Axial Spondyloarthritis - Market Insight, Epidemiology and Market Forecast - 2032

This ‘Axial Spondyloarthritis (axSpA)- Market Insights, Epidemiology, and Market Forecast-2032' report delivers an in-depth understanding of the Primary Hyperoxaluria (PH) historical and forecasted epidemiology as well as the Axial Spondyloarthritis (axSpA) market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

The Axial Spondyloarthritis (axSpA) market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Axial Spondyloarthritis (axSpA) market size. The Report also covers current Axial Spondyloarthritis (axSpA) treatment practice, market drivers, market barriers, SWOT analysis, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market

Geography Covered

• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2019-2032

Axial Spondyloarthritis (axSpA) Disease Understanding and Treatment Algorithm

Axial Spondyloarthritis (axSpA) Overview

Axial spondyloarthritis (axSpA) is a chronic, immune-mediated, inflammatory condition that consists of two subsets, which clinically have been defined as ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA). Nr-axSpA is characterized by the absence of definitive x-ray evidence of structural damage to the sacroiliac (SI) joint by plain x-ray. Since the SI joint x-ray interpretation is subjective, the distinction between nr-axSpA and AS is not absolute. Sacroiliitis (inflammation of the SI joint) and inflammation of the spine are predominant features of axSpA; hence patients typically present with inflammatory back pain. Other manifestations, such as enthesitis, dactylitis, peripheral arthritis, anterior uveitis, psoriasis, and inflammatory bowel disease, are common. Over time many patients with nr-axSpA develop the structural damage of sacroiliac joints, ultimately progressing to AS; however, some nr-axSpA patients will never advance to this stage. The clinical manifestations for axSpA and nr-axSpA are similar to the patients' disease burden experience.

Patients with axSpA commonly complain of back pain that starts before 45 years of age. Back pain's characteristic features include chronicity (>3 months), insidious onset, improvement with exercise, an occurrence at night with improvement upon waking, and no rest. Inflammatory back pain (IBP) criteria are essential in screening for axSpA. Among at-risk patients, the sensitivity of IBP (approximately 70-95%) for axSpA is relatively high (back pain >3 months with onset age).

Axial Spondyloarthritis (axSpA) Diagnosis

The diagnosis of axSpA is based upon a combination of symptoms, physical examination, blood tests, and imaging tests such as X-ray and magnetic resonance imaging (MRI). Based on the results, a clinician can assign a degree of probability to whether axSpA is causing the symptoms. The diagnosis cannot be made by ticking a checklist. In general, axSpA should be considered if the patients have daily back pain for more than 3 months that starts before 45, especially if this back pain is predominantly present in the morning and wakes the patient up at night and improves after movement.

There are no blood tests that, by themselves, can definitively diagnose or exclude axSpA. However, testing for the presence of one particular type of the human leukocyte antigen (HLA) gene, HLA-B27, can be helpful in certain people. AxSpA is less likely in a person with a negative test for HLA, tests for proteins called “acute phase reactants” are sometimes helpful but are not diagnostic for axSpA; these tests, which are markers of inflammation in the body, include C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) tests.

Patients with axSpA develop characteristic changes in the sacroiliac joints. These are the joints that connect the base of the spine (sacrum) to the large pelvic bone (ilium) on both sides. In ankylosing spondylitis (AS), these changes can be seen on radiograph (X-ray) images.

Imaging tests such as MRI detect the disease earlier than plain X-rays. In nr-axSpA, findings suggesting inflammation in the sacroiliac joints may be present on MRI when the X-rays are negative. The interpretation of X-ray and the MRI requires training and is observer-dependent, to a certain extent. Clinicians might not agree on the same X-ray or MRI. MRI changes suggestive of SpA can sometimes be seen even in healthy people. Imaging tests should always be interpreted in the context of the symptoms, physical examination, and blood tests.

