Heparin Market Size, Share & COVID-19 Impact Analysis, By Product (Unfractionated Heparin (UFH) and Low Molecular Weight Heparin (LMWH)), By Source (Bovine and Porcine), By Application (Deep Vein Thrombosis & Pulmonary Embolism, Atrial Fibrillation, Heart Attacks, Stroke, and Others), By Route of Administration (Intravenous Infusion and Subcutaneous Injection), By End-user (Hospitals & ASCs, Clinics, and Others), and Regional Forecast, 2023-2030

The global heparin market size was valued at USD 9.53 billion in 2022 and is projected to grow from USD 9.89 billion in 2023 to USD 13.22 billion by 2030, exhibiting a CAGR of 4.2% during the forecast period.

Heparin is considered as one of the most critical life-saving drugs available in the world currently. It can be used for the management and treatment of various chronic diseases. This product belongs to the anticoagulant class of drugs and is used as a therapy for several cardiovascular diseases, including deep vein thrombosis and pulmonary embolism. However, the market suffered from several undesirable causes, such as product contamination, and issues concerned with supply chain disruption in past years. Despite that, the crucial nature of the drug has led to its persistent existence by several major companies, such as Baxter and Pfizer, aiding the global market growth during the forecast period.

Moreover, there has been considerable evidence that supports the hypothesis. Apart from this product’s anticoagulant properties, it also possesses significant anti-inflammatory properties, due to which the market is expected to grow during the forecast period. Such benefits attributed to this product and various R&D initiatives are expected to boost the global market growth further.

COVID-19 IMPACT 

Critical Nature of these Products and Increased Incorporation into COVID-19 Treatment Protocols Enabled the Market’s Steady Growth

The COVID-19 pandemic had a positive impact on the global market as the drug is considered a life-saving medication for certain chronic disorders. This resulted in increased demand for heparin products. At the same point, the accumulation of certain types of the product along with the usage of this product as a COVID-19 therapeutic has stimulated the demand for certain treatment procedures. However, in some instances, the pandemic posed certain barriers to global market growth in the initial days due to a sharp reduction in hospital visits worldwide and supply issues of essential materials that are required to be sourced from China. After the outbreak, the global market recovered well from the initial negative impact of the pandemic.

• For instance, in March 2023, a research study was published in the Indian Journal of Critical Care Medicine in which researchers demonstrated the use of nebulized heparin for the treatment of COVID-19 pneumonia with mild ARDS. The results showed that this treatment improved oxygenation in the study population.


• In 2020, according to a news article published in the Times of India, a heparin injection of 5000 IU/ml was considered an essential medicine for the treatment of COVID-19 patients by the Health Ministry of India.

Also, the pandemic exerted a negative impact in the initial days of the pandemic on the sales of these products across the globe due to the reduction of hospital visits and a strong decline in the number of cardiovascular disease diagnoses. However, in 2021, several R&D initiatives toward the treatment and management of COVID-19 led certain researchers to study the efficacy of the U.S. FDA-approved heparin as a neutralizer of the virus.

• As per a study published in 2021 by Hematology, 94.7% received Low Molecular Weight Heparin (LMWH), mostly enoxaparin, to prevent thrombosis and inflammation in patients hospitalized for COVID-19 treatment. As the number of COVID-19 cases is subsidizing, the demand for these products is expected to grow at a steady rate over the forecast period.

LATEST TRENDS

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Increasing R&D Initiatives for Synthetic Heparin to Escalate Trade Openings

In terms of technological advancements, there have been continuous initiatives undertaken by government authorities as well as operating players to expand these products’ applications as well as introduce alternatives to animal-derived products. However, the criticality and importance of this therapy during the anticoagulation process remain unaffected. Another reason such as the availability of porcine raw material for the drug's development and manufacturing has caused global concerns, especially for the U.S. market. Furthermore, current research initiatives focus on the control of enzymes that regulate these drugs and offer great potential in terms of the development and preparation of synthetic unfractionated heparin, LMWH, and Ultra Low Molecular Weight Heparin (ULMWH).

The development of the synthetic version can give rise to products with reduced side effects of Heparin-induced Thrombocytopenia (HIT) and with more defined physical, chemical, biological, and pharmacological properties. For instance, a new synthetic version of sulfated polysaccharide heparin is expected to have a better safety profile and more-reversible activity than the currently approved versions of the anticoagulant.

Furthermore, some of the emerging players such as Optimvia, Midas Pharma GmbH, and others are collaborating to introduce synthetic variants of these products at a cheaper cost to replace animal-derived products.

