HLA Typing Market by Product (Instruments, Software), Technology (Molecular [PCR, Sequencing [Sangers, NGS]], Serology), Application (Diagnostics [Cross Match, Cancer, Infectious Disease, Transfusion], Research), End User, and Geography - Global Forecast to 2029

The HLA Typing Market is expected to grow at a CAGR of 5.6% from 2022 to 2029 to reach $1.90 billion by 2029. The increasing number of organ transplants, increasing prevalence of chronic and infectious diseases, and technological advancements in the molecular assays used for HLA typing are expected to propel the global HLA typing market. The availability of funding for HLA typing research is also expected to positively impact the HLA typing market. Furthermore, the increasing awareness amongst people regarding organ donations offers an opportunity for the growth of the HLA typing market.

However, the high costs associated with molecular assays related to HLA typing and the huge gap between organ donations and organs required for transplantation pose a major challenge for the HLA typing market.

Growing Number of Organ Transplants Fuels the HLA Typing Market Growth

Human leukocyte antigen (HLA) molecules are expressed in almost all nucleated cells. These molecules trigger an immune response responsible for the rejection of transplanted grafts. The ideal condition for a successful transplant is that the HLA genes in both the donor and recipient match as closely as possible. Hence, HLA matching is an essential test to ensure a successful transplant and reduce the possibility of graft rejection. The demand for organ transplants has increased over the last decade. For instance, in 2021, organ transplants increased to 33.25 per million people from 20.49 transplants in 2019 (Source: Global Observatory on Donation and Transplantation).

This demand can be attributed to the increasing incidence of organ failure and the high success rate of transplants due to new immunosuppressants, robot-assisted organ transplantation, organ-specific solutions (reagents) for preservation, and logistics management in organ procurement. As HLA matching is an essential aspect of transplant diagnostics in checking the compatibility between the donor’s and recipient’s HLA genes, the need for high organ transplantation success rates is expected to drive the global HLA typing market.

Click here to: Get Free Sample Pages of this Report 

Molecular Assays for HLA Matching: Preferred Method of Typing

Before 1990, serotyping was critical in HLA typing for organ transplants. However, most of the HLA antisera are polyclonal in nature and result in cross-reactions, making it complicated to differentiate antigens with subtle differences, which may result in incorrect identification. In addition, numerous factors, such as the time required to transport blood samples and the excessive number of immature cells, affect the serotyping results. These limitations of serotyping for HLA drove the adoption of molecular assays.

Molecular technologies have substituted conventionally used serological assays. Molecular technologies provide higher resolution, accuracy, sensitivity, and specificity in HLA typing. Non-molecular techniques utilize polyclonal antisera that lead to cross-reactions, which makes it difficult to differentiate antigens with subtle differences, leading to inaccuracy. Serological methods are used only for low-resolution typing, whereas molecular methods are used for high-resolution typing.

Key Findings of the Global HLA Typing Market Study:

Based on Technology, the Molecular Assay Segment is Estimated to Grow at a CAGR of 5.6% During the Forecast Period

The growth of the molecular assay segment is attributed to advancements in molecular technologies, companies focusing on developing and launching products based on new technologies, and the benefits of molecular technologies compared to non-molecular technologies. The molecular assay techniques, such as next-generation sequencing, provide high-resolution HLA genotyping. The combination of HLA sequencing (for increased sequence length) and advanced bioinformatics tools has enabled the accurate HLA genotyping of variants and full-length HLA haplotypes without phase ambiguity. Moreover, HLA genotyping overcomes many of the disadvantages of using conventional technologies, such as the inability to distinguish between different alleles at a locus and the need for multiple endonucleases to break down nucleotide chains in two or more fragments.

Based on Product, the Consumables Segment is Estimated to Dominate the HLA Typing Market in 2022

Recurrent use of the consumables, availability of diverse tests, and companies focused on launching new assays contribute to the large share of this segment. For instance, in 2021, Versiti, Inc. (U.S.) launched a test for the detection of loss of heterozygosity in the HLA region. This test is useful to gain information on patients with post-transplant relapse. Test kits & assays offered by major players operating in the HLA typing market are based on several technologies and are designed to be used with specific platforms. For instance, HLA SSP kits offered by Bio-Rad Laboratories (U.S.) are based on PCR systems. Similarly, NGSgo-MX-11-3 amplification kits are designed to be used with next-generation sequencing NGS platforms.

