Heparin Market Size, Share & Industry 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, 2024-2032

The global heparin market size was valued at USD 9.83 billion in 2023 and is projected to grow from USD 10.21 billion in 2024 to USD 14.45 billion by 2032, exhibiting a CAGR of 4.4% during the forecast period (2024-2032). North America dominated the global market with a share of 51.17% in 2023.

Heparins are a class of first-line anticoagulant drugs used to prevent blood clotting. They work by inhibiting the activity of clotting factors in the blood, thus reducing the formation of blood clots. These products are typically administered through subcutaneous injections or intravenous infusion to reduce the risk of deep vein thrombosis, pulmonary embolism, or during surgeries.

The market has faced various unfortunate challenges in the previous years, including product contamination and disruptions in the supply chain. Despite these issues, the importance of the drug has ensured its continued presence in the market, with major companies, such as Baxter and Pfizer, supporting its growth globally during the projected period.

Furthermore, various new product launches, partnerships & collaborations, and significant R&D initiatives support the global heparin market growth. Apart from that, the binding ability of this product makes it an anti-inflammatory and anti-viral substance.  Hence, an increasing number of indications that can use this product for treatment are expected to drive the demand for this product and its derivatives over the projected years.

• As per a study published in December 2021 by Hematology, 94.7% received Low Molecular Weight Heparin (LMWH), mostly enoxaparin, to prevent thrombosis and inflammation in patients hospitalized for the COVID-19 treatment.

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 these products during the pandemic years. However, in post-pandemic years, the demand for such products is expected to slow down as the number of COVID-19 cases is subsidizing, and the COVID-19-related demand is reduced. Despite that, the importance of this drug remains unparalleled, and the market is expected to witness steady growth prospects.

Heparin Market Trends

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

Increasing R&D initiatives for synthetic product have been gaining traction in recent years. Pharmaceutical companies and research institutions have been investing in developing new synthetic formulations and production methods. These initiatives have led to the development of promising candidate fondaparinux sodium and, some of which are in advanced stages of development. Additionally, the increasing demand for these products is driven by the need for a stable and safe source of anticoagulant drugs.

Rising number of initiatives for the development and manufacturing of synthetic molecules across the globe is accelerating the growth of the market. These initiatives include collaborations and investments in the development of synthetic and biosynthetic heparin. It is expected to launch new synthetic drugs and new processing methods in the coming years and contribute to the growth of the market.

• For instance, in January 2022, Optimvia collaborated with Ginkgo Bioworks to produce biosynthetic heparin. In this partnership, Optimvia leveraged Ginkgo’s cell and enzyme engineering platform and its fermentation process development expertise to improve the manufacturing efficiency of biosynthetic product.

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Heparin Market Growth Factors

Increasing Incidence of Thrombosis and Embolism to Boost Market Growth Significantly

The incidence of thrombosis and embolism has been on the rise globally due to various factors, such as sedentary lifestyles, aging population, obesity, and certain medical conditions, including cardiovascular diseases. Additionally, thrombosis and embolism are the common complications associated with surgeries.

• According to the June 2023 updated data by the Centers for Disease Control and Prevention (CDC), an estimated 900,000 Venous Thromboembolism (VTE) and Pulmonary Embolism (PE) events occur each year in the U.S. and an estimated 60,000-100,000 people die due to VTE and PE.

The increased prevalence of these conditions leads to a greater demand for anticoagulant therapies, including heparin. Especially, for the diseases, such as atrial fibrillation, deep vein thrombosis and pulmonary embolism, it necessitates long-term anticoagulation therapy.

The potential of this drug and the currently robust patient population globally are driving the strong demand for these products, as indicated by the trends and statistics. Additionally, the growing awareness among patients about the effectiveness of these medications in treating thrombosis and embolism conditions is also anticipated to contribute to the market's expansion.

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

Currently, heparin and its derived products are used in various conditions. These conditions include Deep Venous Thrombosis (DVT) and prophylaxis acute coronary syndromes, percutaneous coronary intervention, pulmonary embolism, venous thromboembolism, and prophylaxis in a variety of scenarios, and peri-procedural anticoagulation, among others.

The primary reason is the efficacy of these drugs as an anticoagulant. Investments in R&D and innovative product launches for specific indications are anticipated to drive the market growth over the forecast period.

• 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 the COVID-19 pneumonia with mild acute respiratory distress syndrome (ARDS). The results showed that this treatment improved oxygenation in the study population. This broadens its application range even more for the treatment of viral infections as well as acute inflammatory conditions.

Furthermore, initiatives undertaken by market players to extend the application areas and investigate alternatives are consistently boosting the market growth. For example, ongoing collaborations on synthetic versions of the product are expected to propel the market expansion during the forecast period positively.

