Digital Therapeutics – Landscape assessment and potential market entry strategies

Healthcare is shifting from Hospital to Home

The evolution of healthcare has been remarkable to observe: whereas before the patient would have to go to a hospital or clinic to avail their services, now these services come to the patient’s doorstep. Earlier there would be long calls and waiting times to get an appointment with a doctor, medical records were lost or not up to date as patients didn’t make frequent visits to the doctor or hospital, there could be mistakes in data entry and maintenance of paper records, and it was cumbersome for patients to travel such long distances to go to the healthcare center. Now however, there is technology in place that can monitor vital signs round the clock, wearable devices that record a patient’s SPO2, heart rate, breathing and blood pressure as well. This data is seamlessly transferred via Bluetooth or cloud to the physician and is accurate and up to date. It is prudent to invest in electronic health records and big data, as organization of this information is vital in healthcare.

Some examples of smart tech used in medicine include the Abilify MyCite – a Smart Pill: it is a small pill which contains a sensor that can transmit information directly to a mobile phone of the patient and the physician, and helps monitor if the patient is compliant with their medications. This is necessary in patients who cannot be expected to take their drugs regularly, such as those with schizophrenia, acute manic and bipolar disorder patients. In general, about 50% of patients are non-compliant with their medicines which are prescribed, and around 30% of all prescribed meds are never picked up from the pharmacy. This smart pill can thus reduce the disease burden by timely treatment and notification of medication compliance. It has been approved for use by the Food and Drug Administration. Another great mention here is the Bluestar software which is focused on diabetes type 1 and 2 management of patients and takes a holistic approach to it, by syncing with glucose meters, pharmacies, activity and fitness bands and trackers. All this data and insights are delivered to the consumer’s healthcare team and makes it easier to have the data related to their disease stored in the cloud and in one place. It can be tailored to the user’s specific needs and is helpful in getting help 24/7 should it be required. There are contact lenses created by Korean scientists which can detect the level of glucose in tears and give a reading of the body’s sugar levels in diabetics. This eliminates the need for invasive finger prick blood tests. There are also wearable patches which can take your electrocardiogram by detecting the heartbeat and pulse. With such convenience available, more than 80% of consumers are ready to try such wearable devices that can monitor their health, and over 44% of them feel they have more control over their health through these. Health has become an on demand service, with 77% of appointments with doctors being booked online. With everyone owning a smartphone, it is no surprise that around 47% people will research their doctor before a visit, and 38% patients will read up about the hospital they want to go to. AI startups in healthcare have increased manyfold, as much as fourteen times their market share in 2000. Not just with patients, even doctors find tech and AI makes them perform better. Those surgeons who trained virtually have been shown to do 29% faster in surgery and with 7 times fewer mistakes. This is possible through Virtual Reality software enabling them to simulate an operative environment. VR also finds uses in allowing children with autism to find their way in the world and gives them confidence. Not only this, but VR is also being used in chronic pain management. By 2016, 50 million people in the US alone had some form of chronic pain. The use of VR will alleviate the need for opioid medications and subsequent opioid epidemic.

Technological advancements and increased awareness are driving adoption of Digital Health Solutions

Digital Health is a broader field which includes the consumer more actively on a regular basis through providing articles online, platforms for healthcare discussions and queries, lifestyle and wellness apps, storing of health records and data, and transmission of the same. It doesn’t require clinical evidence support. As these are not considered to be medical devices, they don’t require any oversight or review. This is more generally what comes to mind when a person thinks of digital healthcare.

Compared to the market size of $106 billion in 2019 for digital health, by 2026, it is expected to grow by 6.03 times, with a whopping $639 billion. Wearable health devices will grow in the market for a share of $22 billion by the year 2025, a mighty leap of 80 times from 2015. With sedentary lifestyle trends on the rise and a larger population slipping into obesity and consumption of adulterated foods leading to more diabetes cases, the chronic disease burden by 2020 will have risen by 57%. With this, however, people are also becoming more aware of the importance of preventive care and its long term benefits in saving money in healthcare costs in the future. People are becoming more aware about taking preventive measures by reading and sharing such information through the internet. The pandemic has also brought forth to light mental health issues, and many younger people are seeking help before it gets too late: this market of mental health services and software will reach an estimated $2.31 billion by the year 2022. There are various causes for such rising trends in online healthcare systems: smartphones have become the norm and make information easy to access. Advanced technologies such as IoT and AI can be applied to various sectors of patient care to develop products. People are using mobile health technologies to monitor their chronic diseases by themselves, and keep them in check, E.g. for diabetics.

