Axial Spondyloarthritis - Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• Axial spondyloarthritis is a multifactorial disease characterized by inflammation in sacroiliac joints and spine, bone reabsorption, and aberrant bone deposition, which may lead to ankylosis.
• Disease pathogenesis depends on genetic, immunological, mechanical, and bioenvironmental factors. HLA-B27 represents the most important genetic factor (other relevant genes include genes encoding interleukin-23 receptor and endoplasmatic reticulum aminopeptidase 1-ERAP1), although the disease may also develop in its absence.
• It includes two distinct clinical categories: nonradiographic axial-SpA (nr-axial-SpA) and radiographic axial-SpA (r-axial-SpA), the latter traditionally known as ankylosing spondylitis (AS).
• According to the analyst's estimates, the total prevalent population of axial spondyloarthritis was approximately 4,575,000 in 2023 in the 7MM, and these cases are expected to significantly increase during the study period [2020-2034].
• The United States accounts for the largest market size of axial spondyloarthritis, in comparison to EU4 (Germany, Spain, Italy, France) & the UK, and Japan. The year 2023 recorded a considerable number of axial spondyloarthritis in Japan, with approximately 21,300 prevalent cases.
• Among the genes associated with axSpA, HLA-B27 accounts for a higher number of diagnosed prevalent cases of AS compared to genes such as ERAP 1, IL-12, IL-17, and IL-23.
• The US FDA has approved UCB’s CIMZIA, Eli Lilly’s TALTZ, Novartis’s COSENTYX, and AbbVie’s RINVOQ for treating both r-axSpA and nr-axSpA. In contrast, Immunex/Amgen’s ENBREL, Pfizer’s XELJANZ, and Johnson & Johnson’s SIMPONI are approved only for ankylosing spondylitis. Additionally, LUMICEF is approved in Japan for both r-axSpA and nr-axSpA.
• In December 2023, UCB announced that Japan’s Ministry of Health, Labor, and Welfare approved BIMZELX (bimekizumab) for adults with nr-axSpA and AS who do not respond well to existing treatments. In June 2023, the European Commission granted marketing authorization for BIMZELX to treat adults with active axSpA, including both nr-axSpA and AS.
• Currently, there is no complete cure for axial spondyloarthritis, and the pipeline for new treatments is also dry.

This report delivers an in-depth understanding of the indication axial spondyloarthritis, historical and forecasted epidemiology as well as the axial spondyloarthritis market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The axial spondyloarthritis market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM axial spondyloarthritis market size from 2020 to 2034. The report also covers current axial spondyloarthritis treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Axial Spondyloarthritis Understanding and Treatment Algorithm

Axial Spondyloarthritis Overview, Country-Specific Treatment Guidelines and Diagnosis

Axial Spondyloarthritis is a type of arthritis that primarily causes pain and swelling in the spine and the sacroiliac joints, which connect the bottom of the spine to the pelvis. It can also affect other joints and is a systemic disease, potentially impacting other body parts and organs. AxSpA often runs in families and can be categorized into two types: ankylosing spondylitis, or radiographic axSpA, where damage to the sacroiliac joints and spine is visible on X-rays, and non-radiographic axSpA, where damage may not be visible on X-rays but can be detected through magnetic resonance imaging (MRI). The condition typically begins between age 20 and 40 and is more common in men, although nr-axSpA may affect men and women equally.

The axial spondyloarthritis report provides an overview of axial spondyloarthritis pathophysiology, diagnostic approaches, and detailed treatment algorithm along with a real-world scenario of a patient’s journey beginning from the first symptom, the time taken for diagnosis to the entire treatment process.

Axial SpondyloarthritisTreatment

There is no cure for Axial Spondyloarthritis, but treatment focuses on relieving pain and stiffness in the back and other affected areas, maintaining spinal alignment, preventing joint and organ damage, preserving joint function and mobility, and improving the overall quality of life. Early and aggressive treatment is essential to prevent long-term complications and joint damage. A comprehensive treatment plan typically includes medication, non-drug therapies, healthy lifestyle habits, and, in rare cases, surgery.

