Biopharmaceuticals: Economic data and progresses for patients by cell and gene therapies
The new Biotech-Report describing the situation of medical biotechnology in Germany is now available. It was provided by Boston Consulting Group for vfa bio. This yearly report is the only one recording all activities within medical biotechnology in Germany – ranging from startup to big companies. In addition to key economic data on medical biotechnology in Germany in 2019, the focus of this year’s report is on progresses for patients by cell and gene therapies.
Key economic data on medical biotechnology in Germany for 2019 at a glance:
- Sales of biopharmaceuticals (in the pharmacy and hospital market) increased by 13% relative to 2018, to €12.7 billion. The share of this revenue as a percentage of the total pharmaceuticals market increased from 27.1% to 28.7%. All fields of application saw growth.
- Biosimilars grow quickly in Germany after their market launch; they already achieve significant market share of up to 60% within one year. On average, they made up 42% of revenues in 2019 in the corresponding biopharmaceutical segment.
- 15 new biopharmaceuticals were approved, corresponding to 45% of all new approvals.
- The pipeline has stabilized at a high level: The number of biopharmaceutical compounds in clinical development rose slightly within the space of one year, from 635 to 640.
- Companies active in medical biotechnology continue to hire. The workforce grew significantly by 5.8% to over 42,300—a new record.
Focus ATMP (= Advanced Therapy Medicinal Products)
ATMP are gene therapy medicinal products, cell therapy medicinal products, and tissue-engineered products. As of May 2020, ten ATMPs had a central approval in the EU, and thus also in Germany. ATMPs are novel in many ways, which is why they are also referred to as “novel therapies”. This novelty is associated with special characteristics in terms of their development, production, approval, and market access or reimbursement.
Compared to traditional pharmaceuticals, in which the active ingredient consists of a chemical molecule or protein, the active ingredients of ATMPs are nucleic acids (such as genes) or even whole cells or tissues. While traditional pharmaceuticals often have to be taken lifelong in the treatment of hereditary diseases, ATMPs could yield long-term therapeutic efficacy, or possibly even a cure, after a single application.
Courses of action to establish an “ATMP welcome” culture and structure in Germany
In 2018, Germany—with just 4.4%—trailed far behind the United States (47.5%) and China (39.2%) in the worldwide share of gene therapy studies with patients. In order to establish an "ATMP welcome" culture and structure in Germany and give the country a leading role in these promising and innovative technologies, we propose the following courses of action:
- Establish a German Center for Health Research for ATMPs to create the necessary infrastructure and network
- Create an ATMP task force to harmonize the requirements of the local supervisory authorities for the specific handling and logistics of these advanced therapies
- Increase personnel at the Paul-Ehrlich-Institut to reduce waiting times for advisory services and processing times for study applications, thereby making Germany more competitive once again within Europe
- Education of qualified personnel, capacity expansion, and automation in production to establish Germany as an ATMP production location
- Close the funding gap in hospitals to ensure the quick use of ATMPs
If these recommendations are implemented, Germany will be able to generate medical and economic advantages from innovations in the field of ATMPs instead of largely importing medical innovations. This would benefit not only Germany as a business location, but also society and the patients waiting for new treatment options.