HLA Typing for Transplant Market

Market Overview

The global HLA typing for transplant market size was valued at USD 1.1 billion in 2023 and is projected to reach a value of USD 2.4 billion by 2032, registering a CAGR of 9.5% during the forecast period (2024-2032). The growing number of diseases that require bone marrow transplants, including lymphomas, multiple myeloma, leukemia, and immune deficiency disorders, will drive the HLA Typing for Transplant Market share. 

HLA typing, or Human Leukocyte Antigen typing, is a critical step in organ and tissue transplantation that determines the compatibility of the donor and recipient. HLA molecules are proteins found on the surface of cells that play an important role in the immune system by identifying self and non-self cells. In transplantation, a close match between the donor and recipient's HLA types reduces the risk of rejection.

Technological breakthroughs in the field of Transplant Diagnostics have recently increased demand for improved transplant diagnostics products, which is likely to contribute to the market's revenue growth throughout the forecast period. Furthermore, the growing elderly population worldwide and the rising burden of chronic diseases will likely drive market expansion over the forecast period. 

 Furthermore, the growing number of operations involving organ, stem cell, and soft tissue transplantation has increased demand for HLA typing before surgical interventions to assess transplant feasibility and prevent postoperative complications and damage. This is projected to fuel market expansion throughout the forecast period. However, unfavorable reimbursement rules and the high costs associated with PCR-based apparatus and equipment are projected to limit market growth to some extent throughout the projection period.

Highlights

• Instruments generate the highest revenue share by products and services.
• Sequencing-based molecular assays hold the major market share in terms of technology.
• Diagnostic Applications are the most common application in the market.
• Hospitals and Transplant Centers occupy the maximum share of the market by end-user.
• Solid Organ Transplant dominates the market by transplant type.

Market Dynamics

Global HLA Typing for Transplant Market Drivers

Increasing Demand for Organ Transplant

The global demand for organ transplants is increasing due to the prevalence of organ failure, end-stage organ diseases, and an aging population. As more people seek life-saving transplant procedures, accurate HLA typing becomes critical to ensuring compatibility and lowering the risk of rejection. In 2023, there were 46,632 organ transplants from living and deceased donors. This is an 8.7% increase over 2022 and a 12.7% increase over 2021, the first year with more than 40,000 organ transplants. The demand for organs, such as kidneys, livers, hearts, and lungs, has consistently exceeded the supply of suitable donors.

The increasing demand for organ transplants directly impacts the HLA typing for the transplant market. The need for precise HLA matching to improve transplant success rates has spurred investment in advanced HLA typing technologies. This includes using high-throughput sequencing and other molecular techniques for comprehensive HLA profiling.

With ongoing efforts to address organ shortages and advances in regenerative medicine, the demand for organ transplants is expected to continue. Future trends in the HLA typing market include increased typing process automation, greater use of artificial intelligence in data analysis, and the development of point-of-care HLA typing solutions to streamline transplantation procedures.

Global HLA Typing for Transplant Market Restraints

High Cost of HLA Typing Procedures

HLA typing procedures, particularly those that use advanced technologies like Next-Generation Sequencing (NGS), can be costly. The costs associated with comprehensive HLA typing may present financial challenges for healthcare institutions and patients, potentially limiting widespread adoption. Healthcare providers use molecular tests for HLA typing, which can be costly. For example, Illumina's Trusight HLA V2, an amplicon-based NGS HLA typing kit, costs around USD 5,000 for 11 HLA genes and 24 samples, or USD 208 each. 

 In Delhi, India, HLA typing for the Molecular B51 locus costs between ?3,000 and ?34,000. In Mumbai, the High-Resolution HLA Typing Test (A, B, C, DP, DQ, DR) costs ?14,980. Apollo 24/7's HLA Typing test costs ?6,000 and typically provides results within eight days. The high cost of HLA typing procedures discourages widespread adoption and may limit access to advanced HLA typing technologies. This restraint may impact the overall growth of the HLA typing for transplant market, particularly in regions or healthcare systems with limited budgets.

Global HLA Typing for Transplant Market Opportunity

Technological Advancement and Innovation

The ongoing evolution of HLA typing technologies, focusing on precision and efficiency, presents significant opportunities for market growth. For example, Next-Generation Sequencing (NGS) in HLA typing has transformed the field by providing high-resolution genotyping, allowing for a more detailed assessment of HLA alleles. 

