THE U.S. DIGITAL THERAPEUTICS MARKET WAS VALUED AT USD 1.5 BILLION IN 2021 AND IS EXPECTED TO REACH USD 8.8 BILLION BY 2027, GROWING AT A CAGR OF 33.15%.

The U.S. Digital Therapeutics Market Size, Share, Trends Analysis

  • Application: Treatment & Disease Management (Chronic Care, Mental Health & Neurological Disorders, and Others) and Preventive Care (Pre-Diabetes, Weight Management, and Others)
  • End-User: Healthcare Providers, Patients/Individuals, Payers, Employers, and Others

Industry Analysis Report, Regional Outlook, Growth Potential, Price Trends, Competitive Market Share & Forecast, 2022-2027

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188 Pages

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56 Tables

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74 Charts

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1 Regions

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1 Countries

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45 Companies

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4 Market Segment

U.S. DIGITAL THERAPEUTICS MARKET REPORT SCOPE

Report Attribute Details
Market Size (2027) USD 8.8 Billion
Market Size (2021) USD 1.5 Billion
CAGR (2022-2027) 33.15%
Base Year 2021
Forecast Year 2022-2027
Market Segments Application & End-user
Geographic Analysis U.S.
KEY VENDORS 2Morrow, Akili Interactive Labs, Cognoa, Fitbit, Kaia Health, Lark Technologies, Teladoc Health, Omada Health, Pear Therapeutics, ResMed, Voluntis, WellDoc, Dario Health, Happify Health, One Drop, and Virta Health

MARKET INSIGHTS

The U.S. digital therapeutics market is expected to grow at a CAGR of over 33% from 2022 to 2027 and is expected to cross $8 billion by 2027. Continuous research & innovation, an increase in the incidence of chronic diseases, awareness among the masses, and approval by the regulatory government will help to expand the U.S. digital therapeutics market size in the upcoming years. However, increased pharma investment and healthcare focussed start-ups are more likely to act as market drivers for the digital therapeutics market and impact and shape the future of the U.S. digital therapeutics market to a more significant extent.

Healthcare and technology have merged and created a new category of digital health known as digital therapeutics. Digital therapeutics (DTx) is a subset of digital health that delivers therapeutic interventions to patients utilizing evidence-based, clinically evaluated software for treating, managing, and preventing a broad spectrum of behavioral, mental, and physical diseases and disorders. Digital therapeutics plays a significant role in the treatment and disease management of various chronic and mental health conditions. It presents potential solutions for chronic disease management, including congestive heart failure, type 2 diabetes, Alzheimer's disease, and cancer.

Digital therapeutics (DTx) deliver evidence-based therapeutic interventions to patients driven by high-quality software programs to prevent, manage, or treat a medical disorder or disease. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes. DTx products incorporate advanced technology best practices for design, clinical validation, usability, and data security. Regulatory bodies must validate them to support product claims about risk, efficacy, and intended use. It empowers patients, healthcare providers, and payers with intelligent and accessible tools for addressing various conditions through high-quality, safe, and effective data-driven interventions.

Regulatory jurisdictions most frequently categorize digital therapeutics as a subset of software as a Medical Device (SaMD), a framework developed by the International Medical Device Regulators Forum (IMDRF). All DTx products qualify as SaMD, but not all SaMD products are approved as digital therapeutic. However, a dedicated FDA regulatory framework for SaMD products remains in flux. Some DTx must undergo randomized controlled trials under the premarket approval process to demonstrate safety and efficacy like traditional pharmaceuticals.

IMPACT OF COVID-19 ON DIGITAL THERAPEUTICS

After the COVID-19 pandemic broke out, the utilization of DTx applications in various fields boomed. DTx provides unique solutions to satisfy healthcare needs, reducing the danger of COVID-19 exposure during a hospital visit. The COVID-19 pandemic joined the other major drivers for the growth of DTx, such as enhanced focus on preventive healthcare, high incidence of chronic diseases, and affordable gadgets due to technological advancements. In the post-COVID era, DTx became a dominant player in the digital health market, and its scope is likely to lift the U.S. digital therapeutics market.

Entry of Several Start-ups and Rapid Surge in Funding & Investments for DTx Companies

The goal of digital therapeutics is to treat chronic conditions at scale, relieving some of the significant stressors on the medical system, such as physician shortages. With the rise in the prevalence of chronic diseases, there has been a growing awareness of digital therapeutics. Owing to the gradual adoption of DTx, several companies have emerged in the digital therapeutics market, working with extreme expertise and intent to satisfy therapeutic needs. Furthermore, U.S. digital therapeutics market saw significant funding growth in 2021, with start-ups delivering medical interventions using evidence-based software for managing and treating a broad spectrum of diseases reporting surging investments. Investments in DTx were at a record in 2020 with $1,065 million with 64 deals. DTx start-ups are likely to increase at an incredible rate, and competition is fierce for the favor of providers, payors, and employers.

Digital therapeutic solutions have caught the eye of big pharmaceutical organizations that started to invest and form strategic alliances with digital therapeutic companies. The rising need to create value beyond drug discoveries, increasing pricing pressures, and the steady incline in chronic and complex diseases all around the globe have majorly contributed to these partnerships. For instance, in early 2021, Click Therapeutics and Otsuka Pharmaceuticals announced a new remote clinical trial conducted on Verily's Project Baseline platform. In addition, many DTx companies have attracted significant venture and private equity financing to compete with traditional biotech pharma & companies developing drugs for similar indications. For instance, Pear Therapeutics developing DTx for substance and opioid use disorder raised around $139 million.

