The global self-diagnostic medical devices market size was US$ 22.26 billion in 2022, and the market size is projected to reach US$ 39.88 billion by 2030. It is expected to register a CAGR of 7.6% in 2022-2030.
Market Insights and Analyst View:
Self-diagnostic medical devices are used to measure and monitor vital parameters such as blood sugar level, heart rate, hypertension, and other conditions. The major factors accentuating the growth of SDMD market include rising prevalence of chronic and lifestyle diseases, technological advancements, increasing preference for remote patient monitoring, increasing healthcare awareness and rising population. These devices are portable, cost-effective, and enable the patient to stay at home/workplace or any preferred destination across globe, allowing them to manage their health independently. The addition of features such as real-time remote communication in SDMD enables the healthcare personnel to interpret the results for further diagnosis and treatment.
Growth Drivers and Restraints:
The medical device industry is one of the most R&D-intensive industries globally due to the increasing adoption of software and hardware to develop technologically advanced products. The value of devices is becoming increasingly important; medical device companies are more than ever interested in ensuring R&D achieves their intended goal. Products with advanced technologies offer more effective benefits in diagnosis and treatment. As the prevalence of diseases increases worldwide, the demand for more products with advancements also accelerates. Thus, researchers have been conducting research activities resulting in product innovations over the years. For instance, in April 2023, Abbott received clearance from the U.S. Food and Drug Administration (FDA) for a reader for its FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system, which features the world's thinnest, smallest, and most discreet glucose sensor. The FreeStyle Libre 3 reader is a small handheld device that displays glucose readings in real-time directly from a small sensor worn on the back of a patient's upper arm, allowing them to manage diabetes quickly and easily by viewing their glucose readings on an easy-to-see screen.
Self-diagnostic devices are vulnerable to malicious cyberattacks. Therefore, the number of data breaches associated with healthcare information and patient data has gradually increased. According to a survey published in the HIPAA Journal 2021, about 50.41 million people were affected by healthcare data breaches, with a 24% rise over the previous year. The study includes 905 instances, reporting a 19% surge from the previous year. According to an article by GE Healthcare, healthcare breaches has increased over 84% in 3 years, i.e., from 386 in 2019 to 711 in 2021. According to the data provided by IBM’s Security annual report, the average data breach cost in 2020 was US$ 3.86 million across all global industries. The healthcare industry recorded the highest industry-average cost of US$ 7.13 million in 2020. Thus, digital healthcare is a lucrative target for cyberattacks and data breaches, with misconfigured cloud storage buckets, weaponized ransomware, and phishing e-mails, which, in turn, restrains the adoption of self-diagnostic medical devices.
Strategic Insights
Report Segmentation and Scope:
The “Global Self-Diagnostic Medical Devices Market” segmentation is done based on product type, components, application, end user, and geography. The self-diagnostic medical devices market is segmented based on product type into wearable, implantable, handheld/portable, stationary, and others. Based on components, the self-diagnostic medical devices market is segmented into software, devices, and accessories. Based on application, the self-diagnostic medical devices market is segmented into blood pressure, temperature, blood glucose, pregnancy/fertility test kits, sleep apnea devices, and others. The self-diagnostic medical devices market is segmented based on end users into home care settings, rehabilitation centers, and others. The self-diagnostic medical devices market based on geography is segmented into North America (US, Canada, and Mexico), Europe (Germany, France, Italy, UK, Russia, and the Rest of Europe), Asia Pacific (Australia, China, Japan, India, South Korea, and the Rest of Asia Pacific), Middle East & Africa (South Africa, Saudi Arabia, UAE, and the Rest of Middle East & Africa), and South & Central America (Brazil, Argentina, and the Rest of South & Central America).
Segmental Analysis:
Based on product type, the self-diagnostic medical devices market is segmented into wearable devices, implantable devices, handheld/portable devices, stationary devices, and others. In 2023, the handheld/portable devices segment, by product type, held the largest market share of the self-diagnostic medical devices market. However, the wearable devices segment is expected to grow at the highest CAGR during the forecast period. Increasing cases of diabetes blood pressure and use of pregnancy kits for pregnancy detection fuel the growth of the handheld/portable devices segment. According to World Heart Federation, 1.3 billion people globally are affected by high blood pressure every year. Increase in demand for wearable devices for continuous monitoring of blood pressure, heart rate, and blood glucose is expected to fuel the growth of the wearable devices segment in the forecast period.
The self-diagnostic medical devices market is segmented based on end users into home care settings, rehabilitation centers, and others. In 2023, the home care settings segment held the largest self-diagnostic medical devices market share. The shift of point of care (PoC) from hospital to home provides good chances for better, consistent, and timely interaction between patient and doctor, making cloud and mobility-driven medical devices a foremost trend. Also, the COVID-19 crisis triggered the importance of AI in healthcare, which led to the growing emphasis on home-based care due to limited hospital bed capacity and a scarcity of skilled healthcare professionals. By monitoring the patient’s vitals remotely, healthcare professionals can avoid hospital admission if cases can be handled virtually, thereby reserving hospital beds only for patients requiring critical care. Home monitoring, often known as remote patient monitoring (RPM), has a subset of applications with different requirements and data delivery frequency, including monitoring chronic diseases and tracking patients’ health status.
