+353-1-416-8900REST OF WORLD
+44-20-3973-8888REST OF WORLD
1-917-300-0470EAST COAST U.S
1-800-526-8630U.S. (TOLL FREE)

PRINTER FRIENDLY

Market Spotlight: Axial Spondyloarthritis (axSpA) 2020

  • ID: 5008189
  • Report
  • February 2020
  • Region: Global
  • 56 Pages
  • Datamonitor Healthcare
1 of 3

Enquire about COVID-19 updates for this product.

Enquire Now

FEATURED COMPANIES

  • Amgen
  • Bio-Thera Solutions
  • Samsung
  • MORE

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, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, 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, and IL-17. These are commonly administered via the subcutaneous route, with the remainder being intravenous and oral formulations.
  • The majority of industry-sponsored drugs in active clinical development for axSpA are in Phase III. Therapies in development for axSpA focus on targets such as JAK/STAT, IL-17, tumor necrosis factor-alpha, and granulocytemacrophage colony-stimulating factor (GM-CSF). 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, expected PDUFA dates, a CHMP opinion, a supplemental CHMP opinion, and supplemental CHMP filing results.
  • The overall likelihood of approval of a Phase I arthritis asset is 9.9%, and the average probability a drug advances from Phase III is 80%. Drugs, on average, take 8.8 years from Phase I to approval, compared to 9.0 years in the overall autoimmune/immunology space.
  • There have been 10 licensing and asset acquisition deals involving axSpA drugs during 2015–20. The $132m agreement signed in 2018 between Grunenthal and AstraZeneca for the acquisition of European rights to Nexium and global (ex-US and Japan) rights to Vimovo was the only deal with a publicly released value.
  • The distribution of clinical trials across Phase I–IV indicates that the majority of trials for axSpA 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 substantial lead in the number of axSpA clinical trials globally, while South Korea has the top spot in Asia. Clinical trial activity in the axSpA space is dominated by completed trials. AbbVie has the highest number of completed clinical trials for axSpA, with 27 trials.
  • Pfizer leads industry sponsors with the highest overall number of clinical trials for axSpA, followed by AbbVie
Note: Product cover images may vary from those shown
2 of 3

FEATURED COMPANIES

  • Amgen
  • Bio-Thera Solutions
  • Samsung
  • MORE

1. OVERVIEW

2. KEY TAKEAWAYS

3. DISEASE BACKGROUND
Definition
Patient segmentation
Symptoms
Risk factors
Diagnosis

4. TREATMENT

5. NSAIDs

6. DMARDs
Steroids
Surgery

7. EPIDEMIOLOGY
Epidemiology of axial spondyloarthritis

8. MARKETED DRUGS

9. PIPELINE DRUGS

10. RECENT EVENTS AND ANALYST OPINION
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)
Taltz for Axial Spondyloarthritis (April 22, 2019)
SensoReady Injector Pen for Axial Spondyloarthritis (April 9, 2019)
Taltz for Axial Spondyloarthritis (October 22, 2018)
Taltz for Axial Spondyloarthritis (October 20, 2018)
Filgotinib for Axial Spondyloarthritis (September 6, 2018)

11. KEY UPCOMING EVENTS

12. KEY REGULATORY EVENTS
Amgen Gets US Infliximab Nod
With Launch Years Away, FDA Touts Approval Of Fifth Humira Biosimilar
Bio-Thera Solutions Has China’s First Adalimumab Biosimilar
Lilly’s Taltz Approved For AS As New Guidelines Keep TNF Inhibitors In Front Line
Samsung Bioepis Gets US Adalimumab Nod
Eticovo Becomes Second Approved Enbrel Biosimilar After Under-The-Radar Review
Cimzia Lands New Indication For Unmet Need

13. PROBABILITY OF SUCCESS

14. LICENSING AND ASSET ACQUISITION DEALS

15. PARENT PATENTS

16. REVENUE OPPORTUNITY

17. CLINICAL TRIAL LANDSCAPE 3 PROBABILITY OF SUCCESS

18. LICENSING AND ASSET ACQUISITION DEALS

19. PARENT PATENTS

20. REVENUE OPPORTUNITY

21. CLINICAL TRIAL LANDSCAPE
Sponsors by status
Sponsors by phase
Recent events

22. BIBLIOGRAPHY

23. 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: Cosentyx for Axial Spondyloarthritis (November 12, 2019): Phase III – PREVENT
Figure 7: Rinvoq for Axial Spondyloarthritis (November 12, 2019): Phase II/III – SELECT Axis 1
Figure 8: Cosentyx for Axial Spondyloarthritis (September 17, 2019): Phase III – PREVENT
Figure 9: Taltz for Axial Spondyloarthritis (April 22, 2019): Phase III – COAST-X
Figure 10: Taltz for Axial Spondyloarthritis (October 22, 2018): Phase III – COAST-V
Figure 11: Taltz for Axial Spondyloarthritis (October 20, 2018): Phase III – COAST-W
Figure 12: Filgotinib for Axial Spondyloarthritis (September 6, 2018): Phase II – TORTUGA (Ankylosing Spondylitis)
Figure 13: Key upcoming events in axSpA
Figure 14: Probability of success in the axSpA pipeline
Figure 15: Licensing and asset acquisition deals in axSpA, 2015–20
Figure 16: Parent patents in axSpA
Figure 17: Clinical trials in ankylosing spondylitis
Figure 18: Top 10 drugs for clinical trials in ankylosing spondylitis
Figure 19: Top 10 companies for clinical trials in ankylosing spondylitis
Figure 20: Trial locations in ankylosing spondylitis
Figure 21: Ankylosing spondylitis trials status
Figure 22: 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: Cosentyx for Axial Spondyloarthritis (November 12, 2019)
Table 5: Rinvoq for Axial Spondyloarthritis (November 12, 2019)
Table 6: Taltz for Axial Spondyloarthritis (November 12, 2019)
Table 7: Inflectra for Axial Spondyloarthritis (September 19, 2019)
Table 8: Cosentyx for Axial Spondyloarthritis (September 17, 2019)
Table 9: Taltz for Axial Spondyloarthritis (April 22, 2019)
Table 10: SensoReady Injector Pen for Axial Spondyloarthritis (April 9, 2019)
Table 11: Taltz for Axial Spondyloarthritis (October 22, 2018)
Table 12: Taltz for Axial Spondyloarthritis (October 20, 2018)
Table 13: Filgotinib for Axial Spondyloarthritis (September 6, 2018)
Table 14: Historical global sales, by drug ($m), 2014–18
Table 15: Forecasted global sales, by drug ($m), 2020–24

Note: Product cover images may vary from those shown
3 of 3
  • Amgen
  • Bio-Thera Solutions
  • Samsung
Note: Product cover images may vary from those shown
Adroll
adroll