1. Market Research
  2. > Pharmaceutical
  3. > Therapy Market Trends
  4. > Opportunity Analyzer: Axial Spondyloarthritis - Opportunity Analysis and Forecast to 2024 - Event-Driven Update

Opportunity Analyzer: Axial Spondyloarthritis - Opportunity Analysis and Forecast to 2024 - Event-Driven Update

Summary

Ankylosing Spondylitis (AS) is an autoimmune disease that causes inflammation of the sacroiliac joint accompanied by pain and stiffness of the lower back, which typically gets better with exercise. Ankylosis (fusion) of the spine is typically a late-stage complication and has been nicknamed “bamboo spine”, due to its appearance on X-ray. It is now recognized that the pathological changes leading to ankylosis develop over time, and an early stage of the disease, known as non-radiographic axial spondyloarthritis (nr-axSpA) is characterized by the same symptoms of inflammatory back pain without radiographic changes observed by X-ray. Together, AS and nr-axSpA are known as axial spondyloarthritis (axSpA). AS and nr-axSpA affect roughly 1.3 million and 700,000 individuals, respectively, in the seven major pharmaceutical markets (7MM) (US, France, Germany, Italy, Spain, UK, and Japan) covered in this report and the prevalence is expected to grow mainly due to changes in diagnosis rates. The anti-TNFs have been effective in treating the signs and symptoms of axSpA, however, there is a lack of effective therapeutic classes, and no treatment options for patients who have failed anti-TNF therapy, representing a key unmet need and opportunities for drug developers.

Highlights

Key Questions Answered

- What are the preferred anti-TNFs for and how will competition from pipeline agents and biosimilars affect sales? Are rheumatologists across the 7MM expected to prescribe biosimlars for axSpA?
- Will there be strong uptake of pipeline agents and how will Novartis’s Cosentyx, J&J’s Stelara, and Celgene’s Otezla be used in the clinic?
- According to key opinion leaders (KOLs), what are the most important unmet needs in axSpA? Will these needs be addressed by pipeline agents? What needs will remain by the end of the forecast period in 2024?
- How will disease awareness change over the forecast period and will this affect diagnosis?
- How is non-radiographic axial spondyloarthritis (nr-axSpA) treated and will the diagnosis and treatment change over the next decade? Which drugs are expected to gain label expansions into nr-axSpA?

Key Findings

- Increased diagnosis and treatment are key drivers in the axSpA market.
- Novartis’s Cosentyx and J&J’s Stelara will address the unmet need for drugs with novel MOAs and pose a threat to anti-TNFs, which are currently the only therapeutic class beyond NSAIDs.
- Label expansions into AS and nr-axSpA are expected to be an increasingly popular life-cycle management strategy for pharmaceutical companies developing drugs that target the immune system.
- Biosimilars are expected to change the landscape for axSpA and will create pricing pressure in the market.

Scope

- Overview of axial spondyloarthritis (axSpA), including etiology, pathophysiology, symptoms, and current treatment recommendations.
- Annualized axSpA market revenue, annual cost of therapy and treatment usage pattern data from 2014 and forecast for ten years to 2024, segmented by ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, R&D strategies, clinical trial design, and implications for the axSpA market for branded drugs and biosimilars.
- Pipeline analysis: comprehensive data split across different phases and emerging trends, specifically Novartis’s IL-17 inhibitor, Cosentyx; J&J’s IL-12/IL-23 inhibitor, Stelara; Celgene’s novel PDE4 inhibitor, Otezla; and biosimilars.
- Analysis of the current and future market competition in the global axSpA market. Clinical and commercial benchmarking of promising pipeline products versus standard of care treatments and competitive assessment of all therapies for both AS and nr-axSpA . Insightful review of the key industry drivers, restraints and challenges.

