What-Is-Digital-Medicine-And-Why-Does-It-Matter.Pdf
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What is digital medicine and why does it matter? Content Foreword 3 Executive Summary 4 In search of a magic pill 6 Digital Health: from wellness to clinically driven solutions 7 Defining digital medicine 8 What would a winning DTx solution require? 11 Demonstration of proven efficacy through clinical trials 11 Regulatory clearance by FDA or an equivalent 12 Incorporation into the standard of care and provider prescribed/payor reimbursed model 14 Viable business model 15 White-box AI based predictive and personalised clinical intervention and patient guidance based on clinical grade data 16 Compliance with the highest standards of cybersecurity and privacy 18 Openness and flexibility of system and data architecture 20 Which areas are most ready for digital therapeutics, and why? 22 Where is value for me? 24 Pharmaceutical companies 24 Large technology players 27 Start-up and scale-up tech pure-plays and venture investors 29 Insurance companies 30 Healthcare providers 32 Private equity 33 How we can help 35 We help clients build, grow and transform their businesses 35 Why Engelworks 36 References 37 References 37 Figures 38 ©Engelworks Limited 2019 3 What is digital medicine and why does it matter? Carl Engelmarc, Founder & CEO, and Irina Pafomova, Managing Partner. Foreword It’s common knowledge that health systems We love feedback, around the world are under incredible cost so please email us at pressure, and everyone would love to find [email protected] and sustainable solutions to this problem. [email protected]. Is digital therapeutics the magic pill everyone has been looking for? Our research shows that there is potentially massive value in digital therapeutics, and to some extent, this has already been proven. In this paper, we look at where the value sits, and how incumbents, upstarts and venture and private equity investors could unlock it. At Engelworks, we help companies in the health sector create sustainable value through smart and innovative growth strategies, business models and new products and services. Our perspective is informed by our 360° experience of working with big pharma and healthcare providers, as well as building and scaling businesses and investing in them. If you do have a DTx challenge in mind, please get in touch. ©Engelworks Limited 2019 4 What is digital medicine and why does it matter? 2024 $379bn The digital health market is projected to reach $379bn by 2024 Executive summary interventions, clinical grade data quality, compliance with the highest standards of With all health systems being under privacy and cybersecurity, and transparency high-cost pressure, digital medicine in using AI (‘white box’) is a must. and digital therapeutics (‘DTx’) are well placed to help raise the quality Inclusion into standard care and payor of care while reducing costs. reimbursement lists are essential for gaining broad adoption, as the Large pharma companies have seen a majority of consumers are reluctant collapse in their R&D returns over the to pay for their care out of pocket. past decade, which has led to a lacklustre Outcome-linked pricing models help performance in the public markets. make DTx more attractive to payors. On the contrary, investors have shown much enthusiasm for digital health Our research shows that DTx is best and wellbeing, where US$14.6bn was positioned for health conditions that can be invested in 2018 (14x 2010). The addressed, by behavioural solutions; areas digital health market is projected where demand is outgrowing treatment to reach $379bn by 2024. capacity (e.g. elderly care); conditions where connected devices can play a huge role in As digital health matures, investment medical adherence (e.g. asthma and COPD), focus is shifting from consumer and personalised, or precision medicine. wellness applications to DTx, which are clinically focussed solutions DTx could help pharma companies for disease management. improve their R&D returns by shifting from a pill to a total care package for both DTx products need to demonstrate existing drugs and pipeline assets or even efficacy through clinical trials and obtain launching digital-only solutions. As they regulatory clearance to be successful. As lack DTx implementation capabilities, DTx provide direct personalised clinical the best strategy would be partnering ©Engelworks Limited 2019 5 What is digital medicine and why does it matter? with tech companies which have built For healthcare providers using DTx could cross-sector platforms to support R&D help cut costs and improve the retention or buying niche tech players for key of customers by providing them with more therapeutic areas and scaling them. convenient and cost-efficient treatment options. This value could be realised via We believe that the best ways of capturing partnerships with startups providing the value in DTx for Big Tech players are on-point solutions, or buying a startup building or buying & scaling platforms and rolling out a solution