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市场调查报告书
商品编码
1798007
处方数位化治疗 (PDTx) 市场预测至 2032 年:按产品类型、交付平台、给药方式、年龄层、应用、最终用户和地区进行全球分析Prescription Digital Therapeutics (PDTx) Market Forecasts to 2032 - Global Analysis By Product Type (Software-based PDTx and Hardware-based PDTx), Delivery Platform, Mode of Administration, Age Group, Application, End User and By Geography |
根据 Stratistics MRC 的数据,全球处方数位疗法 (PDTx) 市场预计在 2025 年达到 27.2 亿美元,到 2032 年将达到 89.4 亿美元,预测期内的复合年增长率为 18.5%。
处方数位疗法 (PDTx) 是由医疗保健专业人员开立的、基于实证的、软体主导的治疗性介入,用于预防、管理和治疗医学疾病。与典型的健康应用程式不同,PDTx 经过严格的临床试验和监管审查,以确保安全性和有效性。这些疗法透过行动装置和网路平台提供,通常可以补充或取代传统的医疗手段,为精神健康障碍、糖尿病和物质使用障碍等疾病提供个人化护理。
据美国医学协会称,包括 PDT 在内的数位健康技术的使用正在增加,据报道,近年来医疗保健专业人员的采用率增加了 30%。
数位健康科技的采用日益增多
智慧型手机、平板电脑和穿戴式装置的广泛普及,使得数位医疗解决方案更容易为患者所用。这项技术变革实现了即时监测、远端患者参与和个人化治疗性介入。此外,行动医疗应用、云端运算和远端医疗的进步也提高了PDTx的可扩展性和效率。随着全球医疗保健系统积极拥抱数位转型,以改善疗效并降低成本,对经临床检验的数位疗法的需求持续增长,从而推动了创新并获得了广泛的市场认可。
有限的报销政策
与传统药物不同,光动力治疗 (PDTx) 通常缺乏明确的监管和报销途径,这使得医疗保健提供者难以获得医疗保险。这种不确定性阻碍了医生开PDTx处方,患者也因自付费用而不愿使用PDTx。此外,不同地区和付款方之间报销模式的不一致阻碍了市场的扩充性。由于缺乏标准化框架和基于价值的定价机制来认可PDTx的临床和收益,开发者在创新商业化方面面临挑战,从而减缓了这一前景广阔领域的投资和扩张。
与人工智慧和巨量资料分析的集成
人工智慧能够即时分析大量患者数据,从而製定更个人化和适应性更强的治疗方案。巨量资料增强了我们追踪患者行为、治疗顺从性和健康结果的能力,为持续改善提供了宝贵的见解。这些技术支援预测模型、自动化临床决策并优化治疗效果。医疗保健正日益转向数据主导医疗,人工智慧、巨量资料和光动力治疗 (PDTx) 之间的协同作用将提升临床价值,提高病人参与,并加速各个市场的创新。
资料隐私和安全问题
PDTx 平台收集并储存敏感的患者信息,包括医疗记录和行为数据,使其成为网路攻击和资料外洩的主要目标。加密不足、网路安全通讯协定薄弱以及第三方资料共用可能会削弱用户信任,并违反《健康保险流通与责任法》(HIPAA) 和《一般资料保护规范》(GDPR) 等资料保护条例。这些担忧阻碍了患者和医疗保健提供者全面采用数位治疗方法。此外,不遵守隐私标准可能带来严重的法律和经济影响,为寻求开发和商业化 PDTx 解决方案的公司带来更多障碍。
新冠疫情对处方数位疗法 (PDTx) 市场的发展起到了关键作用。由于面对面咨询受限,医疗系统面临巨大压力,远端医疗需求迅速成长。 PDTx 为居家管理心理健康、慢性病和服药顺从性提供了有效的支持。此外,这场危机促使监管机构加快审批速度并扩大远端医疗报销范围,从而提高了医护人员和患者在疫情期间及疫情过后对 PDTx 的认知度和使用率。
预计基于软体的 PDTx 细分市场将在预测期内占据最大份额
由于慢性病的增加、个人化护理的需求以及远端医疗的需求,基于软体的PDTx领域预计将在预测期内占据最大的市场占有率。人工智慧、机器学习和扩增实境等技术增强了治疗的客製化和参与度。数位双胞胎、元宇宙平台和即时分析等新兴创新正在改变PDTx的交付方式。最近的发展包括FDA核准的针对ADHD和成瘾的数位化治疗方法,以及德国DiGA报销模式。这些里程碑凸显了PDTx在解决行为、神经病变和代谢疾病方面日益增强的临床可靠性和扩充性。
预计基于智慧型手机的平台部分将在预测期内实现最高复合年增长率
受行动装置使用量成长、慢性病发病率上升以及远端个人化治疗需求的推动,基于智慧型手机的平台细分市场预计将在预测期内实现最高成长率。人工智慧、机器学习和嵌入式感测器等关键技术有助于持续监测和快速护理。互动式游戏化、语音辅助功能以及身临其境型AR/VR 应用程式等趋势正在提升用户参与度和易用性。这些进步将使 PDTx 成为一种易于获取且扩充性的管理行为、神经病变和代谢疾病的工具。
预计亚太地区将在预测期内占据最大的市场占有率,这得益于慢性健康问题的增加、智慧型手机的广泛普及以及对远距医疗解决方案日益增长的需求。人工智慧、机器学习和穿戴式装置等先进技术支援个人化的即时治疗。值得关注的趋势包括游戏化的认知行为疗法 (CBT)、语音驱动应用程式和基于人工智慧的睡眠疗法。中国的「Asleep」应用程式、SONY与诺华在日本的多发性硬化症 (MS) 治疗伙伴关係等重要倡议,以及韩国和新加坡的支持性政策,正在推动该领域的扩张。
预计北美将在预测期内呈现最高的复合年增长率,这得益于慢性病发病率的上升、良好的保险覆盖率以及美国食品药物管理局 (FDA) 的强力监管支持。人工智慧、机器学习和连网穿戴装置等先进技术使个人化、即时的治疗方案成为可能。趋势包括游戏化认知疗法、数据驱动的预测工具和企业健康倡议。关键里程碑包括 FDA 批准用于偏头痛管理的 CT-132 以及达梭系统对 Click Therapeutics 的策略投资,这些都凸显了协作和数位健康创新的兴起。
