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Executive summary: mHealth can revolutionize how healthcare services are delivered, leading to better outcomes, decreased costs and improved sustainability of the healthcare system. The market for mHealth solutions is still in an early stage, but on the brink of entering a strong growth phase that will last for many years to come. At the end of 2013, there were 3.0 million patients using connected home medical monitoring devices worldwide. This figure comprises all patients that were remotely monitored by a professional caregiver. Patients that use connected medical devices for various forms of personal health tracking are not included in this figure. Berg Insight estimates that the number of patients using connected home medical monitoring devices will grow at a compound annual growth rate (CAGR) of 44.4 percent to reach 19.1 million by 2018. Cellular connectivity has already replaced PSTN and LAN as the de-facto standard communication technology for most types of connected home medical monitoring devices and will account for 14.1 million connections in 2018. Using patients' own mobile devices as health hubs has thus far not been a viable option for remote patient monitoring, but will emerge as the favoured alternative for some groups of patients in the long term. Berg Insight estimates that revenues for remote patient monitoring (RPM) solutions reached €_4.3 billion in 2013, including revenues from medical monitoring devices, mHealth connectivity solutions, care delivery platforms and monitoring services. RPM revenues are expected to grow at a CAGR of 35.0 percent between 2013 and 2018, reaching € 19.4 billion at the end of the forecast period. Connected medical devices accounted for 76.7 percent of total RPM revenues in 2013. However, revenues for mHealth connectivity solutions, care delivery platforms and monitoring services are growing at a faster rate and will account for 40.0 percent of total revenues in 2018, up from just 23.3 percent in 2013.
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There is a strong trend towards incorporating more connectivity in medical devices in order to enable new services and value propositions. Implantable cardiac rhythm management (CRM) device vendors such as Medtronic, Biotronik and St Jude Medical have marketed connected CRM solutions for years. Today, CRM is by far the largest segment, representing 65 percent of all remotely monitored patients. Sleep therapy has emerged as the second largest market segment, accounting for 18 percent of all connections in 2013. Furthermore, connectivity is gaining momentum in several other device categories such as glucose monitoring and air flow monitoring, as well as enabling the emergence of new categories such as telehealth hubs and medication compliance monitoring solutions. Examples of companies that have launched connected solutions in these market segments include ResMed, Philips Respironics, Fisher & Paykel Healthcare, Propeller Health, MIR, iSonea, Telcare, J&J, Honewell, Bosch, Tunstall, Alere, Evondos and InRange Systems. Pharmaceutical companies will also be active in this space in the future. Care delivery platforms and mHealth connectivity solutions are two of the most rapidly developing parts of the mHealth value chain. Care delivery platforms are software solutions that enable the remote delivery of healthcare services and allow care efforts to be coordinated between patients, various professional caregivers and other stakeholders such as the patient's family.
Care delivery platforms will be instrumental for engaging patients in their own care and delivering remote monitoring services to a large number of people in a cost efficient way. There are various types of care delivery platforms available on the market. Generalpurpose platforms are provided by companies such as BePatient, Exco InTouch, Get Real Health, HealthyCircles, Medixine and Verizon. Similarly, solutions specific to one therapeutic area are provided by companies such as Scottcare, Voluntis and Welldoc. mHealth connectivity solutions include products and services that are used for collecting data from medical monitoring devices, transmitting this data to caregivers and enabling the data to be used by care delivery platforms. Examples include the 2net platform from Qualcomm Life, HealthGO from eDevice, Connected Health Centre from Orange and HealthKit from Apple. The adoption of remote patient monitoring solutions is driven by a wide range of incentives, related to everything from demographics and technology development to new advancements in medical treatment. However, there are a number of barriers, including resistance to change among healthcare organizations and clinicians, misaligned incentive structures and the financing of wireless solutions by what is at large an underfunded healthcare sector. Several catalysts are nevertheless speeding up the rate of adoption – in particular incentives from payers and insurance companies, national health systems that support remote monitoring and a shift to performance-based payment models.
