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U.S. Congestive Heart Failure Device Markets
Frost & Sullivan, March 2006
This Frost & Sullivan research service entitled U.S. Congestive Heart Failure Device Markets provides an overview of alternate treatment options in the U.S. markets for the treatment of CHF along with a complete analysis of key market drivers, restraints, and trends. In this research service, Frost & Sullivans expert analysts thoroughly examine the U.S cardiac resynchronization therapy (CRT) and ventricular assist devices (VAD) markets.
Market Sectors
Expert Frost & Sullivan analysts thoroughly examine the following market sectors in this research:
- Cardiac resynchronization therapy (CRT) market
- Ventricular assist devices (VAD) market
Market Overview
Congestive Heart Failure Devices to face Stiff Competition from Drug Industry
The acceptance and usage of congestive heart failure (CHF) devices when compared to drugs have been relatively slow over the past few years. In addition to drug therapy, less-invasive procedures such as mitral valve repair and ventricular restoration pose a challenge to CHF device manufacturers. However, even with intensive pharmacological and lifestyle therapy, the mortality rate due to CHF remains high. Considering the heavy investment in scientific research as well as the direct and indirect costs of therapy and workdays associated with CHF, device manufacturers now have the ideal opportunity to offer alternative treatment methods.
The majority of the revenue potential is in some of the niche areas, especially the end-user segment favoring the drug industry. 'A combination of device and drug is expected to pave the way for a slow but steady progress into this domain,' explains the analyst of this research service. 'The company that taps into this market segment successfully is more likely to establish a greater stronghold in the CHF market due to the immense popularity of drugs, combined with the technological strength of mechanical devices.'
Timely FDA Approvals Essential to Remain Competitive
Competition is on the rise in the U.S. CHF devices markets and manufacturers need to have strong marketing and sales strategies in place to succeed in this field. Already, a large number of devices are in the pipeline and at various stages of development or are awaiting approval from the U.S. Food and Drug Administration (FDA). 'CHF device vendors compete for every resource that is likely to boost sales once their devices are approved by the FDA, whether it is high-profile clinical trials or publicized endorsements by expert cardiologists supervising them,' says the analyst.
Gaining quick and timely FDA approval is proving to be a strong challenge for CHF device manufacturers due to stricter regulations and safety standards. While delay in market entry is a significant issue, the long-term success of a device hinges on superior performance, safety features, and end-user confidence. Popularity of large-base clinical trials such as the SCD-HeFT, CARE-HF, COMPANION, and MIRACLE series are playing an important role in establishing the relevance and efficacy of devices in CHF treatment. The proven benefits of various devices such as biventricular pacemakers and implantable cardioverter defibrillators (collectively, cardiac resynchronization therapy) are also likely to increase prescription support for CHF devices.
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