dimanche 16 décembre 2018

Digital health business models in France: from reality to perspectives

by Jean-Christophe GUILLERM, MD, Paris France

Executive summary: In France, digitization drives a significant part of innovation and economy. However, despite tremendous political, economic and medical expectations, digital health only represents 1% of total healthcare market, yet one of the most innovative sectors of the French economy. In this article, we will deep dive into the different categories of digital-health solutions developed in France, the added-value they could bring to health care system, and originally map them according their respective business models before drawing value perspectives for 2022/23. Interviews and robust recent primary sources support this analysis.
Digital health is the convergence of digital technologies and health, aiming at enhancing healthcare efficiency and making therapeutic options more personalized and precise. Digital technologies relate to the use of computerized devices and may integrate artificial intelligence, block-chain, connected devices (Internet of Things) or interfere with   pharma industry 4.0.
As a result of the review, E-health was estimated to generate in France a turnover of 2,67 billion euros in 2017. Six different business models of digital health were identified: Access to medical data, access to health care professionals, access to patients, access to medicines, access to digital therapeutic solutions and access to personalized medicine through pharma industry 4.0. A value-creation of 1.5 billion euros is expected to be created by 2022/2023. Nevertheless, further push is clearly needed to overcome gaps, mainly for the implementation of digital therapeutic solutions, and concrete proposals could help business and policy makers to remove barriers: Involve patients and multidisciplinary teams from the early phase of development; Ensure from the authorities clear, transparent and consistent rules for development; Favor early binding agreements between companies and payors to ease market access.
In this context, e-health carries promise to improve the efficiency of French healthcare system and to create significant value by 2022/23 in an otherwise flat health care market.

Introduction: Digital is disrupting French economy and may indubitably disrupt healthcare.

Digitization drives a significant part of innovation and economy, impacts social behaviors and shifts traditional business models everywhere in the world, including France.
French consumers are highly invested in digital technologies, 74 percent of them using the internet regularly, above European-average (Arcep, 2017). In France, e-commerce’s turnover reached 82 billion euros in 2017, representing 5.5% of the gross domestic product (GDP) and the fifth worldwide market (Dicharry, 2018). Besides these relatively good figures, there is still a long way to fully capture the value digitization could bring to the French economy, with great variations across its different sectors. Among the latter, healthcare clearly lags behind (Figure 1, extracted from McKinsey, 2016).

Figure 1: Index of digitization according to countries and economic sectors

Healthcare is, in France, one of the leading economic sectors, representing a global turnover of 286 billion euros, equivalent to 11,1% of the national GDP and ranking 5th position among OECD countries (O.C.D.E., 2017). Within this sector, pharma and medtech markets, with respectively 54 and 28 billion euros, represent very dynamic segments, generating both innovation and value, and being the third source of French exports (Leem, 2017; Snitem, 2018). In contrast, the extent to which health care providers and traditional pharma companies have used digital to redefine business models or their labor forces is today still relatively low. Recently, digital health was evaluated to generate a turnover of around 2,7 billion euros in France, ie less than 1% in market share of the total French healthcare market (Pipame, 2016).
As this emerging and promising market is permanently evolving, and that very few figures are available, a “deep-dive” approach was initiated to draw a comprehensive picture of its economic fabric in France. To our knowledge, no extensive review regarding this topic and the description of its business models was already published.

Definition of digital health and objectives of the report

To define the subject, “digital health (or e-health) is the convergence of digital technologies with health, health care and society to enhance efficiency of healthcare delivery and make therapeutic options more personalized and precise” (Bhavhnani, 2016). Digital technologies relate to the use of computerized devices, most of the time connected, and digital data. These technologies may now integrate artificial intelligence, block-chain, industry 4.0 or Internet of Things (IoT)... In this report, we will review the different categories of digital-health solutions developed in France, the added-value they could bring to care, and map them according their respective business models before drawing value perspectives for the five years to come. To be precise, as consolidated figures only exist for 2017, forecasts will be made for 2022/23. Recommendations to maximize the value created by these strategic segments will then be formulated.

