There are an estimated 33.3 million people living with HIV (the virus which causes AIDS) worldwide and approximately 2.6 million people are newly-infected each year. While the Asian and African regions account for more than 90% of the HIV-infected population (with the highest number in Sub-Saharan Africa), the U.S. and European regions make up greater than 60% of the HIV testing market. This TriMark Publications report provides a comprehensive examination of the HIV/AIDS testing market, a specific segment of the in vitro diagnostics (IVD) market as it relates to infectious diseases. It examines the available and emerging technologies being utilized by the HIV testing field, defines the dollar volume of sales'both in the U.S. and worldwide'and analyzes the factors that influence the size and growth of the market. The chief HIV testing assays, i.e., predictive, screening, prognostic, monitoring, pharmacogenomic and theranostic, are covered thoroughly, as are high-growth applications in different clinical diagnostic areas and expanding markets, such as employee screening, emergency medicine and satellite clinic testing. Additionally, this analysis covers the following areas in details: enzyme-linked immunosorbent assay (ELISA), antibody/p24 antigen test (fourth-generation test), Western blot assay, line immunoassays, indirect fluorescent antibody (IFA) assay, nucleic acid tests for infectious diseases, and the emerging technologies related to HIV and AIDS diagnosis. Moreover, this study also provides a thorough analysis of the companies known to be marketing, manufacturing or developing HIV testing products, as well as provides detailed tables and figures covering HIV testing markets around the globe.
There will be a steady increase in demand for new diagnostic testing services in the next five-year period, along with pressures to improve the quality of healthcare delivered in the clinic and also to lower its costs. Clinical labs experienced a substantial growth during the last decade. The emphasis in this TriMark Publications report is on those companies that are actively developing and marketing high-growth diagnostic testing technologies in the clinical hospital market. It defines the dollar volume of sales, both worldwide and in the U.S., of the market and analyzes the factors that influence the size and growth of market segments. The study goes on to discuss in detail trends that have developed which have stimulated this market, and also comments in detail patterns of information processing in the high-growth diagnostic testing technologies. Moreover, this exanimation provides an overview of the diagnostic testing market, including the latest information regarding exciting new products and industry trends. It will not only quantify but also qualify the market high-growth segments as an area of research and investment. Forecasts of the market and analyses of products in the worldwide prescriptions market will provide a basis for understanding the significance of past developments and future possibilities within this therapeutic category.
Eua authorization letter for LYHER Covid-19 IgG/IgM Antibody rapid Test KitsHK HuZef
LYHER Covid-19 IgG/IgM Antibody Rapid test Kits, US FDA EUA Approval Certificate.
This product, CFUS Anti-SARS-CoV-2 Reference Material Kit Series 1000, is formulated for use with the LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit under the Emergency Use Authorization only.
CFUSSeries1000includes both antibody positive and negative reference materials. The positive is manufactured from human serum or plasma reactive for SARS-CoV-2IgG/IgM andnonreactiveforHBsAg and antibodies to HIV 1and 2, HTLV I and II, and HCV. There is a single vial of positive reference material (red cap) contained within each kit. The negative reference material is manufactured from human serum or plasma non-reactive for antibodies to SARS-CoV-2,aswellasHBsAgandantibodies to HIV 1 and 2, HTLV I and II, and HCV. There is a single vial of negative reference material (clear caps) contained within each kit. PACKAGE DETAIL:
Positive (Redcaps): 1x1.0mLvials Negative(Clearcaps): 1 x 1.0 ml vials This control contains stabilizers (EDTA, buffering agents), and 0.1% ProClin® (5- chloro-2-methyl- 4-isothiazolin-3-one & 2-methyl-4-isothiazolin-3-one) as preservative
HandleCFUS Series1000and all human blood products as though capable of transmitting infectious agents. -This product has not been FDA cleared or approved; -This product has been authorized by FDA under a EUA for use by laboratories certified under CLIA, that meet requirements to perform moderate or high complexity tests; -This product is only authorized for the duration of the declaration that circumstances
exist just if ying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.
This report analyzes the worldwide markets for HIV/AIDS Testing in US$ Million by the following product segments: HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, and HIV/AIDS Monitoring Tests. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Annual estimates and forecasts are provided for the period 2007 through 2015. A seven-year historic analysis is also provided for these markets.The report profiles 63 companies including many key and niche players such as Abbott Laboratories Inc., Abbott Molecular Inc., Adaltis S.r.l., Biom
Sona Nanotech is a nanotechnology life sciences firm that has developed multiple proprietary methods for the manufacture of various types of gold nanoparticles. The principal business carried out and intended to be continued by Sona is the development and application of its proprietary technologies for use in multiplex diagnostic testing platforms that will improve performance over existing tests in the market. Sona Nanotech's gold nanorod particles are cetyltrimethylammonium free, eliminating the toxicity risks associated with the use of other gold nanorod technologies in medical applications. It is expected that Sona Nanotech's gold nanotechnologies may be adapted for use in applications as a safe and effective delivery system for multiple medical treatments, subject to the approval of various regulatory boards, including Health Canada and the FDA.
There will be a steady increase in demand for new diagnostic testing services in the next five-year period, along with pressures to improve the quality of healthcare delivered in the clinic and also to lower its costs. Clinical labs experienced a substantial growth during the last decade. The emphasis in this TriMark Publications report is on those companies that are actively developing and marketing high-growth diagnostic testing technologies in the clinical hospital market. It defines the dollar volume of sales, both worldwide and in the U.S., of the market and analyzes the factors that influence the size and growth of market segments. The study goes on to discuss in detail trends that have developed which have stimulated this market, and also comments in detail patterns of information processing in the high-growth diagnostic testing technologies. Moreover, this exanimation provides an overview of the diagnostic testing market, including the latest information regarding exciting new products and industry trends. It will not only quantify but also qualify the market high-growth segments as an area of research and investment. Forecasts of the market and analyses of products in the worldwide prescriptions market will provide a basis for understanding the significance of past developments and future possibilities within this therapeutic category.
Eua authorization letter for LYHER Covid-19 IgG/IgM Antibody rapid Test KitsHK HuZef
LYHER Covid-19 IgG/IgM Antibody Rapid test Kits, US FDA EUA Approval Certificate.
This product, CFUS Anti-SARS-CoV-2 Reference Material Kit Series 1000, is formulated for use with the LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit under the Emergency Use Authorization only.
CFUSSeries1000includes both antibody positive and negative reference materials. The positive is manufactured from human serum or plasma reactive for SARS-CoV-2IgG/IgM andnonreactiveforHBsAg and antibodies to HIV 1and 2, HTLV I and II, and HCV. There is a single vial of positive reference material (red cap) contained within each kit. The negative reference material is manufactured from human serum or plasma non-reactive for antibodies to SARS-CoV-2,aswellasHBsAgandantibodies to HIV 1 and 2, HTLV I and II, and HCV. There is a single vial of negative reference material (clear caps) contained within each kit. PACKAGE DETAIL:
Positive (Redcaps): 1x1.0mLvials Negative(Clearcaps): 1 x 1.0 ml vials This control contains stabilizers (EDTA, buffering agents), and 0.1% ProClin® (5- chloro-2-methyl- 4-isothiazolin-3-one & 2-methyl-4-isothiazolin-3-one) as preservative
HandleCFUS Series1000and all human blood products as though capable of transmitting infectious agents. -This product has not been FDA cleared or approved; -This product has been authorized by FDA under a EUA for use by laboratories certified under CLIA, that meet requirements to perform moderate or high complexity tests; -This product is only authorized for the duration of the declaration that circumstances
exist just if ying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.
This report analyzes the worldwide markets for HIV/AIDS Testing in US$ Million by the following product segments: HIV/AIDS Screening Tests, HIV/AIDS Confirmatory Tests, and HIV/AIDS Monitoring Tests. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Annual estimates and forecasts are provided for the period 2007 through 2015. A seven-year historic analysis is also provided for these markets.The report profiles 63 companies including many key and niche players such as Abbott Laboratories Inc., Abbott Molecular Inc., Adaltis S.r.l., Biom
Sona Nanotech is a nanotechnology life sciences firm that has developed multiple proprietary methods for the manufacture of various types of gold nanoparticles. The principal business carried out and intended to be continued by Sona is the development and application of its proprietary technologies for use in multiplex diagnostic testing platforms that will improve performance over existing tests in the market. Sona Nanotech's gold nanorod particles are cetyltrimethylammonium free, eliminating the toxicity risks associated with the use of other gold nanorod technologies in medical applications. It is expected that Sona Nanotech's gold nanotechnologies may be adapted for use in applications as a safe and effective delivery system for multiple medical treatments, subject to the approval of various regulatory boards, including Health Canada and the FDA.
