Anticoagulants serve a vital role in treating various medical conditions such as atrial fibrillation, myocardial infarction, stroke, deep vein thrombosis (DVT), pulmonary embolism (PE), and in the utilization of artificial heart valves. These medications become essential when a patient's blood tends to clot too quickly, preventing potentially life-threatening complications associated with excessive clot formation.
The global landscape of heart-related ailments underscores the significance of anticoagulation therapies. In 2019, China reported the highest number of deaths due to heart diseases, followed by India, Russia, the United States, and Indonesia. A staggering statistic from an article published in the July 2019 edition of Endovascular Today highlights over 10 million diagnosed cases of DVT and PE worldwide. Within this figure, more than 1 million cases were reported in the US, with an additional 700,000 cases identified in France, Italy, Germany, Spain, Sweden, and the UK combined.
The prevalence of venous thrombotic diseases (VTE) is intricately linked to several contributing factors. For instance, the National Health and Nutrition Examination Survey (NHANES) in 2017 identified over 70 million obese adults in the US, often coupled with a sedentary lifestyle, significantly increasing the risk of VTE. Additionally, the incidence and prevalence of conditions such as cancer, trauma, surgical interventions, and the use of oral contraceptives or hormonal therapies contribute to the rising number of patients susceptible to VTE.
The global landscape also witnesses a surge in factors that further heighten the overall risk of VTE. The increase in international travel, with over 4.5 billion airline passengers in 2019, adds another layer to the risk profile for VTE. These cumulative factors, from lifestyle choices to medical conditions and travel patterns, collectively contribute to the growing prevalence of VTE worldwide.
In essence, the demand for effective anticoagulant therapies remains robust given the prevalence of various conditions requiring such treatments. Addressing the diverse risk factors associated with VTE presents a multifaceted challenge, necessitating comprehensive strategies that encompass both preventive measures and effective treatment modalities to mitigate the burden of these potentially life-threatening conditions.
Report Attribute/Metric | Details |
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Market Opportunities | Increase patient population and patent expiry to support new product launch |
Anticoagulation Market Size was valued at USD 29.73 Billion in 2023. The Anticoagulation industry is projected to grow from USD 31.75 Billion in 2024 to USD 54.23 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 6.92% during the forecast period (2024 - 2032).
Industry News in Anticoagulation Market
Anticoagulants are normally known as blood thinners, which are chemical substances that reduce blood coagulation and blood clotting time.As a pharmacological class of medications, anticoagulants are used in therapy for thrombotic disorders. Oral anticoagulants are available in various dosage forms such as pill or tablet form and intravenous dosage. In addition, some of the anticoagulants are used in medical equipment, such as sample tubes, blood transfusion bags, and dialysis equipment. Moreover, warfarin was first approved as an anticoagulant.
The growth of the global anticoagulation market is driven by the factors such as the rising incidence of cardiovascular and coronary artery diseases,dependence on anticoagulants, and the rising geriatric population. In addition, increasing awareness about the treatment creates a lucrative opportunity for the market. However, stringent regulatory normsare likely to restrain the market growth.
The rise of the anticoagulation sector may be attributed to a number of factors, including the growing incidence of cardiovascular and coronary artery diseases, the dependence of patients on anticoagulants, and the increasing average age of the world's population. When word gets out about the treatment, there will be a considerable increase in the number of business opportunities available. When there are insufficient levels of efficient anticoagulants in the body, the risk of blood clots developing, which can lead to heart attacks and other life-threatening disorders. Over the period under consideration, the growth of the blood thinners market is anticipated to be driven, in part, by the increasing usage of sophisticated anticoagulants as well as the growing prominence of cardiovascular diseases as the primary cause of death.
Products that can aid patients have been developed as a result of the expanding range of therapy options. The increasing number of people who require anticoagulants has led to a rise in the number of products entering the worldwide anticoagulation market. Distributors in untapped markets will be in more demand as new products enter the market. The number of people who need treatment is growing as the incidence of cardiovascular disease and DVT rises. After the patent protection regime expires, the number of producers in the market rises as a result of R&D efforts to launch a generic version of drugs.
