This year, more new medicinal active ingredients were brought onto the German market than in a long time.
(Photo: imago/Science Photo Library)
Frankfurt When it comes to medicines, the supply bottlenecks for individual medicines are currently dominating the discussion. But there are also positive developments in the industry: in Germany this year more new medicines have come onto the market than in a long time.
Pharmaceutical companies have introduced a total of 49 drugs with new active ingredients in Germany. This is shown by the current statistics from the Association of Research-Based Pharmaceutical Manufacturers (VFA).
This figure once again surpassed the already high value of 46 new launches from the previous year. Only in 2014 were the same number of drugs brought onto the market.
Most of the new drugs are used against cancer and Covid-19. Four drugs are aimed at non-small cell lung cancer, the most common form of this cancer.
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Eight new drugs were introduced against so-called solid tumors, i.e. malignant new tissue formations. Five other drugs are used to treat hematological cancers such as blood cancer and lymph node cancer.
Vaccine laggards play little role
In the third year of the corona pandemic, three therapeutic drugs against Covid-19 and three other vaccines came onto the market – not including versions adapted for booster vaccinations. Among them were the vaccine from Novavax and the booster vaccine from Sanofi/GSK.
These work differently than the mRNA vaccines, in which the building instructions for the human body’s immune response are injected. The agents from Novavax and Sanofi/GSK contain artificially produced spike proteins, i.e. the proteins with which the virus docks to the cells. These are injected with an active enhancer. This stimulates the immune system to produce antibodies and T cells against the spike protein, which then act against the real virus in the event of an infection.
The French company Valneva, on the other hand, had developed a classic inactivated vaccine that contains inactivated, i.e. killed, whole virus particles of the original strain of the coronavirus that cannot cause disease. This active ingredient is also combined with an effect enhancer.
In Germany, however, these vaccines played only a minor role in the fight against the pandemic. As of December 18, only 1.9 million doses of the Novavax vaccine and 86,000 doses of Valneva had been delivered, according to the Federal Ministry of Health. The Sanofi/GSK vaccine does not appear on the list. A total of 163.1 and 37.6 million doses, respectively, of the mRNA vaccines from Biontech/Pfizer and Moderna, which came onto the market much earlier, were delivered by the same date.
Gene therapies are on the rise
Other diseases against which newly introduced drugs are used are asthma, migraines and what is known as atopic dermatitis, chronic itchy eczema on the upper layer of the skin. In addition, innovative therapies are on the rise. In 2022, four new gene therapies came out – two to fight rare types of cancer, two for the long-term treatment of rare hereditary diseases.
A biotechnologically processed tissue product for the treatment of articular cartilage defects was also introduced. The manufacturer, the biotech company Codon from Teltow in Brandenburg, is one of a total of five German companies that have brought new products onto the market this year.
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These also include Bayer with a new active ingredient against chronic kidney disease and Fresenius Medical Care with an infusion solution against itching in dialysis patients. The company Paion launched a new broad-spectrum antibiotic, Merck a drug against non-small cell lung cancer. Overall, the US group Pfizer is ahead with four new drugs.
The innovation balance of the pharmaceutical industry has improved significantly over the past 20 years: from 2001 to 2010, an average of 28 new drugs per year were introduced in Germany, from 2011 to 2020 it was around 32.
Industry focused on rare diseases
This reflects the advances in research and development, but also the increasing focus of the industry on rare diseases, for which approval applications can be submitted more quickly. This year, more than a third of the newly introduced drugs are aimed at such “orphan diseases”. The EU considers diseases that affect no more than five out of 10,000 EU citizens to be rare.
VFA President Han Steutel sees the current figures as proof that the innovative power of the industry is intact. “But the big question is whether the German healthcare system can continue to benefit from it to the same extent in the future,” he says, referring to the GKV Financial Stabilization Act that the federal government has just passed.
The law provides for far-reaching discount requirements for pharmaceutical companies and, from the association’s point of view, is not made to convince manufacturers to also offer new medicines in Germany in a timely manner. “The German market will lose a lot of the old attraction for innovative products,” Steutel warned.
More: The pharmaceutical industry sees the supply of innovative medicines at risk