ICIC 2014 Patent Landscape Analysis as a Tool for Public Policies Adjustment:...Dr. Haxel Consult
The innovative multinational pharmaceutical industry is highly dependent on the release and promotion of new drugs. However, recent economic evidence demonstrates a continuing decrease in new drugs’ market approval. Moreover, the industry is challenged by the “patent cliff”, where many blockbuster drugs are losing patent protection and facing ferocious competition.
It seems that the shortage of new drugs points to an intensification of drug development based on molecules already known, leading to incremental patents. However, there is a suspicion that many incremental patents are actually trivial, because they add little or nothing to existing therapies, but still impose high drug costs. To analyze that hypothesis, the present study has drawn the profile of all patents filed in Brazil in the antiretroviral (ARV) field up to 2012. Using VantagePoint® and Questel Orbit® softwares, a patent matrix was constructed with quali-quantitative data. Next, the patent applications' claims were analysed in order to detect incremental patents and classified according to their incrementalities. Finally we looked for evidence of triviality. As a result, it was demonstrated that the ARV market is highly concentrated and patent applications basically belong to six countries. Evidence that many incrementalities are actually trivialities and act as entry barriers, was found. Patent landscape studies such as this one can be extrapolated to other areas or countries, and can be used as a tool for public policy’s analysis to really fuel technological advance.
This report presents a comprehensive analysis of the US blood banking market, including:Major issues pertaining to the US blood banking practice, as well as key economic, regulatory, demographic, social and technological trends with significant market impact during the next ten years. Specifically, the study explores the impact of anticipated changes in government regulations, trends in complicated surgeries, birth rate and other key issues.Ten-year volume and sales forecasts for 40 blood typing, grouping and infectious disease screening tests, including NAT procedures performed in US community and regional blood centers, hospitals, commercial laboratories, and plasma fractionation facilities.Annual placements and installed base estimates for major automated and semiautomated analyzers. Review of current instrumentation technologies, and a feature comparison of over 20 analyzers. Ten-year reagent and instrument sales forecasts.Sales and market shares of leading reagent and instrument suppliers.Review of current and emerging technologies, and their potential market applications.Product development opportunities for instruments ,consumables, and auxiliary products.Profiles of major current and emerging suppliers, including their sales, market shares, product portfolios, marketing tactics, technological know-how, new products in R&D, collaborative arrangements, and business strategies.Business opportunities and strategic recommendations for suppliers.Contains 460 pages and 53 tables
Six infectious diseases--pneumonia, tuberculosis, diarrheal diseases, malaria, measles and HIV/AIDS--account for half of all premature deaths worldwide, killing mostly children and young adults, according to the World Health Organization (WHO). Moreover, threatening pandemics such as swine flu (H1N1 influenza A virus) are adding significant pressure to already strained healthcare budgets of governments around the world. This report TriMark Publications analyzes the anti-infective drugs market and highlights the existing and developing anti-infectives used to ameliorate infectious diseases' afflictions on humankind. Anti-infective drugs include: anti-viral therapeutics, antibiotics, anti-fungal agents and prophylactic treatments such as vaccines. Particular attention is paid to the clinical market segment and the pharmaceutical/biotechnology companies involved in anti-infective drugs with specific emphasis on each company's sales focus, product portfolio and R&D pipeline. To date, the most successful anti-infective drugs target the human immunodeficiency virus (HIV, the virus that causes AIDS), the herpes virus (HSV-1 and HSV-2), bacterial infections and hepatitis C (HCV). A number of exciting novel anti-viral and antibiotic compounds are currently revolutionizing anti-infective drugs markets, including Truvada and Valtrex, which are anti-HIV and anti-herpes therapies, respectively. Significant resources are also being dedicated toward hepatitis A (HAV), hepatitis B (HBV) and Staph infections, including MRSA. What's more, this study will examine the existing and developing anti-infective drugs targeted at infectious diseases that continue to devastate developing countries, including: cholera, dengue fever, meningitis, rotavirus, typhoid and yellow fever.
Pharma Leader Series Top 25 Ophthalmic Drug Manufacturers 2015-2025Visiongain
For an Executive Summary of this report please contact ben.suntivarakom@visiongain.com
(+44 (0)20 7549 9976) or refer to our website: https://www.visiongain.com/Report/1404/Pharma-Leader-Series-Top-25-Ophthalmic-Drug-Manufacturers-2015-2025
Aridis Pharmaceuticals Inc is a late-stage biopharmaceutical company. It is engaged in the discovery and development of targeted immunotherapy using fully human monoclonal antibodies, or mAbs, to treat life-threatening infections.
U.S. dependency on foreign pharmaceutical production imposes vulnerability to failure
Authors: Veronika Valdova, D.V.M. and Ronald L Sheckler
Affiliation: Arete-Zoe, LLC
ABSTRACT
Pharmaceutical supply chains have become increasingly complex due to the shift of manufacturing and critical operations to Asia. U.S. pharmaceutical dependency on foreign sole-source production of essential materials imposes vulnerability affecting the entire industry and national health systems from interruption by exposure to natural events and man-made threats, both accidental and criminal as well as political. Sector vulnerabilities stem from complex regulatory landscape, difficulties for enforcement of quality standards at foreign facilities, single-source supply chain resulting from limited sourcing options, increasing shipping distance exposure to both natural events and complicated by maritime chokepoints. Periodic and chronic shortages of many essential products across therapeutic categories have been significant for more than a decade. The Covid-19 crisis aggravated some of these long-standing issues and made the systemic vulnerabilities publicly evident. The combination of limited capacity to exercise control over essential commodities, the long-term trend of outsourcing, with the politicization of business relationships causes the entire pharmaceutical industrial sector to be internationally dependent, creating numerous potentials for systemic failure.
Innovative Clinical Chemistry and Immunodiagnostic Technologies and Emerging ...ReportLinker.com
This unique 1,115-page report contains 450 tables, and provides sales and market shares of leading reagent and instrument suppliers, as well as test volume and sales forecasts for 100 chemistry, TDM, endocrine, cancer, immunoprotein and abused drug assays, calibrators and controls. Available by country and section.This unique worldwide market intelligence and technology assessment report will help current suppliers and potential market entrants identify and evaluate emerging opportunities and develop effective strategic responses. The report explores future trends in the U.S., five major European countries (France, Germany, Italy, Spain, UK) and Japan; provides estimates of the specimen, test and sales volumes, as well as major suppliers’ sales and market shares; compares features of leading analyzers; profiles key competitors; and identifies specific product and marketing opportunities emerging during the next ten years.The clinical chemistry and immunodiagnostics markets are undergoing significant transformation, caused by convergence of new and more stringent regulations; advances in diagnostic technologies, system engineering, automation, and IT; and intensifying competition. Some segments, like routine chemistry, begin to resemble commodity markets, where product positioning and cost per test are more critical than underlying technology. This evolving marketplace creates exciting opportunities for a variety of new instruments, reagent systems, and auxiliary products, such as specimen preparation devices, controls, and calibrators.
Existing pharmacovigilance post-market surveillance system is based on reporting of adverse drug reactions to national databases in real-time and post-marketing safety studies.
Quantitative evaluation of incidence, prevalence trends, and patterns of use from reporting data is problematic due to under-reporting and missing data on exposure. This is especially true if drugs are used off-label, in populations they were not intended for, or in combination with other medications.
While the case study below emphasizes post-market surveillance of marketed drugs, the same principles apply to other areas within clinical research and drug development, outcomes research, monitoring, and evaluation of the quality of provided care and pharmaco-economic applications.
Catheters are used in a number of processes, such as: cardiovascular, urological, intravenous, oximetry, thermodilution, suction and wound drainage processes, that involve the administration or drainage of fluids from the body. The global market for catheters is vibrant and continually evolving with significant investments to improve the capabilities of existing catheters, improve safety features and identify new medical applications. The growing number of aged people undergoing diagnostic and therapeutic procedures is driving increases in catheter sales. Government regulations also play a key role, mainly in the urological catheter segment, as regulations attempt to promote fewer infections among hospitalized patients through more frequent use of catheterization. This TriMark Publications report provides a detailed analysis of the global market for catheters, including central venous catheters (CVC), peripheral venous catheters (PVC), midline catheters (MC), hemodialysis catheters, pulmonary artery catheters, peripheral artery catheters and umbilical catheters. The study also analyzes almost all of the companies known to be marketing, manufacturing or developing catheter products in the U.S. and worldwide. Detailed tables, charts and figures are included with projected sales data by geographic region for the Americas, EMRA (Europe, the Middle East, Russia, Africa) and Asia-Pacific regions.
