Canada Digital Biomarkers Market Analysis

Canada Digital Biomarkers Market Executive Summary

Canada Digital Biomarkers Market was valued at $232 Mn in 2023 and is predicted to grow at a CAGR of 22.3% from 2023 to 2030, to $949.45 Mn by 2030.

Digital biomarkers are quantifiable physiological and behavioral data collected by digital devices like wearables and smartphones. They provide insights into health, including disease progression and treatment response, enabling continuous monitoring and real-time data collection. These biomarkers are used for various health conditions, such as diabetes, cardiovascular disorders, mental health issues, and neurodegenerative diseases. By tracking metrics like physical activity, heart rate, and sleep patterns, digital biomarkers help clinicians make informed decisions and support research with real-world evidence. As technology advances, their potential to transform healthcare and improve patient outcomes grows.

As of 2021, 45.1% of Canadians aged 12 and older live with at least one major chronic disease, according to Statistics Canada. The breakdown of these common chronic diseases includes hypertension (25%), osteoarthritis (14%), mood and/or anxiety disorders (13%), osteoporosis (12%), diabetes (11%), asthma (11%), chronic obstructive pulmonary disease (COPD) (10%), ischemic heart disease (8%), cancer (8%), and dementia (7%). During the COVID-19 pandemic, market players introduced innovative solutions, such as a cost-effective mobile app by Maastricht University (September 2022) to detect COVID-19 via voice changes. Heightened fitness awareness increased wearable usage, driving demand for digital biomarkers. Disruptions in clinical trials led to advanced platforms for decentralized trials, like Thermo Fisher Scientific's PPD Decentralized Clinical Trials Network (October 2022). The WHO noted over 59,000 active clinical trials globally in 2020, underscoring the rising demand for digital biomarkers.

The market therefore is driven by significant factors like advancements in technology, growing prevalence of chronic diseases, rising healthcare costs, and increasing consumer health awareness. However, data privacy and security concerns, integration with healthcare systems, and high development costs restrict the growth and potential of the market.Prominent players in this field are ActiGraph LLC which specializes in wearable devices and data analytics for physical activity and sleep monitoring, contributing to clinical research through reliable digital biomarkers. AliveCor Inc. excels in portable ECG monitoring and AI-driven cardiac analysis, enhancing early diagnosis and intervention with FDA-cleared devices like KardiaMobile. Others contributors include Koneksa, and Altoida Inc. among others.

Market Dynamics

Market Growth Drivers

Advancements in Technology: Rapid advancements in wearable devices, mobile health applications, and sensor technologies are driving the growth of the digital biomarkers market. These technologies enable continuous and non-invasive monitoring of health parameters.

Growing Prevalence of Chronic Diseases: In Canada, over 45% of the population lives with at least one major chronic disease, including diabetes, cardiovascular diseases, and neurodegenerative disorders. This growing prevalence underscores the need for digital biomarkers that enable early diagnosis, effective disease management, and personalized treatment approaches.

Rising Healthcare Costs: The need to reduce healthcare costs while improving patient outcomes drives the adoption of digital biomarkers. These tools can enhance remote monitoring, reduce hospital visits, and enable timely interventions, leading to cost savings.

Increasing Consumer Health Awareness: Growing awareness among consumers about personal health and wellness encourages the use of digital health technologies, including digital biomarkers, to monitor and manage their health.

Market Restraints

Data Privacy and Security Concerns: The collection and use of personal health data through digital biomarkers raise concerns about data privacy and security. Ensuring compliance with data protection regulations and building consumer trust are significant challenges.

Integration with Healthcare Systems: Integrating digital biomarkers into existing healthcare infrastructure and electronic health records (EHRs) can be challenging. Interoperability issues and resistance to change from healthcare providers can hinder adoption.

High Development Costs: The research and development of digital biomarkers involve significant investment in technology, clinical validation, and regulatory compliance. High costs can be a barrier for small and medium-sized enterprises entering the market.

Regulatory Landscape and Reimbursement Scenario

In Canada, the regulatory landscape for digital health products is primarily managed by Health Canada and the Canadian Standards Association (CSA). Health Canada classifies digital health products into three categories based on their risk profiles: Class I (low risk), Class II (medium risk), and Class III (high risk). This classification dictates the regulatory pathway for approval, including the level of clinical evidence required to demonstrate the product's safety and efficacy. Additionally, digital health products must adhere to stringent cybersecurity standards to ensure patient privacy and data security.

Reimbursement for digital health products in Canada is multifaceted and varies across provinces and territories. There is no unified national reimbursement framework, leading to differences in coverage. Some digital health products may be funded through public healthcare programs in certain provinces, while others might be covered by private health insurance plans. This variability can affect access to and the affordability of digital health interventions across the country.

Competitive Landscape

Key Players

Here are some of the major key players in the Canada Digital Biomarkers Market

• ActiGraph LLC
• AliveCor Inc.
• Koneksa
• Altoida Inc.
• Amgen Inc.
• Biogen Inc.
• Empatica Inc.
• Vivo Sense
• IXICO plc
• Adherium Limited