Reasons to buy

- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the axSpA market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global axSpA market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Track drug sales in the global axSpA market from 2014-2024.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table Of Contents

Opportunity Analyzer: Axial Spondyloarthritis - Opportunity Analysis and Forecast to 2024 - Event-Driven Update
1 Table of Contents
1 Table of Contents 9
1.1 List of Tables 14
1.2 List of Figures 17
2 Introduction 18
2.1 Catalyst 18
2.2 Related Reports 19
2.3 Upcoming Related Reports 19
3 Disease Overview 20
3.1 Etiology and Pathophysiology 20
3.1.1 Etiology 20
3.1.2 Pathophysiology 21
3.2 Symptoms 22
3.2.1 Ankylosing Spondylitis 22
3.2.2 Non-radiographic Axial Spondyloarthritis 24
4 Epidemiology 25
4.1 Risk Factors and Comorbidities 27
4.2 Global Trends 28
4.2.1 US 31
4.2.2 5EU 31
4.2.3 Japan 32
4.3 Forecast Methodology 32
4.3.1 Sources Used for Diagnosed Prevalence of AS 35
4.3.2 Sources Used for Diagnosed Prevalence of Nr-axSpA 38
4.3.3 Sources Used for the Prevalence of HLA-B27 Seropositivity in Diagnosed AS 39
4.3.4 Sources Not Used 40
4.3.5 Forecast Assumptions and Methods, Diagnosed Prevalent Cases of AS — Base Scenario 41
4.3.6 Forecast Assumptions and Methods, Diagnosed Prevalent Cases of Nr-axSpA — Base Scenario 43
4.3.7 Forecast Assumptions and Methods, HLA-B27 Seropositivity in Diagnosed AS 45
4.3.8 Forecast Assumptions and Methods, Diagnosed Prevalent Cases of AS — Alternative Scenario 45
4.3.9 Forecast Assumptions and Methods, Diagnosed Prevalent Cases of Nr-axSpA — Alternative Scenario 46
4.4 Epidemiological Forecast for AS (2014-2024) — Base Scenario 46
4.4.1 Diagnosed Prevalent Cases of AS 46
4.4.2 Age-Specific Diagnosed Prevalent Cases of Ankylosing Spondylitis 48
4.4.3 Sex-Specific Diagnosed Prevalent Cases of AS 49
4.4.4 Age-Standardized Diagnosed Prevalence of AS 51
4.4.5 Diagnosed Prevalent Cases of Nr-axSpA 52
4.4.6 Prevalent Cases of HLA-B27 Seropositivity in Diagnosed AS Cases 54
4.5 Epidemiological Forecast for AS (2014-2024) — Alternative Scenario 57
4.5.1 Diagnosed Prevalent Cases of AS 57
4.5.2 Diagnosed Prevalent Cases of Nr-axSpA 58
4.6 Discussion 60
4.6.1 Epidemiological Forecast Insight 60
4.6.2 Limitations of the Analysis 61
4.6.3 Strengths of the Analysis 61
5 Current Treatment Options 63
5.1 Overview 63
5.2 Product Profiles — Major Brands 65
5.2.1 Enbrel (etanercept) 65
5.2.2 Humira (adalimumab) 69
5.2.3 Remicade (infliximab) 73
5.2.4 Simponi (golimumab) 77
5.2.5 Cimzia (certolizumab pegol) 82
5.2.6 NSAIDs 86
5.2.7 Biosimilars 92
5.2.8 Other Therapies 99
6 Unmet Needs Assessment and Oppportunity Analysis 100
6.1 Overview 100
6.2 Lack of Awareness 101
6.2.1 Unmet Need 101
6.2.2 Gap Analysis 103
6.2.3 Opportunity 105
6.3 Standardization of Diagnosis and Early Treatment 105
6.3.1 Unmet Need 105
6.3.2 Gap Analysis 107
6.3.3 Opportunity 108
6.4 Drugs With Novel MOAs 109
6.4.1 Unmet Need 109
6.4.2 Gap Analysis 110
6.4.3 Opportunity 111
6.5 Recognition of Nr-axSpA 111
6.5.1 Unmet Need 111
6.5.2 Gap Analysis 113
6.5.3 Opportunity 114
7 RandD Strategies 115
7.1 Overview 115
7.1.1 Life-Cycle Management Strategies: Expansion from Key Autoimmune Indications 115
7.1.2 Life-Cycle Management Strategies: Expansion into Nr-axSpA 117
7.1.3 Development of New Formulations and Drug Delivery Methods 118
7.2 Clinical Trial Design 119
7.2.1 Ankylosing Spondylitis 119
7.2.2 Non-radiographic Axial Spondyloarthritis 123
7.2.3 Future Clinical Trials 124
8 Pipeline Assessment 126
8.1 Overview 126
8.2 Promising Drugs in Clinical Development 126
8.2.1 Cosentyx (Secukinumab) 126
8.2.2 Stelara (ustekinumab) 134
8.2.3 Otezla (apremilast) 140
8.3 Additional Drugs in Development for AS 145
9 Pipeline Valuation Analysis 149
9.1 Clinical Benchmarking of Key Pipeline Drugs 149
9.2 Commercial Benchmark of Key Pipeline Drugs 150
9.3 Competitive Assessment 152
9.4 Top Line Ten Year Forecast 154
9.4.1 US 160
9.4.2 5EU 162
9.4.3 Japan 163
10 Appendix 164
10.1 Abbreviations 164
10.2 Bibliography 168
10.3 Methodology 185
10.4 Forecasting Methodology 185
10.4.1 Diagnosed Patients 185
10.4.2 Percent Drug-Treated Patients 186
10.4.3 Drugs Included in Each Therapeutic Class 186
10.4.4 Launch and Patent Expiry Dates 187
10.4.5 General Pricing Assumptions 187
10.4.6 Individual Drug Assumptions 189
10.4.7 Generic Erosion 193
10.4.8 Pricing of Pipeline agents 193
10.5 Physicians and Specialists Included in this Study 194
10.6 Primary Research - Prescriber Survey 195
10.7 About the Authors 196
10.7.1 Author 196
10.7.2 Therapy Area Director 196
10.7.3 Epidemiologist 197
10.7.4 Global Head of Healthcare 197
10.8 About GlobalData 198
10.9 Disclaimer 198

