U.S. Heparin Market Size, Share, 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), and By End-user (Hospitals & ASCs, Clinics, and Others), and Country Forecast, 2024-2032

The U.S. heparin market size was worth USD 4.85 billion in 2022 and is projected to grow at a CAGR of 4.7% during the forecast period. 

Heparin is a critical life-saving drug that is often administered in several life-threatening medical conditions or scenarios. Administration of these products is associated with heart-related diseases. Research published by the American Heart Association (AHA) estimated that cardiovascular diseases affect nearly half of American adults.

The rapidly expanding patient population suffering from cardiovascular as well as other chronic diseases in the U.S. plays a pivotal role in the increasing demand for these products. In addition, the country is witnessing a significant increase in the geriatric population, resulting in a higher number of hospital visits that require the administration of such products. Such factors are expected to boost market growth.

According to statistics updated by the Centers for Disease Control and Prevention (CDC) in February 2023, estimates suggest that as many as 900,000 individuals (1 to 2 per 1,000) could be affected by deep vein thrombosis/pulmonary embolism (DVT/PE) annually in the U.S. 33% of the individuals having deep vein thrombosis have long-term complications. The high prevalence of cardiovascular diseases, along with other chronic diseases, has led to an increased demand for these products in the U.S.

Furthermore, the market registered slightly higher growth owing to the COVID-19 pandemic.  This is due to the increased usage of these products as a COVID-19 medication. However, in 2021, as the number of COVID-19 cases reduced, the demand for these products witnessed steady growth and is expected to continue this trend during the forecast period.

LATEST TRENDS

Development of Synthetic Products identified as One of the Significant Market Trends

In the past few years, the U.S. heparin market has witnessed an upsurge in R&D initiatives for the development of synthetic products. Owing to the various advantages of synthetic products, manufacturers are shifting their focus to the manufacturing of this type of product.

• For instance, in 2019, Optimvia invented the first commercially viable biosynthetic heparin with the help of engineered enzymes.

DRIVING FACTORS

Increasing Prevalence of Chronic Diseases to Propel the Demand for These Products

The increasing prevalence of chronic diseases is considered a key driving factor for market growth. The demand for these products is directly proportional to the number of patients suffering from chronic or several life-threatening medical conditions. Thus, the rising prevalence of chronic conditions in the U.S. is among the major factors responsible for the U.S. heparin market growth.

• For instance, as per the data published by American Kidney Fund data, more than 562,000 Americans are on dialysis.

Furthermore, these products are regularly used during dialysis for the prevention of clotting and allow for efficient dialysis. Thus, the increasing number of dialysis patients in the U.S. and the well-established healthcare infrastructure for dialysis management result in high demand for such products in the country.

• Similarly, according to the Center for Technology & Aging, among older American individuals, eight out of ten have the health issues of one or more chronic diseases.

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The number of U.S. individuals aged 50 years and older with at least one chronic condition is expected to reach 142.66 million by 2050, an increase of 99.5% from 71.52 million in 2020.

RESTRAINING FACTORS

Shortage of Porcine Raw Materials to Impede Market Growth

In recent years, U.S. manufacturers have witnessed a shortage of raw materials sourced from animals such as pigs. Several factors, such as the outbreaks of African swine fever (ASF) in China and other key countries, and manufacturing disruptions, such as contamination issues, have led to a risk of an imminent supply shortage of raw materials sourced from animals.

It has been estimated that since August 2018, China has culled more than one million pigs in an effort to contain the containment spread of ASF within the country. Such factors serve as an impediment to the raw material supply, leading to shortages of these products, which lowers its consumption rate in treating various medical conditions. Thus, all these factors cumulatively contribute to limited market growth.

SEGMENTATION

By Product Analysis

Based on product, the market is segmented into unfractionated heparin (UFH) and low molecular weight heparin (LMWH).

In the U.S., the low molecular weight heparin (LMWH) segment captured the dominating market share in 2022. Higher usage of this product by healthcare professionals owing to its advantages has contributed to the segment’s significant share. In addition, the introduction of this product type has allowed the occurrence of unmonitored once-daily subcutaneous injections and the management of numerous patients in outpatient facilities, especially those suffering from VTE. The confluence of these factors supplemented the segment growth.

The unfractionated heparin (UFH) segment is expected to experience a relatively lower CAGR during the forecast period. This anticipation of decreased market share and a comparatively slower growth rate is due to the early forms of this product included in this type. Consequently, the usage of this product type is linked to several adverse reactions, such as severe bleeding and product-induced thrombocytopenia (HIT).

