The 2011–20 projection period will see the loss of exclusivity for the leading non-insulin antidiabetic Actos franchise, while new launches include the first once-weekly GLP-1 agonists and the oral SGLT-2 inhibitor class, to compete in an increasingly crowded treatment algorithm in type 2 diabetes. This market research report was updated in May 2012 to reflect recent developments in the industry .Forecast leading non-insulin antidiabetic brands in the 2011–20 period.Quantify the sales potential late-stage pipeline products.Assess the impact of generic competition and sales restrictions on the Actos (pioglitazone) franchise.Determine the impact of recent clinical trial results and regulatory decisions.Despite moderate efficacy, a benign safety profile and oral delivery will mean that DPP-IV inhibitors continue to dominate branded non-insulin antidiabetics, with the class projection to be worth over USD 8bn in 2020, led by gold standard Januvia.The GLP-1 agonist class sees once-weekly product launch, but doubts about their efficacy will allow once-daily Victoza (liraglutide; Novo Nordisk) to retain a leading position in the class and reach blockbuster status early in the projection period.The US industry for key non-insulin products will decline temporarily after the loss of exclusivity for Actos in August 2012. Use of the product in Europe has been reduced in 2011 due to bladder cancer risk concerns. However, in Japan Takeda’s strong industry position and poor generic penetration will mean a substantial revenue stream through 2020.Use the Datamonitor patient-based projection to quantify key non-insulin product sales at country, class, molecule and brand levels.Identify which brands will grow in the 2011–2020 projection period and which industry s are more receptive to growth.Use volume data to understand overriding trends in the key non-insulin antidiabetics industry .

Table Of Contents

OVERVIEW•Catalyst
•Summary

EXECUTIVE SUMMARY•Update details: May 2012
•Strategic scoping and focus
•Datamonitor key findings
•Related reports
•Published diabetes reports

MARKET DEFINITION •Market definition for key non-insulin antidiabetic drugs
•Forecast methodology and hypothesis s - Methodology flow
- Patent expiries
- New product launches

•Additional projection methodology

MARKET OVERVIEW AND CONTEXT•Current and future industry dynamics overview - DPP-IV inhibitors and GLP-1 agonists will dominate non-insulin antidiabetics sales
- US continues to dominate antidiabetic sales
- US industry declines with loss of Actos exclusivity before rising again
- Japanese industry provides key late-stage revenues for Actos franchise even with generic competition
- GLP-1 agonists will continue to see a high uptake in France
- Germany’s reimbursement regulations could raise industry entry barrier for pipeline products
- DPP-IV inhibitors will dominate key non-insulin antidiabetic sales in Italy
- Industry ed and pipeline products drive Spanish industry growth
- Strong growth in diagnosed diabetes population drives UK industry

PRODUCT FORECASTS•DPP-IV inhibitor product projections - Januvia franchise (sitagliptin; Merck and Co.)
- Galvus franchise (vildagliptin; Novartis)
- Onglyza franchise (saxagliptin; Bristol-Myers Squibb/AstraZeneca)
- Nesina franchise (alogliptin; Takeda)
- Tradjenta franchise (linagliptin; Boehringer Ingelheim/Eli Lilly)
- Teneligliptin (Mitsubishi Tanabe)

•GLP-1 agonist product projections - Byetta (exenatide twice daily; Amylin)
- Victoza (liraglutide; Novo Nordisk)
- Bydureon (exenatide once-weekly; Amylin/Alkermes)
- Lyxumia (lixisenatide; Sanofi/Zealand Pharma)
- Syncria (albiglutide; GlaxoSmithKline)
- LY2189265 (dulaglutide; Eli Lilly)

•Glitazone product projections - Actos franchise (pioglitazone; Takeda)

•SGLT-2 inhibitor product projections - Forxiga franchise (Bristol-Myers Squibb/AstraZeneca)
- Canagliflozin franchise (Johnson and Johnson/Mitsubishi Tanabe)
- Empagliflozin (BI-10773; Boehringer Ingelheim/Eli Lilly)
- Ipragliflozin franchise (ASP-1941; Astellas)

BIBLIOGRAPHY•General sources
•Datamonitor reports

APPENDIX •Forecast methodology - Volume and value projection methodology
- Price and compliance hypothesis s