Investing in healthcare has become very lucrative, with investors pouring in $13.7 billion, and it was seen as the second highest funded year ever. The most focused on sector is Telemedicine, which saw a funding of $1.7 billion, followed by Analytics and mobile health. Other categories which were also well funded in 2019 are booking apps, clinical decision support portals etc.

Digital health solution companies do not need clinical evidence or regulatory oversight to launch their product in the market. But there is a subset of Digital health – Digital Therapeutics which is regulated, requires clinical evidence and real-world outcomes in order to launch their product / services to improve people lives.

Digital Therapeutics are software products that deliver evidence-based interventions to improve / manage / treat a medical disease

Dtx are narrow spectrum and tightly regulated interventions that can manage or cure a disease. These need to be evidence-based with extensive research to show their efficacy. Proof of their success in clinical trials and in everyday practice has to be shown in order to decide their indications, contraindications, risk and benefits.

The market for digital therapeutics was 2.9 billion USD in 2019, and is expected to grow to 13.8 billion USD by 2027. Some of the largest investments were seen in diseases such as diabetes management, cardiovascular disorders and obesity.

The key players in this sector are Voluntis and ScientificMed for cancer management; metaMe, mahana, and Bold Health for digestive health; kaia, BehaVR, jogo and lucine in pain and musculoskeletal disease management; for diabetes, it is omada, welldoc, glooko, Dario Health and amalgam Rx. In the management of sleep disorders we see Big Health and SusMed dominate the market. In the treatment and management of addictive disorders, the big names are Pear Therapeutics, Lief Therapeutics, BehaVR, and Click Therapeutics. For anxiety and depression, the main companies are Gaia, appliedVR, Palo Alto Health Sciences, happify Health and Limbix. In the management of respiratory disorders, the key players are Propeller, Nuvoair, and Sound Life Sciences.

Active investors in the digital therapeutics market include Specrum Health Ventures, Lead Edge Capital, Providence Ventures, RRE Ventures, US Venture Partners, Bronze Venture Capital and M2. Some of the biggest deals observed in venture capital in 2020 were as follows: a 100 million USD Mindstrong deal, $93.1 million deal of Virta Health, Omada’s 57 million USD deal, and a $51 million deal by Mojo Vision. Investments in digital therapeutics have increased ninefold from 2015 – 2019. Till august 2020, investments into DTx were at a record $709.7 million with 32 deals in place. In 2019, $1.2 billion were invested across 52 deals, up from $134.3 million in 2015 for 22 deals.

a)  Diseases in DTx

The disease which takes up a large chunk of the market in digital therapeutics is diabetes, especially in regions such as the Middle East, North America and North Africa. And in Asia, it is pretty common in India – which is known as the ‘diabetes capital of the world’. Through 2020-2027, the share of diabetes in digital healthcare will increase by a CAGR of 20.5%. The compound annual growth rate of obesity will be 23.5% in the same time period, with USA having the lion’s share of the market. Obesity will contribute $1.01 billion by 2027 and will grow at a rate of 22.7% from 2020-2027. Next comes cardiovascular disease, which is one of the leading causes of death worldwide. It has been shown that 90% of cardio related deaths are preventable by monitoring health related data through wearable devices and platforms for the same. Here also, North America dominates the market of cardiac disease burden. Apart from this, North America has the highest cases of gastrointestinal and central nervous system disease share in the digital therapeutics market. The central nervous system disorders digital therapeutics market is expected to grow at a CAGR of 19.7% during 2020-2027, and GI disorders digital therapeutics at 16.6% during the same period. The burden of respiratory disease digital therapeutics is also highest in North America, valuing at $161 million in 2019, and is expected to grow at a CAGR of 20.5% between this seven year period.

b)  Challenges and Risks

All these minefields of data will also have threats and risks posed to them: data breaches can cost companies billions of dollars of revenue losses, and their stakeholders have suffered as a consequence. Cybercrime will try and steal patients’ data, and this is a serious breach of trust in these healthcare companies too. Another challenge is the changing nature of oversight and review boards, new laws and regulations coming into place that need to be accepted by healthcare startups in order to stay afloat and relevant in the market. Apart from this, the basic requirement of an online healthcare service is that the patient is tech savvy and understands the platform, the platform itself must be able to handle large traffic and run without glitches, and a trained medical staff that can handle this new form of patient care.

