Heparin Market Trends

Growth Drivers

• Rising prevalence of cardiovascular diseases: The growing burden of cardiovascular diseases, such as coronary artery disease, atrial fibrillation, and pulmonary embolism, is the fundamental growth driver for the heparin market. In this context World Health Organization in July 2025 reported that cardiovascular diseases are the leading cause of death and are responsible for nearly 19.8 million deaths in 2022, with heart attacks and strokes accounting for 85% of these cases. The report also mentioned that the majority of CVD deaths occur in low- and middle-income countries, where there is limited access to early detection, preventive care, and treatment, exacerbating health and economic burdens. In addition, the risk factors include unhealthy lifestyles, underlying conditions such as hypertension and diabetes, highlighting the need for prevention, early intervention, and equitable healthcare access.
• Adoption of advanced heparin formulations: Expansion in the use of low molecular weight heparins, which offer better safety profiles, predictable pharmacokinetics, and simpler dosing when compared to traditional unfractionated heparin, is increasing heparin market uptake. Innovations such as next‑generation heparin formulations and novel delivery systems improve therapeutic outcomes and broaden clinical applications. In June 2024, ROVI reported that it had completed the expansion of its Escúzar plant in Spain by adding a new sodium heparin production line with a capacity of 1,200,000 MIU, essential for producing low-molecular-weight heparins. This development strengthens ROVI’s vertical integration strategy for LMWHs, a product considered essential by the European Union and a strategic segment for the company. In addition, the expansion also enhances production autonomy, supports broader clinical use of advanced heparin formulations.
• Regulatory support & drug approvals: Regulatory approvals for the newest heparin-based formulations and supportive policies help to enhance the product portfolio and facilitate heparin market progression over the forecasted years. In May 2024, the U.S. FDA announced clearance of Medtronic’s modified MVR venous reservoir bags, which include versions with the Cortiva BioActive Surface, for use in cardiopulmonary bypass surgery. It also mentioned that these devices consist of blood-contacting surfaces that are coated with nonleaching heparin, derived from porcine intestinal mucosa, thereby enhancing thromboresistance and blood compatibility. Furthermore, the U.S. FDA confirmed that the material and design changes, including a one-way stopcock update, maintain substantial equivalence to predicate devices providing safe and effective use during cardiac procedures, contributing to the heparin market expansion.

Challenges

• Supply chain dependence on animal-derived sources: The major challenge in the heparin market is the reliance on animal-derived sources such as porcine intestinal mucosa. Mostly worldwide, heparin is sourced from pigs, especially in China, which in turn creates vulnerability to supply disruptions owing to disease outbreaks, geopolitical tensions, or trade restrictions. On the other hand, Zoonotic diseases such as the African swine fever can reduce pig populations, leading to fluctuations in heparin availability and price volatility in this field. Meanwhile, the aspect of ethical and environmental concerns regarding large-scale animal farming is rising. In this context, companies face pressure to ensure a stable supply for global demand and explore sustainable alternatives, such as bioengineered or microbial heparin, wherein these solutions require R&D investment and regulatory approval, ultimately slowing adoption.
• Regulatory and quality compliance: Heparin is a critical anticoagulant, so regulatory scrutiny is intense across markets in almost all nations. Administrative bodies such as the FDA, EMA, and PMDA require stringent quality control, batch-to-batch consistency, and contamination-free production, especially after the 2008 heparin adulteration crisis. Therefore, ensuring compliance is costly and time-consuming, particularly for manufacturers who are involved in export activities on an international scale. Small variations in molecular structure can affect efficacy and safety, making analytical testing and process validation highly essential. These regulatory hurdles can also delay product launches, limit market expansion, and increase operational costs. Therefore, companies must make investments in modern manufacturing technologies, robust traceability systems, and compliance certifications, which can be challenging for smaller or emerging players in the heparin market.