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市场调查报告书
商品编码
1525456
全球 HLA 分型市场评估:按产品与服务、按技术、按应用、按最终用户、按地区、机会、预测(2017-2031 年)HLA Typing Market Assessment, By Products and Services, By Technology, By Application, By End-user, By Region, Opportunities and Forecast, 2017-2031F |
全球 HLA 分型市场规模预计将从 2023 年的 13.1 亿美元增至 2031 年的 21.3 亿美元,2024-2031 年预测期间复合年增长率为 6.27%。器官移植需求的不断增长、遗传性疾病病例数量的增加、对研究活动的日益关注以及市场主要参与者推出的新产品支持了市场的增长。
Health Resource and Services Administration(HRSA)估计,美国约有 103,223 名男性、女性和儿童在全国移植等待名单上。这种增加促使器官移植病例和 HLA 分型需求的增加。由于遗传和自体免疫疾病负担的增加,研究活动不断增加,全球 HLA 分型市场规模不断扩大。American Autoimmune 估计约有 5,000 万美国人患有一种或多种自体免疫疾病。
市场领导者开发的新技术、产品和软体正在为市场创造利润丰厚的成长机会。2024 年 6 月,Thermo Fisher Scientific Inc. 宣布推出 Applied Biosystems Axiom BloodGenomiX Array和软体,用于在临床研究中进行准确的血液基因分型。这种新阵列可以在一次检测中检测血小板类型、稀有血型和组织,有助于扩展表型捐赠者血液匹配的进步。基于 DNA 的血型检测的增加预计将支持大规模基因组研究,并引入国际标准以提高输血的有效性和安全性。增加基于可扩展阵列的血型解决方案的使用预计将能够有效筛选不同的血型以进行准确匹配。
HLA 分型技术的进步支持市场扩张
领先的市场参与者和各种研究机构加强开发先进技术,预计将在未来几年为市场提供利润丰厚的成长机会。包括 PacBio 和 Illumina 在内的新一代定序 (NGS) 技术彻底改变了 HLA 分型,因为它们能够对整个 HLA 基因(包括非编码区和编码区)进行定序。
2023 年 11 月,F. Hoffmann-La Roche Ltd 推出了下一代 qPCR 系统,以应对公共卫生课题并推动个人化医疗。LightCycler PRO System预计将透过为诊断和转化研究提供灵活性和敏捷性来提供疫情回应能力。此外,2023年4月,Metropolis Healthcare Limited推出了NextGen HLA分型测试,透过分析HLA基因来识别适合器官移植、脐带血和骨髓的捐赠者。NextGen HLA 分型测试预计将帮助医生和患者确保移植后受者和供者之间 HLA 高度匹配,从而增加移植成功的可能性。
器官移植的增加推动 HLA 分型市场的成长
由于捐赠器官数量的增加而促使的器官移植数量的增加是推动全球 HLA 分型市场需求的主要因素之一。根据Organ Procurement and Transplantation Network(OPTN))的数据,2023年美国约有16,335人将在死亡时捐赠一个或多个器官,比2022年增加9.6%。器官捐赠的增加可归因于人们对该程序及其对捐赠者健康影响的认识的提高。这促进了 HLA 匹配的需求,因为它降低了与移植后併发症相关的风险,并促进健康新血球的发育和生长。捐赠者和接受者必须至少在六个 HLA 标记上配对。不匹配程度越高,患者的免疫系统就越有可能产生抗体来攻击移植物。
本报告针对全球HLA分型市场进行研究分析,提供市场规模及预测、区域市场前景、市场动态、竞争格局等。
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.