There are many examples of real-world diseases that show the efficiency of digital health and therapeutics in detection and management of illnesses: heart disease can be prevented by checking activity, food intake and weight management through wearable smartwatches that keep a track of these parameters. The most prevalent chronic disease is cardiovascular diseases, and according to the CDC, 6/10 people die of chronic illness. Along with this, ADHD, asthma, diabetes and breast cancer can also be tracked and managed through smart devices and platforms. This strategy lowers the cost of treatments as well.

Managing chronic conditions is tricky, as it causes a drain on the money required to manage them, and earlier detection and monitoring through digital therapeutics can bring down costs of insurance companies for management of acute problems. This infrastructure is growing rapidly because of a boom in the smartphones market, which in 2019 was at 82.9% people in the UK using them, 79.9% in Germany, 79.1% in the USA, and worldwide, 55%. However, a different picture comes to light in underdeveloped nations where people set more store in traditional therapies and there is a lack of information, implementation of such digital schemes, and lack of promotion of these platforms. Also, a general concern of 1/3 of patients using digital therapeutics fear that their information might be sold to third parties by tracking their behavior in invasive ways. This research was done by Savvy Cooperative in 2016. However, there is a scope for growth and investment in this sector in Asia-Pacific and LAMEA as more people adopt smartphones, become aware of the benefits of digital health, and the lucrative side of availing treatments online rather than a pricey hospital set up.

c)  DTx Market business models

Along with wearable devices, there need to be software to backup, store and analyze the data being received from patients. This software market holds 68.7% of digital therapeutics. These solutions include mobile and web applications, and other devices to track patient data. The companies in this software solutions market are: Proteus Digital Health, WellDoc, Noom and Twine Health. This software digital market is expected to reach a value of $9760 million by the year 2027.

There are two models of work in digital therapeutics: one is Business-to-business (B2B), and Business-to-Consumer (B2C). In B2B, we see manufacturers supplying their products to healthcare facilities, wellness centers, gyms etc. In B2C, products are sold directly to the consumer. The B2B model is projected to reach $5.61 billion by 2027, and B2C at $8.9 billion by the same year. In the digital therapeutics overall market, the strongest region coming into play is N. America. This is due to a steadily rising ageing population, an increased burden of chronic illnesses, and better awareness programs adopted by the government. Canada and USA together took up 91.9% of the digital health market space in 2019. Mexico is catching up with an expected CAGR of 19.5% during 2020-2027. Other key countries showing promising growth here are Asia-Pacific, with India estimated to grow at the fastest CAGR here at 26.1% from 2020-2027, in Europe, UK dominates with an expected CAGR of 18% for the same seven years, and in LAMEA, Saudi Arabia will grow fastest at a CAGR of 23.8% in this time period.

d)  Top Companies in the Digital Tx market by large have collaborated or partnered with Big Pharma to launch new products in the market

  • Voluntis

Coming to some of the top companies that are key players in the digital health and therapeutics market, the first one is Voluntis: it was founded in 2001, and focuses on patients with diabetes and oncology related issues. They manage chronic conditions and try to improve treatment outcomes, and have collaborated with Biocon Biologics to innovate on digital therapeutics for insulin. They also have a software called Oleena which remotely monitors cancer patients for related symptoms, and has successfully completed the FDA regulatory review for it. Oleena gives personalized recommendations to cancer patients based on the symptoms they enter into the app, and patient can self-manage their symptoms. However, when the severity of the condition becomes too much for the patient to handle by themselves, the app connects them to the medical assistance team, and the app continues monitoring the patient till the symptom has resolved. Apart from this, Voluntis have created other products such as Insulia, Diabeo, CoacguCheck, Theraxium Oncology etc.

  • Omada Health Inc.