According to Stratistics MRC, the Global Prescription Digital Therapeutics (PDTx) Market is accounted for $2.72 billion in 2025 and is expected to reach $8.94 billion by 2032 growing at a CAGR of 18.5% during the forecast period. Prescription Digital Therapeutics (PDTx) are evidence-based, software-driven therapeutic interventions that are prescribed by healthcare professionals to prevent, manage, or treat medical disorders. Unlike general wellness apps, PDTx undergo rigorous clinical trials and regulatory review to ensure safety and efficacy. Delivered via mobile devices or web platforms, these treatments often complement or replace traditional therapies, offering personalized care for conditions such as mental health disorders, diabetes, and substance use disorders.
According to the American Medical Association, the use of digital health technologies, including PDTs, has been on the rise, with a reported increase of 30% in their adoption among healthcare providers in recent years.
Increased adoption of digital health technologies
With the widespread availability of smartphones, tablets, and wearable devices, patients now have greater access to digital healthcare solutions. This technological shift enables real-time monitoring, remote patient engagement, and personalized therapeutic interventions. Additionally, advancements in mobile health apps, cloud computing, and telemedicine have improved the scalability and efficiency of PDTx delivery. As healthcare systems worldwide embrace digital transformation to enhance outcomes and reduce costs, the demand for clinically validated digital therapeutics continues to rise, fostering innovation and wider market acceptance.
Limited reimbursement policies
Unlike traditional pharmaceuticals, PDTx often lack well-defined regulatory and reimbursement pathways, making it challenging for healthcare providers to obtain insurance coverage. This uncertainty discourages physicians from prescribing PDTx and patients from using them due to out-of-pocket costs. Furthermore, inconsistent reimbursement models across regions and payers hinder the market's scalability. Without standardized frameworks or value-based pricing mechanisms that recognize the clinical and economic benefits of PDTx, developers face challenges in monetizing their innovations, slowing down both investment and expansion in this promising field.
Integration with AI and big data analytics
AI enables real-time analysis of large volumes of patient data, allowing for more personalized and adaptive treatment plans. Big data enhances the ability to track patient behavior, treatment adherence, and health outcomes, providing valuable insights for continuous improvement. These technologies support predictive modeling, automate clinical decision-making, and optimize therapeutic effectiveness. As healthcare increasingly shifts toward data-driven care, the synergy between AI, big data, and PDTx enhances clinical value, improves patient engagement, and accelerates innovation across the market.
