Heparin Market Size, Share & COVID-19 Impact Analysis, By Product Type (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, Others), and Regional Forecast, 2021-2028

The global heparin market size was USD 8.82 billion in 2020. The global impact of COVID-19 has been unprecedented and staggering, with heparin witnessing a positive demand shock across all regions amid the pandemic. Based on our analysis, the global market witnessed a strong growth of 5.0% in 2020. The market is projected to grow from USD 9.38 billion in 2021 to USD 12.06 billion in 2028 at a CAGR of 3.7% in the 2021-2028 period. The sudden fall in CAGR is attributable to this market’s demand and growth, returning to pre-pandemic levels once the pandemic is over.

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, used as a therapy for several cardiovascular diseases like deep vein thrombosis and pulmonary embolism. However, the market suffers due to undesirable causes such as product contamination which has led to various deaths in 2007-2008, and issues concerned with the supply chain disruption. Despite that, the crucial nature of the drug has led to its persistent existence by several major companies such as Baxter and Pfizer, aiding global heparin market growth during the forecast period.

Moreover, there has been considerable evidence which supports the hypothesis that 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 coupled with the various R&D initiatives are expected to further boost the growth of the market.

Critical Nature of Heparin Coupled with Increased Incorporation in COVID-19 Treatment Protocols Enabled Global Market’s Steady Growth

The COVID-19 pandemic does not have a significant impact on the global market because the drug is considered as a life-saving medication for chronic disorders. 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 in certain treatment procedures. However, some instances by which the pandemic had created impediments on the global market in the initial days of the pandemic was the sharp reduction in hospital visits worldwide and supply issues as the raw material is sourced from China. However, the global market has recovered well from the initial negative impact of the pandemic.

The pandemic had exerted a negative impact in the initial days of the pandemic on the sales of these products across globe, due to the reduction of hospital visits and strong decline in the number of cardiovascular disease diagnosis. Prominent companies in the market reported strong sales increase in their product revenues in the quarterly filings of FY 2021. For instance, Pfizer, Inc., a key company in the global market reported an increase of 26.3% in revenues of their LMWH product of Fragmin in the six months ended financial period of FY 2021 compared to the same period in FY 2021. Further, increased incorporation of the product in the coronavirus treatment protocols and the critical nature of the drugs have enabled the market to maintain its steady growth in 2020.

LATEST TRENDS

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

There have been various advancements in technology, however, the criticality and importance of heparin therapy during the anticoagulation process remains unaffected. Moreover, at the same instance, various factors such as the availability of porcine raw material for the drug's development and manufacturing have caused global concerns, especially for the U.S. market. Furthermore, current research initiatives which has focused on the control of enzymes associated which regulate these drugs have offered great potential in terms of the development and preparation of synthetic unfractionated, low molecular weight 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 (i.e., HIT), 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 have more-reversible activity than the currently approved versions of the anticoagulant. Such trends are expected to significantly boost the growth of the global market during the forecast period.

DRIVING FACTORS

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

One of the foremost driving factors which influence the global market is the increase in prevalence of cardiovascular diseases in key age groups such as the geriatric population, which is expected to fuel the demand for this product. Almost every form of diseases such as heart attacks, strokes, and venous thromboembolism and cardiovascular conditions such as atrial fibrillation are expected to remain prevalent in the forthcoming years. For instance, as per the statistics published by the Center of Disease Control (CDC), in 2020, approximately 655,000 Americans die from cardiovascular diseases every year. Furthermore, according to the statistics of 2017, 18.2 million adults who are aged 20 and above suffer from coronary artery disease.

Such trends and statistics represent substantial potential and existing patient populations worldwide; these are few of the reasons which lead to a strong demand for these products. Furthermore, increasing awareness among patients regarding the efficiency of these drugs for the treatment of various heart diseases will drive the market. Hence, the rising prevalence and incidence of cardiovascular diseases will boost market growth during the forecast period.

Robust Adoption of These Products in Various Applications to Stimulate Market Growth

One of the key factors anticipated to drive the global market growth is the efficacy of these drugs as an anticoagulant. Furthermore, undeniable factors like advancement in technology, and launch of new products are prominently expected to drive the growth of the global market. The surge in the usage of these drugs has further instigated advancements for the development of LMWH. Furthermore, technological advancements have given rise to newer forms such as the ULMWH. Hence, these factors are expected to positively impact the market during the forecast period.

RESTRAINING FACTORS

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

Few of the restraining factors that affect the growth of the global market are the concerns which are associated with the insufficiency of raw materials which are procured 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, has led to the widespread culling of pigs to control the 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. Hence, this factor might lead to the continued shortage of raw materials. The second restraining factor is the higher costs associated with the LMWH, which might limit its greater adoption in the developing markets, and is anticipated to restrict the market growth in the forthcoming years.

SEGMENTATION

By Product Type Analysis

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 LMWH Segment to Emerge as Dominant Segment in 2021-28

Based on type, the market includes unfractionated heparin (UFH) and low molecular weight heparin (LMWH), and others. The LMWH segment held a dominant share of the market in 2020. The dominance of this segment is due to the high adoption rate of this product type in the developed markets, the higher price associated with this product, and also the greater safety profiles of these products in comparison to other types. Some important LMWH products include Fragmin (Dalteparin sodium), Lovenox (Enoxaparin sodium), and Innohep (Tinzaparin sodium). The key players have also been focused on developing and launching new LMWH Products into the global market. For instance, in November 2019, Valeo Pharma Inc. announced that they filled a New drug Submission for a 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 towards the usage of LMWH, and also the concerns associated with safety profiles of this product type.

