HLA Typing for Transplant Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product & Service (Reagents & Consumables, Instruments, Software & Services), By Technology (Molecular Assay Technologies, Non-molecular Assay Technologies), By Application (Diagnostic Applications, Antibody Screening, Chimerism Monitoring, Research Applications, Others), By Transplant Type (Solid Organ Transplant, Soft Tissue Transplant) Region and Competition, 2020-2030F

Market Overview

The Global HLA Typing for Transplant Market, valued at USD 1.92 Billion in 2024, is projected to experience a CAGR of 6.91% to reach USD 2.87 Billion by 2030. Human Leukocyte Antigen (HLA) typing for transplant is a molecular diagnostic process identifying specific HLA genes and proteins to determine compatibility between organ and stem cell donors and recipients, thereby minimizing immune rejection and enhancing transplant success. The market growth is primarily supported by the escalating global incidence of chronic diseases leading to organ failure, which drives the demand for transplant procedures. Additionally, continuous technological advancements in HLA typing methodologies, including next-generation sequencing, contribute significantly to market expansion by offering enhanced accuracy and efficiency.

According to the World Health Organization and the Spanish Transplant Organization Global Observatory on Donation and Transplantation, in 2023, 172,397 solid organ transplants were performed worldwide, representing a 9.5% increase over 2022. Despite this growth, a significant challenge impeding market expansion remains the persistent global shortage of compatible donor organs, which creates a substantial gap between organ availability and patient demand.

Key Market Drivers

The escalating global demand for organ and stem cell transplants significantly propels the Human Leukocyte Antigen typing market. The rising prevalence of chronic diseases like end-stage renal disease, liver failure, and various hematologic malignancies necessitates these life-saving procedures. This increasing demand directly translates into a greater need for precise HLA compatibility assessment to ensure successful engraftment and minimize rejection rates. For instance, according to the U. S. Organ Procurement and Transplantation Network (OPTN) report 2024, 46,632 organ transplants were performed in the U. S. in 2023, an 8.7% increase over 2022. This continuous upward trend in transplant volumes underscores the critical role of robust HLA typing in facilitating donor-recipient matching.

Concurrently, advancements in HLA typing technologies are revolutionizing the market by offering enhanced accuracy, resolution, and efficiency. The shift towards high-resolution molecular HLA typing methods, particularly next-generation sequencing, enables a more comprehensive understanding of HLA allele diversity, reducing ambiguity in matching and improving transplant outcomes. This technological progression is evident in clinical adoption rates; according to a study published in Frontiers in Genetics in October 2023, 63% of 16 Canadian HLA Laboratories employed Next-Generation Sequencing technology as their primary genotyping tool. This widespread integration of advanced methods highlights the industry's commitment to optimizing compatibility assessment. Broader financial support for improving transplant-related diagnostics and treatments is also significant, with NMDP, in January 2024, "Be The Match Affirms Global Leadership in Life-saving Cell Therapies with New Name, Brand: NMDP", and its collaborative research program investing over $77.2 million in research and infrastructure during 2023.

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Key Market Challenges

The persistent global shortage of compatible donor organs significantly impedes the expansion of the Global Human Leukocyte Antigen typing for transplant market. The foundational demand for HLA typing is intrinsically linked to the volume of transplant procedures performed, as these diagnostic tests are essential for assessing donor-recipient compatibility and mitigating immune rejection. A scarcity of available organs directly limits the number of potential transplant surgeries, thereby reducing the overall requirement for HLA typing.

This constraint is evident in the substantial discrepancy between patients awaiting transplants and available organs. For instance, according to the Health Resources and Services Administration, as of November 2023, over 103,000 candidates were on the waiting list for organ transplants in the United States. This considerable unmet need for organs means that a significant portion of potential transplant recipients cannot proceed with surgery, which consequently restricts the market for pre-transplant HLA diagnostic services, despite ongoing advancements in typing technologies.

Key Market Trends

The increasing application of Artificial Intelligence in Human Leukocyte Antigen data analysis is enhancing the precision of donor-recipient matching for transplantation. AI algorithms efficiently process extensive genomic data, enabling sophisticated pattern recognition and predictive modeling essential for navigating the complex polymorphism of HLA genes. This capability directly improves transplant success rates by identifying optimal matches and mitigating immune complications. Research highlighted in the "Artificial Intelligence Approaches in Hematopoietic Cell Transplantation: A Review of the Current Status and Future Directions" published in October 2023, demonstrated that algorithms incorporating HLA and killer-cell immunoglobulin-like receptor data could increase donor selection prediction accuracy by 3-4% compared to standard methods. This technological advancement supports more informed clinical decisions and improved patient outcomes.

