Antiphospholipid Syndrome - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights:

• The rising cases of APS may be attributed to improved diagnostic capabilities, increased awareness among healthcare providers, and a growing cases of autoimmune conditions such as systemic lupus erythematosus. Additionally, environmental factors, infections, and genetic predisposition may contribute to the increased prevalence, along with better recognition of atypical and non-thrombotic manifestations of the disease.
• Total prevalent cases of APS in the 7MM were approximately 320 thousand in 2024, which is likely to increase during the forecast period (2025-2034).
• The absence of approved therapies for APS highlights a major unmet need, as current treatment relies heavily on off-label use of anticoagulants. This limits therapeutic precision, increases safety concerns, and underscores the urgent demand for dedicated, evidence-based drugs specifically developed and approved for APS management.
• While the current APS pipeline remains relatively limited, companies such as Chugai Pharmaceuticals are actively advancing candidates through key developmental stages, signaling renewed interest in the field. As several therapies progress toward potential regulatory approvals between 2025 and 2034, the therapeutic landscape is expected to broaden significantly, supported by a healthy compound annual growth rate (CAGR).
• The RAINBOW-LTE trial, a Phase Ib open-label extension basket study, is currently underway to evaluate RAY121 for the inhibition of the classical complement pathway in the treatment of immunological disorders, including APS.

DelveInsight's comprehensive report titled "Antiphospholipid Syndrome (APS) - Market Insights, Epidemiology, and Market Forecast - 2034" offers a detailed analysis of APS. The report presents historical and projected epidemiological data covering prevalent cases of APS, diagnosed prevalent cases of APS, age-specific diagnosed prevalent cases of APS, gender-specific diagnosed prevalent cases of APS, type-specific diagnosed prevalent cases of APS, , and clinical manifestation-specific diagnosed prevalent cases of APS. In addition to epidemiology, the market report encompasses various aspects related to the patient population. These aspects include the diagnosis process, prescription patterns, physician perspectives, market accessibility, treatment options, and prospective developments in the market across seven major markets: the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, spanning from 2020 to 2034.

The report analyzes the existing treatment practices and unmet medical requirements in APS. It evaluates the market potential and identifies potential business prospects for enhancing therapies or interventions. This valuable information enables stakeholders to make well-informed decisions regarding product development and strategic planning for the market.

Antiphospholipid Syndrome (APS) Overview

APS is a rare systemic autoimmune disorder marked by the persistent presence of antiphospholipid antibodies (aPLs), which are produced by B-cells and contribute to recurrent arterial or venous thrombosis, pregnancy-related complications, and various non-thrombotic manifestations. APS may occur as a primary condition or develop secondary to other autoimmune diseases, particularly systemic lupus erythematosus. While aPLs were initially thought to target anionic phospholipids like cardiolipin and phosphatidylserine, research has shown that they actually recognize phospholipid-binding proteins such as B2-glycoprotein I (B2-GPI), prothrombin, and annexin. These antibodies interact with their target proteins in ways that activate endothelial cells, enhance pro-coagulant activity, and trigger inflammatory responses-mechanisms that collectively drive the thrombotic complications characteristic of APS.

Antiphospholipid Syndrome (APS) Diagnosis and Treatment Overview

Diagnosing APS requires both clinical and laboratory criteria. Clinically, it involves confirmed arterial, venous, or small-vessel thrombosis, or specific pregnancy complications such as recurrent miscarriages or premature births. Laboratory confirmation includes persistent presence (on two occasions, 12 weeks apart) of lupus anticoagulant, or moderate-to-high titers of IgG/IgM anticardiolipin or anti-B2GPI antibodies. Treatment involves a multidisciplinary approach with hematologists, rheumatologists, and obstetricians, focusing on thrombosis prevention, pregnancy management, and patient education. Regular monitoring and individualized risk assessment help tailor therapy, improve outcomes, and enhance quality of life for those living with APS.

Antiphospholipid Syndrome (APS) Epidemiology

The epidemiology section of the APS market report offers information on the patient populations, including historical and projected trends for each of the seven major markets. Examining key opinion leader views from physicians or clinical experts can assist in identifying the reasons behind historical and projected trends. The diagnosed patient pool, their trends, and the underlying assumptions are all included in this section of the report.

This section also presents the data with relevant tables and graphs, offering a clear and concise view of the prevalence of APS. Additionally, the report discloses the assumptions made during the analysis, ensuring data interpretation and presentation transparency. This epidemiological data is valuable for understanding the disease burden and its impact on the patient population across various regions.

