Antiphospholipid Syndrome Disease

Published Date : Feb 2024
Category : Autoimmune Diseases
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"NeuroMindscape: Launching Innovations in Antiphospholipid Syndrome Discovery and Treatment."

An autoimmune condition called antiphospholipid syndrome (APS) results in abnormal blood clot formation. When your body's immune system produces antibodies that target and harm your tissues or cells, it leads to autoimmune illnesses.

The immune system illness known as antiphospholipid syndrome (APS), referred to as Hughes syndrome, raises the risk of blood clots. This indicates that DVT (deep vein thrombosis), a blood clot that typically forms in the leg, is more common among persons with APS.

It has been estimated that there are about five instances of APS annually per 100,000 people, and there are about 40–50 cases of APS per 100,000 people. Between 1 and 5% of healthy people have antibodies against aPL.

The antiphospholipid syndrome affects 10% to 15% of patients who have repeated miscarriages and 20% of adults under fifty who have a stroke.

Furthermore, antiphospholipid syndrome affects 10 to 15 percent of patients with systemic lupus erythematosus. Similarly, this disorder is present in 10 to 15 percent of women who experience repeated miscarriages. Women make up about 70% of those with antiphospholipid syndrome diagnoses.

According to NCBI, it is estimated that 40–50 cases of APS occur in every 100,000 people in the United States, whereas there are two new diagnoses for every 100,000 people. Albeit systemic lupus erythematosus (SLE), which is linked to about 35% of instances of APS, is an autoimmune disease that most APS patients also have concurrently, though APS can arise as a primary condition. It follows that rheumatologists are typically consulted and involved in the management of APS patients; however, hematologists and obstetricians/gynaecologists are also involved in this care.

Types of Antiphospholipid Syndrome

Primary antiphospholipid syndrome (PAPS):

When APS manifests itself independently of any other autoimmune or connective tissue illnesses, it is referred to as PAPS. When there are no other autoimmune disorders present, people with PAPS exhibit the typical clinical symptoms of APS, such as thrombosis (venous or arterial) and/or difficulties associated to pregnancy.

Secondary antiphospholipid syndrome (SAPS):

When APS is linked to further autoimmune or connective tissue disorders, SAPS develops. Sjögren's disease, systemic sclerosis, rheumatoid arthritis, and systemic lupus erythematosus (SLE) are a few of the illnesses that are frequently connected to secondary APS. In these situations, the original autoimmune disorder is deemed to be the major cause of APS.


  • An autoimmune disorder is called APS. This indicates that the immune system, which typically guards against disease and infection, accidentally targets healthy tissue.
  • The immune system creates aberrant antibodies known as antiphospholipid antibodies in APS patients. These specifically target proteins that are linked to phospholipids, fat molecules that increase the risk of blood clotting.
  • The immune system's aberrant production of antibodies is unknown.
  • Similar to other autoimmune diseases, there is speculation that environmental, hormonal, and genetic variables are involved.

However, APS is a major cause of morbidity and mortality, accounting for 6% of pregnancy morbidity, 13.5% of stroke, 11% of myocardial infarction, and 9.5% of deep vein thrombosis. Symptoms include thrombocytopenia, autoimmune haemolytic anemia, and obstetric complications like recurrent pregnancy loss and intrauterine growth restriction.

Sign and Symptoms of antiphospholipid syndrome

The signs and symptoms of APS include a lace-like pattern on the skin, blood clots, low platelet counts, anemia, livedo reticularis, and abnormalities of the heart valve.

Blood clots caused by antiphospholipid syndrome are frequently associated with  APS symptoms such as headaches, redness, swelling, pain in various parts of the body, shortness of breath, arm or leg pain, and abdominal pain.

Diagnostic Analysis

Examining the Diagnosis of Antiphospholipid Syndrome: Perspectives and Updates

Functional assays and the enzyme-linked immunosorbent assay (ELISA) are two laboratory techniques used to identify APLA.