Table of Contents . iList of Figures .... viiiExecutive summary .. 11 The challenge from welfare diseases .. 31.1 Introduction .... 31.1.1 The ageing world population 41.1.2 Metabolic syndrome and lifestyle related diseases . 51.2 Common chronic diseases 51.2.1 Cardiac arrhythmia . 71.2.2 Ischemic diseases .. 71.2.3 Hypertension 81.2.4 Sleep apnea . 91.2.5 Chronic respiratory diseases ... 101.2.6 Diabetes 131.2.7 Hyperlipidemia 141.3 Healthcare providers and reimbursement systems 141.3.1 Healthcare in Asia-Pacific .... 181.3.2 Healthcare in Europe 191.3.3 Healthcare in North America .... 201.4 Regulatory environment .. 221.4.1 Regulatory environment in Europe .... 231.4.2 Regulatory environment in the US 241.4.3 Regulatory environment in other major markets .... 271.4.4 International standardisation .... 272 mHealth platforms .... 292.1 Overview of the mHealth market .... 29
2.1.1 mHealth market segments .. 302.1.2 Connectivity options for medical devices .... 322.1.3 The mHealth value chain 342.2 mHealth connectivity solutions .. 362.2.1 Apple HealthKit 382.2.2 Axeda 392.2.3 eDevice .. 402.2.4 Ericsson . 422.2.5 KORE Wireless 432.2.6 Microsoft HealthVault 442.2.7 Numera .. 452.2.8 Orange... 472.2.9 Qualcomm Life 492.2.10 Telenor Connexion .... 512.2.11 Vodafone .... 512.3 mHealth care delivery platforms 532.3.1 BodyTel . 552.3.2 BePatient Solutions ... 562.3.3 Exco InTouch .. 572.3.4 Get Real Health .... 582.3.5 HealthyCircles . 592.3.6 Medixine 602.3.7 S3 Group .... 612.3.8 SilverBullet .. 622.3.9 Verizon Mobile Health Solutions ... 632.3.10 Verklizan 64
3 Physiological monitoring solution providers .... 673.1 Medical devices and remote monitoring .. 673.1.1 Medical device revenues by market segment .. 673.1.2 Overview of the remote patient monitoring market 693.2 Cardiac rhythm management .... 703.2.1 Overview of the CRM device market .. 703.2.2 Use cases for CRM monitoring 713.2.3 Remote monitoring solution providers .... 733.2.4 Biotronik 753.2.5 Boston Scientific ... 763.2.6 Medtronic ... 773.2.7 Sorin Group 803.2.8 St. Jude Medical ... 813.3 Remote ECG monitoring . 823.3.1 Overview of the remote ECG monitoring device market.. 823.3.2 Use cases for remote ECG monitoring ... 823.3.3 Remote monitoring solution providers .... 853.3.4 Aerotel Medical Systems 863.3.5 BioTelemetry ... 873.3.6 CardioComm Solutions .. 883.3.7 LifeWatch .... 903.3.8 ScottCare .... 913.3.9 TZ Medical .. 923.3.10 Zenicor .. 923.4 Blood pressure monitoring ... 933.4.1 Overview of the blood pressure monitoring device market .. 933.4.2 Use cases for blood pressure monitoring .... 933.4.3 Remote monitoring solution providers .... 953.4.4 Omron Healthcare 953.4.5 A&D Medical .... 963.4.6 Microlife . 973.4.7 Rossmax 983.4.8 Sotera Wireless .... 983.5 Coagulation monitoring ... 99
