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.
Highlights
Based on Directive 2001/83/EC, medicinal products in Europe have been defined as any substance or combination of substances that have the capability to treat or prevent diseases in humans or may be used with the purpose to restore, correct, or modify physiological functions in conjunction with the capability to be used for medical diagnosis in humans
The year 2007 witnessed an increase in the number of approved tissue engineered product (TEP) products; in the years this amount decreased and this field has not experienced any evident growth trend, which can be seen in two other products (Figure 3B)
Gene Therapy Medicinal Product (GTMP) have faced an obvious progressive trend regarding the number of approved products and this is clearly apparent from the growth in the trend of these products, which may be due to entrance of big pharma in this field to develop a treatment for refractory conditions or rare diseases which do not have an effective pharmaceutical drug
Summary
Based on Directive 2001/83/EC, medicinal products in Europe have been defined as any substance or combination of substances that have the capability to treat or prevent diseases in humans or may be used with the purpose to restore, correct, or modify physiological functions in conjunction with the capability to be used for medical diagnosis in humans. TEPs are engineered cells or tissues that have the properties of regenerating, repairing, or replacing human tissue, all in accordance with the medicinal products general definition and cATMPs comprise another type of these products and contain one or several medical devices that are an integral part of the GTMPs, SCTMPs, or TEPs (Hanna et al, 2016a; Detela and Lodge, 2019). Included is a definition of the available market sizes and sale reports for the related products in an attempt to clarify the commercial point of view for each of the GTMPs, SCTMPs, and TEPs fields To achieving this end, published articles regarding the characteristics, safety and efficacy, and market size of approved ATMPs were reviewed using the search engines PubMed, Scopus, and Google Scholar. Minimum of 50 million activated CD54 + cells, suspended in 250 mL of Lactated Ringer’s solution
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