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

The global HLA typing market in terms of revenue was estimated to be worth $1.4 billion in 2022 and is poised to reach $2.1 billion by 2028, growing at a CAGR of 6.5% from 2022 to 2028.

The new research study includes a market industry trend analysis. The new study report covers industry trends, price analysis, patent analysis, conference and webinar materials, important stakeholders, and market purchasing behaviour. Because elderly citizens are more likely to be referred for organ transplant treatments due to age or chronic illness-related organ failure, the market will expand as the population ages. Tuberculosis (TB), end-stage renal disease (ESRD), and liver cirrhosis are more prevalent among the elderly and may necessitate organ or tissue donation.

HLA typing market: Market Dynamics

Driver: Increasing technical progress in HLA typing

HLA-typing methods have evolved from serology-based to genome-based diagnostic approaches as a result of the emergence of PCR-based genome sequencing and its integration with microfluidics, biomedical devices, and robotics. In compared to serological techniques, increasing technological advances in HLA typing have resulted in higher sample throughput, increased device sensitivity, quicker identification of incompatibility, and greater procedural efficacy. As a result of these advantages, demand for HLA typing systems has increased among key end users such as research laboratories, hospitals, transplant centres, and diagnostic laboratories.

The emergence of molecular diagnostic tools such as Sanger sequencing, PCR, HLA-based genotyping, and NGS, which allow the detection of particular alleles and point mutations in HLA genes, has been a significant advancement in HLA diagnostics. Furthermore, introducing nanofabrication and microfluidic technologies into PCR methods is a crucial element boosting PCR and NGS methodology adoption. NGS methods, when paired with bioinformatics tools, allow deep sequencing of full HLA genes, generating insights into immunological illnesses in which HLA correlations have been implicated. Rheumatological illnesses, celiac disease, and complicated disorders such as type 1 diabetes and systemic lupus erythematosus are examples.

In addition, some market participants have created and commercialised HLA typing reagents based on PCR and NGS that may detect numerous genetic alterations or identify particular HLA alleles. Recent breakthroughs in PCR and NGS-based HLA typing reagents, for example, include:

  • In 2021, BD released the MX instrument, a completely automated tool for molecular diagnostics. The new BD COR system includes this instrument.
  • Bio-Rad Laboratories will release the CFX Opus 96 Dx System and CFX Opus 384Dx Systems in 2021. These devices have homogeneous temperature performance and are employed in quantitative PCR.
  • F. Hoffman LA Roche will introduce its next-generation PCR in 2022. These PCR methods are used for sample sequencing and assist to decrease human error.

Several prominent life sciences companies are involved in the research and marketing of innovative HLA typing reagents, software, and devices. Among the firms engaged are Abbott Laboratories, Inc., Bio-Rad Laboratories, Inc., and F. Hoffmann-La Roche Ltd. The market is expected to grow considerably as industry participants focus on developing technologically advanced PCR, NGS, and Sanger sequencing-based diagnostics.

Opportunity: Cross-matching and chimerism tests are becoming more popular.

Cross-matching is a crucial approach used during donor-recipient screening because it reduces the clinical risk of immunological rejection, pathogenic or other problems in recipients. During the pre-transplantation stage, surgeons commonly execute transplantation operations after determining the findings of cross-matching using HLA typing.

Chimerism testing allows for the diagnosis and treatment of graft rejection or recurrence at an early stage. Chimerism testing is also popular since it examines potential donors' genetic polymorphisms (STR loci). Chimerism testing includes both PCR-based STR/CE methods and HLA typing. In patients with graft failure and leukopenia, these techniques provide therapeutic benefits in terms of improved accuracy.

Challenge: There are a limited number of organ donors and large transplant waiting lists.

The annual number of organ donors and the volume of organ donations required varies substantially. In major international countries, the number of persons waiting for organ transplants continues to climb. For example, between 2003 and July 2019, the number of patients on the waiting list for organ transplants in the United States increased by 37.2%, from 83,731 to 113,000 (Source: US Department of Health and Human Services, 2018). As of December 2021, the European Union has 150,000 patients on the organ donation waiting list (Source: Council of Europe, 2021).

The small amount of organs donated each year is largely owing to severe government rules that limit medical reimbursements for live organ donors and a lack of public knowledge about organ donation, particularly in poor nations. This is exacerbated further by the reduced number of organ donations from dead donors, owing to socio-ethical considerations.

