The World Health Organization has identified a group of diseases that are the world's most pressing health problems. This represents an opportunity for test manufacturers, particularly in POC testing. Because of their ability to deliver fast results at the point of care, rapid testing is a focus area of healthcare providers and payors in infectious disease prevention. Kalorama Information has been reporting on the rapid test area for several years and has identified the segments with the fastest growth, and infectious disease has surfaced as one of those segments.
This report, Point of Care Diagnostics for Emerging Infectious Disease Threats (Market Analysis and Technical Considerations), examines this POC segment with a focus on new threats for which there are markets in the developing world and in developed countries.
Tests can only be marketed if they can be manufactured and if they can function in the healthcare environment. Thus, this report also discusses the technical choices, possibilities and limitations to today's POC tests especially when they are used in the developing world. Reagent issues, testing on strips, instrumented and non-instrumented tests are coved in this report. These factors will impact what tests will reach the market and how they will function.
Infectious disease is a broad category, and in some disease areas, diagnostic companies already own market share. Increasingly hospitals and clinics are seeing new infectious disease threats and tests are being developed to assist them. Within the infectious disease testing market, this report details the opportunities that could be found when diseases of the developing world enter the healthcare system of the developed.
This report provides market projections for point of care diagnostics in the developed and developing world for the following infectious diseases:
Shara Rosen is Kalorama Information’s lead diagnostic industry analyst. She is the author of seven best-selling editions of The Worldwide Market for In Vitro Diagnostics, as well as scores of other titles on segments of the IVD Industry.
Brendan O'Farrell is the President of Diagnostic Consulting Network (www.dcndx.com), a provider of OEM services to developers and manufacturers of rapid assays. Key services include contract rapid assay system development, custom reagent development, industry education and training and consulting services. Among the topics these experts discuss is the number of competitors who have been successful with efforts in developing countries. The following companies are discussed in this report:
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Rapid IVD tests that are easy-to-use and that can provide results in high-temperature and scarce water conditions may be the next big growth opportunity in in vitro diagnostics (IVD), according to a new report by Kalorama Information. The healthcare market research publisher describes a quarter-billion dollar market in the next five years for tests that can detect infectious diseases such as malaria and TB—but also rarer diseases like leptospirosis and chikungunya—in its new report, Point of Care Diagnostics for Emerging Infectious Disease Threats, co-authored by Kalorama's diagnostic market analyst Shara Rosen and Diagnostic Consulting Network President Brendan O'Farrell.
Of the seven biggest killers worldwide, TB, malaria, hepatitis, and, in particular, HIV/AIDS continue to surge, with HIV/AIDS and TB likely to account for the overwhelming majority of deaths from infectious diseases in developing countries by 2020. The response of the international community towards the problem has created a market. The report cites a 13% growth rate for sales of POC tests that treat these most pressing health needs. This is greater than Kalorama forecasts for most areas of the point of care diagnostics market.
"Now that neglected diseases have come onto the radar, the supply of money to deal with it has increased," said Shara Rosen. "For the past 10-15 years politicians and aid agencies have come to understand that infectious diseases are not merely causes of suffering and death but also significant barriers to economic development."
Increased funding for infectious disease diagnostics by groups such as the Gates Foundation, the Program for Appropriate Technology in Health (PATH, Seattle, WA) and The Foundation for Innovative New Diagnostics (FIND, Geneva, Switzerland) is helping to develop a new generation of sophisticated test platforms that are designed to meet the needs of low resource environments (electricity, water, refrigeration, etc.). These efforts may go a long way to improving the detection of pathogens that are found primarily in developing countries (malaria, Chagas, Dengue fever and others).
"However, the same platforms are sorely needed everywhere," according to Rosen. "There is a huge need for user-friendly, highly specific and reliable technologies for rural and underserved communities worldwide, and that is where the opportunity lies."
While it is a growing market, it is not a market without competitors. Kalorama's market research finds that there are at least 75 vendors worldwide that market rapid test kits for emerging infectious diseases. The current market leaders are companies that have invested in sophisticated new technologies and those that have established relationships with governments and international aid agencies.
More specific market categories, as well as trends and detailed company information, can be found in Kalorama Information's Point of Care Diagnostics for Emerging Infectious Disease Threats.
CHAPTER ONE: EXECUTIVE SUMMARY
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