The Unrecognised Revolution in Global Health
An update on the state of the neglected disease R&D product pipeline
Neglected diseases disproportionately affect developing countries, causing significant morbidity and mortality in already disadvantaged populations – more than six million people die each year due to neglected diseases such as tuberculosis (TB), malaria and sleeping sickness. But precisely because these diseases are overwhelmingly restricted to neglected populations, there is insufficient commercial market to attract the R&D investment by private industry that is necessary to develop new health technologies.
However, with the support of public and philanthropic funding (including industry philanthropy), the product pipeline for neglected diseases is healthier now than it has ever been, having more than doubled in size over the last decade. The global effort is largely been driven by public health goals – over three-quarters of these product candidates are being developed by innovative collaboration between public and private sector, such as product development partnerships (PDPs) – meaning that products are being designed specifically to be affordable and appropriate for developing countries. With sustained, appropriate support, we will see the delivery of many exciting transformative technologies over the next 15 years.
This is the first comprehensive global picture of the neglected disease R&D pipeline since 2012. It looks at 34 of the 35 neglected diseases within the scope of G-FINDER survey (Ebola is not included), covering all product categories including vector control products, and all stages of research from early stage R&D through to product registration. The data is the result of a comprehensive review of the neglected disease R&D landscape conducted by Policy Cures in late 2015, and is presented as a snapshot of the pipeline as at October 2015. You can find a detailed explanation of the methodology behind this review and notes on the limitations of the data here.
The online pipeline can be navigated by disease (including secondary-level diseases such as sleeping sickness, rotavirus, lymphatic filariasis, etc.) or by product category (vaccines, drugs, diagnostics and vector control products). Click on any of the disease or product tiles below to view the R&D pipeline for that category.
This resource presents a snapshot of the global R&D product pipeline for neglected diseases as at October 2015. It covers:
- 34 neglected diseases, as defined in the G-FINDER report (not including Ebola)
- All product areas, including drugs, vaccines, diagnostics and vector control products (VCP). Note that microbicide candidates for HIV are included under the drugs category.
The pipeline includes candidates at all stages of development from discovery through to registration. For drugs and vaccines, this is divided into discovery, pre-clinical, or clinical trials (further broken down into Phase I, Phase II and Phase III). For diagnostics and vector control products, which have different development pathways, this is divided into early- and late-stage development. Screening programmes, candidates on hold, and products already registered in any country (including products currently in Phase IV trials, or vector control candidates undergoing WHOPES evaluation) have been excluded.
Additionally, specific disease and product restrictions were applied in line with the scope of the G-FINDER survey:
- Only includes label-extensions and reformulations specifically intended for developing country use (e.g. paediatric or slow-release formulations; fixed dose combinations; low-dose drug formulations for prophylaxis)
- Diarrhoeal diseases:
- Only includes pharmacological interventions that target the pathogen. Supportive therapies (e.g. zinc treatment, oral rehydration therapy, or other fluid and nutritional supplements) are excluded
- Hepatitis C:
- Only includes developing country specific drug research and/or research that has been designed specifically for genotypes 4, 5 or 6
- Drug candidates for bacterial pneumonia & meningitis, diarrhoeal diseases (except cholera, shigella, cryptosporidium and multiple diarrhoeal diseases), trachoma, rheumatic fever and leptospirosis are not included
- Preventive vaccines:
- Candidates for rotavirus and bacterial pneumonia or meningitis are only included if they are being developed specifically for developing-country use
- Excludes giardia, roundworm, whipworm, tapeworm (cysticercosis/taeniasis), lymphatic filariasis, leprosy, dengue, cryptococcal meningitis and leptospirosis
- Only includes diagnostic candidates intended to be cheap, stable, easy-to-use and suited to resource-limited settings
- Excludes rotavirus, roundworm, hookworm, whipworm, tapeworm (Cysticercosis/Taeniasis), rheumatic fever and cryptococcal meningitis
- Applications that may have Western markets or be useful for other STDs (e.g. mucosal delivery technology, adjuvants) are excluded. Please note that microbicide candidates are included under the drugs category
- Therapeutic vaccines:
- Only includes candidates for TB
- Vector control products:
- Pesticides: Only includes chemical pesticides intended for global public health use and which specifically aim to inhibit and kill vectors associated with transmitting poverty-related diseases
- Biological Control Products: Only includes innovative biological control interventions that specifically aim to kill or control vectors associated with transmitting poverty-related diseases (e.g. microbial/bacteriological larvicides, sterilisation techniques, and genetic modification measures)
- Vaccines targeting animal reservoirs: Only includes veterinary vaccines specifically designed to prevent animal to human transmission of neglected diseases
For further information on specific diseases and related product areas within the scope of the pipeline analysis, please see the R&D matrix here.
Data sources and validation
The pipeline information presented here builds on the most recently available comprehensive landscape of the R&D product pipeline for neglected diseases, prepared by Policy Cures in 2012. That work in turn was based on the BIO Ventures for Global Health (BVGH) Global Health Primer, supplemented with additional research and analysis by Policy Cures.
Using the 2012 pipeline as a starting point, Policy Cures reviewed and cross-referenced all major sources of available data on the neglected disease product pipeline in order to prepare this 2015 update. Sources included: the G-FINDER database of neglected disease R&D funding; the World Health Organization (WHO) ‘Rainbow Tables’; background documents prepared for the WHO Product Development for Vaccines Advisory Committee; UNITAID Landscape and Technical Reports; disease-specific pipeline updates prepared by BVGH and the Treatment Action Group (TAG); company and PDP portfolios; journal publications; clinical trial registration portals; and university, government and not-for-profit organisation websites.
Candidates were only included if an authoritative source could confirm they were still in active development. Authoritative sources were considered to be the following:
- The website of the candidate developer (if recently updated)
- Recent reports or other materials from international organisations such as WHO and UNITAID
- Clinical trial portals
- Correspondence with product developers
- Correspondence with experts in the field, including FIND; the Innovative Vector Control Consortium (IVCC); the International AIDS Vaccine Initiative (IAVI); Netherlands Leprosy Relief; Program for Appropriate Technology in Health (PATH); the Sabin Vaccine Institute; and the US National Institute of Allergy and Infectious Diseases (NIAID)
It is inevitable that some candidates might have been missed, while others will have been included as active when in fact they are no longer so. We warmly welcome additions, removals, questions and feedback on our methodology.
It is important to note that although the disease and product scope of the pipeline is aligned with that of the G-FINDER survey, the candidate- and organisation-level information provided here should not be combined with G-FINDER financial data for direct analysis. Attempting to do so would result in a distorted picture for a number of reasons, including that much investment information reported by participants in the G-FINDER survey is for a portfolio of products rather than specific candidates (or indeed is for multiple diseases, rather than just one); that in order to prevent double-counting of financial flows G-FINDER does not report onwards funding provided by PDPs and other intermediaries, and thus does not show the full amount of funding received by individual product developers; and that G-FINDER only uses primary data, whereas the pipeline data came from a variety of sources as described above. It should also be noted that the time required for the collection and publication of financial data means that the most recently-published G-FINDER data is for FY2014, while this pipeline was current as at October 2015.