Tremendous political, economic and medical expectations for digital health

E-health raises tremendous aspirations. They can be political, economic, medical and sociological. French President Emmanuel Macron for example recently stated: « France must become the leader in some battles of tomorrow: The internet of things, artificial intelligence ... and the convergence between digital and healthcare. These battles are the new technological frontiers. The state will invest heavily in it” (Elysée, 2017).  When not expressed at the highest levels of French government, expectations are recurrently formulated in financial press, inspired by large consulting firms or even included in the vision of large French pharma companies. Sanofi, Servier, Ipsen, Urgo and Guerbet all refer to the need for digital transformation and the development of e-health. For example, Sanofi and Google, via Verily, announced last year to join their forces in a project named “Onduo” to develop a digital platform for diabetic patients (Paillé, 2017). Servier and Urgo also recently developed specific entities dedicated to digital health (respectively WeHealth by Servier and Urgotech).
A fact is that important unmet medical needs could be significantly improved through digitization. In particular, digital health could be a game changer in mainly 6 domains.  
E-health could first dramatically ease the access to personal medical data, improving timeliness of care and avoiding waste of money. Second, digital health could improve access to HCPs, notably via telemedicine and teleconsultation. Third, e-health could improve access to medicines via online purchasing and home delivery. Fourth, digitization could improve access to peers (patients) and favor better exchange and knowledge about disease and treatments, thus enhancing patient empowerment. Fifth, e-health could improve early detection of medical signals, triggering early adaptation and better efficiency of treatments, ensuring better follow-up of chronic disease through the use of wearable connected devices and of deep learning algorithms. Sixth, digitization could help to improve the delivery of medicines, by optimizing the agility and efficiency of pharma production, maybe including ability to produce personalized medicines though the implementation of pharma industry 4.0.
These expectations meet a large proportion of French medical needs. Chronic diseases represent in France the leading causes of death (Figure 2, adapted from Dress, 2017) and an improvement of their follow-up through efficient digitization could lead to significant mortality reduction.


Figure 2: Leading causes of death in France, adapted from DRESS, 2018.

For example, in hypertension, the leading contributor to cardiovascular death, whereas treatments are highly effective and could control the disease in most cases, only 60% of patients regularly take their drugs. Coupled with medical inertia, this situation results in a poor control of blood pressure, typically where digital solutions could add effective support (Perrine, 2018). On the same approach, connected devices could also lead to a better detection of small signals of pharmacovigilance, possibly decreasing iatrogenic death which is still responsible for 10 000 deaths in France (Le Monde, 2018). Improving the access to care via teleconsultation has also become a French health imperative in a context of relative medical desertification and difficult access to specialists. Finally, digital health represents also an economic opportunity for better cost-effectiveness of care, treatments and pathways in a context of permanent cost-containment.

Deep dive into 6 business models of digital health in France: from reality to value perspectives.

According to the review performed, 6 different business models of digital health were identified in France. Each of them has specific sources of revenues with specific clients and involves different economic actors and fabrics. These business models interestingly fit with the 6 expectations mentioned above: access to medical data, access to HCPs, access to patients, access to medicines, access to digital therapeutic solutions and access to personalized medicine through pharma industry 4.0. All these domains were ranked according to the value recently created in terms of turnover (euros). Perspectives for potential value-creation are based on extrapolations, in the absence of unexpected innovation.

Access to medical data and its storage: more than 2,3 billion euros per year.

