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 in the axSpA space comprise topline Phase III trial results for bimekizumab, Cosentyx, and Rinvoq; and expected PDUFA dates for Rinvoq and Xeljanz/Xeljanz XR.
- 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 9.2 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 82% of trials in Phase III–IV, and only 18% 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 28 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 Xeljanz/Xeljanz XR for Axial Spondyloarthritis (November 6, 2020)
28 Cosentyx for Axial Spondyloarthritis (November 12, 2019)
29 Rinvoq for Axial Spondyloarthritis (November 12, 2019)
31 Taltz for Axial Spondyloarthritis (November 12, 2019)
32 Inflectra for Axial Spondyloarthritis (September 19, 2019)
33 Cosentyx for Axial Spondyloarthritis (September 17, 2019)
35 KEY UPCOMING EVENTS
36 KEY REGULATORY EVENTS
36 Sandoz Confirms Launch Of Humira Rival In Canada
36 Celltrion Wins Global First Approval For High-Concentration Humira Biosimilar
36 Henlius Gets Green Light For Adalimumab In China
36 AbbVie’s Rinvoq Advances Along Aggressive Growth Plan
37 Extra Indications Approved For Celltrion’s Remsima SC
37 FDA Approves Mylan’s Humira Biosimilar
37 Japan Approves First Humira Biosimilar
37 New Indications For Novartis, Ultragenyx
38 Mylan And Lupin Prepare To Launch EU Etanercept
38 Mylan And Lupin Get EU Etanercept Nod
38 Celltrion Eyes ‘Competitive Edge’ With Adalimumab Filing
40 PROBABILITY OF SUCCESS
41 REVENUE OPPORTUNITY
45 CLINICAL TRIAL LANDSCAPE
46 Sponsors by status
47 Sponsors by phase
49 BIBLIOGRAPHY
49 Prescription information
51 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
28 Figure 6: Xeljanz/Xeljanz XR for Axial Spondyloarthritis (November 6, 2020): Phase III – Ankylosing Spondylitis (A3921120)
29 Figure 7: Cosentyx for Axial Spondyloarthritis (November 12, 2019): Phase III – PREVENT
31 Figure 8: Rinvoq for Axial Spondyloarthritis (November 12, 2019): Phase II/III – SELECT Axis 1
34 Figure 9: Cosentyx for Axial Spondyloarthritis (September 17, 2019): Phase III – PREVENT
35 Figure 10: Key upcoming events in axSpA
40 Figure 11: Probability of success in the arthritis pipeline
45 Figure 12: Clinical trials in ankylosing spondylitis
45 Figure 13: Top 10 drugs for clinical trials in ankylosing spondylitis
46 Figure 14: Top 10 companies for clinical trials in ankylosing spondylitis
46 Figure 15: Trial locations in ankylosing spondylitis
47 Figure 16: Ankylosing spondylitis trials status
48 Figure 17: 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: Xeljanz/Xeljanz XR for Axial Spondyloarthritis (November 6, 2020)
28 Table 5: Cosentyx for Axial Spondyloarthritis (November 12, 2019)
30 Table 6: Rinvoq for Axial Spondyloarthritis (November 12, 2019)
31 Table 7: Taltz for Axial Spondyloarthritis (November 12, 2019)
32 Table 8: Inflectra for Axial Spondyloarthritis (September 19, 2019)
33 Table 9: Cosentyx for Axial Spondyloarthritis (September 17, 2019)
42 Table 10: Historical global sales, by drug ($m), 2015–19
44 Table 11: Forecasted global sales, by drug ($m), 2021–25
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