•Report methodology

TABLES•Table: Industry ed non-insulin antidiabetics projection to brand/franchise level, 2011
•Table: Pipeline non-insulin antidiabetics projection to brand/franchise level, 2011
•Table: Estimated patent expiry dates/generic and biosimilar launches in the antidiabetics industry, 2011-20
•Table: Estimated launch dates for key late-stage pipeline products and industry ed brands in diabetes in the seven major industries, 2011-20
•Table: Key branded sales for non-insulin antidiabetics in the US, by brand ($m), 2011-20
•Table: Key branded sales for non-insulin antidiabetics in Japan, by brand ($m), 2011-20
•Table: Key branded sales for non-insulin antidiabetics in France, by brand ($m), 2011-20
•Table: Key branded sales for non-insulin antidiabetics in Germany, by brand ($m), 2011-20
•Table: Key branded sales for non-insulin antidiabetics in Italy, by brand ($m), 2011-20
•Table: Key branded sales for non-insulin antidiabetics in Spain, by brand ($m), 2011-20
•Table: Key branded sales for non-insulin antidiabetics in the UK, by brand ($m), 2011-20
•Table: Januvia franchise (Merck and Co.) sales for diabetes, by brand ( USD m ), 2011-20
•Table: Januvia (sitagliptin; Merck and Co.) sales for diabetes, by country ( USD m ), 2011-20
•Table: Janumet (sitagliptin + metformin; Merck and Co.) sales for diabetes, by country ( USD m ), 2011-20
•Table: Juvisync (sitagliptin + simvastatin; Merck and Co.) sales for diabetes, by country ( USD m ), 2011-20
•Table: Galvus franchise (Novartis) sales for diabetes, by brand ( USD m ), 2011-20
•Table: Galvus (vildagliptin; Novartis) sales for diabetes, by country ( USD m ), 2011-20
•Table: Eucreas (vildagliptin + metformin; Novartis) sales for diabetes, by country ( USD m ), 2011-20
•Table: Onglyza franchise (Bristol-Myers Squibb/AstraZeneca) sales for diabetes, by brand ( USD m ), 2011-20
•Table: Onglyza (saxagliptin; Bristol-Myers Squibb/AstraZeneca) sales for diabetes, by country ( USD m ), 2011-20
•Table: Kombiglyze (saxagliptin + metformin; Bristol-Myers Squibb/AstraZeneca) sales for diabetes, by country ( USD m ), 2011-20
•Table: Nesina franchise (Takeda) sales for diabetes, by brand ( USD m ), 2011-20
•Table: Nesina (alogliptin; Takeda) sales for diabetes, by country ( USD m ), 2011-20
•Table: Alogliptin + metformin (alogliptin + metformin; Takeda) sales for diabetes, by country ( USD m ), 2011-20
•Table: Liovel (alogliptin + pioglitazone; Takeda) sales for diabetes, by country ( USD m ), 2011-20
•Table: Tradjenta franchise (Boehringer Ingelheim/Eli Lilly) sales for diabetes, by brand ( USD m ), 2011-20
•Table: Tradjenta (linagliptin; Boehringer Ingelheim/Eli Lilly) sales for diabetes, by country ( USD m ), 2011-20
•Table: Jentadueto (linagliptin + metformin; Boehringer Ingelheim/Eli Lilly) sales for diabetes, by country ( USD m ), 2011-20
•Table: Linagliptin + pioglitazone (linagliptin + pioglitazone; Boehringer Ingelheim/Eli Lilly) sales for diabetes, by country ( USD m ), 2011-20
•Table: Tenegliptin (Mitsubishi Tanabe) sales for diabetes ( USD m ), 2011-20
•Table: Byetta (exenatide twice daily; Amylin) sales for diabetes, by country ( USD m ), 2011-20
•Table: Victoza (liraglutide; Novo Nordisk) sales for diabetes, by country ( USD m ), 2011-20
•Table: Bydureon (exenatide once-weekly; Amylin/Alkermes) sales for diabetes, by country ( USD m ), 2011-20
•Table: Lyxumia (lixisenatide; Sanofi/Zealand Pharma) sales for diabetes, by country ( USD m ), 2011-20
•Table: Syncria (albiglutide; GlaxoSmithKline) sales for diabetes, by country ( USD m ), 2011-20
•Table: LY2189265 (dulaglutide; Eli Lilly) sales for diabetes, by country ( USD m ), 2011-20
•Table: Actos franchise (Takeda) sales for diabetes, by country ( USD m ), 2011-20
•Table: Forxiga franchise (Bristol-Myers Squibb/AstraZeneca) sales for diabetes, by country ( USD m ), 2011-20
•Table: Canagliflozin franchise (Johnson and Johnson/Mitsubishi Tanabe) sales for diabetes, by country ( USD m ), 2011-20
•Table: Empagliflozin franchise (BI-10773; Boehringer Ingelheim/Eli Lilly) sales for diabetes, by country ( USD m ), 2011-20
•Table: Ipragliflozin franchise (ASP-1941; Astellas) sales for diabetes, by country ( USD m ), 2011-20
•Table: Drug-treated patient proportion among diagnosed prevalent patients in the seven major industry s (%), 2011-20
•Table: Compliance rates for non-insulin use in the seven major industry s (%), 2011-20
•Table: Survey respondents in the seven major industries, by country and physician type, 2011

