HLA Typing Market: Growth, Size, Share, and Trends

Report Code MD 7576
Published in May, 2025, By MarketsandMarkets™
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HLA Typing Market by Technology (PCR (SSO, SSP, Real-time), Sequencing (NGS, Sanger's)), Product (Instruments, Reagents, Software), Application (Donor-recipient Cross-matching, Transfusion, Cancer), End User (Hospitals, Reference Labs) Global Forecasts to 2030

Overview

The global HLA typing market, valued at US$1.6 billion in 2024, stood at US$1.7 billion in 2025 and is projected to advance at a resilient CAGR of 6.0% from 2025 to 2030, culminating in a forecasted valuation of US$2.3 billion by the end of the period. The HLA typing market is driven by the increasing use of infectious diseases and the rate of patients suffering from end-stage organ failure. Transplantation procedures have been improved, increasing the number of people who could receive transplants and increasing the demand for accurate and reliable HLA typing even more. Rising public and private investments in transplantation and extensive awareness programs are stimulating more individuals to opt for organ donation and transplantation. Growing focus on individualized medicine, advancements in molecular diagnostics, and the increasing number of chronic conditions leading to organ failure are also contributing significantly towards propelling the market.

HLA Typing Market – Global Forecast and Key Opportunities to 2030

Attractive Opportunities in the HLA Typing Market

North America

The North American market is driven by a large and expanding patient population, the rising incidence of infectious diseases, and the growing number of public awareness initiatives promoting organ donations.

The growth of the HLA typing market is being propelled by the rising number of transplant procedures, fueled by advancements in technology.

Acquisitions, technological advancements, and growing public and private funding are driving the expansion of the HLA typing market.

The HLA typing market in the US is expanding at a CAGR of 7.5%.

The high cost of PCR and NGS software poses a limitation to the growth of the HLA typing market in Canada.

Global HLA Typing Market Dynamics

DRIVER: Increasing volume of organ transplant surgeries

Donor-recipient compatibility can be tested through HLA typing before a transplant to eliminate any chances of graft rejection arising from blood component mismatches. HLA typing can help avoid complications such as graft-versus-host (GVHD) disease and post-transplant lymphoproliferative diseases. The increasing number of transplantation procedures will directly support the demand for HLA typing and histocompatibility testing. Historical trends have shown a continuous increase in procedural volumes. In 2024, the United Network for Organ Sharing (UNOS), drawing on data from the Organ Procurement and Transplantation Network (OPTN), reported that 48,149 organ transplants were performed in the US. This achievement marks the first time the US has exceeded 48,000 transplants in a single year. On average, about 132 transplants were performed each day in 2024.

The growing geriatric population will boost the growth of the market, as elderly individuals are frequently referred for organ transplant procedures due to age or chronic ailment-related organ failure. Diseases such as tuberculosis, end-stage renal disease (ESRD), and liver cirrhosis are more common among seniors and may make it necessary for individuals to undergo organ or tissue transplants.

RESTRAINT: Inadequate reimbursement structure

Most HLA typing procedures and related medical diagnostics are priced at a premium, which, combined with limited reimbursement for surgeries like organ transplants, restricts their adoption among patients and healthcare providers. In the US, diagnostic tests such as HLA typing are reimbursed under Medicare only in specific cases, such as pre-kidney transplant evaluations, bone marrow or platelet transfusions (particularly in cases involving multiple infusions), or when diagnosing ankylosing spondylitis where other diagnostic methods are unsuitable or inconclusive. The absence of widespread payment for surgical procedures such as transplants, the treatment of infectious diseases, and the treatment of cancer has resulted in the decline in the adoption of high-tech molecular diagnostics such as HLA typing. This specifically inhibits demand for these expensive diagnostic tools and affects their market growth negatively. Although mature markets such as the US and major European countries have favorable reimbursement structures for organ donation, transplantation, and allied procedures, most growing markets in Asia Pacific, the Middle East, and Africa lack these. Such geographical differences are responsible for the underutilization of molecular diagnostics and immunological tests, thus limiting overall market growth during the forecasting period.

