Digital Therapeutics Market Report by Worldwide Market Trends & Opportunities and Forecast to 2035

Digital therapeutics are clinically validated applications / software / online programs that have demonstrated the capability to facilitate positive outcomes when used in the prevention / treatment / management of diseases / clinical conditions.

The global digital therapeutics market size is estimated to grow from USD 2.31 billion in 2023 to USD 19.76 billion by 2035, representing a CAGR of 19.59% during the forecast period 2023-2035.

Currently, more than to 220 digital therapeutic solutions have already been developed. Of these, majority of the solution have been marketed, followed by solutions that have been approved by regulatory bodies. In addition, majority of the solutions (86%) have been / are being developed targeting old patient populations.

The various developmental stages:

• Discovery and Preclinical Phase: The discovery phase involves the identification of a novel digital therapeutic intervention. At this stage, researchers publish their work in academic journals and continue to investigate the potential applications of their digital solutions in disease treatment / management.

• Clinical Trials and Validation: This phase involves the conduct of proper clinical trials to validate the claims made by a digital therapeutic solution providers, and to evaluate its potential in a real-world setting. It includes testing of the software / hardware on a specific patient population. In case of clinical studies, health outcomes are measured and tracked through data driven insights provided by the software. Disease specific improvements (post application / implementation of the intervention) are also tracked to evaluate the performance of a product. There are multiple challenges associated with conducting clinical trials for digital therapeutics. Firstly, technologies are known to change rapidly and there is a very high probability for a software to undergo upgrades / improvements over the duration of a clinical trial. As a result, there are technical issues in storing and updating patient data. Secondly, digital interventions cannot be studied in a double-blind manner, because the investigator is always aware of whether a trial subject is in the control group or being treated with the intervention under evaluation. Finally, at present, there is less structure and guidelines available, and as a result meaningful and conclusive insights are difficult to be drawn from such trials.

• Negotiations with Insurance Providers / Payers: Post the successful completion of clinical studies, developer companies generally tend to avail reimbursement opportunities for their products in order to promote the use of their proprietary solutions and provide financial benefits to patients / consumers. As is the case with pharmacological interventions, reimbursement plans for these products can be achieved based on the outcomes of clinical trials and depending on the USFDA’s (or the concerned regulatory authority of a particular region) clearance. A number of health insurance providers, such as Medicare and Humana, are actively working to include digital therapeutics as a part of health insurance coverage plans for patients suffering from chronic diseases.

Distribution and Marketing: The pharmaceutical and medical device distribution / marketing system is an established network with well-defined channels through which manufacturers can reach the end-users of their products. Product developers in this domain are presently looking to create a distribution network to sell their offerings in the market via both B2B (healthcare providers, regulators and payers) and B2C (customer) models.

Leading Digital Therapeutics Companies

Examples of key players engaged in digital therapeutics market (which have also been profiled in this report) include (in alphabetical order) Ampersand Health, Akili Interactives, Better Therapeutics, Brain+, Click Therapeutics, CogniFit, GAIA, Healios, JOGO Health, Jolly Good, KORE Digital Health Therapeutics, Livongo Health, Lucid, MedRhythms, Pear Therapeutics, Redicare Control, Susmed, The Learning Corp, Voluntis and WellDoc.

Distribution by Type of Solution - Software Solution, Gaming Solution and Combination Solution

Distribution by Type of Therapy - Curative and Preventive

Distribution by Purpose of Solution - Medication Replacement and Medication Augmentation

Distribution by Type of Business Model - B2B and B2C

Distribution by Target Therapeutic Area - Cardiovascular Disorders, Chronic Pain, Mental Health Problems, Metabolic Disorders, Neurological Disorders Respiratory Disorders, Sleep Disorders, Substance use Disorders and Other Disorder

Key Geographical Regions - North America, Europe, Asia, Latin America, Middle East and North Africa, and Rest of the World.

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