RESTRAINING FACTORS

Shortage of Raw Materials and Safety Concerns from Animal-Derived Products to Restrain Market Growth

One of the major constraints with these products is the limited availability of raw materials. Most of the UFH and LMWH are produced from porcine mucosa, and the pork industry is the only source of it.

China is the largest producer in the pork industry, which has plenty of raw materials for the production of these products. The African Swine Fever (ASF) outbreaks in China resulted in the culling of pig populations to contain the outbreaks. Several recent outbreaks of African Swine Fever (ASF) in China have been reported. These events are resulting in a shortage of raw materials.

• 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.

Overall, safety concerns and a shortage of raw materials are limiting the growth of the overall heparin market growth

Heparin Market Segmentation Analysis

By Product Analysis

Superior Advantages Offered by LMWH Products to Augment Segment’s Dominance

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

In 2023, the Low Molecular Weight Heparin (LMWH) segment dominated the global heparin market share. This dominance is attributed to the high adoption of these products in the developed markets and their perceived safety advantages over other products. Several market players are also focusing on the development and launches of new LMWH products in the global market.

• For instance, in April 2021, Valeo Pharma Inc. launched Redesca HP in Canada. Redesca HP is a low molecular weight product used for various indications.

However, the UFH segment is anticipated to register a lower market share over the forecast period. This is primarily due to the increasing transition toward the usage of LMWH and concerns associated with the safety profiles of this product. However, the binding ability of UFH is higher than low molecular weight products, and certain conditions require intravenous UFH. Owing to that, the segment is expected to witness certain level of growth.

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By Source Analysis

High Anticoagulant Efficiency of Porcine Products Led to Segment’s Dominance

In terms of source, the market is segmented into bovine and porcine.

The porcine segment is anticipated to dominate the market during the forecast period. It is established that porcine sourced product has better anticoagulant activity than the products derived from bovine, and only porcine-derived product is approved in the major markets, including North America and Europe. These are the major factors for the growth of the porcine segment during the forecast period.

Furthermore, the fact that all the LMWHs are derived from porcine is a key factor attributing to the growth of the segment. The rising demand for these products due to a surge in the cases of cardiovascular conditions, surgical interventions, and dialysis across the globe also supports the segmental growth. Also, initiatives from players and regulatory bodies to meet the porcine-based products will result in increasing production of these products in the coming years.

• For instance, in December 2020, Revivicor, Inc. received U.S. FDA approval for its genetically modified GalSafe pigs for human consumption and medicinal uses, including heparin production from GMO pigs.

Bovine-sourced products, 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 over the forecast period. The lack of availability of alternative animal-based anticoagulants is expected to drive the adoption of bovine based products. Along with that, the U.S. Pharmacopeia's acceptable level of impurities for bovine products can lead to the eventual approval and adoption of these products in the coming years. Furthermore, in November 2023, the U.S. FDA published a policy document supporting and encouraging the gradual re-introduction of bovine-based products in the coming years.

By Application Analysis

High Occurrence of Heart Attacks/Myocardial Infarction Boosted Segment Growth

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

The heart attacks segment was the largest market segment in 2023, driven by a significant proportion of the population suffering from this disease, which requires the use of injectable anticoagulants as a crucial intervention. Moreover, initiatives by market players to expand production capabilities to meet growing demand are expected to maintain the dominance of the segment during the study period.

• For instance, in 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.

The atrial fibrillation segment is projected to be the second-largest segment due to a substantial number of people globally suffering from this condition. The deep vein thrombosis & pulmonary embolisms and stroke segments also held significant market shares.

According to a study published by the Journal of American College of Cardiology (JACC) in February 2021, the incidence of deep venous thrombosis & pulmonary embolism is estimated to be 1 to 2 per 1,000 person-years globally. The same study also mentioned that atrial fibrillation increases the risk of stroke by 4-5 times and contributes to approximately 15%-20% of ischemic strokes. The increased number of such cases can be attributed to the growth of the segment.

The others segment includes applications, such as administration during hemodialysis. Significant product launches, collaborations, and a rising number of dialysis cases are anticipated to drive the segment growth.

By Route of Administration Analysis

Benefits Such As Reduced Chances of Microvascular Bleeding Boosted Subcutaneous Injection Segment Growth

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

The subcutaneous injection segment accounted for the largest market share in 2023. It can be attributed to the fact that LMWH is usually administered subcutaneously, and the LMWH is currently administrated widely. Most of the unfractionated product indications had been replaced with LMWH, including orthopedic and neurological surgeries. Additionally, various studies reported that subcutaneous administration reduces the chances of microvascular bleeding. Also, it is reported that subcutaneous prophylaxis dose of low molecular weight product has around 90% bioavailability. Overall, the advantages associated with subcutaneous administration are anticipated to propel the growth of the segment.

