The Center for Global Health R&D Policy Assessment team at the Results for Development Institute (R4D), a Washington-based, contact-supported consulting firm, recently published a brief report that has some useful basic information for those interested in developing global health products specifically to treat the noncommunicable diseases (NCD) like cancer and diabetes. The report, “New Technology Needs for Noncommunicable Diseases in Developing Countries: a Landscaping Study” (R4D report), builds on the growing attention and analysis among the professional global public health community on NCD and their substantial and growing contribution to a substantial to annual mortalities (about a 60% share) and recognition that they are the leading cause of mortality and morbidity in all low- and middle-income countries (LMIC), except those of Sub-Saharan Africa. The report notes a WHO 2008-2013 action plan, a UN General Assembly meeting in 2011, a World Bank report in 2011, and a 2011 RAND report sponsored by the International Federation of Pharmaceutical Manufacturers and Associations. As context for new product needs, the authors offer several points:
- four types of NCD- cardiovascular disease (CVD), diabetes, chronic respiratory disease, and cancer- account for the majority of NCD affliction;
- lifestyle (diet, exercise, drug use) has a significant role in NCD (evidence “suggests” 80%) and therefore theoretically NCD is correctable by behavioral and not diagnostic or therapeutic means; and
- the professional global health community has focused on addressing NCD burden through strengthening of health systems and access to existing medicine and is not calling for new products. That being said, that utility of the report is that, as labeled, it offers a fairly comprehensive overview of where new technologies and products are needed and, for a company managers or founders, a basis for more in-depth research and analysis.
The authors note two general strategies for new product development for global NCD. The first is to repurpose and adapt products found in the high-income countries to use in under-resourced areas where impediments include everything from limited refrigeration and sanitation to cultural perceptions of medical treatment. The second is to invent products specific to aspects of NCD that exist primarily in the LMIC. To identify these product opportunities the report includes tables for each of four main NCD that compares the treatments in the limited settings with the HIC “standard,” the barriers that exist to improving the treatments, and R&D gaps where new or adapted products are needed. This is useful as far as it goes in identifying general new product needs, such as “lower-cost diagnostics” or “telemedicine” or “heat-stable supplies,” but specifics are lacking. In a few instance more specific examples of new products are offered:
- diagnostic platforms that integrate identification of both infections and NCD;
- point-of-care assays for cholesterol and glucose levels (the authors note that PATH has two product development efforts in the latter; PATH Fact Sheet);
- automatic blood pressure cuffs for CVD screening;
- “polypills” for treating CVD (although the report does not mention a polypill that combines four generic meds for preventing heart disease mortality, has been under development for about six years by Dr. Reddy’s Laboratories Ltd. of India, and has shown promising results [Reuters article]);
- a vaccine for rheumatic heart disease;
- better diagnostics, drugs, and a preventive vaccine for Chagas cardiomyopathy; and
- low-cost inhalers for asthma and chronic pulmonary obstruction disease treatment.
I think it would have been an interesting and instructive exercise for the authors to have interviewed representatives of companies about where they saw the opportunities for new technology and product development for the global NCD burden (the authors “conducted expert interviews with key opinion leaders in academia, public health, and advocacy”). The 2011 RAND report cited by the authors offers a perspective more from the pharmaceutical industry (RAND report). In addition to noting that, except for the newer cancer and asthma drugs, most NCD drugs are available as generics, the RAND authors find the primary barriers are not new drugs but:
- a need for better distribution;
- high costs of medicines due to markups during distribution and tariffs;
- inadequate, not timely diagnostics and primary care, and
- lack of regulatory harmonization.
Both reports lead me to think there are major opportunities for the startups and smaller companies to invent new delivery methods for and combinations of existing drugs, especially with generics or in countries where a MNC drug may not be patented, but note the data are lacking.