세계 디지털 치료(DTx) 시장 규모는 2024년 71억 달러에 달했습니다. 향후 IMARC Group은 이 시장이 2033년까지 287억 달러에 달할 것이며, 2025-2033년 연평균 성장률(CAGR)은 16.8%를 보일 것으로 예측했습니다. 북미는 탄탄한 의료 인프라, 강력한 기술 발전, 디지털 헬스케어에 대한 높은 투자로 인해 이 시장을 지배하는 지역으로 자리매김하고 있습니다. 또한, 의료비 증가, 만성질환 유병률 증가, 노인 인구 증가, 쉽게 접근 가능하고 비용 효율적인 맞춤형 의료를 제공하는 기술의 발전으로 시장이 확대되고 있습니다.
의료 기술 개발
디지털 치료제(DTx) 시장은 모바일 애플리케이션, 인공지능(AI), 머신러닝(ML)을 중심으로 한 기술의 끊임없는 발전으로 빠른 속도로 성장하고 있습니다. 이러한 발전은 맞춤형 치료 계획을 제공하고, 대량의 건강 데이터를 처리하고, 환자의 활동을 실시간으로 추적할 수 있는 첨단 디지털 플랫폼의 생성을 촉진하고 있습니다. AI 기반 알고리즘은 진단 능력을 강화하여 질병을 조기에 진단하고 보다 정확한 개입을 가능하게 합니다. 또한, 혈압, 심박수, 혈당 등 다양한 생리적 측정치를 보완하는 웨어러블 기술의 개발로 환자와 의료진이 능동적으로 질병을 관리할 수 있게 되었습니다. 이러한 기술을 의료 시스템에 통합함으로써 환자 결과를 개선하고, 대면 진료의 필요성을 없애고, 보다 편리하고 효과적인 치료를 할 수 있게 되었습니다. IMARC Group은 2033년까지 의료 인공지능 세계 시장이 687억 달러에 달할 것으로 예측했습니다.
만성질환 증가
만성질환 증가도 시장 성장 촉진요인 중 하나입니다. 당뇨병, 비만, 심혈관질환, 호흡기질환 등 만성질환은 전 세계적으로 유행하고 있으며, 그 주요 원인은 고령화, 운동 부족, 불건강한 식습관 등입니다. 디지털 치료제(DTx)는 실시간 모니터링과 맞춤형 개입을 제공하여 장기적인 상태 관리를 위한 솔루션을 제공합니다. 예를 들어, 당뇨병 환자는 디지털 플랫폼을 통해 혈당 수치를 모니터링하고, 인슐린 용량을 변경하고, 실시간 피드백을 기반으로 식단 제안을 받을 수 있습니다. 마찬가지로, 심장병 환자는 디지털 치료(DTx)를 통해 생체 신호를 추적하고, 범위를 벗어난 결과에 대한 알림을 받고, 처방된 치료 프로토콜을 따를 수 있습니다. 이러한 기술을 통해 환자는 자신의 상태를 더 잘 통제할 수 있고, 병원을 여러 번 방문할 필요성을 최소화하고 전반적인 삶의 질을 향상시킬 수 있습니다. 2024년, 처방 의료 솔루션으로서의 디지털 치료제(DTx)의 선두주자인 Click Therapeutics, Inc.는 Better Therapeutics, Inc.의 자산 인수를 통해 비만 및 심대사 질환 개발 노력을 가속화할 것이라고 밝혔습니다. 인수한 자산에는 2형 당뇨병에 대한 최초의 FDA 승인 처방전 디지털 개입인 AspyreRx(BT-001)와 최근 FDA로부터 대사성 지방간염(MASH)에 대한 획기적 치료제로 지정받은 BT-004가 포함됩니다.