Digital therapeutics and telehealth companies can contribute to solutions more effectively than ever by leveraging data from wearables and other digital sources. These technologies can drive more profound insight, influencing patient behaviors to prevent and manage chronic conditions. With the pandemic significantly raising the adoption of telehealth and virtual care, telehealth companies are looking to digital therapeutic platforms to enhance the value of their services. For example, Aetna's telehealth business unit, Healthagen, collaborated with Welldoc and LifeScan to assess the usage and potential health benefits of OneTouch Reveal Plus.

Artificial Intelligence & Virtual Reality assisted Digital Therapeutics.

Software applications are playing a significant role in providing digital therapeutic solutions. Mobile app-based digital therapeutic programs are being delivered at a low cost and massive scale, helping prevent disease progression and saving insurers billions of dollars. Some digital therapeutics are replacing medication with behavioral-based treatment, such as apps that use visualization exercises to help people with insomnia.

For the U.S. Digital Therapeutics market, where many new and innovative applications are launched frequently, A.I. plays a significant role in driving personalization and engagement to help patients achieve better health. AI-enabled therapeutics offer diagnosis and personalized care by tailoring the treatment and anticipating needs and challenges based on the individual's behavior. Digital therapeutics coupled with artificial intelligence (A.I.) and machine learning (ML) allow more effective clinical observations and management at the population level for various health conditions. Furthermore, virtual reality in digital therapeutics is gaining significant attention. It focuses on mental health, such as studying the mental states based on brainwave patterns. It also targets the promotion of healthy lifestyles through innovative virtual coaching.

INSIGHTS BY APPLICATION

In 2021, the treatment & disease management segment accounted for more than 80% of the market share. This treatment & management market will increase its domination during the forecast period and is likely to grow at a faster growth. This segment includes managing and treating diseases like chronic care, mental health & neurological disorders using DTx. Digital therapeutics are being increasingly adopted due to the growing concern of chronic diseases. It is intended to help patients change their behaviors, often through cognitive-behavioral therapy (CBT), to successfully implement care plans for their chronic health or mental health conditions.

  • Treatment & Disease Management: Vendors targeting the treatment and management of various diseases are Teladoc, Canary Health, Noom, Cognoa, Pear Therapeutics, CureApp, 2Morrow, Sharecare, and others
  • Preventive Care: This includes pre-diabetes, weight management, and others. Vendors involved in providing digital therapeutics in these areas are Omada Health, One drop, WellDoc, Lark Health, and others.

INSIGHTS BY END-USERS

In 2021, healthcare providers accounted for the largest share of 29.11% in the digital therapeutics market in the United States Digital Therapeutics empower patients, healthcare providers, and payers with intelligent and accessible tools for addressing a wide range of conditions through high-quality, safe, and effective data-driven interventions. It promises many advantages for physicians, care providers, patients, payers, employers, and other stakeholders. As primary end-users, patients are at the core of the DTx landscape. Most therapies are delivered via smartphones or tablets to patients, increasing access to care compared to traditional treatments.

COMPETITIVE SCENARIO

Vendors dominating the U.S. digital therapeutics market are developing strategies such as partnerships, collaborations, joint ventures, mergers, and acquisitions for their growth and establishment. Major companies made successful partnerships to advance the adoption of DTx. Noom and Eversana partnered to cater to patients with chronic conditions and rare diseases and check patient adherence and engagement for long-drawn-out therapies. The U.S. digital therapeutics market consolidates with vendors indulging in strategic acquisitions and collaborations with pharmaceutical companies to enter the digital therapeutics market and extend their presence in the market. Some significant acquisitions also took place in the U.S. digital therapeutics market are:

  • Biofourmis acquiring Gaido Health
  • Virgin Pulse acquiring Blue Mesa
  • Novartis acquired the digital therapeutics firm, Amblyotech.

Vendor partnerships and strong I.T. capabilities are essential to successfully implementing digital therapeutics across the healthcare value chain. Vendors need to collaborate to take digital therapeutics forward from single-use applications into system-wide integration with other infrastructures to deliver cost-effective and high-quality care to patients.

Major prominent vendors accounting for a significant share in the U.S. digital therapeutics market include 2Morrow, Akili Interactive Labs, Cognoa, Fitbit, Kaia Health, Lark Technologies, Teladoc Health, Omada Health, Pear Therapeutics, ResMed, WellDoc, Dario Health, and Happify.

Frequently Asked Questions

HOW BIG IS THE U.S. DIGITAL THERAPEUTICS MARKET?

The digital therapeutics market in the U.S. was valued at USD 1.5 billion in 2021 and is expected to reach USD 8.8 billion by 2027.

WHAT IS THE GROWTH RATE OF THE DIGITAL THERAPEUTICS MARKET IN THE UNITED STATES?

U.S. digital therapeutics market is expected to grow at a CAGR of 33.15% during 2022-2027.

WHAT ARE THE KEY COMPANIES IN THE DIGITAL THERAPEUTICS MARKET IN U.S.?

Key vendors include 2Morrow, Akili Interactive Labs, Cognoa, Fitbit, Kaia Health, Lark Technologies, Teladoc Health, Omada Health, Pear Therapeutics, ResMed, Voluntis, WellDoc, Dario Health, Happify Health, One Drop, and Virta Health.

