The Reproductive Health Technologies Market
More than $8.4 billion is spent annually in the United States to treat the short- and long-term consequences of STDs. This is a highly conservative estimate because it includes only medical costs and does not consider lost productivity or the human costs of suffering1. Roughly $4.5 billion is spent to treat HIV and AIDS, and another $1.6 billion is spent treating pre-cancerous cervical lesions and cancer of the cervix caused by human papilloma virus (HPV). Most of the $2 billion spent on bacterial STDs per year goes to treat the 1.5 million cases of pelvic inflammatory disease (PID), which has been linked to female infertility1.
When analyzing the costs and benefits for development of new reproductive health technologies (RHT), rather than simply considering the amount spent on STDs and their sequelae, an evaluation of the current market for RHT is needed. Several recently reported studies have examined women's intent-to-purchase RHT products, and overall interest in these products for both men and women2,3. The studies estimate the predicted demand for anticipated products since most of these products, including BufferGel®, are "in the pipeline." Real market data does not exist. However, historic evidence supports the notion that the development of new products will increase overall market demand4. Some individuals (or couples) will switch to a new product, some will use a new product in addition to those he or she currently use, and some people will enter the market because of the introduction of an alternative product.
The Alan Guttmacher Institute has reported its analysis of the potential U.S. market5, which states that there are nearly 60 million women of reproductive age, of whom 15.5 million would describe themselves as "worried about getting and STD." Using data from epidemiological studies, an estimated 12.6 million women would express interest in using a product designed to protect them from an STD, while 11.5 million women would be interested in such a product even if it were not 100% effective. An estimated 7.7 million women would be interested in such technology even if the product was not 100% effective and the cost was twice that of a condom (which was stated to be $1.00). To conservatively estimate market potential, this means that 7 million women may be willing to pay $2.00/dose of product; with an estimated 100 sexual encounters per year, this brings the market total to roughly $1.4 billion in the U.S. alone. At half this level ($700 million), this remains an impressive U.S. market. The world market has been estimated to be greater than $3 billion6.
Maturity of the Microbicide Industry
The reproductive health technologies industry is young in many respects. Currently there are no microbicides on the market. The spermicide, nonoxynol-9 is on the market, but has been fraught with problems; it is microbicidal in vitro and presumably in vivo, but it is not selective in its activity and therefore can damage the reproductive epithelium. The vaginal and cervical epithelium provides a critical barrier, both physically and biologically, to infectious organisms. A woman with "unhealthy" or damaged reproductive epithelium is known to be more susceptible to several STD agents including HIV.
Development of new reproductive health technology in the U.S. has largely been the work of academic research labs funded by the National Institutes of Health (NIH), CONRAD (USAID), the Centers for Disease Control and Prevention (CDC), International Program for Microbicides (IPM), private foundations (the Bill & Melinda Gates Foundation) and small biopharmaceutical companies. Resources for research and development for these products have been limited, but the Alliance for Microbicide Development and the Global Campaign for Microbicides have been strong advocates of increase public sector funding, e.g. the Microbicide Development Act that has been introduced in Congress. The prospective costs of developing these new technologies are substantial. Roughly $20 million is needed to meet FDA requirements for early studies on safety and toxicity (Phase I and II clinical trials), and no less than $30 million is required to complete large-scale efficacy trials (Phase III trials) for a single product. To date much of the funding, including that to ReProtect, Inc., has been obtained through the public sector5.
1American Social Health Association (ASHA), Sexually Transmitted Diseases in America: How Many Cases, and at What Cost? Research Triangle Park, NC: ASHA, 1998, Tables 3 and 4, pp. 24-25.
2Hill, Robert, "Assessment of the Potential Market - A Summary of Survey Results from 11 European and Developing Countries," Hillmark Consulting, Microbicides 2000 Meeting, March 14, 2000.
3Holt BH et al., Microbicide Preference among Young Women in California. J of Women’s Health 2006;15(3):281-294.
4Juul, James, "Approaches to Marketing Microbicides," Curatek Pharmaceuticals, Microbicides 2000 Meeting, March 14, 2000.
5The Alan Guttmacher Institute, Microbicides: A New Defense Against Sexually Transmitted Diseases (eds. Deidre Wulf, Jennifer Frost, Jacqueline E. Darroch), New York, NY, 1999, Figure 6 and 9, pp 18 - 22.
6Fransen, L. and R. Hill for the EU HIV/AIDS Programme in Developing Countries: A study into the market potential for vaginal microbicides. Media conference. 12th World AIDS Conference, Geneva, June, 1998.