Digital Health Tools are Expanding in Scope and Function to Aid Patient Diagnosis, Treatment and Monitoring, Says New Report from The IQVIA Institute
Digital health continues to evolve with 337,000 apps currently available, alongside 360+ software-based digital therapies and 103 digital diagnostics commercially available. Disease-specific apps are expanding beyond mental health and chronic diseases, with 140 prescription digital therapeutics (DTx) approved for home use and 220+ therapies used in clinical settings.
Despite decreased venture funding, digital health solutions are growing in scope, focusing on specific diseases and integrating AI to personalize care. Germany leads in DTx regulation with 56 approved therapies, followed by the US (46) and UK (20). Notable developments include sensor-based digital biomarkers for patient monitoring, FDA-approved digital endpoints, and AI/ML-enabled diagnostic tools, with 801 AI/ML devices approved by FDA as of June 2024.
La salute digitale continua a evolversi con 337.000 app attualmente disponibili, insieme a oltre 360 terapie digitali basate su software e 103 diagnosi digitali commercialmente disponibili. Le app specifiche per le malattie si stanno espandendo oltre la salute mentale e le malattie croniche, con 140 terapie digitali terapeutiche (DTx) approvate per uso domestico e oltre 220 terapie utilizzate in contesti clinici.
Nonostante la diminuzione del finanziamento da parte delle venture, le soluzioni per la salute digitale stanno crescendo in ampiezza, concentrandosi su malattie specifiche e integrando l'IA per personalizzare le cure. La Germania è leader nella regolamentazione delle DTx con 56 terapie approvate, seguita dagli Stati Uniti (46) e dal Regno Unito (20). Sviluppi notevoli includono biomarcatori digitali basati su sensori per il monitoraggio dei pazienti, endpoint digitali approvati dalla FDA e strumenti diagnostici abilitati all'IA/ML, con 801 dispositivi IA/ML approvati dalla FDA entro giugno 2024.
La salud digital sigue evolucionando con 337,000 aplicaciones actualmente disponibles, junto con más de 360 terapias digitales basadas en software y 103 diagnósticos digitales disponibles comercialmente. Las aplicaciones específicas para enfermedades se están expandiendo más allá de la salud mental y las enfermedades crónicas, con 140 terapias digitales terapéuticas (DTx) aprobadas para uso doméstico y más de 220 terapias utilizadas en entornos clínicos.
A pesar de la disminución del financiamiento de capital riesgo, las soluciones de salud digital están creciendo en alcance, enfocándose en enfermedades específicas e integrando la IA para personalizar la atención. Alemania lidera la regulación de DTx con 56 terapias aprobadas, seguida por EE. UU. (46) y el Reino Unido (20). Los desarrollos notables incluyen biomarcadores digitales basados en sensores para el monitoreo de pacientes, puntos finales digitales aprobados por la FDA, y herramientas de diagnóstico habilitadas para IA/ML, con 801 dispositivos de IA/ML aprobados por la FDA hasta junio de 2024.
디지털 헬스는 현재 337,000개의 애플리케이션과 360개 이상의 소프트웨어 기반 디지털 치료제, 103개의 상업적으로 이용 가능한 디지털 진단과 함께 계속 발전하고 있습니다. 질병별 애플리케이션은 정신 건강과 만성 질병을 넘어 확장되고 있으며, 140개의 처방 디지털 치료제 (DTx)가 자택에서 사용하도록 승인되었고, 220개 이상의 치료제가 임상 환경에서 사용되고 있습니다.
투자 자금이 감소했음에도 불구하고 디지털 헬스 솔루션은 특정 질병에 초점을 맞추고 개인 맞춤형 치료를 위해 AI를 통합하며 범위가 확대되고 있습니다. 독일은 56개의 승인된 치료제로 DTx 규정에서 선두를 달리고 있으며, 미국(46개)과 영국(20개)이 뒤를 잇고 있습니다. 주목할 만한 발전으로는 환자 모니터링을 위한 센서 기반 디지털 바이오마커, FDA 승인된 디지털 엔드포인트, 그리고 AI/ML 지원 진단 도구가 포함되며, 2024년 6월 기준으로 FDA에 의해 801개의 AI/ML 장치가 승인되었습니다.