It was founded in 2011 and creates online digital programs which oversee individuals at risk of chronic illness. It combines behavioral data and data science for type 2 diabetics.

  • ResMed Inc.

It is a big presence in the respiratory disease market. It uses cloud computing and medical devices to manage and treat sleep related breathing disorders such as sleep apnea. They have a wide variety of products and services, such as Propeller Health, which is a software program attached to inhalers that detects pattern of usage of inhaler, how often, compliance and breathing patterns of the patient through sensors placed here. It is used in the management of asthma and chronic obstructive pulmonary disease. Other products include ‘myAir’ which tracks sleep therapy progress, AirView, for Obstructive Sleep Apnea patients.

  • Pear Therapeutics, Inc.

The company was started in 2008, which aims to provide clinically validated software solutions which are therapeutic for patients and help them improve their prognosis, allow more engagement and compliance from them, and also give room to clinicians to track the patients’ status. They have made products such as ‘reSET’: it is the first Prescription Drug Therapeutic (PDT), which has received FDA authorization to help enhance disease prognoses, and is a 90-day PDT for patients suffering from Substance Use Disorder. It is indicated for provision of Cognitive Behavioral Therapy (CBT), along with the usual contingency plans and drug regimens prescribed to manage the condition in an outpatient setting. The ‘reSET’ system has a portal where the patient can record the lessons completed, get rewards for compliance, keep a record of their cravings or triggers and the storage of simultaneous data such as in clinic drug test reports.

Along with such revolutionary products, Pear Therapeutics has also come up with solutions like Pear – 003 (for Insomnia and Depression), Pear – 006, for Multiple Sclerosis and ‘reSET-O’ for Opioid Use Disorder. It has collaborated with Novartis to launch ‘reSET’ and ‘reSET-O’.

  • Livongo Health, Inc.

It was founded in 2014, and is focused on diabetes management by providing patients with tools and coaching. The Livongo Diabetes Meter is a pretty nifty device that logs your blood glucose levels directly into the meter through pre-ready strips that come in the packaging. The device stores your glucose readings, and gets you in touch with a certified diabetes management expert should your reading go too low or high, or if you’re feeling under the weather. They provide tips and advice on how best to manage your blood sugar levels day to day, and spare the hassle of unnecessary doctor’s visits and wastage of time. The data is uploaded and synced on cloud. The company has been acquired by myStrength, Inc.

e)  Strategies adopted in the Digital Therapeutics market – Partnership emerging as the top strategy among all the stakeholders

There are many more such big names in the industry, and they partner up or collaborate on numerous products to access the chunk of market that the other company caters to. For example, ResMed has a wider distribution network and a bigger variety of products, more investment and greater geographical presence. The company Fitbit has access to more than 87 countries, with its wearable devices being popular for fitness. Livongo Health also dominates the market as a key player in terms of market penetration, R & D, and capital investment. It has a formidable presence in computer platform as well as smartphone applications. Some successful partnerships in recent years have been as follows: Noom and Eversana partnered up to better cater to patients with chronic conditions and rare diseases, to check patient adherence and engagement for long drawn out therapies. Another great joint initiative was done by Walmart and 2Morrow, and they came up with a digital therapeutics program to curb smoking and vaping via walmart’s website. There are many such companies which have created joint programs for digital therapeutics space. Voluntis and Bristol Myers Squibb partnered up in 2020 to create and investigate digital therapeutics solutions that could support cancer patients by leveraging Voluntis’ platform of Theraxium Oncology, which allows for the creation of a web portal for the patient’s healthcare teams to work seamlessly in one digital space, and also gives prescriptions via the same. Patients are supposed to update any new or severe symptoms of disease and they will immediately receive actionable information to manage it, or have instructions from their healthcare provider, tailored to that specific need.

Propeller and Orion also partnered up in 2019 to bring new digital therapies for patients with COPD and asthma. It connects Orion’s already existing Easyhaler line of inhalers with Propeller’s digital medicine platform via a small sensor. Happify health and Sanofi also teamed up in 2019 to explore digital therapies for people with depression and multiple sclerosis. The company Biofourmis moved to acquire Gaido Health, which places them in a strong position to venture into the Oncology space of DTx. Their joint ventures aim to monitor post-discharge cancer patients and manage their symptoms after leaving hospital. The company Virgin Pulse also acquired Blue Mesa, which is best known for its diabetes prevention program called Transform.