The intravenous infusion segment is anticipated to register a comparatively lower CAGR over the forecast period. It includes several prominent product offerings of UFH that can be administered intravenously. Additionally, there are several advantages of intravenous administration, such as comparatively less costly administration, rapid action as it enters directly into the bloodstream, and it can be rapidly reversed by protamine in case of any side effects. Owing to these advantages, the intravenous infusion segment would witness considerable growth in the coming years.

• 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 achieved by intravenous infusion.

By End-user Analysis

Dependency on Healthcare Professionals for Administration Fueled Hospitals & ASCs Segment Expansion

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

The hospitals & ASCs segment accounted for the largest global market share in 2023. The key factors that are responsible for the dominance of the segment include high prescription flow by healthcare professionals for these products, along with proper administration, especially through intravenous infusion. Since this product is an indispensable drug during surgeries, an increasing number of various surgical procedures across the globe is expected to boost the segment growth.

• As per an article published in Geriatric Nursing in May 2023, around 310 million major surgeries are performed every year across the world.

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. An increasing number of chronic kidney diseases and a growing number of dialysis patients are fueling segmental growth. Increasing the number of product launches to be used during dialysis to reduce catheter-mediated blood infections is being observed in the market, which can further drive the market growth in the segment.

The increased utilization of LMWH via subcutaneous administration in homecare settings is projected to drive substantial growth in the others segment. Retail pharmacies also play a significant role in providing access to this product. Hence, the launch of pens, auto-injectors, and prefilled syringes is anticipated to propel the segment growth.

REGIONAL INSIGHTS

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

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The market size in North America stood at USD 5.03 billion in 2023, and the region is expected to account for the dominant share of the global market during the forecast period. The growth in North America can be attributed to the rising regulatory approvals and rising prevalence of pulmonary embolism and other cardiovascular diseases. Furthermore, the presence of large market players in the region drives the growth of the market.

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

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. Also, well-established R&D facilities and investments in new products are expected to fuel the market in the coming years.

• For instance, as per an article published by the U.K. government in February 2022, about 1 in 1,000 people in the U.K. are affected by venous thrombosis each year.

Asia Pacific is expected to register the highest CAGR over the forecast period due to the increased need for these products, a strong potential patient population, and a significant surge in healthcare expenditure. Moreover, the significant focus of the operating players on increasing production to meet the growing demand further boosts the market growth.

• For instance, in December 2021, Sihuan Pharmaceutical Holdings Group Ltd. received approval from the National Medical Products Administration of the People’s Republic of China to manufacture fondaparinux sodium injection. Fondaparinux is the only synthetic product available on the market.

Besides, the growing applications of LMWH in the diverse application areas in the region are likely to drive the market’s growth during the forecast period.

Latin America and the Middle East & Africa regions are projected to have a smaller market share during the forecast period. Nonetheless, these regions are expected to experience significant growth due to increased healthcare spending. Moreover, the higher population affected by cardiovascular and other chronic conditions are expected to drive the demand for these products.

• 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.

List of Key Companies in Heparin Market

Strong Product Portfolio of Pfizer Inc., Baxter, and Sanofi-Aventis Led to their Dominant Market Positions in 2023

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 2023, accounting for a strong market revenue share. The strong and diverse product portfolios of these market players contribute to their dominance in the industry. This includes products, such as UFH and LMWH offerings.

Pfizer Inc. generates revenue through its major product, Fragmin (Dalteparin sodium), which is a low molecular weight heparin. Other significant players, including Baxter and Sanofi, have established their presence through products, such as Heparin Sodium & 0.9% Sodium Chloride Injection and Lovenox (Enoxaparin Sodium), respectively.

Additionally, emerging market players, such as Opocrin S.p.A. and Aspen Holdings, are expected to expand their market presence and increase revenue in the coming years.

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:

• June 2023:  Biological E. Limited (BE) received U.S. FDA approval for Enoxaparin Sodium (LMWH) single-dose pre-filled syringes for prophylaxis of deep vein thrombosis in various surgeries and conditions.


• August 2022: Malaysia-based Pharmaniaga Berhad collaborated with China’s Suzhou Ronnsi Pharma Co., Ltd. to commercialize halal ovine-derived heparin in Malaysia.


• March 2022: Hepalink Group announced the approval of heparin sodium and enoxaparin sodium APIs in India with the aim of increasing 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.

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The global heparin market 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, and others. In addition to the aforementioned factors, the global heparin market analysis encompasses several factors that have contributed to the growth of the global market in recent years.

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