The Non-Insulin Therapies for Diabetes: GLP-1 Agonists, DPP4 Inhibitors and SGLT2 Inhibitors, 2016-2026 report provides a comprehensive analysis of the current market landscape of these therapies and an informed opinion on how the market is likely to evolve over the next decade. The anti-diabetic drugs market broadly comprises of insulin and non-insulin therapies.
Diabetes, considered to be the most common metabolic disorder in humans, is ranked among the top ten fatal diseases in the US. The increasing incidence, growing prevalence and the progressive nature of the disease has spurred several pharmaceutical companies to develop novel approaches / therapies to provide better treatment options for diabetic patients worldwide. While insulin supplements and insulin based therapies represent a major portion of the anti-diabetic drugs market, non-insulin therapies are first line therapies designed especially for patients suffering from type II diabetes.
Sulfonylureas, biguanides, glinides, TZDs and alpha- glucosidase inhibitors were the first classes of non-insulin therapies to hit the market. Subsequently, incretin based therapies, such as GLP-1 agonists and DPP4 inhibitors, emerged as the standard of care for the treatment of type II diabetes. More recently, SGLT2 inhibitors have also been identified as an effective treatment solution for the same patient population. These three classes have captured a significant portion of the overall anti-diabetes market in a relatively short time span.
GLP-1 agonists and DPP4 inhibitors were introduced in the market over a decade ago while the first SGLT2 inhibitor was approved only in 2012. A number of drugs have emerged as blockbusters; examples include VICTOZA® (GLP-1 agonist), JANUVIA® / JANUMET® (DPP4 inhibitor) and INVOKANA® / INVOKAMET® (SGLT2 inhibitor).
Several companies, including both big pharmaceutical players and small to mid-sized companies, are active in this area. Companies engaged in developing anti-diabetic drug classes have actively entered into collaborations with other stakeholders to either acquire / develop / commercialize candidate therapies or for technology licensing. For instance, Tobira acquired the exclusive rights to develop and commercialize evogliptin from Dong-A ST in April 2016; Eli Lilly and Sumitomo Dainippon Pharma entered into a sales collaboration agreement for Trulicity® in July 2015; Novo Nordisk in-licensed Zosano's technology to develop a transdermal patch formulation of Novo's GLP-1 analogs, including semaglutide in February 2014; Takeda and Sanofi signed a co-promotion agreement for alogliptin in China in April 2013.
Recently issued FDA warnings specifically for DPP4 and SGLT2 inhibitors are likely to impact their adoption. However, new advances in drug development and the introduction of novel technologies are expected to help stakeholders operate within a proper framework and work towards eliminating the current gaps.
- With a current total / combined share of more than 70% in the overall non-insulin market, GLP-1 agonists, DPP4 inhibitors and SGLT2 inhibitors represent the three most prominent anti-diabetic drug classes. In terms of size, currently, the market of GLP-1 agonists, DPP4 inhibitors and SGLT2 inhibitors is worth over USD 4 billion, USD 10 billion and USD 2 billion respectively. Overall, the market is highly fragmented and well distributed across different regions.
- Combined, the three drug classes have over 20 approved drugs (accounting around 40 different formulations / fixed-dose combinations) for the treatment of type II diabetes. In addition, the clinical / preclinical pipeline is rich and has over 70 molecules in different stages of development. Of the three classes, DPP4 inhibitors currently has the maximum number of marketed drugs (over 10, excluding fixed-dose combinations). On the other hand, GLP-1 agonists represent the most active class of drugs with over 40 molecules under development. SGLT2 inhibitors are also emerging at a rapid pace and already have six marketed drugs across different regions. Semaglutide (Novo Nordisk), ITCA 650 (Intarcia Therapeutics), sotagliflozin (Sanofi / Lexicon Pharmaceuticals), ertugliflozin (Merck / Pfizer), retagliptin (Jiangsu Hengrui Medicine) and gosogliptin (SatRx / Pfizer) are examples of late stage drugs that are likely to receive approval in the near future.
- Overall we came across over 80 pharmaceutical companies actively engaged in the discovery, development and commercialization of non-insulin therapies. Established pharmaceutical players have captured a major share of the non-insulin anti-diabetic drugs market. In fact, AstraZeneca, BMS, Eli Lilly and Sanofi are developing non-insulin therapies across all the three drug classes. Several other companies such as Daiichi Sankyo, Janssen, Merck, Mitsubishi Tanabe Pharma, Novartis, Novo Nordisk, Pfizer, Sanofi, Takeda and Zealand Pharma have invested heavily in the development of multiple molecules belonging to these drug classes. A number of start-ups / small companies such as (in alphabetical order) Alteogen, Amunix, ArisGen, C4XD, Diartis Pharmaceuticals, Oramed Pharmaceutical, PegBio, Poxel, Rani Therapeutics, Receptos, SatRx, Sirona Biochem and Spitfire Pharma have entered this space and are also competing to gain a significant share in the overall non-insulin therapies market.
