HLA Typing Market Size & Share Analysis - Growth Trends & Forecasts (2025 - 2030)

The HLA Typing Market Report is Segmented by Product & Service (Instruments, and More), Technology (Molecular Assays and Non-Molecular/Serological), Application (Diagnostic and Research), End User (Hospitals & Transplant Centers, and More), Geography (North America, Europe, Asia-Pacific, The Middle East and Africa, and South America). The Market Forecasts are Provided in Terms of Value (USD).

HLA Typing Market Size and Share

Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0.

Compare market size and growth of HLA Typing Market with other markets in Healthcare Industry

HLA Typing Market Analysis by Mordor Intelligence

The HLA typing market stands at USD 0.80 billion in 2025 and is projected to reach USD 1.14 billion by 2030, reflecting a 7.15% CAGR. Record organ-transplant volumes, the mainstreaming of precision medicine, and a rapid move from serological kits to next-generation sequencing platforms underpin this trajectory. High-throughput molecular assays reduce turnaround times and improve match accuracy, encouraging their uptake among transplant programs. Venture investment and acquisitions signal rising confidence, while policy shifts such as the Medicare IOTA Model reward precise HLA matching through performance-based hospital payments[1]Federal Register, “Kidney Transplant Payment Model (IOTA),” federalregister.gov. At the same time, donor-registry interoperability and cloud bioinformatics expand global testing reach, especially for ethnically diverse populations that struggle to find matches. Cost pressures remain a constraint in low-resource settings, yet tiered product portfolios and pooled-service laboratories are lowering access barriers.

Key Report Takeaways

  • By product, reagents and consumables led with 72.89% revenue share in 2024; software and services are forecast to expand at a 9.56% CAGR through 2030.
  • By technology, molecular assays held 58.45% of revenue in 2024, while non-molecular serological methods are advancing at an 8.77% CAGR.
  • By application, diagnostic testing accounted for 68.54% of total demand in 2024, whereas research use is set to grow at a 10.32% CAGR.
  • By end user, commercial service providers captured 46.67% of the HLA typing market share in 2024, while research and academic laboratories are projected to register a 10.45% CAGR to 2030.
  • By geography, North America retained 44.56% revenue share in 2024, though Asia-Pacific is on track to post an 8.76% CAGR to 2030.

Segment Analysis

By Product & Service: Consumables Dominance Meets Software Acceleration

Reagents and consumables retained 72.89% revenue share in 2024 as every test run consumes locus-specific primers, enzymes, and sequencing reagents. The HLA typing market size for consumables is on course to expand steadily alongside global test-volume growth. Software and services, though smaller, are rising at a 9.56% CAGR as laboratories prioritize data-interpretation tools that resolve ambiguous calls and automate report generation.

Demand patterns underline a pivot from data generation to data insight. Cloud-hosted analytics now allow small-volume sites to upload raw reads and receive curated allele calls within hours. Commercial providers bundle wet-lab reagents with subscription software, transforming revenue into recurring streams. Integrated service packages, from sample logistics to interpretive support, appeal to hospitals that lack in-house specialists. Instruments remain essential as enablers, yet vendors increasingly offer reagent-rental schemes that shift capital costs into operating budgets, broadening entry points for new laboratories.

Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0.

Note: Segment shares of all individual segments available upon report purchase

By Technology: Molecular Methods Lead Despite Serological Resurgence

Molecular assays captured 58.45% of revenue in 2024, cementing their status as the performance benchmark for transplant programs. Rapid turnaround and allele-level precision elevate their use in time-critical kidney and heart allocations, keeping the HLA typing market on a high-accuracy trajectory.

Serological tests, however, post an 8.77% CAGR as budget-sensitive facilities in emerging economies weigh affordability over resolution. Hybrid models are gaining ground, where a serology screen triages samples needing deeper molecular follow-up. The FDA’s 2024 Laboratory Developed Test rule exempted certain transplant assays from added oversight, incentivizing continued innovation without prolonged regulatory drag. Sequencing costs are trending lower, yet reagent reuse and simplified workflows must continue to narrow the cost gap to accelerate molecular dominance.

By Application: Diagnostic Leadership Challenged by Research Expansion

Diagnostic use commanded 68.54% of total tests in 2024 as transplantation and transfusion safety demands remain non-negotiable. The HLA typing market size for diagnostic services is projected to grow in line with rising organ-failure incidence and improved insurance coverage.

Research applications are advancing at a 10.32% CAGR, driven by immunotherapy development where HLA presentation dictates drug efficacy. The FDA clearance of Thermo Fisher’s SeCore CDx HLA A Sequencing System as a companion diagnostic in synovial sarcoma validates the role of HLA typing in oncology. Biobanks now mandate HLA profiles for stored specimens to enable future retrospective analyses. Pharmaceutical pipelines increasingly include peptide-based vaccines that require precise HLA target mapping, expanding research demand beyond academic centers.

HLA Typing Market
Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0.