La santé numérique continue d'évoluer avec 337 000 applications actuellement disponibles, ainsi que plus de 360 thérapies numériques basées sur des logiciels et 103 diagnostics numériques disponibles commercialement. Les applications spécifiques aux maladies s'élargissent au-delà de la santé mentale et des maladies chroniques, avec 140 thérapies numériques sur ordonnance (DTx) approuvées pour un usage domestique et plus de 220 thérapies utilisées dans des contextes cliniques.
Malgré la baisse du financement des capital-risque, les solutions de santé numérique se développent en portée, se concentrant sur des maladies spécifiques et intégrant l'IA pour personnaliser les soins. L'Allemagne est en tête en matière de réglementation DTx avec 56 thérapies approuvées, suivie des États-Unis (46) et du Royaume-Uni (20). Les développements notables incluent des biomarqueurs numériques basés sur des capteurs pour le suivi des patients, des points de terminaison numériques approuvés par la FDA et des outils de diagnostic habilités à l'IA/ML, avec 801 dispositifs IA/ML approuvés par la FDA d'ici juin 2024.
Digitale Gesundheit entwickelt sich weiter mit derzeit 337.000 verfügbaren Apps, über 360 softwarebasierten digitalen Therapien und 103 kommerziell verfügbaren digitalen Diagnosen. Krankheitsbezogene Apps erweitern sich über psychische Gesundheit und chronische Krankheiten hinaus, wobei 140 verschreibungspflichtige digitale Therapeutika (DTx) für den Heimgebrauch genehmigt und über 220 Therapien in klinischen Einrichtungen verwendet werden.
Trotz verringertem Venture-Kapital wächst der Bereich digitale Gesundheit, konzentriert sich auf spezifische Krankheiten und integriert KI zur Personalisierung der Versorgung. Deutschland führt bei der DTx-Regulierung mit 56 genehmigten Therapien, gefolgt von den USA (46) und dem Vereinigten Königreich (20). Bemerkenswerte Entwicklungen umfassen sensorbasierte digitale Biomarker zur Patientenüberwachung, von der FDA genehmigte digitale Endpunkte und KI/ML-unterstützte diagnostische Werkzeuge, mit 801 von der FDA genehmigten KI/ML-Geräten bis Juni 2024.
- 337,000 digital health apps available, showing strong market presence
- 140 prescription digital therapeutics (DTx) approved for patient use
- 801 AI/ML-enabled devices received FDA approval
- 103 digital diagnostics commercially available
- Expanding regulatory approval and reimbursement pathways
- Drop in venture funding over last 2.5 years
- Two-thirds of created apps no longer marketed due to poor differentiation
- technology uptake below investment sustainability levels
- Multiple exits and restructuring by developers
Insights
The digital health landscape is experiencing a significant transformation, with 337,000 active apps and 360+ software-based digital therapies representing a massive market opportunity. The sector's evolution from consumer wellness apps to clinically validated therapeutic tools signals a mature phase with substantial revenue potential. Despite venture funding challenges, the strategic shift toward disease-specific applications and AI integration demonstrates a focus on sustainable business models and clinical utility.
The German market leads with 56 reimbursed digital therapeutics, followed by the U.S. with 46 approved solutions, indicating a growing acceptance from healthcare payers. This regulatory validation creates a clear pathway for monetization and market expansion. The development of 103 commercial digital diagnostics, particularly those leveraging AI/ML, represents a new high-growth segment within the digital health ecosystem.
