Growth in this market is primarily driven by the increasing global prevalence of infectious diseases, shift in focus from centralized laboratories to decentralized point-of-care testing, and growth in funding for research on infectious disease diagnostics.
The global infectious disease diagnostics market was valued at USD 13.93 Billion in 2016 and projected to reach USD 19.35 Billion in 2022, at a CAGR of 5.6%.
Increasing global prevalence of infectious diseases
The global prevalence of infectious diseases such as influenza, HPV, hepatitis, HIV, and tuberculosis is considerably high in spite of significant improvements in sanitation practices and medicine. Many of the currently available diagnostic techniques are slow, involve complex procedures, and lack specific identification of causative agents. Owing to this, patients receive empiric, broad-spectrum antimicrobial therapy rather than appropriate therapies. This has resulted in the emergence of super-resistant microbes.
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Assays, kits and reagents segment to record the highest CAGR during the forecast period.
Increased accessibility and the increasing number of IDD tests conducted are the key drivers for this segment. Globally, the volume of IDD tests is increasing mainly due to the rising geriatric population; increasing prevalence of infectious diseases; increased variety of reagents available and analytical techniques employed; and the continuous launch of newer, faster, and more reliable products.
Roche, Bio-Rad, and bioMérieux are some of the major players in the infectious disease diagnostics market for assays, kits, & reagents.
According to MedPAC (Medicare Payment Advisory Commission), medical testing has witnessed a 40% decline in reimbursements over the past 40 years. Budgetary considerations among healthcare systems act as a major obstacle for the implementation of novel diagnostic techniques in clinical laboratories as reimbursements for these tests are low.
Medicare revised its reimbursement mechanism for some IVD tests, including infectious disease molecular tests, in 2012. Some of these molecular pathology tests do not have their own Healthcare Common Procedure Coding System (HCPCS) codes and are instead billed using unlisted codes. In the case of these codes, Medicare Administrative Contractors (MACs) establish a payment amount for their local jurisdictions.
According to CMS, 75% tests will show reimbursement rate reductions under the proposed 2018 Medicare payment rate. Some of these tests include molecular tests, targeted next-generation sequencing analysis, panels of 5 to 50 genes, and cancer tests.
These reduced reimbursements are expected to adversely affect the adoption of molecular and genetic testing in the US, which will, in turn, hinder the growth of the market.
Opportunity: Growing awareness about personalized medicine
Growing patient awareness about the benefits of personalized medicine is one of the key factors resulting in the increased use of molecular diagnostics and genomics & proteomics technologies in infectious disease testing. Diagnostic tests can be used to assess the efficacy of specific therapeutic agents in particular patients. With the help of diagnostic tests, patients who suffer disproportionately severe adverse effects from a given treatment or dosage can be identified.
Moreover, diagnostic tests help in determining the optimal dosages for drugs whose therapeutic effects are known to vary widely among different patient groups. The extent or progression of a disease and preventive measures can be identified in patients through diagnostic tests. With the growing demand for personalized medicine, the demand for such diagnostic tests is expected to increase globally.
One of the most widely used personalized treatment regimens includes therapeutic drug monitoring tests to select drugs for resistant HIV strains. According to a Los Angeles Times article, in a March 2012 survey conducted by the United Health Center for Health Reform & Modernization, more than 75% respondents agreed that genetic testing allowed physicians to offer personalized treatment.
The survey also stated that the US annually spends USD 5 billion on genetic tests, which could reach USD 15–25 billion by 2021. The growing availability of genetic and molecular diagnostic tests plays a crucial role in enabling the early detection of diseases and providing more personalized treatments; this can potentially result in substantial savings in treatment costs.
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DNA sequencing & next-generation sequencing (NGS) segment to record the highest CAGR during the forecast period.
Factors such as advancements in sequencing technologies, increasing awareness and acceptance of personalized medicine (in which this technology has significant applications), and increasing application of molecular diagnostic technologies in pharmacogenetics and point-of-care testing are expected to boost the growth of this technology in the future.
Currently, NGS has become an important technology in drug discovery and pharmacogenomics; it has changed the way the pharmaceutical industry develops, tests, and targets new medicines. Advancements in technologies and the decreasing prices of NGS-based tests are also driving the growth of this technology.
North America to account for the largest market size during the forecast period.
North America accounted for the largest share of the global infectious disease diagnostics market. The large share of this region is mainly attributed to the presence of a highly developed healthcare system, increasing prevalence of infectious diseases, the presence of a large number of leading national clinical laboratories, and easy accessibility to technologically advanced instruments in the region.
Abbott Laboratories, Becton, Dickinson and Company, Biomérieux SA, Bio-Rad Laboratories, Danaher Corporation, Diasorin, Luminex, Meridian Bioscience, Quidel, Roche Diagnostics, Siemens AG, Thermo Fisher Scientific
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