Belgium was the first European country to launch an Advanced Therapy Medicinal Product (ATMP) on the market in 2009. Over the past twenty years, Belgium has been one of the leading players – in Europe and world-wide – when it comes to ATMP expertise and intensity per capita. essenscia publishes a Technology Watch report on the ATMPs landscape by a review of the patent activity (18 000 patent families).
Advanced Therapy Medicinal Products (ATMPs) are a class of innovative medical products (Gene Therapy, Cell Therapy, and Tissue Engineering) designed to treat, prevent or diagnose diseases by intervening in the body’s cellular and genetic makeup. ATMPs represent a new era in medicine, offering cutting-edge approaches to address unmet medical needs.
Cell & Gene Therapies (CGTs) are on the rise & have known a steady increase the past few years. By the end of 2019, over 75 ATMPs had been launched worldwide, including singular markets such as Japan, Russia and South-Korea. EMA expects the submission or approval of 10 to 20 ATMPs per year during the next 5 years. In Belgium, Research & Development in ATMP is booming, both in Flanders and in Wallonia. Belgium has established itself on the map as a true “Biotech and Health Valley” thanks to its tradition of scientific and industrial excellence and the strength of its ecosystem, which brings together leading players in every stage of the innovation chain.
ATMP key players
Key players in the development and delivery of ATMPs appear to be academic/research centres & small and medium-sized enterprises, whereas large pharmaceutical companies seem to focus primarily on oncologic diseases using modified cytotoxic T-cells and chimeric antigen receptor (CAR) T-cells .
The unmet need for CGTs in Europe seems huge. The estimated patient population for just four indications (SMA, beta-thalassemia, diffuse large B-cell lymphoma & retinitis pigmentosa) addressed by CGTs today is 385,000, roughly three times as large as the equivalent US cohort.
Europe is publishing most of the scientific papers on CGTs, yet struggles to translate such strength in research into market leadership. Between 2005 and 2018, Europe accounted for 16% of total CGT product registrations. The remaining 28% and 56% came from the United States and China, respectively. Looking at developers per headquarter region & per therapeutic approach, we see that the US takes the lead with 1,105 developers followed by Asia Pacific and Europe with 846 and 506 developers respectively.
ATMP Patent Activity
To get an idea of the patent activity in the field of ATMPs, the report looked at the number of first patent publications per year. Looking back in time, the first patent publications on ATMPs were around 1990 (~20). In 1995 this number had increased to ~200 & in 2000 we see ~300 first patent publications. In the period from 2003 till 2019 we have more or less a steady state, with the number of first patent publications per year fluctuating between ~350 and ~500. On average, the ATMP patent activity has tripled in the last decade.
In the top 10 of key players world-wide, we have the US taking a truly dominant position (47%), followed by Europe (26%), Japan (4%), Korea (4%), China (4%). Belgium takes position 15 in the international ranking, which is very good seen the small size of the country. By plotting the filing activity per country over the years, we see that Europe (as a whole) is less explosive qua filing activity in the past 3 years (compared to the US and Asia) but not for individual countries like the UK, France, Germany, Swiss and Belgium. In Europe, the filing activity is more constant over the years. Less venture capital could be at the basis of this performance gap in Europe as a whole.
Read the full Report and find an overview of Belgian companies working on ATMPS (link naar Annex IV)
