Anticoagulation Market Research Report—Global Forecast till 2027

Anticoagulation Market: Information by Drug Class (Novel and Direct Anticoagulants [DOACs], Heparin and Low Molecular Weight [LMWH], Warfarin, Vitamin K Antagonists), Disease Indication(Anti Fibrillation [A-Fib], Stroke, Deep Vein Thrombosis/Pulmonary Embolism [PE], Mechanical Heart Valves [MHV]), Route of Administration (Oral and Injectable), Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), and Region (North America, Europe, Asia-Pacific, and Rest of the World)—Forecast till 2027

ID: MRFR/HC/9168-CR | August 2021 | Region: Global | 145 pages         

Anticoagulation Market

The anticoagulation market is expected to cross USD 31,696.59 million by 2027 at a CAGR of 7.80% during the forecast period.

Segmentation

By Drug Class Novel and Direct Anticoagulants Heparin and Low Molecular Weight [LMWH] Warfarin Vitamin K Antagonists
By Disease Indication Anti Fibrillation Stroke Deep Vein Thrombosis/Pulmonary Embolism Mechanical Heart Valves
By Route of Administration Oral Injectable
By Distribution Channel Hospital Pharmacies Retail Pharmacies Online Pharmacies

Key Players

  • Pfizer Inc (US)
  • Novartis AG (Switzerland)
  • Sanofi (France)
  • GlaxoSmithKline plc (UK)
  • Daiichi Sankyo Company
  • Limited (Japan)
  • Johnson & Johnson Services Inc (US)

Drivers

  • Rising incidence of cardiovascular and coronary artery diseases
  • growing awareness
  • expenditure
  • dependence on anticoagulants.
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Anticoagulation Market Forecast


The anticoagulation market is expected to cross USD 31,696.59 million by 2027 at a CAGR of 7.80% during the forecast period.


Market Overview:


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.


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.


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.


Global Anticoagulation Market Share (%), by Drug Class, 2019
Global Anticoagulation Market Share (%), by Drug Class
Source: MRFR Analysis


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.


Segment Overview:


By DRUG CLASS


  • Direct Oral Anticoagulants (DOACS):


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:


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:


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.


By DISEASE INDICATION


  • Heart Attack


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.


  • Stroke


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.


By Route of Administration (ROA)


  • Oral


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


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.


  • Others


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.
 
By Distribution Channel


  • Retail Pharmacy


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


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.


  • Online Pharmacies


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, 2019

Global Anticoagulation Market Share (%), by Region
Source: MRFR Analysis

Regional Analysis



  • North America


North America is expected to hold the biggestmarket share duringthe study period. In North America, the anticoagulation market is driven by an increasing number of heart patients, rising awareness about chronic and lifestyle diseases, new product launches, andthe presence ofmajor players.Since healthcare expenditure is high in North America, anticoagulation is widely used to reduce clot formation, leading to the risk of heart disease.
In addition, key players are showing keen interest in expanding their market presence and product portfolio by strategic alliances and launching new products. For instance, in 2019, Johnson & Johnson(US) received US FDA approval for XARELTO to treat VTE or blood clots.


  • Asia-Pacific


Asia-Pacific is anticipated to register the highest growth rate during the forecast period from 2020 to 2027. This is due to factors such asan increasing prevalence of chronic disease, large population base, rise in geriatric population, rising disposable income, andincreasing manufacturing facilities of key players.
In addition, the development of advanced treatment and the availability of highly skilled medical professionals also positively impact the growth of this market. Thus, the increasing use of anticoagulation drugs is anticipated to boost market growth.


  • Europe


Europe accounted for a market size of USD 5,205.37million in 2019 and is expected to show a CAGR of 7.26%during the forecast period. The market growth is accredited to the rise in research &development activity, increased prevalence of chronic heart diseases, and a rise in demand for advanced therapeutics. For instance, according to the European Cardiovascular Disease Statistics, in 2019, more than 6 million people were affectedbyheart disease in Europe.
Thus, the increasing prevalence of heart disease would drive the usage of anticoagulation drugs. In addition, with the growing per capita income, people are more conscious about the disease, which would raise the demand foranticoagulants.


  • Rest of the World


The Rest of the World is segmented into the Middle East, Africa, and Latin America. The increasing number of research companies and subsidiaries involved in R&D for anticoagulants, rising prevalence of cardiovascular disorders in this regiondrive the growth of the anticoagulation market.
Furthermore, the increasing burden of cardiacdiseases in the region also raises the demand foreffective anticoagulant therapy, which in turn is pushingthe market growth.

