In Vitro Diagnostics Market Assessment, By Product Type [Instruments, Reagents and Consumables, Data Management Software], By Techniques [Immunodiagnostics, Clinical Chemistry, Molecular Diagnostics, Microbiology, Hematology, Coagulation and Hemostasis, U

Global In Vitro Diagnostics Market size was valued at USD 107.71 billion in 2022 and is expected to reach USD 165.55 billion in 2030 with a CAGR of 5.52% for the forecast period between 2023 and 2030F. In-Vitro Diagnostics (IVD) refers to medical instruments designed to conduct diagnostic tests on biological samples like blood, urine, and tissues. These tests are crucial in identifying and tracking infectious diseases, autoimmune disorders, and various medical conditions. Additionally, they are utilized to assess adjustments in drug therapy at regular intervals. The British In-Vitro Diagnostic Association says these tests significantly impact around 70% of clinical decisions. The market for IVD devices is experiencing significant growth due to increasing demand for and adoption of these devices. This expansion is further propelled by key players' heightened investments in research and development, aiming to innovate products and explore new applications for IVD techniques.

In the global in vitro diagnostics market, the surge in the adoption of in vitro diagnostics (IVD) can be credited to the increased testing during the pandemic. The market is set to expand further, fueled by the introduction of automated IVD systems in laboratories and hospitals, which promise efficient, accurate, and error-free diagnoses. Additionally, the market growth is driven by significant players launching many IVD products. Notably, IVD products equipped with molecular diagnostic capabilities are highly effective, delivering precise and reliable results.

In February 2022, Thermo Fisher Scientific Inc. introduced the Renvo Rapid PCR Test. This innovative test is designed to detect airborne SARS-CoV-2 pathogens and utilizes samples collected through the AerosolSense Sampler. Such cutting-edge product launches are expected to play a significant role in driving the in-vitro diagnostics market.

Increasing Adoption of Point-of-Care Testing Devices

As the burden of diseases continues to increase, medical device companies are diligently working on developing technologically advanced diagnostic devices. In response, hospitals and laboratories are growing inclined towards point-of-care testing devices, seeking accurate real-time data. Point-of-Care (PoC) testing is conducted near the patient, typically requiring only a small blood sample, and delivers rapid test results for immediate clinical decision-making. This capability enables doctors to make prompt treatment decisions without waiting for results from a central laboratory.

FUJIFILM Sonosite, Inc. revealed its plans to introduce the Sonosite PX ultrasound system in India in January 2023. This new product launch aims to enhance clinician ergonomics and efficiency for improved medical performance.

BioGX unveiled its CE-marked Point-of-Care (POC) three-gene multiplex COVID-19 test on the pixl platform in July 2022.

Growing Prevalence of Chronic Diseases

The increasing incidence of various diseases, including genetic, cardiovascular, and neurological conditions, substantially strains the healthcare system. The effective utilization of In Vitro Diagnostics (IVD) for early disease detection enables physicians to implement suitable treatments more efficiently.

For instance, based on a factsheet by the WHO in September 2022, Non-Communicable Diseases (NCDs) accounted for 41 million deaths, representing approximately 74% of all global fatalities.

In the global in vitro diagnostics market, the increasing burden of diseases can be effectively addressed through enhanced awareness of early diagnosis and the optimal use of In Vitro Diagnostics (IVD) at both patient and physician levels. The aging population's heightened vulnerability to various conditions, including hypertension, diabetes, cardiovascular, liver, and kidney diseases, has resulted in greater adoption of homecare IVD devices.

For example, as reported by the United Nations in January 2023, the global population of individuals aged 65 years and older was 761 million in 2021, and this number is projected to increase to 1.6 billion by 2050. The population of those aged 80 years or older is growing even faster.

Increasing Funding and Government Support

In the global in vitro diagnostics market, government organizations, associations, and agencies are actively promoting the utilization of IVD through awareness initiatives, thereby fostering market growth. The World Health Organization (WHO) has introduced a model list of Essential In-Vitro Diagnostics for primary healthcare and medical facilities equipped with clinical laboratories to emphasize the importance of addressing diseases based on their burden and prevalence. These categories are further subdivided to cover general IVDs and specific diseases.

For example, in June 2022, the European Commission allocated approximately USD 203 million (€ 190.9 million) to fund the ""AGLYC Project."" The primary objective of this project was to create an advanced blood-based biomarker for early detection of ischemia, enabling timely intervention before irreversible heart damage occurs. Cardiovascular disease (CVD) is the leading cause of mortality and morbidity globally, and the AGLYC biomarker implementation is anticipated to significantly improve patients' lives.

Advancement in Oncology

Oncology has witnessed remarkable advancements, transforming cancer diagnosis and treatment. Innovations in molecular diagnostics, liquid biopsies, and next-generation sequencing technologies have improved early detection and personalized treatment approaches. Biomarker identification and companion diagnostic tests have enabled targeted therapies, enhanced patient outcomes, and reduced adverse effects. Additionally, artificial intelligence and machine learning algorithms have played a pivotal role in analyzing complex data, facilitating more accurate diagnoses, and predicting treatment responses. These ongoing advancements in oncology within the in vitro diagnostics sector continue to revolutionize cancer care, offering new hope in the fight against this devastating disease.

The rapid growth of this sector can be attributed to the strong inclination of physicians towards in-vitro diagnostics products for cancer diagnosis. Additionally, the segment's expansion is projected to gain momentum due to the growing number of cancer patients worldwide.

Based on the American Cancer Society data, approximately 1.9 million new cancer cases were reported in the U.S. in 2021. Furthermore, the UICC's report highlighted that around 30% of cancers could be screened using in-vitro diagnostics (IVDs).

Impact of COVID-19

IVD encompasses a wide array of tests and techniques utilized to diagnose various disorders. The COVID-19 pandemic had positive and negative effects on different segments of the IVD market. However, the heightened utilization of molecular diagnostics offset the negative impact experienced by other segments, resulting in an overall positive influence on the market during the pandemic. Molecular diagnostic techniques specifically played a crucial role in diagnosing the SARS-CoV-2 virus. As a result, there was a substantial surge in the global demand for point-of-care tests utilizing serology and molecular techniques. Market players experienced significant growth in sales of these tests, leading to a considerable increase in their revenues.

For instance, during June 2021, Bio Rad Laboratories, Inc. introduced the PREvalence ddPCR SARS-CoV-2 Wastewater Quantification Kit. This cost-effective solution serves as a tool to detect SARS-CoV-2 in a community's wastewater.

The global in vitro diagnostics market witnessed substantial growth in 2021, surpassing the pre-pandemic levels. As countries lifted lockdown restrictions during this period, there was a notable increase in the adoption of home-based and laboratory tests. Consequently, the sales of point-of-care and molecular diagnostics products experienced a significant surge.

Key Players Landscape and Outlook

Market players deploy strategies to expand their product portfolios and provide customers with a wide range of technologically advanced and innovative products. Companies are also expanding their diagnostics portfolio to capture a larger market share. Many key market players are adopting organic and inorganic growth approaches, including mergers & acquisitions, collaborations, and developing and launching new products, to strengthen their global market position.

In March 2023, Abbott revealed that its Alinity i laboratory instrument, designed for diagnosing traumatic brain injuries (TBIs) and assessing concussions using two biomarkers, has obtained FDA approval, and is now set for commercial launch.