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June 10, 2022

The Rise of Digital Biomarkers - Drivers and Challenges to Market Growth

Commentary
Maggie O'Donovan
&

The global market for digital biomarkers is set for significant growth at a compound annual growth rate (CAGR) of 36.06% during the forecast period 2022-2028, according to a recent industry report from Research & Markets. Digital biomarkers offer unique insights into patient health through the continuous and passive collection of data using wearable, sensor and remote technology. 

Digital biomarkers have been adopted across many therapeutic areas in both patient care and drug development in recent years. With increasing accessibility of remote technology in both developed and emerging economies, the applicability of digital biomarkers will continue to expand worldwide. The rapid shift to remote healthcare observed during the global pandemic has led to increased acceptance among patients and providers alike. 

In this blog we explore some of the trends predicted to drive and challenge the growth in the digital biomarker market over the projected period. 

Market Growth Drivers

Increased Popularity of Remote Technologies and Recent Innovations

The growing popularity of wearables and mobile applications is a key driver of market growth for digital biomarkers (DBMs). Global smartphone penetration is estimated to be around 84%, indicating broad applicability of smartphone-based DBMs worldwide. Advances in wearable and mobile technology have driven growth in the development of remote data collection tools, which make up the largest technology segment of the DBM market. The increasing accessibility of the internet is boosting this market segment further.  

Beyond the increasing availability of wearables and smart phones, new innovative technology allows for real-time monitoring of complex conditions by measuring biomarkers such as voice, heat, subtle eye movements and breathing. Vocal digital biomarkers in particular have shown a recent emergence, and offer significant market growth potential. They provide an opportunity for the collection of data through voice recordings at a low-burden to the user, and can be collected through devices already in use by patients such as smartphones. Vocal DBMs can provide unique insight into early signs of cognitive impairment that would be inaudible to the naked ear. They can also act as a marker of respiratory and other illnesses. 

By facilitating early detection and early intervention of mental or physical health conditions, the rise in usage of vocal biomarkers has the potential to reduce the burden on health systems and improve patient outcomes. It is expected that due to their ease-of-use and proven effectiveness, vocal biomarkers will be in high demand over the coming years. The US is expected to dominate the vocal digital biomarkers space, with key players including Sonde Health, which recently launched a voice-enabled mental fitness monitoring technology platform.

Investment in Decentralized Trials 

The rising chronic and neurodegenerative disease prevalence, spurred by an aging population, brings an increasing need for expedited drug development to tackle these diseases effectively. DBMs enable real time insight into drug effectiveness, accelerating the drug development process, compared to intermittently-captured traditional endpoints. Recent research suggests that on average a decentralized trial deployment could save one to three months in each trial phase, representing significant savings given that delays in clinical trials can cost up to $8 million per day. Therefore pharma companies are investing in DBMs for decentralized clinical trials, which is expected to be another key driver of the projected market growth.

The Digital Medicine Society (DiME) recently brought together top pharma companies including Biogen, Eli Lilly and Merck, to establish a set of core standard digital endpoints for Alzheimer's disease and related dementias, with the aim to help reduce time and cost in research and development of new therapies, and to tackle the issue of assessing the effectiveness of new treatments in this cohort. AstraZeneca recently announced its intention to acquire a stake worth $33 million in Huma, a UK-based company that supports decentralized clinical trials through remote digital biomarker collection. The partnership aims to expedite the adoption of decentralized clinical trials. Merck Global Health Innovation Fund, and Novartis (dRx Capital) were among investors in digital biomarker startup Koneksa’s recent $45 million Series C funding round. The start-up has developed a clinical platform that integrates data from wearables and sensors for clinical trials.

Expanding Therapeutic Area Application

Digital biomarkers are being used across a growing range of therapeutic areas. The cardiovascular diseases segment holds the largest market share in the global DBM market, and this is expected to continue, as cardiovascular disease remains the biggest killer worldwide, despite being a largely preventable illness. Biofourmis, which is close to commercializing its BioVitalsHF digital therapeutic for heart failure, recently received unicorn status after a substantial series D funding of $300 million.

Respiratory disease is expected to be the fastest growing area of application, with new technologies arising out of the global pandemic era. Pfizer recently acquired ResApp, an Australian-based start up who developed an app that uses artificial intelligence to diagnose and measure the severity of respiratory conditions using the sound of a patient’s cough. Other disease areas driving market growth include psychiatric and neurodegenerative disorders, gastrointestinal diseases, sleep and movement disorders and diabetes. 