WHAT ARE THE MAJOR DRIVERS IN THE US DIGITAL THERAPEUTICS MARKET?

The increase in adoption of healthcare applications & smart wearables, the rising importance of A.I. in digital therapeutics, and the growing demand for virtual reality in DTx are the major drivers in the U.S. digital therapeutics market.

WHAT ARE THE LATEST TRENDS & OPPORTUNITIES IN THE US DIGITAL THERAPEUTICS MARKET?

The promising pipeline of digital therapeutic solutions, the rapid surge in funding & investments in digital therapeutics, and strategic collaborations between DTx vendors and pharma & medical device companies are the latest trends & opportunities in U.S. digital therapeutics market.

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The digital therapeutics market in the U.S. was valued at USD 1.5 billion in 2021 and is expected to reach USD 8.8 billion by 2027, growing at a CAGR of 33.15%.

The following factors are likely to contribute to the growth of the U.S. digital therapeutics market:

  • Rise in Chronic Diseases and Need for Controlling Healthcare Costs
  • Increase in Adoption of Healthcare Applications & Smart Wearables
  • Rising Importance of A.I. in Digital Therapeutics
  • Growing demand for Virtual Reality in DTx

Base Year: 2021

Forecast Year: 2022-2027

The study considers a detailed scenario of the present U.S. digital therapeutics market and its market dynamics for 2022−2027. It covers a detailed overview of several industry growth enablers, restraints, and trends. The report offers both the demand and supply aspects of the market. It profiles and examines leading companies and other prominent ones operating in the market.

Key Vendors

  • 2Morrow
    • Business Overview
    • Product Offerings
    • Key Strengths
    • Key Strategies
    • Key Opportunities
  • Akili Interactive Labs
  • Cognoa
  • Fitbit
  • Kaia Health
  • Lark Technologies
  • Teladoc Health
  • Omada Health
  • Pear Therapeutics
  • ResMed
  • Voluntis
  • WellDoc
  • Dario Health
  • Happify Health
  • One Drop
  • Virta Health

Other Prominent Vendors

  • Ayogo
    • Business Overview
    • Product Offerings
  • BehaVR
  • Calibrate Health
  • Canary Health
  • Cara Care
  • CardioRenal
  • Cerebral
  • CogniFit
  • CureApp
  • Freespira
  • Ginger
  • Glooko
  • Kelvi
  • Mahana Therapeutics
  • Mantra Health
  • Meru Health
  • Monument
  • Neurotrack Technologies
  • NightWare
  • Noom
  • Sharecare
  • SWORD Health
  • Talkspace
  • Thirty Madison
  • TRIPP
  • Vida Health
  • Vivante Health
  • Workit Health

Segmentation by Application

  • Treatment & Disease Management
    • Chronic Care
    • Mental Health & Neurological Disorders
    • Others
  • Preventive Care
    • Pre-Diabetes
    • Weight Management
    • Others

Segmentation by End-User

  • Healthcare Providers
  • Patients/Individuals
  • Payers
  • Employers
  • Others

