Parkinson's Disease - US Sample - MarketResearch · reference code gdhc235cfr | publication date march 2014 parkinson’s disease - us drug forecast and market analysis to 2022

REFERENCE CODE GDHC235CFR | PUBLICAT ION DATE MARCH 2014

PARKINSON’S DISEASE - US DRUG FORECAST AND MARKET ANALYSIS TO

2022

Parkinson’s Disease - US Drug Forecast and Market Analysis to 2022 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

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PARKINSON’S DISEASE - US DRUG FORECAST AND MARKET ANALYSIS TO 2022

Sales for Parkinson’s Disease in the US

The Parkinson’s disease market in the US is

expected to grow at a compound annual growth

rate (CAGR) of 7.3% from sales of $1.1 billion in

2012 to $2.3 billion in 2022.

Major drivers of growth for the US Parkinson’s

disease market during the forecast period are:

Healthcare reform.

Launch of Neupro and Duodopa.

Major barriers of growth for the US Parkinson’s

disease market during the forecast period are:

High out-of-pocket expenses.

Poor patient compliance in the US compared

with the ROW.

The figure given below presents the US sales for

Parkinson’s disease by Therapeutic Class during

the forecast period from 2012–2022.

Sales for Parkinson’s Disease in US by Therapeutic Class, 2012–2022

2012Total: $1.1bn

2022Total: $2.3bn

27%

20%26%

27%

0%

50%

11%

18%

19%2%

Levodopa

COMT Inhibitors

Dopamine Agonists

MAO-B Inhibitors

A2A Antagonists

Source: GlobalData.


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What Do the Physicians Think?

Physicians state that dyskinesia remains a major

unmet need and stress the impact that an anti-

dyskinetic medication would have on the treatment

of Parkinson’s disease.

“Let’s say if we do not consider what is untreatable

today [balance, falls, dementia], then the main

challenge is probably treating dyskinesia.”

[EU] KOL, November 2013

“Wearing-off wouldn’t be a problem, if the patients

do not develop severe dyskinesia. Because if you

can control dyskinesia, then you can use the drug

[at a] high enough [dose] to control any motor

fluctuation. So wearing-off itself, it’s easier to treat.

The problem is most patients with wearing-off, they

do have dyskinesia too, and when you try to adjust

the dose in order to control wearing-off, then the

patient may develop dyskinesia, or a worsening

form of dyskinesia.”


“I think sometimes we’re a bit dismissive in saying

we don’t see the motor complications that we used

to see, and I think that’s true, because we’ve got a

range of different drugs. But, some people are

really still struggling. Twenty percent of the day

they’re OFF, [while] twenty percent of the day

they’re dyskinetic. That’s forty percent of the day

that’s bad for them, and we say, ‘well, it’s not as

bad as the bad ol’ days,’ but it’s still pretty bad for

them… We still don’t really have an oral drug that

is anti-dyskinetic.”

[EU] KOL, October 2013

“The most challenging [unmet need]… Every day I

see a few patients for whom treatment is very

challenging to me, particularly patients with marked

wearing-off, with dyskinesia during ON, it’s very

difficult to treat with the current medication. If they

are eligible for deep brain stimulation, it’s okay, but

patients over [age] 75, with marked wearing-off,

dyskinesia, falling down, and freezing, it’s very

difficult to treat. And it’s very challenging.”

[OUS] KOL, November 2013

Physicians believe that the introduction of slow-

release levodopa will have a significant impact on

the market and be preferred over immediate-

release formulations.


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“Extended-release levodopa will take the place of

regular drugs [immediate-release levodopa]. Even

in the early phase of the disease, they are better

for patients and will reduce the amount of

fluctuations in later disease, as they progress. If

they [slow-release levodopa therapies] were

available, I would prescribe them over the

immediate-release formulations [in early stage.]”


“If extended release of levodopa are available we

may choose such agents as initial therapies, not

only in advanced cases but as initial therapy.”


Current therapeutic options are limited to

symptomatic control and do not treat the

underlying disease. Although there are no late-

stage therapies that will be launched to meet this

need during the forecast period, physicians believe

that early pipeline agents hold the promise of

becoming one of the most significant

advancements for PD in recent history.