The integration of AI/ML in 801 FDA-approved devices marks a pivotal shift in healthcare delivery. The emergence of sensor-based digital biomarkers and remote monitoring capabilities is revolutionizing clinical trials and patient care, potentially reducing trial costs and improving data quality. For IQVIA (IQV), this trend presents significant opportunities in their core clinical research business.
The high churn rate in digital health apps, with two-thirds becoming inactive, underscores the importance of clinical validation and stakeholder value creation. The expansion into specialized areas like visual impairments, auditory issues and dermatological conditions indicates market maturation and increased sophistication in digital health solutions. The development of hospital-at-home solutions particularly stands out as a transformative trend that could significantly impact healthcare delivery models and cost structures.
- The number of digital health apps stands at 337,000, with disease-specific apps that bring more value to health systems growing in number and their focus expanding beyond mental health and chronic diseases to encompass other conditions.
- Approval and reimbursement of digital tools is accelerating as payers recognize clinical utility and cost savings; of the more than 360 software-based digital therapies commercially available, 140 prescription digital therapeutics (DTx) are approved for patient use at home and over 220 therapies are used within digital care or in clinics.
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Sensor-based digital biomarkers that track patient health using wearables now monitor patients in care and research, and the first digital endpoints have been approved by regulators in the
U.S. andEurope . - More than 103 digital diagnostics for disease assessment are now commercially available and used to evaluate disease risk, accelerate diagnosis and monitor patient health; many of these are enabled by artificial intelligence and machine learning (AI/ML).
There are currently 337,000 digital health apps along with more than 360 software-based digital therapies and 103 digital diagnostics commercially available. Simultaneously, the number of AI/ML enabled mobile and point-of-care devices is growing.
“The landscape of digital health has evolved over the past two years, yielding new products that are more commercially viable and meet the needs of stakeholders across a broadening set of uses,” said Murray Aitken, executive director, IQVIA Institute for Human Data Science. “Digital health tools now support both patients and providers as they move from diagnosis to treatment and disease monitoring, with their scope expanding as new health assessment tools such as digital diagnostics have joined more mature digital therapies, accelerating care and closing gaps to improve health outcomes. Ultimately, these solutions will better fit into existing care pathways and bring benefits to more segments of patients and health systems.”
A few key highlights of the report include:
- Digital health apps: Among the 337,000 digital health apps currently available, disease-specific apps continue to grow in number. While many continue to support mental health and patients with diabetes and cardiovascular diseases, recently-launched apps also help those with visual impairments, auditory issues and dermatologic conditions. Since app stores first emerged in 2008, over 1 million digital health apps have been created. However, two-thirds of these are no longer marketed, reflecting a high level of churn as many developers failed to differentiate their apps, consumer/patient uptake is relatively slow and financial returns have been meager. Apps with stronger clinical evidence have seen higher rates of use and more rapid uptake, indicating it is a key driver of consumer adoption and commercial success, as increased stakeholder focus is placed on evidence generation.
