市场调查报告书
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1447731
器官保存市场评估:按解决方案、技术、器官类型、最终用户和地区划分的机会和预测(2017-2031)Organ Preservation Market Assessment, By Solution, By Technique, By Organ Type, By End-user, By Region, Opportunities and Forecast, 2017-2031F |
全球器官保存市场规模将从2023年的2.8186亿美元增长到2031年的4.7176亿美元,在2024年至2031年的预测期内复合年增长率为6.65%。预计规模将会增长。
受全球器官移植数量增加以及延长器官保存期限和维持高器官存活率技术进步等驱动力的影响,器官保存市场预计将呈指数级增长。事实确实如此。 此外,投资者的支持和不断增长的医疗保健支出也正在推动市场成长。 越来越多的器官衰竭导致需要器官移植的病例也进一步增加了器官保存市场的需求。 器官移植手术的增加和器官研究的迅速增加,对器官保存解决方案的需求显着增加。 近年来,监管日益受到重视,多种相关产品的多项监管批准加强了主要参与者的市场地位。 政府对器官移植的支持和各个非营利组织的努力也进一步推动了市场需求。 另一方面,器官移植相关的高成本和併发症是市场成长的主要挑战。 此外,捐赠的器官与正在进行的器官移植之间的差距是市场扩张的另一个障碍。
器官移植数量增加
器官移植数量的不断增加正在推动对器官保存产品的需求。 解剖后的器官往往会很快恶化,因此器官保存液在移植前保护器官方面发挥重要作用。 器官移植增加的原因包括临床进步、可支配收入增加以及对器官捐赠和移植的认识提高。 根据器官取得和移植网发布的数据,2023年,死亡器官捐赠者数量将达到前所未有的高位,达到16,000人,这将是连续13年创下捐赠纪录。 此外,年内器官移植数量急剧增加,为克服器官衰竭而实施了超过 46,000 例挽救生命的手术。 其中,肝臟移植首次突破1万例,肺臟移植首次突破3000例。 此外,肾臟和心臟移植也创下了今年的新纪录,凸显了器官移植的令人瞩目的进展。
器官保存方法的进展
多年来,器官保存方法逐渐进步,以优化器官移植结果。 随后的创新包括复杂的配方,例如柯林斯、欧洲柯林斯和威斯康辛大学 (UW) 的解决方案,可延长保质期并提高器官活力。 目前,进入者正专注于开发具有復兴策略的产品,特别是提供模仿生理条件的动态环境的机械灌注系统。 这些系统为器官修復和长期保存提供了机会,减少了过程失败的可能性。 离体灌注是机械灌注的延伸之一,旨在透过进一步的修復机制和重编程过程进一步增强器官恢復。
本报告调查了全球器官保存市场,提供了市场定义和概述、市场规模趋势和预测、各个细分市场和地区的详细分析、行业结构以及影响市场成长的因素分析、案例研究、竞争格局、主要公司的简介等等。
Global organ preservation market is projected to witness a CAGR of 6.65% during the forecast period 2024-2031, growing from USD 281.86 million in 2023 to USD 471.76 million in 2031. The organ preservation market is anticipated to thrive exponentially under the influence of driving forces like the growing number of organ transplants being performed worldwide, and technological advancements to enhance the preservation time and maintain the high viability of organs. Additionally, rising investors' traction and healthcare spending also catalyze the market growth. Rising cases of organ failure leading to the requisite of organ transplantation further increase the demand in the organ preservation market. The increasing number of organ transplant procedures and the surging research being performed on organs have significantly increased the demand for organ preservation solutions. Increasing regulatory emphasis and various regulatory approvals for several relevant products in recent years have strengthened the market position of key players. Government support and initiatives taken by various non-profit organizations to facilitate organ transplants further enhance the demand in the market. However, the high cost associated with organ transplants and the complications associated with it are major challenges for market growth. The lacuna between the organs donated and organ transplants performed creates another barrier to market expansion.
Increasing Number of Organ Transplants
The increasing number of organ transplants is driving the demand for organ preservation products. Organ preservation solutions play a major role in safeguarding organs before transplantation, as isolated organs tend to deteriorate quickly. The reasons for increasing organ transplants include clinical advancements, high disposable income, and widespread awareness about organ donation and transplants. As per the data published by the Organ Procurement & Transplantation Network, in 2023, the number of deceased organ donors reached an unprecedented high of 16,000, marking 13 consecutive years of record-breaking donations. Moreover, the year witnessed an impressive increase in organ transplants, with over 46,000 life-saving procedures performed to overcome organ failures. Notably, liver transplants crossed the 10,000 mark for the first time, while lung transplants exceeded 3,000. Additionally, kidney and heart transplants also set new annual records, underscoring the remarkable progress in organ transplantation. Similarly, around 1589 kidney transplants, 761 liver, and 250 heart transplants were reported with India in the deceased category throughout the year 2022.
Advancements in Organ Preservation Methods
Organ preservation methods have progressively advanced throughout history, for the sake of optimizing organ transplantation outcomes. Subsequent innovations included refined formulations like the Collins, Euro-Collins, and University of Wisconsin (UW) solutions, which extended storage durations and enhanced organ viability. Presently, market players are focusing on developing products with revitalized strategies, particularly machine perfusion systems that offer a dynamic environment mimicking physiologic conditions. These systems provide opportunities for both organ repair and prolonged storage periods, reducing the chances of process failure. Ex vivo perfusion is one such extension of machine perfusion which aims to further enhance organ recovery through additional repair mechanisms and reprogramming processes.
