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, and a 10-year disease prevalence forecast, as well as presenting drug-specific revenue forecasts.
- Datamonitor Healthcare estimates that in 2018, there were 5.9 million prevalent cases of ankylosing spondylitis in adults aged 20 years and older worldwide, and forecasts that number to increase to 6.4 million prevalent cases by 2027.
- 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, and percutaneous catheter/injection formulations.
- The greatest proportion of industry-sponsored drugs in active clinical development for axSpA are in the NDA/BLA phase. Therapies in development for axSpA focus on targets such as JAK/STAT, interleukin 17, and granulocyte-macrophage colonystimulating factor. These drugs are administered via the oral, intravenous, subcutaneous, and topical routes.
- High-impact upcoming events for drugs in the axSpA space comprise topline Phase III trial results for bimekizumab, Cosentyx, and Rinvoq; expected PDUFA dates for Rinvoq and Xeljanz/Xeljanz XR; as well as an estimated BsUFA date for Yuflyma.
- The overall likelihood of approval of a Phase I arthritis asset is 8.4%, and the average probability a drug advances from Phase III is 80%. Drugs, on average, take 9.0 years from Phase I to approval, compared to 9.3 years in the overall autoimmune/immunology space.
- The distribution of clinical trials across Phase I–IV indicates that the majority of trials for ankylosing spondylitis have been in the late phases of development, with 81% of trials in Phase III–IV, and only 19% in Phase I–II.
- Germany has a significant lead in the number of ankylosing spondylitis clinical trials globally, while South Korea has the top spot in Asia.
- Clinical trial activity in the ankylosing spondylitis space is dominated by completed trials. AbbVie has the highest number of completed clinical trials for ankylosing spondylitis, with 29 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
15 Epidemiology of axial spondyloarthritis
17 MARKETED DRUGS
23 PIPELINE DRUGS
27 RECENT EVENTS AND ANALYST OPINION
27 Multiple Drugs for Axial Spondyloarthritis (September 1, 2021)
28 Xeljanz/Xeljanz XR for Axial Spondyloarthritis (November 6, 2020)
31 KEY UPCOMING EVENTS
32 KEY REGULATORY EVENTS
32 Alvotech And Stada Gain Second Ever Higher-Strength Adalimumab Nod
32 NICE Recommends Taltz For Axial Spondyloarthritis
32 Sorrento And Mabpharm Get ‘Biobetter’ Infliximab Approval In China
32 JAK Inhibitor Extension Becomes Missed Goal Date
33 Alberta Expands Biosimilar Switching With Adalimumab
33 JAK-Inhibitor Review Delays Spur Talk Of US FDA Panel Meeting On Class Safety
33 Sandoz Confirms Launch Of Humira Rival In Canada
34 Celltrion Wins Global First Approval For High-Concentration Humira Biosimilar
34 Henlius Gets Green Light For Adalimumab In China
34 AbbVie’s Rinvoq Advances Along Aggressive Growth Plan
35 PROBABILITY OF SUCCESS
36 REVENUE OPPORTUNITY
41 CLINICAL TRIAL LANDSCAPE
42 Sponsors by status
43 Sponsors by phase
45 BIBLIOGRAPHY
46 APPENDIX
LIST OF FIGURES
15 Figure 1: Trends in prevalent cases of ankylosing spondylitis, 2018–27
23 Figure 2: Overview of pipeline drugs for axSpA in the US
23 Figure 3: Pipeline drugs for axSpA, by company
24 Figure 4: Pipeline drugs for axSpA, by drug type
24 Figure 5: Pipeline drugs for axSpA, by classification
30 Figure 6: Xeljanz/Xeljanz XR for Axial Spondyloarthritis (November 6, 2020): Phase III – Ankylosing Spondylitis (A3921120)
31 Figure 7: Key upcoming events in axSpA
35 Figure 8: Probability of success in the arthritis pipeline
41 Figure 9: Clinical trials in ankylosing spondylitis
41 Figure 10: Top 10 drugs for clinical trials in ankylosing spondylitis
42 Figure 11: Top 10 companies for clinical trials in ankylosing spondylitis
42 Figure 12: Trial locations in ankylosing spondylitis
43 Figure 13: Ankylosing spondylitis trials status
44 Figure 14: Ankylosing spondylitis trials sponsors, by phase
LIST OF TABLES
14 Table 1: Prevalent cases of ankylosing spondylitis, 2018–27
18 Table 2: Marketed drugs for axSpA
25 Table 3: Pipeline drugs for axSpA in the US
27 Table 4: Multiple Drugs for Axial Spondyloarthritis (September 1, 2021)
29 Table 5: Xeljanz/Xeljanz XR for Axial Spondyloarthritis (November 6, 2020)
37 Table 6: Historical global sales, by drug ($m), 2016–20
39 Table 7: Forecasted global sales, by drug ($m), 2021–25
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