Big Data in Drug Safety: Making post-marketing surveillance in pharmacovigila...Arete-Zoe, LLC
The paper makes a case for change in the way data on the safety of medicines is collected, structured, analyzed, visualized, and shared. Post-market surveillance shall move away from active reporting of individual case reports into national and international databases toward the collection and analysis of anonymous structured summary data from health care providers. The objective is to enable an analysis of total numbers of treated patients and treatment outcomes, including adverse drug reactions and off-label drug use, to provide meaningful, population-based, statistically valid, bias-free, real-time information on safety and efficacy of products on the market without endangering patients' privacy. Such approach would significantly reduce privacy concerns and add value for stakeholders who are interested in timely and accurate information on benefit:risk profile of medicinal products.
Innovative Molecular Diagnostic Technologies and Emerging MarketsReportLinker.com
This unique seven-country report contains 1,050 pages, 96 tables, and is designed to help current suppliers and potential market entrants identify and evaluate major business opportunities emerging in the molecular diagnostics market during this decade. The report explores business and technological trends in the US, five major European countries, (France, Germany, Italy, Spain, UK) and Japan; provides 5- and 10-year test volume/sales forecasts; estimates shares of leading competitors; compares features of major analyzers; profiles leading market players; and identifies specific product and business opportunities facing instrument and consumable suppliers during the next ten years.The molecular diagnostics market is unquestionably the most rapidly growing segment of the in vitro diagnostics industry. The next ten years will witness significant developments in reagent systems and automation, as well as introduction of a wide range of new products that will require innovative marketing approaches. The rate of market penetration into routine clinical laboratories, however, will depend on the introduction of cost-effective and automated systems with amplification methods. In order to successfully capitalize on the opportunities presented by the molecular diagnostics market, many companies are already exploiting new DNA probe and biochip technologies as corporate strategic assets, managed in support of business and marketing strategies. Integrating new technology planning with business and corporate strategies will be one of the most challenging tasks for diagnostics companies during the next ten years.
Global Molecular Diagnostics Market: Innovative Technologies and Emerging Bus...ReportLinker.com
This unique seven-country report contains 1,050 pages, 96 tables, and is designed to help current suppliers and potential market entrants identify and evaluate major business opportunities emerging in the molecular diagnostics market during this decade. The report explores business and technological trends in the US, five major European countries, (France, Germany, Italy, Spain, UK) and Japan; provides 5- and 10-year test volume/sales forecasts; estimates shares of leading competitors; compares features of major analyzers; profiles leading market players; and identifies specific product and business opportunities facing instrument and consumable suppliers during the next ten years.The molecular diagnostics market is unquestionably the most rapidly growing segment of the in vitro diagnostics industry. The next ten years will witness significant developments in reagent systems and automation, as well as introduction of a wide range of new products that will require innovative marketing approaches. The rate of market penetration into routine clinical laboratories, however, will depend on the introduction of cost-effective and automated systems with amplification methods. In order to successfully capitalize on the opportunities presented by the molecular diagnostics market, many companies are already exploiting new DNA probe and biochip technologies as corporate strategic assets, managed in support of business and marketing strategies. Integrating new technology planning with business and corporate strategies will be one of the most challenging tasks for diagnostics companies during the next ten years.
Competing in the European Molecular Diagnostics Market: France, Germany, Ital...ReportLinker.com
This new 970-page comprehensive five-country report from Venture Planning Group is designed to help current suppliers and potential market entrants identify and evaluate the major business opportunities emerging in the European molecular diagnostics market during the next five years. The report explores business and technological trends in major European countries (France, Germany, Italy, Spain, UK); provides 5-year test volume/sales forecasts; estimates shares of leading competitors; compares features of major analyzers; profiles leading market players; and identifies specific product and business opportunities facing instrument and consumable suppliers during the next five years.The $4.5 billion molecular diagnostics market is unquestionably the most rapidly growing segment of the in vitro diagnostics industry. The next five years will witness significant developments in reagent systems and automation, as well as introduction of a wide range of new products that will require innovative marketing approaches. The rate of market penetration into routine clinical laboratories, however, will depend on the introduction of and cost-effective automated systems with amplification methods. In order to successfully capitalize on the opportunities presented by the molecular diagnostics market, many companies are already exploiting new technologies as corporate strategic assets, managed in support of business and marketing strategies. Integrating new technology planning with business and corporate strategies will be one of the most challenging tasks for diagnostics companies during the next five years.
ICIC 2014 Patent Landscape Analysis as a Tool for Public Policies Adjustment:...Dr. Haxel Consult
The innovative multinational pharmaceutical industry is highly dependent on the release and promotion of new drugs. However, recent economic evidence demonstrates a continuing decrease in new drugs’ market approval. Moreover, the industry is challenged by the “patent cliff”, where many blockbuster drugs are losing patent protection and facing ferocious competition.
It seems that the shortage of new drugs points to an intensification of drug development based on molecules already known, leading to incremental patents. However, there is a suspicion that many incremental patents are actually trivial, because they add little or nothing to existing therapies, but still impose high drug costs. To analyze that hypothesis, the present study has drawn the profile of all patents filed in Brazil in the antiretroviral (ARV) field up to 2012. Using VantagePoint® and Questel Orbit® softwares, a patent matrix was constructed with quali-quantitative data. Next, the patent applications' claims were analysed in order to detect incremental patents and classified according to their incrementalities. Finally we looked for evidence of triviality. As a result, it was demonstrated that the ARV market is highly concentrated and patent applications basically belong to six countries. Evidence that many incrementalities are actually trivialities and act as entry barriers, was found. Patent landscape studies such as this one can be extrapolated to other areas or countries, and can be used as a tool for public policy’s analysis to really fuel technological advance.
This report presents a comprehensive analysis of the US blood banking market, including:Major issues pertaining to the US blood banking practice, as well as key economic, regulatory, demographic, social and technological trends with significant market impact during the next ten years. Specifically, the study explores the impact of anticipated changes in government regulations, trends in complicated surgeries, birth rate and other key issues.Ten-year volume and sales forecasts for 40 blood typing, grouping and infectious disease screening tests, including NAT procedures performed in US community and regional blood centers, hospitals, commercial laboratories, and plasma fractionation facilities.Annual placements and installed base estimates for major automated and semiautomated analyzers. Review of current instrumentation technologies, and a feature comparison of over 20 analyzers. Ten-year reagent and instrument sales forecasts.Sales and market shares of leading reagent and instrument suppliers.Review of current and emerging technologies, and their potential market applications.Product development opportunities for instruments ,consumables, and auxiliary products.Profiles of major current and emerging suppliers, including their sales, market shares, product portfolios, marketing tactics, technological know-how, new products in R&D, collaborative arrangements, and business strategies.Business opportunities and strategic recommendations for suppliers.Contains 460 pages and 53 tables
Six infectious diseases--pneumonia, tuberculosis, diarrheal diseases, malaria, measles and HIV/AIDS--account for half of all premature deaths worldwide, killing mostly children and young adults, according to the World Health Organization (WHO). Moreover, threatening pandemics such as swine flu (H1N1 influenza A virus) are adding significant pressure to already strained healthcare budgets of governments around the world. This report TriMark Publications analyzes the anti-infective drugs market and highlights the existing and developing anti-infectives used to ameliorate infectious diseases' afflictions on humankind. Anti-infective drugs include: anti-viral therapeutics, antibiotics, anti-fungal agents and prophylactic treatments such as vaccines. Particular attention is paid to the clinical market segment and the pharmaceutical/biotechnology companies involved in anti-infective drugs with specific emphasis on each company's sales focus, product portfolio and R&D pipeline. To date, the most successful anti-infective drugs target the human immunodeficiency virus (HIV, the virus that causes AIDS), the herpes virus (HSV-1 and HSV-2), bacterial infections and hepatitis C (HCV). A number of exciting novel anti-viral and antibiotic compounds are currently revolutionizing anti-infective drugs markets, including Truvada and Valtrex, which are anti-HIV and anti-herpes therapies, respectively. Significant resources are also being dedicated toward hepatitis A (HAV), hepatitis B (HBV) and Staph infections, including MRSA. What's more, this study will examine the existing and developing anti-infective drugs targeted at infectious diseases that continue to devastate developing countries, including: cholera, dengue fever, meningitis, rotavirus, typhoid and yellow fever.
Pharma Leader Series Top 25 Ophthalmic Drug Manufacturers 2015-2025Visiongain
For an Executive Summary of this report please contact ben.suntivarakom@visiongain.com
(+44 (0)20 7549 9976) or refer to our website: https://www.visiongain.com/Report/1404/Pharma-Leader-Series-Top-25-Ophthalmic-Drug-Manufacturers-2015-2025
Aridis Pharmaceuticals Inc is a late-stage biopharmaceutical company. It is engaged in the discovery and development of targeted immunotherapy using fully human monoclonal antibodies, or mAbs, to treat life-threatening infections.
