Digital Therapeutics

DUBLIN--( BUSINESS WIRE )--The "Chronic Disease Management: Therapeutics, Device Technologies and Global Markets" report has been added to ResearchAndMarkets.com's offering. The Chronic Disease Management Market was valued at USD 726.3 billion in 2024, and is expected to reach USD 1.1 trillion by 2029, rising at a CAGR of 8.10%. Growth of the global market is attributed to factors such as the increasing prevalence of chronic conditions, along with the adoption of personalized medicine and remote monitoring solutions. In this report, the market is segmented by product type, application, end user, and geography. Product types include pharmaceutical drugs and biologics, medical devices, and digital therapeutics. Pharmaceutical drugs and biologics are further segmented into drugs and biologics. Medical devices are further segmented into traditional devices and wearable devices. Applications include the following diseases: cancer, metabolic disorders, cardiovascular diseases, immunological disorders, respiratory diseases, musculoskeletal disorders, gastrointestinal disorders, neurological diseases and psychiatric disorders. The end-user market is segmented into home care, hospitals and others. The report also provides a regional market analysis of drug-device combinations. Report Scope Chronic disease management encompasses drugs and medical device-based techniques. This report can serve as an analytical business tool to evaluate the global market for therapeutics and advanced device technologies for chronic disease management. This report analyzes market trends with data from 2023, estimates for 2024 and projections of CAGRs through 2029. It evaluates the market potential for chronic disease management and provides an analysis of the competitive landscape. The report covers the market's drivers, restraints and opportunities, as well as the market shares of leading companies. The market is segmented into product type, application, end user, and geographic region. Product segments include pharmaceuticals and biologics (drugs and biologics), medical devices (traditional and wearable devices) and digital therapeutics. Application areas (disease categories) are cancer, metabolic disorders, musculoskeletal disorders, cardiovascular conditions, immunological disorders, gastrointestinal disorders, respiratory diseases, neurological conditions, psychiatric conditions, and others. End users are categorized into hospitals and other facilities and home care. The global market is segmented into the regions of North America, Europe, Asia-Pacific, and the Rest of the World (RoW). This analysis also includes broken down by country. The report includes: 106 data tables and 39 additional tables Analyses of global market trends, with historic market revenue data (sales figures) from 2021 to 2022, estimates for 2023, forecast for 2024, and projected CAGRs through 2029 Estimates of the current market size and revenue prospects of the global market, along with a market share analysis by product type, application, end user, and region Analysis of the market dynamics, technological advances, regulations, and the macroeconomic factors influencing the market A look into the current state of chronic diseases and disorders, with an emphasis on advance needle-free drug delivery technologies, diagnostic methods, and smart device technologies that support chronic disease management Identification of promising new drugs, biologics, and emerging device technologies still in the development and testing stages A look at the regulatory structure for pharmaceuticals and medical devices, pricing and reimbursement structure, marketed and pipeline products and their potential for commercialization A look at the recent patent grants Overview of sustainability trends and ESG developments, with emphasis on consumer attitudes, ESG score analysis, and the ESG practices of leading companies Analysis of the industry structure, including company market shares, strategic alliances, M&A activity and a venture funding outlook Profiles of market leaders in the Chronic Disease Management market, including Abbott, Bristol Myers Squibb Co., F. Hoffmann-La Roche Ltd., Pfizer and Johnson & Johnson Services. Key Attributes: Report Attribute Details No. of Pages 157 Forecast Period 2024 - 2029 Estimated Market Value (USD) in 2024 $726.3 Billion Forecasted Market Value (USD) by 2029 $1100 Billion Compound Annual Growth Rate 8.1% Regions Covered Global Key Topics Covered: Chapter 1 Executive Summary Chapter 2 Market Overview Market Insights Regulatory Background Chronic Disease Management Act of 2021 (CDMA) Regional Regulatory Frameworks for Chronic Disease Medical Devices Regulatory Systems for Pharmaceuticals, by Region Pricing and Reimbursement for Medical Devices, by Region Pricing and Reimbursement for Pharmaceuticals, by Region Chapter 3 Market Dynamics Market Drivers Growing Aging Population Worldwide Growing Prevalence of Chronic Diseases Technological Advances Government Initiatives and Funding Market Restraints High Cost of Treatments Patent Expiry and Shorter Product Life Cycles Regulatory Issues for Drugs, Medical Devices and Software Applications Limited Access in Low-Income Regions Market Challenges Medication Nonadherence Regulatory Challenges Challenges with Digital Health Applications Market Opportunities Digital Therapeutics Strong Research and Development Initiatives from Key Market Players Chapter 4 Market Segmentation Analysis Market Analysis, by Product Type Pharmaceutical Drugs and Biologics Medical Devices Digital Therapeutics Market Analysis, by Application Oncological Diseases Metabolic Disorders Cardiovascular Diseases Immunological Disorders Respiratory Diseases Musculoskeletal Disorders Chronic Gastrointestinal Diseases Neurological Diseases Psychiatric Disorders Other Applications Market Analysis, by End User Home Care Hospitals and Others Geographic Breakdown Market Analysis, by Region Chapter 5 Emerging Trends and Technologies Mobile Health Technology AI, Machine Learning, and Deep Learning in Chronic Care Management Remote Patient Monitoring Devices Digital Therapeutics Biowearable Technology Glucose-Sensing Contact Lenses Recent Approvals and Launches of Novel Drug and Device Products Chapter 6 ESG Developments ESG in the Chronic Disease Management Industry ESG Risk Ratings BCC Research Viewpoint Chapter 7 Competitive Landscape Mergers, Acquisitions and Collaborations Patent Analysis Patent Review, by Assignee Country Patent Review, by Year Company Share Analysis Strategic Alliances Company Profiles Abbott Amgen AstraZeneca Boston Scientific Bristol-Myers Squibb F. Hoffmann-La Roche GSK Johnson & Johnson Services Medtronic Pfizer For more information about this report visit https://www.researchandmarkets.com/r/qyaqty About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