Key Findings

• In 2024, the US recorded approximately 82 thousansd cases of primary APS and around 45 thousand cases of secondary APS. These figures are projected to rise steadily through 2034, driven by improved diagnostic awareness, increased screening in autoimmune populations, and a growing understanding of APS-related complications, particularly in thrombotic and obstetric contexts.
• In 2024, across the EU4 and the UK, the highest prevalence of age-specific cases was observed in individuals aged 18-44 years, followed by those in the 55-64 and above 75 age groups. Conversely, the 65-74 age group reported the lowest number of cases, highlighting a distinct age-related distribution pattern in the population.
• As per our analysis, higher cases were observed for thrombotic APS than obstetric APS based on clinical manifestation-specific cases of symptomatic APS throughout the 7MM countries.
• In 2024, Japan reported approximately 24 thousand treated cases of APS, reflecting a growing clinical recognition of the condition. This number is expected to rise by 2034, driven by improved diagnostic practices, increased awareness among healthcare providers, and a broader understanding of APS-related thrombotic and obstetric complications.

Antiphospholipid Syndrome (APS) Market Outlook

The APS therapeutics market is further expected to increase by the major drivers, such as the rising prevalent population, technological advancements, and upcoming therapies in the forecast period [2025-2034].

Despite advances in the management of APS, significant unmet needs remain, particularly in preventing recurrent thrombotic events and managing refractory cases. Current standard therapies, such as long-term anticoagulation, are not universally effective and carry risks of bleeding complications. There is also a lack of targeted treatments for non-thrombotic manifestations and for high-risk subtypes like CAPS. Furthermore, limited clinical trial data and the absence of personalized therapeutic strategies hinder optimal care. Improved biomarkers for risk stratification and novel therapies that address the underlying autoimmune mechanisms are urgently needed to enhance outcomes and quality of life for APS patients.

With ongoing research and continued dedication, the future holds hope for even more effective treatments and, ultimately, a cure for this challenging condition. According to DelveInsight, the APS market in the 7MM is expected to change significantly during the study period 2020-2034.

Antiphospholipid Syndrome (APS) Drug Chapters

Emerging APS Drugs

The APS market is expected to experience gradual changes, mainly due to the limited availability of emerging therapies in this area. Key market players, including, Chugai Pharmaceuticals' RAY121, among others, have demonstrated a keen interest in this condition and are actively pursuing the development of potential treatments.

RAY121: Chugai Pharmaceuticals

RAY121 is an innovative therapeutic antibody utilizing Chugai's proprietary Recycling Antibody technology. It specifically targets complement C1s, effectively inhibiting the classical complement pathway (CP). By precisely modulating CP activity, RAY121 is anticipated to offer enhanced efficacy and a favorable safety profile compared to conventional C3/C5 inhibitors, particularly in conditions where CP plays a predominant role. This targeted approach may lead to more precise disease management while minimizing unintended immune suppression, advancing treatment strategies for complement-mediated disorders.

• In April 2025, Chugai Pharmaceuticals reported that RAY121 has advanced to Phase I clinical trials. This milestone signifies the initial stage of human testing, where safety, tolerability, and pharmacokinetics are rigorously evaluated. The progression to clinical trials indicates promising preclinical results, supporting its potential as an innovative therapeutic candidate.

DelveInsight's 'Antiphospholipid Syndrome (APS) - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a detailed outlook of the current and future APS market, segmented within countries, by therapies, and by classes. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies.

APS Market Size by Countries

The APS market size is assessed separately for various countries, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. In 2024, the United States held a significant share of the overall 7MM (Seven Major Markets) APS market, primarily attributed to the country's higher prevalence of the condition and the elevated cost of the available treatments. This dominance is projected to persist, especially with the potential early introduction of new products.

Antiphospholipid Syndrome (APS) Drugs Uptake

This section focuses on the sales uptake of potential APS drugs that have recently been launched or are anticipated to be launched in the APS market between 2020 and 2034. It estimates the market penetration of APS drugs for a given country, examining their impact within and across classes and segments. It also touches upon the financial and regulatory decisions contributing to the probability of success (PoS) of the drugs in the APS market.

The emerging APS therapies are analyzed based on various attributes such as safety and efficacy in randomized clinical trials, order of entry and other market dynamics, and the unmet need they fulfill in the APS market.

Antiphospholipid Syndrome (APS) Market Access and Reimbursement

DelveInsight's 'Antiphospholipid Syndrome (APS) - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a descriptive overview of the market access and reimbursement scenario of APS.

This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments.

KOL Views

To keep up with current APS market trends and fill gaps in secondary findings, we interview KOLs and SMEs' working in the APS domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns or APS market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the APS unmet needs.

APS: KOL Insights

DelveInsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as Division of Rheumatology, Mayo Clinic, Rochester, US; Rheumatology and Clinical Immunology, Italy; University of Cambridge, Cambridge, UK; Radiological Sciences and Public Health, University of Brescia, Brescia, Italy; among others.

