Global Health. 2013 Feb 15;9:6. doi: 10.1186/1744-8603-9-6.
The price of antiretroviral drugs (ARVs) in low income countries declined steadily in recent years. This raises concerns about the commercial viability of the market of ARVs in low income countries.
Using 2 costing scenarios, we modeled the production cost of the most commonly used ARVs in low income countries in 2010 and 2012, and assessed whether, at the median price paid by low income countries, their manufacturers would still make profits. By interviews we consulted 11 generic manufacturers on the current state of the ARV market, and on what would be required to ensure their continued commitment to supply ARVs to low income countries.
Using the lowest prices for active pharmaceutical ingredients (API) quoted to WHO, and applying published assumptions about the production cost of ARVs, our baseline estimate was that Indian generic manufacturers would have made profits on only 1 out of 13 formulations of ARVs in both 2010 and 2012, and publicly owned manufacturers would have made profits on 5 and 3 out of 13 formulations in 2010 and 2012, respectively. We needed to assume a 20% and a 40% lower API cost for our model to predict that publicly owned and Indian manufacturers, respectively, would make profits on the sale of the majority of their ARVs. Between 2010 and 2012, we estimate that--across the ARV portfolio--the gross profit on sales of ARVs to low income countries decreased with between 6% and 7% of their sales price. Generic manufacturers consider that current prices are unsustainable. They suggested amendments to the tender procedures, simplified regulatory procedures, improved forecasting, and simplification of the ARV guidelines as critical improvements to maintain a viable ARV market.
While recent price decreases indicate that there is still space for price reduction, our estimate that gross profit margin on sales decreased by 6 to 7% between 2010 and 2012 lends credibility to assertions by generic manufacturers that the ARV market in low income countries is under considerable price pressure. This might create problems for the quality and/or the continued supply of ARVs to low income countries.
近年来，抗逆转录病毒药物（ARV）在低收入国家的价格稳步下降。这引发了人们对低收入国家 ARV 市场商业可行性的担忧。
我们使用两种成本估算方案，对 2010 年和 2012 年低收入国家最常用的 ARV 生产成本进行了建模，并评估了在低收入国家支付的中位数价格下，其制造商是否仍能盈利。通过访谈，我们向 11 家仿制药制造商咨询了 ARV 市场的现状，以及确保他们继续向低收入国家供应 ARV 所需的条件。
使用向世卫组织报价的最低原料药（API）价格，并应用关于 ARV 生产成本的已公布假设，我们的基线估计是，在 2010 年和 2012 年，印度仿制药制造商只有 13 种 ARV 配方中的 1 种能够盈利，而公有制制造商分别有 5 种和 3 种能够盈利。我们需要假设 API 成本降低 20%和 40%，我们的模型才能预测公有制和印度制造商分别能够从他们销售的大多数 ARV 中获利。在 2010 年至 2012 年期间，我们估计，在整个 ARV 产品组合中，向低收入国家销售 ARV 的毛利润随着销售价格的 6%至 7%而下降。仿制药制造商认为当前价格不可持续。他们建议修改招标程序、简化监管程序、改善预测，并简化 ARV 指南，作为维持可行的 ARV 市场的关键改进。
虽然最近的价格下降表明仍有降价空间，但我们的估计表明，2010 年至 2012 年期间，销售毛利润率下降了 6%至 7%，这为仿制药制造商声称低收入国家的 ARV 市场面临相当大的价格压力提供了可信度。这可能会给低收入国家的 ARV 质量和/或持续供应带来问题。
