Parkinson’s Disease – US Drug Forecast and Market Analysis to 2022

Pages: 209 Published: March 01, 2014 Report Code: GDHC235CFR

Parkinson’s disease is a progressive condition that is characterized by bradykinesia, muscular rigidity, tremor, and postural instability. As the second most common neurodegenerative disorder, Parkinson’s disease may affect individuals of any age but prevalence is increased with age and it is most common in the elderly. Dopaminergic therapies have been fairly effective in treating bradykinesia, but several unmet needs remain. Some needs will be met during the forecast period from 2012-2022, while others, such as the need for disease-modifying drugs, will remain. GlobalData expects that advancements will be made in levodopa administration and that four new molecular entities will be introduced to the market by 2022, these factors along with increased patient numbers from an aging population will drive the market during the forecast period.

This market is expected to grow faster than any other market, including the 5EU, due in part to the introduction of two brands already in use in the 5EU, Neupro and Duodopa, launched in the US at the beginning of the forecast in 2012 and 2014, respectively. Other factors responsible for growth in this market are an aging population that contributes to an increased prevalence of Parkinson’s disease in the US and the launch of six new pipeline agents (in addition to Duodopa and Neupro).

Scope

Overview of Parkinson’s Disease 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 US including product description, safety and efficacy profiles as well as a SWOT analysis.

Sales forecast for the top drugs in US from 2012-2022.

Analysis of the impact of key events as well the drivers and restraints affecting the US Parkinson’s Disease 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 Parkinson’s Disease

