The inadequate access to healthcare facilities and competition from the low-cost domestic market will peg back participants that are looking to establish a toehold in the Indian market.
Indian ECG equipment market has emerged as the most profitable in the patient monitoring segment. The market is benefitting from the rising incidence and awareness of cardiovascular diseases, escalating public expenditure on healthcare services, increasing demand for high-end equity systems, and rapid technological advancements. End users have shown a marked preference for interpretation technology and equipment with more accurate measurements. This has created a wider market for high-end ECG equipment (6- and 12-channel ECGs) market, but shrunk the single-channel ECG market.
Unlike in the case of high-end MedTech devices, where the market is dominated by a few multinational companies, there are a large number of both domestic and foreign companies operating in the Indian ECG equipment market.
Despite the overall vast market potential, participants will face some road blocks while trying to penetrate rural markets. The inadequate access to healthcare facilities and competition from the low-cost domestic market will peg back participants that are looking to establish a toehold in the Indian market. The competition between domestic and major market participants has even led to price wars in the single-channel and three-channel ECG market segments, which have, in turn, eroded the profit margins of prominent market participants.
However, with medical centers in Tier-III cities and towns also looking to provide quality care, Indian companies are also experiencing high demand for their products. Overall, the market is exhibiting a steady growth and promises ample opportunities for all the players operating in the market.
In 2015, the Indian ECG market is estimated at Rs.175 crore, with sales at 28,770 units. The metros and Tier-I show a preference for the 12-channel systems and Tier-II and Tier-III cities are able to afford only the 6-channel and lesser channel machines.
As in other segments, the physician is showing an increased dependence on machines for clinical decision support. There is a marked preference for interpretation technology and equipment with more accurate measurements.
ECG monitoring equipment with enhanced connectivity capabilities has been a primary driver of revenue growth. Smarter, smaller, and lighter ECG devices with Bluetooth-enabled data transfer and cloud-based EMR solutions are gaining steady popularity among corporate healthcare and organized home-healthcare service providers. Advances in ECG interpretation software are also huge game changers that are assisting more and more primary care physicians with quality interpretation backed with credible clinical data.
Recent pushes for preventive healthcare along with escalating cardiovascular disorder diagnoses are creating a surge in ECG equipment sales. The global ECG equipment market is expected to reach USD 6.3 billion by 2022. The rising incidences of cardiovascular disorders and government initiatives to make people aware about health check-ups are expected to boost market growth.
North America dominates the global multi-lead ECG machines market, according to Grand View Research. Europe is expected to show low growth rate due to inadequate reimbursement policies for cardiovascular diseases. Asia-Pacific is expected to witness substantial growth owing to the rising incidence rate of heart diseases and growing manufacturing outsourcing in the region.
Increasing geriatric population to propel the need of monitoring devices and technological advancement and remote monitoring in diagnostic ECG devices are some of the key factors driving the growth of global ECG devices market. However, unstable economy and limited reimbursement policies are some of the major factors restraining the growth of global ECG equipment market.
ECG monitoring equipment have high future growth potential owing to changing trend toward preventive care and new product innovations with data integration.
In February 2014, Medtronic launched its FDA-approved Reveal LINQ. The upgraded version of Reveal XT offers patient heart monitoring for 3 years with 20 percent more data memory than its previous version.
ECG stress testing system is one of the dominating segments of the global market. The growing need for flexible stress systems and comprehensive data management is driving the market for this segment. Quinton 9500 series from Cardiac Science portable system allows physicians to optimize the examination space and enables more data integrations. In 2013, Cardiac Science sold its diagnostic cardiology product line to Mortara Instrument, including the Burdick and Quinton brands.
Holter monitoring system is another segment expected to gain significant market share due to the fact that the system assists in identifying arrhythmias that takes place during certain activities such as exercise, stress, bowel movements, sleep, eating, and stress.
In March 2015, Philips launched Effica ECG100, which is a cost-effective cardiograph that improves patient care and also reduces the cost. Such kinds of technological advancements are leading to market growth.
2M Engineering Ltd. launched the VitaMove 2S ExG movement and ECG recorder, which is equipped with 3-lead ECG Holter that combines daily activities with heart rate events/trends, ECG, and derivatives such as heart rate variability (HRV).
With major industry players situated in North America, the innovations and upgrading rates are higher as compared to other regions. In August 2015, InfoBionic along with Safeguard Scientists raised USD 8 million to commercialize Mome Kardia - a remote patient monitoring system based on cloud technology that could be worn around the neck.
Data integration - with computers, smartphones, or tablets - has led to product innovation in preventive care, both for doctors and patients.
GE introduced its Muse system and Mac 2000 resting ECG system at the American College of Cardiology (ACC) 2014 meeting. Through its i2 ECG Connect interface, Muse enables integration of ECG data from devices manufactured by Philips, Mortara, Nihon Kohden, Edan, and Schiller.