• For instance, in January 2022, Optimvia entered into a partnership with Ginkgo Bioworks, a leading platform for cell programming. In this partnership, Optimvia leveraged Ginkgo’s cell and enzyme engineering platform as well as its fermentation process development expertise to improve the manufacturing efficiency of biosynthetic heparin.

Such strategic initiatives have provided impetus to market players to introduce an alternative to crude heparin API through the upscaling of R&D activities coupled with partnerships with native players. Cumulatively, all these factors will significantly boost the global market growth during the forecast period.

DRIVING FACTORS

Increased Incidence of Cardiovascular and Other Chronic Disorders to Boost Market Growth

A critical driving factor that will influence the global market is the rising prevalence of cardiovascular diseases, which will fuel the demand for these products. Almost every form of cardiovascular disease such as heart attacks, strokes, venous thromboembolism, and other related conditions, such as atrial fibrillation, are expected to remain prevalent in the forthcoming years.

• According to an article published by Heart Research Institute (HRI) in 2022, a heart attack is the leading cause of hospitalization in Australia, with an average of 19 lives claimed every day. Such trends leading to increased awareness are expected to contribute strongly to the greater adoption of these products.

Such trends and statistics represent substantial potential and existing patient populations worldwide, which are influencing the strong demand for these products. Furthermore, increasing awareness amongst patients regarding the efficiency of these drugs for the treatment of various heart diseases will drive the market growth.

Robust Adoption of the Product in Various Applications to Stimulate Market Growth

Efficacy of these drugs as an anticoagulant is another key factor that is anticipated to drive global market growth. Furthermore, undeniable factors such as advancements in technology and launch of innovative products in the forecast period are prominently expected to drive the growth of the global market.

• According to a research study published by bioRXiv in 2020, the action of this drug as an anti-inflammatory agent does not depend on the virus type and, in general, the cause of the acute inflammatory process. This broadens its application range even more for the treatment of viral infections as well as acute inflammatory conditions.

The consistent surge in the usage of these drugs has further initiated advancements in the development of LMWH. Furthermore, technological advancements have given rise to newer forms such as Ultra-low Molecular Weight Heparin (ULMWH). Hence, these factors are expected to impact the market during the forecast period positively.

RESTRAINING FACTORS

Shortage of Raw Material Coupled with Higher Prices of Certain Types to Restrain Market Growth

One of the critical restraining factors that affect the growth of the global market is an insufficient supply of raw materials from China for the manufacturing of porcine-based versions of this product. Multiple recent outbreaks of African Swine Fever (ASF) in China, which is a fatal disease for the swine, have led to the widespread culling of pigs to control outbreaks.

• For instance, in July 2020, according to one of China’s agriculture ministry officials, China’s efforts to control African swine flu stayed complicated, as more than 11 outbreaks were reported along with the presence of new variants. The new outbreaks were reported in the northern regions of China.


• For instance, as per the Europe Animal Disease Information System (ADIS) 2022 report, there were 81 outbreaks of ASF amongst domestic pigs in Europe, which confirms that ASF continues to spread in several countries with serious impacts on the pig production system, animal health, and welfare.

Hence, these factors might lead to the continued shortage of raw materials for the manufacturing of these products. The second restraining factor is the higher costs associated with LMWH, which might limit its greater adoption in developing markets and is anticipated to restrict market growth in the forthcoming years.

SEGMENTATION

By Product Analysis

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Superior Advantages Offered by LMWH Products to Propel Segment’s Growth 

On the basis of product, the market is segmented into Unfractionated Heparin (UFH) and Low Molecular Weight Heparin (LMWH).

The LMWH segment held a dominant global heparin market share in 2022. The dominance of this segment is due to the high adoption rate of this product in developed markets and greater safety profiles of these products in comparison to others. Some important LMWH products include Fragmin (Dalteparin sodium), Lovenox (Enoxaparin sodium), and Innohep (Tinzaparin sodium). Several market players are also focusing on the development and launches of new LMWH products in the global market. For instance, in November 2019, Valeo Pharma Inc. announced that it filed a New Drug Submission for LMWH biosimilar, which has been accepted for review by Health Canada.

However, the UFH segment is anticipated to register a lower market share in the forecast period. This is primarily due to the increasing transition toward the usage of LMWH and the concerns associated with safety profiles of this product.

By Source Analysis 

High Adoption Rate Led to Porcine Segment’s Dominance in 2022

Based on source, the market can be segmented into bovine and porcine.