 

OPPORTUNITY: Increasing awareness of organ donation

The rising incidence of chronic and terminal illnesses, combined with the emphasis on effective treatment and the relatively low risk of disease recurrence following organ transplantation, has significantly increased the demand for transplant procedures in countries such as the US, Japan, Germany, the UK, France, China, and India. One of the most critical signs of this increasing demand is the increasing number of patients added to organ transplant waiting lists. Despite this increase, a huge gap exists between the number of patients in need of transplants and the available registered organ donors annually. Several state governments and public-private entities have initiated programs designed to increase organ donation awareness to alleviate this shortage. On August 13, 2024, an international awareness campaign was conducted to raise awareness of the life-saving, critical function of organ donation and highlight the pressing need for additional donors.

CHALLENGES: Issues related to system integration

New technologies need high-level personnel to function at their best. Without properly trained personnel, the effectiveness of HLA typing protocols is compromised, and this can limit the use and application of HLA typing products and services. Additionally, data from various sequencing technologies, such as NGS and Sanger sequencing, need to be interpreted by bioinformatics tools and HLA typing software, which can disrupt technicians' decision-making.

According to Onramp Bioinformatics, there are only 15,000 bioinformatics professionals supporting over 2 million biologists and researchers worldwide. Many scientists at the forefront of experimental research lack expertise in bioinformatics, contributing to the growing demand for services. With advancements in HLA typing and genomic diagnosis and testing, the need for fast, accurate tools that are easy to use is becoming more critical. Advanced computer skills are also required to manage bioinformatics tools and complex analytics. A paper published in Oxford Briefings in Bioinformatics highlights that although bioinformatics has become essential in life science research, the shortage of experts over the past decade is expected to hinder market growth.

Global HLA Typing Market Ecosystem Analysis

The market for HLA testing consists of several instruments, ranging from instruments, reagents & consumables, and software & services. These solutions find application in diagnostic and research applications. End users of the solutions are quite varied and range from commercial service providers, hospitals & transplant centres, and research laboratories & academic institutes.

HLA Typing Market Ecosystem
 

The reagents & consumables segment registered the largest market share in 2024.

Based on Product & Service, the reagents & consumables segment held the largest revenue share of the HLA typing market. This market is experiencing robust growth, primarily fueled by the increasing number of organ and stem cell transplantation procedures, which require accurate and repeated HLA testing. Due to their limited shelf life and need for frequent replenishment, reagents contribute to continuous market demand. Technological developments in molecular diagnostics, such as PCR and next-generation sequencing (NGS), are propelling demand for high-performance and specialty reagents. The increasing prevalence of chronic conditions such as autoimmune disorders and cancers is propelling broader acceptance of HLA typing to aid in clinical decision-making. The growing network of diagnostic labs and the increasing trend toward personalized medicine support are expected to boost market growth.

The commercial service providers segment dominated the end-user segment in 2025.

In 2025, the commercial service providers dominated the HLA typing market, by end user. This segment is expected to grow due to the rising need for high-throughput, accurate, and speedy HLA typing. Advanced molecular technologies such as PCR and NGS are employed by commercial service businesses to provide accurate and scalable HLA genotyping. The shift from traditional serological methods to molecular technology-based assays has significantly improved the efficiency, precision, and accessibility of HLA typing and made it more available to hospitals, transplant facilities, and research centers.

Growing emphasis on reducing transplant rejection rates and improving patient outcomes is also fueling demand for sophisticated HLA typing solutions. Partnerships between commercial laboratories and healthcare organizations further fuel market penetration. As individualized medicine grows more popular, the need for precise HLA matching is becoming increasingly important, further supporting long-term growth prospects for this category.

North American dominated the HLA Typing Market in 2024.

The HLA typing market in North America is primarily driven by the high volume of organ and stem cell transplants, supported by well-established transplant registries such as the National Marrow Donor Program (NMDP). The region’s advanced healthcare infrastructure and emphasis on precision and personalized medicine are propelling the adoption of HLA typing technologies. Rising incidences of chronic diseases, including leukemia, lymphoma, and autoimmune disorders, are further increasing the demand for accurate tissue matching.

