Class C and D Medical Devices Market Size, Share, Report 2025 to 2034

Class C and D Medical Devices Market Size and Growth 2025 to 2034

The global class C and D medical devices market size was valued at USD 58.69 billion in 2024 and is expected to be worth around USD 679.51 billion by 2034, growing at a compound annual growth rate (CAGR) of 27.75% from 2025 to 2034.

The global class C and D medical devices market consists of high-end medical devices that are crucial in diagnosing, treating and managing various complicated medical conditions. High risk medical devices such as class C devices (infusion pumps and ventilators) and class D devices (implantable defibrillators, pacemakers, etc.) are strictly controlled due to their influence on health. The market has been facilitated by the increasing prevalence of chronic diseases, the usage of advanced medical treatment tools, and the rise in healthcare spending around the world. Leaders of the key players are focusing on innovation as well as implementation of the strategic alliances and geographic expansion to be on the lead. The growth has picked trend owing to an increase in the population and need for effective and less invasive medical techniques. Nonetheless, factors such as strict regulation guidelines and expensive research and development costs are likely to limit the expansion of the market.

LexOrbis– Manisha Singh and Pankaj Musyuni

“Despite the considerable medical equipment possibilities, the country must retain a stimulating environment for its own production of medical devices in the post-pandemic era. For this industry to have long-term prospects, long-term support is required.”

Report Highlights

• The U.S. class C and D medical devices market size was valued at USD 20.05 billion in 2024.
• The North America has lead the market and accounted revenue share of 42.71% in 2024.
• The Europe has generated revenue share of 28.73% in 2024.
• The Asia-Pacific region is expected to witness strong growth during the forecast period.

Class C and D Medical Devices Market Growth Factors

• Increasing Prevalence of Chronic Diseases: The increased prevalence of chronic illnesses especially those of the heart, diabetes, and cancer is one of the primary factors accelerating the acceptance of class C and D medical devices. Such medical equipment, including heart rhythm regulators, insulin delivery systems, and cancer treatment equipment, is very critical in the treatment and management of these illnesses. For instance, the rising issue of diabetes around the world has led to the rising use of devices such as the continuous glucose monitor and insulin pumps. These assist the patients in better adherence to their treatment which helps reduce the effects of the disease subsequently, improving the overall well-being of the patients.
• Technological Advancements: The continuous development in the technology are changing the scenario of medical devices. The class C and D devices are incorporated with the features such as AI-based diagnostics, and advanced sensors along with real-time data analytics which improves its precision and usability. For example, today defibrillators can be connected to applications whereby doctors are able to check the patients remotely. Therefore, these advancements in technology help in achieving better health care as well as lessening the pressure on health care institutions.
• Aging Population: The fact that the world’s population has an increasing number of older people is one of the key forces driving the usage of class C and D medical devices. The elderly are usually at higher risk of non-communicable and degenerative conditions such as cartilage-related disorders, osteoporosis, and diseases of the heart. Such devices including but not limited to joint prosthetics, heart devices, and walking devices are very crucial to this population age group so as to enhance their life.
• Rising Healthcare Expenditures: The increasing amount of money that governments and private corporations are investing in healthcare across the world is encouraging the usage of sophisticated medical devices. Bigger budgets make it possible for health care institutions to install the most advanced technologies like those belonging to class C and even D which are usually on the high price range due to their complexities and life-threatening functionalities. This is more pronounced in developed countries, where health care costs are ranked at the top globally.
• Demand for Minimally Invasive Procedures: Most of the patients and healthcare providers agree that the benefits of minimally invasive procedures have made it possible for the invasive treatments to take one step back. Wound care and recovery time have greatly improved as well as the overall expense of such procedures. This has caused a rise in the market for sophisticated devices such as the robotic surgical systems, endoscopes, catheters and others that are classified mainly under class C and D. These devices allow for greater degree of accuracy and safety thus, their relevance in contemporary medicine is unquestionable.

