Research & Development

What we measure

Innovative R&D

The WHO's 2001 Commission on Macroeconomics and Health distinguished three classes of diseases[1]. Class III, or 'very neglected diseases', are those diseases "overwhelmingly or exclusively prevalent in the developing world"[2]. They include the diseases on the WHO's list of 14 neglected tropical diseases (NTDs) such as chagas disease, sleeping sickness (Human African Trypanosomiasis), Kala-azar (Leishmaniasis), and river blindness (Onchoceriasis), Shistosomiasis. For such diseases, due to absence of individual purchasing power or institutional payers in many Index Countries, the patent system (and its associated exclusivity) fails to create sufficient economic incentives for the industry to develop the needed remedies. This sustained, long-term market failure is one of the key reasons for the absence of suitable products for prevention, diagnosis and treatment of these diseases.

Class II diseases are termed “neglected diseases (NDs)" and occur in both rich and poor countries, but with a substantial proportion of cases (>90%) occurring in poor countries; examples include HIV/AIDS and TUBERCULOSIS. For those diseases the market failure is incomplete due to the presence of some developed world demand or overlapping R&D goals. Nevertheless, it is largely accepted that the level of R&D is “not commensurate with the disease burden”[1]. As these are all Communicable Diseases, new treatments are needed to replace those whose efficacy has waned due to resistance . To address this need, R&D for new chemical entities (NCEs) can play a significant role.

Another major area of need for new products is prevention. The industry’s pipeline for vaccines has expanded during the past few years. However, there are still significant gaps for new vaccines for many Neglected Diseases.

Index 2010 assesses companies’ efforts to meet these needs. Both in-house research and the use of innovative, collaborative business models, such as product development partnerships (PDPs) are covered by Index 2010.

Adaptive R&D

Adaptive R&D or “incremental innovation” offers significant advantages not only to populations living in Index Countries, but also to commonly underdeveloped IC health infrastructures. By making small adaptations to existing molecules or products, they can sometimes be made more suitable for certain IC environments. Such changes aim at: creating soluble forms for small children; extending indications to other diseases (label-extensions); capturing new target groups (such as pregnant women) or age-groups (such as pediatric formulations). Adaptive research can also aim at simplifying dosing regimens through developing Fixed Dose Combinations (FDC) which can delay or prevent emergence of resistance through more rational medicine use. Furthermore, adaptive R&D can also lead to more stable molecules with a longer shelf life and environmental resistance which increase efficiencies in the supply chain.