The HLA typing market is projected to grow at a CAGR of ~6% over the forecast period. Major factors driving the growth include the rising demand for organ transplantation, advancements in molecular diagnostic (NGS and PCR-based) technologies, growing applications of HLA typing in infectious disease research, increasing cases of stem cell and bone marrow transplants, growing prevalence of autoimmune diseases and cancers, and increasing awareness and enhanced organ donation rates globally.
Human leukocyte antigen (HLA) testing, also known as HLA typing or tissue typing, is a genetic test that detects antigens on the surface of cells and tissues. Its primary purpose is to ensure compatibility between organ and tissue transplant recipients and potential donors. Additionally, HLA testing helps screen transplant recipients for antibodies that could trigger an immune response against the donated organ or tissue, increasing the risk of transplant rejection. The number of detected antibodies influences the likelihood of transplant success. Different types of transplants require varying degrees of donor-recipient matching, which determines the specific HLA tests and genes analyzed.
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Advancements in molecular diagnostics technologies increase HLA typing adoption
Since the advent of polymerase chain reaction (PCR), DNA-based methods have become the dominant approach in HLA typing laboratories, offering high precision, reproducibility, sensitivity, and resolution. Key DNA-based techniques include PCR-sequence-specific primers (SSP), PCR-sequence-specific oligonucleotide (SSO), real-time PCR, sequencing-based typing (SBT), and next-generation sequencing (NGS).
Among these, NGS also known as high-throughput sequencing is increasingly emerging as the preferred HLA typing method due to its accuracy, high throughput, and speed. A major advantage of NGS is its ability to resolve ambiguities at a cost comparable to SBT, eliminating the need for additional screenings. The NGS process includes DNA library preparation, targeted gene amplification (via emulsion or solid-phase PCR), sequencing-based typing, and sequence alignment against databases such as the international ImMunoGeneTics project/human leukocyte antigen (IMGT/HLA) database. Additionally, advances in sequencing technologies and AI integration have further enhanced NGS accuracy, efficiency, automation, and portability. As diagnostics continue to evolve, the integration of qPCR and NGS is becoming essential to meet the rising demand for precision and personalized medicine, especially in oncology, where timely genetic insights can dramatically influence treatment choices.
Rising demand for organ transplantation drives market growth
The World Health Organization (WHO), the Global Observatory on Donation and Transplantation (GODT), and the OrganizaciΓ³n Nacional de Trasplantes (ONT) report a significant rise in global organ donation and transplantation activities. According to the 2023 International Report on Organ Donation and Transplantation, solid organ transplants increased by 9.5% in 2023 compared to 2022, reaching a total of 172,397 transplants worldwide. The increasing prevalence of end-stage organ failure, including kidney, liver, heart, and lung diseases, has significantly heightened the demand for organ transplants. Chronic conditions such as diabetes, hypertension, and cardiovascular diseases are leading contributors to kidney failure, driving the need for renal transplants. Likewise, liver transplants remain in high demand due to hepatitis, cirrhosis, and alcohol-related liver diseases.
As the number of patients in need of organ and tissue transplants continues to grow, precise donor-recipient matching has become increasingly essential for successful transplantation. HLA typing plays a critical role in determining compatibility, reducing rejection risks, and improving overall transplant success rates. By identifying the most suitable match, accurate HLA typing significantly lowers the likelihood of transplant rejection, especially in bone marrow, kidney, liver, and heart transplants. As demand for organ transplants surges, the need for high-precision HLA typing also rises, ensuring better patient outcomes and long-term survival.
Competitive Landscape Analysis
The global HLA typing market is marked by the presence of established and emerging market players such as Thermo Fisher Scientific Inc.; Bio-Rad Laboratories Inc.; Qiagen N.V.; Omixon Inc.; GenDx; Illumina Inc.; TBG Diagnostics Limited; Dickinson and Company; Takara Bio Inc.; F. Hoffman-La Roche Limited; Pacific Biosciences; Immucor, Inc.; and CareDx, Inc.; among others. Some of the key strategies adopted by market players include new product development, strategic partnerships and collaborations, and investments.
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Market Segmentation
This report by Medi-Tech Insights provides the size of the global HLA typing market at the regional and country levels from 2023 to 2030. The report further segments the market based on technology, product and service, application, and end user.
β’ Market Size & Forecast (2023-2030), By Technology, USD Million
o Molecular Assay
ο§ PCR
ο§ Next Generation Sequencing
o Non-Molecular Assay
β’ Market Size & Forecast (2023-2030), By Product & Service, USD Million
o Reagents & Consumables
o Instruments
o Software & Services
β’ Market Size & Forecast (2023-2030), By Application, USD Million
o Diagnostic Applications
ο§ Donor-Recipient Cross-Matching
ο§ Infectious Disease Testing
ο§ Cancer Diagnosis & Prevention
ο§ Transfusion Therapy
ο§ Other Diagnostic Applications
o Research Applications
β’ Market Size & Forecast (2023-2030), By End User, USD Million
o Commercial Service Providers
o Hospitals & Surgical Centers
o Research Laboratories & Academic Institutes
β’ Market Size & Forecast (2023-2030), By Region, USD Million
o North America
ο§ US
ο§ Canada
o Europe
ο§ UK
ο§ Germany
ο§ France
ο§ Italy
ο§ Spain
ο§ Rest of Europe
o Asia Pacific
ο§ China
ο§ India
ο§ Japan
ο§ Rest of Asia Pacific
o Latin America
o Middle East & Africa
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