  • IgG or IgM Anticardiolipin Antibodies (ELISA): An ELISA test technique called Anti-Cardiolipin IgG/IgM is used to measure autoantibodies of the IgG and IgM classes against cardiolipin in human serum or plasma. It is only meant to be used for expert in vitro diagnostic purposes. A systemic autoimmune condition called antiphospholipid syndrome (APS) is responsible for stroke, thromboses, and recurrent miscarriages. Autoantibodies attach themselves to phospholipids such as coagulation cascade proteins or cardiolipin. Whereas secondary APS antibodies are found in conjunction with other autoimmune disorders, primary APS autoantibodies manifest on their own.
  • IgG or IgM anti-beta-2-glycoprotein-I antibodies (ELISA): An ELISA test technique called the Beta2-Glycoprotein I Ag IgG/IgM is used to measure autoantibodies of the IgG and IgM classes against beta-2-Glycoprotein I in human serum or plasma. It also Detects aCL and aβ₂GPI. It is only meant to be used for expert in vitro diagnostic purposes. A systemic autoimmune condition called antiphospholipid syndrome (APS) is responsible for stroke, thrombosis, and recurrent miscarriages. Autoantibodies can also be present in patients with various autoimmune illnesses and attach to phospholipids such as beta-2-glycoprotein I or cardiolipin.

Anticoagulants for lupus (functional assays):  Lupus anticoagulant is a significant risk factor for APS-related thrombotic events, and a functional test can identify all antiphospholipid antibodies. Two functional coagulation assays, dRVVT and aPTT, are commonly used to detect lupus anticoagulants. Positive results indicate a person is positive for lupus anticoagulant. However, interpretation is crucial due to elevated levels of acute-phase reactants and anticoagulant therapy.

CT and MR imaging: Common abnormalities seen in patients with APS on CT and MR imaging include large territorial infarctions, lacunar infarctions, bilateral border zone infarctions, anterior basal ganglia lesions, infarcts and hyperintense white matter foci, localized cortical infarctions, and stenotic arterial lesions.

Top Players of Diagnostic Kits

The global antiphospholipid syndrome diagnostic market is highly competitive and owing to the number of large market players with a global presence below in the given table there is list of top manufacturers of diagnostic testing of antiphospholipid syndrome globally.

                                                    Diagnostic Market Players for Antiphospholipid Syndrome


Lupus anticoagulant

Imaging Studies

Inova Diagnostics


General Electric (GE) Healthcare


Diagnostica Stago

Siemens Healthineers

Bio-Rad Laboratories

Instrumentation Laboratory (IL)

Philips Healthcare



Toshiba Medical Systems (now Canon Medical Systems)

Thermo Fisher Scientific


Hitachi Healthcare

Randox Laboratories

Siemens Healthineers

Fujifilm Medical Systems

DRG International, Inc.

Sysmex Corporation

Shimadzu Corporation

Aniara Diagnostica

Bio-Rad Laboratories


Sekisui Diagnostics

Helena Laboratories

Samsung Medison

Axis-Shield Diagnostics Ltd.

Diagnostica Siemens


Alpha Diagnostics International Inc.


Hologic, Inc.

Binding Site

Inova Diagnostics

Canon Medical Systems

Demeditec Diagnostics GmbH

LAbor BioMedical Technologies

Carestream Health

Kamiya Biomedical Company

Haematex Research

NeuroLogica Corporation (a subsidiary of Samsung)

Orgentec Diagnostika

Axis-Shield Diagnostics Ltd.

Agfa-Gevaert Group

Abbott Laboratories

Sekisui Diagnostics

Bracco Imaging

Siemens Healthineers

BioMedica Diagnostics

Varian Medical Systems

Immunovision, Inc.

Affinity Biologicals

Ziehm Imaging

BioVendor - Laboratorní medicína a.s.

Tulip Diagnostics (P) Ltd.


Biorbyt Ltd.

Acris Antibodies GmbH

Mindray Bio-Medical Electronics Co., Ltd.





Imaging Studies

Anti-Phospholipid Screen ELISA Kit

General Electric (GE) Healthcare

Human Antiphospholipid Antibody ELISA Kit - APLA

Philips Healthcare

Anti-Phospholipid Screen IgG/IgM

Toshiba Medical Systems (now part of Canon Medical Systems)


Hitachi Healthcare


Fujifilm Medical Systems




Shimadzu Medical Systems

Bioprocess ELISA Kits



Carestream Health


Samsung Medison




Agfa Healthcare


Canon Medical Systems


Ziehm Imaging


SonoSite (a Fujifilm company)


Varian Medical Systems




Siemens Healthineers


DiseaseLandscape Insights supports industry leaders in the creation of diverse diagnostic kits. Furthermore, the use of state-of-the-art technology to improve present diagnostic processes and the dissemination of data on current market players and their products to comprehend market dynamics.