The porcine segment is anticipated to dominate the market during the forecast period as key markets such as North America and Europe are some of the regions where porcine-based products are the only permitted version derived from an animal-based source. The growth of the segment is attributable to the increasing rate of diagnosis of cardiovascular diseases in emerging and developed countries. Lack of availability of other animal-based alternatives as an anticoagulant is set to increase the adoption rate. Hence, this segment maintains an undisturbed dominance in the global market.

Bovine, which is present in certain Islamic and Latin American countries, accounted for a lower share of the global market and also registered a comparatively lower CAGR. However, the bovine segment is expected to witness positive growth in the forecast period as developed countries such as the U.S. are planning to reintroduce this product to meet the growing demand. For instance, in February 2020, a study published in Frontiers in Medicine reported that the bovine -based version of the product can be used as an alternative to conventional porcine based version of the product in the U.S. as it produces an acceptable level of impurity mentioned by the U.S. Pharmacopeia.

By Application Analysis

High Incidence Rate of Heart Attacks will Propel the Market Growth in 2023-2030

In terms of application, the market is segmented into deep vein thrombosis & pulmonary embolism, atrial fibrillation, heart attacks, stroke, and others.

The heart attacks segment is expected to dominate the market due to significant proportion of the populace suffering from this disease for which one of the most important interventions is the administration of injectable anticoagulants.

The atrial fibrillation segment is anticipated to be the second-largest segment in the forecast period since a sizable proportion of the global populace suffers from the disease.

The deep vein thrombosis & pulmonary embolisms and strokes segments also account for significant market shares during the forecast period as the product is an important treatment option for these medical conditions. As per an article published by the Journal of American College of Cardiology (JACC) in February 2021, the overall incidence of deep venous thrombosis & pulmonary embolism is estimated to be 1 to 2 per 1,000 person-years across the world. In the same article, it was further stated that atrial fibrillation increases the risk of stroke by 4-5 times and accounts for an estimated 15%-20% of ischemic strokes.

The others segment consists of application areas such as administration during hemodialysis and is expected to register a comparatively lower CAGR over the forecast period.

By Route of Administration Analysis

Advantages Offered by Subcutaneous Injection Segment over Intravenous Administration Led to the Segment’s Dominance in 2022

By route of administration, the market is segmented into intravenous infusion and subcutaneous injection.

The subcutaneous injection segment is anticipated to dominate the market. This is attributed to the fact that LMWH is usually administered subcutaneously. The growth of the segment is attributable to technological advancements and sophistication of subcutaneous injection as compared to other administration types. Additionally, some of the advantages attributed to this route of administration include the elimination of the need for constant laboratory monitoring to check the patient’s anticoagulation response.

The intravenous infusion segment is anticipated to register a comparatively lower growth rate in the forecast period. It includes several prominent product offerings of UFH that can be administered intravenously. For example, as per an article published in 2020 by the National Institutes of Health (NIH), in severe renal impairment, a rapid offset of anticoagulant is required, which is administered through intravenous infusion.

By End-user Analysis

Dependency on Healthcare Professionals for Administration is Expected to Drive Hospitals & ASCs Segment’s Growth in 2023-2030

Based on end-user, the market is segmented into hospitals & ASCs, clinics, and others.

The hospitals & ASCs segment is expected to account for the highest share of the global market in the forecast period. This is fundamentally due to greater dependency on healthcare professionals for prescribing these products, along with proper administration, especially through intravenous infusion.

The clinics segment is expected to account for the second-largest market share during the forecast period as many of these products are administered at dialysis clinics. The others segment is expected to witness high CAGR primarily due to an increase in the use of LMWH through subcutaneous administration at homecare settings. The product is also available through retail pharmacies. This is attributed to the fact that home care settings offer the patient greater ease and convenience.

REGIONAL INSIGHTS

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On the basis of region, the global market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

The market size in North America stood at USD 4.87 billion in 2022 and the region is expected to account for the dominant share of the global market during the forecast period. North America dominates the global market due to the region’s strong prevalence of cardiovascular disorders such as pulmonary embolism, higher adoption of advanced products, strong healthcare expenditure, and the presence of significant market players engaged in these product sales. For instance, according to the estimates by the Centers for Disease Control and Prevention (CDC) in October 2022, every year, an estimated 805,000 individuals in the U.S. suffer from a heart attack, out of which 605,000 were newly reported cases.

The market in Europe is anticipated to be the second-largest market in the globe owing to the strong adoption of technologically advanced products in the region along with an increase in the number of individuals suffering from a range of cardiovascular diseases. For instance, as per an article published by the U.K. government in February 2022, in the U.K. about 1 in 1,000 people are affected by venous thrombosis each year.