1 RESEARCH METHODOLOGY

2 RESEARCH OBJECTIVES

3 RESEARCH PROCESS

4 SCOPE & COVERAGE

4.1 MARKET DEFINITION

4.1.1 INCLUSIONS

4.1.2 EXCLUSIONS

4.1.3 MARKET ESTIMATION CAVEATS

4.2 BASE YEAR

4.3 SCOPE OF THE STUDY

4.3.1 MARKET SEGMENTATION BY APPLICATION

4.3.2 MARKET SEGMENTATION BY END-USER

5 REPORT ASSUMPTIONS & CAVEATS

5.1 KEY CAVEATS

5.2 CURRENCY CONVERSION

5.3 MARKET DERIVATION

6 MARKET AT A GLANCE

7 INTRODUCTION

7.1 OVERVIEW

7.1.1 STEPS TO INTEGRATE DIGITAL THERAPEUTICS

7.1.2 CORE PRINCIPLES FOR DIGITAL THERAPEUTIC PRODUCTS

7.1.3 DIGITAL THERAPEUTIC PRODUCT CATEGORIES

7.1.4 SOME MAJOR MILESTONES IN DTX HISTORY

7.2 SOFTWARE AS A MEDICAL DEVICE (SAMD)

7.3 REGULATORY SCENARIO

7.4 REIMBURSEMENT SCENARIO

7.5 MAJOR FDA APPROVED DIGITAL THERAPEUTICS

7.6 IMPACT OF COVID-19 ON DIGITAL THERAPEUTICS

8 MARKET OPPORTUNITIES & TRENDS

8.1 MARKET ENTRY OF NUMEROUS DTX START-UPS

8.2 STRATEGIC COLLABORATIONS BETWEEN DTX VENDORS AND PHARMA & MEDICAL DEVICE COMPANIES

8.3 RAPID SURGE IN FUNDING & INVESTMENTS IN DIGITAL THERAPEUTICS

8.4 PROMISING PIPELINE OF DIGITAL THERAPEUTIC SOLUTIONS

8.5 TELEHEALTH PLAYERS LEVERAGING DTX PLATFORMS TO EXPAND CAPABILITIES

9 MARKET GROWTH ENABLERS

9.1 RISE IN CHRONIC DISEASES & NEED FOR CONTROLLING HEALTHCARE COSTS

9.2 INCREASED ADOPTION OF HEALTHCARE APPLICATIONS & SMART WEARABLES

9.3 ACQUISITIONS & COLLABORATIONS IN DIGITAL THERAPEUTICS

9.4 RISING IMPORTANCE OF AI IN DIGITAL THERAPEUTICS

9.5 GROWING DEMAND FOR VIRTUAL REALITY IN DTX

10 MARKET GROWTH RESTRAINTS

10.1 GROWING CONCERNS ABOUT PATIENT DATA PRIVACY

10.2 ECONOMICAL & TECHNICAL CHALLENGES INVOLVED WITH DTX

10.3 CHALLENGES WITH CLINICAL VALIDATION & STRINGENT REGULATORY GUIDELINES

11 MARKET LANDSCAPE

11.1 MARKET OVERVIEW

11.2 MARKET SIZE & FORECAST

11.2.1 INSIGHTS BY APPLICATION

11.2.2 INSIGHTS BY TREATMENT & DISEASE MANAGEMENT

11.2.3 INSIGHTS BY PREVENTIVE CARE

11.2.4 INSIGHTS BY END-USERS

11.3 FIVE FORCES ANALYSIS

11.3.1 THREAT OF NEW ENTRANTS

11.3.2 BARGAINING POWER OF SUPPLIERS

11.3.3 BARGAINING POWER OF BUYERS

11.3.4 THREAT OF SUBSTITUTES

11.3.5 COMPETITIVE RIVALRY

12 APPLICATION

12.1 MARKET SNAPSHOT & GROWTH ENGINE

12.2 MARKET OVERVIEW

13 TREATMENT & DISEASE MANAGEMENT

13.1 MARKET OVERVIEW

13.2 MARKET SIZE & FORECAST

13.3 CHRONIC CARE

13.3.1 MARKET OVERVIEW

13.3.2 MARKET SIZE & FORECAST

13.4 MENTAL HEALTH & NEUROLOGICAL DISORDERS

13.4.1 MARKET OVERVIEW

13.4.2 MARKET SIZE & FORECAST

13.5 OTHERS

13.5.1 MARKET OVERVIEW

13.5.2 MARKET SIZE & FORECAST

14 PREVENTIVE CARE

14.1 MARKET OVERVIEW

14.2 MARKET SIZE & FORECAST

14.3 PRE-DIABETES

14.3.1 MARKET OVERVIEW

14.3.2 MARKET SIZE & FORECAST

14.4 WEIGHT MANAGEMENT

14.4.1 MARKET OVERVIEW

14.4.2 MARKET SIZE & FORECAST

14.5 OTHERS

14.5.1 MARKET OVERVIEW

14.5.2 MARKET SIZE & FORECAST

15 END-USER

15.1 MARKET SNAPSHOT & GROWTH ENGINE

15.2 MARKET OVERVIEW

15.3 HEALTHCARE PROVIDERS

15.3.1 MARKET OVERVIEW

15.3.2 MARKET SIZE & FORECAST

15.4 PATIENTS/ INDIVIDUALS

15.4.1 MARKET OVERVIEW

15.4.2 MARKET SIZE & FORECAST

15.5 PAYERS

15.5.1 MARKET OVERVIEW

15.5.2 MARKET SIZE & FORECAST

15.6 EMPLOYERS

15.6.1 MARKET OVERVIEW

15.6.2 MARKET SIZE & FORECAST

15.7 OTHERS

15.7.1 MARKET OVERVIEW

15.7.2 MARKET SIZE & FORECAST

16 COMPETITIVE LANDSCAPE

16.1 COMPETITION OVERVIEW

