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MEDICAL DEVICES PHARMACEUTICALS CHEMICALS FOOD & BEVERAGE ELECTRONICS

THE 2014 BLOOD BANKING MARKET: US, EUROPE, JAPANEmerging Opportunities and Business Development Strategies

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! Clinical Syndromes

The incubation period of West Nile virus is between x and xx days. Most

people who are infected with the West Nile virus either have no symptoms or

experience mild illness, such as fever, headache and body aches before fully

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Encephalitis is the most serioius manifestation of viral infection. Fewer than x%

of people infected with West Nile virus develop encephalitis, and among those

hospitalized with West Nile encephalitis, the case fatality rate changes from x%

to xx%. Therefore, fewer than 1 in 1000 people infected with West Nile virus

die. The elderly, are at increased risk for the development of encephalitis, which

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polio-loke syndrome has been reported. Genetic factors may influence the

potential for severe encephalitis. Symptoms of encephalitis (inflamation of the

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! Diagnostic Tests

The FDA has cleared the first test for West Nile virus. The test detects IgM


days of the onset of illness. The test was evaluated using over 1,000 patient

samples, which were tested at four different clinical sites. The test identified


The UVC is well-suited in inactivating non-enveloped viruses that are not

targeted by chemical methods, such as solvent/detergent usage and low pH

techniques. UVC targets the viral DNA and causes the production of photo dimers

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Light energy can also be used to activate a chemical that then can work to

inactivate pathogens. Most of the research in this area has been done pertaining

to psoralens. Psoralens preferentially bind to nucleic acids in the dark, and upon

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more than six-log inactivation could be achieved with xxxx against HIV, HBV,

HCV, and HCMV viruses. It was further shown by examining bleeding parameters



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The company is working with another group of compounds called xxxxxx

which require light for viral inactivation. xxxxxx are being developed for viral

inactivation in units of red blood cells. One xxxxxxxxxxxx, has been used to treat

red cells. Early clinical trials of red cells treated with xxxxx have shown that S-

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7. Grifols Diana

The Diana user gel cards, which consists of plastic support of eight

micro tubes. The tubes contain a gel in a buffered solution with particle sizes to



vessel after centrifugation. The micro tubes consist of a reaction chamber and a

column. The sensitising and agglutination reactions takes place in the reaction


identification and cross matches). In direct tests, such as cell group typing and

direct Coombs, the chamber is the place where samples are dispensed. The




the micro tube. The gel is mixed with reagents for direct typing or polyvalent anti-

human globulin for the Coombs test. All reagents for direct tests are monoclonal.



instruments and five infectious disease tests used for screening donated blood to

the xx members of the American Blood Centers.

The company's traditional marketing strategy for selling diagnostic products

is to place the instruments free of charge in return for the reagent contract. This


successful for marketing Hepatitis and AIDS tests.

Outside the U.S., Abbott is present in over xxx countries, including all major

European markets, Japan Canada and Australia. The company is also very active



through approximately xxx field representatives and the local country distributing

agents.

In addition to extending its portfolio of immunodiagnostic blood screening

tests, the company is also developing molecular diagnostic assays for blood and

plasma screening. xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

target cycling background reduction process based on magnetic separation

hardware system. xxxxx has developed the HIV nucleic acid probe-based assay

designed to determine the quantity of AIDS virus RNA in the blood. The assay


Philadelphia. The detection sensitivity of the test is approximately xx infected

cells per cubic centimeter of blood. xxxxx has also obtained a non-exclusive

license to xxxxxx four patents (including the patent for sandwich hybridization

technology) in order to simplify the company's xxxxxxx replicase amplification

acute rheumatoid arthritis and some individuals will have detectable rheumatoid

factor transiently. It is not clear whether B19 arthropathy is due to autoimmune

mechanisms or direct viral infection. B19 nucleic acid has been found in the



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? Transient Aplastic Crisis

Parvovirus B19 can cause a severe erythropoietic arrest in patients


spherocytosis, thalassemia, hemoglobin SC, and other chronic hemolytic states.

The virus can also cause red blood cell aplastic crisis in healthy individuals who do


profound fatigue and lethargy, dyspnea, and may or may not have a history of a

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with absent reticulocytes. Urgent transfusion may be necessary. Examination of

the bone marrow shows erythroid hypoplasia with other cell lines usually intact.

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pathognomonic for this infection. B19 viremia has been demonstrated during this

time, and patients are potentially still infectious. The aplastic crisis usually

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? Transient Pancytopenia

Other cells besides the erytrocytes can be involved with an acute

parvovirus B19 infection. Potentially life-threatening declines in the neutrophil

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TABLE III-14

FRANCEALL MARKET SEGMENTS

BLOOD TYPING AND GROUPING REAGENT MARKET2012-2017($ millions)

Annual Growth 2012-2017

Test 2012 2017 (%)

Hospitals

Blood Banks

Commercial/Private Laboratories

Total

TABLE IV-11

GERMANYBLOOD BANKS

INFECTIOUS DISEASE SCREENING TEST VOLUME2012-2017

(millions of tests)


Test 2012 2017 (%)

AIDS HIV NAT HIV-1/2CytomegalovirusHepatitis HAV NAT HBV NAT HBs Ag HCV NAT HCV ALT/SGPTParvovirus B19 NATSyphilis

Total

TABLE IX-10

U.S.A.COMMUNITY AND REGIONAL BLOOD CENTERSBLOOD TYPING AND GROUPING TEST VOLUME

2012-2017(millions of tests)


Test 2012 2017 (%)

ABOAntibody PanelsAntibody Screening/Indirect AntiglobulinAntigen Typing C c Duffy E e I, i Kell Kidd Le a, b MN P S sAntiglobulin Direct C3 + IgG IgG C3Crossmatching Immediate Spin Full CrossmatchRh D DuOthers

Total

TABLE IX-17

U.S.A.PLASMA FRACTIONATION CENTERS

INFECTIOUS DISEASE SCREENING TEST VOLUME2012-2017

(millions of tests)


Test 2012 2017 (%)

AIDS HIV NAT HIV-1/2CytomegalovirusHepatitis HAV NAT HBV NAT HBs Ag Anti-HBc HCV NAT HCV ALT/SGPTHTLV-I/IIParvovirus B19 NATSyphilisWest Nile Virus NAT

Total

TABLE IX-23

U.S.A.COMMUNITY AND REGIONAL BLOOD CENTERS

BLOOD TYPING AND GROUPING REAGENT MARKET BY MAJOR TEST2012-2017($ millions)


Test 2012 2017 (%)

ABOAntibody PanelsAntibody Screening/Indirect AntiglobulinAntigen TypingAntiglobulin Direct OthersCrossmatchingRhOthers

Total

TABLE IX-33

U.S.A.MAJOR SUPPLIERS OF BLOOD TYPING AND GROUPING REAGENTS

ESTIMATED SALES AND MARKET SHARES2012

Sales Market ShareSupplier ($ millions) (%)

Total

TABLE IX-35

U.S.A.HEPATITIS B BLOOD SCREENING MARKET

REAGENT SALES BY MAJOR SUPPLIER2012

Sales Market ShareSupplier ($ millions) (%)

Total

TABLE IX-38

U.S.A.WEST NILE VIRUS NAT MARKET

REAGENT SALES BY MAJOR SUPPLIER2012

Sales Market ShareSupplier ($ millions)(*) (%)

Total

(*) Includes community and reagent blood centers.

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