By Source Analysis

Based on source, the market is divided into bovine and porcine.

The porcine segment held the largest U.S. heparin market share. In the country, any other animal-based products, such as those derived from bovine, are not approved. Thus, due to regulatory requirements of the U.S. FDA, only porcine-based products are available in the U.S. Hence, this segment accounted for 100% market share in the U.S.

However, the U.S. FDA has invited bovine-based product manufacturers for discussions relating to the consideration of re-introducing bovine-based products in the country. One of the key rationales in the U.S. FDA’s encouragement with respect to the usage of bovine-based products includes the evidence that bovine-based products have been safely used and are currently available in Brazil and Argentina. Thus, this segment is expected to account for a certain share of the overall market during the forecast period.

By Application Analysis

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

The heart attacks segment held the dominating share of the market in 2022. The dominance of this segment can be attributed to the higher prevalence of heart attacks in the country and the strong usage of these products as a primary treatment. For instance, according to the CDC, every year, an estimated 805,000 individuals in the U.S. suffer from a heart attack.

The atrial fibrillation segment is poised to grow at a notable CAGR during the forecast period. Increasing the patient pool for atrial fibrillation would support segment growth. For instance, as per the CDC data, an estimated number of individuals having atrial fibrillation is expected to be 12.1 million in the U.S. by 2030.

By Route of Administration Analysis

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

The subcutaneous injection segment dominated the market in 2022. The dominance of this segment is due to the higher adoption of subcutaneous injection due to its numerous advantages, such as the possibility of homecare settings administration. Moreover, the easy availability of LMWH as a subcutaneous injection also supports segment growth.

The intravenous infusion segment is anticipated to experience a comparatively lower CAGR during the forecast period. This decline in the segment is attributed to the increasing trend among patients shifting toward subcutaneous injection, which is technologically more advanced. However, intravenous infusion remains actively used for the administration of the unfractionated type (UFH).

By End-user Analysis

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

The hospitals & ASCs segment held the largest market share in 2022 due to the high number of hospital admissions requiring the administration of these products. Additionally, hospitals & ASCs are relied upon for the administration of several types of these products.

• According to the American Hospital Association 2020 data, the total number of hospitals recorded were 6,093 in the U.S. These products can only be prescribed by an accredited healthcare professional situated at these locations, which further contributes to the segment’s dominance. Furthermore, in cases of intravenous infusion, the administration can only be conducted by a trained medical professional.

The others end-user segment is anticipated to witness a strong growth rate during the forecast period. This can be attributed to the increasing usage of low molecular weight products in homecare settings.

KEY INDUSTRY PLAYERS

The U.S. heparin market space represents a moderately fragmented structure, with the presence of both established as well as emerging players offering these products. However, Pfizer Inc. is the most dominant entity in the U.S. market. This is due to its prominent product offering of Fragmin, a low molecular weight product. The company has a strong presence in the U.S. market with the recent U.S. FDA approval for administration to pediatric patients.

Some other noticeable entities operating in the market with a considerable market share include B. Braun SE, Mylan N.V., Baxter, Fresenius SE & Co. KgaA, and Sagent Pharmaceuticals. In addition, Celgene (Bristol-Myers Squibb) has a prominent presence in the U.S. due to the presence of Innohep, a low molecular weight product.

LIST OF KEY COMPANIES PROFILED:

• Pfizer Inc. (U.S.)


• Fresenius SE & Co. KGaA (Germany)


• B. Braun SE (Germany)


• Sagent Pharmaceuticals (U.S.)


• Mylan N.V. (U.S.)


• Baxter (U.S.)


• Amphastar Pharmaceuticals, Inc. (U.S.)


• Scientific Protein Laboratories (U.S.)

KEY INDUSTRY DEVELOPMENTS: 

• March 2023 – The U.S. FDA approved Techdow USA Inc.’s Enoxaparin Sodium in pre-filled syringes for the U.S. market.


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


• November 2020: Fresenius Kabi and Premier Inc. collaborated for the supply of single-use, pre-filled IV bags of heparin sodium injection under the ProvideGx program.

REPORT COVERAGE

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The U.S. heparin market research report provides an in-depth industry analysis. It focuses on market segments such as product, source, application, route of administration, and end-user. Besides this, it offers insights related to the market overview, the impact of COVID-19, and market trends. In addition, the report consists of several factors that contribute to market growth. The report also provides the competitive landscape at the U.S. level.

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