3.5.1 Overview of the coagulation monitoring device market ... 993.5.2 Use cases for blood coagulation monitoring .... 993.5.3 Remote monitoring solution providers .. 1003.5.4 CoaguSense .. 1003.5.5 Helena Laboratories 1013.5.6 International Technidyne Corporation .. 1013.6 Sleep therapy monitoring ... 1013.6.1 Overview of the sleep therapy device market . 1023.6.2 Use cases for sleep therapy monitoring .... 1023.6.3 Remote monitoring solution providers .. 1043.6.4 Fisher & Paykel Healthcare .... 1063.6.5 Philips Respironics .. 1073.6.6 ResMed .... 1093.6.7 SRETT . 1113.6.8 Weinmann 1123.7 Home sleep diagnostics 1133.7.1 Overview of the home sleep diagnostics market . 1143.7.2 Use cases for home sleep diagnostics . 1153.7.3 Remote monitoring solution providers .. 1153.7.4 Cadwell Laboratories ... 1163.7.5 CareFusion .... 1163.7.6 Compumedics .... 1173.7.7 Natus Medical 1183.7.8 NovaSom .. 1183.7.9 SleepMed . 1183.8 Blood oxygen monitoring ... 1193.8.1 Overview of the blood oxygen monitoring device market .. 1193.8.2 Use cases for blood oxygen monitoring .... 1203.8.3 Remote monitoring solution providers .. 1203.8.4 ChoiceMMed . 1213.8.5 Covidien ... 1213.8.6 Masimo 1223.8.7 Nonin Medical .... 1233.9 Air flow monitoring .... 124
3.9.1 Overview of the air flow monitoring device market ... 1243.9.2 Use cases for air flow monitoring 1243.9.3 Remote monitoring solution providers .. 1253.9.4 Aerocrine .. 1263.9.5 Clement Clarke International .. 1263.9.6 iSonea . 1263.9.7 Medical International Research ... 1283.9.8 Ndd Medizintechnik. 1283.9.9 nSpire Health . 1283.9.10 Propeller Health .. 1293.9.11 Sibelmed .. 1303.9.12 Vitalograph .... 1313.10 Glucose level monitoring .... 1313.10.1 Overview of the glucose monitoring device market .. 1313.10.2 Use cases for glucose monitoring ... 1333.10.3 Remote monitoring solution providers .. 1363.10.4 Abbott .. 1383.10.5 Bayer Healthcare 1393.10.6 Johnson & Johnson 1403.10.7 Roche .. 1413.10.8 Dexcom .... 1423.10.9 Voluntis 1433.10.10 Telcare . 1443.10.11 Welldoc 1453.11 Other 1463.11.1 Implantable medical devices .. 1463.11.2 Home hemodialysis . 147
3.11.3 Telerehabilitation 1474 Medication and integrated monitoring solution providers .. 1494.1 Telehealth solution providers .. 1494.1.1 Overview of the telehealth solutions market ... 1494.1.2 Use cases for telehealth solutions ... 1514.1.3 Telehealth solution providers . 1514.1.4 Alere .... 1534.1.5 American TeleCare .. 1554.1.6 Authentidate .. 1554.1.7 Bosch Healthcare .... 1554.1.8 Care Innovations 1574.1.9 H2AD ... 1574.1.10 Honeywell HomMed 1594.1.11 Ideal Life ... 1604.1.12 Grandcare Systems . 1614.1.13 Medvivo .... 1624.1.14 Philips Healthcare ... 1624.1.15 SHL Telemedicine ... 1644.1.16 Telefónica . 1654.1.17 Tunstall Healthcare Group 1664.1.18 Vitaphone . 1684.2 Medication compliance monitoring ... 1694.2.1 Overview of the medication compliance monitoring market ... 1694.2.2 Use cases for medication compliance monitoring .... 1704.2.3 Compliance monitoring solution providers 1704.2.4 DayaMed .. 1714.2.5 Evondos ... 173
4.2.6 Innospense .... 1754.2.7 InRange Systems .... 1764.2.8 Medicpen .. 1784.2.9 Merck Serono 1794.2.10 Compliance Meds Technologies 1804.2.11 MedSignals .... 1814.2.12 Proteus Digital Health ... 1814.2.13 Vitality .. 1825 Market analysis and forecasts .... 1855.1 Market forecasts .. 1855.1.1 Cardiac rhythm management 1885.1.2 Sleep therapy 1895.1.3 Telehealth . 1915.1.4 ECG monitoring .. 1925.1.5 Glucose level monitoring .. 1935.1.6 Medication compliance monitoring .. 1955.1.7 Other medical devices.. 1965.2 Revenue forecasts .... 1975.2.1 Medical monitoring devices ... 1975.2.2 mHealth connectivity solutions ... 