With a yearly turnover above 2,3 billion euros, recently evaluated by a robust interdepartmental mission this business-model represents 86% of the total current turnover generated by digital-health in France (recalculated from Pipame, 2016),. It relates to the storage and monitoring of data generated by healthcare activities, including access to personal medical information. This “Systèmes d’information”(SI) market has been in France mostly sponsored by public funds and hospitals and is highly fragmented. It involves more than 300 medium to small-size companies, mainly SSII such as Enovacom, recently acquired by Orange Health Care (Dumoulin, 2018) and also digital technologic consulting companies such as Acsantis, Effigen, Keyrus or Viseo (Rapport du Sénat 2007; Aubin, 2017; D.G.O.S., 2017). Data (ie number and nature of medical acts) are mainly generated by HCPs (ie 300 000 in France) and care-units (ie 3 000 hospitals and clinics) for the benefit of the Système National d’Information Inter-Régimes de l’Assurance Maladie (Sniiram), a sub entity of the French national health insurance (l’Assurance Maladie). For both HCPs and care units, data are used to price the medical acts performed. Hospitals and clinics also use “les systèmes d’information hospitaliers” for business intelligence purpose. The data collected by the Sniiram contribute to the monitoring of “l’Assurance maladie” financial balance, and also to the tracking of patient pathways and medical practices, ensuring global assessment of health-care policies (L’assurance Maladie, 2016).
One of the critical -and highly debated- aspects of this sector is certainly the management of personal medical data. According to a survey performed in march 2018, 65% of French patients support the use of a digital medical dossier (Carenity, 2018). At the same time, only 10 % of them are aware that such a tool already exists, explaining why only 600 000 “Dossier Medical Partagé” (DMP) were already opened in France (Ministère de la Santé, 2018). Initiated in 2004, partially available in pilot regions since 2017, the “DMP” aims at allowing access to personal medical data, both for patients and HCPs in order to improve care efficiency (ie for example: immediate access to key information such as allergy, treatment prescribed, former exams in order to save time, outcomes and money). Its access should be generalized in October 2018 (Mon-dmp.fr). Its total development cost, supported by public funds, was estimated between 200 and 500 million euros, according to different “La cour des comptes” audits and generated significant business for SSII companies (AFP, 2014; Ministère de la Santé, 2018). The DMP’s deployment will also generate new business opportunities for certified “Hébergeurs de Santé” companies.
“Hebergeurs de Santé” companies, by ensuring safe and certified storage of personal medical data, will become a growing actor of digital health market. Recently, 57 % of public care entities declared that they would prefer externalizing such activities (Wawestone, 2018).  In France, 120 companies have been recently listed by « L’Agence française de la santé numérique » as ISO 27001 certified (ASIP, 2018). One of the main actors of this domain is a company named « Claranet e-santé », generating a turnover of 27 million euros. Recently, Orange but also Microsoft declared their willingness to enter that promising domain (Ronfaut, 2018). According to the large-scale development of DMP (+ 20 million files planned for 2020), the trend for externalization, the need for certification and maintenance, value creation could reach here up to 50 million euros in the 5 coming years (Beckrich, 2018). The added value brought by Block-chain technology has not been extrapolated here according to the lack of already published business cases.
In parallel with this growing market trend, SI’s heterogeneity, with more than 300 solutions available, represents both an obstacle to an effective data sharing but also a fantastic opportunity for growth for SSII companies. Recently, a report from “La Direction Générale de l’Offre de Soins » (DGOS) clearly set up that only 13% of SI systems were ensuring full interoperability (Moreaux, 2018). 400 million euros, coming from public funds, should be allocated to solve this issue, offering significant business perspectives (Hospitalia, 2017). Moreover, growing needs for easy access to data, notably on apps, will also generate new opportunities, not only for hospital dashboarding but also probably for personal DMPs (Aubin C, 2017).
In total, it could be extrapolated that value creation in this domain will exceed 450 million euros within the 5 coming years.

Access to HCPs and business support : 270 million euros per year.

