Two Decades of Global Progress in Authorized Advanced Therapy Medicinal Products: An Emerging Revolution in Therapeutic Strategies

Abstract

The introduction of advanced therapy medicinal products (ATMPs) to the global pharma market has been revolutionizing the pharmaceutical industry and has opened new routes for treating various types of cancers and incurable diseases. In the past two decades, a noticeable part of clinical practices has been devoting progressively to these products. The first step to develop such an ATMP product is to be familiar with other approved products to obtain a general view about this industry trend. The present paper depicts an overall perspective of approved ATMPs in different countries, while reflecting the degree of their success in a clinical point of view and highlighting their main safety issues and also related market size as a whole. In this regard, published articles regarding safety, efficacy, and market size of approved ATMPs were reviewed using the search engines PubMed, Scopus, and Google Scholar. For some products which the related papers were not available, data on the relevant company website were referenced. In this descriptive study, we have introduced and classified approved cell, gene, and tissue engineering-based products by different regulatory agencies, along with their characteristics, manufacturer, indication, approval date, related regulatory agency, dosage, product description, price and published data about their safety and efficacy. In addition, to gain insights about the commercial situation of each product, we have gathered accessible sale reports and market size information that pertain to some of these products.

Comparing the Therapeutic Potential of Stem Cells and their Secretory Products in Regenerative Medicine

“…Stem Cell Clinical Trials. Thus far, many clinical trials using MSCs have been completed, and some of the therapies, e.g., Cupistem®, Queencell®, Cartistem®, Cellgram®, Neurorata-R®, Prochymal®, Stempeucel®, and MesestroCell, have received market authorization in Korea, Canada, India, and Iran [139]. A list of worldwide clinical studies using stem cells in different phases can be found in National Institutes of 2).…”

Retrospective Evaluation of Progenitor Biological Bandage Use: A Complementary and Safe Therapeutic Management Option for Prevention of Hypertrophic Scarring in Pediatric Burn Care

“…Therein, many bioengineered solutions have been proposed (e.g., Allox ® , Epicel ® , OrCel ® , ReCell ® , Apligraf ® , TransCyte™, Lyphoderm ® ) for burn wounds, with the objective of combining traditional surgical management with novel regenerative solutions, to optimally stimulate resurgence of normal tissue structure and function [40][41][42][43][44][45]. Despite high interest and considerable development efforts, commercialization rates of such complex biological products remain relatively low [46][47][48].…”

Evolution of Diploid Progenitor Lung Cell Applications: From Optimized Biotechnological Substrates to Potential Active Pharmaceutical Ingredients in Respiratory Tract Regenerative Medicine

“…Therefore, similar to other domains of regenerative medicine, the origin and processing of the considered therapeutic cellular materials are often limiting factors in the effective development of novel therapies or products, mainly due to safety, consistency, sustainability, or manufacturing cost issues [93][94][95][96][97][98][99]. Adequately isolated lung tissue-derived progenitors (e.g., FE002-Lu cell types) constitute prime developmental candidates Appropriate cell-based product formulations are considered for local delivery in view of obtaining potential anti-inflammatory or tissue modulation effects during recovery.…”