By Source Analysis

Porcine Segment Accounted for Highest Market Share in 2020

Based on the source, the market is segmented into bovine, and porcine. The porcine segment is anticipated to dominate the market during the forecast period because, in key markets such as North America and Europe, porcine based products are the only permitted version derived from an animal-based source. Hence, this type maintains an undisturbed dominance over the global market.

The bovine segment, which is present in certain Islamic countries 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 a positive growth in the forecast period, as research shows that bovine can be used as an alternative to porcine. 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. region, as it produces the acceptable level of impurity mentioned by the U.S. Pharmacopeia.

By Application Analysis

Heart Attacks Segment Dominated Market in 2020

Based on the application, the market can be segmented into deep vein thrombosis & pulmonary embolism, atrial fibrillation, heart attacks, stroke, and others. The heart attacks segment is expected to dominate the market because of the significant proportion of the populace suffering from the disease for which one of the most important interventions is the administration of anticoagulants such as these products.

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 embolism and the stroke segment also account for significant market shares during the forecast period as this product is an important treatment option for these medical conditions. For example, in 2018, the American Heart Association published that 92.1 million American adults suffer from cardiovascular diseases. Along with this 1 out of 3 deaths in the U.S region are caused by cardiovascular disease, which accounts to 2,300 deaths every day. The other segment consists of application areas such as administration during hemodialysis amongst others and is expected to register a comparatively lower CAGR.

By Route of Administration Analysis

Subcutaneous Injection Segment Registered Highest CAGR in 2020

Based on the route of administration, the market can be segmented into intravenous infusion and subcutaneous injection. The subcutaneous injection segment is anticipated to dominate the market. This is because low molecular weight heparin (LMWH) is usually administered subcutaneously. These products are usually priced higher compared to other product offerings.

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.

By End User Analysis

Hospitals & ASCs to be remain as Dominant Segment in 2021-2028

Based on the end user segment, the market is segmented into hospitals & ASCs, clinics, and others. The hospitals & ASCs are 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 the prescription of 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 amongst others. The other segment is expected to witness high CAGR primarily due to increase in use of LMWH through subcutaneous administration, at homecare settings. The product is also available through retail pharmacies. This is because the homecare settings offer the patient a greater ease and convenience.

REGIONAL INSIGHTS

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

The market size in North America stood at USD 4.50 billion in 2020 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 diseases such as pulmonary embolism, the 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 Centers for Disease Control and Prevention (CDC) in September 2020, it was estimated that approximately 12.1 million people will be affected by atrial fibrillation by the year 2030 in the U.S.

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 the increase in number of individuals suffering from a range of cardiovascular diseases. For instance, the European Society of Cardiology estimated that over 7.6 million people over the age of 65 suffer from atrial fibrillation. The number of patients is expected to increase by 89.0% to 14.4 million.

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.

The other regions include Latin America, and the Middle East & Africa which is 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 the product demand. For Instance, in February 2020, according to an article published by Glob Heart, an official journal for World Heart Federation, 13.0% of all deaths in sub-Saharan Africa occur due to cardiovascular diseases. Furthermore, 23.0% of the world’s rheumatic heart disease cases are prevalent in sub-Saharan African regions. Increased awareness in the general population regarding these diseases are anticipated to contribute to greater product adoption rates.

KEY INDUSTRY PLAYERS

Robust Product Portfolio of Baxter, Pfizer, Inc., and Sanofi-Aventis to Offer Dominant Market Position

In the competitive scenario, the global market is characterized by the presence and dominance of a few key companies such as Baxter, Pfizer, Inc., and Sanofi-Aventis. In the current competitive scene, Pfizer, Inc., and Baxter are dominating the global market in 2020, accounting for a strong market revenue share. The dominance of these market players are attributable to their strong and robust product portfolio and comprises several product types. For example, Pfizer, Inc. is the dominant company due to its prominent product offering of Fragmin (Dalteparin sodium), a LMWH product.

Other important players include Baxter whose market presence is due to their product offering, and also Sanofi-Aventis due to their product offering of Lovenox (Enoxaparin sodium). Some other emerging players include Opocrin S.p.A. and Aspen Holdings, and these companies’ market expansion strategies are anticipated to aid them to increase their market revenue share in the forecast period.

LIST OF KEY COMPANIES PROFILED:

• Opocrin S.p.A. (Formigine, Italy)


• Baxter (Deerfield, U.S.)


• Pfizer Inc. (New York, U.S.)


• Bioiberica S.A.U. (Barcelona, Spain)


• Fresenius SE & Co. KGaA(Bad Homburg, Germany)


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


• B. Braun Melsungen AG (Melsungen, Germany)


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


• LEO Pharma A/S (Ballerup, Denmark)


• Aspen Holdings (Durban, South Africa)

KEY INDUSTRY DEVELOPMENTS:

• 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 FDA Approval of additional manufacturing capacity and future facility expansion plans for production of Heparin Sodium Injection, USP.

REPORT COVERAGE

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The global 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, china market overview, blood clot: stats & facts, 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, 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 over recent years.

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