Axial spondyloarthritis (axSpA) Market and Forecast Analyst to 2024

  • ID: 3797416
  • Report
  • 331 pages
  • Datamonitor Healthcare
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Axial spondyloarthritis (axSpA) is a chronic, systemic, inflammatory rheumatic disease that predominantly affects the spine and sacroiliac (SI) joints, leading to chronic back pain. The chronic inflammation can eventually result in new bone formation in the SI joints and spine, causing permanent impairment in spinal mobility. Ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA) are the two sub-diseases that comprise axSpA, the former of which is defined by radiographic evidence of inflammatory damage to the SI joints (radiographic sacroiliitis), whereas the latter is defined by findings of sacroiliitis on magnetic resonance imaging scans but without the detection of advanced sacroiliitis by conventional radiography.

Although the etiology of axSpA remains unclear, the condition is inheritable and genetics play a major role, with mutations in certain genes, including the human leukocyte antigen B27 gene, known to be associated with an increased risk of developing AS. The initial signs and symptoms of the disease, including spinal pain and stiffness, are not specific to axSpA, therefore there is often a lag time between onset and diagnosis. Studies suggest that axSpA is most prevalent in Caucasian populations and AS is typically more common in male adults, whereas nr-axSpA occurs more frequently in females. Furthermore, axSpA is often associated with a series of extra-articular manifestations and co-morbidities, including uveitis, cardiovascular risk, and inflammatory bowel disease. As a result, direct medical spending on the diagnosis and treatment of these conditions intensifies axSpA’s economic impact.
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Forecast: Axial Spondyloarthritis
  • Executive Summary
  • Market Overview and Trends
  • Market Definition and Methodology
  • Cimzia (certolizumab)
  • Cosentyx (secukinumab)
  • Enbrel (etanercept)
  • Humira (adalimumab)
  • Remicade (infliximab)
  • Simponi (golimumab)
  • Stelara (ustekinumab)
  • Taltz (ixekizumab)
  • Primary Research Methodology
Treatment: Axial Spondyloarthritis
  • Executive Summary
  • Primary Research Methodology
  • Disease Definition and Diagnosis
  • Current Treatment Options
  • Prescribing Trends
  • Compliance
  • Treatment Challenges and Unmet Needs
  • Impact of Pipeline Agents
  • Impact of Biosimilars
Epidemiology: Axial Spondyloarthritis in the US, Japan, and 5EU
  • Executive Summary
  • Disease Background
  • Sources and Methodology
  • Forecast: Ankylosing Spondylitis
  • Forecast: Non-Radiographic Axial Spondyloarthritis
  • Forecast: Axial Spondyloarthritis
  • Epidemiologist Insight
  • Strengths and Limitations
  • Appendix: Additional Sources
Marketed Drugs: Axial Spondyloarthritis
  • Executive Summary
  • Product Overview
  • Key Opinion Leader Research
  • Product profile: Cimzia
  • Product profile: Cosentyx
  • Product profile: Enbrel
  • Product profile: Humira
  • Product profile: Remicade
  • Product profile: Simponi
Pipeline: Axial Spondyloarthritis
  • Executive Summary
  • Clinical Pipeline Overview
  • Key Opinion Leader Research
  • Product profile (late stage): Otezla
  • Product profile (late stage): Stelara
  • Product profile (late stage): Taltz
List of Figures:
Figure 1: Total axial spondyloarthritis sales across the US, Japan, and five major EU markets, by country, 2016-25
Figure 2: Total axial spondyloarthritis sales in the US, 2016-25
Figure 3: Total axial spondyloarthritis sales across the five major EU markets, 2016-25
Figure 4: Total axial spondyloarthritis sales across Japan, 2016-25
Figure 5: Total axial spondyloarthritis sales according to drug class, 2016-25
Figure 6: Sales of Enbrel and Humira versus other established biologics within axial spondyloarthritis in the US, Japan, and five major EU markets, 2016-25
Figure 7: Total axial spondyloarthritis patients across the US, Japan, and five major EU markets, by drug class, 2016-25
Figure 8: Total sales of Cosentyx versus Cimzia and Simponi for axial spondyloarthritis in the five major EU markets, 2016-25
Figure 9: Total number of patients forecast to be prescribed Cosentyx versus Cimzia and Simponi for axial spondyloarthritis in the five major EU markets, 2016-25
Figure 10: axial spondyloarthritis forecast methodology
Figure 11: Price sources and calculations, by country
Figure 12: Cimzia sales in axial spondyloarthritis across the US and five major EU markets, by country, 2016-25
Figure 13: Cosentyx sales in axial spondyloarthritis across the US, Japan, and five major EU markets, by country, 2016-25
