NEW YORK, Aug. 23, 2016 /PRNewswire/ -- INTRODUCTION
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.
SCOPE OF THE REPORT
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. Non-insulin therapies are further classified under various categories based on their respective mechanisms of action. Of the different types of non-insulin therapies, GLP-1 agonists, DPP4 inhibitors and SGLT2 inhibitors have been the most popular in the last few years. As mentioned earlier, these therapeutic classes have captured the attention of a number of pharmaceutical companies and drug developers worldwide. Several companies, including pharmaceutical giants, mid-sized players and start-ups, have come up with innovative technologies and novel formulations of these drug classes. Such advances have generated and sustained significant momentum in this segment of the industry. Specifically, GLP-1 agonists, which have been researched for several years, have a rich pipeline of clinical and preclinical molecules. DPP4 inhibitors currently have a relatively larger market share; however, they are now giving way to other relatively newer and emerging classes such as SGLT2 inhibitors.
During the course of our study, we identified over 80 molecules belonging to these three drugs classes. More than 70% of the candidates are currently under clinical / preclinical development; the efforts are actively being led by several companies. Focused primarily on these three classes of drugs, this report features:
- An overview of the market landscape highlighting important details on each molecule such as key players, current phase of product development, route of administration and dosage regime.
- Detailed profiles of drugs that have been recently approved / marketed or are in the late stages of development.
- A list of key opinion leaders (KOLs) who were involved in the discovery and development of GLP-1 agonists, DPP4 inhibitors and SGLT2 inhibitors.
- An analysis of recently published clinical trial data depicting the prevalent trends and technical developments that have taken place in the industry.
- A discussion on the potential side effects and warnings issued by regulatory authorities suggesting areas of improvement / guidance for future drug development.
- A list of upcoming non-insulin novel therapies that are currently in early stages of development and likely to become a part of the anti-diabetic drugs market in the near future.
The report also provides an estimate of the likely future size of the non-insulin therapies for diabetes. Our forecast model was built based on an understanding of the existing market trends and likely future opportunities for GLP-1 agonists, DPP4 inhibitors, SGLT2 inhibitors and other non-insulin anti-diabetic drug classes. We have provided informed estimates of the expected future sales of marketed and late stage product candidates under each category, highlighting their share in the overall market over the next ten years.
The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. Actual figures have been sourced and analyzed from publicly available data. Unless otherwise specified, all financial figures are presented in USD.
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market may evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include:
- Annual reports
- Investor presentations
- SEC filings
- Industry databases
- News releases from company websites
- Government policy documents
- Industry analysts' views
While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.
Chapter 2 is an executive summary of the insights captured in our research. The summary offers a high level view on the likely evolution of GLP-1 agonists, DPP4 inhibitors and SGLT2 inhibitors during the coming decade.
Chapter 3 provides a general introduction to diabetes and discusses associated symptoms, available diagnostic methods and tests, and other complications associated with the condition. It also includes a detailed classification of the various therapeutic interventions available for the treatment of diabetes. These include both insulin based and non-insulin therapies. The chapter also provides brief descriptions of their respective mechanisms of action.
Chapter 4 provides a comprehensive overview of the market landscape of GLP-1 agonists, DPP4 inhibitors and SGLT2 inhibitors. It includes information on over 100 different molecules that fall under these classes of drugs. Some of these are already approved and are available in different regions across the globe. The rest are currently in various stages of preclinical / clinical development. The chapter presents analysis of the molecules based on their current phase of development, the various routes of administration being considered for their systemic delivery, dosage frequency, type of molecule and key players involved in developing these molecules.
Chapter 5 contains detailed profiles of recently approved and late stage GLP-1 agonists. Each profile covers information on several aspects of these drugs such as their history of development, clinical trial results, dosage form and regime, recent sales of the product (for marketed drugs), the current status of development, and the collaborations and partnerships that have been inked related to that particular drug / drug candidate.
Chapter 6 contains detailed profiles of recently approved and late stage DPP4 inhibitors. Each profile covers information on several aspects of these drugs such as their history of development, clinical trial results, dosage form and regime, recent sales of the product (for marketed drugs), the current status of development, and the collaborations and partnerships that have been inked related to that particular drug / drug candidate.
Chapter 7 contains detailed profiles of recently approved and late stage SGLT2 inhibitors. Each profile covers information on several aspects of these drugs such as their history of development, clinical trial results, dosage form and regime, recent sales of the product (for marketed drugs), the current status of development, and the collaborations and partnerships that have been inked related to that particular drug / drug candidate.
Chapter 8 focusses on the various side effects reported by patients treated using these drugs. It includes detailed discussions on the potential complications that may arise upon using these drugs, and the warnings issued by the FDA and other regulatory bodies regarding the associated risks. In addition, the chapter lists the various GLP-1 agonists, DPP4 inhibitors and SGLT2 inhibitors that have been terminated during development due to various reasons.
Chapter 9 provides a brief introduction to other novel interventions that are currently being investigated as potential treatment options for diabetes. The chapter also includes an analysis of these novel therapeutic options based on the type of molecule being investigated and phase of development.
Chapter 10 provides a detailed analysis on the likely future size of the non-insulin therapies market over the next decade. It presents comprehensive forecast scenarios for each individual drug class mentioned in the report, namely GLP-1 agonists, DPP4 inhibitors, SGLT2 inhibitors and other non-insulin anti-diabetic drugs.
Chapter 11 presents an analysis of the Key Opinion Leaders (KOLs) in this domain. It contains schematic representations of world maps highlighting the geographical locations of these eminent scientists / researchers. The chapter presents a detailed 2X2 analysis to assess the relative experience of certain KOLs based on the number of clinical studies they participated in and the highest phase of development they investigated.
Chapter 12 provides a detailed analysis of recently published clinical data on GLP-1 agonists, DPP4 inhibitors and SGLT2 inhibitors. It identifies various aspects of the ongoing research and presents analysis highlighting the active drugs, study focus areas and clinical endpoints (safety / efficacy / tolerability / pharmacodynamics / pharmacokinetics) across the published data.
Chapter 13 is a collection of interview transcripts of the discussions we held with key stakeholders in the industry.
Chapter 14 summarizes the entire report. The chapter presents a list of key takeaways and offers our independent opinion on the current market scenario and evolutionary trends that are likely to determine the future of this segment of the industry.
Chapter 15 is an appendix, which provides tabulated data and numbers for all the figures in the report.
Chapter 16 is an appendix, which contains the list of companies and organizations that have been mentioned in the report.
1. 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.
2. 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.
3. 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.
4. 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.
5. 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).
6. 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).
7. 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.
8. 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.
9. 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.
10. 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%).
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