随着医学影像检查需求提升、CT设备普及率提高及增强影像检查渗透率增长，造影剂及其上游原料药市场的重要性持续凸显。弗若斯特沙利文发布《造影剂原料药行业研究报告》，围绕原料药、造影剂、碘造影剂及碘造影剂原料药市场开展系统研究。
造影剂原料药具有较高的工艺、质量控制及注册准入壁垒，较中间体环节更强调工艺稳定性、杂质控制、质量体系和供应保障能力。随着下游制剂放量及集采后价格体系逐步稳定，行业正迈向更加规范和高质量的发展阶段。
宇田医药作为中国碘造影剂原料药市场的重要参与者之一，2025年位居国产碘造影剂原料药厂商第二，在碘克沙醇、碘佛醇等细分品种中具备代表性市场表现。展望未来，造影剂原料药市场将在规模扩张与结构升级的双重驱动下持续向好。随着国内厂商技术能力持续提升，国产替代进程有望进一步加速，行业将逐步从价格竞争向价值竞争转型。
Driven by rising demand for medical imaging, increasing CT equipment penetration and growing adoption of contrast-enhanced imaging examinations, the importance of contrast agents and their upstream APIs continue to increase. Frost & Sullivan released the “Contrast Agent Active Pharmaceutical Ingredient Market Research Report”, which provides a systematic study of the API, contrast agent, iodinated contrast agent and iodinated contrast agent API markets.
Contrast agent APIs have high barriers in production process, quality control and regulatory registration. Compared with intermediates, API production places greater emphasis on process stability, impurity control, quality systems and supply reliability. With downstream formulation volume growth and the gradual stabilization of the post-procurement pricing system, the industry is moving toward a more standardized and high-quality stage of development.
As an important participant in China’s iodinated contrast agent API market, Yutian Pharmaceutical Co., Ltd. ranked second among domestic iodinated contrast agent API manufacturers in 2025 and demonstrated representative market performance in selected products such as iodixanol and ioversol. Looking ahead, the contrast agent API market is expected to maintain a positive growth trajectory, driven by both market expansion and structural upgrading. As domestic manufacturers continue to strengthen their technological capabilities, the process of domestic substitution is expected to further accelerate, and the industry will gradually shift from price-based competition to value-based competition.
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沙利文 毛先生
