Neuropathic Pain - US Drug Forecast and Market Analysis to 2022

Neuropathic pain (NP) is defined as a disorder of the sensorimotor system and is distinctly different from nociceptive pain, which is a consequence of trauma, injury, or inflammation. The main difference between neuropathic and nociceptive pain is the absence of a continuous nociceptive input in neuropathic pain. Although the term neuropathic pain is used to describe a wide range of pain syndromes with varying etiologies, this report focuses on 3 distinct forms of NP: Painful diabetic neuropathy, Postherpetic neuralgia and trigeminal neuralgia. The main classes of drugs used to treat these three neuropathic pain indications include anticonvulsants, antidepressants, opioids and topical treatments. However, despite the availability of multiple pain medications only 50% of patients respond to any given drug and there are numerous the side effects associated particularly with systemically administered drugs, that reduce their tolerability.

The obesity epidemic in the US, which will lead to an increased prevalence of PDN, and the launch and uptake of seven pipeline drugs, will also be key growth drivers. Among these pipeline drugs, DS-5565, which is in development for PDN, is anticipated to offer an improvement upon Lyrica’s efficacy and safety, and as such, it is expected to be the market-leading brand-name drug at the end of the forecast period, with sales of $389m in 2022.

Scope

Overview of Neuropathic Pain 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 the US including product description, safety and efficacy profiles as well as a SWOT analysis.

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

Analysis of the impact of key events as well the drivers and restraints affecting the US Neuropathic Pain market.

Reasons to buy

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Stay ahead of the competition by understanding the changing competitive landscape for Neuropathic Pain.

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Obtain sales forecast for drugs from 2012-2022 in the US.

Table of Contents

1Table of Contents1

1.1List of Tables7

1.2List of Figures9

2Executive Summary10

2.1Sales for Neuropathic Pain (NP) in the US10

2.2What Do ...

1Table of Contents1

1.1List of Tables7

1.2List of Figures9

2Executive Summary10

2.1Sales for Neuropathic Pain (NP) in the US10

2.2What Do Physicians Think?12

3Introduction14

3.1Catalyst14

3.2Related Reports14

4Disease Overview16

4.1Clinical Manifestations of Neuropathic Pain – Signs and Symptoms18

4.1.1Painful Diabetic Neuropathy20

4.1.2Postherpetic Neuralgia21

4.1.3Trigeminal Neuralgia21

4.2Etiology and Pathophysiology22

4.2.1Etiology23

4.2.2Pathophysiology24

5Disease Management32

5.1Diagnosis and Treatment Overview32

5.1.1Diagnosis32

5.1.2Treatment Overview and Guidelines39

5.2US48

5.2.1Diagnosis and Referral48

5.2.2Drug Treatment50

6Competitive Assessment53

6.1Overview53

6.2Tricyclic Antidepressants58

6.2.1Overview58

6.2.2Efficacy59

6.2.3Safety60

6.3Calcium Channel Alpha-2-Delta Ligands (Anticonvulsants)61

6.3.1Overview61

6.3.2Efficacy62

6.3.3Safety63

6.3.4Lyrica63

6.4Sodium Channel-Blocking Anticonvulsants (TN)67

6.4.1Overview67

6.4.2Efficacy68

6.4.3Safety68

6.5Serotonin-Norepinephrine Reuptake Inhibitors (Antidepressants)69

6.5.1Overview69

6.5.2Efficacy70

6.5.3Safety70

6.5.4Cymbalta70

6.6Opioids73

6.6.1Overview73

6.6.2Efficacy74

6.6.3Safety75

6.6.4Nucynta ER/Palexia SR75

6.7Topical Therapies78

6.7.1Overview78

6.7.2Efficacy79

6.7.3Safety79

6.7.4Lidoderm/Versatis80

6.7.5Qutenza82

7Unmet Need and Opportunity85

7.1Overview85

7.2Physician Knowledge or Awareness86

7.2.1Unmet Need86

7.2.2Gap Analysis87

7.2.3Opportunity88

7.3Diagnostic Challenges88

7.3.1Unmet Need88

7.3.2Gap Analysis89

7.3.3Opportunity89

7.4Low Treatment Rate and Underdosing of Medications89

7.4.1Unmet Need89

7.4.2Gap Analysis91

7.4.3Opportunity91

7.5Unsatisfactory Efficacy and Safety Profiles of Pharmacological Treatments92

7.5.1Unmet Need92

7.5.2Gap Analysis92

7.5.3Opportunity93

7.6Elderly Patient Population – Drug Tolerability94

7.6.1Unmet Need94

7.6.2Gap Analysis94

7.6.3Opportunity95

7.7Rational or Personalized Therapies95

7.7.1Unmet Need95

7.7.2Gap Analysis96

7.7.3Opportunity96

8Pipeline Assessment97

8.1Overview97

8.2Promising Drugs in Clinical Development98

8.2.1Eslicarbazepine Acetate101

8.2.2Topical Clonidine Gel104

8.2.3Cebranopadol107

8.2.4DS-5565110

8.2.5CNV-2197944113

8.2.6CNV-1014802116

8.2.7Eladur (bupivacaine patch)119

9Market Outlook122

9.1Drivers and Barriers – Global Issues122

9.1.1Driver: Aging Population in the 7MM123

9.1.2Driver: Increase in Prevalence and Diagnosis of Type 2 Diabetes Will Grow the PDN Market123

9.1.3Driver: Approval of New NP Drugs123

9.1.4Barrier: NP Market Dominated by Generics123

9.1.5Barrier: Challenges Selecting the Most Relevant Pathophysiological Targets for Drug Development124

