At phase IIb, companies have a solid Target Product Profile (TPP) and a commercialization strategy. As a company prepares for phase III studies the roadmap gets finalized. Male contraceptive products in development have varying mechanisms of action and product profiles, and will therefore have different go-to-market strategies that may require different levels of external partnerships.
Early-stage projects really only need to have a vision of how they are going to pursue product development and present a go-to-market strategy that passes the “smell test.” Most companies will on-board an experienced commercialization team as programs advance clinically. Below is an example of a human resourcing plan for the roles that a “traditional” biopharmaceutical company would fill if they were taking a product to market (likely requiring significant financing events, like an IPO, btw).
Early-stage projects really only need to have a vision of how they are going to pursue product development and present a go-to-market strategy that passes the “smell test.” Most companies will on-board an experienced commercialization team as programs advance clinically. Below is an example of a human resourcing plan for the roles that a “traditional” biopharmaceutical company would fill if they were taking a product to market (likely requiring significant financing events, like an IPO, btw).
Table compiled by Stephan Loose of Old Street Strategy (shared on LinkedIn)
Note on the uniqueness of contraceptive development:
It has historically been challenging to identify industry partners for late-stage product development/market introduction of new contraceptive products. This is undoubtedly due, in part, to these products (predominantly hormonal methods for female contraception) directly competing with existing products that are considered cheap global commodities (the most generic of generic, if you will). The novel male contraceptives in development have a range of mechanisms of action across the pipeline and will either be non-competitive or indirectly competitive with the current armamentarium of female-centric methods. While it is challenging for analysts to determine market size without comparator products, first and best-in-class products in a new and large market category should offer a compelling investment opportunity.
Given the history of contraception, there is significant emphasis and precedent set with respect to global access woven into the contraceptive R&D. Today’s product developers have the unique opportunity to build commercialization strategies that include conditions for supporting global access from the inception. MCI continues to gather information to learn how best to advise product developers in their pursuit of global access, aiming to facilitate parallel introduction of products in developed and developing drug markets. Feel free to reach out to the MCI team directly if you would like to learn more or discuss options, and watch this space for future recommendations.
Note on the uniqueness of contraceptive development:
It has historically been challenging to identify industry partners for late-stage product development/market introduction of new contraceptive products. This is undoubtedly due, in part, to these products (predominantly hormonal methods for female contraception) directly competing with existing products that are considered cheap global commodities (the most generic of generic, if you will). The novel male contraceptives in development have a range of mechanisms of action across the pipeline and will either be non-competitive or indirectly competitive with the current armamentarium of female-centric methods. While it is challenging for analysts to determine market size without comparator products, first and best-in-class products in a new and large market category should offer a compelling investment opportunity.
Given the history of contraception, there is significant emphasis and precedent set with respect to global access woven into the contraceptive R&D. Today’s product developers have the unique opportunity to build commercialization strategies that include conditions for supporting global access from the inception. MCI continues to gather information to learn how best to advise product developers in their pursuit of global access, aiming to facilitate parallel introduction of products in developed and developing drug markets. Feel free to reach out to the MCI team directly if you would like to learn more or discuss options, and watch this space for future recommendations.