The four second-generation hormonal therapies have been racing to acquire approvals and label expansions over the past couple of years. These are Johnson & Johnson’s (J&J’s) Zytiga (abiraterone acetate) and Erleada (apalutamide), Astellas/Pfizer’s Xtandi (enzalutamide), and Bayer/Orion’s Nubeqa (darolutamide), 

Between 2018 and 2019, three of these agents gained approval in non-metastatic castration-resistant prostate cancer (nmCRPC). Zytiga gained a label expansion for metastatic hormone-naive prostate cancer (mHNPC) in 2017 for the EU and in 2018 for the US. The other three agents are expected to soon follow. J&J filed for FDA approval of Erleada in mHNPC in April 2019, and Xtandi was given an FDA priority review in August.  

Market predictions

GlobalData expects that the prostate cancer market will undergo moderate growth. Across the eight major markets (US, France, Germany, Italy, Spain, UK, Japan, and China), the market is anticipated to rise from an estimated at $9.3B in 2018 to $12.8B in 2028 at a Compound Annual Growth Rate of 3.3%.

One of the biggest drivers of growth is the expansion of second-generation hormonal agents into mHNPC and nmCRPC, bringing these expensive drugs into earlier lines of therapy. This will doubly impact market growth, as the shifting paradigm will create space in the metastatic castration-resistant prostate cancer space where these agents once reigned. As such, pipeline agents will be afforded a chance to gain substantial market share and fill this void.

Global (8MM) Sales Forecast by Country for Prostate Cancer in 2018 and 2028