Market Spotlight: Axial Spondyloarthritis (axSpA)
Market Spotlight: Axial Spondyloarthritis (axSpA)
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This Market Spotlight report covers the Axial Spondyloarthritis (axSpA) market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, and a 10-year disease prevalence forecast, as well as presenting drug-specific revenue forecasts.
Author: Informa Pharma Intelligence
Publisher: Meddevicetracker
- Description
- Contents
Overview
This Market Spotlight report covers the Axial Spondyloarthritis (axSpA) market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, licensing and asset acquisition deals, and a 10-year disease prevalence forecast, as well as presenting drug-specific revenue forecasts.
- Datamonitor Healthcare estimates that in 2020, there were approximately 6.0 million prevalent cases of ankylosing spondylitis in adults aged 20 years and older worldwide, and forecasts that number to increase to 6.5 million prevalent cases by 2029.
- The approved drugs in the axial spondyloarthritis (axSpA) space target tumor necrosis factor-alpha, prostaglandin E receptor 1, prostaglandin E receptor 2, interleukin 17, IL-17 receptor, and JAK/STAT. These are commonly administered via the subcutaneous route, with the remainder being intravenous, oral, topical, and percutaneous catheter/injection formulations.
- There are only three industry-sponsored drugs in active clinical development for axSpA, with one drug each in Phase I, Phase III, and the NDA/BLA phase.
- Therapies in development for axSpA focus on targets such as JAK/STAT, interleukin 17, and mitogen-activated protein kinaseactivated protein kinase 2. These drugs are administered via the oral, intravenous, and subcutaneous routes.
- High-impact upcoming events for drugs in the axSpA space comprise topline Phase III trial results for Cosentyx; an expected NDA/BLA filing for Bimzelx; an estimated BsUFA date for Yuflyma; and expected CHMP supplemental filing results, a PDUFA date, as well as an estimated Europe supplemental approval decision for Rinvoq.
- The overall likelihood of approval of a Phase I arthritis asset is 8.1%, and the average probability a drug advances from Phase III is 79.2%. Drugs, on average, take 9.0 years from Phase I to approval, compared to 9.4 years in the overall autoimmune/immunology space.
- There are almost equal proportions of clinical trials for ankylosing spondylitis across Phase I–IV, with 51% of trials in Phase III–IV, and 49% in Phase I–II.
- Germany has had the most ankylosing spondylitis clinical trials globally, while China has the top spot in Asia. Clinical trial activity in the ankylosing spondylitis space is dominated by completed trials. Pfizer has the highest number of completed clinical trials for ankylosing spondylitis, with 50 trials.
- Pfizer leads industry sponsors with the highest overall number of clinical trials for ankylosing spondylitis, followed by AbbVie.