The proposed new Medicare billing codes in the proposed Physician Fee Schedule (PFS) for 2025 include three specific codes for digital mental health treatment (DMHT) relating to professional services involving DMHT devices. This is the first time CMS has proposed Medicare reimbursable codes specific to digital therapeutic products through the physician services benefit. Under the proposal from CMS, covered products must have FDA clearance. This distinction is crucial as it differentiates general wellness apps and DMHT devices that have proven efficacy and safety. When someone searches for "insomnia" or "anxiety" in an app store, they will find hundreds, if not thousands, of apps. However, most of these apps have not submitted evidence for FDA review to support their effectiveness. FDA clearance ensures a product has undergone rigorous testing and validation, providing assurance of its therapeutic benefits. Additionally, DMHT devices must be furnished "incident to" a qualified practitioner's professional services via a prescription or order in association with ongoing treatment under a plan of care – and patients can use DMHT devices at home, in an office or in other outpatient settings (if that is how the device has been cleared by the FDA). The codes encompass several key components: supply of the DMHT device, the initial education and onboarding of the patient, the first 20 minutes of monthly treatment management services related to the patient's therapeutic use of the device, and each subsequent 20 minutes of monthly treatment management services. And that's just the tip of the iceberg. To get a deep understanding of these proposed new codes for digital mental health treatment, Healthcare IT News sat down with Andy Molnar, CEO of the Digital Therapeutics Alliance , an organization working to advance the clinical development of digital therapeutics and key collaborator with Lindus Health. Q. What are digital mental health treatments? A. Under the proposed PFS, CMS states that DMHT devices include "the term 'digital CBT' we used in prior rulemaking and in general to refer to software devices cleared by the Food and Drug Administration that are intended to treat or alleviate a mental health condition, in conjunction with ongoing behavioral healthcare treatment under a behavioral health treatment plan of care, by generating and delivering a mental health treatment intervention that has a demonstrable positive therapeutic impact on a patient's health." CMS goes on to state "the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM) does not refer to psychiatric disorders but to mental disorders. In this section, following the DSM, we use the term behavioral health conditions and mental disorders interchangeably and to mean psychiatric disorders as referenced in FDA regulation, 21 CFR 882.5801." The Digital Therapeutics Alliance will be requesting clarification from CMS regarding the scope of products eligible for reimbursement under the proposed DMHT codes. Q. What are the implications of Medicare's proposed codes for digital mental health treatments? A. There is a shortage of mental health services available to patients in the United States. The only solution in many cases is digital therapeutics. These codes, if finalized, will expand access for Medicare patients to much needed mental health services. Medicare is a trend setter. By legitimizing these treatments within the Medicare system, it sets a precedent for other insurers to follow suit, potentially transforming the landscape of mental healthcare delivery. Q. What is the potential impact on health tech startups and the broader healthcare ecosystem? A. The introduction of these billing codes represents a significant opportunity. Coding, coverage and reimbursement are critical to national access in the U.S. With clear payment pathways, this will lead to additional investment and innovation. Q. What is the future of digital therapeutics and steps for broader reimbursement and adoption? A. The future of digital therapeutics is incredibly promising. There has been a significant global adoption of digital therapeutics, with clear payment pathways established in countries such as Germany, France and South Korea. It's exciting to see the U.S. begin to cover these innovative products. For the Digital Therapeutics Alliance, our immediate next step is to collaborate with our members to submit comments to CMS on the proposed Medicare Physician Fee Schedule. More broadly, the Digital Therapeutics Alliance will continue to work closely with the FDA. We will also continue to engage with the American Medical Association to identify and address gaps in coding and communicate the needs of the digital therapeutics industry. The Digital Therapeutics Alliance is excited about this first step toward Medicare coverage for digital therapeutics and remains committed to advocating for legislation that will broaden and clarify Medicaid and Medicare coverage of digital therapeutics including S. 723 (the Access to Prescription Digital Therapeutics Act) and 8816 (the American Medical Innovation and Investment Act). Q. How does this proposal fit within mental healthcare reform and digital health innovation? A. This proposal fits within mental healthcare reform and digital health innovation by: Reducing stigma. Making mental health treatments more accessible in the patient's home environment and integrating these treatments into everyday healthcare can help reduce the stigma associated with seeking mental healthcare. Addressing gaps in care. Access to mental healthcare can be challenging with shortages, especially in rural, underserved communities. DMHTs are poised to address these challenges in mental health. Promoting innovation. The recognition and reimbursement of digital therapeutics by Medicare can attract more investment into health tech startups focused on developing innovative solutions. By embracing digital health technologies, the proposal supports ongoing innovation and the development of new, effective treatment modalities. Follow Bill's HIT coverage on LinkedIn: Bill Siwicki Email him: bsiwicki@himss.org Healthcare IT News is a HIMSS Media publication.

