Contents:

Overview Introduction The brief will focus on the epidemiology of bacterial infections across the seven major pharmaceutical markets. Focusing on reported data for key sites of infection and causative pathogens, it will examine the various factors that are likely to affect patient potential for existing and novel antibacterial products. DRIVERS AND TRENDS The antibacterial market is one of high value and therefore represents an area of substantial interest for novel products. However, in order to maximize ROI, it is necessary to target drug development effectively. The causative pathogens, site of infection and epidemiology of disease can all have an impact on drug efficacy and need to be fully understood before appropriate product development can take place. BACTERIAL INFECTIONS Bacterial infections are defined and classification broken down into the most appropriate means of segmenting the market. The three main categories by which they are diagnosed and treated are broken down into greater detail and epidemiology of infections is discussed. RESPIRATORY TRACT INFECTIONS Respiratory tract infections (RTIs) comprise infections pertaining to the lower and upper respiratory tract. Many lead to hospitalization and high levels of mortality. The nature and number of RTIs means data collection is difficult, since many infections are misdiagnosed or fall into the community acquired-community treated arena reducing the notification rate. This section of the brief looks at three of the more serious RTIs, the pathogens responsible for causing the diseases and the epidemiology of infection. - pneumonia - Legionnaires’ disease - tuberculosis URINARY TRACT INFECTIONS Urinary Tract Infections are common community acquired and treated infections. Unlike most other bacterial infections, they are prevalent among all ages. However, many fail to be diagnosed correctly and patient potential for treatment is underestimated. This section of the Brief discusses the most frequent UTIs and the pathogens which cause them, and goes on to discuss the epidemiology of both community and hospital acquired UTIs. INTRA ABDOMINAL INFECTIONS Intra Abdominal Infections comprise some of the most serious bacterial infections. IAIs are among the most difficult infections to diagnose early and treat effectively. These deep-seated infections generally occur after the continuity of the gastrointestinal tract is interrupted by trauma, intrinsic disease or surgery. Therefore IAIs tend to be hospital treated. Causative pathogens and the epidemiology of IAIs are examined in this section CENTRAL NERVOUS SYSTEM INFECTIONS Infections of the Central Nervous System (CNS) can cause a number of diseases including meningitis, encephalitis and brain abscesses. The nature of the site of infection means most bacterial infections of the CNS result in hospitalization. The seriousness of CNS infections, and the high incidence rate in children, has resulted in an increased public awareness, and a drive towards eradication, of the diseases. This section looks at the bacteriology and epidemiology of meningitis in detail and also examines encephalitis, brain abscesses, tetanus and botulism. INFECTIVE ENDOCARDITIS Infective endocarditis (IE) is an infection of the lining of the heart, which damages the cusps of valves but can also affect other intracardiac sites. It is common in males over the age of 65 but affects all age groups. The brief looks at the different types, and incidence rates, of endocarditis. BONE INFECTIONS This section examines acute and chronic osteomyelitis infections and the causative pathogens in detail, and provides an overview of the epidemiology of infection. It also looks at other, less common, bone infections such as syphilis and tuberculosis. SKIN AND SOFT TISSUE INFECTIONS Bacterial infections of the skin and underlying soft tissues are among the most common complaints encountered. Most skin infections, for example cellulitis, impetigo and wound-related infections, can be managed in the community. However, some variants, may lead to hospital admission. A number of pathogens cause SSTIs and identification is often difficult. types and incidence of diseases, ranging from the common superficial infections to the life threatening serious deep tissue infections causes and epidemiology of surgical site infections BLOODSTREAM INFECTIONS Bloodstream Infections (BSIs) occur when bacteria gets into the blood. They are usually known as bacteremia, with the term septicemia used in more serious cases. Most result in hospitalization and are commonly nosocomial. For this reason, there has been a push by national health services for increased surveillance and control of bacteremia. This section looks at the causative pathogens and the epidemiology for both community acquired and nosocomial bacteremia. It will also briefly examine septicemia. DATASETS Table 1: Incidence of TB in the 7 major pharmaceutical markets, 2000 and 2001 Table 2: Estimated Incidence of Cystitis in 7 major pharmaceutical markets Table 3: Incidence of Infective Endocarditis Table 4: Pathogens causing Infective Endocarditis (%) Table 5: Estimated Incidence of Infective Endocarditis Across the Seven Markets, 2002 Table 6: Microbiology of vertebral osteomylitis in the US Table 7: Estimated incidence of TB osteomyelitis in the 7 markets, 2000-2001 Table 8: Estimated SSTI Incidence in 7 markets Table 9: Incidence of SSI by category of surgical procedure in the UK, 1997-2001 Table 10: Microbial causes of community-acquired pneumonia (CAP) Table 11: Incidence of LD in England and Wales in males, 1990-2002 Table 12: Incidence of LD in England and Wales in women, 1990-2002 Table 13: Legionnaires’ Disease cases, England and Wales, 1990-2002 Table 14: Distribution of UTI pathogens in females and males Table 15: Distribution of the top five pathogens between the ICU/non ICU Table 16: Estimated Cystitis rates in the 7 major pharmaceutical markets Table 17: Pathogens commonly isolated in peritonitis Table 18: Bacteriology of community acquired vs. postoperative peritonitis Table 19: Hospitalization due to CNS infections in the UK, 1998-2001 Table 20: Laboratory Confirmed Neisseria Meningitis in England and Wales by serotype, 1989-2001 Table 21: Rates of Meningococcal Disease in Adolescents and Young Adults in the US, 2001 Table 22: The most common bacterial pathogens causing meningitis in each age group Table 23: Tetanus notifications in England and Wales by age group and sex, 1995-2001 Table 24: Location of Infective Endocarditis in Patients (n=390) Table 25: Location of vertebral osteomyelitis in 237 cases in the US Table 26: Operations and Likely SSI Pathogens Table 27: SSTIs due to GAS in Ontario, 1992-1996 Table 28: Sources of bacteremia, (%) Table 29: Pathogens causing hospital acquired bacteremia in the US, 1994-1997 Table 30: Pathogens causing bacteremia in England and Wales