1.1 List of Tables
Table 1: Clinical History Screening for AS 23
Table 2: Symptoms of AS 24
Table 3: Diagnostic Criteria for AS and Nr-axSpA 26
Table 4: Risk Factors and Comorbidities for AS 28
Table 5: Summary of the Global Reported Prevalence of AS 29
Table 6: Incidence of AS, Cases per 100,000 Population, 1935-1973, Rochester, Minnesota, US 30
Table 7: Annual Incidence of AS, Cases per 100,000 Population, 1980-1990, Finland 30
Table 8: 7MM, Sources of Diagnosed Prevalence Data for AS used in the Epidemiology Forecast 33
Table 9: 7MM, Sources of Diagnosed Prevalence Data for Nr-axSpA used in the Epidemiology Forecast 34
Table 10: 7MM, Sources of HLA-B27 Seropositivity Data in Diagnosed AS Cases used in the Epidemiology Forecast 35
Table 11: 7MM, Diagnosed Prevalent Cases of AS, Both Sexes, Ages ?15 Years, Select Years, N, 2014-2024 47
Table 12: 7MM, Age-Specific Diagnosed Prevalent Cases of AS, Both Sexes, N (Row %), 2014 48
Table 13: 7MM, Sex-Specific Diagnosed Prevalent Cases of Ankylosing Spondylitis, Ages ?15 Years, N (Row %), 2014 50
Table 14: 7MM, Diagnosed Prevalent Cases of Nr-axSpA, Both Sexes, Ages ?15 Years, Select Years, N, 2014-2024 53
Table 15: 5EU and Japan, Prevalent Cases of HLA-B27 Seropositivity in Diagnosed AS Cases, Both Sexes, Ages ?15 Years, Select Years, N, 2014-2024 55
Table 16: 5EU and Japan, HLA-B27 and Non-HLA-B27 Seropositivity Status Among Diagnosed AS Cases, Both Sexes, Ages ?15 Years, N, 2014 56
Table 17: 7MM, Diagnosed Prevalent Cases of AS, Both Sexes, Ages ?15 Years, Select Years, N, 2014-2024 57
Table 18: 7MM, Diagnosed Prevalent Cases of Nr-axSpA, Both Sexes, Ages ?15 Years, Select Years, N, 2014-2024 59
Table 19: Leading Treatments for Ankylosing Spondylitis, 2015 64
Table 20: Drug Approvals for AS and Nr-axSpA Across the 7MM, July 2015 65
Table 21: Product Profile — Enbrel 67
Table 22: Enbrel SWOT Analysis, 2015 69
Table 23: Product Profile — Humira 71
Table 24: Humira SWOT Analysis, 2015 73
Table 25: Product Profile — Remicade 75
Table 26: Safety of Remicade in AS — the ASSERT trial 76
Table 27: Remicade SWOT Analysis, 2015 77
Table 28: Product Profile — Simponi 78
Table 29: Efficacy of Simponi in AS — the GO-RAISE Trial, Week 104 80
Table 30: Safety of Simponi in AS — the GO-RAISE Trial, Week 104 81
Table 31: Simponi SWOT Analysis, 2015 82
Table 32: Product Profile — Cimzia 83
Table 33: Safety of Cimzia in axSpA — the RAPID-axSpA Trial, Week 24 85
Table 34: Cimzia SWOT Analysis, 2015 86
Table 35: Product Profile — NSAIDs 88
Table 36: Evidence for a Disease-Modifying Effect of NSAIDs in axSpA 90
Table 37: NSAIDs SWOT Analysis, 2015 92
Table 38: Biosimilars Pipeline for axSpA, 2015 95
Table 39: Physician Uptake of Biosimilar Products for axSpA Across the 7MM, 2015 98
Table 40: Summary of Minor Therapeutic Drug Classes Used to Treat AS/Nr-axSpA, 2015 99
Table 41: Unmet Need and Opportunity in axSpA, 2015 101
Table 42: Modified New York Criteria for AS 120
Table 43: Criteria for AS Disease Activity 121
Table 44: Instruments Used for AS Clinical Trial Endpoints 122
Table 45: Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) 123
Table 46: ASAS Criteria for axSpA 125
Table 47: Ankylosing Spondylitis — Late Stage Pipeline, July 2015 126
Table 48: Product Profile — Cosentyx 128
Table 49: Cosentyx Phase III Trial, MEASURE1: Week 16 131
Table 50: Cosentyx SWOT Analysis, 2015 133
Table 51: Product Profile — Stelara 135
Table 52: Stelara Phase II Trial, TOPAS: Week 24 137
Table 53: Stelara SWOT Analysis, 2015 139
Table 54: Product Profile — Otezla 141
Table 55: Otezla SWOT Analysis, 2015 145
Table 56: Early-Stage Pipeline Products in AS, May 2015 147
Table 57: Clinical Benchmark of Key Pipeline Drugs for Ankylosing Spondylitis 150
Table 58: Commercial Benchmark of Key Pipeline Drugs for Ankylosing Spondylitis 151
Table 59: Top-Line Sales Forecasts ($m) for axSpA, 2014-2024 155
Table 60: Top-Line Sales Forecasts ($m) by Indication, 2014-2024 156
Table 61: Key Events Impacting Sales for axSpA, 2014-2024 159
Table 62: Global AS/nr-axSpA Disease Market — Drivers and Barriers, 2014-2024 160
Table 63: Key Launch Dates 187
Table 64: Key Patent Expiries 187
Table 65: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country 195

