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REFERENCE CODE GDHC242CFR | PUBLICATION DATE MAY 2014

MAJOR DEPRESSIVE DISORDER - US DRUG FORECAST AND MARKET ANALYSIS TO

2023

MAJOR DEPRESSIVE DISORDER - US DRUG FORECAST AND MARKET ANALYSIS TO 2023

Executive Summary

Sales for Major Depressive Disorder (MDD) in Figure below presents the sales for MDD by the US therapeutic class in the US during the forecast period in 2013 and 2023. GlobalData estimates the drug sales for MDD in

2013 were approximately $7.5 billion in the US Sales for MDD in the US by Therapeutic Class, covered in this forecast. By the end of the forecast 2013 -2023 period in 2023, sales will grow to approximately MDD: 2013 Total: $7.5bn $7.6 billion with a Compound Annual Growth Rate 7% (CAGR) of 0.12%. 25%

The growth of the MDD market in the US is driven SSRIs by: SNRIs 10% Other  The launch of /Takeda’s Brintellix 58% Adjunctive therapies

 The introduction of four adjunctive therapies MDD: 2023 and three other therapies Total: $7.6bn 7% during the forecast period

36%  Increasing prevalent cases of MDD 23%

 Expanded access to medical care as a result of healthcare reforms

34% The barriers to the growth of MDD market in the US are: Source: GlobalData

 Intense competition from available generic products

 Key branded drug patent expiries leading to sales erosion

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MAJOR DEPRESSIVE DISORDER - US DRUG FORECAST AND MARKET ANALYSIS TO 2023

Executive Summary

What Do The Physicians Think? “I think Brintellix has more than an SSRI. The question is how big the advantage over SSRIs in Selective reuptake inhibitors (SSRIs) are terms of tolerability and efficacy is. There are some the fist-line treatment choice in the MDD market. studies showing promising results, but we have to “My general opinion for SSRIs is that they are the see how it works in clinical practice.” standard of first-line care, so you cannot hope for something in a more exulted position than that. [OUS] Key Opinion Leader, February 2014 They have limitations however, that is why we “Brintellix may have some advantages, but it is not have unmet needs. I think they are slightly less a first-line drug in my mind, it is not the first thing I effective as a class than the SNRIs [serotonin- would prescribe. It is [a] brand new product and reuptake inhibitors], but they are unproven in the real world. Although the somewhat better tolerated as a class, so, the registration trials demonstrated safety, tolerability, overall advantage goes to the SSRIs.” and efficacy, it is not the same thing as the drugs that are being around for years.” [US] Key Opinion Leader, February 2014

“SSRIs are available generically now, they are [US] Key Opinion Leader, March 2014 inexpensive, they are the safest antidepressants, The most pressing unmet need in the depression work reasonably well, are easy to prescribe, and market is for the development of drugs with relevantly easy to take. So, low cost, good improved efficacy, according to the physicians tolerability, decent-great safety, and adequate interviewed by GlobalData. efficacy make these products first-line treatments.” “The major unmet need still is efficacy. It is the [US] Key Opinion Leader, February 2014 most pressing one.”

Physicians need to gain experience with [OUS] Key Opinion Leader, March 2014

Lundbeck/Takeda’s Brintellix in clinical practice in “The biggest unmet need is that we do not have order to become convinced about the added good treatments. The remission and response benefits of this product in treating patients with rates are low, and we have not found new, more depression. effective agents.”

[US] Key Opinion Leader, February 2014

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MAJOR DEPRESSIVE DISORDER - US DRUG FORECAST AND MARKET ANALYSIS TO 2023

Executive Summary

Physicians acknowledge that Alkermes’s ALKS- Products that demonstrate better efficacy, 5461 is one of the most promising products in the improved safety, and rapid antidepressant effects pipeline for MDD. will move to the forefront of the treatment line.

“It [ALKS-5461] is [a] very intriguing product. It has “Something has to be tangibly better, not tangibly a different mechanism of action, so if it really does different, [but] tangibly better to become a first-line work, then, I think it has really good potential for antidepressant.” adoption. I would see ALKS-5461 as being [US] Key Opinion Leader, February 2014 preferred as an augmenter over second generation “If a new compound has better efficacy, [can] show .” rapid action and low metabolic impact, for me, it [US] Key Opinion Leader, March 2014 will be a first-line treatment.” “We have lots of things that are just the same, but [OUS] Key Opinion Leader, February 2014 this [ALKS-5461] looks a bit different and is exciting. There is a story about buprenorphine and depression anyway, and if this is a mu [ receptor]-blocker it might take some of the problematic aspects, such as dependence.”