globally and/ to provide functional cross-therapeutic or rolling up other companies/solutions area solutions in the digital medicine into a new model care provider. space. Extending their wellness products into health by partnering with healthcare Given high multiples paid by private equity companies for expertise and market access; (‘PE’) firms for healthcare assets and and building digital-led, behaviour change more extended holding periods, building a driven total care products in growing reliable growth engine becomes crucial. PE therapeutic areas such as autoimmune firms are well positioned to create platform and mental health conditions. solutions for a particular therapeutic area or a function using an acquired asset as For startup and scale up tech pure-plays a core, and complementing it with bolt- and investors in this space the most on acquisitions. With their robust access significant opportunity is creating a highly to capital, PE firms could build disruptive focussed DTx solution for a therapeutic models that can disintermediate traditional area, function or geography. For those industry players, e.g. new model clinics. with access to large volumes of capital, a roll-up of on-point technologies and Healthcare has been a slow-moving becoming a systems integrator for a industry that works on evidence, particular therapeutic area might be an precedence and practices that spread excellent way to accelerate value creation. from flagship projects. However, once a few of these projects get results, For insurance companies, DTx presents we will see what happens very rarely an opportunity to cut the volume of in healthcare: a sudden and very, very claims by using digital diagnostics and rapid change and exponential growth. disease management tools, improve We believe that DTx is approaching its customer retention by providing them inflexion point, so the time to act would with more convenient treatment options be now. and attractive insurance deals, as well as unlock new customer segments that were previously uninsurable. The best way to realise this value is through partnerships and selective acquisitions. ©Engelworks Limited 2019 6 In search of a magic pill Research by Roche UK indicates that 82% of 16-24 year olds want to see more use It is common knowledge that healthcare of digital technology on the NHS. 63% systems in most countries have been of young people would be comfortable creaking under the strain of growing with a chatbot giving them a diagnosis.3 costs exacerbated by new lifestyle- related epidemics such as obesity, diabetes and hypertension. Can a piece of software code be the ‘magic pill’ that would $14.6bn help solve the problem? was invested in digital health & wellbeing Investors are certainly prepared to bet in 2018 on this: the current decade has seen a rush of investment into digital health & wellbeing, with US$14.6bn being invested in 2018, which is 14 times more than in 2010.1 An average deal has gone up by $6m to $21m in 2018 vs 2017. The This is x14 times largest deal in 2018 was a $300m Series C more than in 2010 funding round for Grail, which has created a solution for early detection of cancer using a test for circulating cancer DNA. A recent report by Global Market Insights estimates that the digital health market 2018 will reach $379bn by 2024.2 ©Engelworks Limited 2019 7 What is digital medicine and why does it matter? FIGURE 1. Your.MD4 is a free service that uses Artificial Intelligence to help customers find safe health information so they can make the best choices for their health. Digital Health: from wellness health data, educate them and help make to clinically driven solutions informed choices. Real-time clinical- grade data helps optimise treatment As digital health matures, investment either involving doctors or in some focus is shifting from consumer wellness instances, without human intervention. applications to clinically focussed solutions. Wellness applications comprising consumer Engaged patients correlate with lower activation solutions brought to life as costs and better outcomes. According to part of the quantified self-movement (e.g. Silicon Valley Bank, healthcare costs for myfitnesspal, Runkeeper) and education least-engaged patients are 21% higher & transparency platforms such as WebMD than those for the most engaged patients. have raised multiple rounds of venture Over the past few years, clinical evidence funding in the early 2010s and have of digital health efficacy has grown successfully exited. As these solutions substantially: of 571 studies published have been largely unregulated, their between 2007 and August 2017, 138 buyers have been predominantly outside were published in January - August the traditional pharma and life sciences 2017. 860 clinical trials were underway space and included sports and fashion as of August 2017, with 82% of US trials comwpanies as well as private equity run by patient care organisations.5 firms. Several category leaders have been created, and as the price of entry has risen, the investor appetite has diminished.