While vendors are responding to the changing lifestyle and environment with constant technology upgradation, it is the government which needs to step in and make this lifesaving device more easily available.
Defibrillators are devices used to deliver therapeutic shock to a patient's heart in life-threatening conditions, such as ventricular fibrillation, cardiac arrhythmia, and pulseless ventricular tachycardia. The defibrillation procedure encompasses delivery of an electric shock to the heart, which depolarizes heart muscles and restores its normal electric impulse. Growing focus toward public access defibrillator (PAD) by the public and private organizations, along with the key players, has fuelled the market growth. Other factors such as technologically advanced defibrillator devices, rapidly growing geriatric population with elevated risk of targeted diseases, and increasing incidences of cardiac diseases are driving the market growth. However, frequent product recalls, increasing pricing pressure on players, and lack of awareness about sudden cardiac arrest (SCA) are restraining the growth of this market.
Indian Market Dynamics
The Indian market for defibrillators in 2015 was valued at 7500 units, at Rs.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, unlike in 2014 and 2013, 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 saw orders from the government from Rajasthan, Chattisgarh, PGI-Chandigarh, West Bengal 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.
The global defibrillators market is expected to reach USD 15.75 billion by 2020 from USD 10.01 billion in 2016, at a CAGR of 6.8 percent between 2016 and 2020.
By products, the defibrillators market is segmented into implantable cardioverter defibrillators (ICDs) and external defibrillators. The ICDs segment is further divided into transvenous implantable cardioverter defibrillators (T-ICDs) and subcutaneous implantable cardioverter defibrillators (S-ICDs). The T-ICDs segment is further classified into single-chamber ICDs, dual-chamber ICDs, and cardiac resynchronization therapy defibrillators (CRT-Ds). The external defibrillators segment is categorized into manual external defibrillators, automated external defibrillators (AEDs), and wearable cardioverter defibrillators (WCDs). The AEDs segment is further divided into semi-automated external defibrillators and fully automated external defibrillators.
Implantable cardioverter defibrillators are expected to report revenue of over USD 8 billion by 2020 due to enhancement in the technology and reduced number of sudden deaths. External defibrillators are expected to report a CAGR of 7.1 percent due to new software and smaller implant development. Ilesto DX, a product offered by Biotronik is first of its kind, allowing complete atrial diagnosis with a single defibrillator lead. Homecare and public access market together are expected to register lucrative growth with revenue over 1.1 billion by 2020. Faster treatment availability and reduced hospital visits are the principal drivers for market development.
The North American region is anticipated to contribute over 35 percent of revenue in 2020. Asia-Pacific region is projected to reach over USD 3.5 billion by registering lucrative growth throughout the forecast period. The growth is attributed to the larger untapped opportunities, rising healthcare expenditure, augmenting disease prevalence rate, and supportive government initiatives and concession.
Key players operating in the global defibrillators market include Asahi Kasei Corporation, Stryker Corporation, Biotronik SE & Co. KG, Boston Scientific Corporation, Philips Healthcare, LivaNova PLC, Medtronic plc, Cardiac Science Corporation, Nihon Kohden Corporation, and St. Jude Medical, Inc.
The development of technologically advanced defibrillators, rapid growth in the aging population with high risk of target diseases, growing focus of public and private organizations and key market players toward public access defibrillation, and increasing number of training and awareness programs across the globe will majorly drive the defibrillators market.
Rising work-related stress and exposure to harmful chemicals such as carbon monoxide, lead, arsenic, and unhealthy lifestyle habits are vital causes triggering cardiac diseases. Lack of availability of prompt treatment in case of SCA is another important factor promoting the growth.
Strategic initiatives by healthcare federal bodies such as the distribution and widespread access to AEDs in public buildings and spaces further propel the growth of the market.
There have been several recent advancements in defibrillator technology to extend battery life, improvements in patient monitoring to avoid needless shocks, the introduction of quadripolar lead devices to improve device programming and to improve therapy effectiveness, and development of magnetic resonance imaging (MRI)-safe ICDs.
Several newer ICDs offer pacing functions, and many vendors offer wireless remote monitoring/interrogation of the device data with bedside sending units so patients do not need to come in for regular office visits.
Traditionally, patients with ICDs were unable to undergo MR exams, and underwent CT, cardiac catheterization, EKG, and X-ray exams instead. According to data from the University of California, Los Angeles, out of the more than 200,000 patients who have an ICD implanted per year, about 75 percent of them will have a medical situation in their lifetime that may benefit from MR.
Therefore, those patients whose physicians did not wish to entertain the presumed risks of MR with a defibrillator did not have the opportunity of having this superior diagnostic information that in turn could lead to a change in therapy and management.
But MR-compatible ICDs made out of non-ferrous materials have recently come to the market. In September 2015, Medtronic received FDA approval for its Evera MRI SureScan ICD System. In December 2015, Biotronik's Iperia ICD system won approval to be used during MR exams. Many studies have investigated the safety of using these devices during MR exams, but no one had investigated the value that MR brings to patients with ICDs.
Biederman and fellow researchers at AGH decided to pioneer research in this area. They evaluated 157 patients who were placed in one of three implantable cardiac device case groups. There were 114 patients put into the neurological group, 36 in the cardiovascular group and seven in the musculoskeletal group. In 88 percent of the neurology cases, MR provided value for the final diagnoses, and in 18 percent of the cases MR exam altered the diagnoses entirely. For the cardiac and musculoskeletal cases, the extra value percentage was even higher at 92 and 100 percent, respectively.