The Swiss pharmaceutical company Novartis acquired digital therapeutics firm of Amblyotech that provides their novel digital therapy for treatment of amblyopia. This acquisition moves Novartis further into the refractive disorder line in ophthalmology. The software utilizes video gaming with 3D glasses, which trains the patient with lazy eye to use both eyes simultaneously to view the images as a whole. The software uses something called ‘dichoptic display’ where an algorithm presents each eye with different images. Recently, CVS health also announced that they had added five new companies to their digital health platform for PBM clients, including Hinge Health, Livongo, Hello Heart, Torchlight and Whil.

Akili launched a product in 2020, EndeavorTM, which is aimed for children with ADHD, and is an action based video game shown to improve concentration and attention. MedRhythms in 2020 announced that they were developing a Patent Advisory Board, which is the first of its kind in the industry. This will bring a patient’s perspective into decisions that motivate the company’s goals, vision and products, through the lens of living with the effects of Parkinson’s, MS and strokes. Pear Therapeutics also announced a limited distribution program for its product, Pear – 004, for management of people living with schizophrenia. Big Health launched a CBT based app called DaylightTM, which focuses on combating and reducing feelings of anxiety.

Partnership by far remains the best strategy for growth, closely followed by collaboration, product launch, product approval, acquisition, agreement, and business expansion.

f)  Regulation

Devices related to digital therapeutics are divided into three classes, namely Class 1: which are subjected to general controls like establishment registration and device listing , labelling, medical device reporting and prohibitions against adulteration and misbranding. Class 2 devices: Subjected to general controls, performance standards and other special controls. Requires prior 510(k) clearance before commercially marketing in US. And Class 3: Devices that pose the greatest risk (such as life sustaining, life-supporting, or implantable devices. Such devices require PMA permission supported by clinical trial data. To get FDA approval and clearance, there are two pathways as well: the 510k Clearance Pathway: any device which doesn’t require Premarket Approval Pathway or PMA, and if any modification is done to it prior to getting the 501k approval, which can be any change in its design, intended use, will need a new clearance. The same applies for PMA.

The FDA in 2017 announced a new policy which would provide better guidelines for digital health, and launched a software precertification pilot program for the same, called Pre-Cert. Some successful FDA approvals that have come this way are as follows: Pear is a digital therapeutics startup which received FDA approval for its app Somryst, to manage older patients with chronic insomnia.

When it comes to defining the digital therapeutics solutions, there is the example of Apple Inc, which is a multinational organisation that produce wearable devices among other things, and there are services and software apps available to improve patient costs. These apps and the sotware itself are used by a number of healthcare professionals. This is known as Full-scale Market Attributes. When it comes to Pure Play Attributes, these are done through pharmaceutical partners, which will augment current pharmaceutical solution through addition of a software component or becoming part of pharma-based platform. It will need a digital subscription and is reimbursable. A great example of this is Pear Therapeutics, which integrates clinically validated software apps with previously approved treatment modules.

Current Disease Trends & Investing in Them

Healthark internal analysis has identified two conditions as the top investment pockets: diabetes and obesity. With the rise of diabetes, it takes up a market share of 24% in 2020, and will be the highest revenue generator in digital therapeutics by 2027. Obesity too, will take up a market share of 24% by 2027, and will see a growth of 23.2% between 2019-2027. This data has shown us that diabetes is a chronic and highly costly disease to manage along with having such high prevalence rates. There is great opportunity here for manufacturers of R and D in digital therapeutic products. Some big names already in the diabetes management sector are Noom, WellDoc, Glooko, and Omada Health. They are providing customers with software apps and programs to handle and monitor their diabetes.

This trend is observed as in 2018, 10.5% of the American population was suffering from diabetes and was the 7th leading cause of death. Currently, there are 425 million diabetics around the world, and this number will reach 625 million by 2045. In 2016, 1.6 million people had lost their lives due to diabetes, according to data put forth by WHO. Along with all these, the cost of treating diabetes has also gone up by 26% since 2012.