Based on End User, the Diagnostic Laboratories Segment is Projected to Register the Highest Growth in the HLA Typing Market by 2029

The factors propelling this segment's growth include outsourcing laboratory services by hospitals and transplant centers and a consolidation trend among diagnostics laboratories. Transplant centers and hospitals partner with diagnostic laboratories to undertake diagnostic procedures. For instance, SBC’s Histocompatibility & Immunogenetics Laboratory (HLA LAB) (U.S.) carries out testing for the Stanford Hospital (U.S.) and Lucile Packard Children’s Hospital (U.S.). Owing to the outsourcing of laboratory services, the diagnostics centers perform HLA typing, contributing to a higher revenue share.

China: Second Largest Share Holding Country

In 2022, China is expected to account for the second largest share of 9% of the market, after the U.S. China faced a great shortage of organs for transplants after the government stopped harvesting organs from executed prisoners in 2015. However, the Chinese government is taking steps toward reforming organ donation and procurement. For instance, in 2021, the Government of China introduced the Human Organ Transplant Act. As a result, the country saw an increase in organ donation volunteers by 45% since the start of the COVID-19 pandemic. As of June 2021, 1.77 million volunteers registered for organ donation at the Organ Transportation Development Foundation (COTDF) (China). The increase in organ donation volunteers is expected to increase the adoption of HLA typing in the country.

Key Players

The report includes a competitive landscape based on an extensive assessment of the product portfolio offerings, geographic presences, and key strategic developments in leading industry market players over the past four years. The key players profiled in the global HLA Typing Market are Thermo Fisher Scientific Inc. (U.S.), Bio-Rad Laboratories (U.S.), Qiagen N.V. (Netherlands), Genome Diagnostics B.V. (GenDx) (Netherlands), Illumina, Inc. (U.S.), CareDx (U.S.), Immucor Inc. (U.S.), TBG Diagnostics Limited (Australia), BAG Diagnostic GmbH (Germany), Omixon Inc. (Hungary), Luminex Corporation (U.S.), inno-train Diagnostik GmbH (Germany), Pacific Biosciences of California, Inc. (U.S.), and Fujirebio Holdings, Inc. (Japan). The global HLA typing market is fragmented in nature and dominated by four top players, namely, Thermo Fisher Scientific Inc. (U.S.), Becton, Dickinson and Company (U.S.), and Illumina, Inc. (U.S.). In 2021, these players collectively accounted for a share of 20%–25% of the HLA typing market.

Product launches & enhancement were the most preferred growth strategies adopted by key players, accounting for the largest share of the total strategic developments between 2019 and 2022. These strategies enabled companies to broaden their product portfolios, advance the capabilities of their existing products, cater to the changing demands of users, and ensure a competitive edge in the global HLA typing market. The leading players that actively adopted these strategies were Thermo Fisher Scientific, Inc. (U.S.), CareDx Inc. (U.S.), Genome Diagnostics B.V. (Netherlands), Immucor, Inc. (U.S.), and Omixon, Inc. (Hungary).

Scope of the Report:

HLA Typing Market, by Product

• Consumables
• Instruments
• Software & Services

HLA Typing Market, by Technology

• Molecular Assays
  • PCR-based Molecular Assays
    • Sequence-specific Primers
    • Sequence-specific Oligonucleotide
    • RT-PCR
    • PCR-based Molecular Assays
      (Note: Other PCR-based molecular assays include RPLF-PCR, SNP-PCR, and PCR-SSCP.)
• Sequence-based Molecular Assays
  • Sangers Sequencing
  • Next-generation Sequencing
  • Other Sequence-based Molecular Assays
    (Note: Other sequence-based molecular assays include Gene Chip and DNA Microarray.)
• Non-molecular Assays
  • Serological Assay
  • Mixed Lymphocyte Cultural Assay

HLA Typing Market, by Application

• Diagnostics
  • Donor Recipient Cross-Matching
  • Infectious Disease Diagnostics
  • Cancer Diagnosis
  • Transfusion Therapy
  • Other Diagnostic Applications
    (Note: Other diagnostic applications include Autoimmune Disease Diagnosis and Paternity testing.)
• Research

HLA Typing Market, by End Users

• Diagnostics Laboratories
• Hospitals & Transplant Centers
• Academic & Research Institutes

HLA Typing Market, by Geography

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • France
  • U.K.
  • Italy
  • Spain
  • Rest of Europe (RoE)
• Asia-Pacific (APAC)
  • Japan
  • China
  • India
  • Rest of APAC (RoAPAC)
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America (RoLA)
• Middle East & Africa

Key questions answered in the report: