市场调查报告书
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1395976
数位治疗 - 主题智能Digital Therapeutics - Thematic Intelligence |
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数位治疗 (DTx) 是更广泛的数位健康领域解决方案的一个分支,为疾病的预防、治疗和管理提供实证治疗介入。 DTx 产品经过不同程度的临床评估和监管监督,由软体程式提供支持,并在从智慧型手机到虚拟实境 (VR) 耳机等各种设备上提供。 DTx 可能是以患者为中心的医疗保健的未来,随时随地为患者提供个人化方案,甚至可以消除某些适应症的药物需求。
数位治疗 (DTx) 是更广泛的数位健康领域解决方案的一个分支,为疾病的预防、治疗和管理提供实证治疗介入。 DTx 产品经过不同程度的临床评估和监管监督,由软体程式提供支持,并在从智慧型手机到虚拟实境 (VR) 耳机等各种设备上提供。 DTx 可能是以患者为中心的医疗保健的未来,随时随地为患者提供个人化方案,甚至可以消除某些适应症的药物需求。
医疗保健当局和付款人对 DTx 的价值普遍存在不确定性,这阻碍了市场的发展。 漫长的流程和不明确的要求使得报销变得困难并限制了患者的使用。 救赎重要性最明显的例子就是 Pear Therapeutics 的破产。 该公司2021年的估值预计为16亿美元,但2023年拍卖总价降至600万美元。 这是因为 Pear Therapeutics 面临市场波动和研发成本高昂的困扰,同时也未能为其产品获得足够的报销。 该公司的破产证明,监管只是 DTx 製造商面临的第一个挑战,如果不做出改变,其他参与者可能很快就会破产。
全球医疗保健当局正在努力解决 DTx 等数位医疗技术缺乏监管和报销途径的问题。 德国、比利时和法国的医疗当局已经建立了框架,包括韩国在内的其他国家的当局正在寻求效仿。 在美国,透过医疗补助和医疗保险报销的进展可能会根据新立法的成功或失败而有所改善,而在英国,与英国脱欧相关的监管变化可能会导致批准范围扩大。 儘管监管格局目前较为分散,但加强数位医疗监管标准的国际合作可能会在未来改善患者获得更安全、更有效的 DTx 的机会。
本报告审视了全球数位治疗市场,汇集了有关医疗保健、宏观经济、技术和监管趋势将如何影响数位治疗市场的最新见解和预测。,还提供了对整个价值领域的主要进入者和未来颠覆者的见解。链。
Digital therapeutics (DTx) is a segment of solutions within the wider digital health landscape that delivers evidence-based therapeutic interventions to prevent, treat, or manage disease. Subject to different degrees of clinical evaluation and regulatory oversight, DTx products are driven by software programs and delivered across a range of devices from smartphones to virtual reality (VR) headsets. DTx could be the future of patient-centric healthcare, able to provide personalized programs to patients anywhere and at any time, even removing the need for medications for some indications.
DTx provides many benefits to both patients and providers
Digital therapeutics (DTx) is a segment of solutions within the wider digital health landscape that delivers evidence-based therapeutic interventions to prevent, treat, or manage disease. Subject to different degrees of clinical evaluation and regulatory oversight, DTx products are driven by software programs and delivered across a range of devices from smartphones to virtual reality (VR) headsets. DTx could be the future of patient-centric healthcare, able to provide personalized programs to patients anywhere and at any time, even removing the need for medications for some indications.
Reimbursement is crucial for the widespread adoption of DTx
There is widespread uncertainty from both healthcare authorities and payors about the value of DTx, which is staunching the market. Lengthy processes and unclear requirements have made reimbursement difficult to navigate, limiting patient access. The most prominent example of the importance of reimbursement is the bankruptcy of Pear Therapeutics. The company was estimated to be worth of $1.6 billion in 2021, then fell to a total auction price of $6 million in 2023 as Pear Therapeutics failed to generate sufficient reimbursement for its products while also struggling with unstable market conditions and high R&D costs. The company's bankruptcy proves that regulation is only the first challenge for DTx manufacturers, and without change, other players may also fail soon.
Evolving regulatory and reimbursement pathways
Healthcare authorities worldwide are addressing the lack of regulatory and reimbursement pathways for digital health technologies such as DTx. Health authorities in Germany, Belgium, and France have established frameworks, that those in other countries, such as South Korea, are trying to emulate. In the US, progress in reimbursement through Medicaid and Medicare may improve depending on the success of newly introduced bills, while changing regulations in the UK following Brexit could lead to increased approvals. Although the regulatory landscape is currently divided, increasing international cooperation on the regulatory standards of digital health would improve patient access to safer and more effective DTx in the future.
This report consolidates GlobalData's latest thinking and forecasts around how the healthcare, macroeconomic, technology, and regulatory trends will impact the digital therapeutics market, as well as providing insights into the leading players and future disruptors across the value chain.
The report is designed to provide strategic planners, competitive intelligence professionals and key stakeholders in the pharmaceutical industry a clear view of the opportunities and risks over the foreseeable future for digital therapeutics.