Axial Spondyloarthritis (axSpA) Treatment

Optimal treatment of axial spondyloarthritis (axSpA) requires a combination of non-pharmacological and pharmacological treatments. Non-pharmacological strategies involve mainly exercise therapies, education, lifestyle and behavioral changes, and self-management. The currently licensed drug treatments for axSpA are NSAIDs and biologic DMARDs (bDMARDs) targeting TNF or IL-17A, which in general appear to have similar clinical efficacy in AS and non-radiographic AxSpA. Treatment for axSpA usually starts with nonsteroidal anti-inflammatory drugs (NSAIDs), Non-steroidal anti-inflammatory drugs (NSAIDs) are highly effective against the major symptoms of axSpA (pain and stiffness) and may have disease-modifying properties including retarding progression of structural damage in the spine. Therefore, NSAIDs, unless contraindicated, are the treatment of choice for the majority of patients with axSpA. Beyond NSAIDs, only tumor necrosis factor (TNF) α blockers are effective and approved for the treatment of active axSpA. Medicines like naproxyn (Naprosyn) or indomethacin (Indocin), can relieve pain and inflammation.

All medicines have side-effects, including NSAIDs. Risk increases with higher doses and longer use. High doses are usually needed to control symptoms of axSpA. Acetaminophen (Tylenol) may be used to reduce pain if the patient is not able to take NSAIDs.

Axial Spondyloarthritis (axSpA)Epidemiology
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Prevalent Cases of Axial Spondyloarthritis, Total Diagnosed Prevalent Cases of Axial Spondyloarthritis, Gender-specific Diagnosed Prevalent Cases of Axial Spondyloarthritis, Age-specific Diagnosed Prevalent Cases of Axial Spondyloarthritis, Gene-specific Diagnosed Prevalent Cases of Axial Spondyloarthritis scenario in the 7MM countries covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom) and Japan from 2019 to 2032.

Key Findings

• The total prevalent population of axSpA in the 7MM was 3,981,346. These cases are anticipated to increase in during the forecast period [2022-2032].
• The highest prevalent cases of axSpA were accounted by the US in 2021, making up to 2,217,315 cases, while the EU5 countries accounted for 1,751,778 cases in the same year.
• Among the different types of genes in axSpA, i.e., HLA-B27, and Others (ERAP 1, IL-12, IL-17, and IL-23), the former accounts for a higher number of diagnosed prevalent cases of axSpA (789622) in the EU-5 in 2021.
• As per the analysis, a higher percentage of diagnosed prevalence was observed in males in AS, in comparison to females, in all the 7MM countries
• In 2021, 70.90% of the total diagnosed prevalent population of Ankylosing spondylitis (AS) in Japan were male, which is equivalent to 2,903 cases. In comparison, for females, 1,192 cases were observed in 2021.
• Japan had 5,000 diagnosed prevalent cases for axSpA in 2021, being the lowest of all other countries in 7MM.

“The diagnosis of axial spondyloarthritis (axSpA) can be tough to spot as so many people have back pain - its main symptom. Additionally, there are no specific lab tests to identify the condition. All these factors play a major role in the low diagnosis of axSpA. Gender difference in both the types of axSpA has shown different trend. In case of nr-axSpA, female dominance is observed, whereas in AS, male dominance is there.”

Axial Spondyloarthritis (axSpA) Epidemiology

The epidemiology segment also provides the axSpA epidemiology data and findings across the United States.

Axial Spondyloarthritis (axSpA) Drug Chapters

Axial Spondyloarthritis (axSpA) Marketed Drugs

Taltz (ixekizumab): Eli Lilly and Company

Taltz (ixekizumab) is the first humanized interleukin (IL)-17A antagonist therapy approved for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients with objective inflammation signs. The therapy is now eligible to treat all types of axSpA including ankylosing spondylitis (AS), or radiographic axSpA, and nr-axSpA. It is a sterile, preservative-free, clear, and colourless to a slightly yellowish solution available as an auto-injector and prefilled syringe for subcutaneous administration. Both the injections contain a single dose of 80mg/ml solution of Taltz.

Cosentyx: Novartis

Cosentyx (secukinumab) is a recombinant human monoclonal IgG1/κ antibody, which is developed by Novartis. This therapeutic molecule binds specifically to IL-17A cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. It also inhibits the release of pro-inflammatory cytokines and chemokines. This therapeutic molecule is indicated for the treatment of patients with Ankylosing Spondylitis, Psoriatic Arthritis, and Plaque Psoriasis.