As interoperability becomes a priority with most healthcare systems, ECG manufacturers have started to partner with ECG management, CVIS, and EMR vendors to develop better interoperability. An example of this includes Philips Healthcare and ScImage Inc. creating an integration option between ScImage's PicomEnterprise CVIS and the Philips PageWriter TC series ECGs. Another is Cerner partnering with Mortara Instrument to introduce CareAware waveform management earlier this year. The system displays waveforms and other physiological data from patient monitoring systems and integrates them into the EMR.
Industry players are constantly fueling the market with newer technologies or upgrading existing technology. In May 2015, CardioComm Solutions, Inc. launched HeartCheck pen. This Bluetooth wireless connectivity pen could be connected for data acquisition with Android and Apple smartphones.
Apart from technology innovations, many industry players are also expanding their global presence by signing distribution agreements with domestic distributors. In October 2015, iNeedMD Holdings, Inc. signed a distribution agreement with Clifton Africa Ltd. This one-year distribution agreement is worth USD 1.5 million.
The resting ECG has been used as a basic cardiac diagnostic for a century, and while the premise remains the same, testing systems are evolving to meet today's technology demands. There has been a trend over the past decade toward smaller, more compact, mobile ECG monitoring systems. These can be used either inside a hospital, clinic, or on the road with a visiting nurse or on a cart for mobility between patient rooms. Another innovation offered by several vendors includes small box systems that connect via a USB to convert a standard PC or tablet computer into a resting ECG system.
Automation for diagnosis and anatomical detection. ECG interpretation algorithms now come standard on many systems. These use gender- and age-specific criteria to provide a virtual second opinion for resting ECG interpretation. This includes ST segment elevation myocardial infarction (STEMI) detection and diagnostic aids to provide interpretation of rhythm and morphology for a variety of patient populations. Some systems include critical values, ST maps, and culprit artery identification. Some systems have anatomical interfaces to help reduce improper lead placement or detection systems for the presence of a pacemaker.
Workflow improvements. ECG systems have been simplified to ease workflow. Examples of this include simplified step-by-step operation, introduction of touch-screen systems, and better connectivity with ECG management systems, electronic medical records (EMRs), and cardiovascular information systems (CVIS). The interoperability component will become increasingly important, as healthcare reforms and meaningful use requirements for information technology (IT) systems call for tight integration and easy interoperability to enable paperless healthcare and free flow of all patient data among departments, hospitals, and referring physicians. A major roadblock to interoperability has been that older-generation ECG systems were not built using proprietary software and the fact that there is no standard format for waveforms. Vendors are now addressing these issues and creating systems with more open IT standards to enable easier integration, even into software systems produced by other vendors.
Need to standardize ECG formats. Unlike medical imaging and data that have standardized on DICOM and HL7 formats, there is no standard format for ECG waveforms. The result is an array of file formats for ECGs, including DICOM, XML, TIFF, JPEG, GDT, PDF, ZIP, UNIPRO, DVD, and others. The variety of formats may cause interoperability issues when attempting to save ECGs to a CVIS, or if attempting to data-mine patient information for ECG reports saved as JPEGs. The bidirectional transmission options for ECGs also come in a variety of interfaces, including USB, internal modem, GSM/GPRS mobile, LAN, or WLAN. Some vendors now offer wireless ECG acquisition, so patients no longer need to be tethered to the ECG system. Departments will want to address these formats and transmission options with a vendor ahead of installation to ensure the waveforms generated by the ECG systems can be transferred into the cardiology department's ECG management system and/or CVIS. This data should in turn be easily shared in a usable format with the hospital EMR.
Remote access. One advantage of paperless ECG review through an electronic ECG management system is the ability to access ECGs and enable remote viewing and reporting outside of the traditional workstation. Most modern CVIS offer remote, anywhere Web-based access to the ECG management system. This functionality includes access to ECGs and fully enabled reporting functions at home or anywhere in the hospital or clinics where a cardiologist finds some time to read cases.
In addition to improved physician workflow, remote access and mobile device access to dynamic waveforms is a trend to enable faster reads on suspected STEMI cases. Immediate reads on mobile devices can help enable lower door-to-balloon times for heart attack patients with earlier cath lab activation times.
While the traditional 12-lead ECG system will remain a mainstay in cardiac diagnostics in the clinical or hospital setting, the future of cardiac assessment may shift to patients triaging themselves before requiring analysis by these more complex systems. There is a trend in the Holter monitoring and consumer markets toward inexpensive wearable or smartphone-based ECG monitors.
Unlike traditional Holter and cardiac event recorders, the new-generation devices are inexpensive or even disposable, and are much easier to use - with the elimination of electrode wires, devices are simply stuck on the patient's chest.
Some new devices interface with cell phones to eliminate the need for an external base station hardwired in the patient's home. These devices - combined with consumer-grade, app-based ECG monitors that interface directly with a patient's smartphone - will likely result in widespread expansion of basic ECG monitoring and represent a novel method for patient engagement in cardiology.
IT systems that currently handle ECG management may need to include ways to record data from these types of remote devices to include in a patient's EMR. This may be required to meet future patient engagement, remote monitoring, and other mandated health IT interoperability standards to enable full reimbursement from insurance providers.