Report Identifies 15 Key Drugs Predicted to Achieve Blockbuster Status by 2027

A new report from Clarivate highlights promising therapeutic developments for conditions such as psoriasis, HIV, Parkinson disease, and Crohn disease, with new indications and drugs predicted to have blockbuster status by 2027.

The annual report provides updates and predictions in the drug innovation landscape and has identified more than 70 Drugs to Watch. The analysis identifies drugs entering the market or launching new indications in 2023 that are predicted to achieve blockbuster status by 2027 or be clinical game changers for patients worldwide. Additionally, analysts identified 15 late-stage experimental treatments that are each forecast to deliver annual sales of more than $1 billion within 5 years.¹

The 2023 Drugs to Watch list primarily includes treatments targeted to specific biomarkers, which ensures greater efficacy and faster time to treatments. Personalized medicines are evolving quickly, accounting for more than 25% of FDA approvals in the past 7 years, according to the report.¹

The report also focuses on the pharmaceutical industry’s progress in addressing diseases highlighted by the United Nations Sustainable Development Goals, including infectious diseases such as tuberculosis, malaria, neglected tropical diseases, and water-borne illnesses, as well as maternal mortality and non-communicable diseases, such as mental illness and substance abuse.¹

The 15 drugs likely to achieve blockbuster status by 2027 include drugs for a wide range of diseases:¹

• Bimekizumab (Bimzelx, UCB) is the first dual interleukin (IL)-17 A/F inhibitor indicated to treat moderate to severe plaque psoriasis. Results from a phase 3 trial showed superior skin clearance outcomes compared with existing treatments, and its less frequent dosing schedule and improved safety profile is predicted to be beneficial for patients and clinicians, according to the report.
• Capivasertib (AZD5363, AstraZeneca) is a novel, highly potent, selective adenosine triphosphate (ATP)-competitive pan-AKT kinase inhibitor for patients with breast cancer. Encouraging data have been announced from early phase trials, with clinical benefit irrespective of patients’ PIK3CA/AKT1/PTEN mutational status. Several phase 3 trials are currently underway.
• Daprodustat (Duvroq, GSK) is an oral treatment for chronic kidney disease (CKD)-related anemia and is a hypoxia-inducible factor‑prolyl hydroxylase inhibitor. It is already available for CKD-related anemia in Japan, and the report noted that uptake there has been impressive.
• Deucravacitinib (Sotyktu, Bristol Myers Squibb) is a first-in-class oral, targeted agent that selectively inhibits tyrosine kinase 2, which mediates cytokine-driven immune and inflammatory signals. It could potentially fill treatment gaps in plaque psoriasis.
• Foscarbidopa/foslevodopa (ABBV-951, AbbVie) is a novel reformulation of carbidopa/levodopa, which is the gold standard treatment for Parkinson disease. It is delivered via a subcutaneous pump for the treatment of motor fluctuations in patients with advanced Parkinson disease. It may offer better efficacy than orally administered carbidopa-levodopa, dosing flexibility, and a more convenient pump than other competitors, according to the report.
• Lecanemab (BAN2401, Eisai Co Ltd and Biogen Inc) and Donanemab (LY-3002813, Eli Lilly and Co) are both indicated to treat early-stage Alzheimer disease. Lecanemab, a next-in-class anti-Aβ, is supported by landmark phase 3 clinical data and received FDA accelerated approval on January 6, 2023.² Donanemab and others in the class may follow closely behind, pending trial results.
• Lenacapavir (Sunlenca, Gilead Sciences Inc) is already approved in Europe and is the first-in-class, long-acting HIV-1 capsid inhibitor approved to treat multi-drug resistance HIV in patients who have been heavily treated. It is also being investigated to treat HIV and for pro-exposure prophylaxis. Its infrequent dosing and self-administration will likely make it an attractive option for patients and clinicians, according to the report.
• Mirikizumab (LY-3074828, Eli Lilly and Co) is a monoclonal antibody targeting the p19 subunit of IL-23 and will likely be first-in-class for the treatment of ulcerative colitis and third in class approved for Crohn disease. As a set of emerging therapies with novel mechanisms of action, it will contribute to the growing market share for these therapies, according to the report.
• Pegcetacoplan (Empaveli/Aspaveli/APL-2, Apellis Pharmaceuticals Inc) has already launched in the United States for the treatment of Paroxysmal nocturnal hemoglobinuria, a rare hematological disease. As one of the few drugs to have completed phase 3 trials for geographic atrophy, it is expected to be the first drug to launch for this indication or dry late age-related macular degeneration, which has no approved pharmacotherapy options.
• Ritlecitinib (PF-06651600, Pfizer Inc) is expected to be a first-in-class treatment for both adults and adolescents diagnosed with alopecia areata. It also benefits from a rapid onset of action, according to the report.
• Sparsentan (Travere Therapeutics Inc) is a first-in-class, orally active, single molecule that functions as a high-affinity, dual-acting antagonist of both endothelin type A and angiotensin 2 subtype 1 receptors, which are associated with the progression of kidney disease. Its development is expected to halt that progression for many patients and fill a gap in treatment options.
• Teclistamab (Tecvayli, Janssen) is a first-in-class bispecific antibody targeted to B-cell maturation antigen for the treatment of multiple myeloma and has received conditional approval from the European Commission. Ongoing phase 3 trials are expected to provide confirmatory evidence and lead to label expansions in other multiple myeloma patient populations, including in combination with other agents.
• Teplizumab (Tzield, Provention Bio Inc) is the first immunotherapy to launch for type 1 diabetes mellitus and is a landmark drug with the potential ability to preserve beta cell function and delay the need for insulin treatment.
• Valoctocogene roxaparvovec (Roctavian, BioMarin Pharmaceutical Inc) was approved by the European Commission in August 2022 and is expected to be the first gene therapy to launch in the United States for severe hemophilia A. It has an expected treatment benefit of years and is expected to reduce the number of bleeding events, minimize the need for replacement factor VIII, and negate the use of prophylaxis treatment.

Reference

1. Clarivate Identifies Fifteen Potential Blockbuster Drugs in Annual Drugs to Watch Report. News release. Clarivate; January 10, 2023. Accessed January 9, 2023. Email.
2. Hunter, E. FDA Grants Accelerated Approval to Lecanemab for Early Stage Alzheimer Disease. Pharmacy Times; January 6, 2023. Accessed January 9, 2023. https://www.pharmacytimes.com/view/fda-grants-accelerated-approval-to-lecanemab-for-early-stage-alzheimer-disease