Bivalirudin and Desmopressin Market Trends

Growth Drivers

• Advancements in research and market impact: NIH allocated $58 million in research grants in 2023 to advance research in hemostatic control and antithrombotic therapies based on desmopressin and bivalirudin. Currently, 42 clinical trials have been completed by assessing these agents in unique populations, such as pediatric bleeding disorders, CKD, or high-risk PCI patients. These trials aid in developing new clinical pathways and expanding new labeled indications, fostering adoption of new treatments in higher-income and middle-income markets, and increasing confidence among payers and providers.
• Rising patient volume with hematologic conditions: Nearly 7.6 million PCI procedures were performed in North America and Europe, and bivalirudin is used in almost 29% to 33% of cases. Similarly, hemophilia A and von Willebrand disease are affected in both regions, with patients recorded to 250,010, with desmopressin being the initial stage in treatment in both mild and moderate cases. Further, Europe has also witnessed a 19.4% rise in diagnosed bleeding cases over the past ten years, fueled by enhanced screening in France and Germany. As the elderly population expands continuously, having chronic cardiovascular and kidney diseases is demanding for both drugs.
• Supply chain and trade dynamics: The U.S. has imported nearly USD 3.2 billion of pharmaceutical raw materials in 2022, with synthetic peptides such as desmopressin and bivalirudin having significant volume. India and China are the major suppliers of API, holding 60.3% to 70.5% of the bulk peptide exports. Europe relies completely on non-EU suppliers and is surging the regulatory calls for regional API production, mainly after COVID. Moreover, the rising energy cost and freight have spurred the assembly line burden on U.S. and EU-based formulation plants. In order to ensure long-term market stability, diversification of API sources and nearshoring of peptide synthesis capacity are now crucial requirements.

Challenges

• Export barriers and supply chain disruptions: India temporarily avoided API export mainly in desmopressin to secure local supply during the COVID-19 pandemic. This impacted global supply chains mainly in low- and middle-income nations, which as entirely dependent on exports in India. The World Health Organization indicated 24 countries continue to have intermittent availability of bivalirudin and desmopressin in 2024, owing to persistent raw material unavailability and insufficient manufacturing redundancy. These changes have caused delayed treatments and procurement backlogs in many national health systems, evidence of the susceptibility of global therapeutic supply chains to export controls and production concentration.
• Pricing pressures limiting profits for manufacturers: In France and Germany, national health agencies impose price caps that heavily limit revenue margins. For instance, according to Germany's AMNOG system, Teva was subject to a 15.3% price cut on generic bivalirudin in 2023, slowing their commercial launch. Manufacturers tend to find it difficult to achieve ROI levels with capped reimbursement rates. HAS (France) states that only those medicines that are considered "high medical benefit" receive favorable price treatment. This system compels firms to either focus on innovative formulations or collaborate with local distributors to avoid regulatory and pricing pressures.