Coming to obesity, its prevalence has increased to 42.4% from 2017 to 2018 and it is the second most prevalent chronic disease after diabetes. Also, in 2018 it was shown that among adults aged 20-39, obesity was 40%, and 44.4% in adults aged 40-59 years, and at a whopping 42.8% among adults aged 60 and older. This condition also provides opportunities for prevention by usage of digital therapeutics, by tracking and monitoring lifestyle, and daily exercise along with intake of healthy food. In a 2017 analysis by Noom, it was found that 78% of the users would download it for losing weight (Noom Weight Loss Coach).

North America will dominate the DTx for the next decade

It contributes to 49% share of the digital therapeutics market as of 2020, and will be growing at a CAGR of 19.2% during 2019-2027. Even through Asia-Pacific is expected to grow at the highest rate, North America will still hold the majority of market share in the forecasted period. By 2027, North American markets will take up 6.28 billion USD in digital therapeutics. Europe and Asia will take up 3.27 and 2.96 billion USD respectively. These trends are observed because the US led FDA has put in place strong guidelines to oversee the digital therapeutics market, establishing standards for the product quality before it hits the market. This increases the product reliability and efficacy. There has also been a rise in chronic diseases burden in North America, with 6 in 10 adults having 2 or more chronic disease in the USA. It is estimated that by 2023, 49% of the American population will be having some form of chronic illness.

There is also a need to bring down healthcare costs as 84% of the management money is directed towards treatment of chronic diseases, making up 19.9% of the country’s GDP. This price will only rise in the future with increasing burdens of chronic disease. There is also a positive shift towards reimbursement for digital therapies, showing that 25% of organisations already cover digital Tx, and 45% more are interested in covering for this in the future. The two major PBMs which are CVS Caremark and Express Scripts, together make up 53% of the reimbursement market, and have made adaptations to include DTx in their plans.

Strategic steps for building a digital therapeutics solution

In order to better allow the digital therapeutics to flourish, awareness of this service must be made clear to both the patient and the provider, through social media, word of mouth, research and more. Development of a business model is necessary which can be tailor made for the specific client, along with investments needed in specific areas: in order to expedite your product launch, it is important to get into partnerships and joint ventures, acquisition. Also, a company may need to license and integrate multiple digital therapeutics products to complement an existing treatment by developing its own platform.

Partnerships are useful in fulfilling unmet patient needs that have already been identified along with pairing of technical capabilities and digital skillset of a technology company with regulatory expertise. A great example of this is seen with HARMAN, which is a subsidiary of Samsung electronics, and it entered into a long-term partnership with Roche, in order to develop a digital therapy solution for people with autism.

Another strategy that can lead the way forward is acquisition: identification of a specific company to leverage its therapeutics area, then investing in scaling the digital capability. An example for this is Apple acquiring asthma monitoring company called Tueo Health, to collect relevant data, alert users of changes in condition and set up a live consultation should the need arise, via the Tueo Health asthma educator.

A third tip for growth in DTx is licensing: a company can easily license and integrate multiple digital therapeutics products to complement existing treatment, by developing its own platform. It can also create an app store to integrate multiple digital offerings. A thriving example of this is the integration of Amazon’s Alexa services with Livongo’s blood glucose monitoring services. Users may use the voice service feature of Alexa to ask on their blood glucose status and health tips.

Tackling the entry barriers for your DTx solution

They present many challenges as well which can be addressed to make use of their full potential. It’s an opportunity for software based technology companies where they can leverage their technical knowledge and venture into the healthcare market, and capitalise on the growth potential in digital therapeutics. A key challenge here is creating awareness that DTx can provide patients: this can be tackled by using social media and holding seminars and conferences, where patient success stories can be narrated, and using messaging that promotes knowledge about digital health on social media. Getting approval from regulatory bodies such as the FDA is also a challenge, which can be overcome by collaboration of software and pharmaceutical companies, to leverage their understanding of the regulatory bodies in healthcare industry.

Launching new products can be a herculean task as well, whereby companies will need to work across multiple industries to ensure they mark unchartered territories with expertise. This can be achieved by developing a reimbursement model that provides significantly more benefits than existing models.

Digital therapeutics does present challenges that need to be overcome, by creating awareness of the products on offer, launching the product by wise collaborations, and getting timely approvals from regulatory bodies. It presents growth potential that can be capitalised with the right investment and research.


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