In vitro diagnostics (IVD) refer to tests that are used to detect or diagnose diseases or infections performed under a controlled environment such as in a laboratory. The global IVD market was valued at USD 51.67 billion in 2012 and is expected to grow at a CAGR of 5.4% from 2014 to 2020. Increasing demand for rapid and non-invasive medical procedures and the growing global prevalence of infectious and chronic diseases such as cancer, tuberculosis (TB), diabetes and cardiovascular diseases are expected to drive IVD market demand over the next six years. On account of the fact that IVD entails minimally invasive and non-invasive procedures, rising demand for these procedures will drive the global IVD market. The speed with which the results are generated also play an important role in the selection of a particular diagnostic tool/technique. For instance, the time required for sputum analysis in TB patients may be several weeks. Rapid diagnostic tests utilizing cartridge-based molecular technology have been useful in delivering results for TB diagnosis, in less than two hours. This kind of rapid diagnostics will help in early detection of the disease, better control, and consequently curb the burden of disease in the country or region.
In addition, the growing global prevalence of infectious and chronic diseases will have a high impact on the overall market during the next six years. There has been a substantial rise in the number of patients who have succumbed to infectious diseases such as respiratory, gastrointestinal and sexually transmitted diseases. Early diagnosis and regular monitoring of these patients is essential to identify, treat and control the spread of these diseases. Therefore, the rising base of target patient population will serve the market as a driver. In 2011, approximately 5 million deaths occurred from these diseases and out these deaths almost half of them were due to three diseases namely tuberculosis (TB), malaria, and AIDS. According to W.H.O estimation, in 2011, 8.7 million new cases of TB were found and approximately 1.4 million people died from TB. Molecular diagnostics are of great use in the diagnosis of these infectious diseases. IVD also plays an important role in the diagnosis of HIV. The high prevalence of this disease will also drive the market. In 2011, W.H.O estimated that approximately 34 million people were living with an HIV infection. Cancer causes approximately 7.6 million deaths annually. It is expected that this death toll will rise to over 11 million in 2030. Similarly non-communicable diseases such as diabetes and cardio-vascular diseases (CVDs) too generate substantial demand for in vitro diagnostics owing to the number of patients affected by these diseases. It is estimated that the global prevalence of diabetes will increase from 382 million in 2013 to 592 million by 2035.
Key product segments analyzed and reported in this study include tissue diagnostics, molecular diagnostics, professional diagnostics and diabetes monitoring. The professional diagnostics segment, which includes immunoassays, clinical chemistry and coagulation tests, dominated the market, accounting for 70.26% of total revenue in 2012. Growth in this segment is driven by factors such as the presence of high unmet medical needs especially in the infectious disease category and its ability to render reliable and rapid diagnostic results. The diabetes monitoring segment followed professional diagnostics in terms of revenue share in 2012 at 16.37% owing to the high global prevalence of diabetes and rising patient awareness levels. According to statistics published in the U.S. National Diabetes Fact Sheet, 2011, approximately 25.8 million people in the United States (which accounts to 8.3% of the population) suffer from diabetes of which 7 million people remain undiagnosed. This large number of patients indicates a good market opportunity for test strips and other diagnostics for diabetes testing and monitoring. On the other hand the global tissue diagnostics market is expected to grow at the highest CAGR of 10.2% from 2014 to 2020 on account of the rising demand for lab automation and the growing global incidence rates of cancer.
North America IVD market revenue share by products, 2012
North America dominated the overall market in terms of revenue share in 2012 and its market was valued at USD 20.06 billion in 2012. The growing prevalence of chronic disorders in this region highlights the urgency for more accurate and cost-effective diagnostic technologies. The current major share of North America in the in vitro diagnostics market and anticipated healthy growth during the forecast period can be justified by the increase in healthcare investment due to rising patient awareness levels. Europe was the second largest IVD market in terms of revenue share in 2012 at 30.7%. The U.K., Germany, France, Spain and Italy are the major IVD markets in this region. In most of Europe, especially Western Europe, the healthcare system primarily depends on government funding. In 2011, the overall healthcare expenditure of the U.K., Germany, France and Italy were 9.3%, 11.1%, 11.6% and 9.5% of the total GDP, respectively. Although the rising budgetary pressure has led to deeper cuts in the healthcare per capita expenditure in Europe, the increasing burden of diseases is expected to drive the growth of the IVD market in this region. According to WHO estimates, around 3 million new cases of various types of cancers were diagnosed in the European region, accounting for around 20% of the total deaths. Cancer is the most important cause of mortality and morbidity in this region. Pneumonia causes 14% of total deaths of children under the age of five years, whereas more than 60,000 people die annually due to tuberculosis. IVD techniques such as molecular diagnosis and flow cytometry enable the timely diagnosis of these diseases and can help control their spread in the region. Thus, rising prevalence of chronic disorders and aging population will contribute to the growing demand of IVD products and technologies in Europe. In addition, the availability of highly automated and advanced diagnostic technologies are likely to further drive growth of the IVD market in Europe.
Many large and small industry players providing different solutions in the form of instruments, reagents and services operate in the IVD market. This market is marked by the presence of large untapped opportunities and companies in an attempt to gain sustainability and market share make extensive R&D investments to develop new products catering to segments with high future growth rates such as molecular and tissue diagnostics. Some of the major participants of this market include Roche Diagnostics, Siemens Healthcare, Abbott Laboratories, Johnson and Johnson, Beckman Coulter Inc. and Becton Dickinson.