Global Pain Therapeutics Market to 2023 – Innovative New Products to Address Unmet Need within Chronic Pain and Migraine, and Tackle Opioid Abuse

The pain therapeutics market covers the drugs used for the relief of acute and chronic pain. This market has long been characterized by high levels of generic revenue, derived largely from opioids, which see high levels of usage worldwide and particularly within the US.

However, the last decade has seen the addition of new premium products to the market, including a wave of drugs approved for the treatment of neuropathic pain conditions – a patient population that previously had very poor treatment options. This influx of premium products is forecast to continue through to 2023.

The causes of the resurgence of premium analgesics are multi-faceted, but the primary driver is to meet the many unmet needs of the market, such as the treatment of neuropathic pain and migraines, and the need to limit the risk of abuse associated with many analgesics, primarily opioids. The revived interest in this market has led to a very high frequency of licensing deals for pain products over the past decade.

Scope

– The pain therapeutics market is forecast to reach $28.8 billion in 2023. What are the key market segments driving this growth?

– The pipeline contains over 800 products. What molecule types and molecular targets are in the pipeline? What are the commercial prospects of promising late stage products?

– Despite historical high levels of generic drug development, there is a very high proportion of novel drugs in the pipeline. How do failure rates, clinical trial size and clinical trial duration differ by indication and molecular target?

– Which of the leading companies will have the highest market share by 2023? Which new companies will enter the market?

– What licensing and co-development deals have occurred within this therapy area since 2006?

Reasons to buy

- Understand the current clinical and commercial landscape through a comprehensive analysis of innovation in the pain therapeutics market, in the context of the overall pipeline and current market landscape. The report also includes analysis of the deals landscape, including both licensing deals and co-development deals. Key indications covered in detail include neuropathic pain, inflammatory pain (including osteoarthritis pain) and migraine.

- Understand the current treatment landscape, with portfolios of key marketed products and a focus on historical and forecast sales patterns, and an overview of each drug’s mechanism of action.

- Analyse the pain therapeutics pipeline through a comprehensive review, segmented by stage of development, molecule type and molecular target. This review also provides a detailed look at pain therapeutics clinical trials, to provide an insight into the risk associated with attempting to bring pipeline analgesics to market.

- Predict growth in market size, with in-depth market forecasting from 2016 to 2023. The forecast will provide an understanding of how epidemiology trends, new drug entries and new drug patent expirations will influence market value.

- Identify the key pipeline products, with a particular focus on those due to be brought to market in the near future, as well as sales forecasts for these products.

- Identify the leading companies in the market, in terms of market share and growth. Company analysis determines how dependent the key companies in the market are on revenue derived from pain therapeutic products. In addition, analysis determines the primary factors that will drive market growth for the key companies in the market.

- Assess the licensing and co-development deal landscape for pain therapies.

