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Phase-Xs | Biologics & Biosimilars | Coherent Market Insights

Fractional flow reserve (FFR) is a technique used to determine the blood pressure difference across coronary artery stenosis (blockage). FFR is considered as a standard to determine the need for angioplasty. This technique is carried out during the process of angiography and is useful for evaluating the amount of oxygen delivered to the heart due to the stenosis (blockage). Fractional flow reserve can be defined as the pressure after a stenosis, relative to the pressure before the stenosis.

During coronary catheterization, a catheter is inserted into the femoral or radial arteries using a sheath and guidewire. The wire has a sensor on the tip, called as the transducer, which measures the blood pressure, temperature, and flow to determine the severity of the blockage.

Global Fractional Flow Reserve Market Drivers

Leading manufacturers are indulged in the manufacture products for the management of coronary heart disease (CHD). For instance, Phillips launched Instant Wave Free Ratio (iFR) in May 2019, which is the modified version of the currently available FFR in the market. This modified version does not require adenosine which is usually used in FFR for inducing hyperemia in the patients.

Moreover, Heartflow launched a FFR embedded new cardiac CT scanner (FFRCT) in 2014, which allowed patients to skip the invasive testing procedure carried out during cardiac catheterization process. Furthermore, Opsens, Inc. introduced a guide wire with optic sensing technology called “Optowire” in November 2019. In addition, CathWorks, a company based in Japan, received regulatory approval from U.S. FDA for FFRangio, a non-invasive FFR technique in December 2018.

According to the Centers for Disease Control and Prevention (CDC), 2019, coronary heart disease (CHD) resulted in the death of 365, 914 people world-wide in the year 2017. Moreover, according to the same source, world-wide 18.2 million adults over the age of 20 are suffering from CHD, and 2 in 10 deaths occur in people less than 65 years of age. Development of CHD can be attributed to unhealthy lifestyle such as consumption of food with high sodium levels and fat, decrease in physical activity, smoking, alcohol consumption, and others.

For instance, according to the Heart Disease and Stroke Statistics of AHA report, 2016, around15.5 million people in the U.S. had CHD in the year 2016. According to the same source, around 37.5% men and 18.3% women are suffering from CHD. These factors are expected to drive the global fractional flow reserve market growth over the forecast period.

Global Fractional Flow Reserve Market - Restraints

According to the review report of American College of Cardiology (ACC), 2017, FFR is not used by patients, owing to high cost of the guidewire, longer time taken for the FFR procedure, lower availability of adenosine, and use of adenosine as a stressor during the FFR procedure makes some patients uncomfortable.

Moreover, according to the same source, high income regions such as North America and Western Europe frequently use FFR in patients suffering from CHD, while low income regions such as Latin America, Asia Pacific, Middle East, and Africa do not use this technique frequently due to cost effectiveness.

Global Fractional Flow Reserve Market - Regional Analysis

North America is expected to hold the dominant position in the global fractional flow reserve market over the forecast period. Factors such as increasing prevalence of cardiovascular diseases requiring surgical interventions is supporting growth of the market in North America. For instance, according to the National Center for Biotechnology Information (NCBI), 2016, around 15.5 million people in the U.S suffered from CHD. The mortality rate of the patients suffering from CHD is expected to decline due to use of advanced technologies such as FFR in the medical care as U.S is categorized as high income country.

Moreover, according to same source, regions such as Asia Pacific, Middle East, and Latin America show higher incidence of deaths due to CHD as the above regions are categorized as low income regions. According to the World Health Organization (WHO) report 2016, half of the total number of deaths across Europe are caused due to cardiovascular diseases. According to the National Centre for Biotechnology Information (NCBI), 2019, approximately 1,000,000/year cardiac catheterization procedures are performed worldwide. Therefore, introduction of existing as well as new treatment options across North America and Europe is expected to boost the global fractional flow reserve market growth over the forecast period.

Global Fractional Flow Reserve Market - Key Players

Some of the key players operating in the global fractional flow reserve market include Abbott Laboratories, Boston Scientific Corporation, Koninklijke Philips N.V., Opsens Inc., ACIST Medical Systems, Inc., GE Healthcare, Heartflow, Pie Medical Imaging BV, Cathworks Ltd., and Medtronic plc.

Global Fractional Flow Reserve Market - Market Taxonomy

By Product Type

  • Instrument
    • Invasive
    • Non-invasive
  • Accessories

By Technology

  • Fractional Flow Reserve (FFR)
  • Instant Wave Free Ratio (IFR)

By End User  

  • Hospitals
  • Ambulatory Surgical Centre
  • Cardiovascular Clinics

By Region

  • North America
  • Latin America
  • Europe
  • Asia Pacific
  • Middle East
  • Africa
N/A

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