- The IVD product portfolio includes devices that assist in clinical chemistry and immunoassays, urinalysis, point-of-care testing, and patient self-testing devices. IVDs may be used in a variety of environments, including laboratories, clinics, diagnostic centers, educational institutes, or homes. They are employed for preventive diagnosis, early-stage screening, therapy selection, and monitoring.

- According to a leading industry player, Roche Holding AG, IVDs are extremely valuable resources for disease prevention, detection, and management. They influence roughly two-thirds of clinical decision-making while accounting for just 2% of healthcare spending.

- Furthermore, innovative development in the IVD field is currently driven by four significant trends, such as point-of-care testing, automation, digitalization, and the concept of personalized medicine.

- Moreover, the rapid spread of existing diseases and new discovery of diseases are increasing the demand for early remedies and diagnosis. This is expected to ascend the rate of clinical diagnostic application, thereby fueling the incorporation of lab automation solutions.

- The global clinical diagnostics industry has witnessed laboratory consolidation and the shift toward a data-driven environment, with significant investments in advanced technologies and transformation in business models, driven by products and value-added services.

- Evidently, the IVD market is also expected to witness the advantages of technologies, such as cognitive machine-learning capabilities and Big Data, to complement diagnostic test information and technologies, in order to enable seamless connectivity between multiple instrument systems.

- Any form of inaccuracy could lead to the mismanagement of a patient’s disease or condition. Given this potential risk, as well as the impact on the overall delivery of healthcare, the governments have assumed a role in the regulation of IVDs through several agencies, including the Food and Drug Administration (FDA), ISO, and the Centers for Medicare & Medicaid Services (CMS). These factors have significantly contributed to the market growth over the years.

Key Market Trends

Digital Transformation of Labs Aids the Market Growth

- Technological innovations have improved the productivity of clinical labs. With the increasing reliance on technology-based systems and the drastic growth of internet-driven processes, the need for automation is increasing. Digital transformation, i.e., connecting devices to the internet, ensures remote monitoring, alerts, remote control, and notifications for everything, ranging from temperature to threats.

- As manual systems always expose the process to the risk of errors, the implementation of IoT systems helps in collecting the data digitally and accurately, which has been proven to reduce the time by 60%.

- IoT also provides IVD with the capability to directly interact with the support layer, which allows event capture in an electronic way. Diagnostic devices play an essential role in improvising the healthcare industry. It is estimated that 60% of the medical decisions in the world are made with the support of IVD solutions.

- Owing to the ongoing advances in connected technologies and cloud-based laboratory information management systems (LIMS) platforms, these tools are helping businesses to access the benefits of the digital transformation and provide laboratories a secure way to organize data, making accessing insights quick and easy, while allowing businesses to control which data is sent to third-party instrument vendors.

- Systems with IoT implementation offer server control and monitoring of various sensors and can be easily configured to handle more hardware interface modules. Sensors loaded onto the devices could help in data collection and communication, with cloud servers and other devices. According to Telecoms.com survey, in 2018, 45% respondents in a survey felt that healthcare is one of the most important markets for IoT to address in the coming years.

- Additionally, laboratories can maintain data through high levels of security while providing accurate and unhampered data through IoT.

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North America to Hold the Largest Market Share

- North America has been a pioneer in clinical research for years. This region is home to some of the major pharmaceutical companies, like Pfizer, Novartis, GlaxoSmithKline, J&J, and Novartis. The region also has the highest concentration of contract research organizations (CROs). Some of the significant CROs are Laboratory Corp. of America Holdings, IQVIA, Syneos Health, and Parexel International Corp.

- The region is expected to account for the largest share of the market, owing to the availability of government funds, stringent FDA regulations, the growing use of molecular diagnostics in genetic disorders and cancer screening, and the presence of most of the major players in this region.

- Also, the increasing number of surgeries and the prevalence of various chronic diseases are also significantly driving the demand for automation in the clinical diagnostics industry. According to the American Orthopedic Surgeons (AAOS), approximately 3 million total knee arthroplasty surgeries are likely to be performed in the United States by 2030. The diagnosis of these and other chronic conditions requires sample collection, thereby boosting the demand for the market studied.

- Besides, accessibility to superior technologies, demand for laboratory automation, expansion of molecular diagnostics for genetic disorders and cancer screening, and the presence of major leading companies in the United States may also stimulate the market demand in North America.

- Further, with the outbreak of COVID-19, the region has been witnessing an increase in tests being performed to detect the virus. According to the World Health Organization (WHO), a total of 153,078 tests were performed in the United States, as of April 1, 2020. With the increase in the spread of the virus in the country, the demand for highly efficient and fast testing has increased. This is anticipated to boost the adoption of lab automation solutions rapidly in the country.

Competitive Landscape

The lab automation for in-vitro diagnostics market is a consolidated market. The entry cost for setting up lab infrastructure remains high, and hence, there are only a few major players that dominate the market. Moreover, this market has undergone a round of consolidation already. The major players in this market are Cognex Corporation, Roche Holding AG, Thermo Fisher Scientific Inc., and Abbott Laboratories, among others. Market domination through innovative product launches and strategic agreements continues across this industry.

- April 2020- Amid the outbreak of the novel coronavirus across the world, Roche Diagnostics has initiated a clinical trial of medicine ‘Actemra’ or ‘RoActemra’ to explore its potential use in the treatment of severe COVID-19 pneumonia patients. Roche Diagnostics has received a green signal from the central government to carry out the COVID-19 test in India. The company is expanding both in terms of diagnostics and medicine, by adapting to the market demands.

March 2020- Thermo Fisher Scientific Inc. launched Chromeleon 7.3 CDS software, which is designed to provide greater automation and better workflow support to help customers achieve significant productivity gains of up to 33%. It can be easily integrated into company systems and seamlessly scaled from workstation to global enterprise deployment, ensuring continuity throughout the business.

- January 2020- Agilent Technologies Inc. launched a new product designed to address key challenges that laboratories encounter when preparing DNA sequencing libraries for their research. The company's new SureSelect XT HS2 kit will help researchers accelerate their capture-based enrichment library preparation, without sacrificing the quality.

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