Treatment Analysis

A patient should be sent to a rheumatologist for additional assessment and therapy if APS is suspected. For yet, there is no treatment for APS. The purpose of treatment is to stop blood clots from forming in the future and to stop further organ damage.


APS and miscarriages, blood clot can be avoided with the use of anticoagulant medication, which thins the blood. The most often utilized medications are heparin, warfarin, and low-dose aspirin.

Blood Thinning Drugs

Frequently, an anticoagulant medication will be administered to thin your blood to lower your risk of developing APS. The kind of care you get will be determined by your symptoms.

Direct oral anticoagulants

In the general population, direct oral anticoagulants (DOACs) such apixaban, dabigatran, and rivaroxaban are authorized for use in the secondary prevention of VTE and the prevention of arterial thrombosis in nonvalvular atrial fibrillation. Since they don't require blood monitoring, have fewer food and pharmacological interactions, and have a quick and predictable beginning of action that eliminates the requirement for heparinization in an acute situation, they make an appealing option to VKAs.

Therefore, it should be mentioned that a number of frequently prescribed medications, such as carbamazepine, ketoconazole, and diltiazem, can either increase or decrease DOAC activity.


Statins are used to treat hypercholesterolaemia and prevent atherosclerotic disease. They have pleiotropic effects, inhibiting vascular adhesion molecules, interleukin six, and tissue factor. Fluvastatin has been shown to reduce pro-inflammatory and prothrombotic markers in APS patients, regardless of rheumatic disease or asymptomatic carrier. Pravastatin was also associated with improved placental blood flow and longer gestation in pregnant individuals with APS.

Antiplatelet and anticoagulant drugs used in the antiphospholipid syndrome (APS)

Anticoagulant Drugs

Antiplatelet Drugs

Market Player


Aspirin (acetylsalicylic acid)


Heparin (unfractionated)



Low molecular weight heparin (LMWH), such as enoxaparin


Johnson & Johnson






Bristol Myers Squibb









Boehringer Ingelheim



Bristol Myers Squibb









Various generic manufacturers






Daiichi Sankyo


P2Y12 receptor inhibitors (various agents in this drug class)



Mechanism of action Rituximab for the treatment of antiphospholipid syndrome (APS)

Rituximab is a murine/human chimeric monoclonal immunoglobulin G1 antibody that specifically targets the B-cell differentiation marker CD20. A cell-surface marker called CD20 is only present on pre-B and mature B lymphocytes; it is not present on other cell types or freely circulated. On B-cells, CD20 is the exclusive binding site for rituximab. Three mechanisms complement-dependent cytotoxicity, promotion of apoptosis, or antibody-dependent cytotoxicity can cause the demise of a B lymphocyte when rituximab binds to cell surface CD20 on the lymphocytes.

Market Trends Analysis

In the context of antiphospholipid syndrome (APS), market trends analysis includes assessing supply, demand, and therapy developments. Research and development activities have been pushed by an increased awareness of APS, according to official organizations including the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC). The development of therapeutic alternatives and diagnostic technologies has become a prominent trend.

For instance, the investigation of new anticoagulant drugs and tailored therapies signifies a movement in the market toward more efficient and user-friendly medical care.

The dynamic relationship that exists between healthcare organizations, research institutes, and pharmaceutical companies which is demonstrated by government-backed initiatives highlights how APS management is changing. It is imperative for stakeholders to closely monitor these market changes in order to adjust their tactics and make a positive impact on the lives of APS victims.

For instance, in June 2022, the BeLimumab Antiphospholipid Syndrome Trial (BLAST) was a clinical trial conducted by the University of Turin to evaluate the safety and effectiveness of belimumab. Usually, those who are resistant to heparin or warfarin are evaluated for this medication.

