HLA Typing Market – Global Industry Size, Share, Trends, Opportunity, & Forecast, Segmented By Technique (Molecular Assay, Sequenced-based Molecular Assay, Non-Molecular Assay), By Application (Diagnosis, Research), By Product (Instruments, Reagents & Consumables, Software & Services), By End User (Commercial Service Providers, Hospitals and Transplant Centers, Research Labs & Academic Institutes), By Region and Competition, 2020-2030F

Market Overview

The Global HLA Typing Market, valued at USD 1.92 Billion in 2024, is projected to experience a CAGR of 6.50% to reach USD 2.80 Billion by 2030. Human Leukocyte Antigen (HLA) typing constitutes the process of identifying specific HLA alleles or groups of alleles to determine compatibility between donors and recipients in transplantation procedures and for assessing disease predisposition. The market’s expansion is primarily supported by the increasing global demand for organ and hematopoietic stem cell transplantation, coupled with continuous advancements in molecular diagnostic techniques that enhance the precision and efficiency of HLA analysis. Additionally, the growing prevalence of autoimmune and other genetic disorders necessitating detailed immunogenetic profiling contributes to market growth.

According to the World Health Organization and the Organización Nacional de Trasplantes (WHO-ONT), 172,397 solid organ transplants were performed worldwide in 2023, representing a 9.5% increase over 2022. Moreover, the World Marrow Donor Association reported that its members facilitated over 24,000 unrelated transplants in 2023, each requiring comprehensive HLA matching. A substantial challenge for market development lies in the significant capital investment required for adopting advanced, high-resolution HLA typing technologies and maintaining the specialized infrastructure essential for their operation.

Key Market Drivers

The increasing demand for organ and stem cell transplantation significantly drives the global Human Leukocyte Antigen typing market. As the number of patients requiring life-saving transplants grows, the critical need for precise HLA matching intensifies to prevent graft rejection and improve patient outcomes. This necessitates extensive HLA typing services for both recipients and an expanding donor pool. According to the World Marrow Donor Association, at the end of 2023, 44.1 million potential stem cell donors were registered, marking a 3.3% increase from 2022. This expanding registry directly fuels demand for efficient and accurate HLA assessment. Concurrently, advancements in molecular HLA typing technologies represent another pivotal factor shaping market growth. Innovations in techniques such as Next Generation Sequencing offer enhanced resolution and speed, providing more detailed and rapid HLA profiles for complex matching scenarios. These technological strides improve donor-recipient pairing and broaden accessibility. According to Metropolis Healthcare Limited, in April 2023, they introduced the 'NextGen HLA' High Resolution Typing Test, a molecular diagnostic tool for hematopoietic stem cell and solid organ transplantation. Such developments highlight the ongoing evolution of typing capabilities.

These foundational drivers are bolstered by consistent national and international efforts to expand donor networks and enhance transplant accessibility. For instance, according to La Moncloa, in 2023, Spain's Bone Marrow Donor Registry (REDMO) added 23,686 new donors, representing an 8% increase over the prior year. Such sustained growth in donor registrations globally underscores the continuous requirement for sophisticated HLA typing solutions to facilitate successful transplant procedures.

Download Free Sample Report

Key Market Challenges

A substantial challenge for market development lies in the significant capital investment required for adopting advanced, high-resolution Human Leukocyte Antigen (HLA) typing technologies and maintaining the specialized infrastructure essential for their operation. This substantial financial outlay directly hampers the expansion of the global HLA typing market by creating considerable barriers to entry and upgrade for many laboratories. Establishing and equipping facilities with next-generation sequencing platforms and the necessary bioinformatics capabilities demands considerable upfront capital, which smaller institutions or those in regions with limited healthcare budgets often cannot afford.

This financial constraint restricts the widespread deployment of advanced HLA typing methods, consequently limiting the number of laboratories capable of offering comprehensive, high-resolution analysis. For instance, according to the European Federation for Immunogenetics (EFI), as of October 31, 2024, only 276 laboratories had been granted accreditation across Europe. This limited number of accredited facilities underscores the difficulty in meeting the rigorous standards and investing in the requisite sophisticated equipment and infrastructure. Such an environment slows the overall market penetration of innovative HLA typing solutions, despite their recognized clinical benefits.

Key Market Trends

Two prominent trends are shaping the Global HLA Typing Market. The widespread adoption of laboratory automation and high-throughput systems represents a significant shift in operational efficiency. This trend addresses the increasing demand for rapid and precise HLA typing by streamlining complex workflows and reducing manual intervention. Automation enables laboratories to process a larger volume of samples with improved consistency, which is crucial for managing extensive donor registries and urgent transplant cases. Supporting the ongoing evolution in laboratory practices, the American Society for Histocompatibility and Immunogenetics (ASHI) indicated in its October 2023 report that approximately 75% of its educational modules were reviewed, updated, or newly written between 2021 and 2023, reflecting a continuous effort by the association to keep its members abreast of modern methodologies and efficient practices. Further illustrating this trend, Thermo Fisher Scientific launched its One Lambda HybriType HLA Plus Typing Flex kit in April 2025, significantly reducing total workflow time to under 5.5 hours and hands-on time to less than 2.5 hours, making it highly suitable for high-throughput environments.

