The Europe cell and gene therapy market was valued at USD 2.17 billion in 2022, is projected to cross USD 15.15 billion by 2028, and is growing at a CAGR of 38.20%. Investing in R&D activities to develop novel therapies is key for the long-term sustainability of companies operating in the Europe cell and gene therapy market. Therefore, many players, including key and emerging companies and smaller vendors, are investing in significant R&D activities. Moreover, the major players focus on strategic acquisitions, licensing, and collaboration agreements with emerging players to enter the cell and gene therapy market and gain access to commercially launched products.
In recent years, the Europe cell and gene therapy market has seen both approvals and withdrawals of cell and gene therapies. Most withdrawals seem to be due to a lack of commercial viability for the manufacturers rather than safety concerns. Further, drug developers are prioritizing developing and commercializing CAR-T cell-based gene therapies. Globally, more than 1,000 clinical trials are being conducted on CAR T-cell therapies, of which at least 500 clinical trials are for cancer alone. Kymriah (Novartis), Yescarta (Gilead Sciences), Tecartus (Gilead Sciences), Breyanzi (Bristol Myers Squibb), Abecma (Bristol Myers Squibb), and Carvykti (Janssen Biotech / Legend Biotech) are the commercial CAR-T therapies available in the market.
The European Medicines Agency (EMA) has approved over nineteen cell and gene therapy drugs. Still, the new product pipeline has approximately 193 investigational therapies, with more than half of these in Phase 2 clinical trials. Oncology and rare diseases remain the top areas targeted by gene therapies from preclinical through pre-registration. Also, approximately 1,564 clinical trials are under investigation for various cell and gene therapies in Europe. This increase could be because of increased funding for cell and gene therapy. The industry-sponsored trials continue to dominate with a share of 78.71%.
MARKET TRENDS & DRIVERS
Robust Cell & Gene Therapy Pipeline
Vendors are conducting clinical trials to gain regulatory approval in countries and regions with huge untapped potential. The Europe cell and gene therapy market vendors are actively conducting clinical studies to gain regulatory approval and extend their presence in these major markets for cell & gene therapy products. European market provides the required facilities for cell & gene therapy product development, so major vendors are entering the European market.
Increase in Strategic Acquisitions
Many vendors are planning to tap the potential of the Europe cell and gene therapy market by developing and commercializing innovative products. This increasing list of potential investigational cell & gene therapy products encourages many companies to make acquisitions an important strategy to penetrate the market further.
Regulatory Support for Cell & Gene Therapies
The European Medicines Agency (EMA) is the centralized regulatory body of the EU. Within the EMA, The Committee for Advanced Therapies (CAT) provides an expert opinion on products and recommends approval or rejection. To protect vendors from competition, they provide orphan designation to the product, as a limited number of patients undergo treatments.
SEGMENTATION INSIGHTS
- The Europe cell and gene therapy market by product type is classified into cell and gene therapy. In 2022, the gene therapy segment accounted for the most significant. Cell and gene therapy is one of the revolutionary medicines in recent times, providing promising results in various cancer treatments for rare genetic disorders in patients. Furthermore, the number of clinical trials investigating gene therapies is increasing in Europe despite the limited number of products that have successfully reached the industry.
- The hospital end-user segment accounted for the most prominent share of the Europe cell and gene therapy market in 2022. Hospitals being the first point of care for any disease condition, and cell and gene therapies demanding advanced equipment and skilled professionals available in hospitals prompts most patients to prefer hospitals to other clinics or centers.
- The European cell and gene therapy industry by application type is classified into oncology, genetic disorders, dermatology, musculoskeletal, and others. In 2022, the oncology segment dominated the segmental share of the European industry.
REGIONAL ANALYSIS
Germany was the first-largest cell and gene therapy market among EU5, followed by France and the UK in 2022. The growth of the Europe cell and gene therapy market can be attributed to the rising target patient population, regulatory body support, and higher access to healthcare due to well-established healthcare infrastructure. Furthermore, Italy and Germany are introducing innovative payment methods for expensive cell & gene therapy products, thus motivating patients to opt for advanced medical products such as cell therapy and gene therapy. In addition to sophisticated healthcare infrastructure, healthcare spending in Europe is high, favoring the industry growth during the forecast period.
VENDOR LANDSCAPE
The competitive market in the Europe cell and gene therapy market is intensifying, with players offering a diverse range of products. A few major players dominate the market in terms of market share. Some companies currently dominating the industry are Novartis, Gilead Sciences, Spark Therapeutics (Roche), Amgen, and Orchard Therapeutics. The major players focus on strategic acquisitions, licensing, and collaboration agreements with emerging players to enter the cell and gene therapy market and gain access to commercially launched products. For instance, Novartis operates through two business segments: Innovative Medicines, which promotes innovative patent-protected prescription medicines, and Sandoz, under which it produces and markets generic pharmaceuticals and biosimilars. The Innovative Medicines division is further segmented into the oncology and pharmaceutical business units. The major products target therapeutic conditions such as neuroscience, immunology, oncology, ophthalmology, and hematology. Further, some companies currently dominating the cell therapy industry are Organogenesis, Smith + Nephew, Vericel, and others.