[OUS] Key Opinion Leader, February 2014

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MAJOR DEPRESSIVE DISORDER - US DRUG FORECAST AND MARKET ANALYSIS TO 2023

Table of Contents

1 Table of Contents

1 Table of Contents ...... 5

1.1 List of Tables ...... 10

1.2 List of Figures ...... 13

2 Introduction ...... 14

2.1 Catalyst ...... 14

2.2 Related Reports ...... 14

2.3 Upcoming Related Reports ...... 16

3 Disease Overview ...... 17

3.1 Etiology and Pathophysiology ...... 17

3.1.1 Etiology ...... 17

3.1.2 Pathophysiology ...... 17

3.2 Classification ...... 19

3.3 Symptoms and Subtypes of Major Depressive Disorder ...... 21

3.4 Prognosis ...... 22

3.5 Quality of Life ...... 22

4 Disease Management ...... 23

4.1 Diagnosis and Treatment Overview ...... 23

4.1.1 Diagnosis ...... 23

4.1.2 Treatment Guidelines and Leading Prescribed Drugs ...... 24

4.1.3 Clinical Practice ...... 25

4.2 US...... 28

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MAJOR DEPRESSIVE DISORDER - US DRUG FORECAST AND MARKET ANALYSIS TO 2023

Table of Contents

5 Competitive Assessment ...... 31

5.1 Overview ...... 31

5.2 Product Profiles: Major Brands, Selective Serotonin Reuptake Inhibitors ...... 33

5.2.1 Lexapro () ...... 33

5.2.2 Viibryd () ...... 37

5.2.3 Other Selective Serotonin Reuptake Inhibitors ...... 40

5.3 Product Profiles: Major Brands, Serotonin-Norepinephrine Reuptake Inhibitors ...... 44

5.3.1 Effexor () ...... 44

5.3.2 Cymbalta () ...... 47

5.3.3 Pristiq () ...... 51

5.3.4 Fetzima () ...... 55

5.3.5 Savella () ...... 59

5.4 Product Profiles: Major Brands, Other Antidepressants ...... 61

5.4.1 Norepinephrine- Reuptake Inhibitors ...... 61

5.4.2 Noradrenaline and Specific Antidepressants ...... 65

5.4.3 Monoamine Oxidase Inhibitors ...... 69

5.4.4 Antidepressants ...... 71

5.4.5 Brintellix () ...... 73

5.5 Product Profiles: Major Brands, Antipsychotics ...... 79

5.5.1 Abilify () ...... 79

5.5.2 Seroquel XR () ...... 83

5.6 Other Therapeutic Classes...... 87

6 Unmet Needs and Opportunities ...... 88

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MAJOR DEPRESSIVE DISORDER - US DRUG FORECAST AND MARKET ANALYSIS TO 2023

Table of Contents

6.1 Overview ...... 88

6.2 More Effective Pharmacotherapies ...... 89

6.2.1 Unmet Needs ...... 89

6.2.2 Gap Analysis ...... 90

6.2.3 Opportunities ...... 91

6.3 More Favorable Side Effect Profiles ...... 91

6.3.1 Unmet Needs ...... 91

6.3.2 Gap Analysis ...... 92

6.3.3 Opportunities ...... 92

6.4 Rapid Onset of Antidepressant Effects ...... 93

6.4.1 Unmet Needs ...... 93

6.4.2 Gap Analysis ...... 93

6.4.3 Opportunities ...... 93

6.5 Personalized Treatment Approach ...... 94

6.5.1 Unmet Needs ...... 94

6.5.2 Gap Analysis ...... 95

6.5.3 Opportunities ...... 95

7 Pipeline Assessment...... 96

7.1 Overview ...... 96

7.2 Promising Drugs in Clinical Development ...... 96

7.2.1 (OPC-34712) ...... 99

7.2.2 (RGH-188) ...... 105

7.2.3 ALKS-5461 ...... 110

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MAJOR DEPRESSIVE DISORDER - US DRUG FORECAST AND MARKET ANALYSIS TO 2023