U.S. dependency on foreign pharmaceutical production imposes vulnerability to failure
Authors: Veronika Valdova, D.V.M. and Ronald L Sheckler
Affiliation: Arete-Zoe, LLC
ABSTRACT
Pharmaceutical supply chains have become increasingly complex due to the shift of manufacturing and critical operations to Asia. U.S. pharmaceutical dependency on foreign sole-source production of essential materials imposes vulnerability affecting the entire industry and national health systems from interruption by exposure to natural events and man-made threats, both accidental and criminal as well as political. Sector vulnerabilities stem from complex regulatory landscape, difficulties for enforcement of quality standards at foreign facilities, single-source supply chain resulting from limited sourcing options, increasing shipping distance exposure to both natural events and complicated by maritime chokepoints. Periodic and chronic shortages of many essential products across therapeutic categories have been significant for more than a decade. The Covid-19 crisis aggravated some of these long-standing issues and made the systemic vulnerabilities publicly evident. The combination of limited capacity to exercise control over essential commodities, the long-term trend of outsourcing, with the politicization of business relationships causes the entire pharmaceutical industrial sector to be internationally dependent, creating numerous potentials for systemic failure.
Innovative Clinical Chemistry and Immunodiagnostic Technologies and Emerging ...ReportLinker.com
This unique 1,115-page report contains 450 tables, and provides sales and market shares of leading reagent and instrument suppliers, as well as test volume and sales forecasts for 100 chemistry, TDM, endocrine, cancer, immunoprotein and abused drug assays, calibrators and controls. Available by country and section.This unique worldwide market intelligence and technology assessment report will help current suppliers and potential market entrants identify and evaluate emerging opportunities and develop effective strategic responses. The report explores future trends in the U.S., five major European countries (France, Germany, Italy, Spain, UK) and Japan; provides estimates of the specimen, test and sales volumes, as well as major suppliers’ sales and market shares; compares features of leading analyzers; profiles key competitors; and identifies specific product and marketing opportunities emerging during the next ten years.The clinical chemistry and immunodiagnostics markets are undergoing significant transformation, caused by convergence of new and more stringent regulations; advances in diagnostic technologies, system engineering, automation, and IT; and intensifying competition. Some segments, like routine chemistry, begin to resemble commodity markets, where product positioning and cost per test are more critical than underlying technology. This evolving marketplace creates exciting opportunities for a variety of new instruments, reagent systems, and auxiliary products, such as specimen preparation devices, controls, and calibrators.
Existing pharmacovigilance post-market surveillance system is based on reporting of adverse drug reactions to national databases in real-time and post-marketing safety studies.
Quantitative evaluation of incidence, prevalence trends, and patterns of use from reporting data is problematic due to under-reporting and missing data on exposure. This is especially true if drugs are used off-label, in populations they were not intended for, or in combination with other medications.
While the case study below emphasizes post-market surveillance of marketed drugs, the same principles apply to other areas within clinical research and drug development, outcomes research, monitoring, and evaluation of the quality of provided care and pharmaco-economic applications.
Catheters are used in a number of processes, such as: cardiovascular, urological, intravenous, oximetry, thermodilution, suction and wound drainage processes, that involve the administration or drainage of fluids from the body. The global market for catheters is vibrant and continually evolving with significant investments to improve the capabilities of existing catheters, improve safety features and identify new medical applications. The growing number of aged people undergoing diagnostic and therapeutic procedures is driving increases in catheter sales. Government regulations also play a key role, mainly in the urological catheter segment, as regulations attempt to promote fewer infections among hospitalized patients through more frequent use of catheterization. This TriMark Publications report provides a detailed analysis of the global market for catheters, including central venous catheters (CVC), peripheral venous catheters (PVC), midline catheters (MC), hemodialysis catheters, pulmonary artery catheters, peripheral artery catheters and umbilical catheters. The study also analyzes almost all of the companies known to be marketing, manufacturing or developing catheter products in the U.S. and worldwide. Detailed tables, charts and figures are included with projected sales data by geographic region for the Americas, EMRA (Europe, the Middle East, Russia, Africa) and Asia-Pacific regions.
Big Data in Drug Safety: Making post-marketing surveillance in pharmacovigila...Arete-Zoe, LLC
The paper makes a case for change in the way data on the safety of medicines is collected, structured, analyzed, visualized, and shared. Post-market surveillance shall move away from active reporting of individual case reports into national and international databases toward the collection and analysis of anonymous structured summary data from health care providers. The objective is to enable an analysis of total numbers of treated patients and treatment outcomes, including adverse drug reactions and off-label drug use, to provide meaningful, population-based, statistically valid, bias-free, real-time information on safety and efficacy of products on the market without endangering patients' privacy. Such approach would significantly reduce privacy concerns and add value for stakeholders who are interested in timely and accurate information on benefit:risk profile of medicinal products.
Innovative Molecular Diagnostic Technologies and Emerging MarketsReportLinker.com
This unique seven-country report contains 1,050 pages, 96 tables, and is designed to help current suppliers and potential market entrants identify and evaluate major business opportunities emerging in the molecular diagnostics market during this decade. The report explores business and technological trends in the US, five major European countries, (France, Germany, Italy, Spain, UK) and Japan; provides 5- and 10-year test volume/sales forecasts; estimates shares of leading competitors; compares features of major analyzers; profiles leading market players; and identifies specific product and business opportunities facing instrument and consumable suppliers during the next ten years.The molecular diagnostics market is unquestionably the most rapidly growing segment of the in vitro diagnostics industry. The next ten years will witness significant developments in reagent systems and automation, as well as introduction of a wide range of new products that will require innovative marketing approaches. The rate of market penetration into routine clinical laboratories, however, will depend on the introduction of cost-effective and automated systems with amplification methods. In order to successfully capitalize on the opportunities presented by the molecular diagnostics market, many companies are already exploiting new DNA probe and biochip technologies as corporate strategic assets, managed in support of business and marketing strategies. Integrating new technology planning with business and corporate strategies will be one of the most challenging tasks for diagnostics companies during the next ten years.
Global Molecular Diagnostics Market: Innovative Technologies and Emerging Bus...ReportLinker.com
This unique seven-country report contains 1,050 pages, 96 tables, and is designed to help current suppliers and potential market entrants identify and evaluate major business opportunities emerging in the molecular diagnostics market during this decade. The report explores business and technological trends in the US, five major European countries, (France, Germany, Italy, Spain, UK) and Japan; provides 5- and 10-year test volume/sales forecasts; estimates shares of leading competitors; compares features of major analyzers; profiles leading market players; and identifies specific product and business opportunities facing instrument and consumable suppliers during the next ten years.The molecular diagnostics market is unquestionably the most rapidly growing segment of the in vitro diagnostics industry. The next ten years will witness significant developments in reagent systems and automation, as well as introduction of a wide range of new products that will require innovative marketing approaches. The rate of market penetration into routine clinical laboratories, however, will depend on the introduction of cost-effective and automated systems with amplification methods. In order to successfully capitalize on the opportunities presented by the molecular diagnostics market, many companies are already exploiting new DNA probe and biochip technologies as corporate strategic assets, managed in support of business and marketing strategies. Integrating new technology planning with business and corporate strategies will be one of the most challenging tasks for diagnostics companies during the next ten years.
Competing in the European Molecular Diagnostics Market: France, Germany, Ital...ReportLinker.com
This new 970-page comprehensive five-country report from Venture Planning Group is designed to help current suppliers and potential market entrants identify and evaluate the major business opportunities emerging in the European molecular diagnostics market during the next five years. The report explores business and technological trends in major European countries (France, Germany, Italy, Spain, UK); provides 5-year test volume/sales forecasts; estimates shares of leading competitors; compares features of major analyzers; profiles leading market players; and identifies specific product and business opportunities facing instrument and consumable suppliers during the next five years.The $4.5 billion molecular diagnostics market is unquestionably the most rapidly growing segment of the in vitro diagnostics industry. The next five years will witness significant developments in reagent systems and automation, as well as introduction of a wide range of new products that will require innovative marketing approaches. The rate of market penetration into routine clinical laboratories, however, will depend on the introduction of and cost-effective automated systems with amplification methods. In order to successfully capitalize on the opportunities presented by the molecular diagnostics market, many companies are already exploiting new technologies as corporate strategic assets, managed in support of business and marketing strategies. Integrating new technology planning with business and corporate strategies will be one of the most challenging tasks for diagnostics companies during the next five years.
