The market

Congestive heart failure is a global endemic disease affecting 26 million people, and the numbers are steadily rising. Organ transplantation is the best possible treatment when a patient suffers from advanced congestive heart failure. The supply of donated organs is however vastly limited compared to the demand. Therefore, there has been development of new medtech solutions in order to treat patients. The products found on the market today are however not optimal for those patients whose entire hearts are weakened, but there is one possibility to dramatically improve a patient’s quality of life with a safer and more user friendly total artificial heart: Realheart TAH.

Congestive heart failure in numbers

The American Heart Association estimates that approximately 6,5 million people older than 20 years suffer from congestive heart failure in the United States. Around one million new cases are diagnosed each year and approximately 75 000 deaths yearly can be directly correlated to congestive heart failure. The prognosis is that 8 million patients will be diagnosed with congestive heart failure by the year 2030.

In Europe, between 7,4 and 14,8 million people are estimated to suffer from congestive heart failure, based partly on the United Nations newly published statistics on populations for the estimated number of citizens in the year 2015, and partly on the occurrence of congestive heart failure which is found in 1 to 2,2% of the population in European countries.

The present TAH market

The present TAH market is dominated by SynCardia, which is the only TAH on the market. Even though the company’s heart pump went through a change in the materials used, the product is basically similar to the one approved by the FDA in 1969. Therefore, SynCardias product is based upon technology from 1969. Use was for many years limited, as insurance companies didn’t approve the cost. However, in 2008, it was decided that SynCardia would be financed at hospitals that performed controlled clinical studies and this led to SynCardia increasing its turnover from 4 to 20 million dollars between 2009 and 2013. The number of implants using SynCardia increased from 63 to 161 during this period. After discussions with physicians, Realheart views that many patients find this product unsatisfactory because of the impaired quality of life it creates, and the physicians therefore stopped using the product.

Even in a conservative market estimate of 16 500 patients in the United States in need of a heart transplant, SynCardia hasn’t penetrated more than 1% of the market.

Product 2015 2016 2021 CAGR% 2016-2021 2026 CAGR% 2021-2026
Heart assist 1 011,4 1 102,6 1 685,0 8,9 2 572,5 8,8
Total artificial heart 18,6 21,4 43,0 15,0 86,5 15,0
Total 1 030,0 1 124,0 1 728,0 9,0 2 659,0 9,0

The global market for heart pumps per product category. Source: BCC Reasearch

Market growth

The number of patients diagnosed with congestive heart failure is estimated to increase, mainly due to increased life span of the population. Also, heart pumps are expected to become a permanent alternative to heart transplants as the technology develops and artificial hearts prologue the expected life span as much as transplants.

Because of an increased knowledge of the use of artificial hearts combined with SynCardias two clinical trials, the present TAH market is estimated to grow by 15% between 2016 and 2026, equivalent to 86,5 million US dollars, which corresponds to 700 artificial hearts. One of the clinical trials aims at broadening the use for the present product to become a permanent solution (destination therapy). The other trial focuses on their smaller heart pump and aims to include younger patients waiting for a heart transplant. Thus, the speed of expansion is based on a product with the same technology as 40 year ago. It is therefor plausible that the market will grow faster when a new and more advanced product is introduced.

Geographic market share

The largest geographical markets for all types of heart pumps is the United States, EU, Japan, Canada, Australia. The U.S. is also the fastest growing market with an estimated GAGR of 9,2% per year until 2026. The Canadian market is estimated to grow at an equivalent rate. The EU, Japan and Australia is estimated to grow at a slower pace, at a GAGR of approximately 7,9 to 8,7%.

Factors that determine market expansion

The market research company BCC Research depicts the following factors as influencial for expansion of the total artificial heart market.
-Trends in the number of heart transplant operations (for “bridge to transplant” applications)
-Trends in the number of patients who need but cannot receive a heart transplant
-The willingness of the insurance companies to cover the application for a permanent treatment (destination therapy).
-Limitations of the number of heart surgeons that have experience of heart pump surgery.

Clients

Clients are mainly the specialist hospitals that perform heart transplants and who already use heart pumps. Initiators are the heart surgeons and the heads of the clinics who make the final decisions as long as the insurance company – and/or state depending on the geographical market – cover the cost. The client base is relatively easy to assess based on available statistics from the transplant networks, conference presentations and published research studies. In the United States, California, Texas and Florida are the states that perform the highest number of heart transplants. An example of a potential customer in California is the Cedar-Sinai in Los Angeles.