Human Leukocyte Antigen (HLA) typing is used to match patients and donors for bone marrow or cord blood transplants. Due to growing transplant failures, there is an escalating need to match the organ transplant probability before the surgery to evade any loss. Globally, government and private players are heavily investing in R&D for HLA typing.
The HLA typing for the transplant market was estimated at USD 590 million in 2019 and is expected to grow with a CAGR of 9.5%.
The continually rising number of patients suffering from chronic disorders has surged the prevalence of organ failure, ultimately generating an upsurge in demand for transplant procedures. The 'Organ-Donor'org states that above 1 million tissue transplants are performed annually. According to the National Health Council's statistics, nearly 133 million Americans are suffering from chronic ailments, and by 2020, it is expected to upsurge at an estimate of 157 million.
Amongst all, chronic kidney disease (CKD) is the most leading cause of kidney transplantation procedures. NIDDK states that 14% of the general population suffers from CKD, and more than 661,000 Americans have kidney failure. Of these, 468,000 individuals are on dialysis and roughly 193,000 live with a functioning kidney transplant. Thus, the escalating prevalence of chronic ailments and growing disability of vital organs has led to high demand for organ transplantation, further contributing to the high demand for HLA Typing.
The continually increasing elderly population has surged the need for transplantations as this age group is highly prone to chronic disorders. By 2050, the global population aged 60 years and older is expected to reach 2 billion, up from 900 million in 2015. Currently, 125 million people are aged 80 years, and above and by 2050, there might be 434 million. Thus, the large patient pool for organ transplantation is concentrated in the geriatric age group.
Technological breakthroughs in molecular assay techniques positively influence the growth of HLA typing for transplant market. Currently, to track causative pathogen disease, a target-sensitive PCR technique is used. Firms are focusing more on designing novel HLA typing platforms. Developments have been made from initial phases of single pathogen identification to nucleic acid amplification techniques to deliver rapid and precise performance.
Techniques such as nucleic acid amplification and detection, genomic analysis, proteomics, and metabolomics have enabled several molecular diagnostic assays. Advances in genetic sequencing also provided novel growth prospects for more custom-made medical approaches, coupled with developments in metabolomics and proteomic profiling technology. The rising demand for molecular diagnostics has retained pressure on market leaders to produce new technologies to accomplish the buyer needs for their potential to deliver reliable results in less time.
With hematology and chemistry analyzers, numerous laboratories are conducting molecular experiments. A research study reveals that the test for gene sequencing costs USD 5,000 to USD 10,000 per test, which is not affordable for most of the population. Besides, the issues of HLA ambiguity and phasing multiple short-read fragments are resolved with 3rd-generation sequencers able to examine long-reads covering entire intronic-exonic regions of whole genes. The optimization and steadily reducing cost and error rates of these sequencers might institute their dominance in the field of HLA typing.
Instruments are nowadays being designed with more focus on function and cost-effectiveness. The introduction of new technology has made it possible to develop methods that produce more precise and accurate information rapidly. For instance, Thermo Fischer provides Lambda's complete line of instrumentation designed to simplify assay workflows and surge testing efficacy in the HLA laboratory.
Technological advancements in computational capabilities with modern hardware and software solutions installed in these instruments are expected to propel the instruments' usability. For example, in January 2019, Oxford Nanopore Technologies launched NanoPipe, a web-based server to analyze data generated from nanoporeMinION. The server is designed to provide simple User interface-based options such that it can be easily used by wet-lab biologists with little knowledge about bioinformatics platforms and coding and experienced bioinformaticians. Also, instruments often have a longer shelf life, which would help fuel the HLA typing equipment market.
The rising number of patients visit and the growing number of transplant procedures in hospitals has surged the demand for HLA. In the European Union, around 60,000 people were on the waiting lists for organ transplants in 2017. The waiting list is mounting due to an upsurge in diabetes, which has led to the urgent need for more kidney and pancreas transplants.
The Organ Procurement and Transplantation Network (OPTN) has launched a collaborative improvement project for 2020. The OPTN has employed a new liver and intestinal organ distribution system to advance the process of matching life-saving organs to candidates with urgent needs. Increasing solid organ and bone marrow transplantation may further impel the segment growth of HLA typing in hospitals.
Source – Organdonor.gov (U.S. Government Information on Organ Donation and Transplantation)
North America dominates the HLA typing for the transplant market in the estimated study period. The escalating prevalence of chronic ailments, the growing occurrence of loss, and the disability of vital organs have led to high demand for organ transplantation across the globe in the past few years. Due to the escalating number of organ transplantation, there has been a surge in need for more testing services through transplant-related health care facilities. As per the U.S. Government Information on Organ Donation and Transplantation, the number of men, women, and children on the national transplant waiting list as of March 2020 was around 112,000. About 39,718 transplants were performed in 2019. As of March 2020, more than 112,000 candidates for transplant on the U.S. national waiting list.
The U.S. and Canada are very well equipped with funded organizations, infrastructure, and active government involvement in raising funds and consciousness elevating to encourage transplantation of the patient's diseased organs. Many initiatives and awareness programs are being carried out by companies, such as Roche working with hospitals, and organizations, such as the American Transplant Foundation, UNOS, National Kidney Foundation, and Donate Life America, to bolster organ donors rate. With a comprehensive portion of the world's population seeking the U.S and Canada for better health care services, the region is projected to be extremely profitable for development and winning over the forecast era.
In the COVID-19 pandemic, all registries have been affected, including HLA typing for transplantation, as they face significant difficulties in exporting goods. In April 2020, the FDA issued updated information for organizations accumulating human cell and tissue products (HCT/Ps), including PBSC and marrow, to address these effects and reactions to COVID-19. Besides, industry leaders in this region are concentrating on R&D investments can contribute to HLA typing advances, affecting the expansion of the market.
Asia-Pacific is expected to emerge as the fastest-growing region in market share for HLA typing for transplants market. The growth can be attributed to the high demand for accurate and high-quality diagnostics tests, a rise in awareness for early and precise diagnoses of chronic and genetic diseases, and the rising elderly population. Investment in the healthcare sector is growing in China and India. Other private companies are now participating in healthcare systems in developed nations.
The critical regulatory agencies and their efforts to promote quality control systems in molecular diagnosis have further fueled the market growth. For instance, the Asia-Pacific Federation of Clinical Biochemistry and Laboratory Medicine (APFCB) has encouraged the adoption of molecular diagnostic quality control systems. Besides, regulatory authorities, such as the Ministry of Health and Welfare, Pharmaceuticals and Medical Devices Evaluation Agency, and the ministry of food processing industries, ensure precise monitoring of molecular quality control systems.