Future Horizons in the European Molecular Diagnostics Market--France, Germany...ReportLinker.com
This comprehensive five-country report is designed to help current suppliers and potential market entrants identify and evaluate major business opportunities emerging in the molecular diagnostics market during the next five years. The report explores business and technological trends in major European countries (France, Germany, Italy, Spain, UK); provides 5-year test volume/sales forecasts; estimates shares of leading competitors; compares features of major analyzers; profiles leading market players; and identifies specific product and business opportunities facing instrument and consumable suppliers during the next five years.The $4.5 billion molecular diagnostics market is unquestionably the most rapidly growing segment of the in vitro diagnostics industry. The next five years will witness significant developments in reagent systems and automation, as well as introduction of a wide range of new products that will require innovative marketing approaches. The rate of market penetration into routine clinical laboratories, however, will depend on the introduction of cost-effective and automated systems with amplification methods. In order to successfully capitalize on the opportunities presented by the molecular diagnostics market, many companies are already exploiting new technologies as corporate strategic assets, managed in support of business and marketing strategies. Integrating new technology planning with business and corporate strategies will be one of the most challenging tasks for diagnostics companies during the next five years. Contains 970 pages and 75 tables
Roundup of This Year's AACC Meeting in AtlantaBruce Carlson
The American Association of Clinical Chemistry was held this year in Atlanta, GA. Kalorama was at the meeting and notes several developments, with a particular focus on point-of-care.
There will be a steady increase in demand for new diagnostic testing services in the next five-year period, along with pressures to improve the quality of healthcare delivered in the clinic and also to lower its costs. Clinical labs experienced a substantial growth during the last decade.
Coronary Disease Global Clinical Trials Review, H1, 2012ReportLinker.com
Coronary Disease Global Clinical Trials Review, H1, 2012
Summary
GlobalData's clinical trial report, 'Coronary Disease Global Clinical Trials Review, H1, 2012" provides data on the Coronary Disease clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Coronary Disease. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Coronary Disease. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData's team of industry experts.Note: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.
Scope
- Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations - Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type- Listings of discontinued trials (suspended, withdrawn and terminated)
Reasons to buy
- Understand the dynamics of a particular indication in a condensed manner- Abridged view of the performance of the trials in terms of their status, recruitment, location, sponsor type and many more- Obtain discontinued trial listing for trials across the globe- Espy the commercial landscape of the major Universities / Institutes / Hospitals or Companies
The global sexually transmitted disease (STD) diagnostics market size reached US$ 104.1 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 159.5 Billion by 2032, exhibiting a growth rate (CAGR) of 4.71% during 2024-2032.
More Info:- https://www.imarcgroup.com/sexually-transmitted-disease-diagnostics-market
ReportsnReports – Point of Care Diagnostic Testing World MarketsReportsnReports
Point of care testing (POCT) enables rapid diagnostic tests to be performed while the patient is at the point of care facility where results can be obtained immediately, rather than waiting hours or even days for outside lab results to arrive. Point of care testing covers: blood glucose testing, blood gas and electrolytes analysis, rapid coagulation testing, rapid cardiac markers diagnostics, drugs of abuse screening, urine strips testing, pregnancy testing, fecal occult blood analysis, food pathogens screening, hemoglobin diagnostics, infectious disease testing and cholesterol screening.
Veterinary Molecular Diagnostics Market PPT: Overview, Dynamics, Trends, Segm...IMARC Group
The global veterinary molecular diagnostics market size reached US$ 690.8 Million in 2023. Looking forward, IMARC Group expects the market to reach US$ 1,391.9 Million by 2032, exhibiting a growth rate (CAGR) of 7.9% during 2024-2032.
More Info:- https://www.imarcgroup.com/veterinary-molecular-diagnostics-market
Genital Herpes Global Clinical Trials Review, H1, 2013ReportLinker.com
Genital Herpes Global Clinical Trials Review, H1, 2013
Summary
GlobalData's clinical trial report, 'Genital Herpes Global Clinical Trials Review, H1, 2013" provides data on the Genital Herpes clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Genital Herpes. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Genital Herpes. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData's team of industry experts.Note: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.
Scope
- Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations - Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type- Listings of discontinued trials (suspended, withdrawn and terminated)
Reasons to buy
- Understand the dynamics of a particular indication in a condensed manner- Abridged view of the performance of the trials in terms of their status, recruitment, location, sponsor type and many more- Obtain discontinued trial listing for trials across the globe- Espy the commercial landscape of the major Universities / Institutes / Hospitals or Companies
Smartphones: When is the first and last time you check yours?ReportLinker.com
Nearly half (46%) of Americans say they check their smartphones as soon as they wake up, while they’re still in bed, according to ReportLinker’s survey results. This is especially true of Millennials, 66% of whom say it’s the first thing they do before getting out of bed.
75% of Ameircans say they keep their smartphones active all day and night, and a staggering 83% of Millennials say they do.
In fact, disconnecting can be hard. More than half of Americans say their last check is right before bed – and 13% say they disconnect only after they’ve gotten into bed for the night. Even after they fall asleep, about 10% say they’ll wake up and check it during the night.
This graphic shows Samsung's customers are still loyal: 86% of Samsung Customers would consider Samsung next time they upgrade their smartphone. More info on reportlinker.com/inisght
Allegra Strategies is proud to release the 2012 report on European branded coffee shop market, providing comprehensive research on this fast developing market.The ProjectCaf
Allegra's definitive annual study on the UK branded coffee shop market is now available; with insight from over 25,000 consumers the report provides an authoritative view of the market.Drawing on more than 12 years in-depth research, it is considered to be the bible of the coffee sector.KEY AREAS COVERED' Market size and growth projections for the total UK market' Impact of recent economic downturn on trading performance' Key player profiles, including financial performance, pricing analysis and forecasts' Importance of ethical and sustainability issues' Key success factors and market trends' Opportunities and challenges for suppliers' Consumer coffee consumption patterns' Consumer brand awareness and perceptions of key players' Differences between customer demographics, including age, gender, occupation and location by the reportSOURCE OF INFORMATION' Interviews with CEOs, managing directors, senior managers and store managers of major industry players, including:' leading UK coffee and food-focused chains' major coffee roasters and key equipment suppliers' non-specialist players including department stores, supermarkets, bookstores' leading property companies, letting agents and landlords' local authorities' Online surveys with UK coffee shop visitors' Desk research including: News articles and trade press, the Internet and company websites,industry associations, published accounts, data supplied by operators' In-store observations and analysis
Wireless Infrastructure: Market Shares, Strategies, and Forecasts, Worldwide,...ReportLinker.com
WinterGreen Research announces that it has published a new study Wireless Infrastructure: Market Shares, Strategy, and Forecasts, Worldwide, 2013 to 2019. Next generation mission critical systems are leveraging new technology. The 2013 study has 554 pages, 245 tables and figures. Worldwide Wireless Infrastructure markets are poised to achieve significant growth as Building out core networks and backhaul for smart phones.A smart phone is not very smart if the infrastructure can't support its applications. In response to the high growth smart phone markets, wireless infrastructure promises to grow dramatically in the near term.. Wireless Infrastructure technologies include WiMax, LTE, 4G and HSPA. These technologies are driving much higher capacity from the base station back to the fiber core. Fiber core is putting extreme pressure on provider's infrastructure and backhaul networks.WinterGreen Research predicts that the dramatic growth of wireless infrastructure is based on the growth of smart phones to a one trillion market by 2019, serving an installed base of 8.5 billion, many people having more than one smart phone. Wireless infrastructure markets at $58 billion in 2012 will be $163 billion by 2019, new markets evolved because of the value that apps provide to smart phones, mobile devices, tablets, and the Internet of things.According to Susan Eustis, lead author of the study, 'Wireless Infrastructure is being installed to upgrade core networks and upgrade backhaul and base stations to make systems more modern. Infrastructure for the Internet and for smart mobile devices creates demand for more sophisticated web development and web applications that in turn depend on more sophisticated infrastructure. Everything is going mobile. This evolution is driven by mobile smart phones and tablets that provide universal connectivity. Modern systems represent a significant aspect of Internet market evolution.'The proportions of wireless infrastructure market industry segments are expected to remain much as they are, with the small cells and femtocells achieving strong growth on the access side, the core infrastructure must be upgraded to support the added backhaul backbone infrastructure. Wireless apps are expected to achieve $37 trillion revenue by 2019. This unbelievable growth occurs as the Internet is expanded to implement the interconnection of everything.Digital devices proliferate, machine to machine capabilities vastly expand instrumentation. The digital devices become the engine of a world economy, with apps collecting pennies a day for millions of apps from 8.5 billion people with smart phones by 2019.
Global Electric Resistance Welded Pipes IndustryReportLinker.com
This report analyzes the worldwide markets for Electric Resistance Welded Pipes in Thousand Tons by the following Product Segments: Mechanical Steel Tubing, Structural Tubing, Structural Steel Pipes, Pressure Tubing, Standard Pipes, Oil Country Tubular Goods, and Line Pipes. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Middle East, and Latin America. Annual estimates and forecasts are provided for the period 2010 through 2018. Also, a six-year historic analysis is provided for these markets. The report profiles 181 companies including many key and niche players such as Al Jazeera Steel Products Company SAOG, Arabian Pipes Company, ArcelorMittal SA, ERW Pipes Portfolio of ArcelorMittal ChelPipe, Choo Bee Metal Industries Berhad, EVRAZ North America, JFE Steel Corporation, Maharashtra Seamless Limited, Melewar Industrial Group Berhad, Nippon Steel & Sumitomo Metal Corporation, Northwest Pipe Company, OAO TMK, TMK IPSCO, PT Bakrie Pipe Industries, Salzgitter Mannesmann Line Pipe GmbH, Tata Steel Europe, Techint Group SpA, Tenaris S.A., TenarisSiderca, Ternium S.A., United States Steel Corporation, United Metallurgical Company /OMK, Welspun Corp Ltd., Wheatland Tube Company, and Select Products of Wheatland Tube Company. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.
