Global TAVR procedures are evolving with around $4B market size at present and continuous evolution expected in upcoming years estimated to reach $7B by 2024 mainly driven by indication expansion (low risk approval), therapy awareness and technology advances. Despite this evolution, diagnosis and treatment rates of Aortic Stenosis(AS) remain low with majority of underserved AS population coming by over 70 years old patient population. (source: Edwards Lifesciences Investor Presentation November 2020). 

At the same time, PARTNER 3 TAVR results have shown significant clinical superiority of TAVR treatment vs Conventional Surgery in areas such as hospitalization that has decreased from 7 days to 3, discharge to home and self-care that has increased from 73.1% to 96% and rehospitalization for Heart Failure in one year that has decreased from 3.6% after Conventional Surgery to 1.4% to TAVR patient group.

Another series of robust clinical application and results have been published lately by US registry. Key findings include that only in US, TAVR volume has increased around 23% with 72,991 procedures done in 2019 vs 59,168 done in 2018. Some other important indicators include that for first time TAVR volume exceeded all forms of SAVR (57,626) and it is performed in 715 sites and all 50 states. (STS-ACC TVT registry of Transcatheter Aortic Valve Replacement Journal of the Americal College of Cardiology Vol 76, No 21 ,2020).

Some other key considerations coming by the US study registry include the use of Balloon Expandable Valves in 72.3% of the cases while 26.7% were self- expandable and 1% the mechanically expanded valves. For V-in-V TAVR, 53.3% were self-expanding valves, 46.6% balloon expandable valves and 0.2% were mechanically expanded valves.

Having said that, clinical data published by JAMA Cardiology on September were further supporting that a balanced and optimized TAVR hospital program, offering both balloon expandable and self-expandable valve options, respecting individual patient anatomy and unique characteristics, is the way moving forward and most likely the best approach for optimal TAVR clinical benefits at present.(Considerations for Optimal Device Selection in Transcatheter Aortic Valve Replacement A Review JAMA Cardiol. Published online September 9, 2020. doi:10.1001/jamacardio.2020.3682)

Looking to a specific part of Europe, South Europe, TAVR continues to be underpenetrated taking as an indicator TAVR procedures per million in 65+ years of age population with Italy being in 514, Spain in 354 and Greece just 273 compared to the most penetrated markets in Europe such as Germany with 1245 followed by Switzerland with 1107 and France with 973.

Going deeper in South Europe by analyzing Greece, key highlights of Greek TAVR 2020 market include:

Ø Total 2020 market has reached around 712 implants in 19 centers growing 10.3% in implanted units vs last year despite coronavirus lockdown effects in most of the hospitals, landing around 11M€ in sales ,almost same number like last year due to average end user market price erosion observed in some accounts .

Ø Prerequisite of patient approval from Central committee of HealthCare System from a committee consist of 7 Interventional Cardiologists and 4 Cardiac Surgeons before implant is still a decisive therapy approval and market access factor.

Ø Official Reimbursement is 18.150 Euros for TAVR devices while the average market price is around 15.3K Euros. Important note is that lower market prices include Value Based Healthcare agreements that include Volumes, Favorable payment terms and overall collaboration of certain hospitals and hospital Groups with Medical Device Manufacturers.

Ø Medtronic (MDT) is by far the dominant medical device company in TAVR segment in Greece with 65.3 % market share in implanted units and 10.2% growth in units over prior year (PY) with presence in all active centers. Practically the MDT team locally, has managed to grow at exactly the same rate of the market and in this respect, they have maintained and protected their overall outstanding market share vs last year. Another important consideration is the fact that MDT clinical team has demonstrated and established a significant clinical advantage with a track record of much higher annual number of treated patients for a number of years in HCPs eyes vs competitive devices locally.

Ø Edwards Lifesciences (EW) is going south (-13.2%) vs PY loosing 3pps in market share which is now 11.1% in implanted units in 9 hospitals out of which 68% coming from one hospital, while at the same time is keeping its premium price discipline, being 7% higher than the average market price. EW locally is paying the bill of weak Value-Based Healthcare Strategies vs Competitors in major implanting centers. This is one of the key elements among others that drive self-expanding valve only programs in many centers , something that is directly opposite with what is happening at present in Western World in average where both balloon expandable and self expandable valves are present in an optimized program, with most obvious example the US 2019 Registry and other publications mentioned above.

