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Issue Report

Issue Report

Korea Healthcare Business Issue Report DTx 2023
June 202392 PagesFormat: PDF

Synex Consulting Ltd.


Terms and Definitions
Disclaimer
Preface

1 Understanding Digital Therapeutics
   1.1 Definition of DTx
   1.2 Characteristics of Digital Therapeutics
   1.3 Development History of Digital Therapeutics
   1.4 Applications of Digital Therapeutics
   1.5 Global Digital Therapeutics Market

2 DTx Market in Korea
   2.1 Breakthrough Device Designation
   2.2 Product Approval of MFDS
   2.3 NHIS Listing and Coverage
      2.3.1 Breakthrough Technology Designation
   2.4 Clinical Trial Approval of MFDS
   2.5 Current R&D in Korea

3 Major Suppliers of DTx in Korea
   3.1 NUNAPS
   3.2 DoBrain
   3.3 LifeSemantics
   3.4 S-Alpha Therapeutics
   3.5 AIMMED
   3.6 WELT
   3.7 Other Suppliers
      3.7.1 Neudive
      3.7.2 Medimind (formerly known as F&I Korea)
      3.7.3 Emocog
      3.7.4 HAII
      3.7.5 Huraypositive

4 Business Issues in DTx Market
   4.1 Scope of DTx Classified as Medical Devices
   4.2 Scope of Reimbursement DTx
   4.3 Market Access Model of DTx in Korea
      4.3.1 Target Conditions and Intended Uses
      4.3.2 Clinical Grounds
      4.3.3 Outlook for NHIS Coverage
      4.3.4 Business Model Forecast

Table 1 Types and examples of personal healthcare products
Table 2 Product examples Digital Therapeutics by purpose
Table 3 The development history of the Digital Therapeutics
Table 4 Key applications of Digital therapeutics
Table 5 Trends in Digital Therapeutics product launch by overseas companies
Table 6 Designation status of innovative Medical Devices related to Digital Therapeutics (as of 2023.05.19.)
Table 7 Licensing status of Digital Therapeutics (as of 2023.05.10.)
Table 8 Digital Therapeutics License Estimated Product Name
Table 9 New Medical Technology Notification Status - Cognitive Behavioral Therapy for Chronic Insomnia Using Digital Therapeuticss
Table 10 Status of Innovative Medical Technology Assessments - Improvement of chronic insomnia using cognitive behavioral therapy software (Aimmed - Somzz)
Table 11 Review Criteria for Innovative Medical Technologies
Table 12 Criteria for potential valuation of innovative medical technologies
Table 13 Clinical trial approvals for digital therapeutic devices by category 2021-2023
Table 14 Clinical Trial Approvals for DTx in Korea 2021-2023 (as of 2023.05.10.)
Table 15 Domestic R&D Trends on Digital Therapeuticss (as of 2023.05.11.)
Table 16 R&D and major companies related to Digital Therapeuticss 2020-2023
Table 17 Product development and launch trends by major companies
Tables 18 S-ALPHA Therapeutics Product Development Trends
Table 19 Aimmed's Somzz License Information
Table 20 New Medical Technology Notification Status - Cognitive Behavioral Therapy for Chronic Insomnia Using Digital Therapeuticss
Table 21 Welt's Pillow Rx (model name: WELT-IP) clearance information
Table 22 Welt Digital Therapeutics Development Trends
Table 23 Health Insurance Enrollment Process for Digital Therapeutic Devices - Innovative Medical Technologies

Fig 1 Spectrum of Digital Therapeutics
Fig 2 Digital Therapeutics Flowchart
Fig 3 Key Features of Digital Therapeutics
Fig 4 Global DTx Market Size and Forecast 2022-2025 (Unit: USD 10,000)
Fig 5 Digital Therapeutics Alliance (DTA) Flowchart
Fig 6 Integrated Review Process for Innovative Medical Devices
Fig 7 Digital Therapeutic Device IND Approvals by Year 2021-2023
Fig 8 Five-Year (2023-2027) Comprehensive Plan
Fig 9 VIVIDBrain product image of Neural Networks
Fig 10 DoBrain Education Mobile App Product Screen
Fig 11 Product Image of Redpill Breath
Fig 12 Redpill Breath Process
Fig 13 Aimmed's Somzz product screen
Fig 14 Aimmed's NUROW game screen.
Fig 15 Welt's Pillow Rx product screen
Fig 16 NHIS Registration Process Outlook
Fig 17 Innovative Medical Technology Evaluation Process
Fig 18 Digital Therapeutics Pricing System Forecast
Fig 19 Prescription DTx Reimbursement Outlook
Fig 20 Prescription DTx Reimbursement Outlook

1 NUNAPS
2 DoBrain
3 LifeSemantics
4 S-Alpha Therapeutics
5 AIMMED
6 WELT
7 Neudive
8 Medimind
9 Emocog
10 HAII
11 Huraypositive
12 NeuroEars
13 Neopons
14 DIGITAL PHARM
15 MINDsAI
16 Tech Village

US$ 1,000 (excluded VAT)


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