Earlier this year, we wrote a post about Target Product Profiles (TPPs) and the generalized versions that the IMPT developed in 2015 for two MPT product types. As we argue in that post, a product that meets all clinical targets listed in a TPP will not necessarily correlate to its public health impact in the real world. That is, not unless we work to understand what the future end-users of MPTs – who include both the women who will use MPTs to protect their sexual and reproductive health as well as the health providers who will prescribe MPTs for these women – want and need in a product and then integrate those learnings into the product development process. Of course, it is critical that an MPT be efficacious and safe, but how can we expand the product evaluation process to better ensure that future end-users will be able to access, want to try, and continue to use an MPT?
In collaboration with our program officers at USAID’s Office of HIV/AIDS, our team developed a concept to do just that. A paper published by several IMPT scientific advisors a few years prior had theorized around the inclusion of market factors into a TPP for MPTs using a framework developed by Tebbey and Rink called a Strategic Evaluation Framework (SEF). An SEF consists of three pieces: 1) a Target Market Profile (TMP), 2) a Strategic Target Profile (STP), and 3) a Target Product Profile (TPP).
For the scope of this project, we decided to give it a try – to create an SEF for MPT development and introduction, with a focus on HIV prevention products. Having already developed generalized MPT TPPs, we zeroed in on the TMP, which characterizes the target market for MPTs, and the STP, which builds off the TMP to set market-based targets for MPT development.
We developed the foundations for the TMP and STP, which are described in this report, by reviewing the literature and interviewing key informants. For the TMP, we included epidemiological and demographic profiles as well as a data summary on inferred drivers of potential MPT use. For the STP, we identified key market-based evaluation indicators for which targets could be set: health impact, market segmentation, value proposition, tolerated toxicity/side effects, acceptability, uptake and adherence, costs, accessibility, and community/market engagement.
In a second report, we further expanded the STP component to include additional context to inform target setting for each indicator. For example, when determining the optimal MPT value proposition, one might consider using a descriptive threshold, inclusive of a range of factors for each established market segment that influence product value. These factors could include:
- Efficacy, whether proven, perceived, or potential
- Dual or multipurpose products, as value may be additive across indications. However, positioning an MPT as a contraceptive may not attract potential end-users who are satisfied with their current family planning methods
- Difference in risk between unintended pregnancy and HIV infection from an unprotected sex act
- Perceived risk of unintended pregnancy and/or HIV infection
- Medical benefits other than pregnancy or HIV prevention
- Perceived product effect on one’s own or partner’s sexual well-being
- Perceived harms or side effects
As each MPT product type will require unique market-side considerations, these broader points aim to provide a useful starting place for more tailored, product-specific STPs based on what is currently known in the MPT field.
Why not build a full SEF for MPTs? Well, first we recognized that in the absence of a product-neutral assessment to identify a specific target market where MPTs could have the greatest impact (stay tuned for more on an IMPT project underway that aims do this!), we’d have to rely on a proxy even if it may not fully represent the most strategic target market for MPTs. Second, we also recognized that the body of end-user research necessary to fully describe the market in a TMP and to inform robust target setting for an STP, as suggested by Tebbey and Rink, is relatively limited in the women’s global health context.
These reports, however, can be an informative starting place for MPT product development projects. For partners working on later-stage MPTs, there are STP indicators with applications for product introduction strategies. For earlier-stage products, the STP can help guide design and early development process. And building off the great momentum for MPT development and end-user research for HIV prevention and MPTs, the IMPT looks forward to continually updating this tool as the MPT field grows and evolves.