This report analyzes the worldwide markets for Wireless Gaming in US$ Million by the following Product Segments: Messaging Based Wireless Gaming, Browser/Web Based Wireless Gaming, and Downloadable Wireless Gaming. The report provides separate comprehensive analytics for the US, Japan, Europe, and Rest of World. Annual estimates and forecasts are provided for the period 2010 through 2018. The report profiles 90 companies including many key and niche players such as Blockdot, Inc., DeNA Co., Ltd., Electronic Arts, Inc., Gameloft SA,GAMEVIL, GREE International, Inc., Glu Mobile Inc., GigaMedia Limited, HandyGames, I-play, Itsmy
Hyperalgesia Global Clinical Trials Review, H1, 2013ReportLinker.com
Hyperalgesia Global Clinical Trials Review, H1, 2013
Summary
GlobalData's clinical trial report, 'Hyperalgesia Global Clinical Trials Review, H1, 2013" provides data on the Hyperalgesia clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Hyperalgesia. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Hyperalgesia. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData's team of industry experts.Note: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.
Scope
- Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations - Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type- Listings of discontinued trials (suspended, withdrawn and terminated)
Reasons to buy
- Understand the dynamics of a particular indication in a condensed manner- Abridged view of the performance of the trials in terms of their status, recruitment, location, sponsor type and many more- Obtain discontinued trial listing for trials across the globe- Espy the commercial landscape of the major Universities / Institutes / Hospitals or Companies
The Future of Direct Communications Technologies and Proximity-based Applicat...ReportLinker.com
Overview: There are a number of technologies that may be deployed that all provide the ability for devices to "discover" one another, although over different distances ranging from centimeters (Near Field Communications), to meters (Bluetooth), to 10s of meters (Wi-Fi). They also all provide the ability for the devices to communicate directly with one another without a centralized network. Some of these use direct communication as their primary mode of communication e.g. NFC or RFID. Others are more traditional networks which provide direct communication ability as an adjunct to their primary network functions e.g. LTE-Direct or Wi-Fi Direct. Most of the short-term drivers for proximity-based services will be mobile advertising and social networking, especially friend-finder services or dating services, and gaming. In the longer term, other applications will come into play within the scope of the so called Internet of Things. The challenge and opportunity for network operators will be to develop new user scenarios and even new business models to generate revenues from these services. This research uncovers opportunities that will be both beneficial and disruptive to the existing ecosystem and value chain. This research is must reading for any company that is considering offerings within proximity and direct communications and any company that wants to stay ahead of the crowd in terms of preparation for these disruptive technologies. Target Audience: ' Mobile network operators' Industry verticals of all types' Wireless device manufacturers' Network infrastructure companies' Advertising agencies, brands, and merchants' Social networks, advertising, and content providers' Proximity, location, and direct communications vendors Key Report Benefits: ' Market forecasts for each significant technology/solution approach' Recognize the upcoming role and importance of LTE Direct compared to other solutions' Analysis of the major vendors focused on proximity and direct communications solutions' Understand the relationship between proximity, direct communications and the Internet of Things' Understand the technical and business-related differences between proximity/presence and location' Identify each of the major technologies/solutions for proximity detection, location determination, and direct communications' Evaluation of the market for major applications including public safety, social networking, advertising, the Internet of Things, and general location services Select Companies in Report: ' 3M Company' Alcatel-Lucent' iSIGN' LG' Nokia' Samsung' Qualcomm' Verizon Wireless
Competing in the European Clinical Chemistry and Immunodiagnostic Markets: Fr...ReportLinker.com
This new 900-page five-country market intelligence and technology assessment report from Venture Planning Group will help current suppliers and potential market entrants identify and evaluate emerging opportunities and develop effective strategic responses. The report explores future trends in major European countries (France, Germany, Italy, Spain, UK); provides estimates of the specimen, test and sales volumes, as well as major suppliers sales and market shares; compares features of leading analyzers; profiles key competitors; and identifies specific product and marketing opportunities emerging during the next five years.The clinical chemistry and immunodiagnostic markets are undergoing significant transformation, caused by convergence of new and more stringent regulations; advances in diagnostic technologies, system engineering, automation, and IT; and intensifying competition. However, this evolving marketplace creates exciting opportunities for a variety of new instruments, reagent systems, and auxiliary products, such as specimen preparation devices, controls, and calibrators.
Bradycardia Global Clinical Trials Review, H1, 2013ReportLinker.com
Bradycardia Global Clinical Trials Review, H1, 2013
Summary
GlobalData's clinical trial report, 'Bradycardia Global Clinical Trials Review, H1, 2013" provides data on the Bradycardia clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Bradycardia. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Bradycardia. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData's team of industry experts.Note: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.
Scope
- Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations - Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type- Listings of discontinued trials (suspended, withdrawn and terminated)
Reasons to buy
- Understand the dynamics of a particular indication in a condensed manner- Abridged view of the performance of the trials in terms of their status, recruitment, location, sponsor type and many more- Obtain discontinued trial listing for trials across the globe- Espy the commercial landscape of the major Universities / Institutes / Hospitals or Companies
Acid Indigestion / Heartburn/ Pyrosis Global Clinical Trials Review, H1, 2013
Summary
GlobalData's clinical trial report, 'Acid Indigestion / Heartburn/ Pyrosis Global Clinical Trials Review, H1, 2013" provides data on the Acid Indigestion / Heartburn/ Pyrosis clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Acid Indigestion / Heartburn/ Pyrosis. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Acid Indigestion / Heartburn/ Pyrosis. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData's team of industry experts.Note: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.
Scope
- Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations - Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type- Listings of discontinued trials (suspended, withdrawn and terminated)
Reasons to buy
- Understand the dynamics of a particular indication in a condensed manner- Abridged view of the performance of the trials in terms of their status, recruitment, location, sponsor type and many more- Obtain discontinued trial listing for trials across the globe- Espy the commercial landscape of the major Universities / Institutes / Hospitals or Companies
The biomass market suffered during the economic downturn in the face of low coal prices, logistic barriers and supply issues. 2010 saw more movement in the sector as coal prices are beginning to rise once again making co-firing coal plants with biomass more attractive. Furthermore, the biomass component of a coal-fired plant may be eligible for feed-in tariff or count towards renewable portfolio standards.Most of these plants rely on wood pellets, often transported at great distance, rather than wood chips or other less dense biomass sources. In the wood pellets market, supplies from the US and Canada are cheaper than their European counterparts and thus North America is a major suppli- ers for European biomass plants. CIS countries, Russia, Australia and South Africa have entered as significant suppliers, which if they could ramp up supply, could be serious competitors to the US and Canada. Or in the case of Russia, resolve supply delay issues, could be one of the biggest players in the market.
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HIV-AIDS Testing Markets
Published on January 2012
Report Summary
There are an estimated 33.3 million people living with HIV (the virus which causes AIDS) worldwide and approximately 2.6 million
people are newly-infected each year. While the Asian and African regions account for more than 90% of the HIV-infected population
(with the highest number in Sub-Saharan Africa), the U.S. and European regions make up greater than 60% of the HIV testing
market. This TriMark Publications report provides a comprehensive examination of the HIV/AIDS testing market, a specific segment of
the in vitro diagnostics (IVD) market as it relates to infectious diseases. It examines the available and emerging technologies being
utilized by the HIV testing field, defines the dollar volume of sales'both in the U.S. and worldwide'and analyzes the factors that
influence the size and growth of the market. The chief HIV testing assays, i.e., predictive, screening, prognostic, monitoring,
pharmacogenomic and theranostic, are covered thoroughly, as are high-growth applications in different clinical diagnostic areas and
expanding markets, such as employee screening, emergency medicine and satellite clinic testing. Additionally, this analysis covers
the following areas in details: enzyme-linked immunosorbent assay (ELISA), antibody/p24 antigen test (fourth-generation test),
Western blot assay, line immunoassays, indirect fluorescent antibody (IFA) assay, nucleic acid tests for infectious diseases, and the
emerging technologies related to HIV and AIDS diagnosis. Moreover, this study also provides a thorough analysis of the companies
known to be marketing, manufacturing or developing HIV testing products, as well as provides detailed tables and figures covering
HIV testing markets around the globe.