맞춤형 의료에 대한 수요 증가
디지털 치료제(DTx) 시장 보고서에 따르면, 맞춤형 의료가 의료의 핵심 초점으로 부상하고 있습니다. 환자들은 유전, 생활습관, 특정 건강 상태 등의 고려사항을 포함하여 자신의 요구사항에 맞는 맞춤형 치료를 점점 더 많이 기대하게 되었습니다. 디지털 치료제(DTx)는 실시간 정보를 활용하여 치료 계획을 맞춤화함으로써 임상의가 보다 개인화된 치료를 제공할 수 있게 해줍니다. 이 플랫폼은 웨어러블 기기의 데이터, 건강 기록, 자가 보고 정보를 활용하여 매우 개인화된 치료 계획을 세울 수 있습니다. 예를 들어, 심리 앱은 환자의 기분, 수면, 행동에 대한 정보를 활용해 인지행동치료(CBT) 등의 치료법을 수정합니다. 마찬가지로, 만성질환 디지털 치료(DTx)는 질병의 진행을 추적하고 그 정보를 바탕으로 치료를 수정할 수 있습니다. 맞춤형 헬스케어는 환자가 자신의 상태를 능동적으로 관리할 수 있도록함으로써 의료에 혁명을 일으켜 치료 효과와 참여율을 모두 높이고 있습니다. 맞춤형 치료의 필요성이 높아지는 가운데, 디지털 치료제(DTx)는 맞춤형 치료에 필수적인 존재가 되고 있습니다. 2024년 Merz Therapeutics는 뇌졸중 후 경련을 경험한 환자의 재활을 개선하기 위해 설계된 맞춤형 디지털 솔루션인 iFlexo를 출시할 예정입니다. S3 Connected Health와 협력하여 만든 이 용도는 경증에서 중등도의 경련을 경험한 사람들의 운동 능력을 향상시키기 위해 고안된 특정 운동과 재활 계획을 제공합니다. iFlexo는 구조화된 운동을 제공함으로써 뇌졸중 환자의 자립을 돕고 전반적인 삶의 질을 향상시키는 것을 목표로 합니다. Merz Therapeutics는 신경독에 특화된 유일한 제약회사로 자가 재활 지원 플랫폼을 제공합니다.
규제 지원 및 의료비 상환
디지털 치료(DTx) 산업을 지탱하는 중요한 원동력 중 하나는 이러한 플랫폼에 대한 규제 당국의 지원과 상환 메커니즘의 구축이 확대되고 있다는 점입니다. 미국 식품의약국(FDA) 등 규제 당국은 디지털 치료(DTx)를 적절한 의료 개입으로 검증하는 데 적극적으로 나서고 있습니다. FDA는 소프트웨어 기반 치료 승인에 대한 새로운 가이드라인을 제정하여 디지털 치료(DTx) 기업이 제품을 시장에 출시하는 과정을 간소화했습니다. 이번 규제 당국의 승인으로 디지털 치료제(DTx)의 안전성과 유효성이 보장되어 의료진과 환자들의 수용도가 높아지고 있습니다. 또한, 보험 상환 정책도 디지털 치료(DTx)를 지원하기 위해 진화하고 있으며, 더 많은 보험사가 환자 결과를 개선하고 의료비를 절감하는 이러한 솔루션의 가치를 인정하고 있습니다. 디지털 치료의 급여화가 확산됨에 따라 이러한 솔루션의 경제적 접근성이 향상되어 더 많은 환자들이 혜택을 받을 수 있게 되었습니다. 이러한 규제와 상환의 발전은 디지털 치료(DTx)가 의료의 주류에 널리 채택될 수 있는 길을 열어주고 있습니다.