“At this point, it’s not [enough] to show that you can

have an improvement of one hour of time. It’s

interesting, and it should be the first step. But we

[are] wait[ing] for the next step; we [are] wait[ing]

for drugs that have disease-modifying properties.

Meaning that if we take [these drugs], we can have

a better fate than not having these drugs for six

month[s] or one year… I’m afraid that if a drug

could arrive on the market, it will not have a huge

impact if it just [demonstrates] symptomatic

improvement of one hour of time.”


“Current treatment options are all symptomatic

treatments, therefore many people want to

discover disease-modifying treatments for

Parkinson’s disease, but none have been

successful yet.”



Table of Contents


1 Table of Contents

1 Table of Contents ....................................................................................................................... 5

1.1 List of Tables .................................................................................................................... 10

1.2 List of Figures ................................................................................................................... 14

2 Introduction ............................................................................................................................... 15

2.1 Catalyst ............................................................................................................................. 15

2.2 Related Reports ................................................................................................................ 15

3 Disease Overview ..................................................................................................................... 18

3.1 Etiology and Pathophysiology ........................................................................................... 18

3.1.1 Etiology ......................................................................................................................... 18

3.1.2 Pathophysiology ............................................................................................................ 21

3.1.3 Prognosis ...................................................................................................................... 23

3.1.4 Quality of Life ................................................................................................................ 24

3.2 Symptoms ......................................................................................................................... 24

4 Disease Management ............................................................................................................... 26

4.1 Overview ........................................................................................................................... 26

4.1.1 Diagnosis – The UK Brain Bank Criteria ........................................................................ 26

4.1.2 Treatment Guidelines and Leading Prescribed Drugs ................................................... 27

4.2 Treatment Synopsis .......................................................................................................... 28

4.2.1 Dopaminergic Therapy Classes..................................................................................... 29

4.2.2 Treatment of Parkinson’s disease by Stage .................................................................. 31

4.2.3 Other Treatment Options ............................................................................................... 34


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4.3 Parkinson’s Disease Assessment Scales .......................................................................... 34

4.3.1 Unified Parkinson’s Disease Rating Scale (UPDRS) ..................................................... 35

4.3.2 Hoehn and Yahr Clinical Staging ................................................................................... 37

4.3.3 Other Clinical Assessments ........................................................................................... 38

4.4 Diagnosis and Treatment of Parkinson’s Disease by Country ........................................... 38

4.4.1 US ................................................................................................................................. 38

5 Competitive Assessment .......................................................................................................... 41

5.1 Overview ........................................................................................................................... 41

5.2 Strategic Competitor Assessment ..................................................................................... 43

5.3 Product Profiles – Levodopa Combination Therapy .......................................................... 44

5.3.1 Sinemet (carbidopa/levodopa) ....................................................................................... 45

5.3.2 Duodopa (carbidopa/levodopa intestinal gel) ................................................................. 49

5.4 Product Profiles – COMT Inhibitors ................................................................................... 53

5.4.1 Stalevo/Comtan (entacapone) ....................................................................................... 53

5.5 Dopamine Agonists ........................................................................................................... 58

5.5.1 Neupro (rotigotine transdermal patch) ........................................................................... 59

5.5.2 Requip/Requip XL (ropinirole) ....................................................................................... 65

5.5.3 Apokyn (apomorphine) .................................................................................................. 68

5.6 Product Profiles – MAO-B Inhibitors .................................................................................. 72

5.6.1 Azilect (rasagiline) ......................................................................................................... 72

5.7 Product Profiles – Adenosine 2A Inhibitor ......................................................................... 77

5.7.1 Nouriast (istradefylline) .................................................................................................. 78

5.8 Product Profiles – Other Therapies ................................................................................... 81


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6 Opportunity and Unmet Need ................................................................................................... 82

6.1 Overview ........................................................................................................................... 82

6.2 Treatment of Motor Complications – Dyskinesias and OFF Episodes ............................... 84

6.2.1 Unmet Need .................................................................................................................. 84

6.2.2 Gap Analysis ................................................................................................................. 86

6.2.3 Opportunity ................................................................................................................... 89

