Steerable Medical Devices Market

Market Overview

The global steerable medical devices market was valued at USD 3.47 billion in 2023. It is estimated to reach USD 6.76 billion by 2032, growing at a CAGR of 7.7% during the forecast period (2024–2032). The rising prevalence of chronic diseases like cardiovascular diseases, gastrointestinal disorders, neurological diseases, etc., is estimated to drive the global steerable medical devices market growth. The surge in the demand for minimally invasive surgical procedures is further estimated to augment the global market expansion. Moreover, the primary stakeholders in the market are receiving regulatory approval from authorities such as the FDA and the European Commission for their recently launched products, thereby creating opportunities for market expansion.

Highlights

• Electrophysiology dominates the application segment
• North America contributed to the largest steerable medical devices market share

Steerable medical devices are instruments designed for precise navigation within the body to perform diagnostic or therapeutic procedures. Unlike traditional rigid tools, these devices feature flexible shafts or mechanisms that allow controlled movement in multiple directions. Steerable devices commonly used in minimally invasive surgeries, such as endoscopy or catheterization, offer enhanced maneuverability and access to intricate anatomical structures.

They often incorporate advanced technologies like robotics or remote control systems, enabling physicians to manipulate the device with accuracy and dexterity. Applications range from cardiac interventions to neurosurgery, where precise navigation is crucial for successful outcomes while minimizing patient trauma. Steerable medical devices represent a significant advancement in medical technology, facilitating complex procedures with greater precision, safety, and efficiency, ultimately improving patient care and outcomes in various medical specialties.

Market Dynamics

Global Steerable Medical Devices Market Drivers:

Rising Incidence of Chronic Diseases

The rising incidence of chronic illnesses, such as cardiovascular ailments, neurological disorders, and gastrointestinal conditions, fuels demand for steerable medical devices. For instance, according to WHO, cardiovascular diseases (CVDs) are the primary cause of mortality worldwide, resulting in approximately 17.9 million deaths annually. Neurological disorders are the primary reason for disability-adjusted life years, and a study published in the Lancet in 2020 identifies them as the second most common cause of mortality worldwide, resulting in 9 million deaths annually.

These conditions often require intricate interventions and precise treatments, whereas steerable devices offer unparalleled accuracy and control. As the global population ages and lifestyles evolve, the prevalence of chronic illnesses continues to escalate, driving the need for advanced medical solutions. Steerable devices enable minimally invasive procedures, reducing patient trauma and recovery times while enhancing treatment outcomes. Their pivotal role in addressing the complexities of chronic diseases positions them as indispensable tools in modern healthcare, propelling market growth.

Growing Demand for Minimally Invasive Procedures

The growing preference for minimally invasive procedures is a significant driver in the steerable medical device market. These procedures offer numerous advantages over traditional open surgeries, including reduced trauma, shorter recovery times, and lower risk of complications. Steerable medical devices play a crucial role in enabling minimally invasive approaches by providing physicians with enhanced precision, control, and maneuverability within the body. As patients increasingly seek less invasive treatment options, the demand for steerable devices rises. However, healthcare providers are incentivized to adopt minimally invasive techniques due to their potential cost savings and improved patient outcomes. This further drives the market for steerable medical devices in minimally invasive procedures.

Global Steerable Medical Devices Market Restraint:

Regulatory Hurdles 

Regulatory hurdles pose a significant restraint on the steerable medical devices industry. Strict adherence to safety and efficacy requirements, comprehensive testing, and documentation are required to obtain regulatory approval from organizations such as the FDA. The regulatory process is time-consuming and costly, often requiring substantial investments in clinical trials and compliance efforts.

Additionally, the evolving nature of regulations means that companies must stay abreast of changing requirements, further adding to the complexity and uncertainty. Delays or failures in obtaining regulatory clearance can significantly impede market entry and product commercialization, hampering innovation and industry growth. Moreover, differing regulatory frameworks across regions necessitate navigating multiple approval processes, increasing regulatory burden and market entry barriers for international expansion. Thus, regulatory hurdles represent a formidable challenge for companies operating in the steerable medical devices market.

Global Steerable Medical Devices Market Opportunities:

Rise in Regulatory Approvals

The regulatory environment significantly influences the market for steerable medical devices, as adherence to stringent standards ensures product safety, efficacy, and quality. Regulatory approvals, such as FDA clearance in the United States or CE marking in Europe, are essential for market entry. Compliance with these regulations instills confidence in healthcare providers and patients and facilitates market access and reimbursement. Thus, the key players are increasingly obtaining regulatory approval from the abovementioned authorities for their newly launched products.

For instance, in September 2022, Serpex Medical received approval from the U.S. Food and Drug Administration (FDA) for its Compass Steerable Needles. These needles are designed for biopsies and may be steered to provide accurate access to lung nodules located within the intrapulmonary area. Serpex Medical aims to utilize the capabilities of steerable equipment to enhance accuracy and accessibility in diagnosing and treating lung cancer. The approval of the Compass Steerable Needles comes after the recent approval of Serpex's Recon Steerable Sheath. This is projected to generate opportunities for market expansion.