16.2 MARKET SHARE ANALYSIS

17 KEY COMPANY PROFILES

17.1 2MORROW

17.1.1 BUSINESS OVERVIEW

17.1.2 PRODUCT OFFERINGS

17.1.3 KEY STRATEGIES

17.1.4 KEY STRENGTHS

17.1.5 KEY OPPORTUNITIES

17.2 AKILI INTERACTIVE LABS

17.2.1 BUSINESS OVERVIEW

17.2.2 PRODUCT OFFERINGS

17.2.3 KEY STRATEGIES

17.2.4 KEY STRENGTHS

17.2.5 KEY OPPORTUNITIES

17.3 COGNOA

17.3.1 BUSINESS OVERVIEW

17.3.2 PRODUCT OFFERINGS

17.3.3 KEY STRATEGIES

17.3.4 KEY STRENGTHS

17.3.5 KEY OPPORTUNITIES

17.4 FITBIT

17.4.1 BUSINESS OVERVIEW

17.4.2 PRODUCT OFFERINGS

17.4.3 KEY STRATEGIES

17.4.4 KEY STRENGTHS

17.4.5 KEY OPPORTUNITIES

17.5 KAIA HEALTH

17.5.1 BUSINESS OVERVIEW

17.5.2 PRODUCT OFFERINGS

17.5.3 KEY STRATEGIES

17.5.4 KEY STRENGTHS

17.5.5 KEY OPPORTUNITIES

17.6 LARK TECHNOLOGIES

17.6.1 BUSINESS OVERVIEW

17.6.2 PRODUCT OFFERINGS

17.6.3 KEY STRATEGIES

17.6.4 KEY STRENGTHS

17.6.5 KEY OPPORTUNITIES

17.7 TELADOC HEALTH

17.7.1 BUSINESS OVERVIEW

17.7.2 PRODUCT OFFERINGS

17.7.3 KEY STRATEGIES

17.7.4 KEY STRENGTHS

17.7.5 KEY OPPORTUNITIES

17.8 OMADA HEALTH

17.8.1 BUSINESS OVERVIEW

17.8.2 PRODUCT OFFERINGS

17.8.3 KEY STRATEGIES

17.8.4 KEY STRENGTHS

17.8.5 KEY OPPORTUNITIES

17.9 PEAR THERAPEUTICS

17.9.1 BUSINESS OVERVIEW

17.9.2 PRODUCT OFFERINGS

17.9.3 KEY STRATEGIES

17.9.4 KEY STRENGTHS

17.9.5 KEY OPPORTUNITIES

17.10 RESMED

17.10.1 BUSINESS OVERVIEW

17.10.2 PRODUCT OFFERINGS

17.10.3 KEY STRATEGIES

17.10.4 KEY STRENGTHS

17.10.5 KEY OPPORTUNITIES

17.11 VOLUNTIS

17.11.1 BUSINESS OVERVIEW

17.11.2 PRODUCT OFFERINGS

17.11.3 KEY STRATEGIES

17.11.4 KEY STRENGTHS

17.11.5 KEY OPPORTUNITIES

17.12 WELLDOC

17.12.1 BUSINESS OVERVIEW

17.12.2 PRODUCT OFFERINGS

17.12.3 KEY STRATEGIES

17.12.4 KEY STRENGTHS

17.12.5 KEY OPPORTUNITIES

17.13 DARIO HEALTH

17.13.1 BUSINESS OVERVIEW

17.13.2 PRODUCT OFFERINGS

17.13.3 KEY STRATEGIES

17.13.4 KEY STRENGTHS

17.13.5 KEY OPPORTUNITIES

17.14 HAPPIFY HEALTH

17.14.1 BUSINESS OVERVIEW

17.14.2 PRODUCT OFFERINGS

17.14.3 KEY STRATEGIES

17.14.4 KEY STRENGTHS

17.14.5 KEY OPPORTUNITIES

17.15 ONE DROP

17.15.1 BUSINESS OVERVIEW

17.15.2 PRODUCT OFFERINGS

17.15.3 KEY STRATEGIES

17.15.4 KEY STRENGTHS

17.15.5 KEY OPPORTUNITIES

17.16 VIRTA HEALTH

17.16.1 BUSINESS OVERVIEW

17.16.2 PRODUCT OFFERINGS

17.16.3 KEY STRATEGIES

17.16.4 KEY STRENGTHS

17.16.5 KEY OPPORTUNITIES

18 OTHER PROMINENT VENDORS

18.1 AYOGO

18.1.1 BUSINESS OVERVIEW

18.1.2 PRODUCT OFFERINGS

18.2 BEHAVR

18.2.1 BUSINESS OVERVIEW

18.2.2 PRODUCT OFFERINGS

18.3 CALIBRATE HEALTH

18.3.1 BUSINESS OVERVIEW

18.3.2 PRODUCT OFFERINGS

18.4 CANARY HEALTH

18.4.1 BUSINESS OVERVIEW

18.4.2 PRODUCT OFFERINGS

18.5 CARA CARE

18.5.1 BUSINESS OVERVIEW

18.5.2 PRODUCT OFFERINGS

18.6 CARDIORENAL

18.6.1 BUSINESS OVERVIEW

18.6.2 PRODUCT OFFERINGS

18.7 CEREBRAL

18.7.1 BUSINESS OVERVIEW

18.7.2 PRODUCT OFFERINGS

18.8 COGNIFIT

18.8.1 BUSINESS OVERVIEW

18.8.2 PRODUCT OFFERINGS

18.9 CUREAPP

18.9.1 BUSINESS OVERVIEW

18.9.2 PRODUCT OFFERINGS

18.10 FREESPIRA

18.10.1 BUSINESS OVERVIEW

18.10.2 PRODUCT OFFERINGS

18.11 GINGER

18.11.1 BUSINESS OVERVIEW

18.11.2 PRODUCT OFFERINGS

18.12 GLOOKO

18.12.1 BUSINESS OVERVIEW

18.12.2 PRODUCT OFFERINGS

18.13 KELVI

18.13.1 BUSINESS OVERVIEW

18.13.2 PRODUCT OFFERINGS

18.14 MAHANA THERAPEUTICS