6.3 Treatment of Non-Motor Symptoms and Dementia ........................................................... 89

6.3.1 Unmet Need .................................................................................................................. 89

6.3.2 Gap Analysis ................................................................................................................. 90

6.3.3 Opportunity ................................................................................................................... 92

6.4 Neuroprotective/Disease-Modifying Agents ....................................................................... 92

6.4.1 Unmet Need .................................................................................................................. 92

6.4.2 Gap Analysis ................................................................................................................. 93

6.4.3 Opportunity ................................................................................................................... 96

6.5 Improved Drug Formulations ............................................................................................. 97

6.5.1 Unmet Need .................................................................................................................. 97

6.5.2 Gap Analysis ................................................................................................................. 97

6.5.3 Opportunity ................................................................................................................... 98

6.6 Identification of Reliable Biomarkers ................................................................................. 98

6.6.1 Unmet Need .................................................................................................................. 98

6.6.2 Gap Analysis ................................................................................................................. 99

6.6.3 Opportunity ................................................................................................................. 100

6.7 Improved Clinical Trial Design ......................................................................................... 100


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6.7.1 Unmet Need ................................................................................................................ 100

6.7.2 Gap Analysis ............................................................................................................... 101

6.7.3 Opportunity ................................................................................................................. 101

7 Pipeline Assessment............................................................................................................... 102

7.1 Overview ......................................................................................................................... 102

7.2 Promising Drugs in Clinical Development ........................................................................ 102

7.2.1 Safinamide .................................................................................................................. 104

7.2.2 Tozadenant ................................................................................................................. 111

7.2.3 CVT-301 ...................................................................................................................... 114

7.2.4 Rytary/IPX066 ............................................................................................................. 119

7.2.5 Opicapone ................................................................................................................... 125

7.2.6 Mavoglurant/AFQ056 .................................................................................................. 129

7.2.7 CD/LD-GR ................................................................................................................... 132

7.2.8 Other Late-Stage Pipeline Products ............................................................................ 137

8 Current and Future Players ..................................................................................................... 138

8.1 Overview ......................................................................................................................... 138

8.2 Trends in Corporate Strategy .......................................................................................... 139

8.3 Company Profiles ............................................................................................................ 140

8.3.1 Merck .......................................................................................................................... 140

8.3.2 Roche.......................................................................................................................... 142

8.3.3 AbbVie ........................................................................................................................ 144

8.3.4 UCB ............................................................................................................................ 146

8.3.5 GlaxoSmithKline .......................................................................................................... 147


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8.3.6 Novartis ....................................................................................................................... 149

8.3.7 Orion ........................................................................................................................... 152

8.3.8 Newron........................................................................................................................ 153

8.3.9 Civitas ......................................................................................................................... 155

8.3.10 Impax .......................................................................................................................... 157

8.3.11 Lundbeck .................................................................................................................... 159

9 Market Outlook ....................................................................................................................... 162

9.1 US................................................................................................................................... 162

9.1.1 Forecast ...................................................................................................................... 162

9.1.2 Key Events .................................................................................................................. 166

9.1.3 Drivers and Barriers – Global Issues ........................................................................... 166

9.1.4 Drivers and Barriers .................................................................................................... 169

10 Appendix................................................................................................................................. 171

10.1 Bibliography .................................................................................................................... 171

10.2 Abbreviations .................................................................................................................. 186

10.3 Methodology ................................................................................................................... 190

10.4 Forecasting Methodology ................................................................................................ 190

10.4.1 Diagnosed Parkinson’s Disease Patients .................................................................... 190

10.4.2 Percent Drug-Treated Patients .................................................................................... 191

10.4.3 Drugs Included in Each Therapeutic Class .................................................................. 191

10.4.4 Launch and Patent Expiry Dates ................................................................................. 192

10.4.5 General Pricing Assumptions ...................................................................................... 193

10.4.6 Compliance Assumptions ............................................................................................ 193


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10.4.7 Individual Drug Assumptions ....................................................................................... 194

10.4.8 Generic Erosion .......................................................................................................... 202

10.4.9 Pricing of Pipeline Agents............................................................................................ 202

10.5 Physicians and Specialists Included in this Study ........................................................... 204

10.6 About the Authors ........................................................................................................... 206

