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Market Spotlight: Axial Spondyloarthritis (axSpA)

  • ID: 5008189
  • Report
  • March 2021
  • Region: Global
  • 52 Pages
  • Datamonitor Healthcare
Definition

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.
  • The publisher 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
Note: Product cover images may vary from those shown
OVERVIEW

KEY TAKEAWAYS

DISEASE BACKGROUND
  • Definition
  • Patient segmentation
  • Symptoms
  • Risk factors
  • Diagnosis
TREATMENT

NSAIDs

DMARDs
  • Steroids
  • Surgery
EPIDEMIOLOGY
  • Epidemiology of axial spondyloarthritis
MARKETED DRUGS

PIPELINE DRUGS

RECENT EVENTS AND ANALYST OPINION
  • Xeljanz/Xeljanz XR for Axial Spondyloarthritis (November 6, 2020)
  • Cosentyx for Axial Spondyloarthritis (November 12, 2019)
  • Rinvoq for Axial Spondyloarthritis (November 12, 2019)
  • Taltz for Axial Spondyloarthritis (November 12, 2019)
  • Inflectra for Axial Spondyloarthritis (September 19, 2019)
  • Cosentyx for Axial Spondyloarthritis (September 17, 2019)
KEY UPCOMING EVENTS

KEY REGULATORY EVENTS
  • Sandoz Confirms Launch Of Humira Rival In Canada
  • Celltrion Wins Global First Approval For High-Concentration Humira Biosimilar
  • Henlius Gets Green Light For Adalimumab In China
  • AbbVie’s Rinvoq Advances Along Aggressive Growth Plan
  • Extra Indications Approved For Celltrion’s Remsima SC
  • FDA Approves Mylan’s Humira Biosimilar
  • Japan Approves First Humira Biosimilar
  • New Indications For Novartis, Ultragenyx
  • Mylan And Lupin Prepare To Launch EU Etanercept
  • Mylan And Lupin Get EU Etanercept Nod
  • Celltrion Eyes ‘Competitive Edge’ With Adalimumab Filing
PROBABILITY OF SUCCESS

REVENUE OPPORTUNITY

CLINICAL TRIAL LANDSCAPE
  • Sponsors by status
  • Sponsors by phase
BIBLIOGRAPHY
  • Prescription information
APPENDIX

LIST OF FIGURES
Figure 1: Trends in prevalent cases of ankylosing spondylitis, 2018–27
Figure 2: Overview of pipeline drugs for axSpA in the US
Figure 3: Pipeline drugs for axSpA, by company
Figure 4: Pipeline drugs for axSpA, by drug type
Figure 5: Pipeline drugs for axSpA, by classification
Figure 6: Xeljanz/Xeljanz XR for Axial Spondyloarthritis (November 6, 2020): Phase III - Ankylosing Spondylitis (A3921120)
Figure 7: Cosentyx for Axial Spondyloarthritis (November 12, 2019): Phase III - PREVENT
Figure 8: Rinvoq for Axial Spondyloarthritis (November 12, 2019): Phase II/III - SELECT Axis 1
Figure 9: Cosentyx for Axial Spondyloarthritis (September 17, 2019): Phase III - PREVENT
Figure 10: Key upcoming events in axSpA
Figure 11: Probability of success in the arthritis pipeline
Figure 12: Clinical trials in ankylosing spondylitis
Figure 13: Top 10 drugs for clinical trials in ankylosing spondylitis
Figure 14: Top 10 companies for clinical trials in ankylosing spondylitis
Figure 15: Trial locations in ankylosing spondylitis
Figure 16: Ankylosing spondylitis trials status
Figure 17: Ankylosing spondylitis trials sponsors, by phase

LIST OF TABLES
Table 1: Prevalent cases of ankylosing spondylitis, 2018–27
Table 2: Marketed drugs for axSpA
Table 3: Pipeline drugs for axSpA in the US
Table 4: Xeljanz/Xeljanz XR for Axial Spondyloarthritis (November 6, 2020)
Table 5: Cosentyx for Axial Spondyloarthritis (November 12, 2019)
Table 6: Rinvoq for Axial Spondyloarthritis (November 12, 2019)
Table 7: Taltz for Axial Spondyloarthritis (November 12, 2019)
Table 8: Inflectra for Axial Spondyloarthritis (September 19, 2019)
Table 9: Cosentyx for Axial Spondyloarthritis (September 17, 2019)
Table 10: Historical global sales, by drug ($m), 2015–19
Table 11: Forecasted global sales, by drug ($m), 2021–25
Note: Product cover images may vary from those shown
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