Figure 14: Enbrel sales in axial spondyloarthritis across the US, Japan, and five major EU markets, by country, 2016-25
Figure 15: Humira sales for axial spondyloarthritis across the US, Japan, and five major EU markets, by country, 2016-25
Figure 16: Remicade sales for axial spondyloarthritis across the US, Japan, and five major EU markets, by country, 2016-25
Figure 17: Simponi sales for axial spondyloarthritis across the US, Japan, and five major EU markets, by country, 2016-25
Figure 18: Simponi Aria sales for axial spondyloarthritis in the US, 2016-25
Figure 19: Stelara sales for axial spondyloarthritis across the US and five major EU markets, by country, 2016-25
Figure 20: Taltz sales for axial spondyloarthritis across the US and five major EU markets, by country, 2016-25
Figure 21: Proportion of ankylosing spondylitis patients and non-radiographic axial spondyloarthritis patients, by country (%)
Figure 22: Assessment of SpondyloArthritis International Society classification criteria for axial spondyloarthritis
Figure 23: Diagnosed versus undiagnosed axial spondyloarthritis patients, by country (%)
Figure 24: Diagnosed axial spondyloarthritis patients treated by each type of healthcare professional, by country (%)
Figure 25: Type of therapy received by diagnosed axial spondyloarthritis patients, by country (%)
Figure 26: Treated axial spondyloarthritis patients receiving monotherapy versus combination therapy, by country (%)
Figure 27: Distribution of axial spondyloarthritis patients according to monotherapy/combination use, by country (%)
Figure 28: Top four regimens used for the treatment of first-line axial spondyloarthritis patients, by country (%)
Figure 29: Top four biologic disease-modifying antirheumatic drugs used for the treatment of first-line axial spondyloarthritis patients, by country (%)
Figure 30: Total combined biologic disease-modifying antirheumatic drug use for the treatment of axSpA patients at each line of therapy, by country (%)
Figure 31: Total combined use of Remicade across all lines of therapy for the treatment of axial spondyloarthritis, by country (%), 2014 and 2016
Figure 32: Top four biologic DMARDs prescribed in Japan for the treatment of axial spondyloarthritis patients after traditional DMARDs, by line of therapy (%)
Figure 33: Top five biologic disease-modifying antirheumatic drugs used for the treatment of second-line axial spondyloarthritis patients, by country (%)
Figure 34: All prescribed biologic DMARDs used for the treatment of third-line axial spondyloarthritis patients after traditional DMARDs, by country (%)
Figure 35: All prescribed biologic DMARDs used for the treatment of fourth-line and later axial spondyloarthritis patients, by country (%)
Figure 36: Compliance rate for axial spondyloarthritis treatment, by formulation type and country (%)
Figure 37: Top three treatment challenges in axial spondyloarthritis
Figure 38: Expected market shares of DMARD-treated axial spondyloarthritis patients for currently approved and pipeline agents five years after launch, by country (%)
Figure 39: Physician confidence in prescribing biosimilars for axial spondyloarthritis approved on the basis of indication extrapolation, by country (%)
Figure 40: Summary of future usage of biosimilars at one year and three years post-launch (%)
Figure 41: Taxonomy of spondyloarthritis
Figure 42: Assessment of Spondyloarthritis International Society classification criteria for axial spondyloarthritis
Figure 43: Trends in total prevalent cases of ankylosing spondylitis in the US, Japan, and five major EU markets, by country, 2015-35
Figure 44: Absolute growth in prevalent cases of ankylosing spondylitis in the US, Japan, and five major EU markets, by country, 2015-35
Figure 45: Trends in diagnosed prevalent cases of ankylosing spondylitis in the US, Japan, and five major EU markets, by country, 2015-35
Figure 46: Trends in total prevalent cases of non-radiographic axial spondyloarthritis in the US, Japan, and five major EU markets, by country, 2015-35
Figure 47: Absolute growth in prevalent cases of non-radiographic axial spondyloarthritis in the US, Japan, and five major EU markets, by country, 2015-35
Figure 48: Trends in diagnosed prevalent cases of non-radiographic axial spondyloarthritis in the US, Japan, and five major EU markets, by country, 2015-35
Figure 49: Trends in total prevalent cases of axial spondyloarthritis in the US, Japan, and five major EU markets, by country, 2015-35
Figure 50: Absolute growth in prevalent cases of axial spondyloarthritis in the US, Japan, and five major EU markets, by country, 2015-35
