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IVD Assay Development Market: Key Insights

   October 30, 2024

Rising Prevalence of Chronic Diseases & the Increasing Geriatric Population

The prevalence of chronic diseases such as cancer, diabetes, arthritis, and heart disease is on the rise globally. According to the World Health Organization (WHO), chronic diseases account for 41 million deaths each year (around 74% of all deaths) globally. Growth in the geriatric population, tobacco & alcohol use, physical inactivity, and unhealthy diets are driving a steady increase in the prevalence of chronic diseases. According to the International Diabetes Federation (IDF), the global prevalence of diabetes is estimated to increase from 10.5% of the global population in 2021 to 11.3% in 2030. According to the IDF, in 2021, 537 million individuals were diagnosed with diabetes globally (Western Pacific accounted for 206 million cases, while Southeast Asia accounted for 90 million cases, the Middle East & North Africa for 73 million cases, Europe for 61 million cases, North America & the Caribbean for 51 million cases, South & Central America for 32 million cases, and Africa for 24 million cases). The number of diabetes cases is projected to reach 643 million in 2030 and 783 million in 2045.

Growing Focus on the Development of POC IVD Assays

Point-of-care (POC) testing is used for diagnosis at or near the site where the patient is located. POC assays have been approved for the diagnosis of infectious diseases, such as chlamydia, gonorrhea, and influenza, and help medical professionals in initiating treatment early. In decentralized setups, POC assays help physicians monitor infectious diseases and improve clinical workflows. Furthermore, POC assays allow for rapid turnaround, helping medical professionals make timely treatment decisions, which is especially important for patients in remote places, emergencies, and instances where immediate action is required. POC IVD assays enable better patient outcomes by allowing for speedier treatment and evaluation. Early disease identification, monitoring, and treatment plan adjustments based on real-time outcomes improve patient care. Furthermore, POC IVD assays are useful in remote or underserved areas where access to regular laboratory facilities is restricted. These assays help with disease diagnosis, screening, and monitoring in populations with poor healthcare infrastructure. 

High Burden of Infectious Diseases

Infectious diseases are caused by organisms such as bacteria, viruses, fungi, and parasites. Infectious diseases are transmitted from person to person or through bites from insects or animals. The burden of infectious diseases has increased globally, driving the need for safe and effective diagnostic assays. Hence, the demand for IVD assay development is expected to grow with the increasing utilization of diagnostic assays.

The following statistics indicate the high burden of infectious diseases:

  • In 2023, 39.9 million individuals had HIV globally, of which 1.4 million were children. There were 20.8 million individuals with HIV in Eastern and Southern Africa, 5.1 million in Western and Central Africa, 6.7 million in Asia and the Pacific, and 2.3 million in Western and Central Europe and North America (Source: HIV.gov).
  • According to the WHO, in 2022, an estimated 254 million individuals had chronic Hepatitis B, and 50 million individuals had Hepatitis C globally. A significant number of those chronically infected develop cirrhosis or liver cancer. HCV leads to approximately 242,000 deaths annually, largely due to cirrhosis and hepatocellular carcinoma.

Thus, the increasing burden of infectious diseases is expected to boost the need for diagnosis, driving the development of IVD assays.

Ahead of the Curve: IVD Assay Development Market Analysis

Recent insights from Meticulous Research® provide valuable perspectives on the future trajectory of the IVD assay development market. Projections suggest a potential worth of $8.39 billion by 2031, driven by a remarkable Compound Annual Growth Rate (CAGR) of 7.9% from 2024 to 2031.

As the global landscape takes shape, the North American region is expected to hold a substantial market share in 2024. Influential industry players, including Creative Biolabs, Inc. (U.S.), Avioq, Inc. (U.S.), Bio-Techne Corporation (U.S.), and Thermo Fisher Scientific Inc. (U.S.), have established a broad presence across various regions, leading to the widespread adoption of their IVD assay development services. In essence, this comprehensive overview from Meticulous Research serves as a gateway into the IVD assay development market.

Conclusion

The rising prevalence of chronic diseases associated with the geriatric population, the high burden of infectious diseases, the growing focus on the development of POC IVD assays, and rising healthcare expenditures have propelled the demand for IVD assay development services.

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