Table of Content
TABLE OF CONTENTS
1. Overview 7
1.1 Statement of Report 7
1.2 About This Report 8
HIV-AIDS Testing Markets (From Slideshare) Page 1/16
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1.3 Scope of the Report 8
1.4 Objectives 9
1.5 Methodology 9
1.6 Executive Summary 10
2. Overview of HIV and AIDS 13
2.1 HIV Virus 13
2.1.1 Structure 13
2.1.2 Genetic Code 14
2.1.3 Subtypes 14
2.1.3.1 HIV-1 14
2.1.3.2 HIV-2 15
2.2 Viral Mechanism of Action (HIV Life Cycle) 15
2.2.1 Entry into the Cell 16
2.2.2 Replication and Transcription 16
2.2.3 Assembly and Release 16
2.3 HIV Transmission 16
2.4 Symptoms of HIV and AIDS 17
2.4.1 Acute (Primary) Infection 17
2.4.2 Clinically Asymptomatic Infection 17
2.4.3 Symptomatic HIV Infection 17
2.4.4 AIDS 18
2.5 Diagnosis of HIV and AIDS 18
2.6 Brief Summary of Current Therapies 21
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3. Profile of HIV/AIDS: Statistics and Epidemiology 24
3.1 Worldwide HIV/AIDS Incidence 24
3.1.1 Sub-Saharan Africa 25
3.1.2 Asia 26
3.1.3 Eastern Europe and Central Asia 26
3.1.4 Caribbean 26
3.1.5 Central and South America 27
3.1.6 Middle East and North Africa 27
3.1.7 North America and Western and Central Europe 27
3.1.8 Oceania 27
3.2 HIV/AIDS in the U.S. 28
3.3 Economic Impact of HIV/AIDS 32
4. Overview of HIV Testing 33
4.1 Main Objectives of HIV Testing 33
4.2 HIV Screening Tests 33
4.3 HIV Confirmation Tests 34
4.4 HIV Monitoring Tests 34
4.4.1 Measuring Viral Loads 34
4.4.2 Genotyping Assays 35
4.4.3 Phenotyping Assays 35
4.5 Proposed Changes to the HIV Testing Algorithm 35
4.6 U.S. Recommendations for HIV Testing 37
4.7 U.S. HIV Testing Statistics 40
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5. Technological Platforms Used in HIV Testing 42
5.1 Enzyme-Linked Immunosorbent Assay (ELISA) 42
5.1.1 Rapid HIV Tests 44
5.1.1.1 Immunoconcentration (Flow Through Assay) 47
5.1.1.2 Immunochromatography (Lateral Flow Assay) 47
5.1.1.3 Particle Agglutination 49
5.1.1.4 Solid Phase (Dipstick Assay) 49
5.2 Antibody/p24 Antigen Test (Fourth-Generation Test) 50
5.3 Western Blot Assay 51
5.4 Line Immunoassays 52
5.5 Indirect Fluorescent Antibody (IFA) Assay 53
5.6 Nucleic Acid Tests 53
5.7 Emerging Technologies 56
6. Issues Affecting HIV Testing 57
6.1 Overview of Specimens Used in HIV Testing 57
6.1.1 Blood Samples 57
6.1.1.1 Dried Blood Spot Samples 57
6.1.2 Oral Fluid Samples 58
6.1.3 Urine Samples 58
6.2 Limitations of Existing HIV Testing Products 58
6.2.1 Sensitivity and Specificity 59
6.2.1.1 False Negative Rates 59
6.2.1.2 False Positive Rates 60
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6.2.1.3 Positive Predictive Values 60
6.2.2 Indeterminate Results 61
6.2.3 Window Period (Delayed Detection of HIV Infection) 61
6.3 Quality Control Criteria 62
6.4 Challenges Associated with HIV Testing 63
6.5 Potential Areas of Improvement in HIV Testing and Assay Performance 64
6.6 Factors Influencing Selection and Use of HIV Tests 65
6.7 Barriers and Facilitators to Routine HIV Testing 65
6.7.1 Routine HIV Testing in Emergency Departments 66
6.7.2 Compatibility of State Laws with CDC HIV Testing Recommendations 66
6.8 Clinical Laboratory Improvement Amendments (CLIA) 68
7. HIV Tests on the Market 71
7.1 Overview of the Types of HIV Tests on the Market 71
7.2 Anti-HIV Antibody Screening Tests 72
7.2.1 Whole Blood, Serum, or Plasma-based HIV Tests 72
7.2.1.1 Abbott Diagnostics 73
7.2.1.2 Ani Labsystems 73
7.2.1.3 Avioq, Inc. 73
7.2.1.4 Bio-Rad Laboratories 74
7.2.1.5 Green Cross 74
7.2.1.6 Maxim Biomedical 74
7.2.1.7 Ortho-Clinical Diagnostics 75
7.2.1.8 Shanghai Kehua 75
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7.2.1.9 Siemens Healthcare Diagnostics 75
7.2.1.10 Span Diagnostics 75
7.2.1.11 Biomedical, Inc. 75
7.2.2 Oral HIV Tests 76
7.2.2.1 Avioq, Inc. 76
7.2.2.2 Chembio Diagnostic Systems 76
7.2.2.3 Immunoscience, Inc. 76
7.2.2.4 Maxim Biomedical 77
7.2.2.5 OraSure Technologies 77
7.2.2.6 Oral Collection Devices 78
7.2.3 Urine-based HIV Tests 79
7.2.3.1 Maxim Biomedical 79
7.2.4 Rapid HIV Tests 79
7.2.4.1 Alere 82
7.2.4.2 bioLytical Laboratories, Inc. 82
7.2.4.3 Bio-Rad Laboratories 83
7.2.4.4 MedMira Laboratories, Inc. 83
7.2.4.5 OraSure Technologies 84
7.2.4.6 Trinity Biotech 85
7.2.4.7 Alere 85
7.2.4.8 bioMérieux 86
7.2.4.9 Bioner 86
7.2.4.10 Chembio Diagnostics 86
7.2.4.11 Core Diagnostics 86
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7.2.4.12 EY Laboratories 86
7.2.4.13 Green Cross 87
7.2.4.14 InTec Products 87
7.2.4.15 J Mitra & Co. 87
7.2.4.16 Orgenics, Ltd. 87
7.2.4.17 Premier Medical Corporation 87
7.2.4.18 Qualpro Diagnostics 88
7.2.4.19 Savyon Diagnostics 88
7.2.4.20 Shanghai Kehua 88
7.2.4.21 Span Diagnostics 88
7.2.4.22 Standard Diagnostics, Inc. 89
7.2.4.23 Additional Companies Selling Non-FDA-Approved Rapid HIV Assays Outside
of the U.S. 89
7.3 HIV Antibody/p24 Antigen Tests (Fourth-Generation Tests) 90
7.3.1 FDA-Approved Fourth-Generation HIV Assays 91
7.3.1.1 ARCHITECT HIV Ag/Ab Combo Assay (Abbott Laboratories) 91
7.3.1.2 GS HIV Ag/Ab Combo EIA (Bio-Rad Laboratories) 92
7.3.2 Fourth-Generation HIV Assays Commercially Available Outside of the U.S. 92
7.3.2.1 ABBOTT AxSYM HIV Ab/Ag Combo (Abbott Laboratories) 92
7.3.2.2 Determine' HIV 1/2 Ag/Ab Combo (Alere) 93
7.3.2.3 Vironostika® HIV Uni-Form II Ag/Ab (bioMérieux) 93
7.3.2.4 GENEDIA® HIV Ag-Ab ELISA (Green Cross) 93
7.3.2.5 HIV TRI-DOT + Ag (J Mitra & Co.) 93
7.3.2.6 Fourth-Generation Microlisa HIV Ag and Ab (J Mitra & Co.) 93
7.3.2.7 Immunocomb® II HIV 1&2 TriSpot Ag-Ab (Orgenics) 94
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7.3.2.8 Enzygnost HIV Integral II (Siemens Healthcare Diagnostics) 94
7.3.2.9 Enzaids Duet (Span Diagnostics) 94
7.4 Anti-HIV Antibody Confirmation Tests 94
7.4.1 Western Blot 94
7.4.1.1 Cambridge Biotech HIV-1 Western Blot Kit (Maxim Biomedical) 94
7.4.1.2 GS HIV-1 Western Blot (Bio-Rad Laboratories) 95
7.4.1.3 OraSure HIV-1 Western Blot Kit (OraSure Technologies) 95
7.4.1.4 HIV Blot 2.2 (MP Diagnostics) 95
7.4.2 Line Immunoassays 95
7.4.3 Indirect Fluorescent Antibody 95
7.5 Nucleic Acid Tests 96
7.5.1 Measuring Viral Loads and Resistance Testing 97
7.5.2 Instruments and Reagents 97
7.5.2.1 Abbott Molecular 97
7.5.2.2 Gen-Probe, Inc. 98
7.5.2.3 Roche Molecular Systems 99
7.5.2.4 Siemens Healthcare Diagnostics 102
7.5.2.5 bioMérieux 103
7.5.2.6 Qiagen 103
7.5.3 Diagnostic Testing Services 104
7.5.4 Comparisons of HIV Nucleic Acid Testing Platforms 105
7.5.5 HIV Molecular Diagnostic and NAT HIV Monitoring Market History 106
7.6 Home HIV Testing 106
7.6.1 Home HIV Testing Kits 106
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7.6.1.1 Direct Access Diagnostics 106
7.6.1.2 Home Access Health Corp. 106