Figure 51: Trends in diagnosed prevalent cases of axial spondyloarthritis in the US, Japan, and five major EU markets, by country, 2015-35
Figure 52: Drug assessment summary for axial spondyloarthritis
Figure 53: Cimzia for axial spondyloarthritis - SWOT analysis
Figure 54: Drug assessment summary of Cimzia in axial spondyloarthritis
Figure 55: Drug assessment summary of Cimzia in axial spondyloarthritis
Figure 56: Cosentyx for axial spondyloarthritis - SWOT analysis
Figure 57: Drug assessment summary of Cosentyx in axial spondyloarthritis
Figure 58: Drug assessment summary of Cosentyx in axial spondyloarthritis
Figure 59: Enbrel for axial spondyloarthritis - SWOT analysis
Figure 60: Drug assessment summary of Enbrel in axial spondyloarthritis
Figure 61: Drug assessment summary of Enbrel in axial spondyloarthritis
Figure 62: Humira for axial spondyloarthritis - SWOT analysis
Figure 63: Drug assessment summary of Humira in axial spondyloarthritis
Figure 64: Drug assessment summary of Humira in axial spondyloarthritis
Figure 65: Remicade for axial spondyloarthritis - SWOT analysis
Figure 66: Drug assessment summary of Remicade in axial spondyloarthritis
Figure 67: Drug assessment summary of Remicade in axial spondyloarthritis
Figure 68: Simponi for axial spondyloarthritis - SWOT analysis
Figure 69: Drug assessment summary of Simponi in axial spondyloarthritis
Figure 70: Drug assessment summary of Simponi in axial spondyloarthritis
Figure 71: Otezla for axial spondyloarthritis - SWOT analysis
Figure 72: Drug assessment summary of Otezla in axial spondyloarthritis
Figure 73: Drug assessment summary of Otezla in axial spondyloarthritis
Figure 74: Stelara for axial spondyloarthritis - SWOT analysis
Figure 75: Drug assessment summary of Stelara in axial spondyloarthritis
Figure 76: Drug assessment summary of Stelara in axial spondyloarthritis
Figure 77: Taltz for axial spondyloarthritis - SWOT analysis
Figure 78: Drug assessment summary of Taltz in axial spondyloarthritis
Figure 79: Drug assessment summary of Taltz in axial spondyloarthritis

List of Tables:
Table 1: Total market sales for axial spondyloarthritis in the US, Japan and five major EU markets ($m), 2016-25
Table 2: Total axial spondyloarthritis sales according to drug class ($m), 2016-25
Table 3: Total axial spondyloarthritis patients according to drug class, 2016-25
Table 4: Total sales of tDMARDs methotrexate and sulfasalazine across the US, Japan, and five major EU markets ($m), 2016-25
Table 5: Annual treatment cost per patient of Cosentyx, Cimzia, and Simponi in the US, Japan, and five major EU markets ($), 2016
Table 6: Total number of patients forecast to be prescribed Cosentyx versus Cimzia and Simponi for axial spondyloarthritis in the five major EU markets, 2016-25
Table 7: Total number of patients to be prescribed Stelara versus Taltz for axial spondyloarthritis in the US and five major EU markets, 2016-25
Table 8: Annual treatment cost per patient for Taltz versus Stelara for axial spondyloarthritis in the US and five major EU markets ($), 2019*
Table 9: Summary of brands and molecules included in patient-based axial spondyloarthritis forecast
Table 10: Exchange rates used for calculating prices
Table 11: Patent expiry dates for key marketed brands in axial spondyloarthritis in the US, Japan, and five major EU markets
Table 12: Forecasted launch dates of biosimilar versions of key marketed brands in axial spondyloarthritis across the US, Japan, and five major EU markets
Table 13: Forecast launch dates of key late-stage pipeline products in axial spondyloarthritis in the US, Japan, and five major EU markets, 2016-25
Table 14: price assumptions for Cimzia, by country, 2016
Table 15: Cimzia sales in axial spondyloarthritis across the US and five major EU markets, by country ($m), 2016-25
Table 16: price assumptions for Cosentyx, by country, 2016
Table 17: Cosentyx sales in axial spondyloarthritis across the US, Japan, and five major EU markets, by country ($m), 2016-25
Table 18: price assumptions for Enbrel, by country, 2016
Table 19: Enbrel sales in axial spondyloarthritis across the US, Japan, and five major EU markets, by country ($m), 2016-25
Table 20: price assumptions for Humira, by country, 2016
Table 21: Humira sales for axial spondyloarthritis across the US, Japan, and five major EU markets, by country ($m), 2016-25
Table 22: price assumptions for Remicade, by country, 2016
Table 23: Remicade sales for axial spondyloarthritis across the US, Japan, and five major EU markets, by country ($m), 2016-25
Table 24: price assumptions for Simponi, by country, 2016
Table 25: price assumptions for Simponi Aria in the US, 2018
Table 26: Simponi and Simponi Aria sales for axial spondyloarthritis across the US, Japan, and five major EU markets, by country ($m), 2016-25
