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市場調查報告書
商品編碼
1798007
處方數位化治療 (PDTx) 市場預測至 2032 年:按產品類型、交付平台、給藥方式、年齡層、應用、最終用戶和地區進行全球分析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 |
根據 Stratistics MRC 的數據,全球處方數位療法 (PDTx) 市場預計在 2025 年達到 27.2 億美元,到 2032 年將達到 89.4 億美元,預測期內的複合年成長率為 18.5%。
處方數位療法 (PDTx) 是由醫療保健專業人員開立的、基於實證的、軟體主導的治療性介入,用於預防、管理和治療醫學疾病。與典型的健康應用程式不同,PDTx 經過嚴格的臨床試驗和監管審查,以確保安全性和有效性。這些療法透過行動裝置和網路平台提供,通常可以補充或取代傳統的醫療手段,為精神健康障礙、糖尿病和物質使用障礙等疾病提供個人化護理。
據美國醫學協會稱,包括 PDT 在內的數位健康技術的使用正在增加,據報道,近年來醫療保健專業人員的採用率增加了 30%。
數位健康科技的採用日益增多
智慧型手機、平板電腦和穿戴式裝置的廣泛普及,使得數位醫療解決方案更容易為患者所用。這項技術變革實現了即時監測、遠端患者參與和個人化治療性介入。此外,行動醫療應用、雲端運算和遠端醫療的進步也提高了PDTx的可擴展性和效率。隨著全球醫療保健系統積極擁抱數位轉型,以改善療效並降低成本,對經臨床檢驗的數位療法的需求持續成長,從而推動了創新並獲得了廣泛的市場認可。
有限的報銷政策
與傳統藥物不同,光動力治療 (PDTx) 通常缺乏明確的監管和報銷途徑,這使得醫療保健提供者難以獲得醫療保險。這種不確定性阻礙了醫生開PDTx處方,患者也因自付費用而不願使用PDTx。此外,不同地區和付款方之間報銷模式的不一致阻礙了市場的擴充性。由於缺乏標準化框架和基於價值的定價機制來認可PDTx的臨床和收益,開發者在創新商業化方面面臨挑戰,從而減緩了這一前景廣闊領域的投資和擴張。
與人工智慧和巨量資料分析的整合
人工智慧能夠即時分析大量患者數據,從而製定更個人化和適應性更強的治療方案。巨量資料增強了我們追蹤患者行為、治療順從性和健康結果的能力,為持續改善提供了寶貴的見解。這些技術支援預測模型、自動化臨床決策並最佳化治療效果。醫療保健正日益轉向數據主導醫療,人工智慧、巨量資料和光動力治療 (PDTx) 之間的協同作用將提升臨床價值,提高病人參與,並加速各個市場的創新。
資料隱私和安全問題
PDTx 平台收集並儲存敏感的患者資訊,包括醫療記錄和行為數據,使其成為網路攻擊和資料外洩的主要目標。加密不足、網路安全通訊協定薄弱以及第三方資料共用可能會削弱用戶信任,並違反《健康保險流通與責任法》(HIPAA) 和《一般資料保護規範》(GDPR) 等資料保護條例。這些擔憂阻礙了患者和醫療保健提供者全面採用數位治療方法。此外,不遵守隱私標準可能帶來嚴重的法律和經濟影響,為尋求開發和商業化 PDTx 解決方案的公司帶來更多障礙。
新冠疫情對處方數位療法 (PDTx) 市場的發展起到了關鍵作用。由於面對面諮詢受限,醫療系統面臨巨大壓力,遠端醫療需求迅速成長。 PDTx 為居家管理心理健康、慢性病和服藥順從性提供了有效的支持。此外,這場危機促使監管機構加快核准速度並擴大遠端醫療報銷範圍,從而提高了醫護人員和患者在疫情期間及疫情過後對 PDTx 的認知度和使用率。
預計基於軟體的 PDTx 細分市場將在預測期內佔據最大佔有率
由於慢性病的增加、個人化護理的需求以及遠端醫療的需求,基於軟體的PDTx領域預計將在預測期內佔據最大的市場佔有率。人工智慧、機器學習和擴增實境等技術增強了治療的客製化和參與度。數位雙胞胎、元宇宙平台和即時分析等新興創新正在改變PDTx的交付方式。最近的發展包括FDA核准的針對ADHD和成癮的數位化治療方法,以及德國DiGA報銷模式。這些里程碑凸顯了PDTx在解決行為、神經病變和代謝疾病方面日益增強的臨床可靠性和擴充性。
預計基於智慧型手機的平台部分將在預測期內實現最高複合年成長率
受行動裝置使用量成長、慢性病發病率上升以及遠端個人化治療需求的推動,基於智慧型手機的平台細分市場預計將在預測期內實現最高成長率。人工智慧、機器學習和嵌入式感測器等關鍵技術有助於持續監測和快速護理。互動式遊戲化、語音輔助功能以及身臨其境型AR/VR 應用程式等趨勢正在提升用戶參與度和易用性。這些進步將使 PDTx 成為一種易於獲取且擴充性的管理行為、神經病變和代謝疾病的工具。
預計亞太地區將在預測期內佔據最大的市場佔有率,這得益於慢性健康問題的增加、智慧型手機的廣泛普及以及對遠距醫療解決方案日益成長的需求。人工智慧、機器學習和穿戴式裝置等先進技術支援個人化的即時治療。值得關注的趨勢包括遊戲化的認知行為療法 (CBT)、語音驅動應用程式和基於人工智慧的睡眠療法。中國的「Asleep」應用程式、SONY與諾華在日本的多發性硬化症 (MS) 治療夥伴關係等重要舉措,以及韓國和新加坡的支持性政策,正在推動該領域的擴張。
預計北美將在預測期內呈現最高的複合年成長率,這得益於慢性病發病率的上升、良好的保險覆蓋率以及美國食品藥物管理局 (FDA) 的強力監管支持。人工智慧、機器學習和連網穿戴裝置等先進技術使個人化、即時的治療方案成為可能。趨勢包括遊戲化認知療法、數據驅動的預測工具和企業健康舉措。關鍵里程碑包括 FDA 批准用於偏頭痛管理的 CT-132 以及達梭系統對 Click Therapeutics 的策略投資,這些都凸顯了協作和數位健康創新的興起。
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.