The HLA Typing Market is projected to grow at a compound annual growth rate (CAGR) of 5.6% from 2022 to 2029, with an anticipated market value of $1.90 billion by the end of 2029. This growth is attributed to the increasing incidence of organ failures and advancements in HLA typing technologies.
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Critical Role of HLA Genes
HLA genes are expressed by nearly all nucleated cells and play a vital role in the body’s ability to accept or reject transplanted organs. Accurate HLA matching between donors and recipients is essential for successful organ transplantation, driving the demand for precise HLA typing.
Factors Contributing to Organ Failures
Chronic health conditions, including diabetes, high blood pressure, metabolic syndrome, and chronic kidney disease (CKD), are significant contributors to organ failures. In 2021, the CDC noted that about 37 million Americans had CKD, which heightens the risk of organ failure and escalates the demand for transplantation services.
Organ Transplant Procedures Influence Market Growth
The rise in organ transplant procedures, along with better success rates and improved post-transplant outcomes, continues to foster growth in the HLA typing market. The technological advancements in HLA typing solutions further propel this expansion.
Evolution of HLA Typing Technologies
Early HLA typing methods relied on serological assays, which were limited in resolution and faced challenges due to polyclonal sera. The introduction of Polymerase Chain Reaction (PCR) technology marked a significant improvement in HLA genotyping accuracy, although it had difficulties in distinguishing between alleles. More sophisticated technologies, such as Sanger sequencing, and the introduction of Next Generation Sequencing (NGS) and third-generation sequencing, have transformed HLA typing.
High-Resolution Genotyping with NGS
NGS allows for high-resolution genotyping by enabling the parallel sequencing of DNA molecules, offering comprehensive characterization of entire HLA genes. Meanwhile, third-generation sequencing mitigates PCR bias by providing long reads, significantly enhancing the precision of HLA typing.
Major Innovations in the Industry
Industry leaders are increasingly focusing on developing advanced HLA typing solutions. For example, in 2021, Thermo Fisher Scientific launched a rapid NGS assay capable of generating high-resolution data in just five hours, particularly for characterizing HLA genes in solid organs from deceased donors. Additionally, Genome Diagnostics B.V. (GenDx) released the NGStrack reagent and TRKengine software for HLA typing with chimerism monitoring using NGS technology.
Broadening HLA Typing Applications
Beyond organ transplantation, HLA typing is becoming crucial in diagnosing infectious diseases, immune disorders, and cancer. The HLA region is associated with susceptibility to various diseases, and HLA gene markers are used to diagnose autoimmune conditions. For instance, HLA-B27 antigens in white blood cells can indicate autoimmune diseases such as ankylosing spondylitis and reactive arthritis.
Positive Market Outlook
With the continued increase in organ transplant demand and ongoing innovations in HLA typing technologies, the market is well-positioned for robust growth in the coming years. The introduction of advanced molecular assays and sequencing platforms is expected to enhance the accuracy and efficiency of HLA typing, ultimately improving transplant success rates and expanding its applications in healthcare.
Key Market Players
Key players in the global HLA Typing Market include Thermo Fisher Scientific Inc. (U.S.), Bio-Rad Laboratories (U.S.), Qiagen N.V. (Netherlands), Genome Diagnostics B.V. (GenDx) (Netherlands), Illumina, Inc. (U.S.), CareDx (U.S.), Immucor Inc. (U.S.), TBG Diagnostics Limited (Australia), BAG Diagnostic GmbH (Germany), Omixon Inc. (Hungary), Luminex Corporation (U.S.), inno-train Diagnostik GmbH (Germany), Pacific Biosciences of California, Inc. (U.S.), and Fujirebio Holdings, Inc. (Japan). The market is fragmented, with major players Thermo Fisher Scientific Inc., Becton, Dickinson and Company, and Illumina, Inc. collectively accounting for 20%–25% of the HLA typing market in 2021.
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