Humira (adalimumab): AbbVie

Humira (adalimumab) is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). It was created using phage display technology resulting in an antibody with human-derived heavy and light chain variable regions and human IgG1: k constant regions. It consists of 1,330 amino acids and has a molecular weight of approximately 148 kilodaltons. It binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors. It also lyses surface TNF expressing cells in vitro in the presence of complement. Perhaps, it does not bind or inactivate lymphotoxin (TNF-beta). Adalimumab is approved in the United States, Europe, and Japan under the brand name “Humira” for the treatment of patients with Rheumatoid Arthritis (RA), Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, and Crohn's Disease. Cuurently, the drug is in phase III study for the treatment of non-radiographic axial spondyloarthritis.

Axial Spondyloarthritis (axSpA) Emerging Drugs

Bimekizumab: UCB Biopharma

Bimekizumab (UCB4940) is the first humanized monoclonal IgG1 antibody that potently and selectively neutralizes IL-17A and IL-17F. These are the two key pro-inflammatory cytokines that share similar biological function and structural homology. IL-17A and IL-17F are the most closely related members of the IL-17 family of cytokines. They are both co-expressed at sites of inflammation and have overlapping pro-inflammatory functions. Both IL-17A and IL-17F can independently cooperate with other inflammatory mediators to drive chronic inflammation and tissue destruction. This therapeutic candidate is in the Phase III stage of development to treat patients with AS. The company is using the subcutaneous route of administration for AS, and non-radiographic axial spondyloarthritis.

CC-99677: Celgene

CC-99677 is a novel, oral, selective mk2 inhibitor with sustainable multi-cytokine inhibitor for the treatment of AS and other inflammatory diseases. The mitogen-activated protein kinase-activated protein kinase-2 (MK2) pathway is activated downstream of p38, and activation of MK2 increases the stability and translation of mRNA of proinflammatory factors (e.g., TNF-α, IL-17, IL-6). Inhibitors of p38 are associated with tachyphylaxis in patients with RA and other inflammatory diseases, where early reduction in ex vivo production of cytokines, such as TNF-α, or endogenous inflammatory markers, such as CRP, did not persist despite continued treatment. Thus, p38 inhibitors have not advanced in clinical development. Targets downstream of p38 have been identified to avoid these limitations.

Axial Spondyloarthritis (axSpA) Market Outlook

Axial spondyloarthritis (axSpA) is a term that covers both patients with structural damage in the sacroiliac joints (SIJ) visible on X-rays, termed radiographic axSpA - r-axSpA (also known as ankylosing spondylitis/AS) - and patients who have not yet developed such structural damage in the SIJ, termed non-radiographic (nr)-axSpA. A substantial part of patients with axSpA will move from nr-axSpA to rad axSpA over time, but not all of them. The inflammation normally starts in the SIJ but can, later on, extend to inflammatory and structural changes in the spine. AxSpA is a disease of young people (starting before the age of 45 years, but often beginning in the third decade of life), and men are slightly more frequently affected than women.

A common treatment regimen for the various forms of spondyloarthritis (AS, psoriatic arthritis, enteropathic arthritis, reactive arthritis, juvenile spondyloarthritis, and undifferentiated spondyloarthritis) involves medication, exercise, physical therapy, good posture practices, and other options such as applying heat/cold to help relax muscles and reduce joint pain. In severe cases, posture correcting surgery may also be an option.

Depending on the type of spondyloarthritis, there may be some variation in treatment. For example, in psoriatic arthritis, both the skin component and joint component must be treated. In enteropathic arthritis (spondylitis/arthritis associated with inflammatory bowel disease), medications may need to be adjusted, so the gastrointestinal component of the disease is also treated and not exacerbated.

Treatment for axSpA usually starts with nonsteroidal anti-inflammatory drugs (NSAIDs), physical therapy, and exercise. As long as the disease is not too advanced, NSAIDs and regular movement are usually enough to keep things under control. Nonsteroidal anti-inflammatory drugs (NSAIDs), such as naproxen (Naprosyn) and indomethacin (Indocin and Tivorbex) are the medications preferred by doctors. They can relieve inflammation, pain, and stiffness. However, these medications might cause gastrointestinal bleeding. If NSAIDs are not helpful, the doctor might suggest starting a biologic medication, such as a tumor necrosis factor (TNF) blocker or an interleukin-17 (IL-17) inhibitor. Exercise or physical therapy is an integral part of any spondylitis program. Physical therapy is an important part of treatment and can provide several benefits, from pain relief to improved strength and flexibility. A physical therapist can design specific exercises for needs. Range-of-motion and stretching exercises can help maintain flexibility in the joints and preserve good posture. Proper sleeping and walking positions and abdominal and back exercises can help maintain upright posture. In recent years, many specialized diets have gained popularity among some people with arthritis.

