HLA Typing Market

Market Definition

HLA (Human Leukocyte Antigen) typing, is a molecular diagnostic technique used to identify specific HLA genes vital for immune response regulation. The market involves the development and commercialization of technologies and services for accurate tissue matching in organ transplantation, disease association studies, and vaccine development. 

It plays a crucial role in hematopoietic stem cell transplants, autoimmune disease research, and personalized medicine advancements across clinical and research settings.

HLA Typing Market Overview

The global HLA typing market size was valued at USD 1,243.1 million in 2024 and is projected to grow from USD 1,307.5 million in 2025 to USD 1,958.8 million by 2032, exhibiting a CAGR of 5.95% during the forecast period. 

The market is growing, due to the rising prevalence of autoimmune diseases and increased awareness of genetic matching for early diagnosis and personalized treatment. Additionally, technological advancements are driving the demand for faster, high-resolution sequencing solutions that enhance laboratory efficiency and support real-time clinical analysis.

Major companies operating in the HLA typing industry are BD, Thermo Fisher Scientific Inc, Bio-Rad LaboratoriesInc., Bruker, F. Hoffmann-La Roche Ltd, BAG Diagnostics GmbH, Creative Biolabs, Fujirebio, GenDx, HistoGenetics LLC, Hansa Biopharma, Illumina, Inc., inno-train Diagnostik GmbH, Immucor, Inc., and PacBio.

The market is expanding, due to the rising number of organ transplants globally, supported by consistent year-over-year growth in deceased and living donors. Increasing transplant volumes across major organs such as liver, lung, kidney, and heart drive the demand for accurate HLA matching to ensure graft survival and reduce rejection rates. 

The need for reliable and rapid HLA typing solutions becomes critical to support clinical decision-making and improve patient outcomes in transplant procedures as transplant programs scale up globally.

• In January 2024, the Organ Procurement and Transplantation Network reported over 16,000 deceased organ donors and more than 46,000 organ transplants, marking record highs. Milestones included over 10,000 liver transplants, 3,000 lung transplants, and new records for kidney and heart transplants. A 9.6% rise in deceased donors highlights sustained growth in U.S. transplant and donation activity.

Key Highlights:

1. The HLA typing industry size was valued at USD 1,243.1 million in 2024.
2. The market is projected to grow at a CAGR of 5.95% from 2025 to 2032.
3. North America held a market share of 42.02% in 2024, with a valuation of USD 522.3 million.
4. The PCR-based segment garnered USD 770.7 million in revenue in 2024.
5. The reagents & consumables segment is expected to reach USD 881.2 million by 2032.
6. The transplantation segment is estimated to grow at a share of 59.20% by 2024.
7. The hospitals segment held a market share of 44.94% in 2032.
8. The market in Asia Pacific is anticipated to grow at a CAGR of 6.35% during the forecast period.

Market Driver

Growing Prevalence of Autoimmune Diseases

The HLA typing market is driven by the growing prevalence of autoimmune diseases worldwide. Increasing incidence of conditions such as rheumatoid arthritis, multiple sclerosis, and type 1 diabetes is boosting the demand for precise HLA typing to support early diagnosis and personalized treatment. 

Rising awareness among healthcare providers and patients about the importance of genetic matching in disease management further accelerates the market growth. This expanding patient population and enhanced focus on improving clinical outcomes are fueling the market.

• In March 2025, the Sjögren’s Foundation reported that over 50 million Americans (8% of the U.S. population) are affected by autoimmune diseases, with global incidence rising 19.1% annually. Women comprise 80% of cases, linked to X chromosome genes regulating immune response. Studies indicate elevated Sjögren’s prevalence in individuals with extra X chromosomes, underscoring genetic influence in disease progression.

Market Challenge

Sample Quality and Handling Issues

The HLA typing market faces a significant challenge related to sample quality and handling, as the accuracy of typing depends on the integrity of DNA samples. Improper collection, transportation, or storage can lead to contamination or degradation, resulting in unreliable results and delays in transplant procedures.

Companies are investing in robust sample preservation kits, automated extraction systems, and standardized protocols that minimize human error. Additionally, real-time monitoring solutions and quality control checks are being integrated into laboratory workflows to ensure consistent sample integrity. These innovations aim to enhance reliability, reduce re-testing rates, and support high-confidence clinical decisions.

Market Trend

Technological Advancements in HLA Typing

The HLA typing market is registering the trend of technological advancements, with a focus on faster, high-resolution, and whole-gene sequencing solutions. Innovations now enable complete HLA typing within hours, significantly improving laboratory workflow efficiency. 

New platforms integrate rapid amplification and streamlined preparation processes, supporting real-time analysis. This shift reflects the growing demand for precision tools in transplantation and research, encouraging continued development of compact, automated, and sequencing-based systems tailored to time-sensitive clinical environments.

• In October 2023, GenDx launched NGS-Turbo, a next-generation HLA typing solution optimized for Oxford Nanopore Technologies platforms. Designed for high-speed and high-resolution results, it delivers complete HLA typing in as little as three hours. The workflow includes NGS-TurboAmp for 90-minute amplification of 11 HLA loci and NGS-TurboPrep, enhancing efficiency and precision in transplantation diagnostics.