This second business model gathers scheduling software providers, health software publishers and telemonitoring solutions providers. Clients and payers are here directly HCPs. As revealed in July 2018, Doctolib recently acquired Mon Docteur. Altogether, these 2 digital medical scheduling providers help patients and HCPs to virtually and rapidly agree on appointments. With 55 thousand HCPs as clients and a monthly fee of 109 euros, this new merger will generate a turnover of approximatively 70 million euros per year for 600 employements (extrapolated from A.F.P., 2018). With a market share of 43% among private practitioners, 18% among total doctors and of only 10% of total HCPs, perspectives for growth in this domain remain important (A.F.P., 2018). Value creation could here reach 100 million euros within the 5 years (data extrapolated with 25% obtained market share among total French HCPs).
Other digital services directly bought by practitioners are prescription softwares. 265 certified publishers are listed in France, generating a global turnover of around 200 million euros per year, growing by +4% a year (Sesame, 2017). Among them, 2 leaders (Cegedim and Compugroup) represent a market-share of 30%. If 85% of general practitioners and 75% of pharmacists already use a prescription software, only half of care-units and of total HCPs do so. Here again, potential for value creation is significant, notably at the level of care units and nurses. It could be extrapolated a value creation of 80 million euros within the 5 years to come (data extrapolated, reaching a 75% market share in total HCPs population).
From the 15th of September 2018, teleconsultation will be authorized and reimbursed in France as well as tele-expertise (concomitant expertise in presence of a second HCP) (Martos, 2018). This represents an important opportunity for isolated patients living in so-called “medical desert”, but also to decrease useless displacements, and why not greenhouse gas emissions. It also represents an important opportunity for GPRD-certified teleconsultation software makers (HAS, 2018). Consulting a professional catalog allows to count dozens of already available products emanating from different companies, Cisco appearing one of the most established. A recent survey, commissioned by the French ministry of Health assessed a potential for 25 million teleconsultations a year in France (ie representing a market share of 5% of total consultations) (Management en milieu de santé, 2017). A credit of 525 euros per medical doctor being already provisioned for such activities, value creation could be extrapolated from 70 to 100 million euros reaching only 50% of projections within the 5 years to come.
In total, a value creation of 280 million euros could be expected in France in digital HCPs business-support.

Patient websites and patient apps: 50 million euros per year 

In this business model, users are patients, most of the time using the services for free, while revenues are generated through traffic, direct and indirect advertisements but also, more and more, through the access to user’s data.
Surfing on patient forums has become an important social trend. Indeed, the creation of Doctissimo in 2000 by Malhuret and Alexandre dramatically changed the access to medical information, allowing interactions and direct discussions between patients, not only regarding their disease but also their treatment, which was initially not allowed so far. With 9 million “unique visitors” in 2018, Doctissimo is the leading French website dedicated to health (Médiamétrie, 2018). Recently, Doctissimo was sold by Laguardère to TF1 for 15 million euros (ie approximately equivalent to one year of turnover) an amount 9 times lower than its purchase value in 2000 (Verif, 2012 ; Bfm, 2018). The business-model of such websites seem mainly based on revenues coming from traffic and advertisement. Recently, Carenity developed a new web activity by developing communities among chronic patients, using the model initiated by “Patientslikeme” in the US (500 000 patients in the US). This approach potentially allows patients to have more specific exchanges about their needs, their disease, their treatment or their support. It also allows to have access to crowdsourcing data and to perform anonymous surveys on specific patient groups to generate revenues with pharma industry, scientific societies or even marketing consulting companies (Harvard business school, 2017). Even if Carenity did not publish any figure except 160 000 users, its turnover could be estimated around several million euros. Perspectives for growth could be here reasonably expected, according to the importance of chronic disease patients in France. Other social networks, notably among HCPs, like Sermo in the US, never really broke in France. Launched in 2016, the French sites HeyDoctor, or Medpics, could however progress, notably in the context of tele-expertise deployment, where effective networks will be critical.
Surprising as it seems, free patient apps belong still today to this business model. Users are patients, most of the time using the services for free or for very little amount of money, while revenues are (possibly) generated by a third party. According to a recent market research, more than 300 000 apps are available worldwide, with more than 70 000 new comers each year... (Health apps, 2018). One would have thus expected this business to be highly profitable... Reading headlines of specialized articles may provide a good overview of the situation: from “Les applis santé: un juteux bénéfice” published in 2013 to “E santé: des modèles économiques difficiles à mettre au point”, everything may be said (Google, typing for “business modèles des applications en santé”, 2018). In fact, the most downloaded “health” applications regard in France mainly fitness or weight loss and generate some revenues (Google, 2018). For the free-apps allowing a better follow-up of chronic diseases, most of them have been developed by pharma industry, in order to sustain products and improve customer experiences. Here figures are confidential, but always far below expectations (professional sources interviewed in 3 pharma companies). Even if some services are based on common sense and could be useful, as supporting observance for example, these apps are rarely used in the long term. Importantly, these free apps have to be differentiated from the “Dispositifs médicaux”, ie digital solutions with demonstrated impact on outcomes and with paid subscription, and most of the time reimbursed in France. They will be further detailed. Nevertheless, even without any tangible impact, the development of such apps is still pushed by many pharma companies. A reasonable extrapolation could estimate the yearly turnover generated by SSII companies around 30 million euros (ie 1 app developed every 2 years by each of the TOP 100 French pharma companies integrating costs for local adaptations, low assumption according to interviews).
To conclude, perspectives of value creation in this domain could reasonably be estimated around 150 million euros for the 5 years to come.

