Last Updated 12 September 2014
The type 2 diabetes therapy market will rapidly expand over our 2013-2023 study period, fueled by the disease’s increasing prevalence and a high unmet need for drugs that can effectively control the disease in the long term. A rich pipeline of novel agents is expected to launch, promoting sustained market growth. Among the drug classes expected to undergo the most rapid growth is the sodium glucose cotransporter (SGLT)-2 inhibitors, led by AstraZeneca’s dapagliflozin (Forxiga/Farxiga) and Johnson & Johnson/Mitsubishi Tanabe Pharma’s canagliflozin (Invokana). However, these and other emerging therapies will face major challenges, including reimbursement hurdles and an increasingly stringent regulatory environment. Nevertheless, as the patient population expands and significant needs remain, commercial opportunity will continue to grow.
Questions Answered in This Report:
- The dipeptidyl peptidase (DPP)-IV inhibitor class will continue to experience strong growth over the study period, until anticipated genericization of the class toward the end of the forecast period. Are emerging once-weekly DPP-IV inhibitors likely to receive significant uptake? What is the potential impact of Actavis’s approval of generic saxagliptin on the DPP-IV inhibitor market?
- The GLP-1 receptor agonist class will also continue to expand over 2013-2023 as more treatment options offer dosing advantages over the first-to-market agents exenatide (AstraZeneca’s Byetta) and liraglutide (Novo Nordisk’s Victoza). Will albiglutide’s (GlaxoSmithKline’s Tanzeum/Eperzan) significant price discount relative to liraglutide encourage uptake despite inferior efficacy? What is the anticipated uptake of dulaglutide (Eli Lilly’s Trulicity) following the results of the AWARD-6 trial? What impact will Intarcia Therapeutics’ GLP-1 receptor agonist implant, ITCA-650, have over the forecast period?
- The first two members of the SGLT-2 inhibitor class, canagliflozin and dapagliflozin, have recently launched in the United States and Europe, while ipragliflozin (Astellas/Kotobuki’s Suglat) was first-to-market in Japan. Several new entrants are also expected in the SGLT-2 inhibitor class over the forecast period. How will later-to-market entrants such as Eli Lilly/Boehringer Ingelheim’s empagliflozin (Jardiance) distinguish themselves from first-to-market competitors? Considering their unique clinical profile, how will the SGLT-2 inhibitors be positioned in the treatment algorithm for type 2 diabetes?
- Several novel insulin formulations, such as Eli Lilly/Boehringer Ingelheim’s insulin peglispro, are in late-stage development, including the first biosimilar versions of insulin glargine. How do the experts expect new insulin analogues to fare against established insulin analogues such as Sanofi’s insulin glargine (Lantus) and Novo Nordisk’s insulin detemir (Levemir)? What are physicians’ opinions regarding potential use of biosimilar insulin glargine? What is the consensus of opinion on the need for, and potential of, Sanofi/MannKind’s inhalable Technosphere insulin? ?
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 27 country-specific interviews with thought leaders.
Epidemiology: Prevalence of type 2 diabetes, segmented by body mass index (BMI) status and renal impairment status. Prevalence of prediabetes (impaired glucose tolerance [IGT]).
Population segments in market forecast: Type 2 diabetes.
Emerging therapies: Phase II: 21 drugs; Phase III: 12 drugs; preregistration: 9 drugs. Coverage of select preclinical and Phase I products.
Market forecast features: Using a patient-based model, we forecast population sizes and drug sales for type 2 diabetes through 2023.
Alternative market scenarios: Actavis’s generic saxagliptin is not considered to violate AstraZeneca’s U.S. patent 7,915,400 and enters the market in February 2017.
Catherine Vasilakis-Scaramozza, Ph.D., M.P.H.