Table 27: price assumptions for Stelara, by country, 2019
Table 28: Stelara sales for axial spondyloarthritis across the US and five major EU markets, by country ($m), 2016-25
Table 29: price assumptions for Taltz, by country, 2019
Table 30: Taltz sales for axial spondyloarthritis across the US and five major EU markets, by country ($m), 2016-25
Table 31: Rheumatologists surveyed for the axial spondyloarthritis primary research study, 2016
Table 32: Rheumatologists surveyed for the axial spondyloarthritis primary research study, March 2016
Table 33: Key generic traditional disease-modifying antirheumatic drugs for the treatment of axial spondyloarthritis
Table 34: Key marketed biologic disease-modifying antirheumatic drugs for the treatment of axial spondyloarthritis
Table 35: Total combined usage of methotrexate and sulfasalazine, as monotherapies and combinations, for treatment of axSpA, by line of therapy and country (%)
Table 36: Total combined biologic disease-modifying antirheumatic drug use for the treatment of axSpA patients at each line of therapy, by country (%)
Table 37: Current usage of biosimilar infliximab, according to respondents currently prescribing the biosimilar, by country (%)
Table 38: Compliance rate for axial spondyloarthritis treatment, by formulation type and country (%)
Table 39: Relative importance of treatment challenges in axial spondyloarthritis
Table 40: Future usage of biosimilar infliximab, according to respondents aware of biosimilars, by country (%)
Table 41: Sources used for the epidemiological analysis of axial spondyloarthritis in the US, Japan, and five major EU markets
Table 42: Notable sources not used for the epidemiological analysis of axial spondyloarthritis in the US, Japan, and five major EU markets
Table 43: Total prevalent cases of ankylosing spondylitis in the US, Japan, and five major EU markets, by country, 2015-35
Table 44: Age-specific total prevalent cases of ankylosing spondylitis in the US, Japan, and five major EU markets, by country, 2015
Table 45: Gender-specific total prevalent cases of ankylosing spondylitis in the US, Japan, and five major EU markets, by country, 2015
Table 46: Diagnosed prevalent cases of ankylosing spondylitis in the US, Japan, and five major EU markets, by country, 2015-35
Table 47: Age-specific diagnosed prevalent cases of ankylosing spondylitis in the US, Japan, and five major EU markets, by country, 2015
Table 48: Gender-specific diagnosed prevalent cases of ankylosing spondylitis in the US, Japan, and five major EU markets, by country, 2015
Table 49: Prevalence of clinical features of ankylosing spondylitis in Japan, Germany, and Spain, 2015
Table 50: Total prevalent cases of non-radiographic axial spondyloarthritis in the US, Japan, and five major EU markets, by country, 2015-35
Table 51: Diagnosed prevalent cases of non-radiographic axial spondyloarthritis in the US, Japan, and five major EU markets, by country, 2015-35
Table 52: Prevalence of clinical features of non-radiographic axial spondyloarthritis in Germany, 2015
Table 53: Total prevalent cases of axial spondyloarthritis in the US, Japan, and five major EU markets, by country, 2015-35
Table 54: Diagnosed prevalent cases of axial spondyloarthritis in the US, Japan, and five major EU markets, by country, 2015-35
Table 55: Key marketed drugs for axial spondyloarthritis
Table 56: Cimzia drug profile
Table 57: Cimzia pivotal trial data in axial spondyloarthritis
Table 58: Cimzia ongoing late-phase trial in axial spondyloarthritis
Table 59: Cosentyx drug profile
Table 60: Cosentyx pivotal trial data in axial spondyloarthritis
Table 61: Cosentyx ongoing late-phase trials in axial spondyloarthritis
Table 62: Enbrel drug profile
Table 63: Enbrel pivotal trial data in axial spondyloarthritis
Table 64: Enbrel late-phase trial data in axial spondyloarthritis
Table 65: Humira drug profile
Table 66: Humira pivotal trial data in axial spondyloarthritis
Table 67: Humira late-phase trial data in axial spondyloarthritis
Table 68: Remicade drug profile
Table 69: Remicade pivotal trial data in axial spondyloarthritis
Table 70: Simponi drug profile
Table 71: Simponi pivotal trial data in axial spondyloarthritis
Table 72: Simponi Aria late-phase trial data in axial spondyloarthritis
Table 73: Drugs currently in late-stage development for axial spondyloarthritis
Table 74: Otezla drug profile
Table 75: Otezla Phase III data in axial spondyloarthritis
Table 76: Stelara drug profile
Table 77: Stelara Phase III trials in axial spondyloarthritis
Table 78: Taltz drug profile
Table 79: Taltz Phase III trials in axial spondyloarthritis
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