India Digital Biomarkers Market Analysis

India Digital Biomarkers Market Executive Summary

India Digital Biomarkers Market was valued at $52.74 Mn in 2023 and is predicted to grow at a CAGR of 25.3% from 2023 to 2030, to $255.74 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.

Nearly 42% of adults in India have at least one chronic disease, with hypertension affecting 27%, diabetes 12%, and arthritis 9%. The market therefore is driven by significant factors like the rising prevalence of chronic diseases, increasing smartphone penetration, government initiatives, and growing focus on preventative care. However, data privacy concerns, limited healthcare infrastructure, and limited integration with healthcare systems 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. Other contributors include Koneksa, and Altoida Inc. among others.

Market Dynamics

Market Growth Drivers

Rising Prevalence of Chronic Diseases: In India, 42% of adults have at least one chronic disease, including hypertension (25-30%), diabetes (12%), arthritis (9%), and significant cases of cancers and chronic respiratory diseases. This large population segment necessitates continuous medical care. The increasing prevalence of chronic conditions such as diabetes, heart disease, and cancer fuel the demand for digital biomarkers, crucial for early detection, monitoring, and management, thus driving market expansion.

Increasing Smartphone Penetration: India boasts a rapidly growing smartphone user base. This creates a large potential market for app-based digital biomarker solutions that leverage smartphone technology for data collection and analysis.

Government Initiatives: The Indian government actively promotes digital health initiatives through programs like "Ayushman Bharat" and the "National Digital Health Mission (NDHM)." These initiatives aim to improve healthcare accessibility and encourage the adoption of digital health solutions, including digital biomarkers.

Growing Focus on Preventative Care: There's an increasing emphasis on preventative healthcare in India. Digital biomarkers can empower individuals to take a more proactive approach to their health by tracking health indicators and identifying potential risks early on.

Market Restraints

Data Privacy Concerns: Data security and privacy are major concerns in India. Building trust with users regarding data collection, storage, and usage practices is crucial for market growth. The Personal Data Protection Bill (PDPB) is still under development, and stakeholders need to ensure compliance with evolving regulations.

Limited Healthcare Infrastructure: Disparities exist in healthcare infrastructure across different regions of India. This can limit access to digital biomarker technologies and expertise in some areas.

Limited Integration with Healthcare Systems: Seamlessly integrating digital biomarker data with existing healthcare information systems in India is crucial for optimal use by healthcare professionals. At present, this integration may be insufficient.

Regulatory Landscape and Reimbursement Scenario

In India, the regulatory landscape for digital biomarkers is primarily overseen by the Central Drugs Standard Control Organization (CDSCO), which classifies these tools under categories such as software as a medical device (SaMD) based on their functionality. The Department of Telemedicine (DoT) also plays a role in regulating telemedicine applications, intersecting with digital biomarkers used for remote patient monitoring. Stakeholders need to understand the specific classification of their digital biomarkers by the CDSCO to determine the appropriate regulatory pathway for approval. Additionally, compliance with India's emerging data privacy framework, particularly the draft Personal Data Protection Bill (PDPB), is critical for ensuring the legal handling of data collection, storage, and usage.

The reimbursement landscape for digital biomarkers in India is still developing. The National Health Insurance Scheme (NHIS), a government-funded program, currently offers limited coverage for medical devices, but digital biomarkers with strong clinical evidence and demonstrated cost-effectiveness may be considered for future inclusion. Meanwhile, private health insurance is gaining traction in India, with some insurers potentially offering coverage for specific digital health solutions that incorporate digital biomarkers, depending on the plan and technology involved.

Competitive Landscape

Key Players

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

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