Table of Contents

1 Table of Contents

1 Table of Contents 4

1.1 List of Tables 6

1.2 List of Figures 6

2 Introduction 9

2.1 Disease Cluster Introduction 9

2.2 Symptoms 9

2.2.1 Migraine 9

2.2.2 Inflammatory pain and neuropathic pain 10

2.3 Diagnosis 10

2.4 Pathophysiology 10

2.4.1 Nociceptive pain transmission 10

2.4.2 Pain modulation in the brain 12

2.4.3 Inflammatory pain 13

2.4.4 Migraine 13

2.4.5 Neuropathic pain 14

2.5 Epidemiology 14

2.5.1 Migraine 14

2.5.2 Inflammatory pain 15

2.5.3 Neuropathic pain 16

2.6 Comorbidities and Complications 17

2.7 Treatment 17

2.7.1 Non-steroidal anti-inflammatory drugs 18

2.7.2 Opioid medications 18

2.7.3 Triptans 20

2.7.4 Other medications 20

2.7.5 Conclusion 21

3 Key Marketed Products 22

3.1 Celebrex (celecoxib) - Pfizer 22

3.2 Nucynta (tapentadol) - Depomed 24

3.3 Lyrica (pregabalin) - Pfizer 26

3.4 Exparel (bupivacaine) - Pacira 27

3.5 Voltaren (diclofenac sodium) - Novartis 28

3.6 Pennsaid (diclofenac sodium) - Horizon 29

3.7 Depakine (valproate sodium) - Daiichi Sankyo 30

3.8 Embeda ER (morphine sulfate + naltrexone) - Pfizer 31

3.9 Cymbalta (duloxetine hydrochloride) - Eli Lilly 32

3.10 Conclusion 34

4 Pipeline Landscape Assessment 35

4.1 Overview 35

4.2 Pipeline Development Landscape 35

4.3 Molecular Targets in the Pipeline 38

4.4 Clinical Trial Landscape 42

4.4.1 Failure Rate by Stage of Development, Indication and Molecule Type 43

4.4.2 Clinical Trial Duration by Stage of Development, Indication, and Molecule Type 46

4.4.3 Clinical Trial Size by Stage of Development, Indication and Molecule Type 48

4.4.4 Aggregate Clinical Program Size by Stage of Development, Indication and Molecule Type 50

4.5 Conclusion 53

4.6 Assessment of Key Pipeline Products 54

4.6.1 HTX-011 - Heron 54

4.6.2 Difelikefalin - Cara 55

4.6.3 Fremanezumab - Teva 56

4.6.4 Eptinezumab - Alder 57

4.6.5 Erenumab - Amgen and Novartis 58

4.6.6 Galcanezumab - Eli Lilly 59

4.6.7 Zilretta - Flexion 60

4.6.8 EMA-401 - Novartis 61

4.6.9 Conclusion 62

5 Multi-scenario Market Forecast to 2022 64

5.1 Overall Market Size 64

5.2 Generic Penetration 67

5.2.1 Generic Opioid Usage 68

5.3 Revenue Forecast by Molecular Target 73

5.3.1 Opioid Receptors 73

5.3.2 Serotonin Receptors 1B and 1D 74

5.3.3 Prostaglandin G/H Synthase (COX) 75

5.3.4 Calcitonin Gene Related Peptide Receptors 76

5.3.5 Multiple Targets 77

5.3.6 Ion Channels 78

6 Company Analysis and Positioning 80

6.1 Revenue and Market Share Analysis by Company 82

6.1.1 Teva - Company Set to Enter the Market and Secure Large Market Share by 2023 86

6.1.2 Pfizer - Key Patent Expiries to Drive Negative Growth 86

6.1.3 Pacira - Company to Secure a Large Market Share despite Small Product Portfolio 87

6.1.4 Novartis - Expansion of Pain Therapeutics Portfolio for the First Time since Voltaren 88

6.1.5 Amgen - Company Set to Enter Pain Market in Early Forecast Period and Achieve Rapid Growth 89

6.1.6 Allergan - Expansion of Product Portfolio to Drive Growth 90

6.1.7 Depomed - Revenue to Rise despite Upcoming Patent Cliff 91

6.1.8 Lilly - Lilly to Expand Position in Market as Patent for Cymbalta Expires 92

6.2 Company Landscape 93

6.3 Marketed and Pipeline Portfolio Analysis 94

7 Strategic Consolidations 97

7.1 Licensing Deals 97

7.1.1 Deals by Region, Value and Year 97

7.1.2 Deals by Indication 98

7.1.3 Deals by Stage of Development and Value 99

7.1.4 Deals by Molecule Type, Molecular Target and Value 100

7.1.5 Licensing Deals with Disclosed Values 101

7.2 Co-development Deals 103

7.2.1 Deals by Region, Value and Year 103

7.2.2 Deals by Indication 104

7.2.3 Deals by Stage of Development and Value 104

7.2.4 Deals by Molecule Type and Value 105

7.2.5 Co-development Deal with Disclosed Values 106

8 Appendix 107

8.1 References 107

8.2 List of Pipeline Products 110

8.3 Table of Epidemiology Forecast 142

8.4 Abbreviations 144

8.5 Methodology 145

8.5.1 Coverage 145

8.5.2 Secondary Research 145

8.5.3 Market Size and Revenue Forecasts 146

8.5.4 Pipeline Analysis 146

8.5.5 Competitive Landscape 147

8.6 Contact Us 147

8.7 Disclaimer 147

List of Tables

1.1 List of Tables

Table 1: Pain Therapeutics Market, Global, Approved Indications for Celebrex, 2017 23