On-line drug seller sites: 50 million euros per year.

On-line drug selling is strictly regulated in France, and is restricted to true pharmacies, established on the streets, for the sale and the distribution of medicines that can be delivered without medical prescription (Ordre national des pharmaciens, 2018). Today, the turnover performed on-line is estimated around 50 million euros (ie 2% of total French sales of medicines deliverable without prescription) (Lentschner, 2017). Recently, the Court of Justice took the decision to allow Doctipharma, subentity of Doctissimo, to keep on delivering on-line medicines for the benefit of true pharmacies. Amazon, recently established in the US for the selling of medicinal products, but also Leclerc, could possibly push to enter that domain despite the vigilance and protection exercised by l’Union des groupements des pharmaciens d’officine. Here, reasonable assumptions would predict that market share for on-line pharma sales would reach the level of other domains (ie 5,5% of market share in over-the-counter drugs)(Berger, 2017). Without any law modification, value capture could here reach around 100 million euros.

Digital therapeutic solutions: promising but still emerging market.

This domain is probably towards which converge the highest medical and financial expectations for the years to come. Projects are indeed numerous. In Paris, 17 e-health start-ups are incubated by Techcare (Techcare, 2018). In Agoranov or in other dynamic incubators, about 15% of projects are also digital health solutions, However, ability of such innovations to reach the market, get reimbursement and generate revenues takes time (Bietry, 2017). Digital therapeutic solutions can be considered as part of Medtech. They are considered in France as “Dispositif médical”, meaning a digital equipment aiming at improving healthcare in another way than by pharmacological or immunological treatments, but being possibly supported by them (Code de la santé public, 2018). Concretely, these solutions could address various situations: from better disease detection, better patient monitoring to improvement of disease management and patient-journey. In this domain needs are tremendous. Whereas high blood pressure is still one of the main causes of death and strokes, only 50% of French patients are effectively controlled by their treatments (Perrine, 2018). A situation, mainly due to therapeutic inertia, that could be typically improved by automated telemonitoring solutions, integrating deep-learning treatment algorithms. In diabetes, challenges are the same and explained why Diabeo was among the first innovative digital solutions to be developed in the 2000s, with first patients enrolled in clinical studies in 2007. Whereas the “Haute Autorité de Santé” (HAS) recently issued a favorable opinion, Sanofi and Voluntis are still waiting for the results of ongoing real-life and medico-economic studies before getting their digital solution reimbursed. In this case, time to market would have been long as for medicines, a duration that seems hardly compatible with the relatively short life-cycle of digital products. It is unfortunately a high price to pay for pioneers to open new frontiers. Even improvable, evaluation processes have positively evolved in 10 years, gaining in clarity and harmonization. The new ETAPES process, established 4 years ago, aims at assessing in real life telemedicine and digital therapeutic solutions before larger use at national level (Etapes, 2018). “ETAPES has improved the way solutions are now assessed, focusing in domains where there are important unmet needs such as diabetes, heart failure, renal insufficiency or also for patients needing cardiac telemonitoring” declared Patrick Jourdain, Professor of cardiology and former DGOS adviser. Nevertheless, process is long and “up to now, no experimentation succeeded in scaling up” declared Olivier Gryson, Head of digital marketing in Servier (Gryson, 2018). In any cases, dozens of experimentations will end in 2019, with the hope to see positive results and solutions reimbursed at national level. In terms of value creation, it could guess that 6 to 10 major projects will get reimbursement at national level by 2022 to improve important unmet needs such as in diabetes, heart failure or hypertension.
In total, value creation could be extrapolated here around 300 and 400 million euros.

