Statistics
German Biotechnology in 2005
Just two decades ago, biotechnology in was taking its first developmental steps in the marketplace. Today, it is firmly established as a commercial branch. This is the picture emerging from the recent national biotechnology survey, taking in biotech companies of all sizes from across , and carried out by biotechnologie.de on behalf of the Federal Ministry for Education and Research (BMBF). For the first time in this sector, the data complies with statistical standards as set by the Organization for Economic Co-operation and Development (OECD), allowing for a reliable and internationally comparable description of the German biotech landscape.
Methods of the biotechnology company survey
In December 2004, the Organization for Economic Co-operation and Development (OECD) consolidated the many existing definitions for the term biotechnology. The OECD is a politically and economically motivated federation of, at present, 30 states, whose goal consists of, among other things, ensuring the proper means of comparing the economic activity of their member countries. To this end, the OECD has compiled guidelines to apply to the most diverse industry statistics, including uniform definitions and term explanations. For the field of biotechnology, the guidelines were presented in 2004. Since then, all OECD countries have been encouraged to conduct all surveys and other information-gathering activities according to the so-called Framework for Biotechnology Statistics.
To date, there has been no application of the OECD standards to the German biotech industry. For this reason, the Federal Ministry of Education and Research (BMBF) assigned biotechnologie.de to carry-out a biotechnology company survey within Germany based on the OECD guidelines, making this the first reliable and description of the German biotech industry which allows valid comparisons to be made with other countries. Most important of all in this survey were the following points: the number of companies that are concerned substantially or exclusively with biotechnology, the specific activities of the industry in terms of content, the number of employees and the turnover generated by these companies. Future surveys will be conducted annually in order to ensure a reliable, internationally comparable and statistically standardized description of the industry.
Biotechnology Definitions
The OECD suggests a two-part definition for biotechnology, which included a so-called ‘single definition’ (1) and a ‘list-based definition’ (2). The single definition is firstly a general definition of what is to be understood by the term biotechnology. It reads as follows:
(1) The single definition of biotechnology:
"Biotechnology is the application of science and technology to living organisms, as well as parts, products and models thereof, to alter living or non-living materials for the production of knowledge, goods and services"
In order to concretize this explanation and particularly to emphasize the emergence of modern biotechnology, the OECD uses the list-based definition. It contains an enumeration of seven biotechnological procedures and methods, to help meaningfully supplement the general definition of the term biotechnology (see table 2). This list is exemplary and lays no claim to completeness, and will be changing particularly with regards to future surveys as well as technological developments in biotechnology.
Biotechnology is described herein as an occupation incorporating traditional, innovative and adjacent fields of activity. Methods from Genomics, Proteomics and bioprocess engineering can also be found in the OECD list, alongside cell and tissue cultures, vectors, bio computer science or nano-biotechnology. On the basis of these criteria, a company survey of the biotech sector was carried out in . Companies, whose fields of activity lay outside of these definitions, were not considered for the survey.
(2) List-based definition of biotechnology:
| DNA | Genomics, pharmacogenomics, gene probes, genetic engineering, DNA/RNA sequencing/ synthesis/ amplification, gene expression profiling, and use of antisense technology. |
| Proteine and other molecules | Sequencing/synthesis/engineering of proteins and peptides (including large molecule hormones); improved delivery methods for large molecule drugs; proteomics, protein isolation and purification, signaling, identification of cell receptors. |
| Cell and tissue culture and engineering | Cell/tissue culture, tissue engineering (including tissue scaffolds and biomedical engineering), cellular fusion, vaccine/immune stimulants, embryo manipulation. |
| Process biotechnology techniques | Fermentation using bioreactors, bioprocessing, bioleaching, biopulping, biobleaching, biodesulphurisation, bioremediation, biofiltration and phytoremediation. |
| Subcellular organisms | Gene therapy, virale vectors. |
| Bioinformatics | Construction of databases on genomes, protein sequences; modelling complex biological processes, including systems biology. |
| Nanobiotechnology | Applies the tools and processes of nano/microfabrication to build devices for studying biosystems and applications in drug delivery, diagnostics etc. |
Source: OECD
Apart from what is meant, in detail, by the term biotechnology, there are additional terms used as a basis for the biotechnology company survey. Ultimately, not every company that concerns itself with the above methods is automatically a biotechnology company, according to the OECD definition.
What is, according to the OECD, a biotechnology enterprise?
The OECD recognises two different categories of companies within the biotech industry: a ‘dedicated biotechnology firm’ (1) and ‘innovative biotechnology firm’ (2). According to the OECD definitions, they are described as follows:
(1) A dedicated biotechnology firm
"... is defined as a biotechnology active firm whose predominant activity involves the application of biotechnology techniques to produce goods or services and/or the performance of biotechnology R&D."
Contrary to the ‘dedicated biotech firms’, the substantial activities of ‘innovative biotechnology firms’ are not exclusively involved with application of biotechnological procedures. The OECD thus describes companies in which biotechnology constitutes only one part of the business and of the field of activity. The definition reads as follows:
(2) An innovative biotechnology firm
"... is defined as biotechnology active firm that applies biotechnology techniques for the purpose of implementing new or significantly improved products or processes (per the Oslo Manual of the OECD 1997 for the measurement of innovation). It includes firms whose predominant activity does not involve exclusivly the application of biotechnological techniques."
Alongside these company definitions, the OECD also specified obligatory descriptions for further relevant terms.
| Biotechnological product | ... is defined as a good or service, the development of which requires the use of one or more biotechnology techniques per the list-based and single definitions above. |
| Biotechnological process | ... is defined as a production or other (e.g. enviromental) process using one or more biotechnological techniques or products. |
| Biotechnological research und experimential development (R&D) | ... is defined as R&D into biotechnilogical techniques, biotechnological products or biotechnological processes, in accordance with both the biotechnological definitions presented above and the Frascati Manual for the measurement of R&D (OECD 2002). |
| Biotechnological employment | ... is defined as the employment involved in the generation of biotechnology products as defined above. For ease of collection, it is suggested, that employment be measured in terms of staff numbers rather than in hours worked. |
For all definitions see Framework for biotechnological statistics: Download (PDF-933 KB)
Data basis of the of the biotechnology company survey
In order to carry out the survey, biotechnologie.de compiled a questionnaire, based on the OECD definitions as given above. Between January and March 2006, a total of 657 companies were sent the survey. In all, 506 of the requested companies returned a completed questionnaire and a further 93 companies gave information by telephone. The participation ratio was 91%, with altogether 599 enterprises taking part in the survey.
The selection of the companies chosen to take part in the survey was undertaken with consideration to the OECD definitions, alongside the use of the existing company databases of BIOCOM AG and the Secretary of Information for Biotechnology (Informationssekretariat Biotechnologie, ISB) from the Society for Chemical Technology and Biotechnology Association (DECHEMA), under the authority of the Federal Ministry of Education and Research (BMBF) until 2005.
In line with the OECD guidelines, in selecting the participating companies, extreme care was taken to include all companies which are resident in Germany and which are active in biotechnology. Therefore, companies that are majority-owned from outside Germany, but have a company office in Germany, were also considered. In surveying the employee figures, number of companies and fields of activity, the survey included only the German locations of a company. If an enterprise has more than one location in Germany, only the figures and data for that company as a whole were considered.
The deadline of the survey was 31.12.2005.
All participating biotech companies can be found in the company database at biotechnologie.de. The entries have been separated according to the two OECD categories for companies. All data published herein is based on the results of this survey.