"A confirmed diagnosis of APS requires the presence of antiphospholipid antibodies in the blood on at least two separate occasions, with tests conducted 12 or more weeks apart. It is possible to carry these antibodies without ever experiencing symptoms. However, APS is only diagnosed when the presence of these antibodies is associated with clinical manifestations, such as thrombotic events or pregnancy-related complications."

"APS is a systemic autoimmune disorder defined by the occurrence of obstetric complications and/or arterial or venous thrombosis in the presence of aPL. It is categorized as primary APS when it occurs independently, without an underlying autoimmune condition, and as secondary APS when it is associated with another autoimmune disease. Among these, systemic lupus erythematosus (SLE) is the most commonly linked condition."

"Current treatment for APS primarily relies on anticoagulation, which may not prevent all thrombotic events and poses bleeding risks. There is a critical need for targeted therapies that address the underlying autoimmune mechanisms, as well as effective options for non-thrombotic manifestations and refractory or high-risk cases like Catastrophic APS."

Competitive Intelligence Analysis

We conduct a Competitive and Market Intelligence analysis of the APS. Market, utilizing various Competitive Intelligence tools such as SWOT analysis and Market entry strategies. The inclusion of these analyses is contingent upon data availability, ensuring a comprehensive and well-informed assessment of the market landscape and competitive dynamics.

Antiphospholipid Syndrome (APS) Pipeline Development Activities

The report offers an analysis of therapeutic candidates in Phase II and III stages and examines companies involved in developing targeted therapeutics for APS. It provides valuable insights into the advancements and progress of potential treatments in clinical development for this condition.

Pipeline Development Activities

The report covers information on collaborations, acquisition and merger, licensing, patent details, and other information for emerging APS therapies.

Antiphospholipid Syndrome (APS) Report Insights

• APS Patient Population
• Therapeutic Approaches
• APS Pipeline Analysis
• APS Market Size and Trends
• APS Market Opportunities
• Impact of Upcoming Therapies

Antiphospholipid Syndrome (APS) Report Key Strengths

• 10 Years Forecast
• The 7MM Coverage
• APS Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed APS Market
• APS Drugs Uptake

Antiphospholipid Syndrome (APS) Report Assessment

• APS Current Treatment Practices
• Unmet Needs
• APS Product Profiles
• APS Market Attractiveness

Key Questions:

• How common is APS?
• What are the key findings of APS epidemiology across the 7MM, and which country will have the highest number of patients during the study period (2020-2034)?
• What are the currently available treatments for APS?
• What are the disease risk, burden, and unmet needs of APS?
• At what CAGR is the APS market and its epidemiology is expected to grow in the 7MM during the forecast period (2025-2034)?
• How would the unmet needs impact the APS market dynamics and subsequently influence the analysis of the related trends?
• What would be the forecasted patient pool of APS in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Among EU4 and the UK, which country will have the highest number of patients during the forecast period (2025-2034)?
• How many companies are currently developing therapies for the treatment of APS?

Reasons to buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the APS 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
• To understand the existing market opportunity 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 current treatment in the US, EU4 (Germany, France, Italy, and Spain), the UK, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the attribute analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders 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.

Frequently Asked Questions:

1. What are the treatment goals for APS?

The primary treatment goals for APS are to prevent recurrent thrombotic events and manage pregnancy-related complications. This involves long-term anticoagulation therapy to reduce the risk of blood clots and tailored management during pregnancy to improve maternal and fetal outcomes. Additional goals include controlling associated autoimmune activity, especially in secondary APS, and addressing non-thrombotic manifestations. Optimizing patient quality of life and minimizing treatment-related risks, such as bleeding, are also essential components of comprehensive APS care.

2. What are the challenges in managing APS?

Managing APS presents several challenges, including the risk of recurrent thrombosis despite anticoagulation and the potential for serious bleeding complications from long-term therapy. Diagnosing APS can be complex due to variability in clinical presentation and antibody profiles. Treatment options are limited, particularly for non-thrombotic manifestations and refractory cases. Managing APS during pregnancy requires specialized care to prevent complications. Additionally, a lack of standardized treatment protocols and limited clinical trial data hinder the development of targeted, evidence-based therapies.

3. What are the key factors driving the growth of the APS market?

Key factors driving the growth of the APS market include increasing awareness and diagnosis rates, advancements in diagnostic technologies, and a rising prevalence of autoimmune and thrombotic disorders. The growing focus on personalized medicine and the development of targeted therapies are also contributing to market expansion. Additionally, increased research funding, clinical trials exploring novel treatment options, and the demand for safer, more effective alternatives to long-term anticoagulation are fueling interest and investment in the APS therapeutic landscape.

4. How will the APS Market and Epidemiology Forecast Report benefit the clients?

The APS Market and Epidemiology Forecast Report will benefit clients by providing comprehensive insights into market trends, treatment options, patient populations, and future growth opportunities, helping them make informed strategic decisions and identify potential areas for investment or expansion.