Fast Market Research recommends "Germany Pharmaceuticals & Healthcare Report Q1 2014" from Business Monitor International, now available

Boston, MA -- (SBWire) -- 12/24/2013 --Since the adoption of the Arzneimittelmarkt-Neuordnungsgesetz (AMNOG) bill in 2011, Germany's health technology assessment and reimbursement decision-making bodies have taken an increasingly hard line when determining whether a new drug provides added value to patients in comparison with existing therapies. The result is that companies have to accept a non-negotiable reference price for their products or not to market their drug in Germany at all. Either option significantly restricts pharmaceutical companies' revenue streams and threatens returns on innovation.
Headline Expenditure Projections

- Pharmaceuticals: EUR39.84bn (US$50.60bn) in 2012 to EUR40.02bn (US$53.22bn) in 2013; 0.4% in local currency terms and 5.2% in US dollar terms.
- Healthcare: EUR290.83bn (US$369.35bn) in 2012 to EUR296.31bn (US$394.09n) in 2013; +1.9% in local currency terms and +6.7% in US dollar terms.

Risk/Reward Rating: In BMI's Q114 Pharmaceutical Risk/Reward Ratings, Germany is ranked the most attractive pharmaceutical market in the Western European region, which covers 14 key markets.

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Key Trends And Developments

- In October 2013, an agreement for a revised mutually acceptable reimbursement price for Sativex (tetrahydrocannabinol+cannabidiol) was reached between Almirall, GW Pharmaceuticals' commercial partner in Germany, and the German National Association of Statutory Health Insurance Funds (GKV-SV). This new agreement has resulted in an increase to the previously reduced price imposed by the German authorities in March, which Almirall considered unacceptable.
- On August 6, Bayer HealthCare announced that the US Food and Drug Administration's (FDA's) Cardiovascular and Renal Drugs Advisory Committee unanimously recommended approval of the oral soluble guanylate cyclase (sGC) stimulator, riociguat, for two forms of pulmonary hypertension. Riociguat addresses a high unmet medical need and is the first drug to demonstrate efficacy in two forms of pulmonary hypertension, one of which has no drug treatment approved to date, according to Dr Kemal Malik of the Bayer Healthcare Executive Committee and Head Of Global Development. In February 2013, Bayer submitted a new drug application for riociguat indicated to improve exercise capacity.

BMI Economic View: The risks to our short-term growth forecasts lie primarily to the downside, given the array of challenges facing the eurozone. The main threat, in our view, is one of confidence, as further flare up in sovereign/banking sector crises in periphery states could prompt another collapse in investment, damaging consumer confidence in the process. There is also a threat of German authorities clamping down on rising house prices for fear of a speculative bubble (the Bundesbank has outlined its concerns over excessive mortgage growth in recent months), which would also act to dampen consumer confidence.

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