On 3 Aug 2023, the global leader in clinical diagnostic products and life science research, Bio-Rad Laboratories, Inc., is growing its partnerships with diagnostic companies by offering InteliQ products, a line of barcoded, load-and-go quality control tubes that streamline workflow, along with Bio-Rad's Unity QC data management solutions, which enhance analytical performance in a laboratory.

Competitive Analysis

Determining Current Trends to Stay Competitive, within the Market of  Antiphospholipid Syndrome."

  • Antiphospholipid Syndrome (APS) competitive analysis includes a detailed investigation of major participants, including pharmaceutical firms, diagnostic equipment producers, and academic organizations. Identification of market opportunities, challenges, vulnerabilities, and strengths is aided by this study. It is imperative for industry participants and healthcare stakeholders to remain up to date on developing trends, client feedback, and potential obstacles. Making well-informed decisions, encouraging creativity, and enhancing outcomes for those impacted by APS are all made easier by this study.


  • On 3 Aug 2023, Sysmex Corporation has expanded its Global Business Partnership with Roche Diagnostics International Ltd., aiming to provide more value to customers and promote sustainability. The expanded agreement includes a renewed Total Laboratory Solution Collaboration Agreement and an Eco-Social Collaboration Agreement for addressing social issues.

Regulatory Framework for Antiphospholipid Syndrome

The regulatory framework for antiphospholipid syndrome (APS) is heavily facilitated by DiseaseLandscape Insights based on different countries’ regulatory norms an autoimmune condition called antiphospholipid syndrome (APS) can lead to problems with blood coagulation and pregnancy. Medical treatments and supportive care are used to manage it. Compliance with clinical standards and protocols by national health agencies and organizations such as the World Health Organization is part of regulatory monitoring. Guarantee the efficacy and safety of their products, pharmaceutical and diagnostic companies also need to abide by these rules. The medical community's ongoing research and collaborations enhance the regulatory framework, leading to better patient outcomes and higher-quality care.

On Aug 30, 2023, the biopharmaceutical company Cadrenal Therapeutics, Inc. has expanded the testing of tecarfarin for the treatment of patients with antiphospholipid syndrome (APS) who require chronic anticoagulation therapy. Tecarfarin is a late-stage novel oral and reversible anticoagulant (blood thinner) that is being developed to prevent heart attacks, strokes, and deaths due to blood clots in patients with certain rare medical conditions.

Clinical Assessment

DiseaseLandscape Insights consultancy firm provides valuable support in future market trends on the development of new pharmaceutical products. This support helps to streamline the planning and execution of clinical trials of novel medications and treatments, implement effective patient recruitment strategies, ensure regulatory compliance, and increase the likelihood of successful trial outcomes.

The below table gives information about some currently ongoing clinical trials, including their study titles and respective stage.


(Therapeutic Exploratory Trail)


(Post Marketing Surveillance)

Evaluation of the Benefit of Adjuvant Treatment with Hydroxychloroquine to the Usual Medical Management for Obtaining an Uncomplicated Term Pregnancy in Primary Obstetric Antiphospholipid Syndrome

Use of Warfarin After the First Trimester in Pregnant Women with Antiphospholipid Syndrome

Certolizumab to Prevent Pregnancy Complications in High-Risk Patients with APS or SLE - (IMPACT Study: Improve Pregnancy in APS With Certolizumab Therapy)


Use of Warfarin After the First Trimester in Pregnant Women with Antiphospholipid Syndrome



DiseaseLandscape Insights (DLI) offers vital information, especially in the battle against antiphospholipid syndrome. A comprehensive number of services are provided by DiseaseLandscape Insights with the goal of assisting the healthcare sector, its practitioners, researchers, and industry participants in enhancing patient outcomes and encouraging business development.

Using the resources of in-depth market research, the DiseaseLandscape Insights services offer useful information on the most recent advancements, therapeutic strategies, and emerging trends in the management of. With the use of these data, healthcare professionals create focused plans, make wise choices, and give patients with customized treatment. Furthermore, our services function as a spark for creativity and teamwork, promoting partnerships between researchers and industry participants to improve antiphospholipid syndrome diagnosis, treatment, and prevention.

 DiseaseLandscape insights (DLI) supports all market players in establishing their greater foothold in antiphospholipid syndrome disease industry.

Vishal SawantBusiness Development

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