Pharma industry 4.0 : promising perspectives

In France, 271 manufacturing sites yearly generate a pharma production equivalent to 20 billion euros (Leem, 2018). These competitive production capabilities rank at the 4th position worldwide. By integrating cyber physical systems, industry 4.0 aims at progressively enhancing the efficiency of pharma production delivered today. It relies on 4 pillars: real time production, with improved workflows, decentralized, machine/IoT-controlled production for finally customized production (Fottner, 2017). Clients of this business opportunity are Pharma manufacturers. Among French pharma companies, Sanofi, for example, is bringing digital transformation to its manufacturing facilities. Each of the company’s digital plants will have a digital twin connected directly to the sensors and data in the physical plant. “The data flows to these digital twins, giving managers a real-time view into the plant’s operation. Simulation on the model provides the level of manufacturing modularity and future flexibility required to support personalized medicine,” Sanofi said in a 2017 press release (Sanofi, 2017). It is still difficult today to extrapolate what is the value created by pharma 4.0 in 2017, nevertheless future value creation could be estimated around 200 million euros in France in the 5 coming years (Extrapolated from (LEEM, 2014), with a mean investment per site and per year of 1 million euros).

Synthesis and perspectives: 1530 million euros expected to be created in digital-health in France by 2022/2023.

As a result of the review, e-health generated in France in 2017 a turnover of 2,67 billion euros. When allocated according to the 6 different business models previously defined, access to data and data storage appears to be, by far, the most important sector (86% of total turnover) (cf Table 1). In terms of value creation, 1,53 billion euros are expected to be created in digital health in France by 2022/2023. Among the different sectors, access to data and data storage will still lead the value capture (+ 450 million expected), but followed by HCPs business supports (+ 280 million euros) and digital therapeutic solutions (+ 350 million euros), the latter focusing the main expectations in terms of medical added value. In total, e-health sector would represent 4,2 billion euros by 2023, ie 1,4 % of total French healthcare market (extrapolation made with 1% CAGR for total health market). Even if this progression is under expectations, it has to be put in perspectives with the growth framed by the “Plan de Financement de la Sécurité Sociale” for the French medicine market (+0,5% CAGR)(Leem, 2018). If respected, this plan would result in a value creation around 1,4 billion euros within the 5 years to come, ie less than the value creation expected for digital health.



Table 1: Value created by digital health in France in 2017
and expected to be created by 2022/23 (in million euros)

Limitations may come from extrapolations formulated for potential value creation, and also from the harmonization of the methodology used to estimate generated turnovers, in particular at hospital level (pipame, 2016).
This review demonstrates that if digital health may generate important value creation by 2022/23, it will not yet reach the level of other economic domains. This situation is mainly due to digital therapeutic solutions that still lag behind, with still uncertain ability to reach market. Further push is clearly needed to overcome this gap and concrete proposals could help business and policy makers to remove barriers. First, the quality of digital solutions developed should be undisputable, with clear demonstrated impact on unmet medical needs achieved in studies performed in real life and versus cohort populations. To produce solutions that will meet practical expectations, teams should mix from the beginning talents coming from various horizons, combining medical and engineering background, but also including inputs of real patients at each step of the development. This may dramatically improve the probability of successfully penetrating the market. Second, transparent rules for development should be clearly expressed by authorities, and an early binding agreement should commit the two parties in the long term. If the demonstration fulfils the requirements, the solution will reach the market at the price initially negotiated. This key condition, not effective today, would ensure more transparency and consistency between parties, ie French health authorities and companies. Third, innovation should be favored and rules should be strictly and impartially applied. As digital solutions are hardly patent protected, any new entrant should ensure the same level of demonstration than its precursors to reach the market.
To conclude, e-health carries promise to face medical challenges and to create significant value by 2022/23 in France, in an otherwise flat health care market. Our review allows a better understanding of its different business models, which represent for each of them significant opportunities to improve the efficiency of French healthcare system, from a better access to care to a better patient journey.























I address special thanks to Dr Olivier Gryson and to Prof Patrick Jourdain
for the time they dedicated to the interviews that help me to consolidate this review.


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