The European Market

bought Amira Medical, an American company specialized in diabetes monitoring. Similarly, Johnson & Johnson bought the diabetes diagnosis activities of Inverness Medical Technology in June 2001. During the same month, Bayer Diagnostics and the Japanese company Matsushita Electric Industrial (better known by its brand name, Panasonic) created a partnership in the medical diagnostics field, particularly for the development of a diabetes monitoring device. Other companies pursued developments in the field of genomics and molecular biology. Genomics is the study of diseasemarker genes and can be used to predict whether a certain treatment will be beneficial or toxic to a patient. This new science made possible by the first complete sequencing of the human genome has opened new horizons in the search for new treatments, particularly in the study of cancer. The global in vitro diagnostics market is estimated to represent 23.8 billion euros and the 8 largest companies make up more than 80% of the global market. Arranged by decreasing turnover, these companies are the following:

1. Roche Diagnostics 2. Abbott 3. Johnson & Johnson 4. Bayer Diagnostics 5. Beckman Coulter 6. Dade Behring 7. Becton Dickinson 8. bioMérieux

21 The European Market

❚ In 2001, the European market was estimated at 6.4 billion euros, an increase of 7.3% compared to 2000. Reagents accounted for 86% of the total market while instruments represented 14%.

The distribution of turnover among the main reagent categories is as follows:

Clinical Chemistry includes assays for urea, glucose, cholesterol, sodium, potassium, hepatic and cardiac enzymes or fecal occult blood...

Immunochemistry includes assays of hormones and cancerous tumor markers, allergy tests... Hematology includes complete blood cell counts, blood and tissue group tests and blood coagulation assays. Microbiology is the characterization of pathogenic or non-pathogenic germs and culture to test antimicrobial susceptibility. Infectious immunology includes the characterization of bacteria, viruses (including those responsible for AIDS, hepatitis A, B and C, and rubella) and parasites such as toxoplasma.

■ Clinical chemistry 35.4% ■ Infectious immunology 15.6% ■ Microbiology (culture) 6.6% ■ Hematology/Cytology 14.4% ■ Immunochemistry 28%

Source: EDMA

European Market: 6.4 Billion euros Increase 2001/2000: 7.3%

The EDMA (European Diagnostics Manufacturers Association) is the organization that governs the national in vitro diagnostics industries. The SFRL (Syndicat de l’industrie du diagnostic in vitro or In vitro diagnostic industry union) is a member of the EDMA Executive Committee. The EDMA classification of all products was approved by a European consensus. Each year, the EDMA gathers all data provided by the various national associations to evaluate the European market. The Self Testing market continues to increase and now represents almost 20% of the European market. Self Tests, performed by the patients themselves, monitor treatment for diabetes or high cholesterol or confirm pregnancy. These tests are more widely used in Germany and Scandinavian countries than in France: they make up 29% of the market in Germany, 31% in Finland and only 14% in France. The market for these tests available in pharmacies is rapidly growing even in France (15% in 2001) due to the increased number of diabetic patients that monitor and adjust their treatment based on the results of these tests. Those products available in French pharmacies are as follows: instruments and assays of glycemia, tests for cholesterol, blood alcohol levels, pregnancy and ovulation and strips for the detection of albumin or sugar in urine. In Germany, in addition to these tests, pharmacies carry tests for uric acid or to screen for Helicobacter pylori, a germ responsible for gastric ulcers. Self tests exist in various countries to screen for drugs in urine samples. In the USA, individuals can be tested for AIDS from a saliva sample collected by the individual into a device then sent to a laboratory for testing. These tests allow patients to actively monitor their health and that of their

Germany Italy France Spain United Kingdom Belgium Switzerland Austria Portugal The Netherlands

Turnover Percent of % increase billion euros european market 2001/2000

1,582 25% 6,2 1,245 19% 9,4 1,142 18% 8,7 649 10% 5,2 610 9% 3,8 211 3% 1,7 210 3% 6,0 189 3% — 181 3% 5,6 180 3% –0,1

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