In May 2023, Pfizer reported successful findings from a major phase 3 study of marstacimab for hemophilia A and B. The medicine was effective in treating hemophilia A and B without causing clots, a problem that has plagued anticoagulation treatments in the past, although it is yet unknown if this benefit will persist. The annualized bleeding rate was shown to be much lower in the study compared to prophylactic and as-needed intravenous regimens, and this difference was clinically meaningful. If authorized, marstacimab would be the first therapy for hemophilia A or B to be given as a flat dosage and the first once-weekly subcutaneous medication for persons with hemophilia B.
COVID-19 Analysis:
Countries and various industries are trying to tackle the challenges thrown up by the novel coronavirus (COVID-19). One such industry surrounded by the uncertainty of the impact of the COVID-19 is the healthcare industry. Social distancing requirements, sharp cuts in consumers’discretionary income during the COVID-19 crisis, and governmental policies have hit patients’ability to undergo diagnosis of diseases and treatment through surgeries. Many hospitals and clinics facea challenge from a shortage of personal protective equipment,affecting the availability of treatment facilities.
The production of anticoagulation drugs starts with the procurement of raw materials. Owing to the urgent measures taken across the globe like lockdowns, physical distancing, and transport limitation to fight surge ability, raw material sourcing is a bit difficult. Apart from this, the anticoagulation market also faced restrictions on the supply of raw materials andworkforce in the first half of 2020. The workforce must source the raw material, assemble raw material into the final product and thenpackage and transport the final product to the end users.
The COVID-19 outbreak has been spreading rapidly globally. However, the anticoagulation drugs market has not been hampered much due to its growing demand from patients. Additionally, failure to access healthcare facilities for thrombolytic therapy is anticipated to increase the demand. For example, on April 6, 2020, Drug Shortages Canada, the website for reporting drug shortages and discontinuations in Canada, reported less availability of Apo-Warfarin marketed by Apotex Inc., which was resolved by May 26, 2020.
Atrial fibrillation, myocardial infarction, stroke, deep vein thrombosis, pulmonary embolism, and utility of artificial heart valves are some of the indications that need the supplement of anticoagulants to stop a patient’s blood from clotting too quickly. China had the highest heart disease deaths in 2019, followed by India, Russia, the US, and Indonesia.
According to an article published in Endovascular Today, July 2019 edition, more than 10 million cases of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) are diagnosed worldwide, with 1 million cases occurring in the US, and over 700,000 in France, Italy, Germany, Spain, Sweden, and the UK combined. The National Health and Nutrition Examination Survey (NHANES) 2017 mentioned over 70 million adults in the US to be obese, along with a sedentary lifestyle, increasing the number of patients with Venous Thrombotic Diseases (VTE). The incidence and prevalence ofsurgery, cancer, trauma and oral contraceptive/hormonal therapy useare also increasing, adding to the overall risk of VTE.
The National Blood Clot Alliance (NBCA), the patient advocacy organization,is working on life-threatening blood clots in partnership with the University of Oklahoma. It also received an award through an Association of University Centers on Disabilities-Centers for Disease Control cooperative agreement for advance research on blood clots. The award will also help in raising awareness among certain high-risk populations. NBCA published Personal Perspectives: My Blood Clot, My Life, an e-magazine focused on issues important to the clotting and clotting disorders community during Blood Clot Awareness Month.
The United States National Vital Statistics Reports, 2018, shows the median life expectancy of patients experiencing myocardial infarction8.3 years. The dependence of these patients on anticoagulants for the thinning of blood is anticipated to increase the market’s growth rate during the mentioned forecast period. The rising need for anticoagulants at affordable cost has paved the way for various manufacturers to launch products in recent years. For example, in December 2020, Natco Pharma (India) launched RPIGAT, an anticoagulant medication used to treat and prevent blood clots.