10.6.1 Author ......................................................................................................................... 206

10.6.2 Global Head of Healthcare .......................................................................................... 207

10.7 About GlobalData ............................................................................................................ 208

10.8 Disclaimer ....................................................................................................................... 208

1.1 List of Tables

Table 1: Symptoms of Parkinson’s Disease ................................................................................................... 25

Table 2: UK Brain Bank Diagnostic Criteria .................................................................................................... 27

Table 3: Diagnosis and Treatment Guidelines for Parkinson’s Disease .......................................................... 28

Table 4: Most Prescribed Drugs for Parkinson’s Disease by Class in the Global Markets, 2014...................... 28

Table 5: Dopaminergic Therapy in Parkinson’s Disease ................................................................................. 31

Table 6: UPDRS Clinical Assessment of Disease Severity ............................................................................. 36

Table 7: Parkinson’s Disease Assessment Scales Used in Clinical Trials ....................................................... 38

Table 8: Parkinson’s Disease, Country Profile – US ....................................................................................... 40

Table 9: Treatment of Motor Symptoms in Parkinson’s Disease ..................................................................... 42

Table 10: Leading Treatments for Parkinson’s Disease, 2014 ........................................................................ 44

Table 11: Product Profile – Sinemet ............................................................................................................... 47

Table 12: Sinemet SWOT Analysis, 2014 ...................................................................................................... 49

Table 13: Product Profile – Duodopa ............................................................................................................. 51


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Table 14: Duodopa SWOT Analysis, 2014 ..................................................................................................... 53

Table 15: Product Profile – Stalevo ................................................................................................................ 55

Table 16: Product Profile – Comtan ............................................................................................................... 56

Table 17: Stalevo/Comtan SWOT Analysis, 2014 .......................................................................................... 58

Table 18: Product Profile – Neupro ................................................................................................................ 61

Table 19: Neupro SWOT Analysis, 2014 ........................................................................................................ 65

Table 20: Product Profile – Requip/Requip XL ............................................................................................... 66

Table 21: Requip/Requip XL SWOT Analysis, 2014 ....................................................................................... 68

Table 22: Product Profile – Apokyn ................................................................................................................ 70

Table 23: Apokyn SWOT Analysis, 2014 ........................................................................................................ 71

Table 24: Product Profile – Azilect ................................................................................................................. 73

Table 25: Azilect SWOT Analysis, 2014 ......................................................................................................... 77

Table 26: Product Profile – Nouriast............................................................................................................... 79

Table 27: Nouriast SWOT Analysis, 2014 ...................................................................................................... 80

Table 28: Summary of Alternative Parkinson’s Disease Therapies ................................................................. 81

Table 29: Unmet Need and Opportunity in Parkinson’s Disease ..................................................................... 83

Table 30: Dyskinesia Pipeline, 2014 .............................................................................................................. 88

Table 31: Dementia Pipeline, 2014 ................................................................................................................ 91

Table 32: Parkinson’s Disease-Modifying Therapeutics Pipeline, 2014 ........................................................... 95

Table 33: Product Profile – Safinamide ........................................................................................................ 106

Table 34: Summary of Relevant Clinical Trials for Safinamide ...................................................................... 107

Table 35: Safinamide SWOT Analysis, 2014 ................................................................................................ 110

Table 36: Product Profile – Tozadenant ....................................................................................................... 112

Table 37: Tozadenant SWOT Analysis, 2014 ............................................................................................... 114


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Table 38: Product Profile – CVT-301............................................................................................................ 116

Table 39: CVT-301 SWOT Analysis, 2014 ................................................................................................... 119

Table 40: Product Profile – Rytary ............................................................................................................... 121

Table 41: Rytary SWOT Analysis, 2014 ....................................................................................................... 125

Table 42: Product Profile – Opicapone ......................................................................................................... 126

Table 43: Opicapone SWOT Analysis, 2014 ................................................................................................ 128

Table 44: Product Profile – Mavoglurant ...................................................................................................... 130

Table 45: Mavoglurant SWOT Analysis, 2014 .............................................................................................. 132

Table 46: Product Profile – CD/LD-GR ......................................................................................................... 133

