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.

用于对抗血吸虫病、恰加斯病及利什曼病（Schistosomiasis, Chagas disease, and leishmaniasis，以下简称SCL）的多款药物，均存在诸多临床局限性：对肝、肾、脾脏具有高毒性；可引发生殖系统、胃肠道及心脏功能紊乱；具有致畸性。有文献表明，药物递送系统（Drug Delivery Systems，DDS）可作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，有助于明确具备应用前景的技术实现商业化落地所需完成的研发步骤。本研究旨在对专利文献中记载的、用于SCL治疗的药物递送系统的研发阶段进行分析。此外，本研究尝试剖析诸多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）推荐的、用于SCL治疗的药物对应的药物递送系统展开了调研。本研究提出论据，以佐证如下假说：学界与产业界之间缺乏协同整合，难以共同为研发（尤其是临床研究开发）提供资金并推进相关工作。本研究提出，转化研究联盟可作为开发用于对抗被忽视热带病（Neglected Tropical Diseases，NTD）的药物递送系统的潜在可行路径。