Abstract
IntroductionThis paper reviews recent trends in the production, supply and price of the active ingredients as well as finished ACT products. Production and cost data provided in this paper are based on an ongoing project (Artepal). Stability data are derived from a development project on rectal artesunate.DiscussionThe artemisinin raw material and its derivatives appear to be very stable compared to the finished products. Supply of artemisinin changed in May 2004 when the Global Fund shifted financial support to qualified countries from chloroquine or sulphadoxine-pyrimethamine to an ACT for treatment of malaria. First, there was a sudden shortage of the starting material, and short term scarcity led to a steep rise in API price: it increased dramatically in 2004, from $350 per kg to more than $1000. Second, there was a parallel increase in the number of companies extracting artemisinin from 10 to 80 between 2003 and 2005 in China, and from 3 to 20 in Vietnam. Commercial cultivation began also in East Africa and Madagascar.A steady and predictable demand for the crop can eliminate such wide fluctuations and indirectly contribute to price stability of the herb, the API and ACT. With appropriate mechanisms to reduce those fluctuations, the cost of artemisinin might decrease sustainably to US$ 250–300 per kg.ConclusionToday the global health community is facing the risk of another cyclical swing with lower demand feeding into reduced planting of A. annua and, thereafter, a new shortage of the raw material and higher API prices. International donors, the largest purchasers for ACTs could better coordinate their activities, in order to guarantee purchase of ACTs and consequently of API with manufacturers. In parallel, the base of quality producers of APIs and finished ACT products needs to be broadened.While the ACT programme is still in its early stages, the consequences of another wave of artemisinin and ACT shortages would permanently discredit it and impede any progress in rolling malaria back.
Highlights
This paper reviews recent trends in the production, supply and price of the active ingredients as well as finished artemisinin-based combinations therapies (ACTs) products
Today the global health community is facing the risk of another cyclical swing with lower demand feeding into reduced planting of A. annua and, thereafter, a new shortage of the raw material and higher active pharmaceutical ingredient (API) prices
The bulk drug substance is seen to be very stable at temperatures of 30°C and 65% relative humidity (RH), conditions required for stability testing for climatic zones III and IV
Summary
From Artemisia annua to ACT (i) A.annua cultivation and production of artemisinin The world's production of Artemisia annua is, at present, dominated by cultivation in East Asia (mainly China and Vietnam) with recent additions of crop in East and Southern Africa, including Madagascar. Factors affecting ACT availability (i) Supply of artemisinin Initially, artemisinin-based products were manufactured and used almost exclusively in China and Vietnam. During this period, it was not difficult for agricultural produc-. A steady and predictable demand for the crop can eliminate such wide fluctuations and indirectly contribute to price stability of the herb, the API and ACT. Other factors such as the increased yield of A. annua due to agronomical improvements or the efficiency of the API extraction process can, in favourable circumstances, permanently lower the price of both the crop and the API. The relatively long stability of the APIs could be used to moderate short-term API price fluctuations by developing a mechanism for guaranteed purchases
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