Biotherapeutics, or biopharmaceuticals, are defined by their mode of production: a biotherapy is produced by a cell or a microorganism, it is bioproduced. As a result, the challenges of production, safety and analysis of biopharmaceuticals are totally different from those of chemically synthesized small molecules.
The emergence of different types of biotherapies has necessitated the introduction of new regulatory frameworks, as well as the creation of an industry sector of its own. In this highly innovative ecosystem, the classification of biologics is constantly evolving: at present, they are divided into four main categories, presented below.
The biopharmaceuticals biotherapeutics
Antibodies & Therapeutic proteins
They include all forms of protein: antibodies, recombinant proteins, peptides, etc.
They can be prophylactic or therapeutic. All types of vaccine (DNA, mRNA, inactivated, oncolytic, etc.) fall into this category.
270 products marketed, including 156 mAbs
6285 products in R&D
361 products on the market, including 19 therapeutic vaccines
3490 products in R&D, including 1079 therapeutic vaccines
4 products on the market
459 products in R&D
These therapies are used in the fight against infectious diseases, in combination with other biotherapeutics against cancer, or to treat autoimmune and inflammatory diseases.
63 products in the market
6303 products in R&D
Advanced therapy medicinal products (ATMPs)
They have emerged more recently than the therapeutic proteins. Cell & gene therapies (e.g. CAR-T cells) and tissue regeneration technology are all part of the ATMPs category.
The latest innovations
Some biotherapies don’t fit into the above three categories, but the therapeutic hope they represent is very strong: for example, microbiota therapy, such as antibacterial phage therapy.
A new market, new challenges
Compared to small chemical molecules, biopharmaceuticals are a relatively recent class of molecules: in 2022, they accounted for just 4% of marketed drugs.
However, the market for biologics is growing rapidly, and is expected to reach $600 billion by 2026. This trend is illustrated by a 64% increase in the number of biopharmaceuticals under development worldwide between 2019 and 2022. In 2023, the biotherapeutics account for 59% of products under development.
Biologics have opened up new prospects, representing a market of the future and a hope for the treatment of many diseases.
of molecules under development worldwide are biopharmaceuticals
22 099 products
Despite the small number of molecules on the market, biopharmaceuticals account for 32% of drug sales: this high proportion in terms of sales is explained by higher sales prices than for small molecules.
With the coming boom in biopharmaceuticals to treat an ever-increasing number of pathologies, these costs will be unsustainable for healthcare systems. The need to reduce development and production costs for biologics makes biomanufacturing a major priority for the sector.
The French industry
As an association of the French biopharmaceutical industry, MabDesign aims to support, federate and increase the visibility of the biopharmaceutical industry, foster exchanges, promote the development and competitiveness of companies, and stimulate innovation by encouraging the emergence of start-ups from academic research. We list the stakeholders, companies and people in the sector as exhaustively and accurately as possible.
The French biotherapy ecosystem is a rich and innovative one, with over a thousand structures, from research institutions to biotech companies. The industry’s stakeholders are distributed across the whole country, with two key regions for historical reasons: Île-de-France and Auvergne-Rhône-Alpes.
The industry’s main goal is to meet future needs in an innovative, fast-growing sector that is constantly evolving.
1035 structures in France
Scroll over the regions to see the distribution of stakeholders (%)
In 2023, the French industry counts 240 biotechs/pharma, developing biologics. These companies are supported by 668 enterprises offering a full range of services: suppliers, bioanalysis, CRO, CDMO, etc.
The French biologics pipeline is rich, with over 840 products in development, 29% of which are currently in clinical phase. In terms of product types, French biotechs are developing products across the entire spectrum of biotherapeutics, with antibodies and MTIs leading the way.
France's biopharmaceuticals pipeline: 847 projects and 540 unique products in development
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