U.S. Digital Therapeutics Market Size to Hit USD 9.50 Billion By 2033

According to the latest study, the U.S. digital therapeutics market size was estimated at USD 1.42 billion in 2023 and is projected to hit around USD 9.50 billion by 2033, growing at a CAGR of 20.9% during the forecast period from 2024 to 2033.

The ever-changing digital world, increased healthcare consumerism, the COVID-19 pandemic, and important company activities are just a few of the key reasons driving market growth. In October 2021, Click Therapeutics, Inc. obtained USD 52 million in Series B fundraising from a number of investors. This enabled the company to build and commercialize its prescription digital pharmaceutical pipeline, as well as expand its platform capabilities.

Technological improvements aimed at providing transformative healthcare solutions are expected to boost market growth in the near future. In an attempt to get into the digital therapeutics market, ATAI Life Sciences introduced the IntroSpect Digital Therapeutics platform in June 2020. The company will offer DTx and precision psychiatry solutions in a study to battle emerging mental health diseases. The growing number of smartphone users in the United States is another significant factor driving market expansion. The rapid growth of smart healthcare gadgets is projected to raise awareness of smart health tracking in the country. Digital therapies can provide patients with on-demand care while also allowing for early diagnosis and treatment. Furthermore, biopharmaceutical companies are cooperating with digital therapeutic providers to improve patient care and accelerate growth.

Despite the benefits of DTx services and a big smartphone user base in the United States, it has never received widespread consumer adoption prior to the COVID-19 pandemic. The pandemic provided a significant expansion potential for this technology. CMS and FDA have already emphasized the importance of virtual care services in the overall COVID-19 response strategy.

Social alienation and self-isolation have led to increasing worry and stress. According to Mental Health America, clinical anxiety increased by over 19% in the first week of February 2020, and by around 12% in the first two weeks of March. DTx treatments can assist manage these diseases and offer evidence-based remedies. During the pandemic, companies like BigHealth, Happify, Palo Alto Health Science, and Pear Therapeutics are continually working to expand their customer base and reach out to more people.

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U.S. Digital Therapeutics Market Key Takeaways

• Based on end use, the patient segment dominated the market growth with more than 32% of the revenue share in 2023.?
• On the basis of the product, the software segment is projected to hold the largest market share from 2024 to 2033.
• On the basis of application, the diabetes segment holds the biggest market share from 2024 to 2033.

Digital Therapeutics Market Size, Share and Growth 2024 to 2033

The global digital therapeutics market size is calculated at USD 5.79 billion for 2024 and is expected to reach around USD 30.55 billion by 2033, growing at a CAGR of 20.3% from 2024 to 2033. North America led the wearable cardiac devices market with the largest market share in 2023.

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Challenges faced by digital therapeutics in the US

• Security and privacy:?Personal data security is a challenge for digital therapeutics in any environment, and the United States is no exception. Companies must comply with HIPAA regulations and maintain robust security measures to protect patient information.
• Lack of skilled professionals:?The market of digital therapeutics in the United States is growing so steadily that the available pool of professionals is only sometimes enough to sustain it. Some factors contributing to the shortage of professionals include the interdisciplinary nature of digital therapeutics, evolving technology, and the need to navigate the complex regulatory landscape. An overall shortage of healthcare professionals also contributes to the issue.
• Reimbursement and pricing:?Gaining reimbursement from insurance providers, including Medicare and Medicaid, is essential for digital therapeutics to become accessible to the general population. This challenge has additional aspects in the United States, where insurance systems are complex and subjected to market change based on a combination of business and political factors.

As demonstrated by the market research on digital health therapeutics presented in this article, digital therapeutics markets in Europe and the United States have many similarities as both are fast-growing markets driven by tech-savvy aging populations looking for smart solutions around rising healthcare costs. However, there are several factors where European and US markets differentiate.

Key players and their products

The striving?digital therapeutics companies?in the United States include large corporations with rich histories and startups that skyrocketed in recent years. The business landscape in the country is varied, allowing many companies to strive. Here are some of the top DTx businesses in the US:

Omada Health

A digital health company with a focus on identity management that provides cloud-native IGA solutions for enterprises.

Big Health

A company headquartered in San Francisco known for developing apps for mental health. Their key products are Sleepio, an app for insomnia management, and Daylight, an app for anxiety management. Both apps use elements of cognitive behavioral therapy.