1.2 List of Figures
Figure 1: Enthesitis and the Pathogenesis of Spondyloarthritis 22
Figure 2: 7MM, Diagnosed Prevalent Cases of AS, Both Sexes, Ages ?15 Years, N, 2014-2024 47
Figure 3: 7MM, Age-Specific Diagnosed Prevalent Cases of AS, Both Sexes, N, 2014 49
Figure 4: 7MM, Sex-Specific Diagnosed Prevalent Cases of AS, Ages ?15 Years, N, 2014 51
Figure 5: 7MM, Age-Standardized Diagnosed Prevalence of AS, Cases per 100,000 Population, Men and Women, 2014 52
Figure 6: 7MM, Diagnosed Prevalent Cases of Nr-axSpA, Both Sexes, Ages ?15 Years, N, 2014-2024 54
Figure 7: 5EU and Japan, Prevalent Cases of HLA-B27 Seropositivity in Diagnosed AS Cases, Both Sexes, Ages ?15 Years, N, 2014-2024 55
Figure 8: 5EU and Japan, HLA-B27 and Non-HLA-B27 Seropositivity Status Among Diagnosed AS Cases, Both Sexes, Ages ?15 Years, N, 2014 56
Figure 9: 7MM, Diagnosed Prevalent Cases of AS, Both Sexes, Ages ?15 Years, N, 2014-2024 58
Figure 10: 7MM, Diagnosed Prevalent Cases of Nr-axSpA, Both Sexes, Ages ?15 Years, N, 2014-2024 59
Figure 11: Biosimilar Prescribing Habits in axSpA Across the 7MM, 2015 98
Figure 12: Competitive Assessment of AS Pipeline Therapies, 2014-2024 152
Figure 13: Global Sales for axSpA by Region, 2014-2024 157
Figure 14: Global Sales for axSpA by Indication, 2014-2024 158

