Digital therapeutics (DTx) are evidence-based therapeutic interventions driven by high-quality software programs to prevent, manage, or treat a medical disorder or disease. They leverage technologies such as artificial intelligence, machine learning, and big data analytics to deliver precise and individualized treatment plans. These interventions are designed to provide personalized treatments and are often used in conjunction with traditional medical care. DTx includes apps, online programs, wearable devices, and digital platforms.
Market size and growth
In 2022, the global digital therapeutics market held a valuation of approximately USD 4.20 billion, and projections indicate significant growth over the next decade. The market is expected to grow at a compound annual growth rate (CAGR) of around 20-25% from 2023 to 2030, driven by the increasing adoption of digital health solutions, the rising prevalence of chronic diseases, and supportive regulatory environments.
Industry players in the digital therapeutics space
Several companies are leading the digital therapeutics (DTx) industry, developing innovative software-based interventions to treat a range of health conditions. Here are some of the key industry leaders in digital therapeutics:
Pear Therapeutics: Pear Therapeutics has developed FDA-approved products for substance use disorder (reSET and reSET-O) and chronic insomnia (Somryst). Their products combine cognitive behavioral therapy (CBT) with digital platforms to deliver evidence-based interventions.
Products: reSET, reSET-O, Somryst.
Product Pipeline
reCALL™ for Indication: Schizophrenia
reVIVE™ for Indication: Major Depressive Disorder (MDD)
reLAY™ for Indication: Generalized Anxiety Disorder (GAD)
Akili Interactive : Akili Interactive focuses on cognitive disorders. EndeavorRx, their flagship product, is an FDA-cleared video game-based treatment for attention-deficit/hyperactivity disorder (ADHD) in children.
Products: EndeavorRx
Product Pipeline : Selective Stimulus Management Engine (SSME™), Body Brain Trainer (BBT™), Spatial Navigation (SNAV™) Engine. These products focus on improving various aspects of cognitive function.
Omada Health: Omada Health offers programs for chronic disease management, including diabetes prevention, diabetes management, hypertension, and behavioral health. Their platform combines human coaching with digital tools to drive behavior change.
Products: Omada Program
Product Pipeline : The pipeline includes efforts to expand into weight management, chronic disease management, and cardiovascular health. Omada’s strategic approach combines personalized coaching, evidence-based interventions, and digital tools to support sustainable health behavior changes, making them a significant player in the digital health space.
Propeller Health: Propeller Health specializes in respiratory health, particularly asthma and chronic obstructive pulmonary disease (COPD). Their platform uses connected inhalers to track medication usage and provide personalized feedback and insights.
Products: Propeller Platform
Click Therapeutics
Products: Clickotine, Click Neurobehavioral Intervention
Product Pipeline
CT-152 for the Major Depressive Disorder (MDD) is in the regulatory approval phase.
CT-155 for Insomnia is in Phase 3 clinical trials.
CT-132 for Migraine is in Phase 3 clinical trials.
CT-111 for Acute coronary syndrome is in Phase 1 clinical trials.
CT-191 for Oncology is in Phase 1 clinical trials.
Other products include CT141, CT181, CT133, CT102, and CT152 for various neurological disorders.
Other major players in the industry
Big Health: Big Health offers digital therapeutics for mental health. Sleepio is a digital sleep improvement program, and Daylight is designed to help manage anxiety.
Products: Sleepio, Daylight.
WellDoc: BlueStar is an FDA-cleared digital therapeutic that provides real-time, personalized coaching and insights for people with diabetes.
Products: BlueStar. WellDoc specializes in diabetes management.
Livongo (Teladoc Health): Livongo, now part of Teladoc Health, offers digital health solutions for chronic conditions, including diabetes and hypertension. Their platform integrates connected devices, data analytics, and personalized coaching.
Products: Livongo for Diabetes; Livongo for Hypertension.
2Morrow: 2Morrow develops digital health programs targeting behavioral health issues, such as smoking cessation (SmartQuit) and weight management.
Products: SmartQuit, 2Morrow Health.