Table 2: Pain Therapeutics Market, Global, Approved Indications for Nucynta, 2017 24

Table 3: Pain Therapeutics Market, Global, Approved Indications for Lyrica, 2017 26

Table 4: Pain Therapeutics Market, Global, Approved Indications for Exparel, 2017 27

Table 5: Pain Therapeutics Market, Global, Approved Indications for Voltaren, 2017 28

Table 6: Pain Therapeutics Market, Global, Approved Indications for Pennsaid, 2017 29

Table 7: Pain Therapeutics Market, Global, Approved Indications for Depakine, 2017 30

Table 8: Pain Therapeutics Market, Global, Approved Indications for Embeda ER, 2017 31

Table 9: Pain Therapeutics Market, Global, Approved Indications for Cymbalta, 2017 33

Table 10: Pain Therapeutics Market, Global, Usage of Generics Across Key Indications, 2016 68

Table 11: Pain Therapeutics Market, Global, Forecast Revenues by Company, 2016-2023 82

Table 12: Pain Therapeutics Market, Global, Pipeline Products, Discovery, 2017 110

Table 13: Pain Therapeutics Market, Global, Pipeline Products, Preclinical, 2017 115

Table 14: Pain Therapeutics Market, Global, Pipeline Products, IND/CTA-filed, 2017 131

Table 15: Pain Therapeutics Market, Global, Pipeline Products, Phase I, 2017 131

Table 16: Pain Therapeutics Market, Global, Pipeline Products, Phase II, 2017 135

Table 17: Pain Therapeutics Market 138

Table 18: Pain Therapeutics Market, Global, Pipeline Products, Pre-registration, 2017 141

Table 19: Pain Therapeutics Market, Global, Pipeline Products, Unknown, 2017 141

Table 20: Pain therapeutics Market, Epidemiology Patterns for Migraine, 2016-2023 142

Table 21: Pain therapeutics Market, Epidemiology Patterns for Post-Herpetic Neuralgia, 2016-2023 143

Table 22: Pain therapeutics Market, Epidemiology Patterns for Trigeminal Neuralgia, 2016-2023 143

Table 23: Abbreviations 144

List of Figures

1.2 List of Figures

Figure 1: Pain Therapeutics Market, Global, Epidemiology Patterns for Migraine, 2016-2023 15

Figure 2: Pain Therapeutics Market, Global, Epidemiology Patterns for Post-Herpetic Neuralgia, 2016-2023 16

Figure 3: Pain Therapeutics Market, Global, Annual Revenue for Nucynta ($m), 2015-2023 25

Figure 4: Pain Therapeutics Market, Global, Annual Revenue for Lyrica ($bn), 2006-2023 27

Figure 5: Pain Therapeutics Market, Global, Annual Revenue for Voltaren ($m), 2006-2023 29

Figure 6: Pain Therapeutics Market, Global, Annual Revenue for Pennsaid ($m), 2015-2023 30

Figure 7: Pain Therapeutics Market, Global, Annual Revenue for Depakine ($m), 2006-2023 31

Figure 8: Pain Therapeutics Market, Global, Annual Revenue for Embeda ER ($m), 2016-2023 32

Figure 9: Pain Therapeutics Market, Global, Annual Revenue for Cymbalta ($bn), 2006-2023 33

Figure 10: Pain Therapeutics Market, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area, 2017 35

