Major Depressive Disorder – 5EU Drug Forecast and Market Analysis to 2023

Pages: 194 Published: May 01, 2014 Report Code: GDHC243CFR

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Major depressive disorder (MDD) is one of the most common psychiatric diseases worldwide. The MDD market is a crowded and competitive market, with more than 30 marketed products available for the treatment of patients with MDD. The depression market is about to enter a dynamic phase with imminent patent expiries for top selling products, such as Eli Lilly’s Cymbalta, and Otsuka/BMS’s Abilify, along with the recent launch of the multimodal antidepressant, Lundbeck/Takeda’s Brintellix, in January 2014, and the potential introduction of seven promising late-stage pipeline products into the market during the forecast period, from 2013 to 2023.

The value of the depression market in France is expected to fall following patent expiries for Lundbeck’s Lexapro in 2014, Eli Lilly’s Cymbalta in 2014, Otsuka Pharmaceutical/BMS’s Abilify in 2014, and AstraZeneca’s Seroquel XR in 2017. GlobalData estimates the drug sales for MDD in Germany were approximately $236.7m in 2013. GlobalData expects Eli Lilly’s Cymbalta and Lundbeck’s Brintellix to be the top-selling products by the end of the forecast period in Italy. GlobalData anticipates seven products in the late-stage pipeline to enter the MDD market in Spain during the forecast period: four adjunctive therapies, and three other antidepressant therapies. If physicians in the UK become convinced from experience in clinical practice that Brintellix offers improvements in cognitive function, Lundbeck will be able to differentiate Brintellix from other available SSRI and SNRI treatments and subsequently drive higher patient share.

Scope

Overview of Major depressive disorder including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.

Detailed information on the key drugs in 5EU including product description, safety and efficacy profiles as well as a SWOT analysis.

Sales forecast for the top drugs in 5EU from 2013-2023.

Analysis of the impact of key events as well the drivers and restraints affecting the 5EU Major depressive disorder market.

Reasons to Buy

Understand and capitalize by identifying products that are most likely to ensure a robust return

Stay ahead of the competition by understanding the changing competitive landscape for Major depressive disorder.

Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential

Make more informed business decisions from insightful and in-depth analysis of drug performance

Obtain sales forecast for drugs from 2013-2023 in 5EU.

Table of Contents

1Table of Contents1

1.1List of Tables6

1.2List of Figures10

2Executive Summary11

2.1Sales for Major Depressive Disorder (MDD) in the Five Major EU Markets11

2.2What Do The Physicians Think?12

3Introduction14

3.1Catalyst14

3.2Related Reports15

3.3Upcoming Related Reports17

4Disease Overview17

4.1Etiology and Pathophysiology17

4.1.1Etiology17

4.1.2Pathophysiology18

4.2Classification20

4.3Symptoms and Subtypes of Major Depressive Disorder22

4.4Prognosis23

4.5Quality of Life23

5Disease Management23

5.1Diagnosis and Treatment Overview23

5.1.1Diagnosis23

5.1.2Treatment Guidelines and Leading Prescribed Drugs25

5.1.3Clinical Practice27

5.2France32

5.3Germany34

5.4Italy36

5.5Spain39

5.6UK41

6Competitive Assessment43

6.1Overview43

6.2Product Profiles: Major Brands, Selective Serotonin Reuptake Inhibitors45

6.2.1Lexapro (Escitalopram)45

6.2.2Other Selective Serotonin Reuptake Inhibitors49

6.3Product Profiles: Major Brands, Serotonin-Norepinephrine Reuptake Inhibitors52

