September is World Alzheimer’s Month, which aims to increase awareness of and challenge the stigma around Alzheimer’s disease and other dementia-associated diseases. According to the Global Burden of Disease Study 2019, dementia is estimated to almost triple, from 57.4 million cases in 2019 to 153.8 million cases by 2050. Coupled with the World Health Organization’s estimate that 60–70% of dementia cases may be Alzheimer’s disease, there is a need for accurate in vitro diagnostics (IVD) devices to aid in early diagnosis in the upcoming years.

Alzheimer’s Disease International (ADI) has stated that there is a need for individuals to be aware of the risk factors associated with dementia and take proactive steps to reduce the risk. This year’s theme, “Never too early, never too late”, highlights risk factors like smoking, physical inactivity, excessive alcohol consumption and infrequent social contact. According to GlobalData, there are currently 76 active Alzheimer’s disease IVD devices in the pipeline and ten devices undergoing clinical trials, indicating a bright future for the market.

While preventative care is ideal, like increasing physical activity, quitting smoking and maintaining strong social relationships, it is not always the reality. Thus, early detection and dementia disease differentiation IVD tests are vital to understanding the onset of the disease and how the whole body is impacted by neurodegenerative disease. For example, the clinical trial “The Swedish BioFINDER Study: Early Diagnosis of Alzheimer’s Disease – A Multidisciplinary Approach” not only aims to release a blood-based biomarker and diagnostic IVD device, SavaDx, but also to evaluate different cohorts clinically over time using various assessments to map out the differences and progression of disease. These cohorts include cognitively healthy elderly patients, patients with Parkinsonian disorders, patients with mild cognitive symptoms and dementia patients.

This research can also be applied to other IVD tests and preventative care. Over the next decade, the current pipeline and clinical trial devices will be released for diagnostic usage, thus boosting the current 63 products on the market. With dementia cases projected to almost triple by 2050, there is a large market for not just diagnostic devices but treatment and preventative care devices as well.

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By GlobalData