1995.2.3 Care delivery platforms 1995.2.4 Monitoring services . 2005.3 Industry trends and analysis .... 2015.3.1 New players enter the market 2025.3.2 Modularization of the value chain .... 2045.3.3 Digitalisation of PSTN networks .. 2055.3.4 BYOD will become a viable option ... 2065.4 Market drivers and barriers . 2075.4.1 An ageing population ... 2085.4.2 Increasing welfare disease prevalence . 2095.4.3 Focus on disease prevention . 2095.4.4 Substitutes to medical monitoring ... 2105.4.5 Resistance to change ... 2115.4.6 Alignment of financial incentives . 2115.5 Potential market catalysts ... 2125.5.1 Increased monitoring during clinical trials . 2125.5.2 Incentives from insurance companies and payers ... 2135.5.3 National health systems support remote monitoring 2145.5.4 New clinical evidence on cost effectiveness ... 2145.5.5 Non-prescribed monitoring and healthcare consumerism . 215Glossary 217
List of Figures: Figure 1.1: Population by age group (EU, North America and Japan 2010–2030) 4Figure 1.2: Direct and indirect costs of chronic welfare diseases in the US and EU .. 6Figure 1.3: Number of people suffering from chronic welfare diseases (EU/US 2008) ... 9Figure 1.4: Percentage of population diagnosed with chronic welfare diseases . 11Figure 1.5: Total and per capita healthcare spending by country (2012) .. 15Figure 1.6: Healthcare expenditure per capita by country (World 2012) ... 17Figure 1.7: Share of population covered by private health insurance by country .... 18Figure 1.8: Healthcare spending by type of service and product (US 2012) .. 21Figure 2.1: mHealth market segments 31Figure 2.2: Connected medical devices and the provision of care .. 33Figure 2.3: Overview of the mHealth landscape . 34Figure 2.4: Main focus areas of mHealth connectivity solution providers .. 37Figure 2.5: HealthGO+ and HealthGO Mini by eDevice ... 41Figure 2.6: Examples of HealthVault-certified devices . 45Figure 2.7: Numera Libris and Numera Home Hub . 46Figure 2.8: Examples of mHealth care delivery platform categories 53Figure 3.1: Medical device market revenues by segment (World 2013–2018) .... 68Figure 3.2: Connected medical devices by segment (World 2013) . 69Figure 3.3: Implantable cardiac rhythm management vendor market shares (2013) .... 71Figure 3.4: Examples of implantable CRM devices . 72Figure 3.5: Examples of remote monitoring devices .... 73Figure 3.6: Market shares for remote monitoring of CRM implants (2013) 74Figure 3.7: MCT sensor and monitor from CardioNet .. 84Figure 3.8: Implantable loop recorder from Medtronic . 85Figure 3.9: HeartCheck devices from CardioComm Solutions ... 89Figure 3.10: Blood pressure monitor from Omron Healthcare .... 94Figure 3.11: Sleep therapy vendor market shares (2013) .... 102Figure 3.12: ResMed S9 CPAP device with FX Series masks ... 103Figure 3.13: Connected sleep therapy solutions by vendor (2013) .... 105Figure 3.14: SleepMapper mobile application .. 108Figure 3.15: SRETT T4P . 111