18.14.1 BUSINESS OVERVIEW

18.14.2 PRODUCT OFFERINGS

18.15 MANTRA HEALTH

18.15.1 BUSINESS OVERVIEW

18.15.2 PRODUCT OFFERINGS

18.16 MERU HEALTH

18.16.1 BUSINESS OVERVIEW

18.16.2 PRODUCT OFFERINGS

18.17 METAME HEALTH

18.17.1 BUSINESS OVERVIEW

18.17.2 PRODUCT OFFERINGS

18.18 MONUMENT

18.18.1 BUSINESS OVERVIEW

18.18.2 PRODUCT OFFERINGS

18.19 NEUROTRACK TECHNOLOGIES

18.19.1 BUSINESS OVERVIEW

18.19.2 PRODUCT OFFERINGS

18.20 NIGHTWARE

18.20.1 BUSINESS OVERVIEW

18.20.2 PRODUCT OFFERINGS

18.21 NOOM

18.21.1 BUSINESS OVERVIEW

18.21.2 PRODUCT OFFERINGS

18.22 SHARECARE

18.22.1 BUSINESS OVERVIEW

18.22.2 PRODUCT OFFERINGS

18.23 SWORD HEALTH

18.23.1 BUSINESS OVERVIEW

18.23.2 PRODUCT OFFERINGS

18.24 TALKSPACE

18.24.1 BUSINESS OVERVIEW

18.24.2 PRODUCT OFFERINGS

18.25 THIRTY MADISON

18.25.1 BUSINESS OVERVIEW

18.25.2 PRODUCT OFFERINGS

18.26 TRIPP

18.26.1 BUSINESS OVERVIEW

18.26.2 PRODUCT OFFERINGS

18.27 VIDA HEALTH

18.27.1 BUSINESS OVERVIEW

18.27.2 PRODUCT OFFERINGS

18.28 VIVANTE HEALTH

18.28.1 BUSINESS OVERVIEW

18.28.2 PRODUCT OFFERINGS

18.29 WORKIT HEALTH

18.29.1 BUSINESS OVERVIEW

18.29.2 PRODUCT OFFERINGS

19 REPORT SUMMARY

19.1 KEY TAKEAWAYS

19.2 STRATEGIC RECOMMENDATIONS

20 QUANTITATIVE SUMMARY

20.1 MARKET BY APPLICATION

20.2 MARKET BY TREATMENT & DISEASE MANAGEMENT

20.3 MARKET BY PREVENTIVE CARE

20.4 MARKET BY END-USER

21 APPENDIX

21.1 ABBREVIATIONS

LIST OF EXHIBITS

EXHIBIT 1 SEGMENTATION OF THE US DIGITAL THERAPEUTICS MARKET

EXHIBIT 2 MARKET SIZE CALCULATION APPROACH 2021

EXHIBIT 3 PATH TO LAUNCHING DIGITAL THERAPEUTICS

EXHIBIT 4 PRODUCT CATEGORIES OF DIGITAL THERAPEUTICS

EXHIBIT 5 WORKFLOW OF A SOFTWARE AS A MEDICAL DEVICE (SAMD)

EXHIBIT 6 US FDA REGULATORY FRAMEWORK FOR DIGITAL THERAPEUTICS

EXHIBIT 7 IMPACT OF MARKET ENTRY OF NUMEROUS DTX START-UPS

EXHIBIT 8 MAJOR DIGITAL THERAPEUTIC START-UP COMPANIES IN US

EXHIBIT 9 IMPACT OF STRATEGIC COLLABORATIONS BETWEEN DTX VENDORS AND PHARMA & MEDICAL DEVICE COMPANIES

EXHIBIT 10 DIGITAL THERAPEUTICS & PHARMA DEALS BY THERAPEUTIC AREA

EXHIBIT 11 IMPACT OF RAPID SURGE IN FUNDING & INVESTMENTS IN DIGITAL THERAPEUTICS

EXHIBIT 12 DIGITAL HEALTH FUNDING IN US 2010–2020 ($ BILLION)

EXHIBIT 13 NUMBER OF DEALS IN DIGITAL HEALTH 2011–2021

EXHIBIT 14 IMPACT OF PROMISING PIPELINE OF DIGITAL THERAPEUTIC SOLUTIONS

EXHIBIT 15 LIST OF DIGITAL THERAPEUTICS PIPELINE BY STAGE OF DEVELOPMENT FOR SELECT VENDORS

EXHIBIT 16 COMPARISON OF INTERVENTIONAL DIGITAL THERAPEUTICS CLINICAL TRIALS BY INDUSTRY & ACADEMIC INSTITUTES 2014-2019

EXHIBIT 17 IMPACT OF TELEHEALTH PLAYERS LEVERAGING DTX PLATFORMS TO EXPAND CAPABILITIES

EXHIBIT 18 IMPACT OF RISE IN CHRONIC DISEASES & NEED FOR CONTROLLING HEALTHCARE COSTS

EXHIBIT 19 IMPACT OF INCREASED ADOPTION OF HEALTHCARE APPLICATIONS & SMART WEARABLES

EXHIBIT 20 IMPACT OF ACQUISITIONS & COLLABORATIONS IN DIGITAL THERAPEUTICS

EXHIBIT 21 IMPACT OF RISING IMPORTANCE OF AI IN DIGITAL THERAPEUTICS

EXHIBIT 22 IMPACT OF GROWING DEMAND FOR VIRTUAL REALITY IN DTX

EXHIBIT 23 IMPACT OF GROWING CONCERNS ABOUT PATIENT DATA PRIVACY

EXHIBIT 24 IMPACT OF ECONOMICAL & TECHNICAL CHALLENGES INVOLVED WITH DTX

EXHIBIT 25 IMPACT OF CHALLENGES WITH CLINICAL VALIDATION & STRINGENT REGULATORY GUIDELINES

EXHIBIT 26 US DIGITAL THERAPEUTICS MARKET 2021–2027 ($ MILLION)

