This is the third consecutive increase after a period of decline. Technological improvements and national guidelines on stent usage (like the NICE appraisal in the UK) suggest cardiologists have progressively reached consensus about a more effective use of coronary DES therapies. However, pricing issues (including different reimbursement mechanisms both from country to country and within countries), combined with residual safety concerns, are factors detrimental to a wider DES penetration into the European market.
The number of percutaneous transluminal coronary angioplasty (PTCA) procedures performed in Western and Central Europe increased to 230,800 (+3.2% over the previous quarter; +1.6% compared to the same time-frame one year earlier). As a consequence, the DES market size increased by approximately 5% to the 138,000-unit level, driving a turnover of $214m.
Germany was the largest European market for stent units in the second quarter. Italy and France were the second and the third largest markets respectively. Germany, Italy and France together accounted for 55.9% of the overall DES market. However, considering turnover data alone, the table is upturned: Italy was the largest European market (with a turnover worth over $66m), followed by France and Germany. This is due to the price composition and different DES penetration levels in these three countries. Italy, France and Germany together accounted for 55.6% of the overall DES market in Europe in terms of dollar value.
Together with the Netherlands (+1.7%) and Switzerland (+1.5%), Germany and France set the most pronounced DES penetration rise in the second quarter, both with +2.1% variation over the previous quarter. UK and Norway DES penetration also increased in Q2, albeit at a conservative rate.
Moving into Central Europe, Czech Republic, Hungary and Poland confirmed their slow but constant growth trends and recorded a 0.7% increase on average in their DES penetration. On the other hand, Greece, Denmark and Sweden all decreased their DES penetration level.
DES prices dropped by an average of 3.6% in the second quarter of the year. However, the strong Euro and weak Dollar ensure that prices for DES continue to stabilise or slightly increase in dollar value, when in reality prices are dropping in almost all countries. Differential pricing across Europe is also a notable issue, as differences can reach as much as 80% of the device’s value in same cases: this cannot be explained in the light of reimbursement mechanisms and volume of procedures only. Interestingly, Italy is the European country with the highest price gap within its domestic market.
Rigid budget limits set by public health systems in France and in Italy these countries, Italy in particular, mean that this trend is set to continue. The report highlights that the price policy will be one the key elements to understand both market share shifts and increase in price gap within the DES market throughout the end of this year and the first quarter of 2009.
Bare Metal Stents (BMS) – BMS penetration rate is at 52.4% in Western & Central Europe. The market size for BMS increased by 1.4% and now has settled around the 150,000-unit level, equal to $94m worth. Drop in BMS penetration rate across Europe can be explained in the light of the faster DES increase in clinical practice in the second quarter. BMS prices were stable over the past quarter, although, once again, the unfavourable euro/dollar exchange rate determined an increase in BMS price of approximately 4%. This fact, combined with discounts applied by many manufacturers on DES devices, has been progressively reducing the price gap between BMS and DES (the original ratio 1:3 has now moved to 1:2.5 or below).
Balloons – Balloon usage was around 289,000 in the second quarter 2008.
Guidewires – Guideware usage was at 414,000-unit level in the second quarter 2008.
Guiding Catheters – Guide catheter units increased to 395,000 units in the second quarter 2008