세계 HLA 타이핑 시장 규모는 2023년 13억 1,000만 달러에서 2031년 21억 3,000만 달러에 달할 것으로 예상되며, 예측 기간인 2024-2031년 동안 연평균 6.27% 성장할 것으로 예상됩니다. 시장 성장은 장기 이식에 대한 필요성 증가, 유전성 질환 사례 증가, 연구 활동에 대한 관심 증가, 시장 주요 기업의 신제품 출시 등에 의해 뒷받침됩니다.
Health Resource and Services Administration(HRSA)의 추산에 따르면, 미국에는 약 10만 3,223명의 남녀와 어린이가 전국 이식 대기자 명단에 올라있습니다. 이러한 증가는 장기 이식 사례의 증가로 이어져 HLA 타이핑의 필요성이 증가하고 있습니다. 미국 자가면역학회(American Autoimmune)의 추산에 따르면 약 5,000만 명의 미국인이 하나 이상의 자가면역질환을 앓고 있는 것으로 추정되며, 유전성 질환과 자가면역질환의 부담 증가에 따른 연구 활동의 증가로 인해 세계 HLA타이핑의 시장 규모가 증가하고 있습니다.
시장의 주요 기업들이 새로운 기술, 제품 및 소프트웨어를 개발함에 따라 시장에 유리한 성장 기회를 제공하고 있으며, 2024년 6월 Thermo Fisher Scientific Inc. Biosystems Axiom BloodGenomiX Array와 소프트웨어를 발표했습니다. 이 새로운 어레이는 혈소판 유형, 희귀 혈액형, 희귀 혈액형 및 조직을 한 번의 분석으로 검출할 수 있어 확장된 표현형 기증자 혈액형 적합성 향상에 기여하고, DNA 기반 혈액형 검사의 사용 증가는 대규모 유전체 연구를 지원하고 수혈의 효과와 안전성을 개선하기 위한 국제 표준을 도입하는 데 도움이 될 것으로 기대됩니다. 수혈의 효과와 안전성을 향상시킬 수 있는 국제 표준이 도입될 것으로 기대됩니다. 확장 가능한 어레이 기반 혈액형 검사 솔루션에 대한 접근성이 높아짐에 따라 다양한 혈액형을 효과적으로 선별하여 정확한 적합성을 확보할 수 있을 것으로 예상됩니다.
HLA 타이핑 기술 발전이 시장 확대를 뒷받침
시장 주요 기업들과 다양한 연구기관들이 첨단 기술 개발을 위한 노력을 강화함에 따라 향후 몇 년 동안 시장에 유리한 성장 기회를 제공할 것으로 예상되며, PacBio와 Illumina를 포함한 차세대 시퀀싱(NGS) 기술은 비코드 영역과 코드 영역을 포함한 전체 HLA 유전자 시퀀싱에 혁명을 일으켰습니다. 비코드 영역과 코드 영역을 포함한 전체 HLA 유전자 시퀀싱을 가능하게함으로써 HLA 타이핑에 혁명을 일으켰습니다.
2023년 11월, F. Hoffmann-La Roche Ltd는 공중보건 문제를 해결하고 개인 맞춤형 의료를 촉진하는 차세대 qPCR 시스템인 LightCycler PRO System을 출시했습니다. 진단 및 중개연구에 유연성과 민첩성을 제공함으로써 발병에 대한 즉각적인 대응력을 가져다 줄 것으로 예측됩니다. 또한 2023년 4월 Metropolis Healthcare Limited는 HLA 유전자를 분석하여 장기 이식, 제대혈 및 골수 기증자를 식별하는 NextGen HLA 타이핑 검사를 출시했습니다. 의사와 환자가 HLA 적합도가 높은 이식을 할 수 있도록 도와 이식 성공 가능성을 높일 수 있을 것으로 기대됩니다.
