Published on January 05, 2022

DTx growth transcends old barriers, presents new challenges

Recent years have seen transformative technological advances—pushed partly by the urgency generated from the COVID-19 pandemic. The need to evolve has affected many industries, Digital Therapeutics (DTx) included.1 DTx manufacturers face fresh challenges in completing clinical trials and commercializing their products. Thankfully, with careful planning and help from the right allies, DTx manufacturers can successfully adapt.


DTx are evidence-based software programs that allow patients and (remotely) their care teams to prevent, manage, or treat a medical disorder or disease.2 DTx usually focus on chronic and behavior-modifiable conditions—everything from diabetes to insomnia to substance use disorders. DTx push the boundaries on what is possible when healthcare meets tech. For example, Renovia’s FDA-approved leva® provides potentially more effective relief than traditional interventions for chronic fecal incontinence.3 Like other medical interventions, such as medications and medical devices, DTx undergo rigorous testing for approval and use.  

DTx market expanding

Grand View Research’s recent report on the DTx market projects expansion at an astonishing 23.1% compound annual growth rate from 2021 to 2028. The following factors can explain this growth:4

  1. As awareness of DTx grows, patients, providers, and payers are now accepting them as valid treatment options.
  2. The pandemic has highlighted humanity’s need for mental health services and convenient and accessible digital health solutions. 
  3. Pandemic-generated urgency changed the pace of regulatory approval. Regulation requirements were suddenly widened to accommodate new and higher-tech approaches to research and medicine. Revisions may speed up the overall regulatory support for next-generation medicine. 
  4. Increased smartphone usage across the globe means more access to DTx and remote healthcare.    

Emerging challenges

New challenges have replaced previous woes despite growing acceptance and the healthcare industry’s increasing demand for DTx. In May 2021, Castor interviewed Chris Bergman, president of Amalgam Rx, about his thoughts on the future of DTx. Bergman identified previous issues as lack of funding, regulatory ambiguity, and a hesitant market. Current issues, according to Bergman, have shifted to establishing evidence, creating adequate payment and business models, and effectively increasing distribution and scale. A few years ago, DTx were scrambling to navigate regulations and establish themselves as valid healthcare options. Today they are making changes to improve growth and prove efficacy.5

Planning for new challenges

DTx manufacturers can meet today’s challenges through careful planning during the development stage. According to Bergman, DTx manufacturers do well to consider the following before commercializing their products:

  • Creating scalable models to accommodate growth.  
  • Investing in advertising campaigns to increase patient awareness. 
  • Designing products that fit into physician workflow—making it easy (and attractive) for healthcare professionals to use the product.
  • Conducting clinical trials to prove efficacy.

Another way to meet new challenges is through strategic alliances. Data management platforms, such as Castor, can fill gaps in DTx manufacturers’ experience in trial development, security, and management. Utilizing innovative tech in clinical trials saves time and money, protects patients’ data, and contributes to trial success—a must in today’s healthcare scene.

The COVID-19 pandemic brought unforeseen changes to the DTx market. Initial challenges such as payer adoption, patient acceptance, and (even) regulatory ambiguities no longer stand at the forefront of challenges for DTx manufacturers. Instead, manufacturers have to deal with how to prove efficacy and ensure product distribution at scale with proper reimbursement. Investing in trial tech, such as Castor products, will help DTx manufacturers meet these challenges. 


1Llopis G. Digital Therapeutics are accelerating personalization in healthcare. Forbes.–personalization-in-healthcare/?sh=34001c2c2176. Published August 9, 2020. Accessed September 3, 2021.
2Understanding DTx. Digital Therapeutics Alliance. Accessed August 26, 2021.
3Renovia. October 29, 2021. Renovia receives Breakthrough Device Designation for leva® Digital Therapeutic as first-line treatment for chronic fecal incontinence [press release].
4Digital Therapeutics market size & trends report, 2021-2028. Grand View Research. Published April 2021. Accessed September 3, 2021.
5The future of digital therapeutics and the impact on care. Linus Accessed September 3, 2021.

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