Table of Contents

7.2.4 (EB-1010) ...... 115

7.2.5 GLYX-13 ...... 120

7.2.6 Tedatioxetine (Lu AA24530) ...... 124

7.2.7 ETS6103 ...... 128

7.3 Other Drugs in Development ...... 133

8 Market Outlook ...... 135

8.1 US...... 135

8.1.1 Forecast ...... 135

8.1.2 Key Events ...... 139

8.1.3 Drivers and Barriers – Global Issues ...... 139

8.1.4 Drivers and Barriers ...... 141

9 Appendix...... 144

9.1 Bibliography ...... 144

9.2 Abbreviations ...... 149

9.3 Methodology ...... 153

9.4 Forecasting Methodology ...... 153

9.4.1 Diagnosed MDD Patients ...... 153

9.4.2 Percent of Drug-Treated Patients ...... 153

9.4.3 Drugs Included in Each Therapeutic Class ...... 154

9.4.4 Launch and Patent Expiry Dates ...... 154

9.4.5 General Pricing Assumptions ...... 155

9.4.6 Individual Drug Assumptions ...... 155

9.4.7 Generic Erosion ...... 160

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MAJOR DEPRESSIVE DISORDER - US DRUG FORECAST AND MARKET ANALYSIS TO 2023

Table of Contents

9.4.8 Pricing of Pipeline Agents...... 160

9.5 Physicians and Specialists Included in this Study ...... 162

9.6 About the Authors ...... 164

9.6.1 Analyst ...... 164

9.6.2 Therapy Area Directors ...... 164

9.6.3 Global Head of Healthcare ...... 165

9.7 About GlobalData ...... 166

9.8 Disclaimer ...... 166

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MAJOR DEPRESSIVE DISORDER - US DRUG FORECAST AND MARKET ANALYSIS TO 2023

Table of Contents

1.1 List of Tables

Table 1: Classification and Criteria of Major Depressive Disorder (DSM-IV) and Major Depressive Episode (ICD-10) ...... 20

Table 2: Subtypes of Major Depressive Disorder ...... 21

Table 3: Severity of Depressive Episodes according to ICD-10 and DSM-IV Diagnostic Criteria ...... 23

Table 4: Treatment Guidelines for Major Depressive Disorder ...... 24

Table 5: Most Prescribed Drugs for MDD by Class in the US, 2013 ...... 24

Table 6: Country Profile – US ...... 30

Table 7: Leading Treatments for MDD, 2013 ...... 32

Table 8: Product Profile – Lexapro ...... 34

Table 9: Safety of Lexapro – Five Most Frequently Reported Adverse Events ...... 36

Table 10: Lexapro SWOT Analysis, 2014 ...... 36

Table 11: Product Profile – Viibryd ...... 38

Table 12: Summary of Efficacy Results for the Primary Endpoint in Viibryd Clinical Trials ...... 38

Table 13: Safety of Viibryd – Five Most Frequently Reported Adverse Events ...... 39

Table 14: Viibryd SWOT Analysis, 2023...... 40

Table 15: Relative Frequency of Common Adverse Effects for Different SSRIs ...... 43

Table 16: Product Profile – Effexor ...... 45

Table 17: Effexor SWOT Analysis, 2014 ...... 47

Table 18: Product Profile – Cymbalta ...... 49

Table 19: Cymbalta SWOT Analysis, 2023...... 51

Table 20: Product Profile – Pristiq ...... 52

Table 21: Efficacy of Pristiq in short-term studies ...... 53

Table 22: Pristiq SWOT Analysis, 2014...... 55

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MAJOR DEPRESSIVE DISORDER - US DRUG FORECAST AND MARKET ANALYSIS TO 2023

Table of Contents

Table 23: Product Profile – Fetzima ...... 56

Table 24: Clinical Efficacy of Fetzima from its Three Pivotal Studies ...... 57

Table 25: Safety of Fetzima – Five Most Frequently Reported Adverse Events in Clinical Studies ...... 58

Table 26: Fetzima SWOT Analysis, 2014 ...... 58

Table 27: Product Profile – Savella ...... 59

Table 28: Savella SWOT Analysis, 2014 ...... 61

Table 29: Product Profile – ...... 63

Table 30: Safety of Bupropion – Five Most Frequently Reported Adverse Events ...... 64

Table 31: Bupropion SWOT Analysis, 2014 ...... 65

Table 32: Product Profile – ...... 67

Table 33: Safety of Mirtazapine – Four Most Frequently Reported Adverse Events ...... 68

Table 34: Mirtazapine SWOT Analysis, 2014 ...... 69

Table 35: MAOI SWOT Analysis, 2014 ...... 71

Table 36: TCAs SWOT Analysis, 2014...... 73

Table 37: Product Profile – Brintellix ...... 75

Table 38: Efficacy of Brintellix in Six-Week to Eight-Week Clinical Trials ...... 76

Table 39: Safety of Brintellix – Five Most Frequently Reported Adverse Events...... 78

Table 40: Brintellix SWOT Analysis, 2014 ...... 78

Table 41: Product Profile – Abilify ...... 80

Table 42: Safety of Abilify – Five Most Frequently Reported Adverse Events ...... 82