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 2012-2022 in US

Table of Contents

1Table of Contents1

1.1List of Tables7

1.2List of Figures10

2Executive Summary10

2.1Sales for Parkinson’s Disease in the US10

2.2What Do the Physicians Think?12

3Introduction13

3.1Catalyst13

3.2Related Reports14

4Disease Overview16

4.1Etiology and Pathophysiology16

4.1.1Etiology16

4.1.2Pathophysiology18

4.1.3Prognosis21

4.1.4Quality of Life21

4.2Symptoms21

5Disease Management24

5.1Overview24

5.1.1Diagnosis – The UK Brain Bank Criteria24

5.1.2Treatment Guidelines and Leading Prescribed Drugs25

5.2Treatment Synopsis26

5.2.1Dopaminergic Therapy Classes26

5.2.2Treatment of Parkinson’s disease by Stage29

5.2.3Other Treatment Options32

5.3Parkinson’s Disease Assessment Scales32

5.3.1Unified Parkinson’s Disease Rating Scale (UPDRS)33

5.3.2Hoehn and Yahr Clinical Staging35

5.3.3Other Clinical Assessments36

5.4Diagnosis and Treatment of Parkinson’s Disease by Country36

5.4.1US36

6Competitive Assessment39

6.1Overview39

6.2Strategic Competitor Assessment41

6.3Product Profiles – Levodopa Combination Therapy42

6.3.1Sinemet (carbidopa/levodopa)43

6.3.2Duodopa (carbidopa/levodopa intestinal gel)46

6.4Product Profiles – COMT Inhibitors49

6.4.1Stalevo/Comtan (entacapone)49

6.5Dopamine Agonists54

6.5.1Neupro (rotigotine transdermal patch)55

6.5.2Requip/Requip XL (ropinirole)60

6.5.3Apokyn (apomorphine)63

6.6Product Profiles – MAO-B Inhibitors66

6.6.1Azilect (rasagiline)67

6.7Product Profiles – Adenosine 2A Inhibitor71

6.7.1Nouriast (istradefylline)72

6.8Product Profiles – Other Therapies75

7Opportunity and Unmet Need75

7.1Overview75

7.2Treatment of Motor Complications – Dyskinesias and OFF Episodes78

7.2.1Unmet Need78

7.2.2Gap Analysis80

7.2.3Opportunity82

7.3Treatment of Non-Motor Symptoms and Dementia83

7.3.1Unmet Need83

7.3.2Gap Analysis84

7.3.3Opportunity85

7.4Neuroprotective/Disease-Modifying Agents86

7.4.1Unmet Need86

7.4.2Gap Analysis87

7.4.3Opportunity90

7.5Improved Drug Formulations90

7.5.1Unmet Need90

7.5.2Gap Analysis91

7.5.3Opportunity92

7.6Identification of Reliable Biomarkers92

7.6.1Unmet Need92

7.6.2Gap Analysis93

7.6.3Opportunity93

7.7Improved Clinical Trial Design94

7.7.1Unmet Need94

7.7.2Gap Analysis95

7.7.3Opportunity95

8Pipeline Assessment96

8.1Overview96

8.2Promising Drugs in Clinical Development96

8.2.1Safinamide99

8.2.2Tozadenant104

8.2.3CVT-301108

8.2.4Rytary/IPX066112

8.2.5Opicapone117

8.2.6Mavoglurant/AFQ056121

8.2.7CD/LD-GR124

8.2.8Other Late-Stage Pipeline Products129

9Current and Future Players129

9.1Overview129

9.2Trends in Corporate Strategy131

9.3Company Profiles132

9.3.1Merck132

9.3.2Roche134

9.3.3AbbVie136

9.3.4UCB137

9.3.5GlaxoSmithKline139

9.3.6Novartis141

9.3.7Orion144

9.3.8Newron145

9.3.9Civitas147

9.3.10Impax149

9.3.11Lundbeck151

10Market Outlook154

10.1US154

10.1.1Forecast154

10.1.2Key Events158

10.1.3Drivers and Barriers – Global Issues158

10.1.4Drivers and Barriers161

11Appendix162

11.1Bibliography162

11.2Abbreviations177

11.3Methodology181

11.4Forecasting Methodology181

11.4.1Diagnosed Parkinson’s Disease Patients181

11.4.2Percent Drug-Treated Patients182

11.4.3Drugs Included in Each Therapeutic Class182

11.4.4Launch and Patent Expiry Dates183

11.4.5General Pricing Assumptions184

11.4.6Compliance Assumptions184

11.4.7Individual Drug Assumptions185

11.4.8Generic Erosion193

11.4.9Pricing of Pipeline Agents193

11.5Physicians and Specialists Included in this Study195

11.6About the Authors197

11.6.1Author197

11.6.2Global Head of Healthcare198

11.7About GlobalData199

11.8Contact Us199

11.9Disclaimer199

List of Tables

Table 1: Symptoms of Parkinson’s Disease23

Table 2: UK Brain Bank Diagnostic Criteria25

Table 3: Diagnosis and Treatment Guidelines for Parkinson’s Disease25

Table 4: Most Prescribed Drugs for Parkinson’s Disease by Class in the Global Markets, 201426