Regional Analysis:
Based on geography, the self-diagnostic medical devices market segments into five key regions: North America, Europe, Asia Pacific, South & Central America, and Middle East & Africa. In 2023, the North America self-diagnostic medical devices market held the largest share of the global self-diagnostic medical devices market, and the Asia Pacific self-diagnostic medical devices market is estimated to register the highest CAGR during the forecast period. The US self-diagnostic medical devices market held the largest share in the North American self-diagnostic medical devices market. The growth of this market is primarily driven by increasing expenditure of research and development expenditures. According to the American Diabetes Association report, over 37 million children and adults have diabetes in the US alone. The estimated total costs of diagnosed diabetes in the US account for US$ 16,752 annually, among which US$ 9,601 is attributed to diabetes. Also, the US holds high expenditure on hospital inpatient care (30% of the total medical cost), anti-diabetic agents and diabetes supplies (15%), prescription medications to treat complications of diabetes (30%), and physician office visits (13%). According to the Government of Canada report, about 3 million Canadians or over 8.9% of the population, have been diagnosed with diabetes. The prevalence is increasing at an average rate of 3.3% annually.
Additionally, 6.1% of Canadian adults live with prediabetes, putting them at risk of developing type 2 diabetes. The alarming growth rate of diabetes in the country is leading to advancements in science and clinical evidence at a rapid pace. The increasing prevalence of chronic diseases such as cardiovascular diseases, diabetes, and blood pressure is fueling the market growth in North America.
India is among the countries in the Asia Pacific region emerging in terms of developments in healthcare. The rising prevalence of diabetes and robustly increasing geriatric population are adding up to the growth of the self-diagnostic medical devices market in the country. As per the International Diabetes Federation 2020, it is estimated that 77.3 million adults live with diabetes in India, which is expected to reach 101.2 million by 2030. WHO has predicted that there about 10 crore Indians will suffer from diabetes in the next 10 years.
Several entrants are entering the market, which is further propelling the market for self-diagnostic medical devices. In November 2020, Abbott unveiled a do-it-yourself version of its continuous glucose-monitoring device in India, a decision prompted by the pandemic. The reader is a one-time cost to the consumer at US$66.61, while the sensor is a recurring cost of US$60.55, possibly every three months. The sensor gives continuous readings for 14 days and analytics cover a three-month period, mapping the sugar levels against diet, exercise, etc. The growing Indian market offers opportunities for international companies to increase their revenues owing to improving healthcare facilities in the country. Thus, the market is likely to experience significant growth in India during the forecast period.
Industry Developments and Future Opportunities:
Various initiatives taken by key players operating in the global self-diagnostic medical devices market are listed below:
- In August 2022, GOQii introduced Smart Vital Ultra and GOQii Stream devices targeting young adults and youth, encouraging them to lead a healthy and active lifestyle. It monitors blood oxygen saturation levels (SpO2) and continuous and non-disruptive heart rate, and detects sleep patterns by analyzing these two factors while a user is asleep.
- In February 2022, CardiAI Inc introduced its new 24-hour ambulatory blood pressure monitoring system, BPAro, a compact, portable, self-monitoring blood pressure device that uses bluetooth for wireless data collection. The data collected by BPAro is then uploaded on a secure cloud database. US Food and Drug Administration and Health Canada validate and approve the device.
- In June 2021, Terumo Corporation launched Japan's Dexcom G6 continuous glucose monitoring (CGM) system. A CGM system is a medical device that supports diabetes control. The Dexcom G6 CGM system allows real-time glucose monitoring. Its innovative technology uses a small, wearable sensor and transmitter to measure and automatically send glucose values wirelessly to a smart device 1 or receiver every 5 minutes.
Competitive Landscape and Key Companies:
Some self-diagnostic medical devices market leaders are Medtronic, Roche, Siemens, Johnson & Johnson, Abbott, Omron, Nova Biomedical, Philips Healthcare, Biotronik, and GE Healthcare. These companies focus on product launches and expansions geographically to meet the increasing consumer demand worldwide and increase their product range in specialty portfolios. These companies have a widespread global presence, allowing them to serve many customers and subsequently increase their market share. The report offers a trend analysis of the self-diagnostic medical devices market emphasizing on various parameters such as market dynamics, technological advancements, and competitive landscape analysis of leading market players across the globe.
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Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
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to segments covered.
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
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The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- 3.1 Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- 3.2 Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- 3.3 Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- 3.4 Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.
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