Table 47: Summary of Relevant Clinical Trials for CD/LD-GR ...................................................................... 134

Table 48: CD/LD-GR SWOT Analysis, 2014 ................................................................................................ 136

Table 49: Late-Stage Pipeline, 2013 ............................................................................................................ 137

Table 50: Key Companies in the Parkinson’s Market, 2014 .......................................................................... 138

Table 51: Merck’s Parkinson’s Disease Portfolio Assessment, 2014............................................................. 142

Table 52: Merck’s PD SWOT Analysis, 2014 ............................................................................................... 142

Table 53: Roche’s Parkinson’s Disease Portfolio Assessment, 2014 ............................................................ 144

Table 54: Roche’s PD SWOT Analysis, 2014 ............................................................................................... 144

Table 55: AbbVie’s Parkinson’s Disease Portfolio Assessment, 2014 ........................................................... 145

Table 56: AbbVie’s PD SWOT Analysis, 2014 .............................................................................................. 145

Table 57: UCB’s Parkinson’s Disease Portfolio Assessment, 2014 ............................................................... 146

Table 58: UCB’s PD SWOT Analysis, 2014.................................................................................................. 147

Table 59: GSK’s Parkinson’s Disease Portfolio Assessment, 2014 ............................................................... 149

Table 60: GSK’s PD SWOT Analysis, 2014.................................................................................................. 149

Table 61: Novartis’ Parkinson’s Disease Portfolio Assessment, 2014 ........................................................... 151


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Table 62: Novartis’ PD SWOT Analysis, 2014 .............................................................................................. 151

Table 63: Orion’s Parkinson’s Disease Portfolio Assessment, 2014.............................................................. 153

Table 64: Orion’s PD SWOT Analysis, 2014 ................................................................................................ 153

Table 65: Newron’s Parkinson’s Disease Portfolio Assessment, 2014 .......................................................... 154

Table 66: Newron’s PD SWOT Analysis, 2014 ............................................................................................. 155

Table 67: Civitas’ Parkinson’s Disease Portfolio Assessment, 2014 ............................................................. 156

Table 68: Civitas’ PD SWOT Analysis, 2014 ................................................................................................ 157

Table 69: Impax’s Parkinson’s Disease Portfolio Assessment, 2014............................................................. 159

Table 70: Impax’s PD SWOT Analysis, 2014 ............................................................................................... 159

Table 71: Lundbeck’s Disease/Therapy Portfolio Assessment, 2014 ............................................................ 161

Table 72: Lundbeck’s SWOT Analysis, 2014 ................................................................................................ 161

Table 73: Sales Forecasts ($m) for Parkinson’s Disease in the US, 2012–2022 ........................................... 164

Table 74: Key Events Impacting Sales for Parkinson’s Disease in the US, 2012–2022 ................................. 166

Table 75: Parkinson’s Disease Market – Drivers and Barriers, 2012–2022 ................................................... 166

Table 76: Parkinson’s Disease Market in the US – Drivers and Barriers, 2012–2022 .................................... 169

Table 77: Key Launch Dates ........................................................................................................................ 192

Table 78: Key Patent Expiries ...................................................................................................................... 193


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1.2 List of Figures

Figure 1: Overview – L-dopa Metabolism and Inhibitor Classes ...................................................................... 30

Figure 2: Overview – Treatment of Motor Symptoms of Parkinson’s Disease ................................................. 32

Figure 3: Pharmacokinetics of Levodopa ....................................................................................................... 85

Figure 4: Parkinson’s Disease – Phase II–III Pipeline, Segmented by Indication, 2014 ................................. 103

Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in Parkinson’s Disease, 2012–2022 ........ 104

Figure 6: Company Portfolio Gap Analysis in Parkinson’s Motor Symptoms, 2012–2022 .............................. 139

Figure 7: Sales for Parkinson’s Disease in the US by Drug Class, 2012–2022 ............................................. 165


Introduction


2 Introduction

2.1 Catalyst

The Parkinson’s disease market is expected to grow from $3.6 billion to $5.3 billion over the 10-

year forecast period. A major driving force behind this is the increase in the global population and

advancements in healthcare that contribute to an aging population at increased risk for Parkinson’s

disease. The population of Parkinson’s disease patients is expected to increase from 3.2 million

people in 2012 to 4.3 million in 2022 in the eight major markets covered. The market for

Parkinson’s disease is expected to grow as it is the second most common neurological disorder,

with an increased prevalence in the elderly.

