Biopharmaceuticals: A success story in figures

Steadily growing market share for biopharmaceuticals, an increase in the number of employees and the number of biopharmaceuticals in development - medical biotechnology continues to be a reliable driver of innovation within the key pharmaceutical industry, and thus plays a major role in securing Germany as a business location, as a current evaluation by the Boston Consulting Group for the vfa shows.

However, the strong figures should not hide the fact that the economic situation for the entire pharmaceutical industry will deteriorate significantly in the current year. This is due to global trends such as the rise in energy and raw material prices and inflation as a result of the war in Ukraine, as well as home-grown problems caused by the German Statutory Health Insurance Financial Stabilisation Act (GKV-FinStG) passed in October 2022.

Sales of biopharmaceuticals (pharmacies and hospital market) increased compared to 2021 to € 17.8 billion. As a result, the share of sales in the overall pharmaceutical market increased from 31.4% to 32.9% in 2022.

A total of 63 drugs with a new active ingredient were approved in 2022. The 37 newly authorised biopharmaceuticals, including biosimilars, correspond to a 59% share of all new approvals, which is higher than ever before.

The sales growth is spread across a wide range of indications, with oncology, immunology and metabolic diseases representing the three strongest areas in terms of sales, with oncology continuing to grow at an above-average rate of +16%. These developments are driven by the high medical demand for innovative therapies for chronic or cancer diseases.

The 37 new approvals for recombinant biopharmaceuticals relate to various therapeutic areas and include the following product classes: recombinant antibodies (16 new plus three biosimilars), four ATMPs (Advanced Therapy Medicinal Products; advanced therapy medicinal products), three new enzymes, two growth hormones, two biosimilar insulins, two further hormones (one new and one biosimilar), one coagulation factor, one biosimilar growth factor and three new recombinant vaccines, including one for the prevention of Covid-19.

At the end of 2022, a total of 398 biopharmaceuticals (including biotechnologically produced vaccines) were authorised for the German market, which corresponds to an increase of 10% or 36 products compared to the previous year.

The biopharmaceutical pipeline has more than doubled since 2005, from 256 clinical development candidates in 2005 to 672 at the end of 2022. This represents continued very high and continuous investment in the biopharmaceutical pipeline and shows that many new innovative active ingredients are still being brought from research into the clinical development phase. As in previous years, the recombinant antibody drug group accounts for the largest share of development candidates at 65% (2021: 66%).

The three largest development priorities are in the areas of oncology, therapy and prevention of infectious diseases and immunology. They cover more than 70% of all development projects with new or biosimilar active ingredients.

In Germany, a total of 135 companies were active in medical biotechnology in 2022, developing and in some cases also marketing their own drugs - an increase of 3.8% on the previous year (2021: 130). The number of employees grew significantly by 8.7% to around 50,000 - an increase of around 4,000 compared to the previous year.

The 10-year comparison of selected economic data for the years 2012 and 2022 clearly shows the growing importance of biopharmaceuticals for patients and Germany as a business location alike:

• The number of biopharmaceuticals (including biotechnologically produced vaccines) grew from 199 to 398.
The biopharmaceutical pipeline (including biotech vaccines) expanded by 16% from 578 to 672.
• Sales of biopharmaceuticals in Germany tripled from € 6.0 billion to € 17.8 billion, while the share of biopharmaceuticals in the overall market increased from 21% to 33%, an increase of 56%.
• The number of employees in biopharmaceutical companies in Germany with their own products on the market or in development grew by 76% from 28,400 to around 50,000 employees.

With 59 per cent of new approvals in the overall market, the highest figure to date was achieved last year and the 30 newly approved original biopharmaceuticals were also a record. This future potential and the concrete hopes of numerous patients must not be carelessly jeopardised by excessive cost-cutting measures or automatic substitution analogous to generics.

Here you can download a summarised fact sheet: https://www.vfa.de/download/biopharmazeutika-2022-one-pager.pdf

Source: Verband Forschender Arzneimittelhersteller e.V. from 22 May 2023