The growing use of next-generation sequencing (NGS) and other molecular diagnostic methods is improving the accuracy and reliability of HLA testing. In addition, government funding and regulatory support for transplant programs and related research are bolstering market expansion. The presence of leading diagnostic firms and prominent research institutions across North America continues to drive technological innovation and expand market potential. For example, in September 2023, Omixon, Inc. (US) introduced the NanoTYPE RUO Multiplex Human Leukocyte Antigen Amplification kit, which is compatible with Oxford Nanopore’s MinION platform.

HIGHEST CAGR DURING FORECAST PERIOD
US: FASTEST-GROWING MARKET IN REGION
HLA Typing Market Region

Recent Developments of HLA Typing Market

  • In November 2023, Roche launched the next-generation qPCR system to advance clinical needs in molecular diagnostics.
  • In October 2023, GenDx (Netherlands) launched the NGS-Turbo, a rapid high-resolution HLA typing kit compatible with Oxford Nanopore Technologies sequencing devices.
  • In September 2023, Hungary-based Omixon launched the NanoTYPE MONO and MONOall kits, developed for high-resolution single-locus HLA typing. These kits streamline laboratory workflows by enabling the independent analysis of each locus, making them ideal for sample confirmation and the evaluation of genetic markers.
  • In October 2023, Eurobio Scientific (US) acquired Genome Diagnostics BV (GenDx) (Netherlands), a company specializing in molecular diagnostics for transplantation.

Key Market Players

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Scope of the Report

Report Metric Details
Market size available for years 2023-2030
Base Year Considered 2024
Forecast period 2025-2030
Forecast units Value (USD)
Segments covered Technology, Product & Service, Application, End User, and Region
Geographies covered North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa

Frequently Asked Questions(FAQ)

What will the addressable market value of the global HLA typing market be within five years?

The global HLA typing market is projected to reach USD 2.3 billion by 2030 from USD 1.7 billion in 2025, at a CAGR of 6.0%.

Which product type segments have the highest potential for growth in the HLA typing market?

Reagents and consumables are expected to exhibit the highest growth rates.

Who are the top 3 players in the market, and how is the market landscape?

The leading players are Becton, Dickinson and Company (BD) (US), Thermo Fisher Scientific Inc. (US), and F. Hoffmann-La Roche Ltd (Roche) (Switzerland). The market is moderately consolidated, with top players holding 30–35% of the market share.

What are the major strategies adopted by leading players to enter emerging regions?

Distribution agreements, partnerships, product launches, and product approvals represent the major growth strategies adopted by major market players.

Which end-user segment will likely show the highest growth in the HLA typing market?

The commercial service providers segment is expected to grow at the highest rate in the end-user market.