- In addition to increased competition of such therapies in the major geographies such as the US and EU, some stakeholders have focused on tapping a localized opportunity. Drugs such as teneligliptin (Mitsubishi Tanabe Pharma), trelagliptin (Takeda), ipragliflozin (Astellas Pharma/ Kotobuki Pharmaceutical) and luseogliflozin (Taisho Pharmaceutical) have been approved only in Japan. Similarly, retagliptin (Jiangsu Hengrui Medicine) and Uni-E4 (Uni-Bio Science Group) are in Phase III clinical development in China only.
- With a vision to increase patient compliance, several pharmaceutical companies have introduced fixed-dose formulations of different drugs. Prominent examples include Eucreas® / Galvumet® / Galvus Met® / Icandra® / Zomarist® (vildagliptin + metformin) (Novartis), INVOKAMET® / VOKANAMET® (canagliflozin + metformin) (Janssen Pharmaceutical Companies / Mitsubishi Tanabe Pharma / Daiichi Sankyo), JANUMET® / Velmetia® (sitagliptin + metformin) (Merck), Xigdua® (dapagliflozin + metformin) (Astra Zeneca / BMS) and Xultophy® / IDegLira (liraglutide + insulin degludec) (Novo Nordisk).
- Technological advancements are amongst the key future growth drivers. Drug developers are investigating new routes of administration using several innovative technology platforms, such as Axcess (Diabetology), Eligen® (Emisphere Technologies), PharmFilm® Technology (MonoSol Rx) and the Protein Oral Delivery (POD) technology (Oramed Pharmaceuticals), to facilitate the oral administration of GLP-1 agonists. Other innovative technologies such as the Intravail® drug delivery platform are attempting to facilitate nasal administration.Companies such as ScinoPharm and Panacea Biotech are developing oral capsule formulations of DPP4 inhibitors. Their molecules, DBPR108 and PBL 1427, respectively, are still in the early stages of clinical development.SGLT2 inhibitors, primarily used to treat type II diabetes, are also being developed for the treatment of type I diabetes. Examples include sotagliflozin (Theracos) and remogliflozin (BHV Pharma).
- Dual agonist drugs are also being developed to provide more effective treatment options. Examples of molecules that target both the GLP-1 receptor and glucagon receptor include MK-8521 (Merck), TTP401 / LY2944876 (Transition Therapeutics / Eli Lilly), MEDI0382 (AstraZeneca), SAR425899 (Sanofi) and MOD-6030 / MOD-6031 (OPKO Biologics). On the other hand, NN9709 (Novo Nordisk) and SAR438335 (Sanofi) are being developed to act on both GLP-1 and GIP receptors.
- Several research institutes, companies and organization have made significant contribution to the discovery and overall development of these therapies. During the study, we identified over 400 key opinion leaders who have played critical role in the development of GLP-1 agonists, DPP4 inhibitors and SGLT2 inhibitors. In addition, we identified over 50 articles, published during the 12 months beginning January 2015, which focused on these three drug classes. The design of these studies primarily focussed on evaluating the safety, efficacy, tolerability, pharmacokinetics and pharmacodynamics of the drugs.
- Extensive efforts are being made by pharmaceutical companies to explore new and innovative therapeutic strategies and agents that are safer and more effective than the already available options. Many novel non-insulin therapies are under clinical development. Examples of these new anti-diabetic drug classes include glucokinase activators, GPR119 agonists, GCGR antagonists, 11-beta hydroxysteroid dehydrogenase type 1 inhibitors, glycogen phosphorylase inhibitors and PTP-1B antagonists.
- It is important to highlight that nearing patent expiries of currently available drugs and the potential health hazards associated with the use of some of these inhibitors are going to negatively impact the market growth. However, our overall outlook is highly promising. We believe that SGLT2 inhibitors are likely to grow at an annualized growth rate of -17%, followed by GLP-1 agonists (expected growth rate of -13.4%).
For more information about this report visit http://www.researchandmarkets.com/research/rkfltl/noninsulin
Related Topics: Immune Disorders Drugs, Endocrinology
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