Note: Segment shares of all individual segments available upon report purchase

By End User: Commercial Providers Lead Academic Acceleration

Commercial service providers held 46.67% revenue share in 2024, reflecting economies of scale in centralized testing models. Outsourcing relieves hospitals of capital and staffing burdens, and bundled post-transplant monitoring further locks in client relationships.

Research and academic laboratories are growing at 10.45% CAGR, buoyed by grant funding and lower-cost benchtop sequencers. The HLA typing market share of these labs is expected to rise as campus-based precision-medicine initiatives internalize genotyping to safeguard data sovereignty. Hospital labs maintain steady volumes for urgent pre-transplant typing, while blood banks adopt HLA screening to prevent platelet transfusion refractoriness. Donor registries increasingly perform their own high-throughput typing to speed listing readiness.

Geography Analysis

North America led with 44.56% revenue share in 2024 thanks to mature transplant networks, more than 250 accredited hospitals, and comprehensive insurance reimbursement. Ongoing OPTN modernization injects advanced matching algorithms and funds laboratory upgrades, keeping adoption momentum high. Workforce shortages and budget scrutiny temper equipment purchase cycles, yet performance-linked payment models provide a counterbalancing pull toward precise typing.

Asia-Pacific is the fastest growing region at an 8.76% CAGR toward 2030. Government investment, rising chronic-disease prevalence, and donor-registry expansions underpin demand. China scales nationwide organ-sharing platforms, Japan leverages biotechnology depth, and India widens access through public-private transplant centers. Cost sensitivity drives uptake of mixed serology-molecular workflows, yet falling sequencing costs and cloud analytics are closing the affordability gap.

Europe shows steady expansion anchored in stringent quality standards and cross-border organ-sharing frameworks such as Eurotransplant. High proficiency-testing compliance drives laboratories toward high-resolution assays. Economic headwinds in certain member states delay top-tier instrumentation purchases, encouraging vendors to roll out reagent-rental and pay-per-use models. Regional participation in WHO’s global transplant strategy positions European expertise as a technical support hub for developing regions.

HLA Typing Market
Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0.

Competitive Landscape

Competition is moderate, with the top tier comprising Thermo Fisher Scientific, Bio-Rad Laboratories, and CareDx. Each company orchestrates a full-stack offering that blends instruments, consumables, and informatics into turnkey solutions. Strategic consolidation continues; Werfen acquired Omixon for USD 25 million in 2024 to marry its transfusion-diagnostics reach with next-generation sequencing depth. Illumina purchased Conexio Genomics to couple its hardware with specialized HLA software that accelerates allele calling.

Technology roadmaps prioritize automation and AI-driven analytics to relieve staffing bottlenecks. Bio-Rad’s collaboration with Oncocyte couples droplet digital PCR with cell-free DNA monitoring, broadening post-transplant surveillance applications. Cloud-based platforms lower entry barriers for small labs and expand total addressable volume. White-space opportunities include affordable sequencers for emerging markets and turnkey bioinformatics pipelines that minimize IT overhead. Regulatory clarity after the 2024 Laboratory Developed Test rule rewards incumbents with compliance infrastructure yet opens windows for nimble entrants.

HLA Typing Industry Leaders

  1. Thermo Fisher Scientific Inc.

  2. Bio-Rad Laboratories Inc.

  3. Qiagen N.V.

  4. Caredx Inc.

  5. Illumina Inc.

  6. *Disclaimer: Major Players sorted in no particular order
HLA Typing Market
Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0.
Need More Details on Market Players and Competitors?
Download PDF

Recent Industry Developments

  • February 2025: Roche launched sequencing by expansion, slashing run time while boosting accuracy for HLA typing.
  • January 2025: FDA issued draft donor-eligibility guidance that updates screening requirements impacting typing workflows.
  • December 2024: Medicare IOTA Model finalized, linking transplant payments to HLA match quality.
  • October 2024: CareDx partnered with Dovetail Genomics to integrate Hi-C-based haplotyping into AlloSeq Tx 17.
  • August 2024: QIAGEN broadened its AstraZeneca collaboration to co-develop companion diagnostics on QIAstat-Dx.

Table of Contents for HLA Typing Industry Report

1. Introduction

  • 1.1 Study Assumptions & Market Definition
  • 1.2 Scope Of The Study

2. Research Methodology

3. Executive Summary

4. Market Landscape

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Rising Incidence of Chronic Diseases Necessitating Transplantation
    • 4.2.2 Technological Advancements in High-Throughput Genotyping
    • 4.2.3 Increasing Healthcare Expenditure and Insurance Coverage
    • 4.2.4 Expansion of Global Donor Registries and Biobank Networks
    • 4.2.5 Growing Adoption of Personalized and Precision Medicine
    • 4.2.6 Supportive Government Policies for Transplant Safety and Efficacy
  • 4.3 Market Restraints
    • 4.3.1 High Cost of Next-Generation HLA Typing Platforms
    • 4.3.2 Shortage of Skilled Laboratory And Bioinformatics Personnel
    • 4.3.3 Stringent and Divergent Regulatory Approval Pathways
    • 4.3.4 Limited Testing Accessibility in Low-Resource Settings
  • 4.4 Regulatory Landscape
  • 4.5 Porter's Five Forces Analysis
    • 4.5.1 Threat Of New Entrants
    • 4.5.2 Bargaining Power Of Buyers
    • 4.5.3 Bargaining Power Of Suppliers
    • 4.5.4 Threat Of Substitute Products
    • 4.5.5 Intensity Of Competitive Rivalry

