US Digital Biomarkers Market Report 2023 to 2030

US Digital Biomarkers Market Analysis

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US Digital Biomarkers Market was valued at $1,218 Mn in 2023 and is predicted to grow at a CAGR of 20.3% from 2023 to 2030, to $4,441.26 Mn by 2030. The key drivers of this industry include advancements in technology, the growing prevalence of chronic diseases, rising healthcare costs, and patient empowerment and engagement. The industry is primarily dominated by ActiGraph LLC, AliveCor Inc., Koneksa, and Altoida Inc. among others.

ID: IN10USDH158 CATEGORY: Digital Health GEOGRAPHY: US AUTHOR: Sarita Yadav

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US Digital Biomarkers Market Executive Summary

US Digital Biomarkers Market was valued at $1,218 Mn in 2023 and is predicted to grow at a CAGR of 20.3% from 2023 to 2030, to $4,441.26 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.

In the US, chronic diseases are widespread: heart disease affects 1 in 4 adults, causing nearly 800,000 deaths yearly; cancer impacts 1 in 4 people with over 600,000 new cases annually. COPD affects 1 in 13 adults, and diabetes affects 1 in 11 adults with over 30 Mn cases reported. Mental illness affects 1 in 5 adults, with over 50 Mn experiencing issues annually. Digital biomarkers like blood pressure monitors, wearable trackers, genetic testing, and glucose monitors aid in managing these conditions. The American Heart Association reported high global rates of cardiovascular disease in 2020, and new wearables like Shimmer Research's Verisense Digital Health Panel (November 2022) were launched. 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 patient empowerment and engagement. However, data privacy and security concerns, limited reimbursement policies, 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. Other contributors include Koneksa, and Altoida Inc. among others.

US Digital Biomarkers Market Report 2023 to 2030

Market Dynamics

Market Growth Drivers

Advancements in Technology: The rapid evolution of digital health technologies, including wearable devices, smartphones, and advanced analytics, drives the adoption of digital biomarkers. Innovations in AI and machine learning enhance the accuracy and predictive power of these biomarkers.

Growing Prevalence of Chronic Diseases: The US faces a rising burden of chronic diseases like diabetes, cardiovascular diseases, and neurodegenerative disorders, driving demand for digital biomarkers. These tools enable early detection, continuous monitoring, and personalized treatment. The Centers for Disease Control and Prevention (CDC) notes that 6 in 10 US adults live with at least 1 chronic disease, emphasizing the widespread need for innovative healthcare solutions.

Rising Healthcare Costs: Digital biomarkers can help reduce healthcare costs by enabling early diagnosis and proactive management of diseases, thus preventing expensive treatments and hospitalizations. This economic benefit encourages their adoption in the healthcare system.

Patient Empowerment and Engagement: Digital biomarkers empower patients by providing them with real-time health data and insights. This increased patient engagement and self-management lead to better health outcomes and drive demand for digital health solutions.

Market Restraint

Data Privacy and Security Concerns: The collection and use of personal health data through digital biomarkers raise significant privacy and security concerns. Ensuring the protection of sensitive information and maintaining patient trust are major challenges.

High Development Costs: Developing and validating digital biomarkers involves substantial investment in technology, research, and clinical trials. These high costs can be a barrier for smaller companies and startups.

Limited Reimbursement Policies: Reimbursement for digital health solutions, including digital biomarkers, is still evolving. Limited reimbursement policies from insurance companies can restrict access and affordability for patients, affecting market growth.

Regulatory Landscape and Reimbursement Scenario

In the US, the regulatory landscape for digital biomarkers is overseen primarily by the FDA, FTC, and CMS. The FDA is crucial in regulating digital biomarkers intended for medical purposes, categorizing them by risk level and requiring rigorous pre-market approval for higher-risk biomarkers. The FDA also issues guidance documents to clarify expectations for digital biomarker development and validation. The FTC monitors digital biomarkers marketed for general wellness purposes without specific medical claims, ensuring that advertising is not deceptive and that consumer protection is maintained. Additionally, CMS influences coverage and reimbursement decisions for digital biomarkers used in Medicare and Medicaid programs, evaluating analytical validity and clinical utility.

The reimbursement scenario for digital biomarkers in the US is evolving, with current coverage being limited. Medicare and Medicaid require strong evidence of clinical utility and cost-effectiveness for broader coverage, which is often a barrier for many digital biomarkers. Private insurance companies are starting to recognize the potential benefits of digital biomarkers, but coverage decisions vary widely depending on the insurer, specific biomarkers, and supporting evidence. Overall, the integration of digital biomarkers into the healthcare reimbursement system requires a clear demonstration of their clinical benefits and cost savings.

