shcri.com - Revenue from the global cardiac rhythm management market, consisting of pacemaker (NYSE:PM), implantable Cardioverter-defibrillator (NYSE:ICD), cardiac resynchronization pacemaker (CRT-P) and cardiac resynchronization therapy defibrillator (CRT-D) devices, is forecast to increase at a compound annual growth rate of 4.6% from $10.9 billion in 2012 to over $15.7 billion by 2020, according to Cardiac Rhythm Management - Global Analysis and Market Forecasts.
This growth will come as a result of increasing incidences of arrhythmia and heart failure in global populations, combined with rising market penetration of pacing and pulse generator technology in the Asia-Pacific and South American regions. Programs supporting this type of therapy are increasingly desirable as the global occurrence of cardiac dyssynchrony continues to rise; it is estimated roughly 1% of the population suffers from an irregular heartbeat, although pervasiveness rises to over 20% in elderly people. While tachycardia and bradycardia are the most common indications for treatment, heart failure, diabetes, and obesity can contribute to ongoing rhythm management concerns. Cardiac Rhythm Management - Global Analysis and Market Forecasts
The extremely competitive CRM market is dominated by several key players, who must continue to innovate in the face of mounting pricing pressure and strict regulation as they battle to gain market share.
New technologies being developed, including leadless pacemakers and energy harvesting generators, promise to heighten products sales and new account openings, while industry standards continue to develop in regards to remote home monitoring and rate-adaptive therapy. Ongoing studies investigating applicability and appropriateness of varying rhythm management modalities are expected to further clarify suitable device indications and therapy best-practices, while advances in diagnostics as well as adjunctive therapy will assure better patient outcomes and shorter hospital stays in future years.
Key Drivers during the Forecast Period
• Growing incidences of arrhythmia and heart failure
• Heightened adoption rates in emerging markets
• New advancements in leadless devices and energy harvesting technology
• Increased emphasis on early intervention and primary prevention
• Strong CRM program adoption in hospitals, resulting in new account openings
Key Barriers during the Forecast Period
• High-costing devices to hinder CRM adoption
• Lacking reimbursement expected to limit market expansion and hospital product offerings
• Intense CRM market competition with limited innovation on the horizon
Biventricular Therapy on the Rise as Devices Approved -Cardiac Rhythm Management - Global Analysis and Market Forecasts
Newly developed biventricular CRT-P and CRT-D devices are expected to undergo significant market adoption in the coming years as physician adoption increases, additional patient outcomes are published, and average selling price declines. Furthermore, as more centers develop their CRT offerings, hospitals will be looking to implement new programs for advanced CRM, to enable their physicians to begin implanting the devices.
Despite higher prices when compared with single-chamber pacemakers, dual-chamber and biventricular CRT-P products have experienced notable rises in procedure volumes, driving growth in total sale revenue from these market segments.
Currently, dual-chamber devices account for the largest segment of the CRM market, although CRT is experiencing adoption rates similar to what dual-chamber devices did several years ago.
Given improved efficacy, better outcomes and physician partiality, these next-generation devices have expanded considerably beyond the mature US and EU markets, seeking additional markets in developing countries. As CRM sales in emerging markets gain momentum, companies are placing appreciable emphasis on international distribution and global expansion to keep pace with industry progression.
Significant Growth in Target Population - Cardiac Rhythm Management - Global Analysis and Market Forecasts
The population requiring CRM therapy continues to grow, due to increasing prevalence of serious risk factors, including obesity, diabetes, hypertension, and congestive heart failure. According to a 2013 briefing published by the World Health Organization, over 1 billion people suffer from hypertension worldwide, which is a major cause of congestive heart failure, a condition common in over 25 million people (WHO, 2013). Similarly, the International Diabetes Federation states an estimated 285 million people had diabetes in 2010, which is predicted to increase to 438 million by 2030 (International Diabetes Federation, 2013). Additionally, the global obesity population is increasing at a rapid, uncontrolled rate. Lifestyle factors, including tobacco, alcohol and caffeine intake, can also greatly increase the risk of arrhythmias. - Cardiac Rhythm Management - Global Analysis and Market Forecasts
With limited pharmacotherapy to treat dyssynchrony, CRM devices are expected to remain the go-to option for patients with rhythm management concerns.
Emerging Market Adoption to Increase Sales - Cardiac Rhythm Management - Global Analysis and Market Forecasts
As the US and EU markets reach a point of maturation, companies are forced to turn to emerging markets for revenue growth. In particular, Japan has experienced significant CRM adoption in the past 10 years, and more recently China, Brazil and India have initiated many new programs. These emerging markets offer significant potential for companies able to establish distribution channels in the region; however, lacking reimbursement and low costs of living will provide intense pricing pressure for market entrants. With limited financial resources available, current devices are largely unaffordable in these developing countries, and significant price reductions are expected in the coming years as manufacturing operations improve and distribution becomes more global.
In response to significant cost-concerns, many companies are developing value-tier platforms, which would enable the sale of lower-costing devices. As physician use and adoption continues to increase in these regions, significant market expansion is expected.
Primary Prevention on the Rise Globally - Cardiac Rhythm Management - Global Analysis and Market Forecasts
Traditionally, the majority of implantable Cardioverter-defibrillators implanted have been implanted for secondary prevention indications; however, this is slowly changing. As mature markets undergo a paradigm shift in treatment, the percentage of primary prevention cases continues to rise; nearly 70% of ICDs implanted in the US in 2012 were for primary prevention indications. This trend has been slow to spread to developing countries, though, and currently only 14% of ICDs implanted in India are for primary indications. A similar situation remains in China and Brazil. As treatment schedules evolve, CRM companies will have an ever-growing opportunity to sell their products for primary prevention indications.
Device Innovation Expected to Drive Sales - Cardiac Rhythm Management - Global Analysis and Market Forecasts
While advancements in device algorithms and rate-adaptive programming, as well as reductions in size and weight, have all distinguished various brands on the market to date, these technological advancements have largely been unaffordable in emerging markets, and offer limited patient outcome improvements from brand to brand.
However, the introduction of remote home monitoring to emerging markets promises to dramatically change treatment. Home monitoring telemetry will decrease the number of patient hospital visits, a particularly attractive feature for customers living in remote regions far from access to healthcare. Furthermore, advances in leadless and energy harvesting technology are expected to be revolutionary to the CRM industry, especially in the US and EU. Through eliminating the need for lead replacement and, especially, generator battery replacement, manufacturers hope to boost device sales in younger and more remote populations, who are reluctant to receive a new device that requires substitution every seven to 12 years.