Axial Spondyloarthritis: Global Drug Forecast and Market Analysis to 2028

Axial Spondyloarthritis: Global Drug Forecast and Market Analysis to 2028



Axial spondyloarthritis (axSpA) is a disease group encompassing both ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA). These conditions are chronic, autoinflammatory disorders of the sacroiliac joints and spine, an area also known as the axial skeleton. The disease is typically diagnosed in young adulthood to middle age (16-45 years) and has a seven- to nine-year delay of diagnosis. The axSpA market has historically been reliant on anti-tumor necrosis factor (TNF) therapies that have been available for over a decade, and the pipeline for drugs in late-stage development was lacking, but recent developments have led to research on novel treatment mechanisms. This will be vital in treating the underdiagnosed nr-axSpA population.

In January 2016, Novartis gained approval for Cosentyx (secukinumab), the first-in-class interleukin (IL)-17 inhibitor that was the first new biologic treatment approved for AS that was not an anti-TNF. Moreover, biosimilars of currently marketed anti-TNF biologics recently entered the market, with Remicade (infliximab) biosimilars first marketed in 2015 in Europe. This is likely to result in a highly competitive market for patients who have failed multiple non-steroidal anti-inflammatory drugs (NSAIDs). Competition will intensify with the arrival of new anti-IL-17 treatments and a new class of therapies in development, Janus kinase (JAK) inhibitors, which will offer a more convenient form of administration. With existing unmet need for all patients, particularly nr-axSpA patients, being diagnosed in a timely manner and having treatment options that are not solely subcutaneously or intravenously administered, axSpA represents an increasingly important rheumatology sector for drug developers.

estimates that sales of drugs in the axSpA market were approximately $3.1B in 2018 in the 7MM. The US was the largest market, with approximately $2.3B in drug sales, which represented 75.3% of the total axSpA market. The 5EU market contributed $705M in sales and Japan contributed sales of $54M in 2018.

Global sales in the axSpA market are expected to grow to $3.6B by 2028, at a Compound Annual Growth Rate (CAGR) of 1.5% from 2018-2028. forecasts the US to grow to $2.7B (74.7% of global sales), the 5EU to grow to $850M (23.9% of global sales), and Japan to shrink to $52M (1.5% of global sales) over the next 10 years.

Key Questions Answered

Over the forecast period, the axSpA market will see the entry of pipeline agents such as the interleukin 17 inhibitors and the JAK inhibitors, the sales of which will offset the loss of sales caused by the entry of biosimilars. How do products compete against each other? Which of these drugs will have the highest peak sales, and why?
Key Opinion Leaders (KOLs) interviewed by have indicated that there are several unmet needs within the axSpA indication. What are the main unmet needs in this market? How can the pharmaceutical industry address these needs? To what degree will the therapies under development fulfill these unmet needs?
The axSpA market is likely to become a turbulent space throughout the forecast period and beyond. Which companies are set to be major players in axSpA during the forecast period?

Key Highlights

The greatest driver of growth in the global axSpA market will be the launches of five pipeline therapies during the forecast period. The entry of these anticipated therapies, including Eli Lillys Taltz and Pfizers tofacitinib, will be subject to moderate uptake among the AS and nr-axSpA populations.

The main barrier to growth in the axSpA market will be the patent expiry, and subsequent launch of biosimilars of Humira (adalimumab) in the US, and the genericization of tofacitinib in the latter half of the forecast across the 7MM.

The most important unmet needs in axSpA are the need for speedier diagnosis and convincing patients to start biologic therapy. The former is being addressed by the increasingly routine use of MRI instead of X-ray to diagnose patients, and the greater understanding and awareness of nr-axSpA. The latter is impacted by poor patient education about their disease and a fear of subcutaneous/intravenous injection.

Factors driving a low biologic therapy treatment rate include some negative or fearful attitudes towards subcutaneously/intravenously administered therapeutics, nr-axSpA patients not perceiving themselves as severe enough to warrant biologic treatment, and a high ACOT for some biologic therapies currently on the market and in late-stage development.

Scope

- Overview of axSpA including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized axSpA therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2018 and forecast for ten years to 2028.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the axSpA therapeutics market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
- Analysis of the current and future market competition in the global axSpA therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to -
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the global axSpA therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global axSpA therapeutics market in future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Track drug sales in the global axSpA therapeutics market from 2018-2028.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.



