by the leading players of the market.

According to the estimates of the Health Resource and Services Administration (HRSA) approximately 103,223 men, women, and children are on the national transplant waiting list in the United States. Due to this increase, the cases of organ transplant procedures are rising, bolstering the requirement for HLA typing. The global HLA typing market size is increasing due to the rising research activities on genetic and autoimmune diseases due to their growing burden. According to the estimates of the American Autoimmune, approximately 50 million Americans are living with one or more autoimmune diseases.

The development of novel technologies, products, and software by the leading players in the market is providing lucrative growth opportunities to the market. In June 2024, Thermo Fisher Scientific Inc. introduced their Applied Biosystems Axiom BloodGenomiX Array and software for precise blood genotyping in clinical research. The new array is capable of detecting platelet types, rare blood groups, and tissues in a single assay, aiding advancements in extended phenotype donor blood matching. Increasing utilization of DNA-based blood typing is expected to support large-scale genomics research and the introduction of international standards for improving the efficacy and safety of blood transfusion. The increasing accessibility of scalable array-based blood typing solutions is expected to effectively screen various blood types for precise matching.

Technological Advancements in HLA Typing Support the Market Expansion

The increasing efforts of the key players of the market and various research institutions toward the development of advanced technologies are expected to provide lucrative growth opportunities to the market in the forecast years. Next-generation sequencing (NGS) technologies, including PacBio and Illumina, have revolutionized HLA typing as they enable the sequencing of entire HLA genes, including noncoding and coding regions.

In November 2023, F. Hoffmann-La Roche Ltd launched a next-generation qPCR system to address public health challenges and advance personalized healthcare. The LightCycler PRO System is expected to provide outbreak readiness by providing flexibility and agility for diagnostics and translational research. Additionally, in April 2023, Metropolis Healthcare Limited launched their NextGen HLA typing test for identifying suitable donors for organ transplantation, cord blood, and bone marrow by analyzing the HLA gene. The NextGen HLA typing test is expected to aid physicians, doctors, and patients in ensuring transplants at a higher HLA match percentage between the recipient and the donor, bolstering the chances of successful transplants.

Increasing Organ Transplantation Boosts HLA Typing Market Growth

The rise in organ transplant procedures due to the increasing availability of donated organs is one of the major factors bolstering the global HLA typing market demand. According to the Organ Procurement and Transplantation Network (OPTN), in 2023, approximately 16,335 individuals donated one or more organs upon their death in the United States, showcasing a 9.6% increase from 2022. The increasing donations can be attributed to the growing awareness about the procedure and the impact of the donation on donor health. This propels the requirement for HLA matching as it reduces the risks associated with post-transplant complications and promotes the development and growth of healthy new blood cells. Donors and recipients should have a match of at least 6 HLA markers, as a high degree of mismatch augments the chances of antibody production from the immune system of the patient, which can attack the graft.

Diagnostics Segment Expected to Witness Significant Growth

The growth of the segment is supported by the rising requirement for organ transplantation and increasing cases of autoimmune and genetic diseases. For instance, the HLA-B27 test is conducted to confirm or dismiss suspected cases of ankylosing spondylitis (AS), juvenile rheumatoid arthritis, and reactive arthritis. The test aids healthcare professionals in determining the presence or absence of the HLA-B27 protein on the surface of the white blood cells in individuals. Additionally, the expansion of the segment is supported by the rising collaborations between different diagnostic and biotech companies to support the development of HLA typing kits. In November 2023, OSE Immunotherapeutics and GenDx announced the partnership for developing NGSengine software and NGSgo HLA-A typing kit as a companion diagnostic (CDx) for cancer vaccines. With the partnership, the companies aim to validate and develop a CDx test for epitope-based cancer vaccines to improve the survival and the quality of patients’ lives.

North America Holds Significant Market Share

The presence of leading market players, rising requirements for organ transplantation in the region, novel product launches, and presence of well-established healthcare infrastructure are some of the major factors boosting the market’s growth. According to estimates from the United Network for Organ Sharing (UNOS), in 2023 over 46,000 organ transplants were performed in the United States. This increase propels the market demand as HLA typing is one of the essential components for matching hematopoietic cells between the recipients and the donors for improving patient outcomes by aiding patients in avoiding graft-versus-host disease (GVHD) and acute graft rejection.

The strong presence of various research institutions and increasing investments in research activities are another significant factors supporting the market’s expansion. For instance, the Memorial Sloan Kettering Cancer Center is conducting an interventional study to evaluate if the addition of specific genetic factors to the process of selecting a stem cell donor reduces the chances of leukemia coming back in patients after the bone marrow has been transplanted. The study is expected to conclude in May 2025 and aims to demonstrate that patients with adult acute myeloid leukemia (AML) who have donors with specific HLA and killer immunoglobulin-like receptors (KIR) genes have better outcomes.

Future Market Scenario (2024 – 2031F)

Market demand is expected to increase significantly over the forecast period due to the rise in the number of organ transplantations. Advancements in bioinformatics and nanopore technology are expected to enhance the efficiency, speed, and reliability of HLA genotyping, revolutionizing their clinical applications and immunogenetics.

The increasing autoimmune diseases incidences are bolstering the requirement for HLA typing, as it can provide insights about various risks of autoimmune diseases and guide the development of prophylactic interventions for reducing the risks in individuals that are susceptible to the disease.

The growing efforts of the key market players towards the development of novel technologies and products is another major factor expected to boost the growth of the market in the coming years.

Key Players Landscape and Outlook

The rising efforts of the key players of the market towards the development of novel products and technologies and increasing receival of approvals from various regulatory bodies are supporting the global HLA typing market growth. These efforts and approvals aid healthcare professionals in accurately diagnosing various diseases and disorders and support the introduction of new products to meet the evolving requirements of the healthcare industry.

In December 2022, Thermo Fisher Scientific Inc. announced that they received De Novo Classification from the US Food and Drug Administration (FDA) for their SeCore CDx HLA Sequencing System, the system allows clinicians to identify patients that will benefit from this immunotherapy breakthrough. The company plans on partnering with leading companies for commercializing and developing immunotherapies for meeting the unmet requirements of patients for a wide range of diseases.