9.1.6Barrier: Underserved Trigeminal Neuralgia Indication124

9.1.7Barrier: Competition from Interventional Therapies124

9.2United States125

9.2.1Forecast125

9.2.2Key Events136

9.2.3Drivers and Barriers136

10Appendix138

10.1Bibliography138

10.2Abbreviations150

10.3Methodology155

10.4Forecasting Methodology155

10.4.1Diagnosed PDN, PHN, and TN Patients155

10.4.2Percent Drug-Treated Patients156

10.4.3Drugs Included In Each Therapeutic Class156

10.4.4Launch and Patent Expiry Dates156

10.4.5General Pricing Assumptions157

10.4.6Individual Drug Assumptions157

10.4.7Generic Erosion160

10.4.8Pricing of Pipeline Agents160

10.5Physicians and Specialists Included in This Study162

10.6About the Authors164

10.6.1Author164

10.6.2Global Head of Healthcare165

10.7About GlobalData166

10.8Contact Us166

10.9Disclaimer166

List of Tables

Table 1: Classification of NP Syndromes Based on the Site of Somatosensory Damage18

Table 2: Signs and Symptoms of NP19

Table 3: Screening Tools for ...

Table 1: Classification of NP Syndromes Based on the Site of Somatosensory Damage18

Table 2: Signs and Symptoms of NP19

Table 3: Screening Tools for NP32

Table 4: NP-Related Signs and Symptoms35

Table 5: Treatment Guidelines for NP39

Table 6: Recommended Drug Therapies for NP Conditions by Line of Therapy46

Table 7: Most Prescribed Drugs for NP by Indication and Line of Therapy in the Global Markets, 201247

Table 8: US – NP Diagnosis and Referral Metrics50

Table 9: US – NP Treatment Metrics53

Table 10: NNT and NNH for Classes of Oral Drugs used in NP Treatment, 201355

Table 11: Select Products Used for NP Treatment, 201358

Table 12: Product Profile – Lyrica64

Table 13: Lyrica SWOT Analysis, 201366

Table 14: Product Profile – Cymbalta71

Table 15: Cymbalta SWOT Analysis, 201373

Table 16: Product Profile – Nucynta ER/Palexia SR75

Table 17: Nucynta ER/Palexia SR SWOT Analysis, 201377

Table 18: Product Profile – Lidoderm/Versatis81

Table 19: Lidoderm/Versatis SWOT Analysis, 201382

Table 20: Product Profile – Qutenza83

Table 21: Qutenza SWOT Analysis, 201385

Table 22: Unmet Need and Opportunity in NP86

Table 23: NP – Promising Drugs in Clinical Development99

Table 24: Comparison of Drugs in Development for NP, 201499

Table 25: Product Profile – Eslicarbazepine Acetate101

Table 26: Phase II: Efficacy of Eslicarbazepine Acetate in PHN102

Table 27: Phase II: Efficacy of Eslicarbazepine Acetate in PDN102

Table 28: Eslicarbazepine Acetate SWOT Analysis, 2013104

Table 29: Product Profile – Topical Clonidine Gel105

Table 30: Topical Clonidine Gel SWOT Analysis, 2013107

Table 31: Product Profile – Cebranopadol108

Table 32: Cebranopadol SWOT Analysis, 2013109

Table 33: Product Profile – DS-5565111

Table 34: DS-5565 SWOT Analysis, 2013113

Table 35: Product Profile – CNV-2197944114

Table 36: CNV-2197944 SWOT Analysis, 2013116

Table 37: Product Profile – CNV1014802117

Table 38: CNV-1014802 SWOT Analysis, 2013118

Table 39: Product Profile – Eladur120

Table 40: Eladur SWOT Analysis, 2013122

Table 41: NP Market – Drivers and Barriers, 2012–2022122

Table 42: Sales Forecasts ($) for NP in the United States, 2012–2022127

Table 43: Sales Forecasts ($) for PDN in the United States, 2012–2022129

Table 44: Sales Forecasts ($) for PHN in the United States, 2012–2022132

Table 45: Sales Forecasts ($) for TN in the United States, 2012–2022134

Table 46: Key Events Impacting Sales for NP in the United States, 2012–2022136

Table 47: NP Market – Drivers and Barriers in the United States, 2012–2022136

Table 48: Key Launch Dates156

Table 49: Key Patent/Exclusivity Expiries157

List of Figures

Figure 1: Sales for Neuropathic Pain in the US by Therapeutic Class, 2012–202211

Figure 2: Nociceptive Versus Neuropathic Pain17

Figure 3: Etiology and Pathophysiology ...

Figure 1: Sales for Neuropathic Pain in the US by Therapeutic Class, 2012–202211

Figure 2: Nociceptive Versus Neuropathic Pain17

Figure 3: Etiology and Pathophysiology of NP22

Figure 4: Pain Pathway – Somatosensory System25

Figure 5: Pathophysiological Mechanisms of NP at Different Levels of the Nervous System29

Figure 6: Pathophysiological Targets of NP Drugs30

Figure 7: NeuSPIG Diagnostic Certainty Algorithm for NP36

Figure 8: General Treatment Algorithm for NP45

Figure 9: Competitive Assessment of Mid-to-Late Stage Pipeline Agents in NP, 2012–2022100

Figure 10: Sales for NP in the United States by Drug Class, 2012–2022129

Figure 11: Sales for PDN in the United States by Drug Class, 2012–2022131

Figure 12: Sales for PHN in the United States by Drug Class, 2012–2022133

Figure 13: Sales for TN in the United States by Drug Class, 2012–2022135

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