Biofourmis: Biofourmis combines digital therapeutics with advanced analytics to manage chronic conditions and optimize patient outcomes. Their Biovitals platform uses wearable sensors and AI to personalize treatment.
Products: Biovitals Platform.
MindMaze: MindMaze specializes in neurorehabilitation and neurological health. Their digital therapeutics use virtual reality (VR) and motion capture technology to support recovery from strokes and other brain injuries.
Products: MindMotion, MindMaze Pro.
Cognoa: Cognoa focuses on pediatric behavioral health, particularly autism spectrum disorder. Canvas Dx is an AI-based diagnostic device for autism, and they are developing digital therapeutics to support behavioral interventions.
Products: Canvas Dx, digital therapeutics for autism.
Key regulatory aspects of digital therapeutics
The regulations surrounding Software as a Medical Device (SaMD) are critical to ensure the safety, efficacy, and reliability of these digital health solutions. Various regulatory agencies around the world have established guidelines and frameworks for SaMD.
International Framework: The IMDRF (International Medical Device Regulators Forum) provides a foundational framework for SaMD regulation. The IMDRF has issued several key documents, including the SaMD, Key Definitions, and the SaMD, Risk Categorization Framework.
Definition of SaMD: software intended to be used for one or more medical purposes without being part of a hardware medical device. It can perform medical functions such as diagnosis, prevention, monitoring, treatment, or alleviation of disease.
Regulatory Considerations
Risk Classification : SaMD is classified based on the risk it poses to patients and users. Higher risk classifications require more rigorous regulatory scrutiny and evidence.
Clinical Evaluation : Demonstrating clinical validity, safety, and effectiveness through robust clinical trials or real-world evidence is essential.
Quality Management System (QMS) : Compliance with QMS standards such as ISO 13485 is often required to ensure that the development and maintenance of SaMD meet quality standards.
Cybersecurity : Ensuring the security of patient data and the SaMD itself is critical. Regulatory agencies provide guidelines for cybersecurity measures and incident response plans.
Post-Market Surveillance : Continuous monitoring of SaMD after it enters the market to detect any issues or adverse events. This includes maintaining a system for reporting and addressing any problems that arise.
Labeling and Instructions for Use : Clear and accurate labeling, including instructions for use, contraindications, and warnings, must be provided.
Regulatory Agencies and Guidelines
United States - US Food and Drug Administration (US FDA): SaMD is classified based on its intended use and the level of risk to the patient. The FDA has issued several guidance documents for SaMD, including:
Policy for Device Software Functions and Mobile Medical Applications - clarifies the regulatory approach for mobile apps and software functions.
Software as a Medical Device (SaMD): Clinical Evaluation - provides guidance on clinical evaluation and evidence requirements.
Approval Pathways:
510(k) Premarket Notification: For devices that are substantially equivalent to a legally marketed device.
De Novo Pathway: For novel devices with no existing predicate.
Premarket Approval (PMA) for high-risk devices requiring extensive evidence of safety and efficacy.
Pre-Cert Program: The Digital Health Software Precertification (Pre-Cert) Program aims to streamline the review process by evaluating the developer rather than the product alone.
European Union
EMA (European Medicines Agency) and the European Commission regulate software as a medical device (SaMD) under the Medical Device Regulation (MDR) (EU) 2017/745.
MDR (Medical Device Regulation)
Classification: SaMD is classified according to its intended use and associated risks, ranging from Class I (low risk) to Class III (high risk).
CE Marking: SaMD must obtain CE marking to be marketed in the EU, demonstrating compliance with MDR requirements.
Clinical Evaluation: This requires robust clinical evidence to demonstrate safety and efficacy.
Digital therapeutics (DTx) represent a groundbreaking approach in the healthcare landscape, merging technology with evidence-based medicine to prevent, manage, or treat medical conditions. With ongoing advancements in technology, increased investment, and a supportive regulatory environment, digital therapeutics are set to become an integral part of modern healthcare, offering innovative solutions that enhance patient outcomes and improve overall quality of life.
For your regulatory needs, contact Atrixio at info@artixio.com now to schedule a consultation and discover how we can help your business thrive.
References:
Comments