5. Market Size & Growth Forecasts (Value, USD)

  • 5.1 By Product & Service
    • 5.1.1 Instruments
    • 5.1.2 Reagents & Consumables
    • 5.1.3 Software & Services
  • 5.2 By Technology
    • 5.2.1 Molecular Assays
    • 5.2.2 Non-Molecular / Serological
  • 5.3 By Application
    • 5.3.1 Diagnostic
    • 5.3.2 Research
  • 5.4 By End User
    • 5.4.1 Hospitals & Transplant Centers
    • 5.4.2 Commercial Service Providers
    • 5.4.3 Research & Academic Laboratories
    • 5.4.4 Blood Banks & Donor Registries
  • 5.5 Geography
    • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
    • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
    • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
    • 5.5.4 Middle East & Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East & Africa
    • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6. Competitive Landscape

  • 6.1 Market Concentration
  • 6.2 Market Share Analysis
  • 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Business Segments, Financials, Headcount, Key Information, Market Rank, Market Share, Products and Services, and analysis of Recent Developments)
    • 6.3.1 Thermo Fisher Scientific Inc.
    • 6.3.2 Bio-Rad Laboratories Inc.
    • 6.3.3 Qiagen N.V.
    • 6.3.4 Caredx Inc.
    • 6.3.5 Illumina Inc.
    • 6.3.6 Becton, Dickinson And Company
    • 6.3.7 F. Hoffmann-La Roche Ltd.
    • 6.3.8 Gendx B.V.
    • 6.3.9 Omixon Inc.
    • 6.3.10 Takara Bio Inc.
    • 6.3.11 Tbg Diagnostics Ltd.
    • 6.3.12 Biofortuna Ltd.
    • 6.3.13 Immucor Inc.
    • 6.3.14 Histogenetics Llc
    • 6.3.15 Oxford Nanopore Technologies Plc
    • 6.3.16 Agilent Technologies
    • 6.3.17 Pacific Biosciences Of California
    • 6.3.18 Beckman Coulter Life Sciences
    • 6.3.19 Bionano Genomics
    • 6.3.20 Eurofins Genomics

7. Market Opportunities & Future Outlook

  • 7.1 White-Space & Unmet-Need Assessment
You Can Purchase Parts Of This Report. Check Out Prices For Specific Sections
Get Price Break-up Now

Global HLA Typing Market Report Scope

HLA typing is referred to as genetic testing that identifies variations in the immune system of the body. This test is used to match patients and donors for bone marrow or cord blood transplants. HLA typing is used is to find out which people will be able to provide the safest tissue transplant. The HLA Typing Market is segmented By Product Type (Instruments, Reagents and Consumables, and Software and Services), Application (Diagnosis, Research) End User (Hospitals, Research Laboratories, Other End Users), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions, globally. The report offers the value (in USD million) for the above segments.

By Product & Service Instruments
Reagents & Consumables
Software & Services
By Technology Molecular Assays
Non-Molecular / Serological
By Application Diagnostic
Research
By End User Hospitals & Transplant Centers
Commercial Service Providers
Research & Academic Laboratories
Blood Banks & Donor Registries
Geography North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East & Africa GCC
South Africa
Rest of Middle East & Africa
South America Brazil
Argentina
Rest of South America
By Product & Service
Instruments
Reagents & Consumables
Software & Services
By Technology
Molecular Assays
Non-Molecular / Serological
By Application
Diagnostic
Research
By End User
Hospitals & Transplant Centers
Commercial Service Providers
Research & Academic Laboratories
Blood Banks & Donor Registries
Geography
North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East & Africa GCC
South Africa
Rest of Middle East & Africa
South America Brazil
Argentina
Rest of South America
Need A Different Region or Segment?
Customize Now

Key Questions Answered in the Report

What is the current value of the HLA typing market?

The market is valued at USD 0.80 billion in 2025 and is projected to reach USD 1.14 billion by 2030.

Which product category generates the most revenue?

Reagents and consumables account for 72.89% of 2024 revenue due to their recurrent use in every test run.

Why is Asia-Pacific the fastest-growing region?

Rising chronic disease prevalence, government investment in transplant capacity, and expanding donor registries support an 8.76% CAGR through 2030.

How are next-generation sequencing platforms influencing the market?

They provide higher allele resolution and faster turnaround times, enabling real-time donor-recipient matching and driving laboratory upgrades.

What are key restraints on market growth?

High capital costs for advanced platforms and shortages of skilled laboratory and bioinformatics personnel remain the primary hurdles.

Which companies lead the competitive landscape?

Thermo Fisher Scientific, Bio-Rad Laboratories, and CareDx are among the leading players, with recent consolidation moves by Werfen and Illumina strengthening market positions.

HLA Typing Market Report Snapshots