Global Advanced Therapy Medicinal Products (ATMPs) Consulting Market Size, Share, Access, Growth, Demand & Competitive Analysis by 2027 - Kinesys, Clarkston, Alacrita, Dark Horse

Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues, or cells. They offer revolutionary and novel opportunities for the treatment of diseases and injuries. ATMPs mainly target diseases with high unmet medical needs. It has extensive therapeutic potential for treating various types of diseases such as cancer, neurodegenerative diseases, and cardiovascular diseases.

Development Complexities and Regulatory Adaptations Triggers the ATMPs Consulting Market Growth

The development of ATMPs is a complex manufacturing process resulting from handling living tissues or generating GMOs. The wide variety of ATMPs and their inherent complexity present different analytical development challenges. Specific characterization, potency, purity, and identity assays are required for each product. Evolving regulatory requirements for ATMPs in key markets such as the EU and U.S. and the need to meet increasingly demanding regulatory expectations pose significant regulatory hurdles. There is elaborate regulatory, non-clinical, clinical, clinical, and chemistry, manufacturing, and control (CMC) documentation required during the development, registration, and lifecycle of ATMPs. To overcome the challenging environment involving ATMPs, pharma, biotech, and CROs are increasingly seeking services of ATMP consulting companies.

"Due to various development challenges and regulatory requirements 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 manifolds in recent years."-Business Development Director, ATMP Consulting Provider, U.S.A
 
Favourable Government Support in Key Markets Drives the Development of Advanced Therapy Medicinal Products Consulting Market

In key markets such as Europe, the European Medicines Agency (EMA) offers a wide range of advisory services (scientific advice and protocol assistance) and incentives to support the development of ATMPs. The European legislation provides scientific and financial incentives to encourage R&D in the area of advanced therapies. Developers of ATMPs can obtain reductions in the fees payable to EMA.

For instance, developers can get 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) provides a forum for the informal exchange of information and guidance in the development process of ATMPs and their planned regulatory strategies between EMA and developers.

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

Competitive Landscape Analysis: ATMPs Consulting Market

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

Organic and Inorganic Growth Strategies Adopted by the Key Market Players to Establish Their Foothold in the Global ATMPs Consulting Market

All key players operating in the global ATMPs consulting market are adopting both organic and inorganic growth strategies such as launching new services, acquiring related firms, and entering into mergers & collaborations to garner a higher market share.

For instance,

In May 2023, The QbD Group acquired Michor Consulting to enhance its regulatory affairs services (including advice and support for ATMPs) across Europe.

In January 2022, PharmaLex Group announced its merger with MAP Group to expand its reach in Italian market and broaden its market access expertise. MAP Group is Italy's leading provider of market access services and specializes in highly innovative products, including advanced therapeutic medicinal products (ATMPs) being developed for rare diseases and oncology.

The global ATMPs consulting market is expected to gain a further momentum in the upcoming years due to an expected rise in ATMP approvals, shifting focus from rare diseases to the development of ATMPs for more common diseases, and aggressive organic and inorganic growth strategies followed by the key market players in the worldwide advanced therapy medicinal products consulting market.

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Ruta Halde
Associate, Medi-Tech Insights
+32 498 86 80 79
info@meditechinsights.com
https://meditechinsights.com/

Medi-Tech Insights is a healthcare-focused business research & insights firm. Our clients include Fortune 500 companies, blue-chip investors & hyper-growth start-ups. We have completed 100+ projects in Digital Health, Healthcare IT, Medical Technology, Medical Devices & Pharma Services.

This release was published on openPR.