Axial Spondyloarthritis Epidemiology

The Axial Spondyloarthritis epidemiology chapter in the report provides historical as well as forecasted in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2024 to 2034. The axial spondyloarthritis epidemiology is segmented with detailed insights into Total Prevalent Cases, Total Diagnosed Prevalent Cases, Gender-specific Cases, Gene-specific Cases, Age-specific Cases, Total Treated Cases of Axial Spondyloarthritis in the 7MM [2020-2034]

• As per estimates, the total diagnosed population of non-radiographic axial spondyloarthritis in the US was around 569,000 cases in 2023.
• Among EU4 and UK countries, Germany had the highest number of prevalent axial spondyloarthritis cases in 2023, followed by Spain.

Axial SpondyloarthritisDrug Chapters

The drug chapter segment of the axial spondyloarthritis report encloses a detailed analysis of axial spondyloarthritis marketed drugs. It also deep dives into the axial spondyloarthritis pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Marketed Drugs

SIMPONI (golimumab): Janssen Pharmaceuticals

SIMPONI is a human IgG1? monoclonal antibody specific for human tumor necrosis factor-alpha (TNF--a) that exhibits multiple glycoforms. It was created using genetically engineered mice immunized with human TNF, resulting in an antibody with human-derived antibody variable and constant regions. It binds to both the soluble and transmembrane bioactive forms of human TNFa. This interaction prevents the binding of TNFa to its receptors, thereby inhibiting the biological activity of TNFa (a cytokine protein). This molecule is produced by a recombinant cell line cultured by continuous perfusion and is purified by a series of steps that include measures to inactivate and remove viruses.

In April 2009, the US FDA approved SIMPONI for the treatment of patients with Ankylosing Spondylitis.

XELJANZ (tofacitinib): Pfizer

XELJANZ, a film-coated immediate-release tablet, is the first and only oral JAK inhibitor approved in the European Union for five indications. It is prescribed for adults with active AS who have not responded adequately to conventional therapy and for adults with moderately to severely active RA after failure or intolerance to disease-modifying antirheumatic drugs (DMARDs). Additionally, it is used for adults with active PsA after DMARD failure or intolerance and for adults with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to conventional therapy or a biologic agent.

In December 2021, Pfizer announced that the US Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for XELJANZ/ XELJANZ XR (tofacitinib) for the treatment of adults with active Ankylosing Spondylitis who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.

Note: Detailed current therapies assessment will be provided in the full report of Axial Spondyloarthritis (AxSpA)

Axial SpondyloarthritisMarket Outlook

• The market size of axial spondyloarthritis in the seven major markets is expected to increase substantially from 2024.
• The United States accounts for the largest market size of axial spondyloarthritis, in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.
• Among EU4 and the UK, Germany has the largest market size, followed by Spain, with France having the smallest market size.
• In 2023, the total market size for axial spondyloarthritis therapies was approximately USD 9 million, with the majority occupied by conventional treatments.

Axial SpondyloarthritisDrugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2024-2034, which depends on the competitive landscape, safety, and efficacy data along with order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Axial Spondyloarthritis Activities

The report provides insights into different therapeutic candidates. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for axial spondyloarthritis emerging therapies.

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility.

The analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Centers such as Nationwide Children’s Hospital, Columbus, OH, the United States, University Hospitals Dorset NHS Foundation Trust, North Shore University Health System, Evanston, Illinois, etc., were contacted. Their opinion helps understand and validate current and emerging treatment patterns of Axial Spondyloarthritis. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

• The report covers a segment of key events, an executive summary, descriptive overview of axial spondyloarthritis, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, and disease progression along with country specific treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the axial spondyloarthritis market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM axial spondyloarthritis.

Axial Spondyloarthritis Report Insights

• Patient Population
• Therapeutic Approaches
• Axial Spondyloarthritis Pipeline Analysis
• Axial Spondyloarthritis Market Size and Trends
• Existing and future Market Opportunity

Axial Spondyloarthritis Report Key Strengths

• Ten Years Forecast
• 7MM Coverage
• Axial Spondyloarthritis Epidemiology Segmentation
• Inclusion of Country specific treatment guidelines
• KOL’s feedback on approved and emerging therapies
• Key Cross Competition
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

Axial Spondyloarthritis Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs

• What is the growth rate of the 7MM axial spondyloarthritis treatment market?
• What was the axial spondyloarthritis total market size, the market size by therapies, market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors/key catalysts for this growth?
• Is there any unexplored patient setting that can open the window for growth in the future?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What are the current and emerging options for the treatment of axial spondyloarthritis?
• How many companies are developing therapies for the treatment of axial spondyloarthritis?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the axial spondyloarthritis Market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.