Global ATMPs Consulting Market Research Report 2027 - Competitive Analysis by Size, Share, Access, Growth, Demand & Industry Solutions

Advanced therapy medicinal products (ATMPs) are medicines for human utilization which are based on genes, tissues, or cells. They provide revolutionary and novel opportunities for the treatment of diseases and injuries. ATMPs primarily target diseases with unfulfilled medical demands. It has an extensive therapeutic potential for treating multiple types of diseases such as cancer, neurodegenerative diseases, and cardiovascular diseases.

Development Complexities and Regulatory Adaptations Drives the ATMPs Consulting Market Growth

The development of ATMPs is a complex manufacturing process resulting from handling living tissues or generating GMOs. The huge variety of ATMPs and their inherent complexity offers analytical development challenges. Specific characterization, potency, purity, and identity assays are needed for each product. Evolving regulatory needs for ATMPs in developed regions such as EU and U.S. and the need to meet demanding regulatory expectations pose various regulatory challenges. There is an elaborate regulatory, non-clinical, clinical, and chemistry, manufacturing, and control (CMC) documentation needed during the development, registration, and lifecycle of ATMPs. To overcome the challenging environment involving ATMPs, pharma, biotech, and CROs are looking for services of ATMP consulting firms.

“Due to many development challenges and regulatory needs involving ATMPs, the demand for specific ATMP consulting services such as CMC consultancy, preclinical and clinical regulatory advice, GMO submissions, support in clinical trial applications to regulatory bodies, and analytical services have grown rapidly in recent years.”-Business Development Director, ATMP Consulting Provider, USA

Emerging Government Support in Developed Regions Propels the Development of ATMPs Consulting Market

In developed regions such as Europe, the European Medicines Agency (EMA) provides a huge range of advisory services and incentives to support the development of ATMPs. The European legislation offers scientific and financial incentives to encourage R&D in the segment of advanced therapies. Developers of ATMPs can obtain reductions in the fees payable to EMA. 

For instance, developers can obtain a 65% fee reduction for a request for scientific advice for ATMPs (90% for SMEs) and a 90% fee reduction for the certification procedure. EMA's Innovation Task Force (ITF) offers a forum for the informal exchange of data and guidance in the development process of ATMPs and their planned regulatory strategies between EMA and developers.

United Kingdom is leading in realizing the potential of advanced therapies. Over the last few years, there have been heavy investments in UK (£3.8bn since 2012) to support ATMP development. The number of ATMP clinical trials in UK grows every year (20% increase in 2020) and approximately 12% of all ongoing global ATMP trials are conducted in UK.

Competitive Landscape Analysis: Global ATMPs Consulting Market

Some of the leading and established players operating in the global ATMPs consulting market are Dark Horse Consulting, PharmaLex, ProPharma Group, QbD Group, Alacrita Life Science Consulting, Voisin Consulting Life Sciences (VCLS), Advanced Cell & Gene Therapy, Kinesys Consulting, Clarkston Consulting, Validant/DataRevive, Asphalion, Putnam.

The global ATMPs consulting market is poised to experience a consistent momentum in the coming years due to a surge in ATMP approvals, moving focus from rare diseases to the development of ATMPs for common diseases, and aggressive growth strategies adopted by the leading market players in the ATMPs consulting market.

Get A FREE Sample Report Copy on ATMPs Consulting Market @ https://meditechinsights.com/advanced-therapy-medicinal-products-atmps-consulting-market/

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