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Table of Contents

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TITLE
PAGE NO
INTRODUCTION
1
RESEARCH METHODOLOGY
34
EXECUTIVE SUMMARY
56
PREMIUM INSIGHTS
76
MARKET OVERVIEW
98
  • 5.1 MARKET DYNAMICS
    DRIVERS
    RESTRAINTS
    KEY GROWTH OPPORTUNITIES
    INDUSTRY-SPECIFIC CHALLENGES
  • 5.2 PORTER’S FIVE FORCES ANALYSIS
  • 5.3 REGULATORY LANDSCAPE
    REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANISATIONS
    REGULATORY FRAMEWORK
  • 5.4 ECOSYSTEM MARKET MAP
  • 5.5 VALUE CHAIN ANALYSIS
  • 5.6 SUPPLY CHAIN ANALYSIS
  • 5.7 PRICING ANALYSIS
    AVERAGE SELLING PRICE TREND OF PRODUCTS, BY KEY PLAYERS, 2022-2024
    AVERAGE SELLING PRICE TREND OF PRODUCTS, BY REGION, 2022 - 2024
  • 5.8 PATENT ANALYSIS
  • 5.9 TRADE ANALYSIS
  • 5.10 TECHNOLOGY ANALYSIS
    KEY TECHNOLOGIES
    - SEQUENCE-BASED TYPING
    - NEXT-GENERATION SEQUENCING
    COMPLIMENTARY TECHNOLOGIES
    - SAMPLE PREPARATION & DNA EXTRACTION TECHNOLOGIES
    - BIOINFORMATICS & DATA ANALYSIS SOFTWARE
    ADJACENT TECHNOLOGIES
    - TRANSPLANT DIAGNOSTICS
  • 5.11 KEY CONFERENCES & EVENTS IN 2025-2026
  • 5.12 TRENDS/DISRUPTIONS IMPACTING CUSTOMER’S BUSINESS
  • 5.13 KEY STAKEHOLDERS AND BUYING CRITERIA
    KEY STAKEHOLDERS IN THE BUYING PROCESS
    BUYING CRITERIA
  • 5.14 CASE STUDY ANALYSIS
  • 5.15 UNMET NEEDS/END USER EXPECTATIONS IN HLA TYPING MARKET
  • 5.16 INVESTMENT AND FUNDING SCENARIO
  • 5.17 AI IN HLA TYPING MARKET
HLA TYPING MARKET DATA, BY PRODUCT & SERVICES (USD MILLION; 2023—2030)
115
  • 6.1 INSTRUMENTS
  • 6.2 REAGENTS & CONSUMABLES
  • 6.3 SOFTWARE & SERVICES
HLA TYPING MARKET DATA, BY TECHNOLOGY (USD MILLION; 2023—2030)
145
  • 7.1 PCR-BASED MOLECULAR ASSAYS
    PCR-BASED MOLECULAR ASSAYS
    - SEQUENCE-SPECIFIC PRIMAR-PCR
    - SEQUENCE-SPECIFIC OLIGONUCLEOTIDE-PCR
    - REAL-TIME PCR
    - OTHER PCR-BASED MOLECULAR ASSAYS
    SEQUENCEING-BASED MOLECULAR ASSAYS-BASED MOLECULAR ASSAYS
    - SANGER SEQUENCING
    - NEXT-GENERATION SEQUENCING
    - OTHER SEQUENCING-BASED MOLECULAR ASSAYS
  • 7.2 NON-MOLECULAR ASSAY TECHNOLOGIES
HLA TYPING SYSTEM MARKET DATA, BY APPLICATION (USD MILLION; 2023—2030)
167
  • 8.1 DIAGNOSTIC APPLICATIONS
    DONOR-RECIPIENT CROSS-MATCHING
    INFECTIOUS DISEASE TESTING
    CANCER DIAGNOSIS & PREVENTION
    TRANSFUSION THERAPY
    OTHER DIAGNOSTIC APPLICATION
  • 8.2 RESEARCH APPLICATIONS
HLA TYPING MARKET DATA, BY END-USERS (USD MILLION; 2023—2030)