Table 43: Abilify SWOT Analysis, 2014 ...... 82

Table 44: Product Profile – Seroquel XR ...... 84

Table 45: Efficacy of Seroquel XR as an Adjunctive Therapy to Antidepressants...... 85

Table 46: Safety of Seroquel XR– Five Most Frequently Reported Adverse Events ...... 86

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MAJOR DEPRESSIVE DISORDER - US DRUG FORECAST AND MARKET ANALYSIS TO 2023

Table of Contents

Table 47: Seroquel XR SWOT Analysis, 2014 ...... 86

Table 48: Summary of Minor Therapeutic Classes in MDD, 2013 ...... 87

Table 49: Unmet Needs and Opportunities in MDD ...... 89

Table 50: Comparison of Therapeutic Classes in Development for MDD, 2013 ...... 98

Table 51: Product Profile – Brexpiprazole ...... 101

Table 52: Safety of Brexpiprazole – Most Frequently Reported Adverse Events ...... 103

Table 53: Brexpiprazole SWOT Analysis, 2014 ...... 105

Table 54: Product Profile – Cariprazine ...... 107

Table 55: Cariprazine SWOT Analysis, 2014 ...... 110

Table 56: Product Profile – ALKS-5461 ...... 112

Table 57: ALKS-5461 SWOT Analysis, 2014 ...... 115

Table 58: Product Profile – Amitifadine ...... 117

Table 59: Amitifadine SWOT Analysis, 2014 ...... 120

Table 60: Product Profile – GLYX-13 ...... 121

Table 61: GLYX-13 SWOT Analysis, 2014 ...... 124

Table 62: Product Profile – Tedatioxetine ...... 126

Table 63: Tedatioxetine SWOT Analysis, 2014 ...... 128

Table 64: Product Profile – ETS6103 ...... 130

Table 65: ETS6103 SWOT Analysis, 2014 ...... 133

Table 66: Drugs in Development for MDD, 2014 ...... 134

Table 67: Sales Forecasts ($m) for MDD in the US, 2013–2023 ...... 137

Table 68: Key Events Impacting Sales for MDD in the US, 2013–2023 ...... 139

Table 69: MDD Market – Drivers and Barriers, 2013–2023 ...... 139

Table 70: MDD Market in the US – Drivers and Barriers, 2013–2023 ...... 141

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MAJOR DEPRESSIVE DISORDER - US DRUG FORECAST AND MARKET ANALYSIS TO 2023

Table of Contents

Table 71: Key Launch Dates ...... 154

Table 72: Key Patent Expiries ...... 155

Table 73: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country ...... 163

1.2 List of Figures

Figure 1: Overview of Targets of Antidepressant Action on Noradrenergic and Serotonergic Neurons ...... 19

Figure 2: Disease Management Model for Major Depressive Disorder ...... 26

Figure 3: Major Depressive Disorder Treatment Algorithm ...... 28

Figure 4: MDD – Phase IIb-III Pipeline, 2014 ...... 97

Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in MDD, 2013–2023 ...... 98

Figure 6: Clinical and Commercial Positioning of Brexpiprazole ...... 104

Figure 7: Clinical and Commercial Positioning of Cariprazine ...... 109

Figure 8: Clinical and Commercial Positioning of ALKS-5461 ...... 114

Figure 9: Clinical and Commercial Positioning of Amitifadine ...... 119

Figure 10: Clinical and Commercial Positioning of GLYX-13 ...... 123

Figure 11: Clinical and Commercial Positioning of Tedatioxetine ...... 127

Figure 12: Clinical and Commercial Positioning of ETS6103 ...... 132

Figure 13: Sales for MDD in the US by Drug Class, 2013–2023 ...... 138

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MAJOR DEPRESSIVE DISORDER - US DRUG FORECAST AND MARKET ANALYSIS TO 2023

Introduction

2 Introduction

2.1 Catalyst

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. The catalysts and objectives for this report are:

 To assess the impact of imminent patent expiries for Cymbalta and Abilify in the MDD market.

 To evaluate the impact of Brintellix’s 2014 launch in the MDD market.

 To evaluate the significance of late-phase pipeline products, and to show how their launch will shape the future treatment landscape of the MDD market.

 To identify the significant unmet needs in the MDD market.

