HIV infection in children is virtually eliminated in many developed countries. However transmission still exists despite efforts such as the global plan to eliminate transmission of HIV in children by 2015. 90% of these children are living in sub-Saharan Africa.
Today a combination of antiretrovirals (ARVs) to treat HIV made it possible for adults and children to lead healthy lives. The antiretrovirals to treat adults and children are the same but the types of formulations are different mainly because young children cannot swallow pills.
What we aimed to do
At the Drugs for Neglected Disease Initiative (DNDi), we are working on developing a simple to use all in one antiretroviral formulation which tastes good, does not require refrigeration and can be easily administered to children infected with HIV.
The reason DNDi, an independent international non-for-profit, patient-needs driven research and development organization, is involved in the development of pediatric ARV formulations is due to the lack of financial incentives for pharmaceutical companies to invest in this field.
The database we analyzed represents 80% of the donor funded procurement of pediatric ARVs worldwide from 2004-2012
This analysis of the pediatric ARV market was conducted because it is known to be a very specific donor supported market due to the fact that 90% of the pediatric HIV population lives in sub-Saharan Africa but no data that we know of has been published on the pricing trends of the pediatric ARV formulations.
The database we analyzed represents 80% of the donor funded procurement of pediatric ARVs worldwide from 2004-2012. With the large amount of information, we decided to focus on what affects the price of the 33 pediatric ARV formulations during this period.
What we found
We found that the pediatric ARVs were initially mainly supplied by originator companies but later generic companies managed to capture the market and by 2012 were up to 95%. The main factors we thought explained this phenomenon were that the prices of generic ARVs were much lower than originator and fixed dose combinations (FDCs) were being introduced by generic companies.
With the exception of one pediatric FDC namely lopinavir/ritonavir where both drugs were owned by the same originator company, no other FDC were made by originator companies. This we believe is due to intellectual property protection and lack of market incentive for originator companies to make better formulations adapted for use in developing countries.
Volumes of purchase and number of manufacturers producing each formulation only affect the prices modestly. We also found that with the huge number of pediatric ARV formulations, 33 in total, there was limited number of manufacturers for each formulation.
This explained the lack of price competition as seen in the stagnation of prices for pediatric FDCs despite a substantial increase in volume of purchase by 12-fold in 2012 compared to 2008.
We also found a huge price difference in prices paid by South Africa for originator drugs, 71% lower compared to sub-Saharan Africa probably due to high volumes and potential price negotiations.
Originator companies practice widely price discrimination, offering different prices in different countries according to the income level or ability to pay which is not seen in generic drug pricing. Lowest pricing are usually available for sub-Saharan African countries. We also found a huge price difference in prices paid by South Africa for originator drugs, 71% lower compared to sub-Saharan Africa probably due to high volumes and potential price negotiations.
Future of Pediatric ARV Market
In a survey made by WHO in 2012, children represent only 6% of the total number of people receiving HIV treatment which further confirms that the pediatric ARV market is a small and fragile market.
We believe that the information generated from this study will be an important reference and advocacy piece to garner the support needed for the sustainability of this market considering the number of children living with HIV will continue to dwindle with success of prevention programs.
Continued donor support and the current initiatives to protect it are important to ensure market viability, especially if new formulations are to be introduced in the future.