Class C and D Medical Devices Market Trends

• Improved Regulatory Frameworks: Regulatory authorities in various countries are revising existing laws to facilitate the clearance of medical appliances without compromising on their safety and effectiveness. For example, the European Union has enacted the European Medical Devices Regulation (EU MDR), while the United States Food and Drug Administration (FDA) has fast-tracked the development and commercialization of medical devices under the FDA Breakthrough Devices Program amongst other strategies. Such frameworks lessening the entry barriers to the markets open up further justifications for the manufacturers to come up with new improved class C and D devices and launch then in the market.
• Increased Awareness of Early Diagnostics: The rise in awareness of the need for diagnosis of disease early has been the engines in the driving forces of diagnostic devices consumption on the class C and D. For instance, advanced imaging diagnostic apparatus MRI and CT scan machines care classified as category 3 devices are important in cancer and diseases of the brain and spine diagnosis at very early stages. With early diagnosis treatment is more effective and less invasive and hence less costly to the health care systems rather than advanced stage treatment.
• Growing Adoption of Home Healthcare Devices: The growing trend of home health care services as a result of increasing availability of such solutions and cost advantages is increasing the need for compact class C and D devices that are easy to use. Solutions such as home dialysis units, cardiac event monitors that can be worn, and insulin delivering devices enable patients to self-care. This is especially true for patients who are suffering from chronic illnesses that require ongoing observation.
• Surge in Surgical Procedures: The worldwide rise of elective and non-elective surgical processes has resulted in the increased need for surgical instruments and devices, many of which are classified as class C and D devices. A typical example is that robotics and extra-detailed observation machineries have assisted in several intricate surgeries today. The medical devices market is further fuelled by the increasing medical tourism in developing countries like Asia Pacific where there is affordable quality surgical treatment for the patients.
• Expansion in Emerging Markets: Development of health care systems in countries like Asia pacific, Latin America and Africa is increasing at an alarming rate. Both governmental and non-governmental players in these sections of the world are sinking a lot of resources so as to upgrade medical care and even purchase advanced equipment. This is due to changes in people’s disposable income, urbanization and awareness of health care quality improving. Besides, global players are also penetrating these markets particularly by cheap offers and distributing the products through local partners.

Report Scope

Class C and D Medical Devices Market Dynamics

Drivers

Rising Prevalence of Lifestyle Diseases

• Lifestyle diseases like obesity, hypertension, type 2 diabetes and others continue to rise thanks to the growing cases of stress, poor eating habits, and lack of physical activity. These conditions are most often managed through the use of sophisticated medical apparatus over a significant period of time. Continuous glucose monitors, automated blood pressure monitors, and other similar devices are on high demand as patients are able to keep track of their health parameters efficiently. The rise in the installation of such equipment is also attributed to focus on preventive care.

Government Support and Subsidies

• Currently, government of many regions provide certain financial support and incentives in order to enhance the uptake of advanced medical devices particularly in the public health facilities. In this particular case such incentive programs, which help pay for advanced life support technology ventilators and dialysis units for instance, help bring the use of these devices into the hands of a greater scope of individuals. Such measures tend to be more beneficial in the third world countries where price remains the major issue of concern. Lessening the load of costs barriers to healthcare providers and patients encourages inducing such programs and hence market expansion.

Restraints

Stringent Regulatory Requirements

• The processes of approval of Class C and D medical devices are more attached to the patient than any other aspect making them very stringent. Coupled with the appropriate level of care and diligence, the FDA and EU MDD guidelines require a considerable amount of clinical efforts, risk assessments, and the relevant paperwork before any marketing can take place. This leads to loss of market opportunity and developments costs for manufacturers. Furthermore, since there are regions with different regulatory policies and structures and the global players are required to adhere to all the policies, the situation creates more complexities.

High Development and Manufacturing Costs

• Creation or construction of class C and class D medical devices cost a lot of money because the research and/or testing and/or fabrication of the device is quite capital intensive. Most of these devices tend to have modern systems such as AI, the Internet of Things, and even technophobe materials which drive the prices even higher. Smaller enterprises as well as new companies may find it difficult to obtain financial resources and bear arms with the more established companies since they are high barriers to entry. In addition, these expenses are typically incurred by the healthcare system and the patients themselves, which restricts access to these devices, particularly in restrictive markets.

Opportunities

Integration of AI and IoT in Medical Devices

• The trend to add Artificial Intelligence (AI) to the Internet of Things (IoT) in medical devices has changed the perspective of the market. It promotes remote patient monitoring, predictive modelling, and personalized treatment strategy, resulting in improved patient care. For instance, images can be analyzed by machines with AI Inhibitors at a high level. Example two, patients and physicians do not need wires due to remote IoT connecting devices.

Growing Incidence of Infectious Diseases

• Increasing numbers of patients with infectious diseases, which has been aggravated by advancement in industrialization and accessibility of air travel has created need for better medical devices. The circumstances of such a pandemic were observed in the case of Boston where, for instance, the use of ventilators and diagnostic kits along with monitoring devices was important in dealing with the health crisis. Class C and D devices, in such cases, are also vital in ensuring proper diagnosis and treatment.

Challenges

Limited Accessibility in Emerging Markets

• Even as there are increasing levels of funding focused on enhancing the healthcare services in developing countries, the situation is worse for the C & D class medical equipment because of the presence of basic infrastructure, high costs and poor health care systems. Also, advanced devices will always come with attached components and trained personnel to operate and maintain the devices, although such professionals may not be present in the developing regions.