Furthermore, technological advances in NGS and other high-throughput sequencing methods present significant opportunities to improve HLA typing accuracy, throughput, and cost-effectiveness. These innovations allow for comprehensive HLA profiling, including identifying rare alleles and detailed characterization of HLA polymorphisms, which contributes to better donor-recipient matching and transplant outcomes. Incorporating artificial intelligence (AI) and machine learning algorithms into NGS data analysis shows promise for streamlining HLA typing workflows and improving interpretation accuracy. 

Furthermore, developing novel sequencing chemistries and bioinformatics tools specifically designed for HLA typing applications is expected to drive further innovation in the field. As technology advances, opportunities to improve HLA typing methods will remain at the forefront of transplant medicine.

Regional Analysis

The global HLA typing for transplant market analysis is conducted in North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates the Global Market

North America is the most significant global HLA typing for transplant market shareholder and is estimated to grow at a CAGR of 9.9% over the forecast period. The rising prevalence of chronic diseases, the increasing occurrence of loss, and the disability of vital organs have resulted in a high demand for organ transplantation around the world in recent years. The growing number of organ transplants has resulted in a greater demand for testing services from transplant-related healthcare facilities.

Additionally, as of February 1, 2024, the national transplant waiting list in the United States numbered 103,223 men, women, and children. Every eight minutes, another individual is added to the list. The United States and Canada are well-equipped with funded organizations, infrastructure, and active government involvement in raising funds and raising awareness to encourage the transplantation of patients' diseased organs. To increase the number of organ donors, companies like Roche are collaborating with hospitals and organizations like the American Transplant Foundation, UNOS, National Kidney Foundation, and Donate Life America on various initiatives and awareness programs. With a sizable portion of the world's population looking to the United States and Canada for better healthcare services, the region is expected to be highly profitable for development and winning over the forecast period.

Furthermore, the increasing launch of HLA products by key market players from the United States is expected to fuel market growth in this region. For example, in March 2022, Immucor released Mia Fora NGS Express HLA Typing Software, which allows users of Mia Fora NGS MFlex HLA Typing assays to perform NGS analyses more quickly and easily. This type of HLA typing software will increase the adoption of HLA typing, driving market growth in this region. 

Asia-Pacific is expected to have the fastest-growing market share for HLA typing for transplants. The high demand for accurate and high-quality diagnostic tests, increased awareness of the importance of early and precise diagnoses of chronic and genetic diseases, and an aging population all contribute to the growth. In 2023, Asia and the Pacific will have an estimated 697 million people aged 60 and up, accounting for roughly 60% of the world's older population. Approximately one in every seven people in the region is 60 or older. By 2050, it is expected that one in every four people in the area will be 60 or older. Investment in healthcare is increasing in China and India. China's total public healthcare and hygiene expenditure will be around 2.24 trillion yuan in 2023. Other private companies are now involved in developed countries' healthcare systems.

Europe holds a significant market share. Several factors are expected to influence the European HLA Typing for Transplant Market, including technological advancements, increased transplant procedures, and collaborative efforts between healthcare institutions and research organizations. HLA typing is critical to transplant success, and the European market is expected to reflect the region's dedication to improving healthcare and transplantation medicine.

Segmental Analysis

The global HLA typing for transplant market is segmented based on product and services, technology, application, end-user, and transplant type.

The market is further segmented by product and services into Reagents and Consumables, Instruments, Software, and Services.

Instruments refer to the laboratory equipment and machinery used for DNA amplification, sequencing, and analysis. This category includes PCR machines, DNA sequencers, and other automated platforms used for high-throughput HLA typing. The efficiency and precision of HLA typing depend on advanced instrumentation capable of processing complex genetic data. Automated instruments improve workflow efficiency, reduce human error, and increase the speed of HLA typing processes. The instruments segment is a crucial driver of the HLA typing market, with continuous investments in cutting-edge technologies and high-performance equipment to meet the growing demand for faster and more accurate typing.

Reagents and consumables are essential components of HLA typing workflows and include a wide range of biochemicals, antibodies, and testing materials used for sample preparation, DNA extraction, and molecular testing. These include PCR reagents, sequencing kits, and HLA antigen-specific antibodies. Consumables have items used in testing, such as pipette tips, tubes, and plates. Reagent quality and specificity significantly impact the accuracy of HLA typing results. Laboratories rely on high-quality consumables to ensure consistent and reproducible results in HLA typing. As a result, the reagents and consumables segment accounts for a significant portion of the HLA typing market, driven by the ongoing need for dependable testing materials to support precise and efficient HLA profiling.

Based on technology, the market is fragmented into Non-molecular Assays, Sequencing-based Molecular Assays.