EXHIBIT 27 US DIGITAL THERAPEUTICS MARKET BY APPLICATION

EXHIBIT 28 US DIGITAL THERAPEUTICS MARKET BY TREATMENT & DISEASE MANAGEMENT

EXHIBIT 29 US DIGITAL THERAPEUTICS MARKET BY PREVENTIVE CARE

EXHIBIT 30 US DIGITAL THERAPEUTICS MARKET BY END-USER

EXHIBIT 31 FIVE FORCES ANALYSIS 2021

EXHIBIT 32 INCREMENTAL GROWTH BY APPLICATION 2021 & 2027

EXHIBIT 33 ANNUAL INCREMENT COST PER PERSON IN US FOR VARIOUS CONDITIONS

EXHIBIT 34 US DIGITAL THERAPEUTICS MARKET BY APPLICATION: INCREMENTAL GROWTH

EXHIBIT 35 US DIGITAL THERAPEUTICS MARKET BY APPLICATION: ABSOLUTE GROWTH

EXHIBIT 36 US DIGITAL THERAPEUTICS MARKET BY TREATMENT & DISEASE MANAGEMENT

EXHIBIT 37 US DIGITAL THERAPEUTICS MARKET BY TREATMENT & DISEASE MANAGEMENT: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 38 MAJOR VENDORS OFFERING DIGITAL THERAPEUTICS FOR TREATMENT & DISEASE MANAGEMENT

EXHIBIT 39 US TREATMENT & DISEASE MANAGEMENT DIGITAL THERAPEUTICS MARKET 2021–2027 ($ MILLION)

EXHIBIT 40 US DIGITAL THERAPEUTICS MARKET BY CHRONIC CARE: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 41 US CHRONIC CARE DIGITAL THERAPEUTICS MARKET 2021–2027 ($ MILLION)

EXHIBIT 42 US DIGITAL THERAPEUTICS MARKET BY MENTAL HEALTH & NEUROLOGICAL DISORDERS: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 43 US MENTAL HEALTH & NEUROLOGICAL DISORDER DIGITAL THERAPEUTICS MARKET 2021–2027 ($ MILLION)

EXHIBIT 44 US DIGITAL THERAPEUTICS MARKET BY OTHERS: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 45 US DIGITAL THERAPEUTICS MARKET BY OTHERS 2021–2027 ($ MILLION)

EXHIBIT 46 US PREVENTIVE CARE DIGITAL THERAPEUTICS MARKET

EXHIBIT 47 MAJOR VENDORS OFFERING DIGITAL THERAPEUTICS FOR PREVENTIVE CARE

EXHIBIT 48 US PREVENTIVE CARE DIGITAL THERAPEUTICS MARKET: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 49 US PREVENTIVE CARE DIGITAL THERAPEUTICS MARKET 2021–2027 ($ MILLION)

EXHIBIT 50 US DIGITAL THERAPEUTICS MARKET BY PRE-DIABETES: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 51 US PRE-DIABETES DIGITAL THERAPEUTICS MARKET 2021–2027 ($ MILLION)

EXHIBIT 52 US DIGITAL THERAPEUTICS MARKET BY WEIGHT MANAGEMENT: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 53 US WEIGHT MANAGEMENT DIGITAL THERAPEUTICS MARKET 2021–2027 ($ MILLION)

EXHIBIT 54 US DIGITAL THERAPEUTICS MARKET BY OTHERS: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 55 US DIGITAL THERAPEUTICS MARKET BY OTHERS 2021–2027 ($ MILLION)

EXHIBIT 56 INCREMENTAL GROWTH BY END-USER 2021 & 2027

EXHIBIT 57 US DIGITAL THERAPEUTICS MARKET BY END-USER

EXHIBIT 58 BENEFITS OF DIGITAL THERAPEUTICS TO KEY STAKEHOLDERS

EXHIBIT 59 US DIGITAL THERAPEUTICS MARKET BY END-USER: INCREMENTAL GROWTH

EXHIBIT 60 US DIGITAL THERAPEUTICS MARKET BY END-USER: ABSOLUTE GROWTH

EXHIBIT 61 US DIGITAL THERAPEUTICS MARKET BY HEALTHCARE PROVIDERS: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 62 US DIGITAL THERAPEUTICS MARKET BY HEALTHCARE PROVIDERS 2021–2027 ($ MILLION)

EXHIBIT 63 US DIGITAL THERAPEUTICS MARKET BY PATIENTS/INDIVIDUALS: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 64 US DIGITAL THERAPEUTICS MARKET BY PATIENTS/INDIVIDUALS 2021–2027 ($ MILLION)

EXHIBIT 65 US DIGITAL THERAPEUTICS MARKET BY PAYERS: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 66 US DIGITAL THERAPEUTICS MARKET BY PAYERS 2021–2027 ($ MILLION)

EXHIBIT 67 US DIGITAL THERAPEUTICS MARKET BY EMPLOYERS: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 68 US DIGITAL THERAPEUTICS MARKET BY EMPLOYERS 2021–2027 ($ MILLION)

EXHIBIT 69 US DIGITAL THERAPEUTICS MARKET BY OTHERS: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 70 US DIGITAL THERAPEUTICS MARKET BY OTHERS 2021–2027 ($ MILLION)

EXHIBIT 71 GROWTH STRATEGIES BY TOP DIGITAL THERAPEUTIC COMPANIES

EXHIBIT 72 PURE AND DIVERSIFIED PLAYERS IN THE US DIGITAL THERAPEUTICS MARKET

EXHIBIT 73 US DIGITAL THERAPEUTICS MARKET: MAJOR VENDOR’S STRENGTH & CAPABILITY ANALYSIS

EXHIBIT 74 POSITION OF MAJOR PLAYERS IN THE US DIGITAL THERAPEUTICS MARKET

LIST OF TABLES

TABLE 1 KEY CAVEATS

TABLE 2 CURRENCY CONVERSION 2015−2021

TABLE 3 US FDA APPROVED DIGITAL THERAPEUTICS (2010-2021)