The increasing development in the treatment option has led to the development of products that can help patients. The rising product launch in the global anticoagulation market is due to the increasing number of patients in need of anticoagulants. With new product launches, an increase in the requirement of distributors in remote geographies is expected. The rising prevalence of patients suffering from cardiovascular diseases and deep vein thrombosis is increasing the target population. The research &development activities to introduce a generic version of medications post-patent-protection regime increase the number of manufacturers in the market.
According to the Institute of Safe Medication Practices (ISMP), oral anticoagulants have been classified as high alert medications because they can potentially harm when used clinically. Many reports have appeared on the risk of bleeding when the anticoagulants are used concurrently with other similar agents like antiplatelet drugs, when the drug treatment is duplicated, in the presence of dosing errors, when there is accidental discontinuation of treatment and when there are problems with monitoring. More importantly, the Joint Commission has designated the cautious use of an oral anticoagulant as part of the National Patient Safety Goals (NQF). Stringent regulatory norms and the classification of anticoagulants in high-risk category drugs are some of the restraints for the market.
Value Chain Analysis
The global anticoagulation market is growing steadily due to the rising demand for anticoagulants, which creates lucrative growth opportunities for thenumber of players coming forward with new and better products. The value chain analysis of the anticoagulationmarket comprises four major components: research & development and designing, manufacturing the products, distribution & sales, and post-sales services.
Research &development start with conceptualizing, followed by design, then development, and lastly, testing. The R&D segment comprises 25-30% of the value chain. After the product designs are final, the manufacturing of the product starts. Manufacturing consists of 45-50% of the value chain. Then comes distribution and sales, which is essential for any industry. Here, awareness about the products is spread across the market to attract customers towards the product. It consists of 10-15% of the value chain. And lastly comes post-sales services.The post-marketing monitoring stage begins with a periodic safety update report of the product submitted to the FDA after the drugs come into the market.It accounts for around 5% of the value chain.
Novel oral anticoagulant drugs include Rivaroxaban, Apixaban, Dabigatran, Edoxaban, and Betrixaban. These drugs are new medications and offer many potential benefits. They have indications, such as reducing the risk of stroke and systemic embolism and helps prevent deep vein thrombosis (DVT) and pulmonary embolism (PE)
According to the article published in the Journal Nursing Critical Carein 2017, NOACs are approved in the US that includes Dabigatran, Rivaroxaban, Apixaban, and Edoxaban drugs. Furthermore, the increasing incidence of stroke worldwide is driving the growth of this segment.
Warfarin and acenocoumarol have been the only oral anticoagulants used for over 60 years. Vitamin K acts as a cofactor in the post-translational carboxylation of glutamate residues to γ-carboxyglutamates in the N-terminal regions of the vitamin K-dependent proteins.
VKA treatment is prescribedin severalmedical conditions such as deep vein thrombosis(DVT) and pulmonary embolism (PE), the prevention of recurrence, atrial fibrillation (AF) and stroke, acute myocardial infarction, vasculopathy, and patients with tissue heart valves or mechanical prosthetic cardiac valves.
Other Vitamin K Antagonists (VKA) include coumarin derivatives (warfarin and acenocoumarol), which have been the only oral anticoagulants used for over 60 years. Vitamin K acts as a cofactor in the post-translational carboxylation of glutamate residues to γ-carboxyglutamates in the N-terminal regions of the vitamin K-dependent proteins.
Treatment with VKA is indicated in various medical conditions such as deep vein thrombosis(DVT) and pulmonary embolism (PE), and the prevention of recurrence, Atrial Fibrillation (AF) and stroke, vasculopathy,and acute myocardial infarction,as well as in patients with mechanical prosthetic cardiac valves or tissue heart valves disease.
LMWH, includingenoxaparin anddalteparin, are anticoagulants. These drugs are used to preventVenous Thromboembolic Disease (VTE) on acute or elective admission to the hospital, and they are also used in the treatment of DVT and PE.
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