정신건강의 중요성
정신건강 질환에 대한 인식이 높아지면서 시장 성장을 뒷받침하고 있습니다. 불안장애, 우울증, 외상 후 스트레스 장애(PTSD) 등 정신건강 장애의 빈도가 증가함에 따라 효과적이고 저렴한 치료법에 대한 요구가 증가하고 있습니다. 디지털 치료제(DTx)는 확장성이 있고, 집에서 쉽게 제공할 수 있는 솔루션을 제시함으로써 정신건강 장애 치료에 새로운 가능성을 열어가고 있습니다. 모바일 앱, 온라인 치료 웹사이트, 컴퓨터 인지행동치료(CBT) 프로그램은 환자들에게 일반적인 진료실 치료의 대안을 제공하는 대안으로 점점 더 많은 인기를 얻고 있습니다. 이러한 옵션은 정신건강 전문가에 대한 접근성이 제한적인 지방이나 인구가 적은 지역에 거주하는 사람들에게 특히 유용합니다. 또한, 온라인 정신건강 사이트는 도움을 요청하는 것에 대한 낙인을 줄일 수 있는 익명성을 제공합니다.
편의성과 원격의료에 대한 소비자 선호도
편리하고 원격지의 의료 제품 및 서비스에 대한 선호도가 시장 성장을 견인하고 있습니다. 오늘날 환자들은 클리닉이나 병원을 여러 번 방문하지 않고도 스스로를 돌볼 수 있도록 활동적인 라이프스타일에 통합된 의료 솔루션을 원하고 있습니다. 디지털 치료제(DTx)는 언제 어디서든 필요할 때 사용할 수 있는 도구를 제공함으로써 이러한 요구에 부응하고, 환자가 자신의 페이스대로 건강을 관리할 수 있도록 돕고 있습니다. 예를 들어, 만성질환을 앓고 있는 사람들은 모바일 애플리케이션이나 웨어러블 기술을 통해 자신의 증상을 모니터링하고, 활력징후를 살피고, 치료 조언을 받을 수 있습니다. 또한, 디지털 플랫폼은 의료 전문가와의 원격 상담을 용이하게 하여 출장의 필요성을 줄이고 의료 비용을 절감할 수 있습니다.
The global digital therapeutics market size reached USD 7.1 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 28.7 Billion by 2033, exhibiting a growth rate (CAGR) of 16.8% during 2025-2033. North America is the dominant region in the market because it has an established healthcare infrastructure, strong technology advancements, and high investment in digital health in the region. Moreover, the market is expanding due to rising healthcare expenditure, increasing prevalence of chronic diseases, the growing geriatric population, and technological advancements offering easily accessible, cost-effective, personalized medical treatments.
Technological Developments in Healthcare
The market for digital therapeutics is growing at a rapid pace because of the relentless progress in technology, especially in mobile applications, artificial intelligence (AI), and machine learning (ML). These advancements are facilitating the creation of advanced digital platforms that are capable of providing customized treatment plans, processing large volumes of health data, and tracking patient activity in real-time. Algorithms based on AI are enhancing diagnostic capabilities, enabling early diagnosis of disease and more targeted interventions. Additionally, the development of wearable technology, which complements different physiological measures, such as blood pressure, heart rate, and blood glucose levels, is facilitating patients and healthcare workers to be proactive in disease management. The integration of these technologies into healthcare systems is enhancing patient outcomes and eliminating the necessity for in-person consultations, making treatment more convenient and effective. IMARC Group predicts that the global artificial intelligence in healthcare market is projected to reach USD 68.7 Billion by 2033.
