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  4. > Denosumab (Prolia) (Rheumatoid Arthritis) - Forecast and Market Analysis to 2023

Denosumab (Prolia) (Rheumatoid Arthritis) - Forecast and Market Analysis to 2023

Summary

Rheumatoid arthritis (RA) is a chronic autoimmune disease which causes inflammation and deformity of the joints . It affects over seven million individuals in the 10MM covered in this report (US, France, Germany, Italy, Spain, UK, Japan, Australia, China, and India) and the prevalence is expected to grow to just over 8.5 million individuals by 2023. The anti-TNFs have been effective in treating the signs and symptoms of RA and inhibiting progression to erosive bone disease. However, the landscape is quickly changing with the introduction of biosimilars, novel biologics, and a class of oral therapies known as JAK inhibitors, all of which will change the market dynamics between 2013 and 2023. With the anti-TNFs as extremely effective therapies for RA, the market is extremely competitive for new entrants and will undergo further pressure as biosimilars are approved and launch.

Denosumab is a fully-human, immunoglobulin G1 (IgG2) mAb against RANKL that is in Phase III of development for RA patients with active, erosive bone disease. The Phase III clinical program is currently supported by Daiichi Sankyo for use in the Japanese population. Denosumab was once under investigation for RA by Amgen, which owns the rights to the molecule in the US and 5EU. However, a Phase II trial was completed in 2007, with no further development, and Amgen does not list denosumab for RA in its March 2014 pipeline on the company’s webpage.

Scope

- Overview of Rheumatoid Arthritis, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on Denosumab including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Denosumab for the top country from 2013 to 2023.
- Sales information covered for Japan.

Reasons to buy

- Understand and capitalize by identifying products that are most likely to ensure a robust return.
- Stay ahead of the competition by understanding the changing competitive landscape for Rheumatoid Arthritis.
- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential.
- Make more informed business decisions from insightful and in-depth analysis of Denosumab performance.
- Obtain sales forecast for Denosumab from 2013-2023 in top country (Japan).

Table Of Contents

Denosumab (Prolia) (Rheumatoid Arthritis) - Forecast and Market Analysis to 2023
1 Table of Contents
2 Introduction 9
2.1 Catalyst 9
2.2 Related Reports 10
2.3 Upcoming Related Reports 13
3 Disease Overview 14
3.1 Etiology and Pathophysiology 14
3.1.1 Etiology 14
3.1.2 Pathophysiology 14
3.2 Symptoms 18
3.3 Prognosis 19
3.4 Quality of Life 19
4 Disease Management 20
4.1 Diagnosis and Treatment Overview 20
4.1.1 Diagnosis 20
4.1.2 Treatment Guidelines 22
4.1.3 Leading Prescribed Drugs for the Treatment of RA 32
4.1.4 Clinical Practice 34
5 Competitive Assessment 39
5.1 Overview 39
6 Unmet Need and Opportunity 41
6.1 Overview 41
6.2 Development of Cost-Effective Therapies 42
6.2.1 Unmet Need 42
6.2.2 Gap Analysis 43
6.2.3 Opportunity 43
6.3 Biomarkers to Predict Responsiveness to Therapy 44
6.3.1 Unmet Need 44
6.3.2 Gap Analysis 46
6.3.3 Opportunity 46
6.4 Early Diagnosis of RA 47
6.4.1 Unmet Need 47
6.4.2 Gap Analysis 48
6.4.3 Opportunity 49
6.5 Personalized Treatment Approach 49
6.5.1 Unmet Need 49
6.5.2 Gap Analysis 50
6.5.3 Opportunity 52
7 Pipeline Assessment 53
7.1 Overview 53
7.2 Promising Drugs in Clinical Development 53
8 Denosumab (Prolia/Xgeva) 61
8.1 Overview 61
8.2 Efficacy 63
8.3 Safety 64
8.4 Dosing and Formulation 64
8.5 Potential Clinical Positioning 65
8.6 Potential Commercial Positioning 65
8.7 Pricing and Reimbursement 65
8.8 SWOT Analysis 66
8.9 Forecast 67
9 Appendix 68
9.1 Bibliography 68
9.2 Abbreviations 71
9.3 Methodology 74
9.4 Forecasting Methodology 74
9.4.1 Diagnosed RA Patients 74
9.4.2 Percentage of Drug-Treated Patients 75
9.4.3 General Pricing Assumptions 75
9.4.4 Generic and Biosimilar Erosion 76
9.4.5 Pricing of Pipeline Agents 76
9.5 Primary Research - KOLs Interviewed for This Report 77
9.6 Primary Research - Prescriber Survey 79
9.7 About the Authors 80
9.7.1 Analyst 80
9.7.2 Reviewer 80
9.7.3 Therapy Area Director 81
9.7.4 Global Head of Healthcare 81
9.8 About GlobalData 82
9.9 Disclaimer 82

1.1 List of Tables

Table 1: Symptoms of RA 18
Table 2: 1987 ACR Diagnostic Criteria for RA 21
Table 3: 2010 ACR/EULAR Diagnostic Criteria for RA 22
Table 4: Treatment Guidelines for RA Used by Each Country in the 10MM 25
Table 5: ACR 2012 Criteria for RA Remission and Low/Moderate/High Disease Activity 28
Table 6: EULAR 2013 Criteria for RA Remission 29
Table 7: Most Prescribed Biologics for RA (After csDMARDs) in the Global Markets, 2014 33
Table 8: Leading Branded Treatments for RA 2014 40
Table 9: Unmet Need and Opportunity in RA, 2014 42
Table 10: Comparison of Therapeutic Drug Classes in Development for RA, 2014 60
Table 11: Product Profile - Denosumab 63
Table 12: Denosumab SWOT Analysis, 2014 66
Table 13: Global Sales Forecasts ($m) for denosumab in RA, 2013-2023 67
Table 14: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 79

1.2 List of Figures

Figure 1: Normal Synovial Joint and Synovial Joint with RA 15
Figure 2: Cellular and Cytokine Targets for the Current RA Drugs 17
Figure 3: Disease Management Flowchart for Early RA - ACR 2012 29
Figure 4: Disease Management Flowchart for Established RA - ACR 2012 30
Figure 5: Flowchart for the Management of RA - EULAR 2013 31
Figure 6: RA - Phase II-III Pipeline, 2014 55
Figure 7: Competitive Assessment of Late-Stage Pipeline Agents in RA, 2013-2023 59
Figure 8: Clinical and Commercial Positioning of denosumab in RA 66

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