Oncology appears to be an emerging area of application, but has been slower to adopt digital endpoints. However, a stark projected growth in cancer prevalence worldwide over the next two decades, is expected to coincide with growing adoption of DBM use in cancer treatment and drug discovery, which is expected to add to the projected market growth in this space. 

In 2021, Medable partnered with digital biomarker company Aural Analytics to assess remote capture of speech patterns in cancer patients to monitor for patient deterioration and wellbeing. Biofourmis acquired Gaido Health in 2020, expanding its remote patient monitoring solution to oncology patients, facilitating early detection of patient deterioration following treatment, using digital endpoints. 

Furthermore, leading digital therapeutic company, Pear Therapeutics have outlined a pipeline development for oncology, in partnership with Apricity Health. With advances in technologies making data collection less and less burdensome for the oncology patient, this area is expected to be one to watch in coming years in the digital biomarker space.

Challenges to Growth

The opportunity for growth doesn’t come without its challenges and there are several potential barriers. 

Regulatory control of DBMs is still evolving. There is no consistent regulatory framework, given the broad applications of DBMs. According to The Innovative Medicines Initiative, a partnership between the European Union and the European pharmaceutical industry, collaboration between international regulatory bodies is a critical variable to the successful adoption of digital endpoints. Collaboration between technology and regulatory stakeholders will also be fundamental in ensuring clear guidance around hardware, software and digital endpoint validation. Standardized and clear guidance on the regulatory process appears to be a key factor in overcoming this barrier. 

The perceived risk attached to return on investment for DBMs is also a potentially limiting factor in their adoption. Pharmaceutical companies may exercise caution in spending a lot of money on reshaping a clinical trial process, due to the high rate of clinical trial failure, and the relatively sparse application of DBMs so far in research compared to traditional biomarkers. Although it is proposed DBMs can significantly reduce the cost of clinical trials, the lack of evidence of ROI to date may act as a deterrent to adoption.However, it appears that attitudes are changing in this regard as a result of the pandemic, with the number of industry-sponsored clinical trials tracked by DiME reportedly doubling in the last two years.

Data privacy concerns remain an issue. Despite increased acceptance of remote healthcare technology in recent years, some people remain concerned about the risk of privacy breaches. Particularly in the US, there is growing concern over the use of personal data collected by wearables by health insurance companies. Strict regulation around personal data misuse, and sufficient patient education around the same, will be required to encourage adoption of DBMs among patients.

With the growing need for enhanced drug development to support the aging population, and the emergence and increasing acceptance of innovative non-invasive technologies, the digital biomarker market looks set to experience considerable growth over the coming years. Time will tell if hurdles to adoption are successfully addressed to help facilitate this growth.

References

ttps://www.bankmycell.com/blog/how-many-phones-are-in-the-world#:~:text=According%20to%20Statista%2C%20the%20current,world%27s%20population%20owns%20a%20smartphone.
https://assets.website-files.com/606a092689ad7f9fc5b493ea/61e73347e7483919491c321f_2112-TuftsWhitePaper_V7.pdf
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https://www.pharmaceutical-technology.com/comment/big-pharma-companies-digital-health/
 https://www.mobihealthnews.com/news/digital-biomarker-startup-koneksa-scores-45m-series-c-funding 
 https://www.who.int/health-topics/cardiovascular-diseases#tab=tab_1 
 https://www.mobihealthnews.com/news/biofourmis-reaches-unicorn-status-300m-series-d 
 https://www.mobihealthnews.com/news/anz/pfizer-offers-au100-million-australian-company-developed-covid-19-cough-diagnostic-app 
 https://www.clinicalleader.com/doc/why-is-oncology-drug-development-late-to-the-digital-biomarkers-game-0001 
 https://www.outsourcing-pharma.com/Article/2021/06/18/Cancer-Moonshot-partnership-hones-in-on-digital-biomarkers 
https://www.pharmaceutical-technology.com/comment/digital-biomarkers-healthcare-trends/
https://www.forbes.com/sites/ganeskesari/2022/01/31/the-future-of-medicine-fighting-deadly-diseases-with-smart-devices-and-digital-biomarkers/?sh=5d69ac7e2c41 
https://www.globenewswire.com/fr/news-release/2022/05/23/2448244/0/en/Global-Digital-Biomarkers-Market-to-2028-Focus-on-System-Component-Type-Application-End-User-and-Region.html 
 https://www.karger.com/Article/FullText/517885  
 https://www.pharmaceutical-technology.com/comment/digital-biomarkers-healthcare-trends/ 


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