The Asia Pacific market is expected to register the highest CAGR in the forecast period due to increased need for technologically sophisticated products, a strong potential patient population, and a significant surge in healthcare expenditure. As per an article published by the Journal of the American College of Surgeons in 2020, administration of LMWH in Japanese patients after a laparoscopic operation for gastrointestinal malignancy is safe to prevent venous thromboembolism. Growing applications of LMWH in diverse application areas in the region including postoperative treatment, will likely to drive the market’s growth during the forecast period.

The other regions such as Latin America and the Middle East & Africa are anticipated to account for a comparatively lesser market share in the forecast period. However, these regions are expected to register strong growth prospects in the forecast period due to increased healthcare expenditure. Further, greater awareness of timely treatment of chronic illnesses such as cardiovascular diseases is expected to boost product demand. For instance, in February 2020, according to an article published by Global Heart, an official journal for the World Heart Federation, 13% of all deaths in sub-Saharan Africa occur due to cardiovascular diseases. Furthermore, 23% of the world’s rheumatic heart disease cases are prevalent in sub-Saharan African regions. Increased awareness in the general population regarding these diseases is anticipated to contribute to greater product adoption rates.

KEY INDUSTRY PLAYERS

Robust Product Portfolio of Pfizer Inc., Baxter, and Sanofi-Aventis Led to their Dominant Market Position in 2022

In the competitive scenario, the global market is characterized by the presence and dominance of a few key companies such as Pfizer Inc., Baxter, and Sanofi-Aventis. In the current competitive scene, Pfizer, Inc. and Baxter dominated the global market in 2022, accounting for a strong market revenue share. The dominance of these market players is attributable to their strong and robust product portfolio, which comprises several products including UFH and LMWH offerings. For example, Pfizer, Inc. is a dominant company due to its prominent product offering of Fragmin (Dalteparin sodium), a LMWH product.

Other important players include Baxter and Sanofi whose presence is mainly due to their product offerings, Heparin Sodium & 0.9% Sodium Chloride Injection and Lovenox (Enoxaparin Sodium), respectively. Some other emerging market players include Opocrin S.p.A. and Aspen Holdings, and these companies’ market expansion strategies are anticipated to aid them in increasing their market revenue share in the forecast period.

LIST OF KEY COMPANIES PROFILED:

• Opocrin S.p.A. (Italy)


• Baxter (U.S.)


• Pfizer Inc. (U.S.)


• Bioiberica S.A.U. (Spain)


• Fresenius SE & Co. KGaA (Germany)


• Hebei Changshan Biochemical Pharmaceutical Co., Ltd. (China)


• B. Braun SE (Germany)


• Dr. Reddy’s Laboratories Ltd. (India)


• LEO Pharma A/S (Denmark)


• Aspen Holdings (South Africa)


• Sanofi (France)

KEY INDUSTRY DEVELOPMENTS:

• March 2023: Techdow USA Inc. received the U.S. FDA approval for its Enoxaparin Sodium in pre-filled syringes for the U.S. market.


• March 2022: Hepalink Group announced the approval of heparin sodium and enoxaparin sodium APIs in India with an aim to increase its distribution channel.


• April 2021: Fresenius Kabi announced two new presentations of Heparin Sodium in convenient, ready-to-administer Freeflex IV bags in the U.S.


• April 2020: Cerus Advisors DMCC, (CERUS), a boutique family office management firm, announced the acquisition of all of Laboratori Derivati Organici SpA (LDO) by Opocrin S.p.A. stocks. The product portfolio of LDO consists of heparin along with a series of other specialized biological APIs.


• February 2020: Meitheal Pharmaceuticals announced the U.S. FDA approval of additional manufacturing capacity and future facility expansion plans for the production of Heparin Sodium Injection, USP.


• April 2019: B Braun Medical Inc. announced the launch of a new Heparin Sodium injection in the U.S. This is the first heparin pre-filled syringe with an attached safety needle for subcutaneous or intravenous use.

REPORT COVERAGE

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The global heparin market research report provides a detailed analysis of the market and focuses on key aspects such as key industry developments - mergers, acquisitions, and partnerships, new product launches, prevalence of key cardiovascular diseases by key countries, an overview of technological advancements, the impact of COVID-19 pandemic on the market, regulatory scenario by key countries, reimbursement scenario by key countries, trends of consumption in Muslim-oriented markets, insights on the usage of UFH & LMWH, China market overview (production/supply impacted by swine fever), purchasing process, and pricing. Besides this, the report offers insights into the market trends and highlights key industry dynamics. In addition to the aforementioned factors, the report encompasses several factors that have contributed to the growth of the global market in recent years.

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