Rising Incidence of Chronic Diseases
The rising occurrence of chronic diseases is one of the primary drivers of market. Chronic diseases like diabetes, obesity, cardiovascular diseases, and respiratory ailments are becoming prevalent globally, largely because of reasons such as aging populations, a lack of physical activity, and unhealthy diets. Digital therapeutics provide a solution for long-term condition management by offering real-time monitoring and tailored interventions. For instance, diabetic patients can use digital platforms to monitor their blood glucose levels, modify their insulin dosage, and get diet suggestions based on real-time feedback. Likewise, heart disease patients can utilize digital therapeutics to track vital signs, get notifications for out-of-range results, and follow prescribed treatment protocols. These technologies allow for patients to better control their conditions, minimizing the need for repeated trips to the hospital and enhancing their overall quality of life. In 2024, Click Therapeutics, Inc., a frontrunner in Digital Therapeutics(TM) as prescription medical solutions, revealed intentions to expedite its development efforts in obesity and cardiometabolic conditions through purchasing the assets of Better Therapeutics, Inc. The acquired assets comprise AspyreRx (BT-001), the inaugural FDA-authorized prescription digital intervention for type 2 diabetes, and BT-004, which recently received FDA Breakthrough Device Designation for addressing metabolic dysfunction-associated steatohepatitis (MASH).
Increased Demand for Personalized Healthcare
As per digital therapeutics market report, personalized healthcare is emerging as the central focus in medicine. Increasingly, patients expect therapies that are customized to their own requirements, including considerations such as genetics, lifestyle, and particular health status. Digital therapeutics allow clinicians to provide more personalized therapies by employing real-time information to customize treatment plans. The platforms can draw on data from wearable devices, health histories, and self-reported information to generate extremely personalized treatment plans. For instance, psychological apps utilize information regarding a patient's mood, sleep, and behavior to modify therapeutic treatments such as cognitive behavioral therapy (CBT). Likewise, chronic condition digital therapeutics are capable of tracking disease advancement and modifying treatments based on the information. Personalized healthcare is revolutionizing healthcare by enabling patients to actively manage their condition, enhancing both treatment efficacy and participation. With the need for personalized therapies increasing, digital therapeutics are becoming integral parts of personalized treatments. In 2024, Merz Therapeutics introduces iFlexo, a tailored digital solution designed to improve rehabilitation for individuals experiencing post-stroke spasticity, reflecting its continuous dedication to assisting stroke survivors. The application, created in partnership with S3 Connected Health, offers specific exercises and rehabilitation plans designed to enhance mobility for individuals experiencing mild to moderate spasticity. Through providing structured exercises, iFlexo seeks to assist stroke survivors in reclaiming their independence and enhancing their overall life quality. Merz Therapeutics is the sole pharmaceutical company specializing in neurotoxins that provides a platform for self-rehabilitation support.
Regulatory Support and Healthcare Reimbursement
One of the key drivers behind the digital therapeutics industry is the growing regulatory support and creation of reimbursement mechanisms for these platforms. Regulators such as the U.S. Food and Drug Administration (FDA) are actively engaging in the verification of digital therapeutics as proper medical interventions. The FDA has established new guidelines for the approval of software-based treatments, which is streamlining the process for digital therapeutics companies to take their products to market. This regulatory approval ensures that digital therapeutics are safe and effective, thus gaining more acceptance from healthcare providers and patients. Moreover, reimbursement policies are evolving to accommodate digital therapeutics, with more insurance companies recognizing the value of these solutions in improving patient outcomes and reducing healthcare costs. As reimbursement for digital therapies becomes more widespread, the financial accessibility of these solutions is improving, allowing more patients to benefit from them. This regulatory and reimbursement progress is paving the way for the broader adoption of digital therapeutics in mainstream healthcare.
Greater Emphasis on Mental Health
The increasing recognition of mental health disorders is supporting the market growth. Mental health disorders like anxiety, depression, and post-traumatic stress disorder (PTSD) are rising in frequency, and there is a growing need for effective, affordable treatments. Digital therapeutics are opening up new possibilities for treating mental health disorders by presenting scalable, easy-to-deliver solutions that can be delivered from home. Mobile apps, online therapy websites, and computerized cognitive behavioral therapy (CBT) programs are becoming increasingly popular as they provide patients with an option to standard in-office therapy. These options are especially useful for those who live in rural or underdeveloped areas, where access to mental health professionals is limited. In addition, online mental health websites offer a level of anonymity that can decrease the stigma of seeking help.