장기 이식의 증가로 HLA 타이핑 시장 성장 촉진
장기 기증 증가로 인한 장기 이식의 증가는 세계 HLA 타이핑 시장의 수요를 증가시키는 주요 요인 중 하나이며, Organ Procurement and Transplantation Network(OPTN)에 따르면 2023년 미국에서 사망 시 1개 이상의 장기를 기증한 사람은 약 16,335명으로 한 사람은 약 1만 6,335명으로 2022년 대비 9.6% 증가했습니다. 장기 기증의 증가는 장기 기증 절차 및 기증자의 건강에 미치는 영향에 대한 인식이 높아졌기 때문인 것으로 보입니다. 이는 HLA 매칭이 이식 후 합병증과 관련된 위험을 줄이고 건강한 새 혈액 세포의 발달과 성장을 촉진하기 때문에 HLA 매칭에 대한 수요를 촉진합니다. 기증자와 수혜자는 최소 6개의 HLA 마커가 일치해야 합니다. 불일치가 많으면 환자의 면역 체계에서 항체가 생성되어 이식편을 공격할 가능성이 높아지기 때문입니다.
이 보고서는 세계 HLA 타이핑 시장에 대해 조사 분석했으며, 시장 규모와 예측, 지역별 시장 전망, 시장 역학, 경쟁 상황 등을 제공합니다.
Global HLA typing market is projected to witness a CAGR of 6.27% during the forecast period 2024-2031, growing from USD 1.31 billion in 2023 to USD 2.13 billion in 2031. The market's growth is supported by the rising requirement for organ transplantation, increasing cases of genetic diseases, growing emphasis on research activities, and novel product launches by the leading players of the market.
According to the estimates of the Health Resource and Services Administration (HRSA) approximately 103,223 men, women, and children are on the national transplant waiting list in the United States. Due to this increase, the cases of organ transplant procedures are rising, bolstering the requirement for HLA typing. The global HLA typing market size is increasing due to the rising research activities on genetic and autoimmune diseases due to their growing burden. According to the estimates of the American Autoimmune, approximately 50 million Americans are living with one or more autoimmune diseases.
The development of novel technologies, products, and software by the leading players in the market is providing lucrative growth opportunities to the market. In June 2024, Thermo Fisher Scientific Inc. introduced their Applied Biosystems Axiom BloodGenomiX Array and software for precise blood genotyping in clinical research. The new array is capable of detecting platelet types, rare blood groups, and tissues in a single assay, aiding advancements in extended phenotype donor blood matching. Increasing utilization of DNA-based blood typing is expected to support large-scale genomics research and the introduction of international standards for improving the efficacy and safety of blood transfusion. The increasing accessibility of scalable array-based blood typing solutions is expected to effectively screen various blood types for precise matching.
Technological Advancements in HLA Typing Support the Market Expansion
The increasing efforts of the key players of the market and various research institutions toward the development of advanced technologies are expected to provide lucrative growth opportunities to the market in the forecast years. Next-generation sequencing (NGS) technologies, including PacBio and Illumina, have revolutionized HLA typing as they enable the sequencing of entire HLA genes, including noncoding and coding regions.
In November 2023, F. Hoffmann-La Roche Ltd launched a next-generation qPCR system to address public health challenges and advance personalized healthcare. The LightCycler PRO System is expected to provide outbreak readiness by providing flexibility and agility for diagnostics and translational research. Additionally, in April 2023, Metropolis Healthcare Limited launched their NextGen HLA typing test for identifying suitable donors for organ transplantation, cord blood, and bone marrow by analyzing the HLA gene. The NextGen HLA typing test is expected to aid physicians, doctors, and patients in ensuring transplants at a higher HLA match percentage between the recipient and the donor, bolstering the chances of successful transplants.
