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Frontier Pharma: Chronic, Acute and Neuropathic Pain - GPCR and Nerve Growth Factor-based therapies offer strong potential in difficult-to-treat subtypes

Summary

Pain, and in particular chronic pain, is a significant global health issue. While pain is not considered a disease in its own right, there is a growing body of evidence that substantiates chronic pain as a disease, rather than just as a symptom of a primary cause. In the US, pain affects more people than cancer, diabetes and heart disease combined, with an estimated 100 million people having experienced at least one chronic pain episode in the last 12 months, at an annual cost of around $600 billion in medical treatment and lost productivity.

The pain therapeutics market has been largely characterized by only incremental product innovation over the last decade, as most market segments continue to be dominated by long-established product categories, active pharmaceutical ingredients and concomitant mechanisms of action.

Moderate-to-severe pain has been and continues to be dominated by opioids, which are increasingly being reformulated to offer abuse-resistance, whereas mild pain is effectively treated with non-steroidal anti-inflammatory drugs (NSAID). However, significant unmet needs remain, as chronic pain subtypes - and particularly neuropathic pain - do not respond well to existing therapies, which do not align to the underlying molecular pathophysiological profile of pain.

However, strong unmet needs remain in core therapy types such as NSAIDs, which are associated with often severe gastrointestinal adverse events (AE), and opioids, which have a range of AEs associated with them - in addition to the potential for abuse, which has not been fully alleviated by the development of abuse-deterrent formulations.

The exceptionally large active pain pipeline, second only to breast cancer in terms of size, consists of 810 products across all stages of development, indicating that a great deal of resources are being invested into R&D, with the aim of ultimately overcoming the limitations of existing therapies.

Moreover, GBI Research’s analyses identified 129 first-in-class programs in active development, constituting 20% of the pipeline for which there is a disclosed molecular target, and acting on 80 distinct first-in-class molecular targets. Although there is significant differentiation in the scientific rationale and clinical prospects across these first-in-class products, the majority of first-in-class targets demonstrate significant preclinical evidence, and alignment to molecular pathophysiological changes.

Scope

- Analysis of innovation in the pain markets (including both nociceptive and neuropathic pain, of both a chronic and acute nature), in the context of the overall pipeline and current market landscape. Also includes analysis of the deals landscape surrounding first-in-class products in pain, and highlights opportunities for in-licensing.
- A brief introduction to chronic and acute pain, including subtypes, symptoms, pathophysiology, and an overview of pharmacotherapy and treatment algorithms.
- The changing molecular target landscape between the market and the pipeline, and particular focal points of innovation in the pipeline.
- Comprehensive review of the pipeline for first-in-class therapies, analyzed on the basis of stage of development, molecule type and molecular target.
- Identification and assessment of first-in-class molecular targets, with a particular focus on early-stage programs for which clinical utility has yet to be evaluated, as well as literature reviews on novel molecular targets.
- Assessment of the licensing and co-development deal landscape for pain therapeutics, and benchmarking of deals involving first-in-class versus non-first-in-class-products.

Reasons to buy

- Understand the current clinical and commercial landscape, including a comprehensive study of disease pathogenesis, diagnosis, prognosis and the available treatment options available at each stage of diagnosis.
- Visualize the composition of the pain markets in terms of dominant molecule types and targets, highlighting what the current unmet needs are and how they can be addressed. This knowledge allows a competitive understanding of the gaps in the current market.
- Analyze the pain pipeline, stratified by pain subtype, stage of development, molecule type and molecular target.
- Assess the therapeutic potential of first-in-class targets. Using a proprietary matrix, first-in-class products have been assessed and ranked according to clinical potential. Promising early-stage targets have been further reviewed in greater detail.
- Identify commercial opportunities in the pain deals landscape by analyzing trends in licensing and co-development deals, and producing a list of pain therapeutics that are not yet involved in deals and may be potential investment opportunities.