7.6.2 Competitive Situation for Home HIV Testing Kits 107
7.6.3 Advantages and Disadvantages of Home HIV Testing 108
7.7 Emerging Technologies and Products 109
8. Market Analysis: Size, Growth, Share and Competitors 111
8.1 Worldwide HIV/AIDS Testing Market 111
8.1.1 U.S. Market 115
8.1.2 European Market 120
8.1.3 Asian Market 120
8.1.4 ROW Market 122
8.2 Market Drivers and Restraints 122
8.2.1 Market Drivers 122
8.2.2 Market Restraints 124
8.3 Market and Technology Trends 124
8.3.1 Market Trends 124
8.3.2 Technology Trends 126
8.4 Competitive Situation 127
8.5 HIV Market Challenges and Strategic Recommendations 129
8.6 Insurance Coverage and Reimbursement 130
8.7 Policies Affecting HIV Testing 130
8.8 Recent Industry Activity 131
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INDEX OF FIGURES
Figure 2.1: Diagram of HIV 13
Figure 2.2: HIV Replication Cycle 15
Figure 2.3: Ten Best-Selling AIDS Drugs in the U.S., 2009 22
Figure 3.1: Global Trend of HIV Infection, 1990-2009 24
Figure 3.2: Number of People Newly Infected with HIV, 1990-2009 25
Figure 3.3: Number of Deaths Due to AIDS, 1990-2009 25
Figure 3.4: Top Ten Countries with the Highest Adult HIV Prevalence Rate, 2009
26
Figure 3.5: Global View of Adult (Ages 15-49) HIV Infection, 2009 28
Figure 3.6: Ethnic Distribution of AIDS Patients in the U.S., 2009 29
Figure 3.7: U.S. Rates for New HIV Cases, 2008 30
Figure 3.8: New HIV Infections by Transmission Category, 2009 31
Figure 4.1: Proposed HIV Testing Algorithm 36
Figure 4.2: Percent of Persons (Ages 18-64) Who Reported Being Tested for HIV in
the U.S., 2011 40
Figure 4.3: Percent of Persons (Ages 18-64) Who Reported Being Tested for HIV in
the U.S. by
Race/Ethnicity, 2011 41
Figure 5.1: Schematic of ELISA Tests 42
Figure 5.2: Concentration of Different HIV Markers in Plasma Following Initial
Infection 44
Figure 5.3: Schematic of a Flow Through Assay 47
Figure 5.4: Schematic of a Lateral Flow Assay 48
Figure 5.5: Basic Components of a Lateral Flow Device 48
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Figure 5.6: Schematic of a Dipstick Assay 50
Figure 5.7: Schematic of an Antibody/p24 Antigen (Fourth-Generation) Test 50
Figure 5.8: Western Blot Assay Preparation 51
Figure 5.9: Western Blot Banding Pattern 52
Figure 6.1: Understanding Positive Predictive Values 60
Figure 6.2: Window Period for Antibody-based HIV Tests 61
Figure 6.3: Concentration of Different HIV Markers in Plasma Following Initial
Infection 62
Figure 6.4: Percentage of Emergency Departments Performing HIV Testing, 2011 66
Figure 6.5: Legislative Changes in State Laws to Increase Compatibility with CDC
Recommendations, 2011 68
Figure 8.1: Global POCT Share of HIV Testing Market, 2010 113
Figure 8.2: HIV Test Kits Procured by WHO in 2009, by Region 115
Figure 8.3: Distribution of HIV Molecular Diagnostic Testing by Purpose 118
Figure 8.4: Market Share Viral Load HIV NAT Diagnostic Testing 119
INDEX OF TABLES
Table 2.1: AIDS-Defining Conditions 18
Table 2.2: Different Types of HIV Screening and Diagnostic Tests 19
Table 2.3: Comparison of CDC and WHO Case Definitions 20
Table 2.4: CDC Case Definition for HIV Infection Among Adults and Adolescents
(Aged =13 years), 2008 20
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Table 2.5: WHO Case Definition for HIV Infection, 2007 20
Table 2.6: WHO Case Definition for Advanced HIV (Including AIDS), 2007 21
Table 2.7: WHO Immunological Classification for Established HIV Infection, 2007
21
Table 2.8: Classes of Antiretroviral HIV Drugs 21
Table 2.9: New Antiretroviral Drugs 23
Table 3.1: Global Summary of the HIV/AIDS Epidemic, 2009 24
Table 3.2: Global HIV Statistics, 2009 27
Table 3.3: Countries with the Greatest Number of People Living with HIV, 2009 28
Table 3.4: Top Ten States by Cumulative AIDS Diagnosis, 2009 32
Table 3.5: Top Ten States by AIDS Diagnosis Rate, 2009 32
Table 4.1: Tests Used to Detect Acute HIV Infection 34
Table 4.2: HIV Antiviral Drug Resistance Testing Recommendations 39
Table 4.3: Common HIV Testing Sites 41
Table 4.4: Public Health HIV Testing Sites 41
Table 5.1: Advantages and Disadvantages of ELISA HIV Tests 43
Table 5.2: Rapid HIV Testing Outlets 45
Table 5.3: Desirable Characteristics of Rapid Tests 46
Table 5.4: Advantages of Rapid HIV Tests 46
Table 5.5: Disadvantages of Rapid HIV Tests 46
Table 5.6: Advantages and Disadvantages of Fourth-Generation Tests 51
Table 5.7: Advantages and Disadvantages of Nucleic Acid HIV Assays 55
Table 6.1: FDA-Approved Assays for Dried Blood Spot Samples 57
Table 6.2: Challenges Associated with HIV Testing 63
Table 6.3: Factors Influencing Assay Selection 65
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Table 6.4: Compatibility of Consent and Counseling Laws with 2006 CDC
Recommendations, 2011 67
Table 6.5: Financial Comparison for Moderate and Waived CLIA Labs 69
Table 7.1: ELISA Assays Detecting Anti-HIV Antibodies 72
Table 7.2: HIV Assays Using Oral Fluid Specimens 76
Table 7.3: Rapid HIV Immunoassay Tests 79
Table 7.4: FDA-Approved Rapid HIV Antibody Screening Tests 81
Table 7.5: USAID List of Approved HIV/AIDS Rapid Test Kits, June 2011 89
Table 7.6: HIV Antibody/p24 Antigen (Fourth-Generation) Tests 90
Table 7.7: FDA-Approved Confirmation Tests 94
Table 7.8: Nucleic Acid HIV Tests 96
Table 7.9: Summary of Assays for HIV Viral Load Testing 104
Table 7.10: Commercially Available Molecular Diagnostic Products for HIV Assay
104
Table 7.11: Comparison of HIV Home Sampling and Home Testing Services 108
Table 8.1: Worldwide HIV Testing Market, 2007-2016 111
Table 8.2: Worldwide HIV Screening and Confirmatory Testing Market, 2007-2016
111
Table 8.3: Worldwide POCT Market for HIV, 2007-2016 112
Table 8.4: Largest POCT Diagnostic Companies Worldwide, 2008 113
Table 8.5: Worldwide HIV Monitoring (NAT) Market, 2007-2016 114
Table 8.6: Number of Testing Facilities and Number of People Who Received HIV
Testing
Worldwide, 2010 114
Table 8.7: U.S. HIV Testing Market, 2007-2016 115
Table 8.8: U.S. HIV Screening and Confirmatory Testing Market, 2007-2016 116
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Table 8.9: U.S. POCT Market for HIV, 2007-2016 116
Table 8.10: Estimated U.S. Market Share for CLIA-waived HIV POCT, 2011 117
Table 8.11: U.S. Market for NAT Testing to Monitor HIV, 2007-2016 118
Table 8.12: HIV Testing Market for OTC Testing in the U.S., 2007-2016 119
Table 8.13: Drivers of Demand for HIV Diagnostic Testing 123
Table 8.14: NAT HIV Monitoring Market: Market Drivers Ranked in Order of Impact
123
Table 8.15: Drivers of Demand for HIV Diagnostic Testing 124
Table 8.16: NAT HIV Monitoring Market: Market Restraints Ranked in Order of
Impact 124
Table 8.17: Competitive Factors Related to HIV Tests 128
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