Drugs in pre-registration phase that are expected to reach blockbuster status by 2025

GlobalData Healthcare 21st February 2020 (Last Updated February 21st, 2020 16:17)

Drugs in pre-registration phase that are expected to reach blockbuster status by 2025

According to the Consensus Drug Forecasts on GlobalData Pharma Intelligence Center, out of all the drugs that are currently in the pre-registration phase and are expected to launch in 2020, ten drugs have the potential to reach blockbuster status over the next six years. Amgen and Allergan’s biosimilar candidate to Roche’s Rituxan (rituximab) shows the greatest potential of these drugs. It is projected to reach almost $4bn in annual sales by 2025, far above the predicted sales for other blockbusters in this group, which will all amass $1bn-$2bn in annual sales in the next six years. The competitive pricing of the biosimilar drug will help its wider use, and the drug will steal a significant proportion of patient share from the mega-blockbuster Rituxan.

Other than one biosimilar drug, all of the hopefuls are innovator drugs that span several therapy areas, mainly oncology and central nervous system (CNS). Table 1 lists the drug details, while Figure 1 shows their sales forecast.

In oncology and hematology space, innovator drugs that are in pre-registration phase target triple-negative breast cancer, hemophilia A and various types of lymphoma. They are all biologics with a unique mechanisms of action, including a gene therapy (BioMarin’s Valoctocogene roxaparvovec) and a cellular immunotherapy (Bristol-Myers Squibb’s Lisocabtagene maraleucel). The high cost of these therapies coupled with high unmet needs in target patient populations will contribute to the soaring revenues from these drugs.

The CNS drugs dominate the pre-registration portfolio of potential blockbusters, with four out of 10 drugs coming from this space. Bristol-Myers Squibb’s Ozanimod and Biohaven’s Zydis are entering the crowded and competitive spaces of multiple sclerosis and migraine, respectively, where the drugs will capture a substantial market share thanks to their differentiated efficacy and safety profiles. On the other hand, Roche’s Risdiplam and Zogenix’s Fintepla target spinal muscular atrophy and some forms of epilepsies in childhood respectively, all rare disease areas with high unmet needs.