FIGURES•Figure: Patient-based projection methodology for type 2 diabetes, 2011
•Figure: Non-insulin antidiabetic sales in the seven major industries, by class ($m), 2011-20
•Figure: Key non-insulin antidiabetic sales in the seven major industries, by country ($m), 2011-20
•Figure: Non-insulin antidiabetic sales in the seven major industries, by country (patient treatment years), 2011-20
•Figure: Key product n on-insulin antidiabetic sales in the US, by class ($m), 2011-20
•Figure: Key product n on-insulin antidiabetic sales in Japan, by class ($m), 2011-20
•Figure: Key product n on-insulin antidiabetic sales in France, by class ($m), 2011-20
•Figure: Key product n on-insulin antidiabetic sales in Germany, by class ($m), 2011-20
•Figure: Key product n on-insulin antidiabetic sales in Italy, by class ($m), 2011-20
•Figure: Key product n on-insulin antidiabetic sales in Spain, by class ($m), 2011-20
•Figure: Key product n on-insulin antidiabetic sales in the UK, by class ($m), 2011-20
•Figure: DPP-IV inhibitor sales in the seven major industries, by product ($m), 2011-20
•Figure: Januvia franchise (Merck and Co.) sales for diabetes, by brand ( USD m ), 2011-20
•Figure: Januvia (sitagliptin; Merck and Co.) sales for diabetes, by country ( USD m ), 2011-20
•Figure: Janumet (sitagliptin + metformin; Merck and Co.) sales for diabetes, by country ( USD m ), 2011-20
•Figure: Juvisync (sitagliptin + simvastatin; Merck and Co.) sales for diabetes, by country ( USD m ), 2011-20
•Figure: Galvus franchise (Novartis) sales for diabetes, by brand ( USD m ), 2011-20
•Figure: Galvus (vildagliptin; Novartis) sales for diabetes, by country ( USD m ), 2011-20
•Figure: Eucreas (vildagliptin + metformin; Novartis) sales for diabetes, by country ( USD m ), 2011-20
•Figure: Onglyza franchise (Bristol-Myers Squibb/AstraZeneca) sales for diabetes, by brand ( USD m ), 2011-20
•Figure: Onglyza (saxagliptin; Bristol-Myers Squibb/AstraZeneca) sales for diabetes, by country ( USD m ), 2011-20
•Figure: Kombiglyze (saxagliptin + metformin; Bristol-Myers Squibb/AstraZeneca) sales for diabetes, by country ( USD m ), 2011-20
•Figure: Nesina franchise (Takeda) sales for diabetes, by brand ( USD m ), 2011-20
•Figure: Nesina (alogliptin; Takeda) sales for diabetes, by country ( USD m ), 2011-20
•Figure: Alogliptin + metformin (alogliptin + metformin; Takeda) sales for diabetes, by country ( USD m ), 2011-20
•Figure: Liovel (alogliptin + pioglitazone; Takeda) sales for diabetes, by country ( USD m ), 2011-20
•Figure: Tradjenta franchise (Boehringer Ingelheim/Eli Lilly) sales for diabetes, by brand ( USD m ), 2011-20
•Figure: Tradjenta (linagliptin; Boehringer Ingelheim/Eli Lilly) sales for diabetes, by country ( USD m ), 2011-20
•Figure: Jentadueto (linagliptin + metformin; Boehringer Ingelheim/Eli Lilly) sales for diabetes, by country ( USD m ), 2011-20
•Figure: Linagliptin + pioglitazone (linagliptin + pioglitazone; Boehringer Ingelheim/Eli Lilly) sales for diabetes, by country ( USD m ), 2011-20
•Figure: Tenegliptin (Mitsubishi Tanabe) sales for diabetes ( USD m ), 2011-20
•Figure: GLP-1 agonist sales in the seven major industries, by product ($m), 2011-20
•Figure: Byetta (exenatide twice daily; Amylin) sales for diabetes, by country ( USD m ), 2011-20
•Figure: Victoza (liraglutide; Novo Nordisk) sales for diabetes, by country ( USD m ), 2011-20
•Figure: Bydureon (exenatide once-weekly; Amylin/Alkermes) sales for diabetes, by country ( USD m ), 2011-20
•Figure: Lyxumia (lixisenatide; Sanofi/Zealand Pharma) sales for diabetes, by country ( USD m ), 2011-20
•Figure: Syncria (albiglutide; GlaxoSmithKline) sales for diabetes, by country ( USD m ), 2011-20
•Figure: LY2189265 (dulaglutide; Eli Lilly) sales for diabetes, by country ( USD m ), 2011-20
•Figure: Sales of branded and generic pioglitazone (and combinations), seven major industry s ($m), 2011-20
•Figure: Actos franchise (Takeda) sales for diabetes, by country ( USD m ), 2011-20
•Figure: SGLT-2 inhibitor sales in the seven major industries, by product ($m), 2011-20
•Figure: Forxiga franchise (Bristol-Myers Squibb/AstraZeneca) sales for diabetes, by country ( USD m ), 2011-20
•Figure: Canagliflozin franchise (Johnson and Johnson/Mitsubishi Tanabe) sales for diabetes, by country ( USD m ), 2011-20
•Figure: Empagliflozin franchise (BI-10773; Boehringer Ingelheim/Eli Lilly) sales for diabetes, by country ( USD m ), 2011-20
•Figure: Ipragliflozin franchise (ASP-1941; Astellas) sales for diabetes, by country ( USD m ), 2011-20

Companies mentioned

GlaxoSmithKline Plc, Hutchison 3G UK Limited, Janssen Pharmaceuticals, Inc.

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