Why do few drug delivery systems to combat neglected tropical diseases reach the market? An analysis from the technology’s stages

Many drugs used to combat schistosomiasis, Chagas disease, and leishmaniasis (SCL) have clinical limitations such as: high toxicity to the liver, kidneys and spleen; reproductive, gastrointestinal, and heart disorders; teratogenicity. In this sense, drug delivery systems (DDSs) have been described in the literature as a viable option for overcoming the limitations of these drugs. An analysis of the level of development (TRL) of patents can help in determine the steps that must be taken for promising technologies to reach the market. This study aimed to analyze the stage of development of DDSs for the treatment of SCL described in patents. In addition, we try to understand the main reasons why many DDSs do not reach the market. In this study, we examined DDSs for drugs indicated by WHO and treatment of SCL, by performing a search for patents. In this present work we provide arguments that support the hypothesis that there is a lack of integration between academia and industry to finance and continue research, especially the development of clinical studies. We cite the translational research consortia as the potential alternative for developing DDSs to combat NTDs.

目前用于对抗血吸虫病（schistosomiasis）、恰加斯病（Chagas disease）与利什曼病（leishmaniasis，以下简称SCL）的多款药物存在诸多临床局限性，具体包括：对肝、肾、脾具有较高毒性；可引发生殖系统、胃肠道及心脏功能紊乱；且具有致畸性。在此背景下，药物递送系统（Drug Delivery Systems，DDSs）被相关文献报道为克服上述药物局限性的可行方案。对专利的技术就绪水平（Technology Readiness Level，TRL）进行分析，有助于明确具备商业化潜力的技术推向市场所需完成的全部步骤。本研究旨在分析专利文献中记载的、用于治疗SCL的DDSs的研发阶段。此外，本研究试图阐明多数药物递送系统未能实现市场化的核心原因。本研究通过专利检索，针对世界卫生组织（World Health Organization，WHO）推荐用于治疗SCL的药物所对应的DDSs展开调研。本研究提出相关论据以支撑下述假说：学界与业界在科研融资及后续研发（尤其是临床研究开发）方面存在协同整合不足的问题。本研究提出转化研究联盟（translational research consortia）可作为开发用于对抗被忽视热带病（Neglected Tropical Diseases，NTDs）的DDSs的潜在可行路径。