In August 2023, TransMedics Group, Inc. announced the acquisition of assets and intellectual property from Bridge to Life Ltd., specifically the Ex-Vivo Organ Support System (EVOSS) and the LifeCradle Heart Preservation Transport System. LifeCradle is a cold perfusion technology used in heart transplantation, whereas EVOSS is a warm perfusion method used in lung and heart transplantation. As the company concentrates on expanding its product portfolio and applications in organ transplantation, TransMedics seeks to enhance these technologies.
Dominance of Static Cold Storage Technique
Static cold storage is preferred for organ preservation because it is a simple, cost-effective, and widely adopted method. It involves flushing the procured organ with preservation solution at a very low temperature and then immersing it in the same solution at the same temperature until transplantation. This technique significantly slows down cellular metabolism and maintains organ integrity, while minimizing the need for specialized equipment and reducing costs associated with alternative methods like machine perfusion. The cost-effectiveness of the static cold storage method is the major factor strengthening the lead of this technique. The hypothermic machine perfusion system segment is anticipated to grow at a relatively faster pace with the highest CAGR as market players are constantly working on it. For instance, in May 2023, Bridge to Life, Ltd. reported meeting promising standards from an interim analysis, prompting an early enrollment conclusion for its multicenter, randomized, controlled Bridge to HOPE Liver Clinical Trial (NCT05045794). This trial evaluates the clinical safety and effectiveness of the static cold storage (SCS) method, the conventional ex-vivo organ preservation technique, against a combination of SCS and hypothermic oxygenated perfusion (HOPE) using the VitaSmart Liver Machine Perfusion System. The trial is being conducted under a U.S. Food and Drug Administration (FDA)-approved investigational device exemption (IDE).
Kidney is the Most Commonly Preserved Organ
Kidneys are the most transplanted organ due to several factors. Kidney transplantation has a higher success rate, offering patients a better quality of life and increased longevity compared to remaining on dialysis. Kidney transplantation does not require removing the recipient's kidneys unless they are severely damaged or causing problems like high blood pressure or infection, making it less invasive than other types of organ transplantation. Additionally, compared to other vital organs like the heart, liver, and lungs, there are relatively more suitable kidney donors available, contributing to the frequency of kidney transplantation. Due to the high number of kidney transplants, the demand for preservation products for kidneys is anticipated to be higher. For instance, in 2023, kidney transplants in the United States reached an all-time high, with 27,329 surgeries performed as reported by the Organ Procurement and Transplantation Network (OPTN). Out of these transplantations, more than 6,900 involved living donors, with kidney transplants comprising over 90% of them. Additionally, the year saw an increase in the number of organ transplants, including kidney transplants, for Black and Hispanic individuals.
North America to be the Dominating Region
North America region is expected to dominate the market with a high-value share throughout the assessment period owing to the growing public commitment to organ donation and collaboration among donor hospitals, organ procurement organizations, and transplant hospitals, as well as advancements in organ preservation techniques and scientific breakthroughs. The United States being a medically advanced nation, has crossed the milestone of 1 million organ transplants in the year 2022. The technological advancements in the region to facilitate organ transplants have further boosted the market expansion in the region. Manufacturers also keep up their position by innovating new products.
For instance, in November 2023, Paragonix Technologies unveiled an extensive network of organ procurement, preservation, and transportation services. Seven specialized hubs have been strategically positioned across the United States to streamline coordination and support. These centers operate round the clock, featuring over 50 experienced professionals like surgeons and preservation experts, demonstrating Paragonix's commitment to revolutionizing organ transplantation.
Future Market Scenario (2024 - 2031F)
Machine perfusion is a new technique to keep organs healthy for transplantation. It works by using a special liquid that flows through the organ to keep it alive. This allows the organ to be stored for longer periods and repaired if it is damaged. Researchers are working to develop even better machine perfusion techniques and solutions to make organs even healthier before transplantation. This could lead to more successful transplants and save more lives. For instance, in March 2023, The FDA granted XT-ViVo and TimeSeal a special designation called "Breakthrough Device Designation" because they can preserve and store kidneys for up to 120 hours. These products could be used to preserve other organs and tissues. Current methods preserve organs for only 4-16 hours, leading to waste, discarding, and countless organs not being recovered. In February 2023, LivaNova PLC unveiled the Essenz Perfusion System in Europe for cardiopulmonary bypass surgical interventions. This cutting-edge device combines a sophisticated heart-lung machine with a revolutionary patient monitor, delivering real-time critical care insights during CPB procedures.
Key Players Landscape and Outlook
XVIVO Perfusion AB, TransMedics, Inc., Preservation Solutions, Inc., Paragonix Technologies, Inc., Dr. Franz Kohler Chemie GmbH, and Waters Medical Systems LLC are some of the renowned players in the organ preservation market. These companies focus on developing and supplying organ preservation solutions, such as University of Wisconsin (UW) Solution, Custodial HTK, Perfadex, and others, while employing different preservation techniques like static cold storage, hypothermic machine perfusion, and normothermic machine perfusion. Regulatory advancements and collaboration lead the way for market expansion. The market is mainly dominated by privately held companies.
In February 2024, Bridge to Life Ltd announced that it had received ISO 13485:2016 certification. This achievement highlights the company's dedication to quality and safety in its products, including Belzer UW, EasiSlush, and VitaSmart1 Machine Perfusion System (Europe). The certification is a strategic move in preparation for the launch of the VitaSmart1 Machine Perfusion System in the US, pending FDA approval. Bridge to Life consistently strives to meet and surpass industry standards.
In February 2024, Atrium Health's Transplant Division, Carolinas Medical Center, joined forces with LifeShare Carolinas and BMI OrganBank to introduce pioneering Organ Banking technology. This advanced system will expand organ preservation and reconditioning possibilities. Atrium Health is among the top five Integrated Delivery Networks in the United States.
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.