Lack of Skilled Professionals

• Operating and managing the class C and class D Medical devices necessitates a certain level of skill and training. Unfortunately, tracers of such medical professionals are rare in the entire world. This is more problematic in the developing regions where their training and educational amenities are scanty. The implications are that such trained health workers are unavailable to service this complex medical fund equipment. High equipment use rates cannot be sustained. Equipment use errors low productivity translate to losses, thereby making such advanced, delicate, and costly medical equipment an unworthy investment for healthcare facilities.

Class C and D Medical Devices Market Segmental Analysis

The class C and D medical devices market is segmented into device type, application, end user and region. Based on device type, the market is classified into therapeutic devices, diagnostic devices and monitoring devices. Based on application, the market is classified into cardiology, neurology and oncology. Based on end user, the market is classified into hospitals & clinics and home healthcare.

Device Type Analysis

Therapeutic Devices: Therapeutic devices encompass life-supporting equipment such as o pacemaker, infusion pump, ventilator or even a surgical robot which are a must in severe medical treatment. Pacemakers and implantable cardioverter defibrillator treat cardiac arrhythmia whereas in case of ventilators, these are used whenever there is a problem associated with breathing. The use of surgical robots is on the rise because of their ability to do accurate surgeries and shorter time taken during recovery. The rise in the adoption of therapeutic devices can be attributed to the increase in chronic diseases such as heart failure and respiratory diseases and the increasing effectiveness of minimally invasive treatments.

Diagnostic Devices: Diagnostic devices include imaging equipment that includes MRI, CT scanners, and laboratory systems, which are instrumental in early detection of diseases. These devices are crucial in diagnosing cancer, disorders of the circulation system and even conditions affecting the nervous system. This particular segment is expanding owing to the increasing focus on preventive healthcare as well as the improvements in imaging systems. Incorporation of AI into these systems has results in incredibly high accuracy levels in lesions diagnosis, as well as a short time needed for the readings.

Monitoring Devices: Monitoring devices such ICU monitoring systems, wearables and implantable monitors are important since they provide real time health data of the patients. These devices greatly help in the control of chronic ailments by providing alert on any risks and minimizing hospitalization. With the invention of IoT and wireless technologies, Patients are now cared for at home by providing them with monitoring capabilities.

Application Analysis

Cardiology: This section includes all the devices including implantable defibrillators, cardiac monitors, and stents which target cardiovascular diseases that contribute to high mortality rates globally. There is a high demand for these devices due to the increased cases of heart-related illnesses, the rise of older adults in the population, and unhealthy lifestyle practices like lack of physical exercise. In addition to these factors, some technology innovations, for example, AI cardiac monitoring devices, and cardiac diseases intervention techniques, help customers in utilizing these devices more.

Neurology: Neurology devices that comprise neurostimulators, EEG systems, as well as advanced brain imaging devices are paramount in treating neurological anomalies such as epilepsy, Parkinson’s disease, and injuries to the brain. There is growing demand in this sub-segment owing to the expanding geriatric populations which have been associated with increasing neurological diseases and improvement in imaging of the brain.

Oncology: Devices in the category of oncology include chemotherapy infusion pumps, radiation oncology devices, and diagnostic imaging systems. The increasing rate of cancer incidences across the globe is the key factor for the growth of this particular sub-segment. There has been a growing trend where devices that do targeted therapies, for instance, linear accelerators, are superior than standard machines since they are accurate and have minimal side effects. Also, the increasing demand of targeted treatment and improvements in diagnostics also assist in propelling this market.

End User Analysis

Hospitals and Clinics: As these institutions are capable of carrying out intricate medical processes, Class C and D medical equipment is in great demand within these facilities. These facilities spend considerable amounts on high-risk medical instruments such as ventilators and complex imaging systems as well as surgical robots in order to provide advanced treatment. In the hospitals, such devices are in increasing demand due to rise in chronic ailments and complicated surgical procedures that are performed.

Home Healthcare: Equipment such as home healthcare devices that provide convenience such as portable ventilators, dialysis machines, and glucose monitors are on the rise thanks to their efficiency and lower costs. Such devices help patients with long lasting illnesses to avoid going to hospitals often enabling them to take care of their health by themselves. There was a radical rise in the provision of home care focused on health care equipment, especially in the extreme period of the COVID-19 pandemic where such equipment proved to be very useful in the mitigation of the health burden posed on the systems. There have been advances in these kinds of devices due to software advancement in their use and incorporation of wireless technology.