Another key trend involves the expanding clinical applications of HLA typing beyond traditional transplant matching. Immunogenetic profiling is increasingly utilized for disease predisposition, pharmacogenomics, and in the diagnosis and management of autoimmune and infectious diseases. This diversification broadens the market's scope and creates new revenue streams. The American Society for Histocompatibility and Immunogenetics (ASHI) supports this expansion, as evidenced by its June 2024 announcement of the Early Career Investigator Award, which offers up to $40,000 for research in disciplines such as transplantation, cancer, autoimmunity, infectious disease, and pharmacogenomics. This demonstrates an institutional commitment to exploring new utilities for HLA typing. Additionally, in October 2025, RheumaGen announced an oral presentation at the American College of Rheumatology Convergence 2025 on its HLA gene-editing preclinical data for a lead autoimmune disease program, highlighting advancing research in therapeutic applications leveraging HLA.

Segmental Insights

In the Global HLA Typing Market, the Molecular Assay segment is experiencing rapid growth, primarily driven by its superior accuracy and resolution in identifying human leukocyte antigen alleles. These advanced techniques, particularly next-generation sequencing, directly analyze DNA to provide high-resolution typing down to the allele level, offering a precise basis for critical clinical applications such as organ transplantation and disease association studies. The heightened sensitivity and specificity of molecular assays, coupled with their ability to deliver faster turnaround times and higher throughput, facilitate broader adoption in transplant centers and donor registries. This shift from traditional serological methods towards more robust gene-based diagnostics, further supported by regulatory frameworks like the U. S. Food and Drug Administration's classification of HLA typing companion diagnostic tests, underpins the segment's accelerated expansion.

Regional Insights

North America leads the Global HLA Typing Market due to its advanced healthcare infrastructure and substantial volume of organ and stem cell transplantation procedures. The region benefits from early and widespread adoption of advanced molecular diagnostic technologies, including next-generation sequencing, critical for precise tissue matching. Furthermore, North America exhibits robust government and regulatory support for transplant programs and related research, exemplified by institutions such as the National Marrow Donor Program (NMDP) and funding from agencies like the Health Resources and Services Administration (HRSA). The presence of numerous leading diagnostic firms and prominent research institutions also drives continuous innovation and market expansion.

Recent Developments

• In July 2025, QIAGEN introduced its QIAseq xHYB Long Read Panels, expanding the company's next-generation sequencing (NGS) portfolio. These panels were developed to support various applications, including Human Leukocyte Antigen (HLA) typing, repeat expansion analysis, and the detection of structural variants. The new offering aimed to address challenges often encountered with short-read sequencing in these complex genomic areas. This launch was positioned as a significant milestone in QIAGEN's genomics strategy, reflecting its commitment to advancing immune profiling, complex disease genetics, and cancer biology research through innovative solutions.

• In March 2025, Thermo Fisher Scientific introduced the One Lambda HybriType™ HLA Plus Typing Flex kit to advance immunogenetics research. This new next-generation sequencing (NGS) hybrid capture assay featured a probe-based design that optimized read balance and uniformity, which aimed to mitigate allele dropout. The HybriType assay provided flexibility in testing configuration and coverage, supporting Human Leukocyte Antigen (HLA) Class I and Class II genotyping analysis across various sample types. The streamlined workflow allowed for rapid automated analysis with high concordance, enhancing the understanding of the major histocompatibility complex (MHC) for clinical and research applications.

• In October 2024, CareDx presented its latest advancements across its Human Leukocyte Antigen (HLA) typing solutions at an industry meeting. The company launched an improved QTYPE® solution, which incorporated single bead antigen resolution to facilitate virtual crossmatching in deceased donor typing. This enhancement aimed for faster transplant decisions. Furthermore, CareDx highlighted new data and product enhancements to its AlloSeq™ NGS-based HLA typing solutions, demonstrating their clinical utility in living organ donation typing and bone marrow transplantation, reinforcing the commitment to advanced pre-transplant matching.

• In August 2024, Thermo Fisher Scientific announced that its SeCore™ CDx HLA A Sequencing System received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This regulatory approval allowed the system to be used as a companion diagnostic with TECELRA® (afamitresgene autoleucel), a T-cell receptor therapy by Adaptimmune. The clearance specifically enabled clinicians to identify adult patients with unresectable or metastatic synovial sarcoma, who were HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive, for this specialized treatment, thereby expanding access to breakthrough therapies.

Key Market Players

• Thermo Fisher Scientific Inc.
• Bio-Rad Laboratories Inc.
• Qiagen LLC
• Omixon Inc.
• GenDx Products Inc.
• Illumina Inc.
• TBG Diagnostics Limited
• Becton, Dickinson and Company
• Takara Bio USA, Inc.
• F. Hoffman-La Roche Limited

Report Scope:

In this report, the Global HLA Typing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• HLA Typing Market, By Technique:

o   Molecular Assay

o   Sequenced-based Molecular Assay

o   Non-Molecular Assay

• HLA Typing Market, By Application:

o   Diagnosis

o   Research

• HLA Typing Market, By Product:

o   Instruments

o   Reagents & Consumables

o   Software & Services

• HLA Typing Market, By End User:

o   Commercial Service Providers

o   Hospitals and Transplant Centers

o   Research Labs & Academic Institutes

• HLA Typing Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global HLA Typing Market.

Available Customizations:

Global HLA Typing Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Global HLA Typing Market is an upcoming report to be released soon. If you wish an early delivery of this report or want to confirm the date of release, please contact us at [email protected]