Osaka (Japan), July 01, 2024 - Maruho Co., Ltd. ("Maruho"; Head Office: Osaka, Japan, President and CEO, Atsushi Sugita) announces that it has entered into a worldwide collaborative development and commercialization agreement (the "Agreement") with Sibel Health Inc. ("Sibel Health", Head Office: Chicago, Illinois (USA); CEO, Steve Xu MD). The agreement includes co-development and future distribution rights for an innovative, prescription-only digital health technology, which is currently under development by Sibel Health (hereinafter referred to as "the product") for the measurement and suppression of scratching associated with itch. Under the terms of the agreement, Sibel Health grants Maruho co-development rights for the product, and an exclusive license for distribution and marketing in the USA, Europe, Japan, China, Hong Kong, Macao, Taiwan, South Korea and the 10 ASEAN*1 member states on the condition that future commercial targets are satisfied. In addition to an upfront payment, Maruho will make payments based on future development milestones. The product consists of an advanced wearable sensor (ADAMTM), mobile software, and a cloud backend. It is currently marketed by Sibel Health under the product name "Discovery" as a digital health technology for clinical trials and research to measure scratching objectively. Sibel Health is currently in the process of applying for additional approvals as a medical device in the USA and Europe. As part of this effort, Maruho will work with Sibel Health to add novel features to Sibel's existing "Discovery" product to develop a new Digital Therapeutic*2 with the ability to measure and suppress scratching to treat unmet medical needs related to itch, such as atopic dermatitis. This is an addition to Maruho's existing efforts to provide value through pharmaceuticals and applications. *3 Maruho and Sibel Health will work to bring smiles to the faces of patients suffering from itching by combining Maruho's expertise in dermatology with Sibel Health's extensive know-how in digital health and wearable sensor technology. NoteThe information contained in this news release in regard to pharmaceutical and developmental products is not intended for the purpose of promotion, advertising or medical advice. 1. The 10 ASEAN member statesSingapore, Malaysia, Thailand, Philippines, Vietnam, Indonesia, Brunei, Cambodia, Laos, and Myanmar 2. Digital TherapeuticsDigital Therapeutics is software that uses digital technology, such as smartphones and applications, to support or implement medical treatments, such as disease prevention, diagnosis, and treatment. It requires a license under the Pharmaceutical Affairs Law and is used either alone or in combination with pharmaceuticals and medical devices. It is expected to be effective in treating diseases and symptoms that are difficult to manage or intervene with conventional drugs. 3. App to Make Your Itches Visible "Itch Tracker"https://www.maruho.co.jp/kanja/app/itchtracker/index.html (Japanese) About DiscoverySibel's Discovery product consists of the ADAMTM wearable sensor, mobile software and a cloud backend, and is a tool for clinical trials and research to measure scratching. When used, the device is attached to the back of the hand and captures the motion and acoustic signatures of scratching. The collected data is analyzed using AI algorithms to detect scratching in real time as well as sleep parameters. For more information about the ADAM Sensor and the Discovery product, please visit https://sibelhealth.com/clinical-trials-and-research/ About SibelSibel Health is an award-winning digital health company with a mission to deliver Better Health Data for All®. Based in Chicago with an international office in Seoul, the company's FDA-cleared ANNE® platform includes advanced wearable sensors, AI-enabled data analytics, and an integrated mobile software and cloud platform. The company's Discovery platform is used by the world's leading pharmaceutical companies for continuous data collection in the home setting for clinical trials. For more information, please visit www.sibelhealth.com and follow them on LinkedIn. About MaruhoMaruho Co., Ltd. has its head office in Osaka and leads Japan in research and development, manufacturing and commercialization of dermatological products. Founded in 1915, Maruho has 1,566 employees (as of the end of September 2023), and net sales were approximately 85.71 billion yen in its fiscal year ended September 30, 2023. With the mission "More smiles, brighter life for you.", Maruho aims to help realize a society where everyone can live with a smile. For more information, please visit https://www.maruho.co.jp/english/ Contact Information: Maruho Co., Ltd. Public Relations Group, Corporate Planning Dept. Tel：+81-(0)6-6371-8831 Fax：+81-(0)6-6371-8679 Email：kouhou@mii.maruho.co.jp