"There was a marked incremental value to perform the MR," says Biederman, "We knew that just because we could do the MR, didn't mean it was the right thing to do. In this case, however, we redirected appropriate care in a high-risk population comprising patients with neurosurgical, orthopedic, and cardiac pathologies." In late March, Biederman was referred to a patient at AGH who was believed to have had cardiac sarcoidosis for 15 years. One of the cardiologists at the hospital decided to have the patient, who had an ICD, undergo an MR exam, so they imaged his heart and found that he did not have the condition.
"In most cases, that information couldn't be obtained with cardiac catheterization, echo, or nuclear, so the MR added real value. Additionally, the patient did not have to have an open-heart-procedure or a biopsy of the heart muscle and [have the patient face] all of the attendant risks," says Biederman.
The key implantable cardioverter defibrillator manufacturing companies include Boston Scientific Corporation, Imricor Medical Systems, Inc., LivaNova PLC, Mayo Clinic US, Medtronic plc, MicroPort Scientific Corporation, MRI Interventions, Inc., and St. Jude Medical, Inc.
Longer Battery Life Needed
The lithium battery in ICDs can last up to seven years, according to the Mayo Clinic. But an article published by the academic research website British Medical Journal in February stated that battery life needs to be extended to 25 years or more to avoid the risks associated with replacement. The risk of infection associated with replacing ICD batteries ranges from 1 to 5 percent, but that may be incorrect because there is no standard definition for what an infection is.
In February 2016, Medtronic received FDA approval for the first and only MR-compatible CRT-Ds for treating heart failure. The Amplia MRI Quad CRT-D SureScan and Compia MRI Quad CRT-D SureScan systems are both approved for MR scans.
CRT-Ds were previously not recommended by the FDA to be used during MR exams because of the potential interaction between the MR and the device that could put the patient at risk. In addition, CMS does not provide coverage for MR exams conducted on patients with non-MR-compatible implanted cardiac devices. The CRT-Ds have the same functionality as ICDs, but also have the ability to pace both sides of the heart. It is used in patients when their heart contractions are out of sync.
AEDs at Sporting Events
Sudden cardiac death accounts for about 100 to 150 deaths per year at sporting events, according to the American Heart Association. Because of that, AEDs are becoming more prevalent at these events. The majority of athletes who suffer sudden cardiac arrest on the field show no warning symptoms. Because of that, it is important that people know how to react if a cardiac event occurs and how to operate the AED equipment on-site.
Having a defibrillator nearby, and in places where people are engaged in vigorous activity, is an essential part of the chain of survival.
Patients with sudden cardiac arrest are traditionally treated with transvenous ICDs, but another option was introduced to the market when Boston Scientific received FDA approval for its subcutaneous ICD (S-ICD) systems in 2012, which are essentially leadless ICDs. Boston Scientific scored approval for its second-generation S-ICD system, the EMBLEM S-ICD System, in March 2015.
The new generation is 20 percent thinner and is expected to last 40 percent longer than the previous system, but it is not MR compatible. S-ICDs utilize a pulse generator and electrode beneath the skin, instead of having a lead run through blood vessels. During the procedures, a shocking coil is implanted in the area under the left arm and tunneled through the soft tissues of the body.
However, one of the downsides of S-ICDs is that they do not have some of the functionalities that regular ICDs have. For example, ICDs are able to pace patients out of bad heart rhythms, but the current generation of S-ICDs cannot do that because they do not have a lead that is enough in contact with the heart.
Medtronic is currently working on a new S-ICD that will still be placed outside of the vasculature and have all of the advantages of the current S-ICD, but will also be able to pace the patient's heart out of a bad rhythm. It is not, however, intended to be MR compatible.
The wearable defibrillator is included in the 2015 European Society of Cardiology guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death and has received formal recommendations in the 2016 American Heart Association science advisory for the wearable cardioverter defibrillator, with endorsement from the Heart Rhythm Society. On any given day, tens of thousands of people around the world are protected from sudden cardiac death (SCD) by the LifeVest wearable defibrillator.
The LifeVest is used for a wide range of patient conditions or situations, including following a myocardial infarction, before or after coronary revascularization, and for those with cardiomyopathy or congestive heart failure that places them at particular risk. The LifeVest gives physicians time to optimize medical therapy and assess a patient's long-term risk for sudden death.
Even after 15 years of continuous research and studies, the S-ICD technology is still evolving and the EMBLEM S-ICD represents one of its most recent advances. However, future research and design improvements are still required to address various aspects. For example, a pediatric model of the S-ICD to be used in small children (e.g., <8 years, <30 kg) may be an alternative option in the future.
At least theoretically, subcutaneous defibrillation would require lower energies in these subjects due to their small cardiac mass and transthoracic impedance, and thus, a smaller pediatric model of the S-ICD with lower energy might be feasible. Ongoing improvements in detection algorithms, as with the recent algorithm to avoid TWOS, should further improve S-ICD performance and reduce inappropriate therapies. The possibility of simultaneously analyzing three, rather than one, available sensing vectors to define the rhythm status might be an advantageous feature to be considered and developed in the future.
Finally, the integration of the S-ICD system with leadless pacing, if proved feasible, could play an important role in defibrillation technology, enabling the expansion of the less-invasive S-ICD therapy to a larger cohort of ICD population.