Immunogenetics Market Size & Share Analysis - Growth Trends and Forecast (2026 - 2031)

Global Immunogenetics Market Trends and Insights

Rising Solid-Organ and HSCT Transplant Volumes

Transplant activity remained the primary source of testing demand in the immunogenetics market. Transplant procedures required testing for donor assessment, recipient preparation, compatibility evaluation, and post-transplant monitoring. The Global Observatory on Donation and Transplantation (GODT) recorded 173,727 solid-organ transplants in 2024, including 110,467 kidney transplants. The 2024 EBMT survey recorded 21,023 allogeneic hematopoietic cell transplants across 688 centers in 53 countries. Unrelated-donor procedures reached 11,716, a 5% increase from the previous year, requiring more detailed matching than sibling transplants.^{[1]Global Observatory on Donation and Transplantation, “Global Data on Donation and Transplantation,” Global Observatory on Donation and Transplantation, transplant-observatory.org.} The U.S. registry facilitated more than 8,400 unrelated blood stem-cell transplants in FY2025, expanding demand for high-resolution testing.

Expansion of High-Resolution NGS-Based HLA Typing

High-resolution NGS-based HLA typing gained importance as laboratories sought definitive allele calls and reduced phasing uncertainties. The immunogenetics market benefited as laboratories replaced lower-resolution serology methods with workflows supporting detailed donor-recipient matching. QIAGEN launched QIAseq xHYB Long Read Panels for HLA typing on PacBio HiFi platforms in July 2025. Illumina’s February 2026 NovaSeq X roadmap included a 40% output increase and DRAGEN enhancements for 4-field HLA typing, while its installed base reached 890 NovaSeq X systems globally by the end of FY2025. Long-read methods supported pre-transplant typing and post-transplant monitoring from a single library, changing laboratory workflows and reagent requirements.

Growing Use of HLA Testing in Pharmacogenomics and Companion Diagnostics

HLA testing expanded beyond transplant laboratories into clinical drug-selection workflows, broadening the buyer base for the immunogenetics market. A 2026 CERSI-PGx guideline recommended HLA genotyping for carbamazepine, oxcarbazepine, and eslicarbazepine to assess severe hypersensitivity risk. A 2026 scientific review linked HLA alleles with anti-infective drug toxicity and vaccine immune response. These applications generated demand beyond transplant volumes and created purchasing opportunities across clinical pharmacy, companion diagnostics, and treatment planning.^{[2]J. Galloway et al., “HLA Genotype Testing for Carbamazepine, Oxcarbazepine and Eslicarbazepine,” British Journal of Clinical Pharmacology, cersi-pgx.org.}

HLA and KIR Complexity Driving Demand for Allele-Level Resolution

The growing diversity of immune gene variants increased the need for allele-level resolution in the immunogenetics market. The IPD-IMGT/HLA database recorded 43,758 alleles in release 3.63 in January 2025. China’s 2025 catalog increased common, intermediate, and well-documented HLA designations from 676 alleles in the 2018 edition to 1,144 alleles across five loci. KIR typing gained attention because KIR-HLA interaction profiles affected allogeneic transplant outcomes in patients with hematological malignancies. The SpecImmune framework achieved 98% accuracy for 4-field HLA typing across 1,019 samples while supporting KIR and germline IG/TCR genotyping from long-read data. Broader HLA and KIR panels enabled laboratories to obtain more clinical information from each sample.

High Cost of Molecular Testing and Sequencing Infrastructure

The cost of molecular typing remains a barrier to broader access in the immunogenetics market, particularly for mid-tier hospitals and public transplant programs. NGS-based workflows require investment in instruments, library reagents, sequencing flow cells, software, staff training, and quality controls. A 2025 study of a nanopore multiplexed HLA typing protocol found that cost competitiveness depended heavily on batch-size optimization. Smaller laboratories often cannot achieve the required volumes, while ISO 15189 accreditation increases spending on quality management, calibration, and personnel training.^{[3]World Marrow Donor Association, “The Registry of Unmet Need: A World Marrow Donor Association Analysis of Patients Without an HLA Match,” HLA, doi.org.} As a result, regional hospitals may rely on external reference laboratories, extending turnaround times for urgent deceased-donor cases.

Uneven Reimbursement and Regulatory Requirements Across Countries

Reimbursement policies and regulatory requirements create uneven incentives for high-resolution HLA testing across countries in the immunogenetics market. The European Union requires HLA typing devices to meet the IVDR conformity certification deadline in December 2027, including technical documentation, clinical evaluation, and quality-management audits under Regulation (EU) 2017/746. China issued registration review guidance for HLA genotyping reagents in January 2026, covering PCR, high-throughput sequencing, and related methods. These requirements can favor companies with the resources to complete validation and certification programs. In countries without dedicated reimbursement for high-resolution NGS testing, laboratories can continue using lower-cost methods despite the clinical value of more detailed testing.

*Our forecasts treat driver/restraint impacts as directional, not additive. The impact forecasts reflect baseline growth, mix effects, and variable interactions.

Segment Analysis

By Product and Service Type: Reagents and Consumables Anchor Revenue While Software Expands

Reagents and consumables held 51.67% of revenue in 2025, representing the largest share in this segmentation. Each NGS typing run requires new library-preparation chemistry, target-capture panels, and sequencing flow cells, creating recurring demand that increases with transplant testing volumes. Services remain essential for transplant centers that lack the volume or capital to operate in-house NGS workflows, while instruments remain critical because laboratory protocols, staff training, and validation processes are often platform-specific.

