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The biopharmaceutical industry remained stable in times of crisis

The German biopharmaceutical industry has come through 2009 without experiencing too many major slumps. The roaring growth of the biopharmaceutical industry in previous years has been replaced by more moderate growth. This is the result published by the 4th “Medical Biotechnology” report in 2010 compiled on behalf of the biotech interest group of the vfa bio (Association of Research-Oriented Pharmaceutical Companies) by the Boston Consulting Group.

Parts of the report were presented in Berlin on 28th April, giving an overview of the German biopharmaceutical industry. The report focuses on the “red biotech” activities of small- and medium-sized companies as well as the big company groups.

Physicians are more cautious when prescribing biopharmaceuticals

The biopharmaceutical industry in Germany is a respectable economic and stability factor, said Dr. Frank Mathias. © vfa bio

The figures published in the report promise high levels of stability. The number of companies in Germany has risen slightly (up 1 per cent) to 380, as has the number of employees (2009: around 35000). Last year, the companies achieved a moderate revenue growth of seven per cent (5.658 billion euros). The revenues obtained with the sale of biopharmaceuticals in Germany rose by around five per cent to 4.7 billion euros. Industry representatives believe that the relatively small amount of growth is the result of the cautious prescription practice of physicians in terms of biopharmaceuticals.

Frank Mathias, chairman of vfa bio and managing director of Martinsried-based MediGene, was very satisfied with the developments: "Medical biotechnology makes an important contribution to Germany's economy and research landscape." Industry representatives clearly criticised the German government's plans to put in place larger discounts for new drugs.

In 2009, biopharmaceuticals developed to treat severe, life-threatening diseases in particular, accounted for around 16 per cent of entire drug revenues. Biopharmaceuticals have attained special importance in some areas, for example in the treatment of immune diseases such as rheumatoid arthritis, Bekhterev's disease and Crohn's disease. In these areas, two out of three drugs are biopharmaceuticals. Thanks to the use of biopharmaceuticals, the number of days people were absent from their jobs due to illness decreased by 50%, said Frank Mathias, indicating that this benefits society as a whole.

Strong revenue increase through the sale of drugs for the treatment of immune diseases

The proportion of biopharmaceuticals used to treat cancer and metabolic diseases such as diabetes accounts for around one third of all drugs. In contrast to the previous year, the revenues increased notably in the fields of immune diseases and oncology (up 26 per cent and 17 per cent, respectively). However, revenues from vaccines decreased considerably.

In contrast to 2008, when only one biopharmaceutical drug received marketing authorisation, a dozen new biopharmaceuticals received marketing authorisation in 2009. The proportion of biopharmaceuticals in all newly approved drugs amounts to 27 per cent. “We are still very innovative,” said Mathias. The majority of new biopharmaceuticals were drugs for the treatment of autoimmune diseases and drugs known as orphan drugs. 2009 figures are very similar to the market admission figures of the last decade.

The pipeline is well filled

The number of new drugs in clinical development (Phase I to III) increased by 12 per cent. At the end of 2009, around 470 drugs were in the clinical stages of development or in the process of obtaining marketing authorisation. Monoclonal antibodies have a strong share in this development (+ 29 per cent). “However, only one in a hundred antibody-based drugs has reached the market,” estimated Mathias.

The development of drugs for the treatment of immune diseases is the greatest growth area. Most drug candidates have been developed for use in the areas of oncology and infectious diseases. Mathias highlighted the efforts of companies to develop new vaccines. The figures show that the era when vaccines were a kind of economic niche seems to be over.

Personalised medicine will increase in importance in the future. This assumption is based on the observation that a growing number of biomarkers are coupled to drug development. In the long term, Mathias believes that biomarker testing will be required for almost all biopharmaceuticals, providing patients with greater safety and efficiency in drug use.

Two thirds of all biopharmaceuticals are developed for use in children

Mathias explained that medical biotechnology has had a pioneering role in the development of drugs for children. “Around two thirds of all biopharmaceuticals are exclusively approved for use in children,” said Mathias going on to add that many companies tend to focus on biopharmaceuticals development for application in children right from the start, for example growth hormones, insulin or enzyme replacement therapies for the treatment of Pompe disease.

Since 2008, it has been mandatory for pharmaceuticals producers to develop drugs that can also be used in minors if requested by the committee of the European EMEA. To compensate producers for increased requirement costs arising from this, companies are given extended patent protection. Mathias also explains that producers intending to focus on a new indication have to put in place special quality control plans for children. Generic drug producers are also given a ten-year market exclusiveness when they decide to carry out paediatric studies. Industry representatives estimated the percentage revenue obtained with children-specific drugs as below five per cent.

Criticism of government plans disguised as plea

“It remains to be seen whether we will be able to come up with such a positive balance in the next year,” said Mathias highlighting that the German government’s health policy endangers the planning security of small- and medium-sized companies. “We can well accept contract solutions and discount contracts, but the situation is different when it comes to having to accept compulsory discounts and reference prices.” The vfa bio managing director Siegfried Throm categorically refused negotiations with the monopolist, the Central Federal Association of the German Health Insurance Funds, but said that he was willing to negotiate with the health insurance groups.

Mathias highlighted that an innovative industry such as the biopharmaceutical industry is willing to accept a benefit evaluation according to international standards that takes the benefits to society as a whole into account. “It is no help at all if the only thing that is compared is the price of drugs,” said Mathias.

Germany is already the European champion in biopharmaceutical production. The photo shows the aseptic filling of biopharmaceuticals. © Boehringer Ingelheim

Mathias called for a consistent policy in which research, healthcare organisations and industry work closely together with the objective of making Germany number one in Europe. He further pointed out that Germany already holds the top position in biopharmaceutical production, and he alluded to the global business activities of the biopharmaceutical industry, which is always looking for the best location for its purposes.

In order to ensure that Germany remains an important biotech location in the future, Mathias called for reliable framework conditions, a newly organised healthcare system, and deregulation. "Excellent research is required for innovations. We need to come together and find out what health and growth really mean to us and whether we are all willing to put the effort into health and growth," said Mathias calling on politicians to put measures in place to ensure that Germany remains an important biotech location.

The print version of the Medical Biotechnology in Germany 2010 BCG report will be published in June 2010.

Quelle: PK des Vfa bio, 28.04.2010, Berlin

Website address: https://www.gesundheitsindustrie-bw.de/en/article/news/the-biopharmaceutical-industry-remained-stable-in-times-of-crisis