Figure 3.16: Weinmann sleep therapy device featuring the somno2CLOUD modem . 113Figure 3.17: Examples of home sleep diagnostics companies and products ... 114Figure 3.18: iSpO2 device and application . 123Figure 3.19: iSonea's device and asthma management app .... 127Figure 3.20: Propeller Health's asthma management app and inhaler sensor .. 130Figure 3.21: Blood glucose meter vendor market shares (2013) ... 132Figure 5.4: Connected sleep therapy devices (World 2013–2018) .... 190Figure 5.5: Telehealth hubs (World 2013–2018) ... 191Figure 5.6: Connected ECG monitoring devices (World 2013–2018) 193Figure 5.7: Connected glucose monitoring devices (World 2013–2018) . 194Figure 5.8: Connected medication monitoring solutions (World 2013–2018) 195Figure 5.9: Other connected medical devices (World 2013–2018) .... 196Figure 5.10: Remote patient monitoring revenues (World 2013–2018) .... 197Figure 5.11: Connected medical device revenues (World 2013–2018) ... 198Figure 5.12: mHealth connectivity solution revenues (World 2013–2018) ..... 199Figure 5.13: Care delivery platform revenues (World 2013–2018) ..... 200Figure 5.14: Monitoring service revenues (World 2013–2018) ..... 201Figure 5.15: New players enter the connected care market .. 202Figure 3.22: CGM and insulin delivery system vendor market shares (2013).... 133Figure 3.23: Medication usage by diabetes patients (US 2011) .... 134Figure 3.24: Glucose meters from LifeScan and Roche .. 135Figure 3.25: Dexcom G4 CGM system ... 135Figure 3.26: Asante Pearl insulin pump .. 136Figure 3.27: Examples of connected blood glucose meters 137Figure 3.28: Examples of connected CGM and insulin pump systems ... 138Figure 4.1: Overview of the telehealth landscape .. 150Figure 4.2: Installed base of telehealth hubs by region (2013) . 151Figure 4.3: Telehealth hub vendor market shares (2013) .... 152Figure 4.4: The Twitoo telehealth hub .... 158Figure 4.5: The Honeywell Genesis DM telehealth monitor with peripherals 160Figure 4.6: Compliance monitoring solution form factors .... 171Figure 4.7: The DayaMed MedPod .... 172Figure 4.8: The Evondos E300 Automatic Medicine Dispenser 173
Figure 4.9: Medido medication dispensers . 176Figure 4.10: The EMMA medication management system .. 177Figure 4.11: The Easypod injector and the Easypod connect transmitter .... 179Figure 4.12: The CleverCap dispenser ... 181Figure 4.13: The Vitality GlowCaps system . 183Figure 5.1: Connected home medical monitoring devices (World 2013–2018) . 186Figure 5.2: Connected home medical monitoring devices by region (World 2013–2018) 187Figure 5.3: Connected cardiac rhythm management devices (World 2013–2018) . 188Figure 5.4: Connected sleep therapy devices (World 2013–2018) .... 190Figure 5.5: Telehealth hubs (World 2013–2018) ... 191Figure 5.6: Connected ECG monitoring devices (World 2013–2018) 193Figure 5.7: Connected glucose monitoring devices (World 2013–2018) . 194Figure 5.8: Connected medication monitoring solutions (World 2013–2018) 195Figure 5.9: Other connected medical devices (World 2013–2018) .... 196Figure 5.10: Remote patient monitoring revenues (World 2013–2018) .... 197Figure 5.11: Connected medical device revenues (World 2013–2018) ... 198Figure 5.12: mHealth connectivity solution revenues (World 2013–2018) ..... 199Figure 5.13: Care delivery platform revenues (World 2013–2018) ..... 200Figure 5.14: Monitoring service revenues (World 2013–2018) ..... 201Figure 5.15: New players enter the connected care market .. 202
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