Frontier Pharma: Schizophrenia - Diverse First-in-Class Pipeline Shows Promise for Treatment of Negative and Cognitive Symptoms
Summary
Schizophrenia is a chronic mental disorder that affects 1% of the population - equivalent to 51 million people worldwide - and is ranked among the top 10 causes of disability in developed countries. It is a debilitating condition that affects those afflicted, their families and society as a whole.
In 2013, the direct and indirect cost of schizophrenia to US society was estimated to be $155 billion. Despite this, the schizophrenia pipeline is relatively small. This is indicative of a low level of R&D funding and investment in schizophrenia, most likely due to a poor understanding of the underlying mechanisms of the disease, which hinders the development of effective pharmaceutical drugs.
There are marketed pharmaceutical products that are effective in treating the positive symptoms of schizophrenia, but none are available for the treatment of negative and cognitive symptoms. There is no single pharmacological drug that addresses all the symptoms of schizophrenia, and therefore it is likely that in the future combined treatments based on pharmacogenetics will be used to provide a tailored approach.
As such there is a strong rationale for continued R&D investment in schizophrenia therapeutics, due to the high levels of unmet need across a large population. This report assesses first-in-class innovation across the schizophrenia pipeline.
Scope
- Innovation within schizophrenia is relatively small. What are the unmet needs across this therapy area?
- There are 160 products in the pipeline for schizophrenia. What proportion of these products are first-in-class? How does first-in-class innovation vary by indication, development stage and molecular target class?
- Although the first-in-class pipeline is small in comparison with other CNS-related disorders, it is relatively diverse, with numerous molecular targets. Which first-in-class targets have been identified as most promising for schizophrenia?
- A total of 77 licensing deals and 44 development deals related to schizophrenia have been completed since 2006. Does schizophrenia attract high-value deals? Which first-in-class products have no prior deal involvement?
Reasons to buy
- Understand the current clinical and commercial landscape. This includes a comprehensive study of symptoms, epidemiology, etiology, pathophysiology, co-morbidities and complications, diagnosis and treatment options.
- Visualize the composition of the schizophrenia market in terms of dominant molecule types and molecular targets, highlighting what the current unmet needs are and how they can be addressed. This knowledge allows a competitive understanding of gaps in the market.
- Analyze the schizophrenia pipeline and stratify by 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 first-in-class targets have been reviewed in greater detail.
- Recognize commercial opportunities in the schizophrenia deals landscape by analyzing trends in licensing and co-development deals, and identifying schizophrenia therapies that have not yet been involved in deals, and that may provide potential investment opportunities.
Frontier Pharma: Schizophrenia - Diverse First-in-Class Pipeline Shows Promise for Treatment of Negative and Cognitive Symptoms
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 3
1.2 List of Figures 3
2 Executive Summary 5
2.1 A Complex and Poorly Understood Disorder with Numerous Unmet Needs 5
2.2 Development and Influence of Antipsychotics 5
2.3 Small Pipeline for Schizophrenia with Few Signs of Innovation 5
3 The Case for Innovation 6
3.1 Growing Opportunities for Biologic Products 7
3.2 Diversification of Molecular Targets 7
3.3 Innovative First-in-Class Product Developments Remain Attractive 7
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Innovation 8
3.5 Sustained Innovation in Schizophrenia 8
4 Clinical and Commercial Landscape 10
4.1 Overview of Schizophrenia 10
4.2 Symptoms 10
4.3 Diagnosis 11
4.4 Disease Etiology 12
4.5 Disease Pathophysiology 12
4.5.1 Susceptibility Genes 13
4.5.2 Neurotransmission Alterations 14
4.5.3 Phosphatidylinositol Signaling 16