187
  • 9.1 COMMERCIAL SERVICE PROVIDERS
  • 9.2 HOSPITALS AND TRANSPLANT CENTERS
  • 9.3 RESEARCH LABORATORIES & ACADEMIC INSTITUTES
HLA TYPING MARKET DATA, BY REGION (USD MILLION; 2023—2030)
206
  • 10.1 INTRODUCTION
  • 10.2 NORTH AMERICA
    MACROECONOMIC OUTLOOK FOR NORTH AMERICA
    US
    CANADA
  • 10.3 EUROPE
    MACROECONOMIC OUTLOOK FOR EUROPE
    GERMANY
    UK
    FRANCE
    ITALY
    SPAIN
    REST OF EUROPE
  • 10.4 ASIA-PACIFIC
    MACROECONOMIC OUTLOOK FOR ASIA-PACIFIC
    CHINA
    JAPAN
    INDIA
    SOUTH KOREA
    AUSTRALIA
    REST OF ASIA-PACIFIC
  • 10.5 LATIN AMERICA
    MACROECONOMIC OUTLOOK FOR LATIN AMERICA
    BRAZIL
    MEXICO
    REST OF LATIN AMERICA
  • 10.6 MIDDLE EAST & AFRICA
    MACROECONOMIC OUTLOOK FOR MIDDLE EAST & AFRICA
    GCC COUNTRIES
    REST OF MIDDLE EAST AND AFRICA
COMPETITIVE LANDSCAPE
250
  • 11.1 INTRODUCTION
  • 11.2 KEY PLAYER STRATEGIES/RIGHT TO WIN (2021-2025)
  • 11.3 REVENUE ANALYSIS
  • 11.4 MARKET SHARE ANALYSIS BY KEY PLAYERS, 2024
  • 11.5 COMPANY EVALUATION MATRIX: KEY PLAYERS, 2024
    STARS
    EMERGING LEADERS
    PERVASIVE PLAYERS
    PARTICIPANTS
    COMPANY FOOTPRINT: KEY PLAYERS, 2024
    - COMPANY FOOTPRINT
    - REGION FOOTPRINT
    - PRODUCT FOOTPRINT
    - APPLICATION FOOTPRINT
    - END-USERS FOOTPRINT
  • 11.6 COMPANY EVALUATION MATRIX: STARTUPS/SMES, 2024
    PROGRESSIVE COMPANIES
    RESPONSIVE COMPANIES
    DYNAMIC COMPANIES
    STARTING BLOCKS
    COMPETITIVE BENCHMARKING: STARTUPS/SMES, 2024
    - DETAILED LIST OF KEY STARTUPS/SMES
    - COMPETITIVE BENCHMARKING OF KEY STARTUPS/SMES
  • 11.7 C0MPETITIVE SITUATION AND TRENDS (2021-2025)
    NEW PRODUCT LAUNCHES & APPROVALS
    DEALS
    OTHER DEVELOPMENTS
  • 11.8 BRAND/PRODUCT COMPARATIVE ANALYSIS
  • 11.9 COMPANY VALUATION AND FINANCIAL METRICS
COMPANY PROFILES
266
  • 12.1 KEY PLAYERS
    ALPHA BIOTECH LIMITED
    BIO-RAD LABORATORIES, INC.
    BECTON, DICKINSON AND COMPANY
    BAG DIAGNOSTICS GMBH.
    BIOFORTUNA LIMITED
    CAREDX, INC
    CREATIVE BIOLABS
    F. HOFFMAN-LA ROCHE LTD
    FUJIREBIO HOLDINGS INC
    GENDX
    HOLOGIC, INC.
    HISTOGENETICS LLC
    HANSA BIOPHARMA AB
    ILLUMINA, INC
    INNO-TRAIN DIAGNOSTIK GMBH
  • 12.2 OTHER PLAYERS
    IMMUCOR, INC.
    KRISHGEN BIOSYSTEMS
    OMIXON INC
    PACBIO.
    PROIMMUNE LTD.
    PACIFIC BIOSCIENCE OF CALIFORNIA INC
    QIAGEN N.V.
    TBG DIAGNOSTICS LIMITED.
    TAKARA BIO INC
    THERMO FISHER SCIENTIFIC
APPENDIX
284

