Introduction:Last Updated 30 September 2013
The type 2 diabetes therapy market will rapidly expand over our 2012-2022 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 most exciting of the new classes will be the sodium glucose cotransporter (SGLT)-2 inhibitors, led by Bristol-Myers Squibb/AstraZeneca’s dapagliflozin (Forxiga) 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 2012-2022 study period. How have newer DPP-IV inhibitors such as linagliptin (Boehringer Ingelheim/Eli Lilly’s Tradjenta/Trajenta/Trazenta) managed to differentiate themselves from the well-established class leader sitagliptin (Merck’s Januvia/Xelevia)? How will the regulatory delay of alogliptin (Takeda/Furiex’s Nesina) in the United States affect its uptake?
The GLP-1 receptor agonist class will also continue to expand over 2012-2022 as more treatment options offer dosing advantages over the first-to-market agents exenatide (Bristol-Myers Squibb/AstraZeneca’s Byetta) and liraglutide (Novo Nordisk’s Victoza). In which patients do interviewed experts expect to use the recently launched exenatide LAR (Bristol-Myers Squibb/AstraZeneca’s Bydureon)? How will emerging once-weekly GLP-1 receptor agonists such as dulaglutide (Eli Lilly) and albiglutide (GlaxoSmithKline’s Syncria/Eperzan) differentiate themselves from exenatide LAR? What impact will Intarcia Therapeutics’ GLP-1 receptor agonist implant, ITCA-650, have over the forecast period? What are the experts’ views on novel insulin/GLP-1 receptor agonist combinations such as Novo Nordisk’s insulin degludec/liraglutide (IDegLira) combination?
The first two members of the SGLT-2 inhibitor class, canagliflozin and dapagliflozin, have recently launched in the United States and Europe, respectively. Until its initial rejection by the FDA for safety reasons, dapagliflozin was expected to be the first member of this class on the market by a margin of several years. How will dapagliflozin’s delayed U.S. launch affect its uptake relative to that of canagliflozin? Considering their unique clinical profile, how will the SGLT-2 inhibitors be positioned in the treatment of type 2 diabetes?
Several novel insulin formulations—including the ultra-long-acting insulin analogues insulin degludec (Novo Nordisk’s Tresiba) and Boehringer Ingelheim/Eli Lilly’s insulin peglispro and MannKind’s inhaled Technosphere insulin (Afrezza)—are in late-stage development. How do the experts expect these new insulin analogues to fare against established insulin analogues such as Sanofi’s insulin glargine (Lantus) and Novo Nordisk’s insulin detemir (Levemir)? What is the consensus of opinion on the need for, and potential of, inhaled insulins?
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 28 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 2022.
Alternative market scenarios: (1) Dapagliflozin fails to launch in the United States and (2) biosimilar insulins are delayed or do not reach the market because of safety concerns.