4.6 Epidemiology 16
4.7 Co-morbidities and Complications 16
4.7.1 Anxiety 16
4.7.2 Depression 16
4.7.3 Post-Traumatic Stress Disorder 17
4.7.4 Obsessive Compulsive Disorder 17
4.7.5 Panic Disorder 17
4.7.6 Cognitive Impairment 17
4.8 Prognosis 17
4.9 Treatment 17
4.10 Overview of Marketed Products 18
4.10.1 Molecule Type and Target Analysis 18
4.11 Current Unmet Needs 19
5 Assessment of Pipeline Product Innovation 20
5.1 Overview 20
5.2 Pipeline by Stage of Development and Molecule Type 20
5.3 Pipeline by Molecular Target 21
5.4 Comparative Distribution of Programs between Schizophrenia Disease Market and Pipeline by Therapeutic Target Family 22
5.5 Comparative Distribution of First-in-Class and Non-First-in-Class Pipeline Programs by Molecular Target Class 23
5.6 Percentage Distribution of First-in-Class and Non-First-in-Class Pipeline Programs 24
5.7 Ratio of First-In-Class Programs to First-in-Class Molecular Targets within the Pipeline 25
5.8 List of All First-in-Class Pipeline Programs 25
6 Schizophrenia Pathophysiology and Innovation Alignment 30
6.1 Complexity of Signaling Networks in Schizophrenia 30
6.2 Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration 31
6.3 First-in-Class Molecular Target Matrix Assessment 31
7 First-in-Class Molecular Target Evaluation 33
7.1 Pipeline Programs Targeting Metabotropic Glutamate Receptor 5 (GRM5) 33
7.2 Pipeline Programs Targeting Metabotropic Glutamate Receptor 3 (GRM3) 35
7.3 Pipeline Programs Targeting Metabotropic Glutamate Receptor 1 (GRM1) 36
7.4 Pipeline Programs Targeting 5-Hydroxytryptamine Receptor 5a (HTR5A) 38
7.5 Pipeline Programs Targeting Metabotropic Glutamate Receptor 2 (GRM2) 39
7.6 Pipeline Programs Targeting D-Amino Acid Oxidase (DAO) 41
7.7 Pipeline Programs Targeting Potassium Voltage-Gated Channel Subfamily C, Member 1 (KCNC1) 43
7.8 Pipeline Programs Targeting Microtubule Associated Protein Tau (MAPT) 44
8 Deals and Strategic Consolidations 47
8.1 Industry-Wide First-in-Class Deals 47
8.2 Licensing Deals 48
8.2.1 Deals by Region, Value and Year 48
8.2.2 Deals by Stage of Development and Value 49
8.2.3 Deals by Molecule Type and Molecular Target 50
8.2.4 List of Deals with Disclosed Deal Values 51
8.3 Co-development Deals 52
8.3.1 Deals by Region, Value and Year 52
8.3.2 Deals by Stage of Development and Value 53
8.3.3 Deals by Molecule Type and Molecular Target 54
8.3.4 List of Deals with Disclosed Deal Values 55
8.4 First-in-Class Programs with and without Prior Involvement in Licensing or Co-development Deals 55
9 Appendix 57
9.1 References 57
9.2 Abbreviations 65
9.3 Methodology 66
9.3.1 Data Integrity 66
9.3.2 Evidence Based Analysis and Insight 67
9.4 Secondary Research 67
9.4.1 Market Analysis 67
9.4.2 Pipeline Analysis 67
9.4.3 Licensing and Co-development Deals 68
9.5 Contact Us 68
9.6 Disclaimer 68
1.1 List of Tables
Table 1: Schizophrenia, US, American Psychiatry Association Definition of Symptoms of Schizophrenia, 2018 11
Table 2: Schizophrenia, US, American Psychiatry Association DSM-5 Schizophrenia Criteria, 2018 11
Table 3: Schizophrenia, Global, World Health Organization ICD-10 Schizophrenia Criteria, 2018 12
Table 4: Schizophrenia, Global, Key Features of Metabotropic Glutamate Receptor 5 (GRM5), 2018 34
Table 5: Schizophrenia, Global, Evidence for Metabotropic Glutamate Receptor 5 (GRM5) as a Therapeutic Target, 2018 34
Table 6: Pipeline Programs Targeting Metabotropic Glutamate Receptor 5 (GRM5), 2018 34
Table 7: Schizophrenia, Global, Key Features of Metabotropic Glutamate Receptor 3 (GRM3), 2018 36
Table 8: Schizophrenia, Global, Evidence for Metabotropic Glutamate Receptor 3 (GRM3) as a Therapeutic Target, 2018 36
Table 9: Schizophrenia, Global, Pipeline Programs Targeting Metabotropic Glutamate Receptor 3 (GRM3), 2018 36
Table 10: Schizophrenia, Global, Key Features of Metabotropic Glutamate Receptor 1 (GRM1), 2018 37
Table 11: Schizophrenia, Evidence for Metabotropic Glutamate Receptor 1 (GRM1) as a Therapeutic Target, 2018 38
Table 12: Schizophrenia, Pipeline Programs Targeting Metabotropic Glutamate Receptor 1 (GRM1), 2018 38
Table 13: Schizophrenia, Global, Key Features of D-Amino Acid Oxidase (DAO), 2018 39