Figure 11: Pain Therapeutics Market, Global, Pipeline by Stage of Development, Molecule Type and Program Type, 2017 36

Figure 12: Pain Therapeutics Market, Global, Pipeline, Key Indications by Stage of Development, 2017 37

Figure 13: Pain Therapeutics Market, Global, Pipeline, Key Indications by Molecule Type, 2017 38

Figure 14: Pain Therapeutics Market, Global, Overall Pipeline by Molecular Target, 2017 40

Figure 15: Pain Therapeutics Market, Global, Pipeline by Neurotransmission Molecular Target, 2017 41

Figure 16: Pain Therapeutics Market, Global, Pipeline for Key Indications by Molecular Target, 2017 42

Figure 17: Pain Therapeutics Market, Global, Clinical Trial Failure Rates by Stage of Development and Indication (%), 2006-2017 44

Figure 18: Pain Therapeutics Market, Global, Clinical Trial Failure Rates by Stage of Development and Molecular Target (%), 2006-2017 45

Figure 19: Pain Therapeutics Market, Global, Clinical Trial Duration by Stage of Development (months), 2006-2017 46

Figure 20: Pain Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Indication (months), 2006-2017 47

Figure 21: Pain Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target (months), 2006-2017 48

Figure 22: Pain Therapeutics Market, Global, Clinical Trial Size by Stage of Development (participants), 2006-2017 48

Figure 23: Pain Drug Market, Global, Clinical Trial Size by Stage of Development and Indication (participants), 2006-2017 49

Figure 24: Pain Therapeutics Market, Global, Clinical Trial Size by Stage of Development and Molecular Target (participants), 2006-2017 50

Figure 25: Pain Therapeutics Market, Global, Aggregate Clinical Program Size by Stage of Development (participants), 2006-2017 51

Figure 26: Pain Therapeutics Market, Global, Aggregate Clinical Program Size by Stage of Development and Indication (participants), 2006-2017 52

Figure 27: Pain Therapeutics Market, Global, Aggregate Clinical Program Size by Stage of Development and Molecular Target (participants), 2006-2017 53

Figure 28: Pain Therapeutics Market, Global, Revenue Forecast for HTX-011 ($m), 2019-2023. 55

Figure 29: Pain Therapeutics Market, Global, Revenue Forecast for Difelikefalin ($m), 2018-2023. 56

Figure 30: Pain Therapeutics Market, Global, Revenue Forecast for Fremanezumab ($m), 2018-2023 57

Figure 31: Pain Therapeutics Market, Global, Revenue Forecast for Eptinezumab ($m), 2018-2023 58

Figure 32: Pain Therapeutics Market, Global, Revenue Forecast for Erenumab ($m), 2018-2023 59

Figure 33: Pain Therapeutics Market, Global, Revenue Forecast for Galcanezumab ($m), 2018-2023 60

Figure 34: Pain Therapeutics Market, Global, Revenue Forecast for Zilretta ($m), 2017-2023 61

Figure 35: Pain Therapeutics Market, Global, Revenue Forecast for EMA-401 ($m), 2019-2023 62

Figure 36: Pain Therapeutics Market, Global, Market Size ($bn), 2016-2023 64

Figure 37: Pain Therapeutics Market, Global, Annual Revenue by Premium and Generic Products ($bn), 2016-2023 67

Figure 38: Pain Therapeutics Market, Global, Annual Revenue for Generic Fentanyl ($bn), 2016-2023 69

Figure 39: Pain Therapeutics Market, Global, Annual Revenue for Generic Hydromorphone ($m), 2016-2023 70

Figure 40: Pain Therapeutics Market, Global, Annual Revenue for Generic Methadone ($m), 2016-2023 71

Figure 41: Pain Therapeutics Market, Global, Annual Revenue for Generic Morphine ($bn), 2016-2023 72

Figure 42: Pain Therapeutics Market, Global, Annual Revenue for Generic Oxycodone ($bn), 2016-2023 73

