Immunogenetics - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2026-2031)

The immunogenetics market size is expected to grow from USD 6.20 billion in 2025 to USD 6.77 billion in 2026 and is forecast to reach USD 10.51 billion by 2031 at 9.20% CAGR over 2026-2031. This report is segmented by Product and Service Type (Instruments, Reagents, Software and Bioinformatics; Services), Technology (Non-Molecular, Molecular Assays), Application (Solid-Organ Transplant, Pharmacogenomic, and More), End User (Hospitals and More), and Geography (North America, Europe, and More). Forecasts in Value (USD).

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. 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.

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. As a result, regional hospitals may rely on external reference laboratories, extending turnaround times for urgent deceased-donor cases.

Other drivers and restraints analyzed in the detailed report include:

• Growing Use of HLA Testing in Pharmacogenomics and Companion Diagnostics
• HLA and KIR Complexity Driving Demand for Allele-Level Resolution
• Uneven Reimbursement and Regulatory Requirements Across Countries

Segment Analysis

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.

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.

Complete Report Scope:

• By Product and Service Type
  • Instruments
  • Reagents and Consumables
  • Software and Bioinformatics
  • Services
• By Technology
  • Non-Molecular Assays
  • Molecular Assays
• By Application
  • Solid-Organ Transplantation
  • Hematopoietic Stem-Cell Transplantation
  • Transfusion Medicine
  • Cellular Therapy
  • Companion Diagnostics
  • Disease Association and Risk Testing
  • Pharmacogenomics
  • Immunotherapy and Vaccine Research
  • Others
• By End User
  • Hospitals and Transplant Centers
  • Independent Reference Laboratories
  • Blood Banks and Transfusion Centers
  • Research Laboratories and Academic Institutes
  • Pharmaceutical and Biotechnology Companies
  • Others
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

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.

List of Companies Covered in this Report:

• Agilent Technologies
• BAG Diagnostics GmbH
• Beckton Dickinson
• Bio-Rad Laboratories
• CareDx, Inc.
• Eurobio Scientific
• Roche
• Fujirebio Co., Ltd.
• GenDx B.V.
• Illumina
• Immucor
• Mylab Discovery Solutions Pvt. Ltd.
• NeoGenomics Laboratories
• Omixon
• Oxford Nanopore Technologies plc
• Pacific Bioscience
• QIAGEN
• Revvity, Inc.
• Takara Bio
• TBG Biotechnology Corporation
• Thermo Fisher Scientific
• Werfen

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support