Consumer Preference for Convenience and Remote Healthcare
The preferences for convenient, remote healthcare products and services is bolstering the market growth. Today's patients increasingly want healthcare solutions that are integrated into their active lifestyle, so they can take care of themselves without having to pay repeated visits to clinics or hospitals. Digital therapeutics are addressing this need by offering tools that are available whenever and wherever needed, helping patients to control their health at their own pace. For instance, individuals suffering from chronic diseases can monitor their symptoms, monitor their vital signs, and receive treatment advice using mobile applications and wearable technology. Furthermore, digital platforms also facilitate remote consultations with medical professionals, curbing the necessity of travel and lowering healthcare expenses.
Diabetes accounts for the majority of the market share
Diabetes holds the largest market share as it is a condition that affects millions globally. Additionally, digital therapeutics in this area leverage cutting-edge technology to monitor blood sugar levels, administer insulin doses, and provide personalized dietary and exercise recommendations. These tools aim to stabilize patient conditions and enhance the quality of life by making disease management more accessible and efficient. Hence, leading market players are introducing advanced product variants to meet these needs. For instance, on 16 October 2023, Better Therapeutics, Inc., a prominent leader in prescription digital therapeutics (PDTs) for cardiometabolic conditions, announced the commercial release of AspyreRx. This is the first cognitive behavioral therapy (CBT) app to gain U.S. Food and Drug Administration (FDA) approval as a Class II device for managing type 2 diabetes (T2D) in adults. It allows healthcare providers to prescribe AspyreRx, which is accessible for download from the Apple App Store and Google Play Store.
Patients holds the largest share of the industry
According to the digital therapeutics industry overview, patients represent the largest segment due to the increasing patient-centric healthcare approach and the widespread adoption of smartphones and internet services, which facilitate easy access to therapeutic applications. These digital solutions offer patients tailored treatments for a range of conditions, including chronic diseases such as diabetes and hypertension, as well as mental health disorders. Additionally, the convenience and efficacy of these applications in managing health conditions through personalized care plans and real-time health tracking significantly contribute to their adoption among patients. This trend is further supported by growing healthcare digitization and a shift toward preventive healthcare measures, reinforcing the dominant position of patients in the digital therapeutics market. Therefore, major players are collaborating and launching sophisticated product variations. For instance, on 5 July 2023, ResMed announced the acquisition of Somnoware, a leading provider of digital diagnostics software for sleep and respiratory care. This acquisition expanded ResMed's sleep management software capabilities, facilitating more efficient patient diagnosis and long-term treatment through enhanced sleep labs and physician tools. The Somnoware platform will complement ResMed's existing post-testing solutions, AirView and Brightree, and will continue to operate as an open platform. This openness allows sleep labs, pulmonary function testing facilities, and physicians to access results from various testing solutions, accelerating the process of getting diagnosed patients the treatment they need.
North America leads the market, accounting for the largest digital therapeutics market share
The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America was the largest regional market for digital therapeutics.
North America represents the leading region in the market. The digital therapeutics market growth factors for the region include the well-established healthcare infrastructure, robust technological advancements, and significant investment in digital health across the region. Moreover, the United States is primarily driven by the widespread adoption rate of digital health technologies among healthcare providers and patients alike. Besides, the presence of major digital therapeutics companies in North America, coupled with favorable government policies and a growing awareness about the benefits of digital therapeutics, further propel the market growth. For instance, on 7 November 2023, Vida Health, a leader in virtual cardiometabolic care, partnered with Withings Health Solutions, a key player in advanced everyday wearables, to provide top-tier digital monitoring devices to Vida members. This partnership offered eligible Vida members access to a Withings Body Pro cellular scale, a BPM Connect Pro cellular blood pressure monitor, or both. Vida's care teams gained reliable and consistent patient-generated health data, which enhanced their personalized care strategies and improved health outcomes by using these devices.
(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)