6.3.1Effexor (Venlafaxine)52

6.3.2Cymbalta (Duloxetine)56

6.3.3Pristiq (Desvenlafaxine)60

6.3.4Savella (Milnacipran)64

6.4Product Profiles: Major Brands, Other Antidepressants67

6.4.1Norepinephrine-Dopamine Reuptake Inhibitors67

6.4.2Noradrenaline and Specific Serotonergic Antidepressants70

6.4.3Monoamine Oxidase Inhibitors74

6.4.4Tricyclic Antidepressants76

6.4.5Brintellix (Vortioxetine)78

6.5Product Profiles: Major Brands, Antipsychotics84

6.5.1Abilify (Aripiprazole)84

6.5.2Seroquel XR (Quetiapine)88

6.6Other Therapeutic Classes92

7Unmet Needs and Opportunities92

7.1Overview92

7.2More Effective Pharmacotherapies94

7.2.1Unmet Needs94

7.2.2Gap Analysis95

7.2.3Opportunities95

7.3More Favorable Side Effect Profiles96

7.3.1Unmet Needs96

7.3.2Gap Analysis96

7.3.3Opportunities96

7.4Rapid Onset of Antidepressant Effects98

7.4.1Unmet Needs98

7.4.2Gap Analysis98

7.4.3Opportunities98

7.5Personalized Treatment Approach99

7.5.1Unmet Needs99

7.5.2Gap Analysis100

7.5.3Opportunities100

8Pipeline Assessment100

8.1Overview100

8.2Promising Drugs in Clinical Development100

8.2.1Brexpiprazole (OPC-34712)105

8.2.2Cariprazine (RGH-188)111

8.2.3ALKS-5461116

8.2.4Amitifadine (EB-1010)121

8.2.5GLYX-13126

8.2.6Tedatioxetine (Lu AA24530)130

8.2.7ETS6103134

8.3Other Drugs in Development138

9Market Outlook139

9.1Global139

9.1.1Drivers and Barriers – Global Issues139

9.2France142

9.2.1Forecast142

9.2.2Key Events146

9.2.3Drivers and Barriers146

9.3Germany148

9.3.1Forecast148

9.3.2Key Events153

9.3.3Drivers and Barriers153

9.4Italy155

9.4.1Forecast155

9.4.2Key Events160

9.4.3Drivers and Barriers160

9.5Spain162

9.5.1Forecast162

9.5.2Key Events167

9.5.3Drivers and Barriers167

9.6UK169

9.6.1Forecast169

9.6.2Key Events174

9.6.3Drivers and Barriers174

10Appendix176

10.1Bibliography176

10.2Abbreviations182

10.3Methodology186

10.4Forecasting Methodology186

10.4.1Diagnosed MDD Patients186

10.4.2Percent of Drug-Treated Patients186

10.4.3Drugs Included in Each Therapeutic Class187

10.4.4Launch and Patent Expiry Dates187

10.4.5General Pricing Assumptions188

10.4.6Individual Drug Assumptions189

10.4.7Generic Erosion193

10.4.8Pricing of Pipeline Agents193

10.5Physicians and Specialists Included in this Study195

10.6About the Authors197

10.6.1Analyst197

10.6.2Therapy Area Directors197

10.6.3Global Head of Healthcare198

10.7About GlobalData199

10.8Contact Us199

10.9Disclaimer199

List of Tables

Table 1: Classification and Criteria of Major Depressive Disorder (DSM-IV) and Major Depressive Episode (ICD-10)21

Table 2: Subtypes of Major Depressive Disorder22

Table 3: Severity of Depressive Episodes according to ICD-10 and DSM-IV Diagnostic Criteria24