Sequencing-based molecular assays, such as Next-Generation Sequencing (NGS), use direct DNA analysis to identify specific HLA alleles and genotypes. These assays are highly detailed, identifying individual nucleotide variations and allowing for precise HLA typing at the allele level. The increased use of sequencing-based molecular assays reflects the need for high-resolution HLA typing in organ and tissue transplantation. These technologies help to improve transplant outcomes by enabling more precise and compatible donor-recipient matches.

Non-molecular assays in HLA typing rely on traditional serological methods and techniques that do not directly analyze DNA sequences. Serological assays detect HLA antigens with antibodies and other immune-based methods. These assays detect the presence or absence of specific antigens on cell surfaces. Non-molecular assays have traditionally been used for HLA typing and are frequently used in blood transfusion compatibility testing. These methods are helpful for quick and cost-effective screening but may not provide the precision and allele-level detail of molecular assays.

The market can be bifurcated by application into Diagnostic Applications, Research Applications.

HLA typing has diagnostic applications in clinical settings for transplantation and immune-related disorders. HLA typing is critical for determining donor-recipient compatibility in organ and tissue transplantation. It aids in identifying suitable matches, lowering the risk of graft rejection, and increasing overall transplant success rates. Diagnostic applications include autoimmune diseases and certain genetic disorders, where HLA typing aids in disease diagnosis and treatment planning. The growing number of transplant procedures, advances in precision medicine, and increased awareness of the role of HLA compatibility in disease management are all driving up demand for HLA typing in diagnostics. Diagnostic laboratories and healthcare institutions make significant contributions to this market segment.

In contrast, HLA typing is used in scientific investigations, population studies, and immunogenetic research. Researchers and academic institutions use HLA typing to study HLA allele diversity, immune responses, and the genetic factors influencing transplantation outcomes. HLA typing is also used in population-based studies to better understand the distribution of HLA alleles across ethnic groups.

The market is sub-segmented by end-users into Independent Reference Laboratories, Hospitals and Transplant Centers, Research Laboratories, and Academic Institutes.

Hospitals and transplant centers use HLA typing as part of their in-house laboratory services to support organ and tissue transplantation. These facilities use HLA testing to determine donor-recipient compatibility, which helps ensure successful transplant outcomes. Hospitals and transplant centers use HLA typing as part of their pre-transplant assessment. Accurate and timely HLA typing results are critical for identifying compatible donors and reducing rejection risk in transplant recipients. The growing number of transplant procedures and the importance of precise HLA matching drive demand for HLA typing in hospitals and transplant centers. These facilities may invest in advanced HLA typing technologies to improve their transplant programs.

Research laboratories and academic institutes use HLA typing in clinical and research settings. They contribute to advancing transplantation science by investigating HLA diversity, immune responses, and genetic factors that influence transplant outcomes. The demand for comprehensive genetic data to support scientific investigations drives the HLA typing market in research and academia. This segment contributes to developing novel HLA typing methodologies while encouraging collaboration between research institutions and industry players.

Based on transplant type, it is further classified into solid organ transplant and hematopoietic stem cell transplant.

Solid organ transplantation is the surgical transfer of a healthy organ from a donor to a recipient, such as the heart, kidney, liver, lungs, or pancreas. HLA typing is essential in solid organ transplantation because it determines whether the donor and recipient's HLA profiles are compatible. A close match reduces the risk of rejection and increases the transplant's success rate. The market is driven by rising demand for organ transplants, advances in surgical techniques, and a growing understanding of the importance of HLA compatibility in transplant outcomes. Healthcare institutions and transplant centers highly value accurate HLA typing for solid organ transplantation procedures.

Hematopoietic stem cell transplantation (HSCT) is the infusion of hematopoietic stem cells, usually derived from bone marrow, peripheral blood, or umbilical cord blood, to treat various hematological disorders, immune deficiencies, and certain cancers. HLA typing is essential in HSCT to match the HLA profiles of donors and recipients, ensuring compatibility and lowering the risk of graft-versus-host disease (GVHD).

Recent Developments

• March 2024- Thermo Fisher Scientific released CorEvitas Clinical Registry in Generalized Pustular Psoriasis.
• January 2024- QIAGEN Digital Insights introduced ultrafast NGS analysis for somatic cancer.
• February 2024- CareDx demonstrated Digital Solutions and Pipeline in Cellular Transplant and Therapy Monitoring.
• January 2024- Thermo Fisher Scientific announced the release of the Axiom PangenomiX Array, a new human genomics research tool that complements the recently developed pangenome, a new set of reference genomes that more accurately represents human genetic diversity.