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一篇用于分析筛选纳米医学市场可行性的阐释性综述。

An Elucidative Review to Analytically Sieve the Viability of Nanomedicine Market.

作者信息

Kad Anaida, Pundir Archit, Arya Shailendra Kumar, Bhardwaj Neha, Khatri Madhu

机构信息

Department of Biotechnology, University Institute of Engineering and Technology, Panjab University, Sector-25, Chandigarh, 160014 India.

Wellcome Trust/DBT IA Early Career Fellow, Panjab University, Chandigarh, 160014 India.

出版信息

J Pharm Innov. 2022;17(1):249-265. doi: 10.1007/s12247-020-09495-5. Epub 2020 Sep 21.

Abstract

The advent of the twenty-first century marked a paradigm shift in the healthcare sector with coming of automated, sensitive, targeted medicines and technologies having diagnostic, prophylactic and therapeutic effects. Nanomedicines also attained wide acclamation in their initial years, but the transformation from being the proof of concept to successfully marketed products seems very daunting. Although the reason for this may be attributed to slow but incremental character of many present-day technologies, the review asserts that there are other significant facets that may purvey a thorough explanation of this scenario. The article elaborately discusses the hurdles hindering clinical translation of nanomedicines including scale-up challenges, in vitro in vivo cascade of toxicology assays, along with unrefined manufacturing guidelines, inadequate regulatory approvals, competitive conventional market, etc., leading to hesitant investments by pharmaceutical giants. The paper also explores the economic viability of nanobiotechnology sector through an empirical investigation of the revenue data of various pharmaceutical industries manufacturing nano-based drugs, which indicates minor commercial importance of these medicines. We also laid down a comprehensive set of recommendations to smoothen the translational pathway of nanomedicines from an idea to reality, efface the consumer distrust and push boundaries for development and launching of safe, efficient and commercially successful products. Graphical abstract.

摘要

二十一世纪的到来标志着医疗保健领域的范式转变,自动化、灵敏、靶向性药物以及具有诊断、预防和治疗作用的技术纷纷问世。纳米药物在其最初几年也广受赞誉,但从概念验证到成功上市产品的转变似乎非常艰巨。尽管造成这种情况的原因可能归因于许多当今技术缓慢但渐进的特性,但该综述断言,还有其他重要方面可能对此情况做出全面解释。本文详细讨论了阻碍纳米药物临床转化的障碍,包括扩大规模的挑战、体外到体内的毒理学检测级联,以及制造指南不完善、监管批准不足、传统市场竞争激烈等,导致制药巨头投资犹豫不决。本文还通过对生产纳米药物的各制药行业收入数据的实证调查,探讨了纳米生物技术领域的经济可行性,这表明这些药物的商业重要性较小。我们还提出了一套全面的建议,以简化纳米药物从想法到现实的转化途径,消除消费者的不信任,并为安全、高效和商业上成功的产品的开发和推出拓展边界。图形摘要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/90ac/7502307/6fe6124f13fa/12247_2020_9495_Figa_HTML.jpg

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