Increasing Organ Transplantation Boosts HLA Typing Market Growth
The rise in organ transplant procedures due to the increasing availability of donated organs is one of the major factors bolstering the global HLA typing market demand. According to the Organ Procurement and Transplantation Network (OPTN), in 2023, approximately 16,335 individuals donated one or more organs upon their death in the United States, showcasing a 9.6% increase from 2022. The increasing donations can be attributed to the growing awareness about the procedure and the impact of the donation on donor health. This propels the requirement for HLA matching as it reduces the risks associated with post-transplant complications and promotes the development and growth of healthy new blood cells. Donors and recipients should have a match of at least 6 HLA markers, as a high degree of mismatch augments the chances of antibody production from the immune system of the patient, which can attack the graft.
Diagnostics Segment Expected to Witness Significant Growth
The growth of the segment is supported by the rising requirement for organ transplantation and increasing cases of autoimmune and genetic diseases. For instance, the HLA-B27 test is conducted to confirm or dismiss suspected cases of ankylosing spondylitis (AS), juvenile rheumatoid arthritis, and reactive arthritis. The test aids healthcare professionals in determining the presence or absence of the HLA-B27 protein on the surface of the white blood cells in individuals. Additionally, the expansion of the segment is supported by the rising collaborations between different diagnostic and biotech companies to support the development of HLA typing kits. In November 2023, OSE Immunotherapeutics and GenDx announced the partnership for developing NGSengine software and NGSgo HLA-A typing kit as a companion diagnostic (CDx) for cancer vaccines. With the partnership, the companies aim to validate and develop a CDx test for epitope-based cancer vaccines to improve the survival and the quality of patients' lives.
North America Holds Significant Market Share
The presence of leading market players, rising requirements for organ transplantation in the region, novel product launches, and presence of well-established healthcare infrastructure are some of the major factors boosting the market's growth. According to estimates from the United Network for Organ Sharing (UNOS), in 2023 over 46,000 organ transplants were performed in the United States. This increase propels the market demand as HLA typing is one of the essential components for matching hematopoietic cells between the recipients and the donors for improving patient outcomes by aiding patients in avoiding graft-versus-host disease (GVHD) and acute graft rejection.
The strong presence of various research institutions and increasing investments in research activities are another significant factors supporting the market's expansion. For instance, the Memorial Sloan Kettering Cancer Center is conducting an interventional study to evaluate if the addition of specific genetic factors to the process of selecting a stem cell donor reduces the chances of leukemia coming back in patients after the bone marrow has been transplanted. The study is expected to conclude in May 2025 and aims to demonstrate that patients with adult acute myeloid leukemia (AML) who have donors with specific HLA and killer immunoglobulin-like receptors (KIR) genes have better outcomes.
Future Market Scenario (2024 - 2031F)
Market demand is expected to increase significantly over the forecast period due to the rise in the number of organ transplantations. Advancements in bioinformatics and nanopore technology are expected to enhance the efficiency, speed, and reliability of HLA genotyping, revolutionizing their clinical applications and immunogenetics.
The increasing autoimmune diseases incidences are bolstering the requirement for HLA typing, as it can provide insights about various risks of autoimmune diseases and guide the development of prophylactic interventions for reducing the risks in individuals that are susceptible to the disease.
The growing efforts of the key market players towards the development of novel technologies and products is another major factor expected to boost the growth of the market in the coming years.
Key Players Landscape and Outlook
The rising efforts of the key players of the market towards the development of novel products and technologies and increasing receival of approvals from various regulatory bodies are supporting the global HLA typing market growth. These efforts and approvals aid healthcare professionals in accurately diagnosing various diseases and disorders and support the introduction of new products to meet the evolving requirements of the healthcare industry.
In December 2022, Thermo Fisher Scientific Inc. announced that they received De Novo Classification from the US Food and Drug Administration (FDA) for their SeCore CDx HLA Sequencing System, the system allows clinicians to identify patients that will benefit from this immunotherapy breakthrough. The company plans on partnering with leading companies for commercializing and developing immunotherapies for meeting the unmet requirements of patients for a wide range of diseases.
All segments will be provided for all regions and countries covered
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.