Table Of Contents

Frontier Pharma: Chronic, Acute and Neuropathic Pain - GPCR and Nerve Growth Factor-based therapies offer strong potential in difficult-to-treat subtypes
1 Table of Contents
1 Table of Contents 2
2 Executive Summary 4
2.1 Substantial Unmet Needs Remain in Core Therapy Types 4
2.2 Highly Diversified Range of Innovative Programs in Early Pipeline 4
2.3 Rich Pipeline Landscape with Numerous Investment Opportunities 4
3 The Case for Innovation 5
3.1 Growing Opportunities for Biologic Products 6
3.2 Diversification of Molecular Targets 6
3.3 Innovative First-in-Class Product Development Remains Attractive 6
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 7
3.5 Sustained Innovation 7
3.6 GBI Research Report Guidance 8
4 Clinical and Commercial Landscape 9
4.1 Disease Overview 9
4.1.1 Chronic and Neuropathic Pain 10
4.1.2 Disease Pathophysiology 11
4.1.3 Diagnosis 14
4.1.4 Treatment Options 15
4.2 Overview of Marketed Products for Pain 15
4.2.1 Analgesic Product Categories 16
4.2.2 Molecular Type Analysis 17
4.2.3 Current Unmet Needs 18
5 Assessment of Pipeline Product Innovation in Chronic, Acute and Neuropathic Pain 20
5.1 Pain Pipeline by Molecule Type, Stage of Development and Molecular Target 20
5.2 Comparative Distribution of Programs between the Pain Market and Pipeline by Therapeutic Target Family 23
5.3 First-in-Class Pipeline Programs 23
5.4 First-in-Class and Established Pipeline Products by Pain Subtype 26
5.5 Table of All First-in-Class Pain Pipeline Products 30
6 Pain Pathophysiology and Innovation Alignment 32
6.1 The Complexity of Signaling Networks in the Central Nervous System 32
6.2 Matrix Assessment 32
7 First-in-Class Target and Pipeline Program Evaluation 35
7.1 Pipeline Programs Targeting Nerve Growth Factor and High Affinity Nerve Growth Factor Receptor 35
7.2 Pipeline Programs Targeting Tumor Necrosis Factor Receptor Superfamily Member 16 37
7.3 Pipeline Programs Targeting Bradykinin B1 Receptor 38
7.4 Pipeline Programs Targeting Opioid Receptor-Like-1 Receptor 41
7.5 Pipeline Programs Targeting Purinoceptor 7 43
7.6 Pipeline Programs Targeting Metabotropic Glutamate Receptors 6 and 7 44
7.7 Pipeline Programs Targeting Calcitonin Gene-Related Peptide Type-1 Receptor 45
8 Deals and Strategic Consolidations 47
8.1 Industry-Wide First-in-Class Deals 47
8.2 Pain Deals Landscape 48
8.3 Licensing Deals 48
8.3.1 Molecule Type 50
8.3.2 Mechanism of Action 51
8.4 Co-development Deals 53
8.4.1 Molecule Type 54
8.4.2 Mechanism of Action 55
8.5 List of Pipeline Products without Prior Licensing or Co-Development Deal Involvement 57
9 Appendix 59
9.1 Abbreviations 59
9.2 References 59
9.3 Contact Us 68
9.4 Disclaimer 68

1.1 List of Tables
Table 1: Pain Market, Global, Categories of Pain, 2016 10
Table 2: Pain Market, Global, Data for Nerve Growth Factor as a Molecular Target, 2016 36
Table 3: Pain Market, Global, Data for High Affinity Nerve Growth Factor Receptor as a Molecular Target, 2016 36
Table 4: Pain Market, Global, Data for Tumor Necrosis Factor Receptor Superfamily Member 16 as a Molecular Target, 2016 38
Table 5: Pain Market, Global, Data for Bradykinin B1 Receptor as a Molecular Target, 2016 40
Table 6: Pain Market, Global, Data for Opioid Receptor-Like-1 Receptor as a Molecular Target, 2016 42
Table 7: Pain Market, Global, Data for Purinoceptor 7 as a Molecular Target, 2016 44
Table 8: Pain Market, Global, Data for Metabotropic Glutamate Receptor 6 as a Molecular Target, 2016 45
Table 9: Pain Market, Global, Data for Metabotropic Glutamate Receptor 7 as a Molecular Target, 2016 45
Table 10: Pain Market, Global, Data for Calcitonin Gene-Related Peptide Type-1 Receptor as a Molecular Target, 2016 46