Data privacy and security concerns
PDTx platforms collect and store sensitive patient information, including health records and behavioral data, making them prime targets for cyberattacks and data breaches. Inadequate encryption, weak cybersecurity protocols, or third-party data sharing can compromise user trust and violate data protection regulations such as HIPAA or GDPR. These concerns deter both patients and healthcare providers from fully adopting digital therapeutics. Moreover, the legal and financial consequences of non-compliance with privacy standards can be severe, creating additional barriers for companies seeking to develop and commercialize PDTx solutions.
The COVID-19 pandemic played a crucial role in boosting the Prescription Digital Therapeutics (PDTx) market. As face-to-face medical consultations became limited and healthcare systems faced immense strain, the need for remote treatment options grew rapidly. PDTx provided effective support for managing mental health, chronic diseases, and medication compliance from home. Additionally, the crisis encouraged regulatory agencies to accelerate approvals and broaden telehealth reimbursement, leading to greater recognition and use of PDTx by both healthcare professionals and patients during and after the pandemic.
The software-based PDTx segment is expected to be the largest during the forecast period
The software-based PDTx segment is expected to account for the largest market share during the forecast period, due to rising chronic diseases, demand for personalized care, and remote treatment needs. Technologies like AI, machine learning, and extended reality enhance therapy customization and engagement. Emerging innovations such as digital twins, metaverse platforms, and real-time analytics are transforming PDTx delivery. Recent developments include FDA-approved digital treatments for ADHD and addiction, and Germany's DiGA model for reimbursement. These milestones highlight PDTx's growing clinical credibility and scalability in addressing behavioral, neurological, and metabolic disorders.
The smartphone-based platforms segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the smartphone-based platforms segment is predicted to witness the highest growth rate, driven by growing mobile usage, increasing chronic conditions, and the demand for remote, individualized treatment. Key technologies like artificial intelligence, machine learning, and embedded sensors facilitate continuous monitoring and responsive care. Trends such as interactive gamification, voice-assisted features, and immersive AR/VR applications are boosting user engagement and ease of use. These advancements position PDTx as accessible, scalable tools for managing behavioural, neurological, and metabolic disorders.
During the forecast period, the Asia Pacific region is expected to hold the largest market share, due to increasing chronic health issues, widespread smartphone adoption, and a rising need for remote healthcare solutions. Advanced technologies such as artificial intelligence, machine learning, and wearable devices support personalized, real-time treatment. Notable trends include gamified CBT, voice-driven applications, and AI-based sleep therapy. Key initiatives like China's "Asleep" app and Japan's Sony-Novartis partnership for MS care, along with supportive policies in South Korea and Singapore, are fueling expansion.
Over the forecast period, the North America region is anticipated to exhibit the highest CAGR, fuelled by increasing chronic conditions, favourable insurance coverage, and robust regulatory support from the FDA. Advanced technologies like artificial intelligence, machine learning, and connected wearables enable tailored, real-time therapeutic solutions. Trending innovations include gamified cognitive therapies, data-driven predictive tools, and corporate wellness initiatives. Significant milestones include FDA clearance of CT-132 for migraine management and Dassault Systemes' strategic investment in Click Therapeutics, highlighting rising collaboration and digital health innovation.
Key players in the market
Some of the key players in Prescription Digital Therapeutics (PDTx) Market include Click Therapeutics, SilverCloud Health, Pear Therapeutics, Noom, Akili Interactive, Limbix, Better Therapeutics, Cognoa, Big Health, Voluntis, Biofourmis, Propeller Health, Happify Health, Welldoc, Omada Health, and Kaia Health.
In April 2025, Noom announced the launch of the Noom Microdose GLP-1Rx Program, a groundbreaking offering designed to unlock weight loss and long-term health benefits while minimizing side effects through personalized microdoses of GLP-1 medication, when clinically appropriate. The Microdose GLP-1Rx Program is priced at $119 to start, followed by $199 per month, which includes medication.
In March 2024, Better Therapeutics, Inc. announced a major partnership with the American College of Lifestyle Medicine's (ACLM) National Training Initiative (NTI), aimed at improving diabetes outcomes in underserved communities across the United States. Through this partnership, Better Therapeutics is committed to making one million prescriptions of its U.S.
In September 2021, Akili Interactive announced that EndeavorRx(R), the first and only prescription video game treatment for kids 8-12 years old diagnosed with ADHD, is now available to patients on Google Play(TM) on devices supporting Android 9.0 or newer. With Android device users making up 46 percent of the mobile market1, this expanded access offers new families and patients the opportunity to benefit from Akili's first-of-its-kind treatment.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.