When attempting to present and interpret relevant key figures of the German statutory health insurance drug market, its complexity becomes apparent. In contrast to other markets, this one is influenced by political interventions and therefore by numerous regulatory measures. In addition, the supply of medicines to insured persons is subject to the conflicting interests of the players involved in the medicines market. Various instruments are available to them, such as the conclusion of discount contracts or contracts for integrated care. The use of these instruments and the extent of their application ultimately influence market activity and must therefore always be seen in connection with the market data presented.
In the present analysis, only GKV prescriptions for finished medicinal products (excluding preparations) billed in public pharmacies are shown. When interpreting the sales figures, it should also be noted that they are presented without deducting discounts and additional payments.
The GKV pharmaceutical market continues to grow
If you look at the entire GKV finished pharmaceuticals market, more than 6,500 active ingredients and over 26,500 products were available in 2013. With around 688 million prescriptions and sales (according to AVP - pharmacy sales price) of over 33.6 billion euros, the figures for 2013 were significantly above the previous year's level. In addition, a further increase can be expected, as over 410 million packs with a turnover (according to AVP) of 20.8 billion euros were prescribed at the expense of the statutory health insurance up to and including July 2014. In addition to the fact that increasing prescription numbers lead to increasing sales, the prescribed pack size also plays a role. The percentage of the largest prescribed pack size N3 was 46 percent in 2011 and rose to 49 percent in 2013 (source: NVI, INSIGHT Health).
When moving from the overall market level to the active ingredient level, the group of biopharmaceuticals catches the eye. These recorded a sales share (according to AVP) of over 17 percent in 2012 and 2013, while at the same time a low share of prescriptions (2 percent) in the overall market. Among the top 10 active ingredients (according to AVP sales) there are three representatives of this group: adalimumab, interferon beta-1a and etanercept. Increasing prescriptions, sales and high-priced medicines lead to the conclusion that statutory health insurance expenditure in the area of medicines is likely to continue to rise despite numerous instruments to curb the increase in expenditure. However, it should be noted again that discounts are not taken into account in this analysis.
East-West comparison: patent vs. generics
In order to take into account the heterogeneity of the GKV pharmaceutical market, the two market segments of patent-protected and generic active ingredients are examined below. It becomes clear that, in addition to discount agreements, doctors' prescribing behavior has a significant influence on regional healthcare. This prescribing behavior is influenced not least by the information policy of the statutory health insurance associations (cf. Kleinfeld/Luley, in: MVF 02/2014).
When looking at the patent-protected market, clear regional differences can be seen. The market share of patent-protected medicines in the KV Westfalen-Lippe was 4.9 percent in 2013, and in Bremen it was only 4.5 percent. In contrast, the proportion in KV Brandenburg is 7.7 percent and is therefore approximately 1.6 times higher. The examination of the generic market (old originals and generics) shows few regional differences. The market shares according to generic prescriptions for 2013 are between 84.0 percent in the KV Baden-Württemberg and 87.8 percent in the KV North Rhine. In this market segment, the shares of generics are increasing over time in all KV regions (source: regioMA, INSIGHT Health). The figures presented make it clear that a high proportion of prescriptions for patent-protected medicines does not necessarily mean that more old originals are prescribed. Rather, regional differences in the patent-protected market must be considered independently of data on the generic market.
Specialist groups: More prescriptions = more sales?
Different market shares in the market segments described above are based not least on the prescribing behavior of doctors. It is therefore worthwhile to look at the prescription numbers of individual specialist groups in combination with their sales. With a share of over 50 percent in 2013, the group of specialists who prescribe the most prescriptions is that of general practitioners and general practitioners. They are followed by internists with a share of 24 percent of prescriptions, whose sales share of 31 percent (according to AVP) is almost equal to that of general practitioners (35 percent) (source : NVI, INSIGHT Health).
An explanation for the different prescription and sales shares can be found in the ATC classes (Anatomical-Therapeutic-Chemical Classification System) of the prescribed products. In 2013, the ATC1 class “L” (according to EphMRA) of antineoplastic and immunomodulating substances achieved the largest share of sales (according to AVP) at 17.5 percent. The biopharmaceuticals that are considered blockbusters, such as interferons and anti-TNF preparations, are essentially responsible for this (cf. Kleinfeld/Pieloth/Knull, in: MVF 03/2014). ATC1 class “L” biologics are prescribed primarily by internists, almost ten times as often as by general practitioners. Therefore, despite the significantly lower number of prescriptions, the relatively high share of sales generated by internists can be at least partially explained (source: NVI, INSIGHT Health).
In contrast to the antineoplastic and immunomodulating substances, the sales shares of all other top 5 ATC classes are falling compared to 2012 and 2013. The sales decline for the ATC classes “N” (nervous system) and “C” (cardiovascular system) is compared to particularly clear in 2011.
Top player in the pharmaceutical market
Who is behind the billions in sales in the GKV pharmaceutical market? Given the many mergers and dynamic developments of high-selling products, it is difficult to keep track. Here we show the ten pharmaceutical companies with the highest sales in alphabetical order based on the year 2013. Together, they account for around 44 percent of the total GKV sales (according to ApU - selling price for pharmaceutical companies) amounting to 21.2 billion euros. Compared to the previous year, total sales (ApU) increased by almost 744 million euros, with the 10 companies with the highest sales contributing 60 percent of this increase (source: NVI, INSIGHT Health).
Analogous to the regional analysis, it is also worth listing the top companies by market segment in addition to presenting the overall market. In 2013, the Novartis Group and the Sanofi-Aventis company were represented in both segments and in the overall market (see Table 1). The Novartis Group includes, among others, the two generic drug manufacturers Hexal and 1 A Pharma, which may place the group among the top companies in the generic drug segment by winning numerous discount contract tenders. The same applies to Sanofi-Aventis with its generic subsidiary Zentiva (formerly Winthrop). It should also be noted here that neither the compulsory discounts nor the unpublished discounts are taken into account within the contracts with the health insurance companies.
In the patent-protected market there are three companies, Boehringer Ingelheim, Berlin-Chemie and Gilead, which in 2013 were unable to assert themselves among the top companies either in the overall market or in the generics segment. From this perspective, too, it will be exciting to see how the situation develops in 2014 and beyond, especially as patent expirations for some biopharmaceuticals are imminent and individual companies have successfully placed products with blockbuster potential on the market.
Conclusion
The key figures and analyzes shown are intended to provide a brief overview of the situation and trends in the GKV finished medicinal products market. They were selected from a variety of market data and represent a wealth of analysis options and conclusions. After primarily using data from 2013 for this article, the key figures will be updated in a follow-up analysis taking into account the data for 2014 in order to manifest or revise trend statements.
Authors/Contact:
Kathrin Pieloth, Matthias König,
Konstantin Knull.