Software and bioinformatics is the fastest-growing category, with the immunogenetics market size for this segment expected to grow at an 11.20% CAGR from 2026 to 2031. Laboratories are shifting from manual reviews of ambiguous allele calls to integrated tools that support data interpretation and laboratory information system workflows. QIAGEN’s long-read panels, launched in July 2025, separate target-enrichment chemistry from sequencing platform selection. Werfen’s NanoTYPER software integrates with the NanoTYPE HLA-11 Plus CE-IVD assay, while IVDR documentation requirements can increase compliance costs and strengthen the position of validated software providers.

By Technology: Molecular Assays Lead Scale and Growth

Molecular assays accounted for 55.45% of revenue in 2025 and led the technology segment. The category includes NGS-based high-resolution typing, real-time PCR, and sequence-specific oligonucleotide probe methods that provide the detailed HLA information required for transplant-matching decisions. The shift from short-read NGS to long-read sequencing on Oxford Nanopore and PacBio platforms can reduce phasing ambiguity and support full-gene characterization in time-sensitive settings.

Molecular assays also recorded the highest projected CAGR at 10.46% from 2026 to 2031. Werfen’s NanoTYPE HLA-11 Plus is a CE-IVD product that provides full-gene coverage from 5′UTR to 3′UTR across 11 classical HLA loci. Non-molecular assays continue to support complement-dependent cytotoxicity crossmatch testing and solid-phase antibody detection, particularly in high-throughput blood bank and transfusion center workflows. A 2025 study reported 100% concordance for a nanopore multiplex PCR method across 90 apheresis platelet donors compared with established approaches.

By Application: Solid-Organ Transplantation Leads While Stem-Cell Transplantation Grows

Solid-organ transplantation accounted for 66.78% of revenue in 2025 and represented the largest application in the immunogenetics market. Kidney transplantation remains the primary demand driver, with 110,467 procedures performed globally in 2024, each requiring donor-recipient typing, compatibility assessment, and crossmatch testing. Donation after circulatory determination of death increased by 17% in 2024, increasing the need for typing results within hours of organ procurement.

Hematopoietic stem-cell transplantation recorded the highest projected CAGR at 11.67% from 2026 to 2031. EBMT-area allogeneic hematopoietic cell transplants reached 21,023 in 2024, an increase of 2.6% from 2023, and unrelated donors accounted for 56% of cases, requiring intensive high-resolution typing. CAR-T recipients in Europe increased by 24.5% to 6,082 patients in 2024. Companion diagnostics, pharmacogenomics, disease-association testing, immunotherapy, and vaccine research continue to broaden the use of HLA characterization.

By End User: Hospitals Lead Revenue While Blood Banks Expand

Hospitals and transplant centers accounted for 55.89% of revenue in 2025 and held the largest revenue share among end users. Major transplant programs often operate in-house histocompatibility laboratories under ASHI and EFI accreditation requirements, supporting demand for validated typing methods and minimum equipment standards. Independent reference laboratories manage overflow testing and serve pediatric and community hospitals without dedicated programs, while pharmaceutical and biotechnology companies use HLA characterization in CAR-T and TCR-T manufacturing, companion diagnostic development, and clinical trial patient selection.

Blood banks and transfusion centers recorded the highest projected CAGR at 12.77% from 2026 to 2031. Molecular blood typing is expanding beyond ABO and Rh serology to include HLA and human platelet antigen profiling, helping prevent platelet refractoriness and other transfusion-related complications. The National Kidney Registry reported in Q1 2026 that DQ molecular mismatch is an emerging prognostic biomarker for primary alloimmunity in living-donor kidney transplantation. DKMS Lab had submitted more than 10,000 HLA sequences, including 6,500 novel alleles, to the IPD-IMGT/HLA Database by January 2025.

Geography Analysis

North America held a 41.23% share of the global immunogenetics market in 2025. The United States supported the regional market through its established transplant infrastructure and molecular testing investments. The OPTN recorded more than 48,000 organ transplants in the United States in 2024, driving recurring pre- and post-transplant testing volumes. The U.S. registry included more than 9.4 million potential adult donors and facilitated over 8,400 unrelated blood stem-cell transplants in FY2025. More than 36,000 new diverse registrants joined the registry in the first quarter of FY2026.

Europe represented the second-largest region in the immunogenetics market, led by Germany, the United Kingdom, and France. NHS Blood and Transplant reported 4,666 organ transplants during the 2025-2026 reporting year and 8,296 patients on the active transplant list as of March 31, 2026. Eurotransplant recorded 4,039 transplants across its seven member countries in the first half of 2026. Germany remained a major HSCT center and contributed significant reference data through DKMS. CareDx received IVDR certification for AlloSeq Tx and QTYPE in October 2025, while Werfen introduced NanoTYPE HLA-11 Plus, a fully certified full-gene HLA assay under the new regulation.

Asia-Pacific is projected to record the highest regional CAGR of 12.98% through 2031. China formalized its registration pathway for HLA genotyping reagents through guidance issued on January 9, 2026. In India, a 2025 study of 130,518 stem-cell donors across eight population groups found 10/10 HLA match probabilities below 15% for most subpopulations, highlighting the need for population-specific, high-resolution reference data. The Middle East and Africa faced registry representation and capacity constraints, while Gulf Cooperation Council states expanded transplant capacity. In South America, Brazil advanced through the HEMOAM center’s 2025 integration of NGS-based HLA typing into the REDOME registry.