 To highlight the remaining opportunities in the MDD market. 2.2 Related Reports

 GlobalData (2014). EpiCast Report: Major Depressive Disorder – Epidemiology Forecast to 2023, February 2014, GDHCER055-14

 GlobalData (2014). PharmaPoint: Schizophrenia – Global Drug Forecast and Market Analysis to 2022, February 2014, GDHC81PIDR

 GlobalData (2014). PharmaPoint: Neuropathic Pain – Global Drug Forecast and Market Analysis to 2022, April 2014, GDHC70PIDR

 GlobalData (2014). PharmaPoint: Major Depressive Disorder – Global Drug Forecast and Market Analysis to 2023, May 2014, GDHC85PIDR

 GlobalData (2014). Major Depressive Disorder – 5EU Drug Forecast and Market Analysis to 2023, May 2014, GDHC243CFR

Major Depressive Disorder - US Drug Forecast and Market Analysis to 2023 14 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

MAJOR DEPRESSIVE DISORDER - US DRUG FORECAST AND MARKET ANALYSIS TO 2023

Introduction

 GlobalData (2014). Major Depressive Disorder – Japan Drug Forecast and Market Analysis to 2023, May 2014, GDHC244CFR

 GlobalData (2014). Major Depressive Disorder – Australia Drug Forecast and Market Analysis to 2023, May 2014, GDHC245CFR

 GlobalData (2014). Lexapro (Major Depressive Disorder) – Forecast and Market Analysis to 2023, May 2014, GDHC415DFR

 GlobalData (2014). Viibryd (Major Depressive Disorder) – Forecast and Market Analysis to 2022, May 2014, GDHC416DFR

 GlobalData (2014). Effexor (Major Depressive Disorder) – Forecast and Market Analysis to 2023, May 2014, GDHC417DFR

 GlobalData (2014). Cymbalta (Major Depressive Disorder) – Forecast and Market Analysis to 2023, May 2014, GDHC418DFR

 GlobalData (2014). Pristiq (Major Depressive Disorder) – Forecast and Market Analysis to 2023, May 2014, GDHC419DFR

 GlobalData (2014). Fetzima (Major Depressive Disorder) – Forecast and Market Analysis to 2023, May 2014, GDHC420DFR

 GlobalData (2014). Savella (Major Depressive Disorder) – Forecast and Market Analysis to 2023, May 2014, GDHC421DFR

 GlobalData (2014). Brintellix (Major Depressive Disorder) – Forecast and Market Analysis to 2023, May 2014, GDHC422DFR

 GlobalData (2014). Abilify (Major Depressive Disorder) – Forecast and Market Analysis to 2023, May 2014, GDHC423DFR

 GlobalData (2014). Seroquel XR (Major Depressive Disorder) – Forecast and Market Analysis to 2023, May 2014, GDHC424DFR

 GlobalData (2014). Brexpiprazole (Major Depressive Disorder) – Forecast and Market Analysis to 2023, May 2014, GDHC425DFR

Major Depressive Disorder - US Drug Forecast and Market Analysis to 2023 15 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

MAJOR DEPRESSIVE DISORDER - US DRUG FORECAST AND MARKET ANALYSIS TO 2023

Introduction

 GlobalData (2014). Cariprazine (Major Depressive Disorder) – Forecast and Market Analysis to 2023, May 2014, GDHC426DFR

 GlobalData (2014). ALKS-5461 (Major Depressive Disorder) – Forecast and Market Analysis to 2023, May 2014, GDHC427DFR

 GlobalData (2014). Amitifadine (Major Depressive Disorder) – Forecast and Market Analysis to 2023, May 2014, GDHC428DFR

 GlobalData (2014). GLYX-13 (Major Depressive Disorder) – Forecast and Market Analysis to 2023, May 2014, GDHC429DFR

 GlobalData (2014). Tedatioxetine (Major Depressive Disorder) – Forecast and Market Analysis to 2023, May 2014, GDHC430DFR

 GlobalData (2014). ETS6103 (Major Depressive Disorder) – Forecast and Market Analysis to 2023, May 2014, GDHC431DFR

 GlobalData (2014). Major Depressive Disorder – Current and Future Players, May 2014, GDHC1035FPR

2.3 Upcoming Related Reports

 GlobalData (2014). PharmaPoint: Insomnia – Global Drug Forecasts and Market Analysis to 2023, November 2014, GDHC107PIDR.

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MAJOR DEPRESSIVE DISORDER - US DRUG FORECAST AND MARKET ANALYSIS TO 2023

Appendix

9.7 About GlobalData

GlobalData is a leading global provider of business intelligence in the healthcare industry. GlobalData provides its clients with up-to-date information and analysis on the latest developments in drug research, disease analysis, and clinical research and development. Our integrated business intelligence solutions include a range of interactive online databases, analytical tools, reports, and forecasts. Our analysis is supported by a 24/7 client support and analyst team.

GlobalData has offices in New York, San Francisco, Boston, London, India, Korea, Japan, Singapore, and Australia.

9.8 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior permission of the publisher, GlobalData.

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