The global serum gonadotrophin API market size was estimated at US$ 131 million in 2024, projected to increase to US$ 137.1 million in 2025 and reach US$ 202.93 million by 2034, showing a healthy CAGR of 4.64% across the forecast years.
Regulatory Approvals: Regulatory approval for serum gonadotrophin APIs varies by region but typically requires compliance with Good Manufacturing Practices (GMP). Manufacturers must submit a Drug Master File (DMF) to authorities such as the U.S. FDA or CDSCO of India, and may also need a Certificate of Suitability (CEP) for the European market. These approvals ensure product quality, safety, and consistency, enabling the API to be legally manufactured, distributed, and used in therapeutic applications across different markets.
Patient Support and Services: Serum gonadotrophin APIs themselves do not offer direct patient support, as they are raw materials used by drug manufacturers. Patient assistance is instead provided by pharmaceutical companies that formulate and supply finished gonadotropin medications, ensuring access, guidance, and support for individuals undergoing fertility or related treatments.
In May 2024, Serum Institute of India (SII) announced a strategic investment in IntegriMedical by acquiring a 20% stake to advance Needle-Free Injection System (N-FIS) technology. The collaboration aims to improve patient comfort, reduce needle-stick injuries, enhance compliance, and increase the effectiveness of liquid medications. SII CEO Adar Poonawalla stated that this investment aligns with the mission of SII to make healthcare accessible and could revolutionize vaccine delivery, offering a more comfortable experience for patients and healthcare providers.
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