Advanced therapy medical products (ATMPs) are human medications based on genes, tissues, or cells. They provide groundbreaking new therapeutic options for ailments and injuries. ATMPs primarily target illnesses with significant unmet medical needs. It offers a wide range of therapeutic possibilities for treating disorders such as cancer, neurological diseases, and cardiovascular disease.

Global ATMPs Consulting Market is Fueled by Development Complexities and Regulatory Adaptations
ATMP development is a sophisticated industrial process that involves the manipulation of live tissues or the creation of GMOs. Because of the great diversity of ATMPs and their intrinsic complexity, analytical development presents a number of obstacles. Each product requires its own characterisation, potency, purity, and identification tests. Evolving regulatory requirements for ATMPs in important areas such as the EU and the United States, as well as the need to fulfill more stringent regulatory standards, provide substantial regulatory challenges. During the development, registration, and lifespan of ATMPs, extensive regulatory, non-clinical, clinical, clinical, and chemistry, manufacturing, and control (CMC) documentation is necessary. To navigate the tough ATMP environment, pharma, biotech, and CROs are increasingly turning to ATMP consulting firms.

“……Due to 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.

Government support in key markets propels growth in the Global ATMPs Consulting Market
The European Medicines Agency (EMA) provides a variety of advisory services (scientific advice and protocol help) and incentives to encourage ATMP development in major markets such as Europe. The European legislation includes scientific and financial incentives to support research and development in the field of advanced medicines. ATMP developers may be eligible for fee reductions from EMA. For example, developers can receive a charge reduction of 65% for requesting scientific assistance for ATMPs (90% for SMEs) and a fee reduction of 90% for the certification procedure. The EMA's Innovation Task Force (ITF) serves as a venue for the informal exchange of information and recommendations between EMA and developers during the development phase of ATMPs and their planned regulatory strategies.

The United Kingdom has been at the forefront in realizing the possibilities of modern therapeutics. Significant investments have been made in the UK to promote ATMP development throughout the years (£3.8 billion since 2012). The number of ATMP clinical studies in the UK is increasing year by year (20% increase by 2020), and the UK is home to about 12% of all active global ATMP trials.

Analysis of the Global ATMPs Consulting Market's Competitive Landscape
Some of the Major players operating in the Global ATMPs Consulting market include 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, among others.
Organic and inorganic growth strategies used by firms to get a Global ATMPs Consulting market foothold
To get a larger ATMPs Consulting market share, players in this market are implementing organic and inorganic development methods such as offering new services, acquiring similar businesses, and going into mergers and partnerships.

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 ATMPs Consulting Market is likely to gain more traction in the future years as the number of ATMP approvals increases, the focus shifts from rare illnesses to the development of ATMPs for more prevalent diseases, and companies pursue aggressive organic and inorganic expansion strategies.

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