Parkinson’s disease has had a history of successful drugs that are highly effective; however, unmet

needs remain. Advancements in technology and drug delivery systems have driven growth in this

market during the forecast period and made it a less risky market than other neurological

conditions, while still holding potential for a big payout. While all products to this point have treated

the signs and symptoms of Parkinson’s disease rather than the underlying condition, the growing

understanding of the nervous system holds promise for a breakthrough in the development of

disease-modifying agents. Ample opportunity in the Parkinson’s disease market remains. As most

products have been launched by collaborative efforts of at least two companies, we expect such

strategic partnerships to continue during the coming decade in the market for Parkinson’s disease.

2.2 Related Reports

GlobalData (2013) EpiCast: Parkinson’s Disease – Epidemiology Forecast to 2022, November

2013, GDHCER043

GlobalData (2012) PharmaPoint: Alzheimer’s Disease – Global Drug Forecast and Market

Analysis to 2022, July 2013 GDHC016PIDR.

GlobalData (2014). PharmaPoint: Parkinson’s Disease – Global Drug Forecast and Market

Analysis to 2022, March 2014, GDHC82PIDR

GlobalData (2014). Parkinson’s Disease – 5EU Drug Forecast and Market Analysis to 2022,

March 2014, GDHC236CFR


Introduction


GlobalData (2014). Parkinson’s Disease – Japan Drug Forecast and Market Analysis to 2022,


GlobalData (2014). Parkinson’s Disease – Brazil Drug Forecast and Market Analysis to 2022,


GlobalData (2014). Madopar (Parkinson’s Disease) – Forecast and Market Analysis to 2022,

March 2014, GDHC389DFR

GlobalData (2014). Sinemet (Parkinson’s Disease) – Forecast and Market Analysis to 2022,


GlobalData (2014). Duodopa (Parkinson’s Disease) – Forecast and Market Analysis to 2022,


GlobalData (2014). Stalevo/Comtan (Parkinson’s Disease) – Forecast and Market Analysis to

2022, March 2014, GDHC392DFR

GlobalData (2014). Neupro (Parkinson’s Disease) – Forecast and Market Analysis to 2022,


GlobalData (2014). Requip/Requip XL (Parkinson’s Disease) – Forecast and Market Analysis

to 2022, March 2014, GDHC394DFR

GlobalData (2014). Apokyn (Parkinson’s Disease) – Forecast and Market Analysis to 2022,


GlobalData (2014). Azilect (Parkinson’s Disease) – Forecast and Market Analysis to 2022,


GlobalData (2014). Nouriast (Parkinson’s Disease) – Forecast and Market Analysis to 2022,


GlobalData (2014). Safinamide (Parkinson’s Disease) – Forecast and Market Analysis to 2022,


GlobalData (2014). Tozadenant (Parkinson’s Disease) – Forecast and Market Analysis to



Introduction


GlobalData (2014). CVT-301 (Parkinson’s Disease) – Forecast and Market Analysis to 2022,


GlobalData (2014). Rytary/IPX066 (Parkinson’s Disease) – Forecast and Market Analysis to


GlobalData (2014). Opicapone (Parkinson’s Disease) – Forecast and Market Analysis to 2022,


GlobalData (2014). Mavoglurant/AFQ056 (Parkinson’s Disease) – Forecast and Market

Analysis to 2022, March 2014, GDHC403DFR

GlobalData (2014). CD/LD-GR (Parkinson’s Disease) – Forecast and Market Analysis to 2022,


GlobalData (2014). Parkinson’s Disease – Current and Future Players, March 2014,

GDHC1033FPR


Appendix


10.7 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, Boston, London, India and Singapore.

10.8 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.

Documents

Parkinson's Disease - US Sample - MarketResearch · reference code gdhc235cfr | publication date march 2014 parkinson’s disease - us drug forecast and market analysis to 2022