Table 5: Dopaminergic Therapy in Parkinson’s Disease29

Table 6: UPDRS Clinical Assessment of Disease Severity34

Table 7: Parkinson’s Disease Assessment Scales Used in Clinical Trials36

Table 8: Parkinson’s Disease, Country Profile – US38

Table 9: Treatment of Motor Symptoms in Parkinson’s Disease40

Table 10: Leading Treatments for Parkinson’s Disease, 201442

Table 11: Product Profile – Sinemet44

Table 12: Sinemet SWOT Analysis, 201446

Table 13: Product Profile – Duodopa47

Table 14: Duodopa SWOT Analysis, 201449

Table 15: Product Profile – Stalevo51

Table 16: Product Profile – Comtan52

Table 17: Stalevo/Comtan SWOT Analysis, 201454

Table 18: Product Profile – Neupro56

Table 19: Neupro SWOT Analysis, 201460

Table 20: Product Profile – Requip/Requip XL61

Table 21: Requip/Requip XL SWOT Analysis, 201463

Table 22: Product Profile – Apokyn65

Table 23: Apokyn SWOT Analysis, 201466

Table 24: Product Profile – Azilect68

Table 25: Azilect SWOT Analysis, 201471

Table 26: Product Profile – Nouriast73

Table 27: Nouriast SWOT Analysis, 201474

Table 28: Summary of Alternative Parkinson’s Disease Therapies75

Table 29: Unmet Need and Opportunity in Parkinson’s Disease77

Table 30: Dyskinesia Pipeline, 201482

Table 31: Dementia Pipeline, 201485

Table 32: Parkinson’s Disease-Modifying Therapeutics Pipeline, 201489

Table 33: Product Profile – Safinamide100

Table 34: Summary of Relevant Clinical Trials for Safinamide101

Table 35: Safinamide SWOT Analysis, 2014104

Table 36: Product Profile – Tozadenant105

Table 37: Tozadenant SWOT Analysis, 2014107

Table 38: Product Profile – CVT-301109

Table 39: CVT-301 SWOT Analysis, 2014112

Table 40: Product Profile – Rytary113

Table 41: Rytary SWOT Analysis, 2014117

Table 42: Product Profile – Opicapone118

Table 43: Opicapone SWOT Analysis, 2014120

Table 44: Product Profile – Mavoglurant122

Table 45: Mavoglurant SWOT Analysis, 2014124

Table 46: Product Profile – CD/LD-GR125

Table 47: Summary of Relevant Clinical Trials for CD/LD-GR126

Table 48: CD/LD-GR SWOT Analysis, 2014128

Table 49: Late-Stage Pipeline, 2013129

Table 50: Key Companies in the Parkinson’s Market, 2014130

Table 51: Merck’s Parkinson’s Disease Portfolio Assessment, 2014134

Table 52: Merck’s PD SWOT Analysis, 2014134

Table 53: Roche’s Parkinson’s Disease Portfolio Assessment, 2014136

Table 54: Roche’s PD SWOT Analysis, 2014136

Table 55: AbbVie’s Parkinson’s Disease Portfolio Assessment, 2014137

Table 56: AbbVie’s PD SWOT Analysis, 2014137

Table 57: UCB’s Parkinson’s Disease Portfolio Assessment, 2014138

Table 58: UCB’s PD SWOT Analysis, 2014139

Table 59: GSK’s Parkinson’s Disease Portfolio Assessment, 2014141

Table 60: GSK’s PD SWOT Analysis, 2014141

Table 61: Novartis’ Parkinson’s Disease Portfolio Assessment, 2014143

Table 62: Novartis’ PD SWOT Analysis, 2014143

Table 63: Orion’s Parkinson’s Disease Portfolio Assessment, 2014145

Table 64: Orion’s PD SWOT Analysis, 2014145

Table 65: Newron’s Parkinson’s Disease Portfolio Assessment, 2014146

Table 66: Newron’s PD SWOT Analysis, 2014147

Table 67: Civitas’ Parkinson’s Disease Portfolio Assessment, 2014148

Table 68: Civitas’ PD SWOT Analysis, 2014149

Table 69: Impax’s Parkinson’s Disease Portfolio Assessment, 2014151

Table 70: Impax’s PD SWOT Analysis, 2014151

Table 71: Lundbeck’s Disease/Therapy Portfolio Assessment, 2014153

Table 72: Lundbeck’s SWOT Analysis, 2014153

Table 73: Sales Forecasts ($m) for Parkinson’s Disease in the US, 2012–2022156

Table 74: Key Events Impacting Sales for Parkinson’s Disease in the US, 2012–2022158

Table 75: Parkinson’s Disease Market – Drivers and Barriers, 2012–2022158

Table 76: Parkinson’s Disease Market in the US – Drivers and Barriers, 2012–2022161

Table 77: Key Launch Dates183

Table 78: Key Patent Expiries184

List of Figures

Figure 1: Sales for Parkinson’s Disease in US by Therapeutic Class, 2012–202211

Figure 2: Overview – L-dopa Metabolism and Inhibitor Classes28

Figure 3: Overview – Treatment of Motor Symptoms of Parkinson’s Disease30

Figure 4: Pharmacokinetics of Levodopa79

Figure 5: Parkinson’s Disease – Phase II–III Pipeline, Segmented by Indication, 201497

Figure 6: Competitive Assessment of Late-Stage Pipeline Agents in Parkinson’s Disease, 2012–202298

Figure 7: Company Portfolio Gap Analysis in Parkinson’s Motor Symptoms, 2012–2022131

Figure 8: Sales for Parkinson’s Disease in the US by Drug Class, 2012–2022157

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