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

Market Growth Outlook Summary

The global HLA typing market growth forecasted to transform from USD 1.4 billion in 2022 to USD 2.1 billion by 2028, driven by a CAGR of 6.5%. 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.

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HLA Typing Market Trends

e- Estimated; p- Projected

HLA typing market: Market Dynamics

Driver: Rising technological advancements in HLA typing

HLA-typing procedures have transitioned from serology-based to genome-based diagnostic techniques due to the advent of PCR-based genome sequencing and its integration with microfluidics, biomedical instrumentation, and robotics. Ongoing technological advancements in HLA typing have resulted in higher sample throughput, increased device sensitivity, early detection of incompatibility, and improved procedural efficacy compared to serological techniques. Such advantages have increased the demand for HLA typing products among key end users such as research laboratories, hospitals, transplant centers, and diagnostic laboratories.

A key development in HLA diagnostics is the introduction of molecular diagnostic techniques such as Sanger sequencing, PCR, HLA-based genotyping, and NGS, which enable the identification of specific alleles and point mutations of HLA genes. Moreover, incorporating nanofabrication and microfluidic technology in PCR procedures is a key factor driving the adoption of PCR and NGS techniques. When combined with bioinformatics tools, NGS approaches provide deep sequencing of complete HLA genes to generate insights on immune disorders in which HLA associations have been implicated. These include rheumatological conditions, coeliac disease, and complex disorders such as type-1 diabetes and systemic lupus erythematosus.

Additionally, several market players have now developed and commercialized PCR and NGS-based HLA typing reagents capable of detecting many genetic changes or identifying specific HLA alleles. For instance, recent developments in line with PCR and NGS-based HLA typing reagents include:

• In 2021, BD introduced the MX instrument, a fully automated instrument that helps in molecular diagnostics. This instrument is included in the new BD COR system.
• In 2021, Bio-Rad Laboratories launched the CFX Opus 96 Dx System and CFX Opus 384Dx Systems. These systems are used in quantitative PCR and have uniform thermal performance.
• In 2022, F. Hoffman LA Roche launched its next-generation PCR. These PCR systems are used for sequencing samples and help reduce human error.

Several prominent players in the life sciences market are involved in developing and commercializing innovative HLA typing reagents, software, and instruments. These players include Abbott Laboratories, Inc., Bio-Rad Laboratories, Inc., and F. Hoffmann-La Roche Ltd. With the growing focus of market players on launching technologically advanced PCR, NGS, and Sanger sequencing-based diagnostics, the market is expected to witness significant growth.

Opportunity: Rising adoption of cross-matching and chimerism testing procedures

Cross-matching is an important procedure during donor-recipient screening that can eliminate the clinical risk of immune rejection or pathogenic or other disorders in recipients. Surgeons usually perform transplantation procedures after ascertaining the results of cross-matching with the help of HLA typing during the pre-transplantation period.

Chimerism testing permits the detection and timely treatment of graft rejection or future relapse. Chimerism testing is also witnessing increasing demand as it analyzes genomic polymorphisms (STR loci) in prospective donors. Chimerism testing uses PCR-based STR/CE systems, including HLA typing. These procedures offer clinical advantages in terms of higher accuracy in patients with graft failure and leukopenia.

Challenge: Limited number of organ donations and long waiting lists for transplantations

There is a significant gap between the number of organs donated annually and the number of organ donations required. The number of patients waiting for organ transplants continuously increases across major countries worldwide. For example, there was a 37.2% increase in waiting list patients for organ transplants in the US, which increased from 83,731 to 113,000 from 2003–July 2019 (Source: US Department of Health and Human Services, 2018). As of December 2021, the European Union had 150,000 patients on the organ donation waiting list (Source: Council of Europe, 2021).

The limited number of organs donated annually worldwide is primarily due to strict government laws that limit medical reimbursements for living organ donors and a lack of public awareness about organ donation, especially in developing countries. This is further aggravated by the lower proportion of organ donations through deceased donors, mainly due to socio-ethical concerns.

Restraint: High cost of HLA typing products

HLA typing is conducted through specialized molecular diagnostic platforms with advanced technologies such as nanofabrication, microfluidics, device automation, and robotics. These advanced technologies are integrated with conventional PCR/NGS instruments to achieve the desired process outcomes, reduce cycle times, and increase sample throughput.

However, such innovative instruments require significant capital investments and extensive scientific validation for market commercialization. Most NGS or PCR-based assay manufacturers offer their instruments at premium prices. Thus, healthcare providers offer NGS and PCR-based diagnostic assays at high procedural costs. For instance, Illumina’s Trusight HLA V2, an amplicon based NGS HLA typing kit, costs around USD 5,000 for 11 HLA genes of 24 samples; this amounts to USD 208 per sample. This is further loaded with additional sequencing costs of around USD 5 (0.3 M, pair-end 100 bp on Illumina X10 platform) per sample.

By technology, the molecular assay technologies segment accounted for the largest share of the HLA typing market during the forecast period.

The molecular assay technologies segment accounted for the largest share of 86.5% in 2022. This segment is projected to reach USD 1,913.3 million by 2028 from USD 1,360 million in 2023, at a CAGR of 6.9% during the forecast period.

By Product & Services, the Reagents & Consumables segment holds the largest share of the HLA typing market.

The reagents & consumables segment accounted for the largest share of 71.8% of the market in 2022. This segment is also projected to register the highest CAGR during the forecast period.

By Application, the diagnostic applications segment accounted for the largest share of the HLA typing market during the forecast period.

The diagnostic applications segment accounted for the largest share of 95.6% of the global market in 2022.

By End User, the commercial service providers segment of HLA typing market is expected to grow at the fastest rate during the forecast period.

The commercial service providers segment accounted for the largest share of 60.2% of the market in 2022. This segment is also projected to register the highest CAGR of 7.0%, reaching USD 1,295.7 million in 2028 from an estimated 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 large share of the North American market is attributed to the high adoption of advanced diagnostic technologies, the increasing prevalence of target diseases, and technological advancements.

Europe accounted for the second-largest share of 29.5% of the global market in 2021.

The Asia Pacific market is estimated to grow at the highest CAGR of 7.5% during the forecast period.

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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

• In March 2023, BioRad received The company received AOAC International and AFNOR approval for its iQ-Check kits, which are used with the CFX Opus Deepwell Real-time PCR System
• In August 2022 Roche developed a new digital Light cycler system that helps determine a patient’s cancer.
• In May 2022, CareDx received CE marking for its AlloSeq HCT chimerism testing kit and AlloSeq HCT software. These AlloSeq are used in patients who have received Hematopoietic cell transplantation.

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