Class C and D Medical Devices Market Regional Analysis

The class C and D medical devices market is segmented into various regions, including North America, Europe, Asia-Pacific, and LAMEA. The North America region has dominated the market in 2024.

Why is North America expected to hit largest share for the class C and D medical devices market?

The North America class C and D medical devices market size was valued at USD 25.07 billion in 2024 and is expected to be worth around USD 290.22 billion by 2034. North America is expected to remain the largest market for Class C and D medical devices due to the availability of sophisticated healthcare facilities, high health care expenditure, and emphasis on technology innovation. With the presence of prominent players in the market alongside extensive R&D activities, the region ensures the constant availability of advanced devices treasure. Furthermore, regions such as the North America market is growing owing to innovation friendly policies such as the fast-track approval of breakthrough device by the FDA.

Why is Europe accounts for a notable portion in the class C and D medical devices market?

The Europe class C and D medical devices market size was estimated at USD 16.65 billion in 2024 and is predicted to surpass around USD 192.78 billion by 2034. Europe also accounts for a notable portion, owing to the growing elderly population and a developed healthcare system. The adoption of the EU Medical Device Regulation (MDR) has improved safety and quality of products leading to confidence in high end medical devices. Further geographies include Germany, the UK and France which have high spending on healthcare and prioritize research and development activities.

What is driving the strong growth of the class C and D medical devices market in the Asia-Pacific region?

The Asia-Pacific class C and D medical devices market size was accounted for USD 12.67 billion in 2024 and is projected to hit around USD 146.64 billion by 2034. Asia-Pacific is the most lucrative region, due to factors such as increasing urbanization, better healthcare settings, and the rising income levels. Countries such as China, India, and Japan are showing the high demand due to increasing healthcare spending and a large patient population. Moreover, opportunities brought by government policies encouraging access to healthcare and insurance, expansion of the medical tourism industry, assist in market growth.

Why is LAMEA experiencing moderate growth in the class C and D medical devices market?

The LAMEA class C and D medical devices market was valued at USD 4.31 billion in 2024 and is anticipated to reach around USD 49.88 billion by 2034. The LAMEA region is experiencing moderate growth on account of higher healthcare spending and increasing burden of chronic diseases. The Latin America region is spearheaded by Brazil and Mexico and is focused on high-end medical devices to enhance the level of care in this region. Middle East and Africa have seen an increase in demand due to efforts aimed at modernizing the health care systems as well as promoting medical tourism. Nevertheless, there are drawbacks to the wider availability of medical devices such as limited infrastructure and cost-effective strategies.

Class C and D Medical Devices Market Top Companies

• Medtronic plc
• Johnson & Johnson (including DePuy Synthes and Ethicon)
• Siemens Healthineers AG
• Philips Healthcare
• GE HealthCare Technologies Inc.
• Stryker Corporation
• Abbott Laboratories
• Boston Scientific Corporation
• Becton, Dickinson and Company (BD)
• Zimmer Biomet Holdings, Inc.
• Intuitive Surgical, Inc.
• Smith & Nephew plc
• Edwards Lifesciences Corporation
• Roche Diagnostics
• Thermo Fisher Scientific Inc.

The medical devices market of Class C and D is now witnessing the entrance of a number of new players who are successfully innovating in their respective niches. This is accomplished through the application of new technologies and the unmet demands of the health care sector. These companies tend to focus on creating high-tech solutions such as AI-based diagnostics systems and other products less invasive to the body, as well as health monitors which a person can wear. They also improve the devices and the results of patients by adding ICTs such as the IoT, telemetry, and big data analytics. Emerging players, on the other hand, are also venturing into offering products in value markets by creating cheaper but better-quality imitations of high-end products offered by existing players. Many of those companies engage in partnerships with research institutions, healthcare providers, as well as other larger firms for faster product development and gaining market share.

Recent Developments

• In 2023, Abbott became one of the companies that received approval from the US Food and Drug Administration to treat abnormal or slow heart rhythms using their dual chamber leadless pacemaker AVEIR dual chamber (DR). Such was done.
• In 2023, Osiris Therapeutics is a manufacturer of regenerative therapy tools, among other products used to heal wounds; a value proposition that Smith & Nephew also holds on this issue of improving medical solutions for such complications was supported after they announced the acquisition of Osiris therapeutics by Smith & Nephew Company which makes it a global medical technology company.

Market Segmentation

By Device Type 

• Therapeutic Devices
• Diagnostic Devices
• Monitoring Devices

By Application  

• Cardiology
• Neurology
• Oncology

By End User

• Hospitals and Clinics
• Home Healthcare

By Region

• North America
• APAC
• Europe
• LAMEA