Ø Abbott (ABT) is growing 37% vs last year gaining 2+ppc in market share landing to 10.8% in implants in 8 hospitals, with 84% of the implants coming from 3 hospitals. ABT has also managed to keep their average price just over the average market price with good management of account mix.

Ø Boston Scientific (BSX) has managed to absorb global product recall issues with Lotus and grow 5.2% in implants vs PY, maintaining a market share of 11.4% in 10 accounts (-0.5 pps vs PY) with 63% of the implants coming from 3 accounts. Main drivers of this result include aggressive price positioning below average market prices and robust clinical team approach, change of focus out of Lotus.

Ø Last, we have a new entrance in Balloon Expandable segment, Meril’s Myval from India that has started a limited launch in Greek market with aggressive pricing positioning in one center in Northern Greece and 10 implants reaching 1.4% in market share in 2020.

Ø 19 centers have used TAVR devices in Greece, out of which 1 center is doing more than 170 TAVR procedures annually, 3 centers are doing more than 80 procedures, 1 more than 65 and another 2 more than 40. On the other side, there are 7 hospitals that are doing less than 10 implants and they have either abandoned the programs within the year becoming inactive or struggling to keep it active and due to this, shifting of patient population to other higher volume centers in the region is observed.

Ø Another indicator worth mentioned is the fact that the first 5 centers doing more than 65 implants represent around 70% of the market in implants.

Ø Market ecosystem has stabilized. Hospital Payments have been improved both in public hospitals and private centers with few exemptions that need close monitoring.

Ø In terms of Local strategy and Tactics and Value-Based Healthcare execution tactics ,  MDT and ABT continue to be the most active, offering bundling product packages in many private centers trying to get advantage of private centers consolidation which is still evolving with US funding vehicles(CVC Capital Partners) to be the most active in the sector. In other news, BSX has faced some restructuring late Q42020 in Upper Management and the impact hasn’t been accessed yet.

Ø Analyzing decision power local schemes, MDT, ABT and BSX have a local decision power for total Structural Heart Portfolio while EW has separated BUs within Structural Heart Portfolio with Regional Managers outside of the country still having the decision power and is it clear that this fact is compromising overall EW company execution and cannot support premium pricing strategy effectively in Structural Heart.

2021    Prediction

Ø Greek TAVR Market is expected to continue evolving within 2021 in double digit close and returning to a 20% growth rate in units since it is clearly underpenetrated with the assumption that Covid19 local vaccination will accelerate in Q2 as anticipated .

Ø The consolidation of TAVR centers is expected to continue and 10-12 centers will have an active program by the end of 2021 with 25-30 procedures annually to be the lowest procedure limit.

Ø Ministry of Health leadership is in the process establishing favorable Ecosystem and processes for Medtech’s technology innovation and disruption to occur in a faster pace for the benefit of patients and Healthcare system at the end and this will definitely affect both TAVR as well as TMVR procedures.

Ø Price erosion tactics are expected by new players (Myval) trying to secure a bigger piece of the pie and this factor could compromise market growth in sales revenue to mid to upper end of single digits.

Ø TMTT procedures are expecting to evolve with ABT Mitraclip, Triclip, EW Pascal in Mitral and Tricuspid, Neochord and Cardiac Dimensions Carillon system existing in the market in repair, EW’s Harpoon expected to come and ABT’s Tendyne first implants expected to be scheduled within first half of 2021 . This fact will further push the Helathcare budget for Transcatheter Valve Technologies moving forward.

Ø Healthcare System Annual Budget spending stabilization in Transcatheter segment and Innovative Technologies should be expected sooner or later making further adoption more predictable .

(source: Hospital unofficial registries, Local congress presentations, industry data, Company’s Investor presentations ,confidence data level greater than 98%)