Table 4: Treatment Guidelines for Major Depressive Disorder25

Table 5: Most Prescribed Drugs for MDD by Class in the 5EU, 201326

Table 6: Country Profile – France31

Table 7: Country Profile – Germany34

Table 8: Country Profile – Italy36

Table 9: Country Profile – Spain38

Table 10: Country Profile – UK40

Table 11: Leading Treatments for MDD, 201342

Table 12: Product Profile – Lexapro44

Table 13: Safety of Lexapro – Five Most Frequently Reported Adverse Events46

Table 14: Lexapro SWOT Analysis, 201446

Table 15: Relative Frequency of Common Adverse Effects for Different SSRIs50

Table 16: Product Profile – Effexor52

Table 17: Effexor SWOT Analysis, 201454

Table 18: Product Profile – Cymbalta56

Table 19: Cymbalta SWOT Analysis, 202358

Table 20: Product Profile – Pristiq59

Table 21: Efficacy of Pristiq in short-term studies60

Table 22: Pristiq SWOT Analysis, 201462

Table 23: Product Profile – Savella63

Table 24: Savella SWOT Analysis, 201464

Table 25: Product Profile – Bupropion66

Table 26: Safety of Bupropion – Five Most Frequently Reported Adverse Events67

Table 27: Bupropion SWOT Analysis, 201468

Table 28: Product Profile – Mirtazapine70

Table 29: Safety of Mirtazapine – Four Most Frequently Reported Adverse Events71

Table 30: Mirtazapine SWOT Analysis, 201472

Table 31: MAOI SWOT Analysis, 201473

Table 32: TCAs SWOT Analysis, 201476

Table 33: Product Profile – Brintellix77

Table 34: Efficacy of Brintellix in Six-Week to Eight-Week Clinical Trials78

Table 35: Safety of Brintellix – Five Most Frequently Reported Adverse Events81

Table 36: Brintellix SWOT Analysis, 201481

Table 37: Product Profile – Abilify83

Table 38: Safety of Abilify – Five Most Frequently Reported Adverse Events85

Table 39: Abilify SWOT Analysis, 201485

Table 40: Product Profile – Seroquel XR87

Table 41: Efficacy of Seroquel XR as an Adjunctive Therapy to Antidepressants88

Table 42: Safety of Seroquel XR– Five Most Frequently Reported Adverse Events89

Table 43: Seroquel XR SWOT Analysis, 201489

Table 44: Summary of Minor Therapeutic Classes in MDD, 201390

Table 45: Unmet Needs and Opportunities in MDD91

Table 46: Comparison of Therapeutic Classes in Development for MDD, 2013101

Table 47: Product Profile – Brexpiprazole104

Table 48: Safety of Brexpiprazole – Most Frequently Reported Adverse Events106

Table 49: Brexpiprazole SWOT Analysis, 2014108

Table 50: Product Profile – Cariprazine110

Table 51: Cariprazine SWOT Analysis, 2014113

Table 52: Product Profile – ALKS-5461115

Table 53: ALKS-5461 SWOT Analysis, 2014118

Table 54: Product Profile – Amitifadine119

Table 55: Amitifadine SWOT Analysis, 2014123

Table 56: Product Profile – GLYX-13124

Table 57: GLYX-13 SWOT Analysis, 2014127

Table 58: Product Profile – Tedatioxetine129

Table 59: Tedatioxetine SWOT Analysis, 2014131

Table 60: Product Profile – ETS6103132

Table 61: ETS6103 SWOT Analysis, 2014135

Table 62: Drugs in Development for MDD, 2014136

Table 63: MDD Market – Drivers and Barriers, 2013–2023137

Table 64: Sales Forecasts ($m) for MDD in France, 2013–2023140

Table 65: Key Events Impacting Sales for MDD in France, 2013–2023142

Table 66: MDD Market in France – Drivers and Barriers, 2013–2023142

Table 67: Sales Forecasts ($m) for MDD in Germany, 2013–2023146

Table 68: Key Events Impacting Sales for MDD in Germany, 2013–2023148

Table 69: MDD Market in Germany – Drivers and Barriers, 2013–2023148

Table 70: Sales Forecasts ($m) for MDD in Italy, 2013–2023152

Table 71: Key Events Impacting Sales for MDD in Italy, 2013–2023154

Table 72: MDD Market in Italy – Drivers and Barriers, 2013–2023154

Table 73: Sales Forecasts ($m) for MDD in Spain, 2013–2023158

Table 74: Key Events Impacting Sales for MDD in Spain, 2013–2023160

Table 75: MDD Market in Spain – Drivers and Barriers, 2013–2023160

Table 76: Sales Forecasts ($m) for MDD in the UK, 2013–2023164

Table 77: Key Events Impacting Sales for MDD in the UK, 2013–2023166

Table 78: MDD Market in the UK – Drivers and Barriers, 2013–2023166

Table 79: Key Launch Dates179

Table 80: Key Patent Expiries180

Table 81: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country188

List of Figures

Figure 1: Sales for MDD in the 5EU by Country, 2013 – 202312

Figure 2: Overview of Targets of Antidepressant Action on Noradrenergic and Serotonergic Neurons20

Figure 3: Disease Management Model for Major Depressive Disorder28

Figure 4: Major Depressive Disorder Treatment Algorithm30

Figure 5: MDD – Phase IIb-III Pipeline, 2014100

Figure 6: Competitive Assessment of Late-Stage Pipeline Agents in MDD, 2013–2023101

Figure 7: Clinical and Commercial Positioning of Brexpiprazole107

Figure 8: Clinical and Commercial Positioning of Cariprazine112

Figure 9: Clinical and Commercial Positioning of ALKS-5461117

Figure 10: Clinical and Commercial Positioning of Amitifadine122

Figure 11: Clinical and Commercial Positioning of GLYX-13126

Figure 12: Clinical and Commercial Positioning of Tedatioxetine130

Figure 13: Clinical and Commercial Positioning of ETS6103134

Figure 14: Sales for MDD in France by Drug Class, 2013–2023141

Figure 15: Sales for MDD in Germany by Drug Class, 2013–2023147

Figure 16: Sales for MDD in Italy by Drug Class, 2013–2023153

Figure 17: Sales for MDD in Spain by Drug Class, 2013–2023159

Figure 18: Sales for MDD in the UK by Drug Class, 2013–2023165

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