2 Axial Spondyloarthritis: Executive Summary
2.1 Axial Spondyloarthritis Market to Experience Mild Growth from 2018-2028
2.2 Late-Stage Pipeline Product Launches Will Result in New Players Establishing Themselves
2.3 Persistent Unmet Needs Will Be Addressed Over the Forecast Period
2.4 Interleukin Inhibitors and Janus Kinase Inhibitors Dominate the Axial Spondyloarthritis Pipeline
2.5 What Do Physicians Think?
3 Introduction
3.1 Catalyst
3.2 Related Reports
3.3 Upcoming Related Reports
4 Disease Overview
4.1 Etiology and Pathophysiology
4.1.1 Etiology
4.1.2 Pathophysiology
4.2 Classification or Staging Systems
5 Epidemiology
5.1 Disease Background
5.2 Risk Factors and Comorbidities
5.3 Global and Historical Trends
5.4 Forecast Methodology
5.4.1 Sources
5.4.2 Forecast Assumptions and Methods, Diagnosed Prevalent Cases of AS - Base Scenario
5.4.3 Forecast Assumptions and Methods, Diagnosed Prevalent Cases of Nr-AxSpA - Base Scenario
5.4.4 Forecast Assumptions and Methods, Diagnosed Prevalent Cases of AS - Alternative Scenario
5.4.5 Forecast Assumptions and Methods, Diagnosed Prevalent Cases of Nr-AxSpA - Alternative Scenario
5.4.6 Forecast Assumptions and Methods, HLA-B27 Seropositivity Among Diagnosed AS Patients
5.5 Epidemiological Forecast for AS and Nr-AxSpA (2018-2028) - Base Scenario
5.5.1 Diagnosed Prevalent Cases of AS
5.5.2 Diagnosed Prevalent Cases of Nr-AxSpA
5.6 Epidemiological Forecast for AS and Nr-AxSpA (2018-2028) - Alternative Scenario
5.6.1 Diagnosed Prevalent Cases of AS
5.6.2 Age-Specific Diagnosed Prevalent Cases of AS
5.6.3 Sex-Specific Diagnosed Prevalent Cases of AS
5.6.4 Diagnosed Prevalent Cases of AS by HLA-B27 Seropositivity
5.6.5 Diagnosed Prevalent Cases of Nr-AxSpA
5.6.6 Age-Specific Diagnosed Prevalent Cases of Nr-AxSpA
5.6.7 Sex-Specific Diagnosed Prevalent Cases of Nr-AxSpA
5.7 Discussion
5.7.1 Epidemiological Forecast Insight
5.7.2 Limitations of the Analysis
5.7.3 Strengths of the Analysis
6 Disease Management
6.1 Diagnosis and Treatment Overview
6.2 US
6.3 5EU
6.4 Japan
7 Competitive Assessment
7.1 Overview
7.2 Biosimilars in the Axial Spondyloarthritis Market
7.2.1 Marketed Biosimilars
7.2.2 Pipeline Biosimilars
7.3 Payer Insight
8 Unmet Needs and Opportunity Assessment
8.1 Overview
8.2 Improved Time to Diagnosis
8.3 Patients Refuse Biologic Treatment
8.4 Addressing Drug Treatment Failure
8.5 Identifying Biomarkers of Drug Response
9 Pipeline Assessment
9.1 Overview
9.2 Promising Drugs in Clinical Development
9.3 Payer Insight
10 Current and Future Players
10.1 Overview
10.2 Trends in Corporate Strategy
10.3 Company Profiles
10.3.1 AbbVie
10.3.2 UCB
10.3.3 Janssen Biotech
10.3.4 Eli Lilly
10.3.5 Kyowa Hakko Kirin
10.3.6 Novartis
10.3.7 Pfizer
11 Market Outlook
11.1 Global Markets
11.1.1 Forecast
11.1.2 Drivers and Barriers - Global Issues
11.2 US
11.2.1 Forecast
11.2.2 Key Events
11.2.3 Drivers and Barriers
11.3 5EU
11.3.1 Forecast
11.3.2 Key Events
11.3.3 Drivers and Barriers
11.4 Japan
11.4.1 Forecast
11.4.2 Key Events
11.4.3 Drivers and Barriers
12 Appendix

List Of Tables


Table 1: Axial Spondyloarthritis: Key Metrics in the 7MM
Table 2: Risk Factors and Comorbidities for AS
Table 3: Treatment Guidelines for Axial Spondyloarthritis
Table 4: Country Profile - US
Table 5: Country Profile - 5EU
Table 6: Country Profile - Japan
Table 7: Leading Treatments for Axial Spondyloarthritis, 2019
Table 8: Marketed Biosimilars for Axial Spondyloarthritis, 2019
Table 9: Pipeline Biosimilars for Axial Spondyloarthritis, 2019
Table 10: Comparison of Therapeutic Classes in Development for Axial Spondyloarthritis, 2018-2028
Table 11: AbbVies Axial Spondyloarthritis Portfolio Assessment, 2019
Table 12: UCBs Axial Spondyloarthritis Portfolio Assessment, 2019
Table 13: Janssen Biotechs Axial Spondyloarthritis Portfolio Assessment, 2019
Table 14: Eli Lillys Axial Spondyloarthritis Portfolio Assessment, 2019
Table 15: Kyowa Hakko Kirins Axial Spondyloarthritis Portfolio Assessment, 2019
Table 16: Novartis Axial Spondyloarthritis Portfolio Assessment, 2019
Table 17: Pfizers Axial Spondyloarthritis Portfolio Assessment, 2019
Table 18: Axial Spondyloarthritis Market - Global Drivers and Barriers, 2018-2028
Table 19: Key Events Impacting Sales for Axial Spondyloarthritis in the US, 2018-2028
Table 20: Axial Spondyloarthritis Market - Drivers and Barriers in the US, 2018-2028
Table 21: Key Events Impacting Sales for Axial Spondyloarthritis in the 5EU, 2018-2028
Table 22: Axial Spondyloarthritis Market - Drivers and Barriers in the 5EU, 2018-2028
Table 23: Key Events Impacting Sales for Axial Spondyloarthritis in Japan, 2018-2028
Table 24: AxSpA Market - Global Drivers and Barriers in Japan, 2018-2028
Table 25: Key Historical and Projected Launch Dates for Axial Spondyloarthritis
Table 26: Key Historical and Projected Patent Expiry Dates for Axial Spondyloarthritis
Table 27: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List Of Figures