Restraint: HLA typing products are expensive.

HLA typing is accomplished by the use of specialised molecular diagnostic platforms that employ cutting-edge technologies such as nanofabrication, microfluidics, device automation, and robotics. These cutting-edge technologies are employed in conjunction with classic PCR/NGS equipment to achieve the desired process outputs, decrease cycle times, and increase sample throughput.

However, for market commercialization, such novel technologies require significant economic investment as well as extensive scientific confirmation. The majority of producers of NGS or PCR-based tests charge a premium for their equipment. As a result, NGS and PCR-based diagnostic tests are charged astronomical costs by healthcare providers. Illumina's Trusight HLA V2, an amplicon-based NGS HLA typing kit, for example, costs around USD 5,000 for 11 HLA genes from 24 samples, or USD 208 per sample. This is augmented by additional sequencing costs of about USD 5 per sample (0.3 M, pair-end 100 bp on the Illumina X10 platform).

By technology, during the forecast period, the molecular assay technologies segment had the biggest share of the HLA typing market.

In 2022, the category of molecular assay technologies had the most share (86.5%). Between 2023 and 2030, this category is expected to grow at a 6.9% CAGR, from USD 1,360 million to USD 1,913.3 million.

By Product & Services, the Reagents & Consumables category accounts for the majority of the HLA typing market.

In 2022, the reagents and consumables sector held the biggest market share of 71.8%. This section is likewise expected to grow at the fastest rate over the projection period.

By Application, during the projection period, the diagnostic applications category held the biggest share of the HLA typing market.

Diagnostic applications will account for 95.6% of the global market in 2022.

By End User, during the forecast period, the commercial service providers sector of the HLA typing market is predicted to develop at the quickest rate.

In 2022, the commercial service providers category held the biggest market share of 60.2%. This category is also expected to grow at the fastest rate, with a CAGR of 7.0%, reaching USD 1,295.7 million in 2028 from an anticipated value of USD 917.1 million in 2023.

North America is expected to be the largest region in the global HLA typing market during the forecast period.

North America accounted for the largest share of 45.0% of the global market.

The widespread use of sophisticated diagnostic methods, the increasing frequency of target diseases, and technological advancements all contribute to North America's sizable market share.

In 2021, Europe held the second-largest share of the worldwide market, accounting for 29.5% of the total.

During the projection period, the Asia Pacific market is expected to develop at the fastest CAGR of 7.5%.

Key Players

Prominent players in the market include Bio-Rad Laboratories, Inc. (US), F. Hoffmann-La Roche Ltd. (Switzerland), QIAGEN N.V. (Netherlands), Thermo Fisher Scientific Inc. (US), and bioMérieux S.A. (France). Other players in the market are Immucor, Inc. (US), among others.

HLA Typing Market Report Scope

This study categorizes the global HLA typing market to forecast revenue and analyze trends in each of the following submarkets:

By Technology

  • Molecular Assay Technologies
    • PCR-based Molecular Assays
      • Sequence-specific Primer-PCR
      • Sequence-specific Oligonucleotide-PCR
      • Other PCR-based Molecular Assays
    • Sequencing-based Molecular Assays
      • Sanger Sequencing
      • Next-generation Sequencing
      • Pyrosequencing
  • Non-molecular Assay Technologies

By Product & Service

  • Reagents & Consumables
  • Instruments
  • Software & Services

By Application

  • Diagnostic Applications
  • Research Applications
  • Donor-recipient cross-matching
  • Infectious disease testing
  • Cancer diagnosis & prevention
  • Transfusion therapy
  • Other diagnostic applications

By End User

  • Commercial service providers
  • Hospitals & surgical centers
  • Research laboratories & academic institutes

By Region

  • North America
    • US
    • Canada
  • Europe
    • Germany
    • France
    • UK
    • Italy
    • Spain
    • Rest of Europe
  • Asia Pacific
    • Japan
    • China
    • India
    • Australia
    • South Korea
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East & Africa

Recent Developments

  • BioRad will get financing in March 2023. AOAC International and AFNOR have authorised the iQ-Check kits for use with the CFX Opus Deepwell Real-time PCR System.
  • Roche will unveil a new digital Light cycler system that assists in cancer diagnostics in August 2022.
  • CareDx gained CE marking for their AlloSeq HCT chimerism testing kit and AlloSeq HCT software in May 2022. AlloSeq is utilised in individuals who have had hematopoietic cell transplants.

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