Propeller Health (ResMed)

A California-based company focusing on solutions for sleep apnea and respiratory diseases. The company's main product is a sensor-based system that connects to inhalers used by patients with these conditions.

Fitbit LLC

A consumer electronic company specializing in wearable technology like physical fitness monitors and activity trackers. Key products are fitness trackers, smart watches, smart scales, and Fitbit App, which integrates all these products into one interface.

Welldoc, Inc.

A Maryland-based biotechnology company specializing in AI-driven digital coaching solutions for chronic diseases like diabetes. The main product is BlueStar, the app for managing diabetes.

Canary Health

A Californian company specializing in health management programs for arthritis, heart disease, diabetes, and depression. A notable product is a chronic disease management app Better Choices, Better Health (BCBH).

Akili Interactive Labs, Inc.

A Boston-based prescription digital medicine company with products like EndeavorRx, an app for the attention treatment of children with ADHD. The company creates video games designed to treat various cognitive disorders.

HYGIEIA?is a Michigan-based company responsible for d_Nav, an application that regulates insulin injection in diabetes patients.

Regulatory landscape in the United States

The regulatory landscape for digital therapeutics in the United States is more centralized than in Europe. It is fully overseen by the Food and Drug Administration (FDA). FDA regulates all medical devices and ensures their safety and efficacy.

Digital therapeutics are classified as medical devices under the FDA's regulatory framework. Their specific classification (Class I, II, or III) depends on the level of risk associated with their intended use.

To prove FDA compliance and enter the market, the product goes through various stages of approval. First, the product is submitted for premarket notification (510(k)) or premarket approval (PMA). Then, digital therapeutics creators must provide clinical evidence demonstrating the product's safety and efficiency. After regulatory decisions and product launch, the devices are subjected to post-market monitoring. The general FDA regulations for Design Controls?21 CFR 820.30?apply to all medical device software.

U.S. Digital Therapeutics Market Recent Developments

• In April 2022, Pear Therapeutics was designated as a product candidate for the treatment of acute and chronic pain by FDA’s Safer Technologies Program (STeP)
• In March 2022, Sanofi US, which is a global healthcare firm announced a collaboration with DarioHealth, a company that is focused on digital therapeutics. This Collaboration will help accelerate the commercial adoption of DarioHealth’s DTx technologies and the expansion of digital health solutions on the Dario platform.
• In April 2021, Omada Health Launches the Omada Insights lap in order to improve healthcare outcomes. The Insights lab is a product development approach that uses multidisciplinary teams to accurately identify what works and does not work in a digital care setting and then expand those tools inside the organization.
• In June 2020, ATAI Life Sciences launched IntroSpect Digital Therapeutics. In order to address the growing number of mental health illnesses, the company will offer DTx and precision psychiatry solutions.??
• In March 2020, the U.S. FDA approved Somryst by Pear Therapeutics for chronic insomnia which combines algorithm-driven sleep limitation, suggestions, and consolidation.?

U.S. Digital Therapeutics Market Companies

• Omada Health Inc.
• 2Morrow Inc.
• Teladoc Health, Inc
• Pear Therapeutics (U.S), Inc.
• Fitbit Health Solutions
• Welldoc, Inc?
• Click Therapeutics
• Noom, Inc.?
• Akili, Inc.
• Better Therapeutics, Inc?

Segments Covered in the Report

By Application?

• Diabetes
• Obesity?
• Central Nervous System Diseases
• Cardiovascular Disease (CVD)?
• Respiratory Disease
• Smoking Cessation
• Gastrointestinal Disorder (GID)?
• Others

By Product?

• Software?
• Device?

By End Use?

• Patients
• Providers
• Payers
• Employers
• Others

What are the Key Data Covered in this Market Research Report?

• CAGR of the market during the forecast period
• Detailed information on factors that will drive the growth of the between 2024 and 2033
• Precise estimation?of the size and its contribution to the market in focus on the parent market
• Detailed analysis of customer landscape covering Diver of price sensitivity, Adoption of the lifecycle, and key purchase criteria?
• Companies landscape comparing criticality of inputs and factors of differentiation.
• Exclusive Matrix on companies' position and classification
• Accurate predictions about upcoming trends and changes in consumer behavior
• Growth of the market across US
• A thorough analysis of the market’s competitive landscape and detailed information about companies
• Comprehensive analysis of factors that will challenge the growth of companies

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