Competitive Landscape

Key Players

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

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

1. Executive Summary
1.1 Digital Health Overview
1.2 Global Scenario
1.3 Country Overview
1.4 Healthcare Scenario in Country
1.5 Digital Health Policy in Country
1.6 Recent Developments in the Country

2. Market Size and Forecasting
2.1 Market Size (With Excel and Methodology)
2.2 Market Segmentation (Check all Segments in Segmentation Section)

3. Market Dynamics
3.1 Market Drivers
3.2 Market Restraints

4. Competitive Landscape
4.1 Major Market Share

4.2 Key Company Profile (Check all Companies in the Summary Section)

4.2.1 Company
4.2.1.1 Overview
4.2.1.2 Product Applications and Services
4.2.1.3 Recent Developments
4.2.1.4 Partnerships Ecosystem
4.2.1.5 Financials (Based on Availability)

5. Reimbursement Scenario
5.1 Reimbursement Regulation
5.2 Reimbursement Process for Diagnosis
5.3 Reimbursement Process for Treatment

6. Methodology and Scope

US Digital Biomarkers Market Segmentation

By Type

Wearable
Mobile-based Applications
Sensors
Others

By Clinical Practice

Diagnostic digital biomarkers
Monitoring digital biomarkers
Predictive and Prognostic digital biomarkers
Other's (Safety, Pharmacodynamics/ Response, Susceptibility)

By Therapeutic Area

Cardiovascular and metabolic disorders (CVMD)
Respiratory disorders
Psychiatric disorders
Sleep & Movement Disease
Neurological disorders
Musculoskeletal disorders
Others (Diabetes, Pain Management)

By End-Use

Healthcare companies
Healthcare Providers
Payers
Others (Patients, caregivers)

Methodology for Database Creation

Our database offers a comprehensive list of healthcare centers, meticulously curated to provide detailed information on a wide range of specialties and services. It includes top-tier hospitals, clinics, and diagnostic facilities across 30 countries and 24 specialties, ensuring users can find the healthcare services they need.

Additionally, we provide a comprehensive list of Key Opinion Leaders (KOLs) based on your requirements. Our curated list captures various crucial aspects of the KOLs, offering more than just general information. Whether you're looking to boost brand awareness, drive engagement, or launch a new product, our extensive list of KOLs ensures you have the right experts by your side. Covering 30 countries and 36 specialties, our database guarantees access to the best KOLs in the healthcare industry, supporting strategic decisions and enhancing your initiatives.

How Do We Get It?

Our database is created and maintained through a combination of secondary and primary research methodologies.

1. Secondary Research

With many years of experience in the healthcare field, we have our own rich proprietary data from various past projects. This historical data serves as the foundation for our database. Our continuous process of gathering data involves:

Analyzing historical proprietary data collected from multiple projects.
Regularly updating our existing data sets with new findings and trends.
Ensuring data consistency and accuracy through rigorous validation processes.

With extensive experience in the field, we have developed a proprietary GenAI-based technology that is uniquely tailored to our organization. This advanced technology enables us to scan a wide array of relevant information sources across the internet. Our data-gathering process includes:

Searching through academic conferences, published research, citations, and social media platforms
Collecting and compiling diverse data to build a comprehensive and detailed database
Continuously updating our database with new information to ensure its relevance and accuracy

2. Primary Research

To complement and validate our secondary data, we engage in primary research through local tie-ups and partnerships. This process involves:

Collaborating with local healthcare providers, hospitals, and clinics to gather real-time data.
Conducting surveys, interviews, and field studies to collect fresh data directly from the source.
Continuously refreshing our database to ensure that the information remains current and reliable.
Validating secondary data through cross-referencing with primary data to ensure accuracy and relevance.

Combining Secondary and Primary Research

By integrating both secondary and primary research methodologies, we ensure that our database is comprehensive, accurate, and up-to-date. The combined process involves:

Merging historical data from secondary research with real-time data from primary research.
Conducting thorough data validation and cleansing to remove inconsistencies and errors.
Organizing data into a structured format that is easily accessible and usable for various applications.
Continuously monitoring and updating the database to reflect the latest developments and trends in the healthcare field.

Through this meticulous process, we create a final database tailored to each region and domain within the healthcare industry. This approach ensures that our clients receive reliable and relevant data, empowering them to make informed decisions and drive innovation in their respective fields.