Regional Analysis

Based on region, the global steerable medical devices market share is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. 

North America Dominates the Global Market

North America is the most significant global steerable medical devices market shareholder and is expected to expand substantially during the forecast period. The regional dominance can be attributed to well-established healthcare infrastructure, the adoption of advanced medical technologies, and a rise in healthcare spending. Similarly, the growing geriatric population in the U.S. and Canada and the increasing prevalence of chronic diseases have prompted the need for steerable medical devices in North America. For instance, according to the CDC, around 60% of adults in the United States presently suffer from a chronic illness, like cancer, heart disease, or diabetes. Heart disease and cancer collectively contribute to approximately 38 percent of all fatalities in the United States, making chronic diseases among the primary causes of death. Moreover, forecasts suggest that Americans aged 65 and over will reach 95 million by 2060, a substantial rise from the 52 million reported in 2018. The percentage of people aged 65 and older is predicted to increase from 16% to 23% within the same period.

Furthermore, the presence of many large institutes carrying research for the development of new steerable medical devices is contributing to North America's dominance in the market. For instance, in August 2021, a team of engineers and physicians from the University of California San Diego created a steerable catheter that allows neurosurgeons to navigate the arteries and blood vessels of the brain with precise steering capabilities in any desired direction. The technology drew inspiration from natural features, namely insect legs, and flagella, which are tail-like appendages that enable small creatures like bacteria to propel themselves by swimming. The efficacy of the steerable catheter was successfully demonstrated in pigs at the Center for the Future of Surgery at UC San Diego. Consequently, all these factors are estimated to drive the market growth in this region.

The Asia-Pacific steerable medical devices market is projected to experience the highest growth rate. The market is primarily influenced by increasing purchasing power, fast population growth, growing awareness of health concerns, technology advancements, and government backing. Furthermore, the region is home to a significant geriatric population, who are vulnerable to experiencing a range of age-related illnesses. As per an article published by BBC, the proportion of individuals aged 80 or older in Japan has recently exceeded 10%, marking a historic milestone. According to national figures, 29.1% of the total population, which is 125 million people, is aged 65 or older. This represents a new record. According to the United Nations, Japan possesses the highest proportion of individuals aged 65 or older, making it the country with the oldest population in the world. This is estimated to boost the Asia-Pacific steerable medical devices industry.

Furthermore, regional steerable medical devices are driven by FDI, the presence of major medical device manufacturers, and rising investment in medical devices. For instance, in 2018, India generated about USD 66 million in FDI in the field of medical devices. The country is backed by the presence of about 750–800 domestic medical device manufacturers, with an average investment of around USD 2 million and a turnover of about USD 6.2 to 6.9 million in 2018. Consequently, the factors above are estimated to augment the regional market expansion.

Segmental Analysis

The global market for steerable medical devices is bifurcated into types of devices and applications.

Based on the type of devices, the global steerable medical devices market is segmented into steerable balloon catheters, steerable needles and guidewires, steerable catheters, steerable sheaths, and others.

Steerable catheters are medical devices used in minimally invasive procedures to precisely navigate the body's intricate pathways. These catheters, which consist of a flexible tube with a controlled tip, are intended to reach hard-to-reach bodily parts like the heart or blood vessels with the least amount of tissue damage. They offer improved maneuverability compared to traditional catheters, enabling physicians to reach target locations more accurately.

Typically controlled by external mechanisms or advanced technologies like electromagnetic fields or robotics, steerable catheters provide real-time feedback to guide movement within the body. This allows for delicate procedures such as cardiac ablations, angioplasties, or neurovascular interventions. By enhancing the physician's ability to access and treat specific areas, steerable catheters contribute to safer and more effective medical interventions, reducing patient discomfort and recovery times while improving outcomes.

Based on the application, the global steerable medical devices market is bifurcated into electrophysiology, endoscopy, urology and gynecology, general and vascular surgery, and others. 

The electrophysiology segment dominates the global market. The study of biological cells' and tissues' electrical characteristics is known as electrophysiology. It investigates how cells generate and propagate electrical signals, primarily focusing on neurons, cardiac cells, and muscle cells. Electrophysiology plays a crucial role in developing and operating steerable medical devices used in various medical procedures. These devices are designed to be navigated through the body's complex anatomical structures, often to reach specific targets such as tumors, lesions, or specific regions of the brain or heart. Electrophysiological techniques and measurements guide these devices effectively and ensure accurate placement and function.

Recent Developments

• March 2023- Merit Medical declared the expansion of its SwiftNinja steerable microcatheter product range. The updated options now feature a 2.4Fr distal diameter choice with a low-profile design, available in both 125-cm and extended 150-cm lengths.
• August 2023- Abbott issued a recall for its Amplatzer Steerable Delivery Sheath (ASDS) because there is a known higher chance of air embolism occurring. Utilizing this device can result in severe injuries and substantial health consequences, such as stroke and fatality.