Contents:

1.1 Project Objectives 1.2 Definitions 1.3 Health Care System and Reimbursement - Healthcare System - Reimbursement Policies - Private Laboratories - EBM - Hospital Laboratories - Maternity Services - IGeL - Individual Health Services 1.4 Laboratory Landscape 1.5 Respondent Population 2. Infectious Diseases Testing in Clinical Laboratories 2.1 Sexual Transmitted Diseases (STD) - Chlamydia Trachomatis - Neisseria - HIV - HCV - Group B Streptococcus - HSV 2.2 Mycobacteria - Mycobacteria Tuberculosis - Mycobacteria Avium - Mycobacteria – NA Purification 2.3 Atypical Pneumoniae - Bordetella - Legionella - Chlamydia sp. - Mycoplasma Pneumoniae 2.4 Cytomegalovirus (CMV) - CMV – Qualitative Tests - CMV – Quantitative Tests 2.5. Viral Meningitis - HSV 1 & 2 - Enterovirus - West Nile Virus (WNV) - Epstein Barr Virus (EBV) - VZV 2.6 Respiratory Viruses - SARS - Adenovirus - Influenza A - Influenza A&B - RSV - Parainfluenza 2.7 HPV 2.8 Chronic Meningitis 2.9 Bacterial Meningitis - Neisseria Meningitis - Haemophilus Influenza - Pneumococcae - Listeria - Enterobacteria 2.10 Tick Born Encephalitis 2.11 Antibiotic Resistant Bacteria - MRSA - VRE 2.12 Candida 3. Equipment & Purchase 3.1 Current Installations & Financing of Laboratory Equipment - Cobas Amplicor, Roche - Light Cycler, Roche - ABI PRISM, Applied Biosystems - RotorGene, Corbett Research - Other Cycler - Other Devices/Manufacturers 3.2 Budget Resources 3.3 Who is Involved in Purchasing Decisions 3.4 How do Laboratories Purchase 3.5 Criteria Influence a Purchasing Decision 3.6 What are Laboratories Willing to Pay for New Tests? 4. Market Sizes and Market Shares 4.1 Market Volumes for Selected Pathogens - STD - Mycobacteria Tuberculosis - Atypical Pneumonia - CMV - Viral Meningitis - Respiratory Viruses - HPV - MRSA 4.2 Market Shares 5. Market Trends 5.1 Problems with Molecular Diagnostics 5.2 Expected Growth per Segment 5.3 Other Growth Areas 5.4 Drivers for Molecular Diagnostics 5.5 Restraints for Molecular Diagnostics 6. Political Influences 6.1 Changes of Reimbursement Policy 6.2 Influence of the EU IVD Act

Sample

Germany 2.1 Sexual Transmitted Diseases (STD) We asked respondents to provide numbers of performed tests per month and pathogen. We have subsumed groups with test ranges that are narrow enough for market estimations rather than detailed numbers. The following table shows how many % of the laboratories test for the given STD-related pathogens. The following table provides an overview about the number of samples per month, performed in the interviewed laboratories within STD. The grey column indicates the percentage of laboratories (total n=32) that run tests for the respective pathogens. (Table available in Full Report) Chlamydia Trachomatis Performer: 93,8% (30/32) For Germany, projections estimate about 100.000 new infections per year countrywide. Up to 90% of the infections are without symptom and therefore not diagnosed (source: health authorities Cologne). The following table shows the used technique (in % of laboratories) among the laboratories that have been interviewed. (Table available in Full Report) Other manufacturers comprise of: - bioMérieux Hybridowell™ - Corbett Research RotorGene - Biometra cycler - Applied Biosystems ABI PRISM 7700 - Biolab ELISA .......... Market Sizes For the calculation we used the sample sizes per month that laboratories provided on the question “how many tests do you run per month” and the total number of laboratories that potentially perform molecular tests for the pathogens. We calculated with a total of 334 laboratories that are involved in microbiology testing. Private laboratories are included. From a total of 464, we estimated on the basis of the contacts made for this survey a share of 58,8% (273 laboratories) that use molecular diagnostic techniques. We provide a calculation that rests upon maximum test numbers possible (for instance “up to 100 tests per month” was included in the calculations as “100 tests per month”. Thus, the market volumes provided here are the absolute maximum estimation that could be generated by the laboratories involved in testing for infectious diseases. The numbers provided in the tables below are calculated as follows: The final number of laboratories that potentially perform the given number of tests per month or year has been calculated as follows: Total number of laboratories (607) --> share of laboratories that perform tests of the given pathogen, no matter which technique applied (variable) --> share of laboratories that perform molecular testing (MT) in Germany, split based upon the contacts made during the survey (52,2%) --> share of laboratories that perform tests for the given pathogen with MT respectively (variable) The resulting number of laboratories that use molecular techniques for the selected pathogens has been multiplied with the following data, gathered during primary research: - the average number of MT based tests (samples per month), - the median number of MT based tests (samples per month). In cases where mean and median sample sizes per month differed widely, we have weighted the calculation the way that it mirrors the split between laboratories that perform small sample numbers (usually up to ten tests per month), medium sample numbers (usually up to 200 tests per month) and numbers that are 500 tests/month and up. All numbers have been cross checked with available secondary information (by Health Institutions, disease centres, disease control systems etc) and our experience in these markets. We have refrained from calculating market volumes based on the number of tests and costs given per tests. The cost for selected test provided by the interviewed end users are too heterogeneous and we think that it would be more valid for the reader to develop own calculations based on internal (price) data and our calculations rather than having the average averaging of all prices. As for Germany, end-users provided information on price per test, meaning that the numbers include the price for the kit and the price for labour, but we have no indication about the split. All figures are calculated in “test numbers” and represent an estimation of the market volume for tests performed within the laboratory population interviewed and with the use of molecular techniques (MT) only.