View This Report »

Get Industry Insights. Simply.

  • Latest reports & slideshows with insights from top research analysts
  • 24 Million searchable statistics with tables, figures & datasets
  • More than 10,000 trusted sources
24/7 Customer Support

Talk to Veronica

+1 718 514 2762

Purchase Reports From Reputable Market Research Publishers
PharmaPoint: Atrial Fibrillation - Global Drug Forecast and Market Analysis to 2025

PharmaPoint: Atrial Fibrillation - Global Drug Forecast and Market Analysis to 2025

  • $ 10995
  • Industry report
  • August 2016
  • by Global Data

PharmaPoint: Atrial Fibrillation - Global Drug Forecast and Market Analysis to 2025 Summary Atrial fibrillation (AF) is the most common cardiac arrhythmia and is a heart condition that causes an irregula ...

PharmaPoint: Venous Thromboembolism - Global Drug Forecast and Market Analysis to 2025

PharmaPoint: Venous Thromboembolism - Global Drug Forecast and Market Analysis to 2025

  • $ 10995
  • Industry report
  • August 2016
  • by Global Data

PharmaPoint: Venous Thromboembolism - Global Drug Forecast and Market Analysis to 2025 Summary Venous thromboembolism (VTE) is a disease that includes a myriad of life-threatening disorders ranging from ...

PharmaPoint: Acute Coronary Syndrome - Global Drug Forecast and Market Analysis to 2025

PharmaPoint: Acute Coronary Syndrome - Global Drug Forecast and Market Analysis to 2025

  • $ 10995
  • Industry report
  • August 2016
  • by Global Data

PharmaPoint: Acute Coronary Syndrome - Global Drug Forecast and Market Analysis to 2025 Summary Cardiovascular diseases (CVD), including ischemic heart disease and stroke, are the leading causes of mortality ...

Ulcerative Colitis: Kol Insight

September 2016 $ 8085

Hepatitis C: Kol Insight

September 2016 $ 8085

ref:plp2015

Reportlinker.com © Copyright 2016. All rights reserved.

ReportLinker simplifies how Analysts and Decision Makers get industry data for their business.