In-vitro diagnostics (IVD) are tests performed on samples, including tissue or blood that is taken from the human body. It can detect diseases and can be utilized to monitor the overall health of a person that enables to cure, treat or prevent disease. IVD may also be utilized in precision medicine to identify patients who can be benefitted from particular therapies. It can comprise next-generation sequencing (NGS) tests which scan an individual DNA for detection of genomic variations. Some IVD tests are intended for consumers to use at home and most commonly are utilized in the laboratory or other healthcare areas. The major factors contributing to the growth of the global IVD market include emerging demand for non-invasive diagnostics and rising prevalence of chronic and infectious diseases, such as cancer, HIV and diabetes.

For instance, as per the World Health Organization (WHO), the global cancer burden is estimated to have risen to 18.1 million new cases and 9.6 million mortalities in 2018. One in 5 men and one in 6 women across the globe develop cancer during their lifetime, and one in 8 men and one in 11 women reported mortalities from the disease. Across the globe, the total number of people who are alive within 5 years of a cancer diagnosis, called the 5-year prevalence, is estimated to be 43.8 million. Cancers of the lung and female breast are the major types across the globe in terms of the number of new cases. 

This results in the rising demand for IVD for cancer diagnosis. Due to a significant rise in the prevalence of cancer, multiple advances in IVD tools were reported over the years. For instance, in May 2019, Roche Diagnostics Corp. declared the global launch of VENTANA ROS1 (SP384) Rabbit Monoclonal Primary Antibody. It is the first and only IVD ROS1 immunohistochemistry (IHC) assay available for recommended lung cancer testing guidelines. It has the added benefits of rapid turnover time. The test is aimed at detecting the presence of ROS1 protein in tissue and may be suitable to identify ROS1-positive cancer cases.

ROS1 is also being investigated in a range of clinical trials in other cancer types. It can also be used for personalized precision medicine in cancer. Several IVD molecular-based tests are encouraging the development of precision oncology and are offering viable alternatives for cancer prognostics and diagnostics. Therefore, a significant rise in the prevalence of cancer is contributing to the demand for IVD techniques.

Segment Outlook

The global IVD market is segmented on the basis of application, product, technology and end-user. Based on application, the market is further classified into diabetes, infectious diseases, cancer, drug testing, autoimmune diseases and others. Based on product, the market is further classified into instruments, reagents and software and services. Based on technology, the market is further segmented into immunodiagnostics, molecular diagnostics, hematology, tissue diagnostics and others. Based on end-user, the market is further classified into hospitals and clinics, diagnostic laboratories and others.

IVD Market: By Application

Infectious diseases segment is anticipated to hold a significant share in the market in 2018 owing to the significant rise in the prevalence of infectious disease coupled with rising demand for advanced diagnostics tests for detecting infectious diseases. As per WHO, infectious diseases kill more than 17 million people a year. This includes Ebola and HIV/AIDS, tuberculosis, and malaria, among others. IVD are crucial tools for potential clinical management of patients with infectious diseases.

Major IVD techniques, including immunohistochemistry assays, such as immuno-agglutination and Enzyme-linked Immunosorbent Assay (ELISA) are used to detect infectious microorganisms, including virus or bacteria in patient samples. Furthermore, reliable IVD devices for infectious markers, including HIV and hepatitis B and C which are utilized for blood donation screening are prerequisite for the production of safe blood and blood products. IVD tests can be employed for disease screening, monitoring treatments and assessment of the safety of blood-related products.

Global IVD Market Share by Application, 2018 (%)

Regional Outlook

Geographically, the global IVD market is further segmented into four major regions including North America, Europe, Asia-Pacific, and RoW. Significant funding for the development of IVD tests and emerging demand for point-of-care testing are encouraging the growth of the market across the regions.

Global IVD Market Growth by Region, 2019-2025

Asia-Pacific is estimated to witness lucrative growth in the market during the forecast period

Significant rise in the incidences of chronic diseases coupled with rising awareness for early diagnosis of the condition are supporting to drive the market growth in the region. As per the International Agency for Research on Cancer, the total number of new cancer cases in China was 4.3 million in 2018. The major prevalent cancer types in China include lung, colorectum, stomach, liver and breast. This significant incidence of cancer cases in the country is estimated to contribute to the demand for IVD technologies, such as molecular diagnostics and tissue diagnostics in the country. Some funding opportunities for molecular diagnostics were also reported in the country. For instance, in February 2019, GenomePrecision raised $15 million B round which is supported by Yizhuang Biomedical M&A Fund. The company is engaged in the development of molecular diagnostics products, Such funding opportunity shows that the companies are working towards the development of IVD tools, which in turn, would offer significant opportunity for the market growth in China.

Competitive Landscape

Some crucial players in the market include Thermo Fisher Scientific, Inc., Abbott Laboratories, Inc., F. Hoffmann-La Roche Ltd., Siemens Healthcare GmbH and QIAGEN GmbH. Mergers and acquisitions and product launches are considered as crucial strategies adopted by these companies to expand market share and gain a competitive advantage over competitors. For instance, in October 2018, Thermo Fisher Scientific received CE Mark for Oncomine Dx Target Test. It is an IVD test for detection of 46 cancer-driver gene variants. All the biomarkers on the panel are associated with approved and investigative targeted therapies in solid tumors, including EGFR, BRAF, KRAS and ERBB2 mutations, as well as ALK, ROS1, RET, NTRK and MET fusions. This represents a significant step of the company to democratize NGS testing and precision oncology across the globe.

The Report Covers

• Market value data analysis of 2018 and forecast to 2025.
• Annualized market revenues ($ million) for each market segment.
• Country-wise analysis of major geographical regions.
• Key companies operating in the global IVD market. Based on the availability of data, information related to pipeline products and relevant news is also available in the report.
• Analysis of business strategies by identifying the key market segments positioned for strong growth in the future.
• Analysis of market-entry and market expansion strategies.
• Competitive strategies by identifying ‘who-stands-where’ in the market.