Figure 1: Global Sales Forecast by Country for Axial Spondyloarthritis in 2018 and 2028
Figure 2: Analysis of the Company Portfolio Gap in Axial Spondyloarthritis During the Forecast Period
Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents That GlobalData Expects to Be Licensed for the Treatment of Axial Spondyloarthritis During the Forecast Period
Figure 4: Pathogenic Mechanisms of Axial Spondyloarthritis
Figure 5: 7MM, Diagnosed Prevalence (%) of AxSpA, Both Sexes, Ages ?18 Years, 2008-2028 - Base Scenario
Figure 6: 7MM, Sources Used, Diagnosed Prevalent Cases of AS - Base Scenario
Figure 7: 7MM, Sources Used, Diagnosed Prevalent Cases of Nr-AxSpA - Base Scenario
Figure 8: 7MM, Sources Used and Not Used, Diagnosed Prevalent Cases of AS - Alternative Scenario
Figure 9: 7MM, Sources Used and Not Used, Diagnosed Prevalent Cases of Nr-AxSpA - Alternative Scenario
Figure 10: 7MM, Sources Used, HLA-B27 Seropositivity Data Among the Diagnosed Prevalent Cases of AS - Alternative Scenario
Figure 11: 7MM, Diagnosed Prevalent Cases of AS, Ages ?18 Years, Both Sexes, N, 2018 - Base Scenario
Figure 12: 7MM, Diagnosed Prevalent Cases of Nr-AxSpA, Ages ?18 Years, Both Sexes, N, 2018 - Base Scenario
Figure 13: 7MM, Diagnosed Prevalent Cases of AS, Ages ?18 Years, Both Sexes, N, 2018 - Alternative Scenario
Figure 14: 7MM, Age-Specific Diagnosed Prevalent Cases of AS, Both Sexes, N, 2018 - Alternative Scenario
Figure 15: 7MM, Sex-Specific Diagnosed Prevalent Cases of AS, Ages ?18 Years, N, 2018 - Alternative Scenario
Figure 16: 7MM, Diagnosed Prevalent Cases of AS by HLA-B27 Seropositivity, Ages ?18 Years, Both Sexes, N, 2018 - Alternative Scenario
Figure 17: 7MM, Diagnosed Prevalent Cases of Nr-AxSpA, Ages ?18 Years, Both Sexes, N, 2018 - Alternative Scenario
Figure 18: 7MM, Age-Specific Diagnosed Prevalent Cases of Nr-AxSpA, Both Sexes, N, 2018 - Alternative Scenario
Figure 19: 7MM, Sex-Specific Diagnosed Prevalent Cases of Nr-AxSpA, Ages ?18 Years, N, 2018 - Alternative Scenario
Figure 20: Flowchart of the Diagnosis and Management of Axial Spondyloarthritis
Figure 21: Prescription of Adalimumab, Etanercept, and Infliximab Biosimilars in Comparison to Reference Biologics Among Physicians in the 7MM, 2019
Figure 22: Unmet Needs and Opportunities in Axial Spondyloarthritis
Figure 23: Overview of the Development Pipeline in Axial Spondyloarthritis
Figure 24: Key Phase II/III Trials for the Promising Pipeline Agents that GlobalData Expects to Be Licensed for Axial Spondyloarthritis in the 7MM During the Forecast Period
Figure 25: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to Be Licensed for the Treatment of Axial Spondyloarthritis During the Forecast Period
Figure 26: Analysis of the Company Portfolio Gap in Axial Spondyloarthritis During the Forecast Period
Figure 27: Global (7MM) Sales Forecast by Country for Axial Spondyloarthritis in 2018 and 2028
Figure 28: Sales Forecast by Class for Axial Spondyloarthritis in the US in 2018 and 2028
Figure 29: Sales Forecast by Class for Axial Spondyloarthritis in the 5EU in 2018 and 2028
Figure 30: Sales Forecast by Class for Axial Spondyloarthritis in Japan in 2018 and 2028

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