: Pfizer Inc and Bristol-Myers Squibb have announced promising Phase 3 clinical trial results for a new anticoagulant therapy targeting specific clotting factors. The novel agent, which is set to advance towards regulatory approval, aims to offer patients a new option with reduced bleeding complications and enhanced effectiveness.
April 2024: Portola Pharmaceuticals has updated guidelines for Andexxa, a reversal agent for direct oral anticoagulants, to include emergency use cases for patients with severe bleeding or urgent procedures, aiming to improve the safety and manageability of anticoagulant therapy.
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.
Anticoagulation Market Dynamics:
Drivers
- Rising incidence of cardiovascular and coronary artery diseases
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.
- Growing awareness, expenditure, and dependence on anticoagulants
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.
Opportunities
- Increasing patient population supporting new product launch
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.
Restraints
- Stringent regulatory norms
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.
Anticoagulation Segment Overview:
Anticoagulation DRUG CLASS Insights
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.
- Low Molecular Weight Heparin (LMWH):
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.
Anticoagulation DISEASE INDICATION Insights
Heart Failure (HF) or heart attack with reduced left ventricular function inflicts a large and growing burden of morbidity and deaths in the US and globally. One source of this burden is stroke. While it appears that HF itself may impose some risk of stroke, it is in the presence of other risk factors, like atrial fibrillation, that the greatest risks are observed. Therapeutic anticoagulation is the mainstay of risk reduction strategies in this population.
Anticoagulation is a type of medication used to manage and prevent stroke. For many years, anticoagulants have been used to treat patients with acute ischemic stroke. Increasing use of these anticoagulants for stroke treatment is driving the growth of this segment Deep Vein Thrombosis/ Pulmonary Embolism DVT/PE
- The rising prevalence of atrial fibrillation, deep vein thrombosis/pulmonary embolism, andmechanical Heart Valves (MHV) worldwide is driving the market growth of this segment. According to the data published in the American College of Cardiology in 2019, approximately 5.3 million people suffer from atrial fibrillation, and every 40 seconds, an American suffers from a stroke.
- The rising number of these cases is driving the market growth of this segment. Furthermore, the presence of top pharma and biopharma companies involved in developing novel therapeutics to help treat these disease indications is contributing significantly towards the market growth.
Mechanical Heart Valves (MHV)
- Valvular heart disease remains a major public health concern; it attracts governments, public health organizations, researchers. Valve substitution is an important part of the treatment for this medical condition. At present, the preferable valve prosthesis is either tissue or mechanical.
- Others
- The others segment is based on disease indication includes coronary artery diseases and myocardial infarction. This segment is a major revenue contributor to the market growth and is anticipated to show domination throughout the forecast period, owing to a large target population and an increase in the use of anticoagulants to treat these conditions.
Anticoagulation Route of Administration (ROA)
The oral route of administration of anticoagulants represents DOACs and signifies a remarkable advancement in anticoagulation. Besides, DOACs have confirmed efficacy across various indications, with increased availability in terms of anticoagulation. As a result, this factor hugelycontributes to the market growth of this segment and, in turn, of the anticoagulation market.
Injectable anticoagulants, Unfractionated heparin (UFH) is administered via intravenous (IV) infusion or subcutaneous (SC) injection, the preferred routes of administration. IV administration (with a bolus dose) rapidly achieves therapeutic plasma concentrations. It is also the preferred method of administration when rapid anticoagulation is required. When given SC, the bioavailability of UFH ranges from 30% to 70%, depending on the dose given. Vitamin K can be given by IV or oral route; the SC route is not recommended.
Factors such as a hike in the number of obese and olderpeople, high unaddressed needs, and a surge in demand fornew therapeutics further backthe market growth of this segment.
Anticoagulation Distribution Channel Insights
Retail pharmacies accounted for a market share of USD 8,618.33 million in 2019. It is projected to register a CAGR of 6.86% becausethe cost of drugs provided by the retail pharmacy is comparatively less than thehospital-associated pharmacies, which isexpected to drive this segment’s market growth. The increasing number of retail pharmacies involved in selling anticoagulant drugs is anticipated to boost the market growth of retail pharmacies during the assessment period.
Hospital pharmacies, a specialized pharmacy field,arean importantpart of the distribution channel. These include a hospital, drug-dependency facility, outpatient clinic, drug information center of a residential care facility. An increasing number of hospital pharmacies involved in selling drugs for anticoagulants is driving the market growth of this segment.
An online pharmacy, internet pharmacy, or mail-order pharmacy is a pharmacy that operates over the internet. It sends orders to customers through mail, shipping companies, or an online pharmacy web portal.The market growth of this segment is due to the availability of high-speed internet, the increasing number of online pharmacies dedicated to anticoagulants, and more discounts offered compared to retail pharmacies. Moreover, expanding urban population contributes to the growth of this segment. For instance, roughly 400 million, i.e., 40% of Africa’s 1 billion population, resides in cities. Global Anticoagulation Market Share (%), by Region
Source: MRFR AnalysisRegional Analysis