Table 14: Schizophrenia, Global, Evidence for 5-Hydroxytryptamine Receptor 5A (HTR5A) as a Therapeutic Target, 2018 39
Table 15: Schizophrenia, Global, Pipeline Programs Targeting 5-Hydroxytryptamine Receptor (HTR5A), 2018 39
Table 16: Schizophrenia, Global, Key Features of Metabotropic Glutamate Receptor 2 (GRM2), 2018 40
Table 17: Schizophrenia, Global, Evidence for Metabotropic Glutamate Receptor 2 (GRM2) as a Therapeutic Target, 2018 40
Table 18: Pipeline Programs Targeting Metabotropic Glutamate Receptor 2 (GRM2), 2018 41
Table 19: Schizophrenia, Global, Key Features of Potassium Voltage-Gated Channel Subfamily C, Member 1 (KCNC1), 2018 42
Table 20: Schizophrenia, Global, Evidence for D-Amino Acid Oxidase (DAO) as a Therapeutic Target, 2018 42
Table 21: Schizophrenia, Global, Pipeline Programs Targeting D-Amino Acid Oxidase (DAO), 2018 43
Table 22: Schizophrenia, Global, Key Features of Potassium Voltage-Gated Channel Subfamily C, Member 1 (KCNC1), 2018 44
Table 23: Schizophrenia, Global, Evidence for Potassium Voltage-Gated Channel Subfamily C, Member 1 (KCNC1) as a Therapeutic Target, 2018 44
Table 24: Schizophrenia, Global, Pipeline Programs Targeting Potassium Voltage-Gated Channel Subfamily C, Member 1 (KCNC1), 2018 44
Table 25: Schizophrenia, Global, Key Features of Tau Protein (MAPT), 2018 45
Table 26: Schizophrenia, Global, Evidence for Tau Protein (MAPT) as a Therapeutic Target, 2018 45
Table 27: Pipeline Programs Targeting Tau Protein (MAPT), 2018 46
1.2 List of Figures
Figure 1: Schizophrenia, US, Innovation Trends in Product Approvals, 1987-2014 6
Figure 2: Schizophrenia, US, Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval, 2006-2013 8
Figure 3: Schizophrenia, Global Market by Molecular Target and Molecule Type, 2018 19
Figure 4: Schizophrenia, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area, 2018 20
Figure 5: Schizophrenia, Global, Pipeline by Stage of Development and Molecule Type, 2018 21
Figure 6: Schizophrenia, Global, Pipeline by Molecular Target and Stage of Development, 2018 22
Figure 7: Schizophrenia, Global, Distribution of Pipeline and Marketed Products by Molecular Target Class, 2018 23
Figure 8: Schizophrenia, Global, Percentage Distribution of First-in-Class and Non-First-in-Class Products by Stage of Development and Molecular Target Class, 2018 25
Figure 9: Schizophrenia, Global, Ratio of First-in-Class Products to First-in-Class Targets by Stage of Development and Molecular Target Class, 2018 25
Figure 10: Schizophrenia, Global, All Pipeline Programs, 2018 (part 1) 26
Figure 11: Schizophrenia, Global, All Pipeline Programs, 2018 (part 2) 27
Figure 12: Schizophrenia, Global, All Pipeline Programs, 2018 (part 3) 28
Figure 13: Schizophrenia, Global, All Pipeline Programs, 2018 (part 4) 29
Figure 14: Schizophrenia, Global, All Pipeline Programs, 2018 (part 5) 29
Figure 15: Schizophrenia, Global, First-in-Class Molecular Target Matrix Assessment, 2018 32
Figure 16: Schizophrenia, Global, Industry-Wide Licensing Deals by Stage of Development, 2006-2014 47
Figure 17: Schizophrenia, Global, Industry-Wide Deals by Stage of Development, 2006-2014 48
Figure 18: Schizophrenia, Global Licensing Deals by Region, Value and Year 2006-2018 49
Figure 19: Schizophrenia, Global, Licensing Deals by Deal Value, Upfront Payment Value and Stage of Development, 2006-2018 50
Figure 20: Schizophrenia, Global, Number and Aggregate Deal Value of Licensing Deals by Molecule Type and Molecular Target Class, 2006-2018 51
Figure 21: Schizophrenia, Global, Licensing Deals with Disclosed Deal Values, 2006-2018 52
Figure 22: Schizophrenia, Global, Co-development Deals by Region, Value and Year 2006-2018 53
Figure 23: Schizophrenia, Global, Number and Aggregate Deal Value of Co-development Deals By Stage of Development and Year, 2006-2018 54
Figure 24: Schizophrenia, Global, Number and Aggregate Deal Value of Co-development Deals by Molecular Target Class, 2006-2018 55
Figure 25: Schizophrenia, Global, Co-development Deals with Disclosed Deal Values, 2006-2018 55
Figure 26: Schizophrenia, Global, First-in-Class Programs with and without Prior Involvement in Licensing or Co-development Deals, 2006-2018 56
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