Figure 43: Pain Therapeutics Market, Global, Annual Revenue Forecast for Drugs Acting on Opioid Receptors ($bn), 2016-2023 74

Figure 44: Pain Therapeutics Market, Global, Annual Revenue Forecast for Drugs Acting on Serotonin Receptors 1B and 1D ($m), 2016-2023 75

Figure 45: Pain Therapeutics Market, Global, Annual Revenue Forecast for Drug Acting on Prostaglandin Signaling ($bn), 2016-2023 76

Figure 46: Pain Therapeutics Market, Global, Annual Revenue Forecast for Drugs Acting on CGRPR ($bn), 2016-2023 77

Figure 47: Pain Therapeutics Market, Global, Annual Revenue Forecast for Drugs Acting on Multiple Molecular Targets ($bn), 2016-2023 78

Figure 48: Pain Therapeutics Market, Global, Annual Revenue Forecast for Drugs Acting on Ion Channels ($bn), 2016-2023 79

Figure 49: Pain Therapeutics Market, Global, Cluster by Growth and Market Share, 2016-2023 80

Figure 50: Pain Therapeutics Market, Global, Company Analysis Matrix, 2017 81

Figure 51: Pain Therapeutics Market, Global, Forecast Market Share by Company (%), 2016-2023 84

Figure 52: Pain Therapeutics Market, Global, Companies by Compound Annual Growth Rate (%), 2016-2023 85

Figure 53: Pain Therapeutics Market, Global, Teva Annual Revenue Forecast, 2018-2023 86

Figure 54: Pain Therapeutics Market, Global, Pfizer Annual Revenue Forecast, 2016-2023 87

Figure 55: Pain Therapeutics Market, Global, Pacira Annual Revenue Forecast, 2016-2023 88

Figure 56: Pain Therapeutics Market, Global, Novartis Annual Revenue Forecast, 2016-2023 89

Figure 57: Pain Therapeutics Market, Global, Amgen Annual Revenue Forecast, 2018-2023 90

Figure 58: Pain Therapeutics Market, Global, Allergan Annual Revenue Forecast, 2016-2023 91

Figure 59: Pain Therapeutics Market, Global, Depomed Annual Revenue Forecast, 2016-2023 92

Figure 60: Pain Therapeutics Market, Global, Lilly Annual Revenue Forecast, 2016-2023 93

Figure 61: Pain Therapeutics Market, Global, High-Activity and Late-Stage Pipeline Developers by Type, 2017 94

Figure 62: Pain Therapeutics Market, Global, Pipeline, Overall, High-Activity and Late-Stage Developers by Level of Specialization, 2017 95

Figure 63: Pain Therapeutics Market, Global, Proportion of Total Company Revenue Attributed to Pain Therapeutics, 2016-2023 96

Figure 64: Pain Therapeutics Market, Global, Licensing Deals by Region, Value and Year, 2006-2016 98

Figure 65: Pain Therapeutics Market, Global, Licensing Deals by Indication, 2006-2017 99

Figure 66: Pain Therapeutics Market, Global, Licensing Deals by Stage of Development and Value, 2006-2016 100

Figure 67: Pain Therapeutics Market, Global, Licensing Deals by Molecule Type, Molecular Target and Aggregate Deal Value, 2006-2017 101

Figure 68: Pain Therapeutics Market, Global, Licensing Deals With Disclosed Values, 2006-2017 102

Figure 69: Pain Therapeutics Market, Global, Co-development Deals by Region, Value and Year, 2006-2017 103

Figure 70: Pain Therapeutics Market, Global, Co-development Deals by Indication and Value, 2006-2017 104

Figure 71: Pain Therapeutics Market, Global, Co-development Deals by Stage of Development, 2006-2017 105

Figure 72: Pain Therapeutics Market, Global, Co-development Deals by Molecule Type, Mechanism of Action and Aggregate Deal Value, 2006-2016 105

Figure 73: Pain Therapeutics Market, Global, Co-development Deals with Disclosed Values, 2006-2017 106

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