The emergence of point-of-care HLA typing solutions is revolutionizing transplant logistics by enabling rapid, decentralized testing. These portable platforms deliver quick genotype results directly in clinical settings, crucial for urgent cases and optimizing organ utilization. Such solutions alleviate the logistical challenges and lengthy turnaround times often associated with centralized laboratory testing. For example, a review in "Advancements in HLA Typing Techniques and Their Impact on Transplantation Medicine" published in December 2024, noted that nanopore sequencing technology, specifically the MinION device with a Flongle adapter, could genotype individual HLA samples in under six hours. This expedited on-site assessment significantly shortens the matching process, improving patient management and potentially reducing ischemia times for transplanted organs.

Segmental Insights

The Reagents & Consumables segment is demonstrating the most rapid expansion within the Global HLA Typing for Transplant Market. This significant growth is primarily driven by the inherently recurrent nature and frequent utilization of reagents and kits in every HLA typing test cycle. The global increase in organ and stem cell transplantation procedures further escalates demand, as each procedure necessitates precise HLA matching, leading to continuous consumption and replenishment of these essential products. Furthermore, ongoing advancements in molecular diagnostic technologies, such as Next-Generation Sequencing, require specialized, high-performance reagents, thereby propelling the segment's rapid growth.

Regional Insights

North America dominates the global HLA Typing for Transplant Market due to its highly advanced healthcare infrastructure and the substantial volume of organ transplant procedures conducted annually. The region benefits from the widespread integration of advanced molecular diagnostic technologies, including Next-Generation Sequencing, which improves the precision and efficiency of HLA typing. Furthermore, strong governmental support through agencies like the Health Resources and Services Administration and well-established organizations such as the United Network for Organ Sharing creates a conducive environment for transplantation diagnostics. This leadership is further strengthened by favorable reimbursement policies and the prominent presence of key diagnostic companies driving continuous innovation within the market.

Recent Developments

• In October 2025, CareDx, Inc. presented new innovations and products at the American Society for Histocompatibility and Immunogenetics Annual Meeting, which occurred earlier this month. The company notably launched AlloSeq Tx11, a next-generation HLA typing solution designed with enhanced Class II coverage to improve donor-recipient matching in both solid organ and hematopoietic stem cell transplantation. Furthermore, CareDx announced that its existing AlloSeq Tx and QTYPE products had received certification for compliance with the In Vitro Diagnostic Regulation (IVDR) in the European Union, reinforcing its global leadership in high-quality HLA diagnostics.

• In April 2025, Thermo Fisher Scientific introduced the One Lambda HybriType HLA Plus Typing Flex kit, an advanced next-generation sequencing (NGS) solution designed to enhance human leukocyte antigen (HLA) typing research. This new product utilizes hybrid capture assay technology to optimize read balance and minimize allele dropout, ensuring high-confidence genotyping results. The kit supports comprehensive Class I and Class II genotyping with robust flexibility and is compatible with diverse sample types. Its streamlined workflow significantly reduces processing and hands-on time, integrating with TypeStream Visual NGS Software for efficient, automated analysis in transplant diagnostics.

• In October 2024, CareDx, Inc. showcased significant advancements across its HLA typing solutions. The company featured new data supporting its AlloSeq NGS-based HLA typing solutions, highlighting their clinical utility in both living organ donation typing and bone marrow transplantation. Additionally, CareDx launched an enhanced version of its QTYPE solution. This updated product now includes single bead antigen resolution, which is critical for facilitating virtual crossmatching in deceased donor typing and ultimately expediting transplant decisions. These innovations underscore the company's commitment to improving donor-recipient compatibility.

• In August 2024, Thermo Fisher Scientific received 510(k) clearance from the U.S. Food and Drug Administration for its SeCore CDx HLA A Sequencing System. This system was approved as a companion diagnostic to support Adaptimmune’s Tecelra (afamitresgene autoleucel), a T-cell receptor therapy. This regulatory approval signifies an expanded application for HLA typing technology, moving beyond traditional transplant compatibility assessment. The clearance positions HLA typing as an essential tool for guiding patient selection in specific therapeutic treatments, thereby broadening its impact within personalized medicine and transplant-related oncology.

Key Market Players

• Thermo Fisher Scientific, Inc.
• Illumina, Inc.
• Qiagen N.V.
• Bio-Rad Laboratories, Inc.
• F. Hoffmann-La Roche Ltd
• Immucor, Inc.
• Caredx. Inc.
• Luminex Corporation (Diasorin)
• Tbg Diagnostics Limited

Report Scope:

In this report, the Global HLA Typing for Transplant Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• HLA Typing for Transplant Market, By Product & Service:

o   Reagents & Consumables

o   Instruments

o   Software & Services

• HLA Typing for Transplant Market, By Technology:

o   Molecular Assay Technologies

o   Non-molecular Assay Technologies

• HLA Typing for Transplant Market, By Application:

o   Diagnostic Applications

o   Antibody Screening

o   Chimerism Monitoring

o   Research Applications

o   Others

• HLA Typing for Transplant Market, By Transplant Type:

o   Solid Organ Transplant

o   Soft Tissue Transplant

• HLA Typing for Transplant Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global HLA Typing for Transplant Market.

Available Customizations:

Global HLA Typing for Transplant Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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