Defibrillators and the treatment of sudden cardiac arrest have come a long way in the recent years, from big bulky devices confined to the hospitals, to smarter and smaller technology at home. With technology constantly getting smaller and more powerful, lightweight and user-friendly public access defibrillators or automated external defibrillators have made their way to the markets. Recommendations for the usage of automated external defibrillators at public places by various cardiology and medical societies have led to an increase in the adoption rate in developed economies.
New cardiovascular device therapies for atrial fibrillation and heart failure are rapidly evolving with the use of innovative materials and new technologies. While new concepts for cardiac technology are not lacking, successful commercialization is a skill that is also required. Companies are inclined toward developing latest technologies that can be used for homecare settings as well as for other end users such as hospitals and emergency medical services.
Advances in technology have allowed the remote transmission of data from cardiac implantable electronic devices (CIED), including permanent pacemakers (PPMs), implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy defibrillators (CRT-Ds). Remote access to device diagnostics has been shown to improve patient safety in comparison to ambulatory conventional monitoring due to earlier detection of arrhythmias or device malfunction.
With improvement in the technology and rise in demand for user-friendly devices, the market for ICD is expected to grow significantly over the next few years. The wearable cardioverter defibrillator (WCDs) market is projected to witness a growth as a temporary alternative or to bridge to a long-term ICD implantation. The new method of creating implantable defibrillators based on light through optogenetics promises a future circumventing the need for an electric shock. The development of optical defibrillators is still in the very early stages and it could be a decade before the technology is used on patients.
One of the major factors favoring growth of the defibrillators market is rise in consumption of tobacco and the increasing number of smokers. Nearly 80 percent of more than 1 billion smokers worldwide live in low- and middle-income countries, where the burden of tobacco-related illness and death is heaviest. Thus, these regions are highly lucrative, yet largely untapped markets, which could provide significant growth potential in the near future.
Indian Market Dynamics
The Indian market for defibrillators in 2015–2016 is valued at 7,500 units, at 99.85 crore. The year saw an increase across all segments, albeit the maximum growth continues to be exhibited by biphasic ones. Monophasic defibrillators are still in demand in smaller cities. The spiraling growth anticipated in the AED segment, will only happen once the government takes a firm decision to make this life-saving device available in all public places, as is happening in the western world.
The prices remained stagnant over 2015–2016, unlike in 2014–2015 and 2013–2014, when they fell appreciably. The discerning buyer is no longer buying a defibrillator by itself; he is opting for one built into the patient monitoring system. The tenders from the government too showed preference for these.
2015–2016 saw orders from the governments of Rajasthan, Chattisgarh, and West Bengal, PGI-Chandigarh, and Tamil Nadu Medical Services Corporation Ltd. (TNMSC). Private procurement included purchases by Apollo, AIIMS, Safdarjung Hospital, Fortis, and Max Group.
Schiller and Philips continue to dominate this segment, with a combined market share in the vicinity of 65 percent. BPL, Mindray, and Nihon Kohden are aggressive in this segment. Zoll, Stryker – earlier Physio Control, GE, Cardiac Science (marketed by AMDL), Nasan, and Metrax are other players.
MRI-Compatible Cardiac Implantable Electronic Devices: Following the FDA approval of the first ICD system approved for use during MRI scans in late 2015, 2016 saw the expansion of additional FDA-approved MRI-conditional CIED and lead systems, additional pacing systems, and some conventional pacing leads approved for MRI use with MRI-compatible devices.
In May 2017, US FDA has granted market clearance for Medtronic's cardiac resynchronization therapy-pacemakers that improve therapy delivery for patients with heart failure. These devices also allow patients to receive MRI scans in either 1.5 or 3 Tesla machines.
In August 2016, Boston Scientific received US FDA approval for the MRI S-ICD system, as well as MR conditional labeling for all previously implanted S-ICD systems. The technology places a pulse generator and electrode just under the skin, leaving the heart and blood vessels untouched and reducing complications associated with conventional ICDs.
Advances in AED: Surge in the demand for AEDs is driving the competition amongst the market leaders and the launch of technologically advanced defibrillators for gaining a competitive edge. AEDs are designed in a way to make them useful to both life-support trained personnel and the general public. Newer AEDs guide the user by either giving signals to the rescuer to deliver shock or the system will automatically deliver the shock. In the next few years, AEDs are expected to change in a few ways, specifically their availability, dimensions, and communication capabilities.
Optogenetics defibrillator: Current treatments for arrhythmia involve administering an intense burst of electricity from a defibrillator in times of cardiac arrest, but these pulses are painful and potentially harmful. The ongoing advancements in optogenetics and research trials in mice and human heart models pave the way to implantable optical defibrillators that provide a gentle and safe alternative to a harsh electric shock. The optogenetics defibrillator can reset a heart arrhythmia using a gentle pulse of light that corrects the arrhythmia slowly instead of the jolting punch used by the electrical shock method.
Quadripolar lead devices: The introduction of quadripolar lead devices is another promising advancement in the field of defibrillators, which in turn would allow more programming operations in pacing and overcoming other issues such as cardiac resynchronization therapy defibrillator (CRT-D). As more patients with cardiac conditions are living longer, the leading market players continue to invest in research and development to bring solutions to the market that improve quality of life for patients.
In April 2017, Abbott launched a new quartet quadripolar left ventricular lead designed for cardiac resynchronization therapy pacemakers and defibrillators. This features a double bend shape that allows for implantation in the most stable position without sacrificing electrical performance.
The pace at which the modern technology is evolving, and investments in R&D for defibrillators are reaching new heights, it will not be too long before these defibrillators reach the pockets of the users. The increasing installations of public access AEDs, growing incidences of cardiovascular diseases, and growing awareness regarding the lifesaving potential of AEDs have fueled the market growth. AEDs are expected to dominate the global defibrillator market with the possibility to shrink to the size of wearable technology. If it is possible to create a smaller version of an AED, at scale, perhaps these lifesaving devices will become more of a commodity for the mainstream market.
With breakthrough advancements in present technologies and new technologies stepping in, the defibrillator market is set to fly high. Development of light-based implantable defibrillators is still a dream to come true over the next 5–10 years. The technology is still nascent and will take time before optical defibrillators see the light of the day.