Research Centre for Pharmaceutical Care & Pharmaco-economics, K.U.Leuven, Belgium.
Pharmacoeconomics. 2011 Oct;29(10):875-82. doi: 10.2165/11585970-000000000-00000.
After the expiry of patents for originator medicines, generic medicines can enter the market, and price competition may occur. This process generates savings to the healthcare payer and to patients, but knowledge about the factors affecting price competition in the pharmaceutical market following patent expiry is still limited.
This study aimed to investigate the relationship between the market share of generic medicines and the change of the medicine price level in European off-patent markets.
Data on medicine volumes and values for 35 active substances were purchased from IMS Health. Ex-manufacturer prices were used, and the analysis was limited to medicines in immediate-release, oral, solid dosage forms. Countries included were Austria, Belgium, Denmark, Germany, France, Italy, the Netherlands, Spain, Sweden and the UK, which constitute a mix of countries with low and high generic medicines market shares. Data were available from June 2002 until March 2007.
Market volume has risen in both high and low generic market share countries (+29.27% and +27.40%, respectively), but the cause of the rise is different for the two markets. In low generic market share countries, the rise was caused by the increased use of generic medicines, while in high market share countries, the rise was driven by the increased use of generic medicines and a shift of use from originator to generic medicines. Market value was substantially decreased in high generic market share countries (-26.6%), while the decrease in low generic market share countries was limited (-0.06%). In high generic market share countries, medicine prices dropped by -43.18% versus -21.56% in low market share countries.
The extent to which price competition from generic medicines leads to price reductions appears to vary according to the market share of generic medicines. High generic market share countries have seen a larger decrease in medicine prices than low market share countries.
原研药专利期满后，仿制药即可进入市场，可能会引发价格竞争。这一过程为医疗保健支付方和患者节省了开支，但对于专利期满后药品市场价格竞争的影响因素仍知之甚少。
本研究旨在调查欧洲专利过期市场中仿制药市场份额与药品价格水平变化之间的关系。
从 IMS Health 购买了 35 种活性药物的药物量和价值数据。采用原研药出厂价，分析仅限于即释型、口服、固体剂型的药物。所包括的国家为奥地利、比利时、丹麦、德国、法国、意大利、荷兰、西班牙、瑞典和英国，这些国家构成了低和高仿制药市场份额的混合体。数据可追溯至 2002 年 6 月至 2007 年 3 月。
高和低仿制药市场份额国家的市场规模都有所增长（分别增长 29.27%和 27.40%），但两个市场的增长原因不同。在低仿制药市场份额国家，增长是由仿制药使用量的增加引起的，而在高市场份额国家，增长是由仿制药使用量的增加和从原研药转向仿制药的使用驱动的。高仿制药市场份额国家的市场价值大幅下降（-26.6%），而低仿制药市场份额国家的降幅有限（-0.06%）。在高仿制药市场份额国家，药品价格下降了-43.18%，而在低市场份额国家，药品价格下降了-21.56%。
仿制药带来的价格竞争导致价格降低的程度似乎取决于仿制药的市场份额。高仿制药市场份额国家的药品价格降幅大于低市场份额国家。