Key Findings

• The market size of Axial Spondyloarthritis (axSpA) in the 7MM was USD 5,594.7 million in 2021.
• The current treatment regimen for the management of axSpA includes rest, ice, and over-the-counter (OTC) pain relievers. As per PMR, certain medications including over-the-counter non-steroidal anti-inflammatory medications, such as ibuprofen and naproxen are recommended for managing the condition.
• Conventional therapies covered a market size of USD 1,243.43 million in 2021 for the treatment of axial spondyloarthritis patients.

The United States Market Outlook

This section provides the total axSpA market size and; market size by therapies in the United States.

EU-5 Market Outlook

The total AxSpA market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

Japan Market Outlook

The total AxSpA market size and market size by therapies in Japan are provided.

Axial Spondyloarthritis (axSpA) Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the axSpA market or expected to get launched in the market during the study period 2019-2032. The analysis covers the axSpA market uptake by drugs; patient uptake by therapies; and sales of each drug.

This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Axial Spondyloarthritis (axSpA) Development Activities

The report provides insights into different therapeutic candidates in phase II, and phase III stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for axSpA emerging therapies.

Reimbursement Scenario in Axial Spondyloarthritis (axSpA)

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

Competitive Intelligence Analysis

The publisher performs competitive and market Intelligence analysis of the axSpA market by using various competitive intelligence tools that include-SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

• The report covers the descriptive overview of axSpA, explaining its causes, symptoms, pathophysiology, genetic basis, and currently available therapies.
• Comprehensive insight has been provided into the axSpA epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for axSpA is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the axSpA market; historical and forecasted is included in the report, covering the the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM axSpA market.

Report Highlights

• The robust pipeline with novel MOA and oral ROA, increasing incidence, effectiveness of drugs as both mono and combination therapy will positively drive the axSpA market.
• The companies and academics are working to assess challenges and seek opportunities that could influence axSpA R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for axSpA. The launch of emerging therapies will significantly impact the axSpA market.
• Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Axial Spondyloarthritis (axSpA) Report Insights

• Patient Population
• Therapeutic Approaches
• axSpA Pipeline Analysis
• axSpA Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Axial Spondyloarthritis (axSpA) Report Key Strengths

• 11 Years Forecast
• 7MM Coverage
• axSpA Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Axial Spondyloarthritis (axSpA) Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers
• SWOT analysis

Key Questions Answered

Market Insights:

• What was the axSpA market share (%) distribution in 2019 and how it would look like in 2032?
• What would be the axSpA total market size as well as market size by therapies across the 7MM countries during the forecast period (2022-2032)?
• What are the key findings pertaining to the market across the 7MM countries and which country will have the largest axSpA market size during the forecast period (2022-2032)?
• At what CAGR, the axSpA market is expected to grow at the 7MM level during the forecast period (2022-2032)?
• What would be the axSpA market outlook across the 7MM countries during the forecast period (2022-2032)?
• What would be the axSpA market growth till 2032 and what will be the resultant market size in the year 2032?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What are the disease risk, burdens, and unmet needs of axSpA?
• What is the historical axSpA patient pool in the 7MM countries?
• What would be the forecasted patient pool of axSpA in the 7MM level?
• What will be the growth opportunities across the 7MM countries with respect to the patient population pertaining to axSpA ?
• Out of the above-mentioned countries, which country would have the highest prevalent population of axSpA during the forecast period (2022-2032)?
• At what CAGR the population is expected to grow across the 7MM countries during the forecast period (2022-2032)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of axSpA along with the approved therapy?
• What are the current treatment guidelines for the treatment of axSpA in the 7MM countries?
• What are the axSpA marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many companies are developing therapies for the treatment of axSpA ?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of axSpA ?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the axSpA therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for axSpA and their status?
• What are the key designations that have been granted for the emerging therapies for axSpA?
• What are the 7MM historical and forecasted market of axSpA?

Reasons to Buy

• The report will help in developing business strategies by understanding trends shaping and driving axSpA.
• To understand the future market competition in the axSpA market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for axSpA in the 7MM countries.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the axSpA market.
• To understand the future market competition in the axSpA market.