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Digital therapeutics: Approvals and adoption of DTx, which treat or alleviate disease by delivering a medical intervention, have proliferated as opportunities to gain regulatory approval and reimbursement grow; 140 have received approval in one or more countries and are intended for patient use at home and more than 220 software-based digital therapies are being used by providers within digital care programs or in their clinics, totaling more than 360 commercially-available digital therapies. The most progress has been seen in
Germany , which has led the regulatory process and reimburses for 56 DTx, followed by theU.S. with 46 approved and theUK with 20. Along with behavioral approaches to treat mental health and chronic diseases such as diabetes and hypertension, recently approved DTx use biofeedback and virtual reality to reduce various types of pain, treat visual impairments, support respiratory and post-stroke neurological rehabilitation, and treat PTSD and phobias. -
Sensor-based digital measures: Through the use of digital sensors and wearables, nuanced aspects of health and patient experience are becoming traceable and measurable in daily life. In patient care and in clinical development programs for innovative medicines, sensor-based measures, including digital biomarkers and clinical outcome assessments, are proving valuable to remotely monitor patients, demonstrate the effects of therapeutic interventions and track outcomes. Life sciences companies have invested in the creation and validation of new digital endpoints, with some even building molecule-to-market digital strategies that overlay their drug development programs. By offering higher quality of data capture, more consistent measurements and increased sensitivity than traditional methods, some digital endpoints have optimized clinical development, allowing trial sponsors to reduce clinical trial enrollment and further promise to reduce trial duration and the need for patients to travel to trial sites. The first sensor-based digital endpoints using wearables have also been formally approved for ongoing use in clinical trials by regulators in the
U.S. andEurope . - Digital diagnostics: Software-based devices that process signals from sensors have rapidly opened new routes to assess disease risk, accelerate diagnosis, monitor patient health and assess patient prognosis; and at least 103 such digital diagnostics are now commercially available. Notably, these digital health assessment tools are bringing new options to screen undiagnosed patients for diseases and enable providers to monitor patients remotely. Conditions now detectable using these tools include autism and autism spectrum disorders, sleep apnea, atrial fibrillation, skin cancers, epilepsy and sepsis, among others.
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Use of AI/ML: Many health assessment devices are enabled by AI/ML, and in the
U.S. , around 75 of these mobile and point-of-care tools have been approved by the FDA. This fits within a broader trend toward using AI to improve diagnostic equipment, and as of June 2024, 801 distinct AI/ML-enabled devices have received approval from the FDA. - Remote patient monitoring: Digital tools such as wearables and symptom-tracking apps are being combined into broader clinical platform solutions for providers to monitor disease progression or response to therapy, detect recurrence and even predict future health changes to triage patients in greatest need of care. This has enabled the creation of hospital-at-home solutions that continuously detect and predict adverse events, thereby speeding patient discharge from hospital settings and improving quality of life for patients being treated with advanced therapies and medicines with higher risk profiles. Growth in this area has also spurred the creation of accelerated approval and reimbursement pathways for remote monitoring technologies.
- The uptake of digital health technologies: While the overall uptake of digital health technologies is rising, over the past two years it has been relatively limited and less than required to sustain high levels of investment, leading to multiple exits and restructuring by developers. Stakeholders in the digital health ecosystem are working through the regulatory and reimbursement challenges to attain sustainable investment and scaling of use that will provide maximum benefits to patients and health systems. The long-term potential for technology-supported and AI/ML-driven digital health interventions remains high despite near-term challenges.
About the IQVIA Institute for Human Data Science
The IQVIA Institute for Human Data Science contributes to the advancement of human health globally through timely research, insightful analysis and scientific expertise applied to granular non-identified patient-level data.
Fulfilling an essential need within healthcare, the Institute delivers objective, relevant insights and research that accelerate understanding and innovation critical to sound decision making and improved human outcomes. With access to IQVIA’s institutional knowledge, advanced analytics, technology and unparalleled data, the Institute works in tandem with a broad set of healthcare stakeholders to drive a research agenda focused on Human Data Science, including government agencies, academic institutions, the life sciences industry, and payers. More information about the IQVIA Institute can be found at www.IQVIAInstitute.org.
About IQVIA
IQVIA (NYSE:IQV) is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. IQVIA’s portfolio of solutions are powered by IQVIA Connected Intelligence™ to deliver actionable insights and services built on high-quality health data, Healthcare-grade AI™, advanced analytics, the latest technologies and extensive domain expertise. With approximately 88,000 employees in over 100 countries, including experts in healthcare, life sciences, data science, technology and operational excellence, IQVIA is dedicated to accelerating the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behavior and scientific advances, in an effort to advance their path toward cures. To learn more, visit www.iqvia.com.
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Kerri Joseph, IQVIA Investor Relations (kerri.joseph@iqvia.com)
+1.973.541.3558
Alissa Maupin, IQVIA Media Relations (alissa.maupin1@iqvia.com)
+1.919.923.6785
Source: IQVIA
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