Global In Vitro Diagnostic Test Market Worth USD 60 Billion

The high growth countries, primarily Saudi Arabia, Brazil, China and India, are witnessing a double-digit growth, fueled by privatization and health insurance initiatives by governments and employers. The rising demand from a growing middle class population in Brazil, India and China is being further supported by international initiatives such as the Clinton Foundation and the Gates Foundation that have begun developing treatment programs for infectious diseases like TB, HIV, malaria, and sexually transmissible diseases.

All this is creating a market for test devices for diagnosing and monitoring the treatment efficacy of these diseases and other infectious diseases. A number of IVD companies have witnessed an increase in their revenues by entering into partnerships with these organizations. In the U.S., new healthcare disease screening and health insurance initiatives proposed by the new administration under the guidance of President Barack Obama is further encouraging the use of IVDs, though continued economic difficulties is making Americans forgo elective procedures as the co-payments are somewhat unaffordable.

The lack of trained lab technologists required to run the more complex new set of molecular and histological tests and immunoassays has led to a proliferation of sophisticated tests and lab automation tools in hematology, blood banking, microbiology, and histology. Further, the revolution in bioinformatics is allowing clinical and traditional medical engineering to blend with components derived from the telecommunications, information and computer sciences industries, thereby opening new niche markets for POC test devices, which will have a positive impact on diagnostic testing. Since getting information to care givers and patients has now become a prerequisite of all lab operations, the healthcare industry will increasingly focus on informatics, wireless communications, data networking and cost/effective healthcare delivery over the next 3-5 years.

Going forward, a modest IVD growth is expected in the developed countries and a stronger IVD growth in the developing countries, along with the shift in focus from infectious diseases to chronic conditions. The IVD industry is expected to be shaped by long-term trends such as biomarker discovery and the use of newer technologies like next generation sequencing. The use of genetic factors for evaluating patients at risk for diseases is still developing. The link between genes and disease risk provides an ongoing market opportunity for IVD research and product development in cancer, autoimmune diseases, cardiac conditions, allergy, diabetes, psychiatric conditions and others. Also, the IVD market is expected witness a shift from blood sampling to breath tests for respiratory infections, gastrointestinal disorders, cancer and even chronic diseases. A number of wearable patch sensors have already been commercialized for glucose and vital signs monitoring, while more applications are under development.

However, there are also challenges for the IVD market, such as increased privatization of healthcare services across the world, including in the developed and emerging economies, thus leading to increased pricing pressure on all devices, including IVDs. Moreover, with the increasing use of healthcare services by an aging society, cost efficiency imperatives continue to exert pressure on patients, providers and suppliers. There is significant pressure on physicians to make the right choices as well as on patients to pay for new technologies that are yet to be proved. With outcomes-based disease management establishing guidelines and directives for patient care, there will be a significant impact on the use of new tests, which have to prove their added value to patient care, along with the impact on how many and which tests are recommended and thus, reimbursed for a specific disease group.

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