1.2 List of Figures
Figure 1: Pharmaceutical Market, Global, Innovation Trends in Product Approvals, 1987-2012 5
Figure 2: Pharmaceutical Market, Global, Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval, 2006-2013 7
Figure 3: Pain Market, Global, Treatment Algorithm 15
Figure 4: Pain Market, Global, WHO Analgesic Ladder 16
Figure 5: Pain Market, Global, Marketed Products by Molecule Type and Molecular Target, 2016 18
Figure 6: Pharmaceutical Market, Global, Developmental Pipeline Overview, 2016 20
Figure 7: Pain Market, Global, Developmental Pipeline Overview, 2016 21
Figure 8: Pain Market, Global, Developmental Pipeline Molecular Target Categories, 2016 22
Figure 9: Pain Market, Global, Molecular Target Category Comparison of Pipeline and Marketed Products, 2016 23
Figure 10: Pain Market, Global, Molecular Target Category Comparison of Pipeline First-in-Class and Established Molecular Targets, 2016 25
Figure 11: Pain Market, Global, Level of First-in-Class Innovation by Stage of Development (%), 2016 26
Figure 12: Pain Market, Global, Level of First-in-Class Innovation by Molecular Target (%), 2016 26
Figure 13: Pain Market, Global, Total Pipeline Products by Pain Subtype and Stage of Development, 2016 27
Figure 14: Pain Market, Global, Total Pipeline Products by Pain Subtype and Stage of Development, 2016 27
Figure 15: Pain Market, Global, First-in-Class Pipeline Products by Pain Subtype and Molecular Target, 2016 28
Figure 16: Pain Market, Global, First-in-Class Pipeline Products by Pain Subtype and Stage of Development, 2016 29
Figure 17: Pain Market, Global, First-in-Class Products in the Pipeline Part 1, 2016 30
Figure 18: Pain Market, Global, First-in-Class Products in the Pipeline Part 2, 2016 31
Figure 19: Pain Market, Global, First-in-Class Molecular Target Analysis Matrix Part 1, 2016 33
Figure 20: Pain Market, Global, First-in-Class Molecular Target Analysis Matrix Part 2, 2016 34
Figure 21: Pain Market, Global, Pipeline Programs Targeting Nerve Growth Factor, 2016 37
Figure 22: Pain Market, Global, Pipeline Programs Targeting High Affinity Nerve Growth Factor Receptor, 2016 37
Figure 23: Pain Market, Global, Pipeline Programs Targeting Tumor Necrosis Factor Receptor Superfamily Member 16, 2016 38
Figure 24: Pain Market, Global, Pipeline Programs Targeting Bradykinin B1 Receptor, 2016 40
Figure 25: Pain Market, Global, Pipeline Programs Targeting Opioid Receptor-Like-1 Receptor, 2016 43
Figure 26: Pain Market, Global, Pipeline Programs Targeting Purinoceptor 7, 2016 44
Figure 27: Pain Market, Global, Pipeline Programs Targeting Glutamate Receptor 6, 2016 45
Figure 28: Pain Market, Global, Pipeline Programs Targeting Glutamate Receptor 7, 2016 45
Figure 29: Pain Market, Global, Pipeline Programs Targeting Calcitonin Gene-Related Peptide Type-1 Receptor, 2016 46
Figure 30: Pharmaceutical Market, Global, Industry-Wide Deals by Stage of Development, 2006-2014 47
Figure 31: Pharmaceutical Market, Global, Industry Licensing Deal Values by Stage of Development, 2006-2014 48
Figure 32: Pain Market, Global, Licensing Deals by Region and Value, 2006-2016 49
Figure 33: Pain Market, Global, Licensing Deals by Stage of Development and Value, 2006-2016 50
Figure 34: Pain Market, Global, Licensing Deals by Stage of Development and Molecule Type, 2006-2016 50
Figure 35: Pain Market, Global, Licensing Deals by Stage of Development and Molecular Target, 2006-2016 51
Figure 36: Pain Market, Global, Summary of Licensing Deals Valued Above $100m, 2006-2016 52
Figure 37: Pain Market, Global, Co-development Deals by Region and Value, 2006-2015 53
Figure 38: Pain Market, Global, Co-Development Deals by Stage of Development and Value, 2006-2016 54
Figure 39: Pain Market, Global, Co-Development Deals by Stage of Development and Molecule Type, 2006-2016 54
Figure 40: Pain Market, Global, Co-Development Deals by Stage of Development and Molecular Target, 2006-2016 55
Figure 41: Pain Market, Global, Summary of Co-development Deals Valued Above $100m, 2006-2016 56
Figure 42: Pain Market, Global, List of Pipeline Products With Prior Licensing or Co-Development Deal Involvement, 2016 57
Figure 43: Pain Market, Global, List of Pipeline Products Without Prior Licensing or Co-Development Deal Involvement, 2016 58

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