About DTx
Realizing ‘the new paradigm of treatment’
Digital Therapeutics (DTx)
A medical device provided to patients through a high-quality software program based on clinical evidence to treat, manage, or prevent a medical disorder or disease.
Digital Therapeutics are used independently or in combination with other therapies like medication.
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1. Software as Medical Device
- Installed and used with hardware such as PCs, mobile products, and Head Mounted Display(HMD)
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2. Applied Area
- Disease Target : International Classification of Diseases, Korean Standard Classification of Causes of Disease
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3. Type of scientific (clinical) evidence (optional)
- Clinical Practice Guideline (CPG) recognized by the Korean Medical Association, etc.
- Exploration, researcher clinical trial data
Is it a software medical device?
Is it applied to patients for the purpose of preventing, managing or treating disease?
Is there a scientific (clinical) basis for the therapeutic mechanism of action?
Applicable to DTX
Not applicable to DTX
Advantages of Digital Therapeutics(DTx)
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Treatment can be offered through devices such as smart phone, tablet, VR headset, and so on.
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Customized medical care can be offered in the environment preferred by patients.
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Available through prescription or non-prescription authorization
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Deliver safe, meaningful results and insights into patient goals and engagement.
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Extend the reach of clinical care and improve health equity through standardization and accessibility of care.
Comparison with Existing Pharmaceutical Development
It is designed based on the clinical practice guideline (CPG, Clinical Practice Guideline) and clinical pathway (CP, Clinical Pathway) that have been clinically verified, so the development cost is relatively lower than that of existing new drugs, and the clinical trial procedure and development period are relatively short as there is no preclinical stage.
| DTx | Existing New Drug | |
| Development Period | 3.5 to 5 years | Existing New Drug |
| Development Cost | 10billion to 20billion KRW |
Average of 3 trillion KRW |
| # of Clinical Subjects | Within 500 people | 10,000 people |
| Medication Compliance | 80% | 60% |
*Source: Predictions on the leading position of digital health (Professor Ung-beom Pyeon, Seoul National University, 2019.11)
DT by Product Purpose
It is designed based on the clinical practice guideline (CPG, Clinical Practice Guideline) and clinical pathway (CP, Clinical Pathway) that have been clinically verified, so the development cost is relatively lower than that of existing new drugs, and the clinical trial procedure and development period are relatively short as there is no preclinical stage.
| Product Purpose | 1. Health Management | 2. Disease Management and Prevention | 3. Optimization of other medicines | 4. Disease Treatment |
| Claims about product effectiveness, harm, purpose of use, etc. |
Regulatory Discretion (Not always regulated) |
Requires third-party verification and is regulated by regulatory agencies | ||
| Coverage of product claims related to disease | Efficacy claims regarding disease are not accepted |
low to medium risk (e.g. slowing down the progression of a disease) |
Medium to high risk (e.g. Increases the effectiveness of an existing drug) |
Medium to high risk (e.g. Medical validity like disease treatment) |
| Clinical Evidence | Clinical trials are required, and evidence needs to be created continuously | |||
| Purchase Methods | DTC(Direct to Customer) purchase Doctor’s prescription not required | Over-the-counter or doctor’s prescription required | Doctor’s prescription required | |
| Usage with other drugs | Used independently or indirectly support other medications | Administration alone or in combination | Administration in combination | Administration alone or in combination |
Global Market Size
$2.19 billion
$9.64 billion
2018
2022
*Source : Allied Market Research, 2020. 1.