Most companies have an R&D strategy in place that explicitly takes patients in developing countries into account. The Index captured 327 R&D products that target high-burden diseases for countries within scope, a large proportion of which are new to the 2014 Index. Most companies have also successfully moved products along their pipelines: 11 companies have been granted regulatory approvals for 30 new products, collectively covering 11 of the 47 conditions within scope.
More than half of all products in development (54%) target five diseases: diabetes, lower respiratory infections, hepatitis, HIV/AIDS and malaria. These same diseases also have the most products in clinical development. The most notable gaps are for maternal and neonatal health conditions: there is a lack of products being adapted for safe and effective use by pregnant women and neonates. The majority of products for neglected tropical diseases are early drug-discovery projects or pre-clinical studies. It will be some time before any of these products are on the market.
Almost half of companies are devoting significant shares of their pipelines to diseases within scope for patients living in countries within scope. For three companies this reaches over 35%. Another six companies devote more than 20% of their pipeline to relevant R&D projects. In total, the industry is developing more than 300 products for relevant diseases.
Approximately 40% of all product development occurs in collaboration, with either publicly funded, privately funded or a mix of partners. More than a third (39%) of these product development partnerships are based on research contracts that include access provisions. Since the 2012 Index, the total number of R&D partnerships has increased by 35%, mainly due to an increase in drug-discovery and early-stage partnerships targeting neglected tropical diseases, malaria and tuberculosis.
Most companies struggle to demonstrate how innovative compounds targeting non-communicable diseases will be accessible to patients living in countries within scope. While there are several such compounds in clinical development, there is no implementation strategy that addresses these patients. No company makes commitments to registering such products in relevant countries. The terms and conditions of partnerships for non-communicable product development are not disclosed to the Index or to the public.
More companies provided strong evidence of having enforcement measures in place to ensure ethical clinical trial conduct for in-house and outsourced trials that are in line with guidelines on good clinical practice (ICH-GCP). This has increased from four companies in 2012 to ten. Seven companies incorporate aspects specific to the Declaration of Helsinki in their clinical trial codes of conduct.
• Sub-ranking and analysis of how companies performed in this area
• Report on companies R&D activities for 47 high-burden diseases
• Analysis of how companies engage in R&D partnerships
• Analysis of clinical trial codes of conduct and data transparency
• Overview of best practices
• Overview of innovative models that address gaps in product development