 

This research study extensively utilized secondary sources, directories, and databases to identify and gather valuable information for analyzing the global HLA typing market. Additionally, in-depth interviews were conducted with primary respondents, including key industry participants, subject-matter experts (SMEs), C-level executives from leading market players, and industry consultants. These interviews helped obtain and validate critical qualitative and quantitative data while assessing the growth prospects. The global market size, initially estimated through secondary research, was then refined and finalized through triangulation with insights from primary research.

Secondary Research

The secondary research process involves the widespread use of secondary sources, directories, databases (such as Bloomberg Businessweek, Factiva, and D&B Hoovers), white papers, annual reports, company house documents, investor presentations, and SEC filings of companies. Secondary research was used to identify and collect information useful for the extensive, technical, market-oriented, and commercial study of the HLA typing market. It was also used to obtain important information about the key players and market classification & segmentation according to industry trends to the bottom-most level and key developments related to market and technology perspectives. A database of the key industry leaders was also prepared using secondary research.

Primary Research

In the primary research process, various sources from the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include industry experts such as CEOs, vice presidents, marketing and sales directors, technology & innovation directors, and related key executives from various companies and organizations in the HLA typing market. The primary sources from the demand side include OEMs, private and contract testing organizations, and service providers, among others. Primary research was conducted to validate the market segmentation, identify key players, and gather insights on key industry trends & key market dynamics.

The following is a breakdown of the primary respondents:

HLA Typing Market

To know about the assumptions considered for the study, download the pdf brochure

Market Size Estimation

The bottom-up approach was used to estimate and validate the total size of the HLA typing market. These methods were also used extensively to estimate the size of various subsegments in the market. The research methodology used to estimate the market size includes the following:

  • A list of the major global players operating in the HLA typing market was generated.
  • Mapping annual revenues generated by major global players from the HLA typing segment (or nearest reported business unit/service category)
  • Revenue mapping of key players to cover a major share of the global market as of 2024
  • Extrapolating the global value of the HLA Typing industry

Global HLA Typing Market Size: Bottom-up Approach and Top-down Approach

HLA Typing Market

Data Triangulation

After arriving at the market size from the market size estimation process explained above, the total market was divided into several segments and subsegments. To complete the overall market engineering process and arrive at the exact statistics for all segments and subsegments, data triangulation and market breakdown procedures were employed, wherever applicable. The data was triangulated by studying various factors and trends from both the demand and supply sides.

Market Definition

HLA typing is a genetic procedure to determine donor-recipient compatibility, cancer & autoimmune disorder diagnosis, pathogen testing, and transfusion therapy. Additionally, it is used in drug testing, disputed paternity, and anthropological studies. Advanced genomic techniques, such as PCR and NGS, are increasingly being used in HLA typing, apart from serological and other conventional techniques for immuno-compatibility testing.

Stakeholders

  • HLA Typing Product Manufacturers
  • Healthcare Service Providers (Hospitals, Transplant Centers, and Blood Transfusion Centers)
  • Blood, Tissue, and Stem Cell Banks
  • Government Organizations
  • Independent Associations and Regulatory Authorities
  • R&D Companies
  • Independent Reference Laboratories
  • Diagnostic Laboratories
  • Clinical Research Organizations
  • Research Laboratories and Academic Institutes

Report Objectives

  • To define, describe, and forecast the HLA typing market based on technology, product & service, application, end user, and region
  • To provide detailed information regarding the major factors influencing the growth potential of the global HLA typing market (drivers, restraints, opportunities, challenges, and trends)
  • To analyze the micro markets with respect to individual growth trends, future prospects, and contributions to the global HLA typing market
  • To analyze key growth opportunities in the global HLA typing market for key stakeholders and provide details of the competitive landscape for market leaders
  • To forecast the size of market segments and/or subsegments with respect to five major regions, namely, North America (the US and Canada), Europe (Germany, the UK, France, Italy, Spain, and Rest of Europe), Asia Pacific (Japan, China, India, Australia, South Korea, and Rest of Asia Pacific), Latin America (Brazil, Mexico, and Rest of Latin America), and the Middle East & Africa (GCC Countries and Rest of Middle East & Africa)
  • To profile the key players in the HLA typing market and comprehensively analyze their market shares and core competencies
  • To track and analyze the competitive developments undertaken in the global HLA typing market, such as agreements, expansions, and acquisitions

 

Previous Versions of this Report

HLA Typing Market by Technology (PCR (SSO, SSP, Real Time), Sequencing (NGS, Sanger)), Product (Instrument, Reagent, Software), Application (Chimerism, Antibody Screening), End User (Hospital, Diagnolab, Academia) & Region - Global Forecast to 2028

Report Code MD 7576
Published in May, 2023, By MarketsandMarkets™

HLA Typing Market by Technology (PCR, NGS, Sanger Sequencing), Product (Instrument, Reagent), Application (Cancer research, infectious & Non infectious diseases, Transfusion therapy), End User (Hospital, Academia and Research) & Region - Global Forecast to 2025

Report Code MD 7576
Published in Mar, 2020, By MarketsandMarkets™
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