HLA Typing Market Report Snapshot

Segmentation	Details
By Technology	PCR-Based, Next-Generation Sequencing (NGS), Sanger Sequencing
By Product & Service	Reagents & Consumables, Instruments, Software & Services
By Application	Transplantation, Disease Diagnostics, Research
By End-user	Hospitals, Diagnostic Centers, Research & Academic Institutes
By Region	North America: U.S., Canada, Mexico
	Europe: France, UK, Spain, Germany, Italy, Russia, Rest of Europe
	Asia-Pacific: China, Japan, India, Australia, ASEAN, South Korea, Rest of Asia-Pacific
	Middle East & Africa: Turkey, U.A.E., Saudi Arabia, South Africa, Rest of Middle East & Africa
	South America: Brazil, Argentina, Rest of South America

Market Segmentation:

• By Technology (PCR-Based, Next-Generation Sequencing (NGS), and Sanger Sequencing): The PCR-based segment earned USD 770.7 million in 2024, due to its widespread adoption in clinical settings for its cost-effectiveness, rapid turnaround time, and established reliability in HLA typing.
• By Product & Service (Reagents & Consumables, Instruments, and Software & Services): The reagents & consumables segment held 48.70% share of the market in 2024, due to their recurring demand in routine HLA testing and the growing volume of diagnostic procedures across laboratories.
• By Application (Transplantation, Disease Diagnostics, and Research): The transplantation segment is projected to reach USD 1030.9 million by 2032, due to the increasing number of organ and stem cell transplants and the critical need for precise HLA matching to ensure graft compatibility.
• By End-user (Hospitals, Diagnostic Centers, and Research & Academic Institutes): The hospitals segment held a market share of 44.94% in 2032, due to the high volume of transplant procedures conducted in hospital settings and the integration of in-house HLA typing capabilities for timely donor-recipient matching.

HLA Typing Market Regional Analysis

Based on region, the market has been classified into North America, Europe, Asia Pacific, Middle East & Africa, and South America.

North America HLA typing market share stood at around 42.02% in 2024, with a valuation of USD 522.3 million. This dominance is attributed to its advanced healthcare infrastructure that enables sophisticated diagnostic testing and transplantation. Strong government regulations and substantial funding support the widespread use of innovative HLA typing technologies. 

Moreover, the region hosts many top biotechnology companies and research institutions, driving continuous innovation and market growth. Together, these factors create a strong environment for high-volume testing and the development of precise HLA typing solutions, securing North America’s dominant position in the market.

The HLA typing industry in Asia Pacific is poised for significant growth at a robust CAGR of 6.35% over the forecast period. The market in Asia Pacific is primarily driven by the rising prevalence of chronic and genetic disorders, which increases the demand for precise tissue matching in transplantation and disease diagnosis. 

Additionally, growing government support through funding and favorable regulatory frameworks encourages research and adoption of advanced HLA typing technologies. These factors collectively enhance market expansion by improving access to accurate diagnostic tools and enabling better clinical outcomes across the region.

Regulatory Frameworks

• In the U.S., HLA typing for solid organ transplants is regulated by the Organ Procurement and Transplantation Network (OPTN), which sets standards for required antigens and testing methods. It mandates HLA typing for deceased donors, especially in kidney and pancreas transplants, to ensure compatibility.
• In India, HLA typing for organ and bone marrow transplants is regulated by the Marrow Donor Registry India (MDR(I)), which sets laboratory standards, defines minimum donor matching criteria, and relies on transplant outcome research to guide its protocols.

Competitive Landscape

Key players in the HLA typing industry are actively pursuing strategies such as mergers and acquisitions, partnerships, and collaborations to strengthen their market position. Companies are also focusing on launching innovative products and expanding their portfolios to address diverse clinical needs. 

Investment in research and development continues to accelerate, with firms introducing advanced technologies and high-throughput platforms. These strategic actions aim to enhance market reach, improve service offerings, and capitalize on emerging opportunities.

• In September 2023, Omixon launched NanoTYPE MONO and MONOall kits for HLA laboratories, providing high-resolution single locus assays. These kits integrate seamlessly into daily workflows and support multiple functions such as sample confirmation, repetition, and genetic marker evaluation, enhancing accuracy and efficiency in HLA typing processes.

List of Key Companies in HLA Typing Market:

• BD
• Thermo Fisher Scientific Inc
• Bio-Rad Laboratories, Inc
• Bruker
• Hoffmann-La Roche Ltd
• BAG Diagnostics GmbH
• Creative Biolabs
• Fujirebio
• GenDx
• HistoGenetics LLC
• Hansa Biopharma
• Illumina, Inc.
• inno-train Diagnostik GmbH
• Immucor, Inc.
• PacBio

Recent Developments

• In October 2024, CareDx showcased the latest advancements in its HLA typing solutions at the American Society for Histocompatibility and Immunogenetics meeting. The portfolio highlights AlloSeq NGS-based typing for living organ and bone marrow transplants, alongside the enhanced QTYPE solution featuring single bead antigen resolution, enabling faster virtual crossmatching and refining transplant decisions of deceased donors.