CONTENTS
6 OVERVIEW
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
8 Definition
8 Patient segmentation
8 Symptoms
9 Risk factors
9 Diagnosis
11 TREATMENT
11 NSAIDs
11 DMARDs
12 Steroids
12 Surgery
13 EPIDEMIOLOGY
13 Epidemiology of axial spondyloarthritis (axSpA)
13 Epidemiology of axial spondyloarthritis subtypes
14 Prevalence methodology
17 MARKETED DRUGS
23 PIPELINE DRUGS
27 RECENT EVENTS AND ANALYST OPINION
27 Bimzelx for Axial Spondyloarthritis (January 18, 2022)
28 Bimzelx for Axial Spondyloarthritis (December 16, 2021)
29 Rinvoq for Axial Spondyloarthritis (October 7, 2021)
31 Rinvoq for Axial Spondyloarthritis (October 7, 2021)
32 Multiple Drugs for Axial Spondyloarthritis (September 1, 2021)
34 Xeljanz/Xeljanz XR for Axial Spondyloarthritis (November 6, 2020)
36 KEY UPCOMING EVENTS
37 KEY REGULATORY EVENTS
37 EMA Reviewing Cardiovascular & Cancer Risk From Five Janus Kinase Inhibitors
37 AbbVie’s Rinvoq Ramps Up As JAK Concerns Recede
37 Coherus Promises ‘Compelling Value Proposition’ After US Adalimumab Approval
38 Pfizer’s Xeljanz Receives FDA Approval To Treat Active Ankylosing Spondylitis
38 Alvotech And Stada Gain Second Ever Higher-Strength Adalimumab Nod
38 NICE Recommends Taltz For Axial Spondyloarthritis
38 Sorrento And Mabpharm Get ‘Biobetter’ Infliximab Approval In China
39 JAK Inhibitor Extension Becomes Missed Goal Date
39 Alberta Expands Biosimilar Switching With Adalimumab
39 JAK-Inhibitor Review Delays Spur Talk Of US FDA Panel Meeting On Class Safety
41 PROBABILITY OF SUCCESS
42 LICENSING AND ASSET ACQUISITION DEALS
42 Henlius Partners With Getz To Commercialize Adalimumab Biosimilar
42 Hikma Adds Remsima SC To Celltrion MENA Collaboration
43 REVENUE OPPORTUNITY
48 CLINICAL TRIAL LANDSCAPE
49 Sponsors by status
50 Sponsors by phase
51 Recent events
52 BIBLIOGRAPHY
54 APPENDIX
LIST OF FIGURES
16 Figure 1: Trends in prevalent cases of ankylosing spondylitis, 2020–29
23 Figure 2: Overview of pipeline drugs for axSpA in the US
23 Figure 3: Pipeline drugs for axSpA, by company
23 Figure 4: Pipeline drugs for axSpA, by drug type
24 Figure 5: Pipeline drugs for axSpA, by classification
29 Figure 6: Bimzelx for Axial Spondyloarthritis (December 16, 2021): Phase III – BE MOBILE 2
31 Figure 7: Rinvoq for Axial Spondyloarthritis (October 7, 2021): Phase III – SELECT AXIS 2 (Study 2 – nr-axSpA)
32 Figure 8: Rinvoq for Axial Spondyloarthritis (October 7, 2021): Phase III – SELECT AXIS 2 (Study 1 – bDMARD-IR)
35 Figure 9: Xeljanz/Xeljanz XR for Axial Spondyloarthritis (November 6, 2020): Phase III – Ankylosing Spondylitis (A3921120)
36 Figure 10: Key upcoming events in axSpA
41 Figure 11: Probability of success in the arthritis pipeline
48 Figure 12: Clinical trials in ankylosing spondylitis
48 Figure 13: Top 10 drugs for clinical trials in ankylosing spondylitis
49 Figure 14: Top 10 companies for clinical trials in ankylosing spondylitis
49 Figure 15: Trial locations in ankylosing spondylitis
50 Figure 16: Ankylosing spondylitis trials status
51 Figure 17: Ankylosing spondylitis trials sponsors, by phase
LIST OF TABLES
15 Table 1: Prevalent cases of ankylosing spondylitis, 2020–29
18 Table 2: Marketed drugs for axSpA
25 Table 3: Pipeline drugs for axSpA in the US
27 Table 4: Bimzelx for Axial Spondyloarthritis (January 18, 2022)
28 Table 5: Bimzelx for Axial Spondyloarthritis (December 16, 2021)
30 Table 6: Rinvoq for Axial Spondyloarthritis (October 7, 2021)
31 Table 7: Rinvoq for Axial Spondyloarthritis (October 7, 2021)
32 Table 8: Multiple Drugs for Axial Spondyloarthritis (September 1, 2021)
34 Table 9: Xeljanz/Xeljanz XR for Axial Spondyloarthritis (November 6, 2020)
44 Table 10: Historical global sales, by drug ($m), 2016–20
46 Table 11: Forecasted global sales, by drug ($m), 2022–26
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