Competitive Landscape


  • The global anticoagulation market is characterized by many global, regional, and local vendors catering to the demand. The availability of branded and generic drugs is creating lucrative growth opportunitiesforthe global anticoagulation market. The key players showa keen interest in strategic business alliances, such as signing contracts and agreements to expand the geographical reach and optimize operational costs. The business models in the global anticoagulation market include importing products and marketing at reasonable costs. The distribution and marketing collaborations are also observed for a direct presence in the global anticoagulationmarket.

  • The market for anticoagulation is also expanding, with rising business operations by key players. The majorcompanies may strengthen their presence through acquisitions and collaborative agreements during the forecast period. It has also been forecasted that government support and industry development fuel market growth, thereby making it the perfect time for new players to enter the market and increase the market share.

  • For instance, Pfizer Inc(US)is a key player in the global anticoagulation market. With a presence in over 150 countries worldwide, Pfizer Inc is a leading manufacturer of products for anticoagulants. The product portfolio of Pfizer Incincludes products such as theEliquis (Apixaban),Fragmin (Dalteparin),and Savaysa/Lixiana (Edoxaban).


List of Key Companies Covered in this Report:


  • Pfizer Inc (US)

  • Novartis AG (Switzerland)

  • Sanofi(France)

  • GlaxoSmithKline plc (UK)

  • Daiichi Sankyo Company, Limited (Japan)

  • Johnson & Johnson Services Inc (US)

  • Boehringer Ingelheim International GmbH (Germany)

  • Bristol-Myers Squibb Company (US)

  • Hoffmann-La Roche Ltd (Switzerland)

  • Portola Pharmaceuticals, Inc (US)


Recent Developments


  • In October 2020, J&J (US) submitted a new drug application to the FDA to expand the use of XARELTO in patients with Pulmonary Artery Disease (PAD) to reduce the risks of a heart attack.

  • In August 2020, Daiichi Sankyo Company (Japan)announced that the primary endpoint had been achieved in the Japan phase 3 clinical trial for the anticoagulant Edoxaban in geriatric patients with high bleeding risk.

  • In December 2020, Natco Pharma(Hyderabad) launchedan anti-blood clot tablet, Rivaroxaban, in India. This productreduces rapid blood clot formation.RPIGAT has been introducedin four strengths - 20 mg, 15 mg, 10 mg, and 2.5 mg.

  • In November 2020, Boehringer Ingelheim (Germany) received a positive The Committee for Medicinal Products for Human Use (CHMP) opinion for the use of Pradaxa (dabigatran etexilate) to treat and prevent venous thromboembolic events in children from birth to less than 18 years of age.

  • In October 2019, J&J (US) received US FDA approval for XARELTO to treat venous thromboembolism (VTE), or blood clots.

  • In May 2018, Portola Pharmaceuticals (US) received US FDA approval for Andexxa as the first antidotefor patients treated with rivaroxaban or apixaban when reversal of anticoagulation is needed life-threatening or uncontrolled bleeding.


Report Overview:


  • The report contains:

  • Global anticoagulation market size and estimation fromhistoric years to forecast period (2018-2027).

  • The major market segments and their share, globally as well as regionally.

  • The market drivers, restraints, and opportunities.

  • Competitive landscape of the global anticoagulation market.

  • Key market players’ profiling along with SWOT analysis.



Report Scope:
Report Attribute/Metric Details
  Market Size   2027 USD 31,696.59Million
  CAGR   7.80%(2020-2027)
  Base Year   2019
  Forecast Period   2020-2027
  Historical Data   2017-2018
  Forecast Units   Value (USD Million)
  Report Coverage   Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
  Segments Covered   Technology,Application, and End Use
  Geographies Covered   North America, Europe, Asia-Pacific, and Rest of the World (RoW)
  Key Vendors   Pfizer Inc (US), Novartis AG (Switzerland),Sanofi (France),GlaxoSmithKline plc (UK),Daiichi Sankyo Company, Limited (Japan),Johnson & Johnson Services Inc (US),Boehringer Ingelheim International GmbH (Germany),Bristol-Myers Squibb Company (US),F. Hoffmann-La Roche Ltd (Switzerland),Portola Pharmaceuticals, Inc (US)
  Key Market Opportunities   Increase patient population and patent expiry to support new product launch
  Key Market Drivers   Rising incidence of cardiovascular and coronary artery diseases, growing awareness, expenditure, and dependence on anticoagulants.


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