The in-vitro diagnostics (IVD) sector is projected to expand from US$ 72,393.80 million in 2022 to US$ 112,103.51 million by 2030, reflecting a compound annual growth rate (CAGR) of 5.6% from 2022 to 2028. Key factors propelling the growth of the in-vitro diagnostics market include the rising incidence of chronic diseases, advancements in technology, and an increasing elderly population.
In vitro diagnostics refer to tests conducted on samples such as blood or tissue extracted from the human body. These diagnostics are specifically designed to identify diseases or conditions that can be monitored to assist in the treatment, management, or prevention of illnesses. Furthermore, in-vitro diagnostics play a crucial role in precision medicine by identifying patients who may benefit from specific therapies. This category of diagnostics includes next-generation sequencing tests that analyze an individual's DNA to uncover genomic variations.
Increasing Incidence of Chronic and Infectious Diseases
Globally, there is a significant rise in the occurrence of infectious diseases, primarily caused by pathogenic microorganisms like viruses, bacteria, and parasites. Contributing factors include poor sanitation, inadequate public hygiene, rising air pollution levels, and lack of access to safe drinking water. For instance, the Public Health Agency of Canada reported 6,736 cases of hepatitis C (including acute, chronic, and unspecified cases) in 2020.
Chronic diseases, which include conditions such as cancer, chronic respiratory diseases, diabetes, and heart disease, are also on the rise. The global increase in these diseases is attributed to biological risk factors, including higher consumption of alcohol and tobacco, unhealthy dietary habits, sedentary lifestyles, and obesity. Chronic diseases are the leading cause of death worldwide. According to the Centers for Disease Control and Prevention (CDC), 6 in 10 Americans are living with at least one chronic condition, such as stroke, cancer, heart disease, or diabetes. These diseases not only lead to high mortality rates but also contribute to significant healthcare costs, which reached approximately US$ 4.1 trillion in the United States in 2021. The CDC indicates that heart disease remains the leading cause of death across various demographics.
Coronary artery disease (CAD) is identified as the most prevalent cause of death among adults, with around 375,476 fatalities attributed to CAD in 2021. The World Health Organization's 2022 National Diabetes Statistics Report estimates that approximately 422 million individuals globally have diabetes, predominantly in low- and middle-income nations, with 1.5 million deaths directly linked to the disease each year. Factors such as obesity, genetic predispositions, aging, and lack of physical activity are contributing to the rising diabetes prevalence. Additionally, a report from Cancer Research UK noted that around 18.1 million new cancer cases were diagnosed worldwide in 2020, with projections suggesting this number could rise to 28 million by 2040. Consequently, the increasing rates of infectious and chronic diseases, including cardiovascular diseases, cancer, diabetes, and respiratory illnesses, are significant drivers of growth in the in-vitro diagnostics market.
Market Trends
Growing Demand for Personalized Medicine and Genomics
North America leads the way in personalized medicine and genomics research, with a notable integration of genomics and molecular diagnostics into standard patient care. Companies are actively developing advanced genetic technologies, presenting substantial opportunities for the in-vitro diagnostics market. The US and Canada are recognized as centers for genomic research, significantly contributing to the understanding of the genetic underpinnings of diseases, biomarker identification, and the development of targeted therapies. Both nations have initiated precision medicine programs aimed at incorporating genomics into clinical practice. North America has been particularly influential in cancer genomics, hosting extensive research and clinical trials focused on the genetic factors associated with various cancers. These trials assess the effectiveness of targeted therapies, immunotherapies, and other innovative treatments tailored to the genetic profiles of patients' tumors. The American Cancer Society anticipates that in 2023, the US will see 1.9 million new cancer cases (approximately 5,370 cases daily) and 609,820 cancer-related deaths, highlighting the urgent need for effective treatments to enhance patient quality of life.
Personalized medicine involves conducting in-vitro diagnostic tests to categorize patients into subgroups based on their unique characteristics. This field, alongside advancements in genomic sequencing, molecular profiling, and other diagnostic technologies, has the potential to transform healthcare by offering targeted, precise, and individualized treatment options. Genetic testing has become increasingly accessible worldwide. In November 2022, Roche, Cancer Research UK, and the University of Manchester launched the DETERMINE trial, a multidrug precision medicine initiative aimed at evaluating whether existing agents, including those approved for more common cancers, could benefit patients with rare cancer types. This trial includes both adult and pediatric patients with rare cancers. Companies like 23andMe and AncestryDNA provide direct-to-consumer genetic testing kits, enabling individuals to explore their ancestry, genetic traits, and potential health risks. Healthcare providers also utilize genetic testing to inform treatment decisions. Thus, the rising demand for personalized medicine and genomics is expected to significantly drive the growth of the in-vitro diagnostics market in the coming years.
The "Global In-Vitro Diagnostic Market" is categorized based on product and service, application, technology, end user, and geography. The product and service segment includes reagents and kits, instruments, and software and services. In 2022, the reagents and kits segment dominated the market, driven by the increasing popularity of self-test kits and point-of-care (POC) devices, as well as the growing availability and adoption of automated instruments that enhance accuracy and efficiency. The rise in viral and fungal infections, exacerbated by poor hygiene conditions, further promotes the use of reagents. Consequently, players in the in-vitro diagnostics market are focusing on providing high-quality molecular reagents and kits to improve patient management and care.
Sources such as the European Medicines Agency, Emergency Use Authorization, Centers for Disease Control and Prevention, International Diabetes Federation, and In-Vitro Diagnostic Research have been referenced in the preparation of the in-vitro diagnostics market research report.