TABLE 4 2MORROW: MAJOR PRODUCT OFFERINGS

TABLE 5 AKILI INTERACTIVE LABS: MAJOR PRODUCT OFFERINGS

TABLE 6 COGNOA: MAJOR PRODUCT OFFERINGS

TABLE 7 FITBIT: MAJOR PRODUCT OFFERINGS

TABLE 8 KAIA HEALTH: MAJOR PRODUCT OFFERINGS

TABLE 9 LARK TECHNOLOGIES: MAJOR PRODUCT OFFERINGS

TABLE 10 TELADOC HEALTH: MAJOR PRODUCT OFFERINGS

TABLE 11 OMADA HEALTH: MAJOR PRODUCT OFFERINGS

TABLE 12 PEAR THERAPEUTICS: MAJOR PRODUCT OFFERINGS

TABLE 13 RESMED: MAJOR PRODUCT OFFERINGS

TABLE 14 VOLUNTIS: MAJOR PRODUCT OFFERINGS

TABLE 15 WELLDOC: MAJOR PRODUCT OFFERINGS

TABLE 16 DARIO HEALTH: MAJOR PRODUCT OFFERINGS

TABLE 17 HAPPIFY HEALTH: MAJOR PRODUCT OFFERINGS

TABLE 18 ONE DROP: MAJOR PRODUCT OFFERINGS

TABLE 19 VIRTA HEALTH: MAJOR PRODUCT OFFERINGS

TABLE 20 AYOGO: MAJOR PRODUCT OFFERINGS

TABLE 21 BEHAVR: MAJOR PRODUCT OFFERINGS

TABLE 22 CALIBRATE HEALTH: MAJOR PRODUCT OFFERINGS

TABLE 23 CANARY HEALTH: MAJOR PRODUCT OFFERINGS

TABLE 24 CARA CARE: MAJOR PRODUCT OFFERINGS

TABLE 25 CARDIORENAL: MAJOR PRODUCT OFFERINGS

TABLE 26 CEREBRAL: MAJOR PRODUCT OFFERINGS

TABLE 27 COGNIFIT: MAJOR PRODUCT OFFERINGS

TABLE 28 CUREAPP: MAJOR PRODUCT OFFERINGS

TABLE 29 FREESPIRA: MAJOR PRODUCT OFFERINGS

TABLE 30 GINGER: MAJOR PRODUCT OFFERINGS

TABLE 31 GLOOKO: MAJOR PRODUCT OFFERINGS

TABLE 32 KELVI: MAJOR PRODUCT OFFERINGS

TABLE 33 MAHANA THERAPEUTICS: MAJOR PRODUCT OFFERINGS

TABLE 34 MANTRA HEALTH: MAJOR PRODUCT OFFERINGS

TABLE 35 MERU HEALTH: MAJOR PRODUCT OFFERINGS

TABLE 36 METAME HEALTH: MAJOR PRODUCT OFFERINGS

TABLE 37 MONUMENT: MAJOR PRODUCT OFFERINGS

TABLE 38 NEUROTRACK TECHNOLOGIES: MAJOR PRODUCT OFFERINGS

TABLE 39 NIGHTWARE: MAJOR PRODUCT OFFERINGS

TABLE 40 NOOM: MAJOR PRODUCT OFFERINGS

TABLE 41 SHARECARE: MAJOR PRODUCT OFFERINGS

TABLE 42 SWORD HEALTH: MAJOR PRODUCT OFFERINGS

TABLE 43 TALKSPACE: MAJOR PRODUCT OFFERINGS

TABLE 44 THIRTY MADISON: MAJOR PRODUCT OFFERINGS

TABLE 45 TRIPP: MAJOR PRODUCT OFFERINGS

TABLE 46 VIDA HEALTH: MAJOR PRODUCT OFFERINGS

TABLE 47 VIVANTE HEALTH: MAJOR PRODUCT OFFERINGS

TABLE 48 WORKIT HEALTH: MAJOR PRODUCT OFFERINGS

TABLE 49 US DIGITAL THERAPEUTICS MARKET BY APPLICATION 2021–2027 ($ MILLION)

TABLE 50 US DIGITAL THERAPEUTICS MARKET BY APPLICATION 2021–2027 (%)

TABLE 51 US DIGITAL THERAPEUTICS MARKET BY TREATMENT & DISEASE MANAGEMENT 2021–2027 ($ MILLION)

TABLE 52 US DIGITAL THERAPEUTICS MARKET BY TREATMENT & DISEASE MANAGEMENT 2021–2027 (%)

TABLE 53 US DIGITAL THERAPEUTICS MARKET BY PREVENTIVE CARE 2021–2027 ($ MILLION)

TABLE 54 US DIGITAL THERAPEUTICS MARKET BY PREVENTIVE CARE 2021–2027 (%)

TABLE 55 US DIGITAL THERAPEUTICS MARKET BY END-USER 2021–2027 ($ MILLION)

TABLE 56 US DIGITAL THERAPEUTICS MARKET BY END-USER 2021–2027 (%)

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