척추 수술 후 통증 증후군(FBSS) 치료 기기 시장 보고서 : 동향, 예측 및 경쟁 분석(-2031년)

The future of the global failed back surgery syndrome treatment device market looks promising with opportunities in the hospital and ambulatory surgery center markets. The global failed back surgery syndrome treatment device market is expected to grow with a CAGR of 7.5% from 2025 to 2031. The major drivers for this market are the increasing prevalence of back pain, the rising demand for non-invasive treatments, and the growing advancements in spinal technologies.

• Lucintel forecasts that, within the type category, spinal cord stimulator is expected to witness higher growth over the forecast period.
• Within the application category, ambulatory surgery center is expected to witness higher growth.
• In terms of region, APAC is expected to witness the highest growth over the forecast period.

Emerging Trends in the Failed Back Surgery Syndrome Treatment Device Market

The market for the failed back surgery syndrome treatment device is drastically transforming, with some major trends changing its landscape. These are taking the market beyond the conventional pain management towards a more integrated, technology-based, and patient-focused strategy. The emphasis is on developing solutions that are not just more effective but also less invasive and more patient-specific, thus solving a complicated and difficult-to-treat clinical condition.

• Minimally Invasive and Percutaneous Implantation: One of the trends is the movement towards minimally invasive and percutaneous implantation methods for devices such as spinal cord stimulators. This minimizes surgical trauma, decreases recovery time, and lessens complications compared to open surgery. Companies are creating smaller, more flexible implants that may be administered through a single tiny incision. The effect is a more tolerable and safer treatment for patients that is becoming an increasingly popular choice among doctors and patients alike, fueling wider adoption of these devices.
• Advanced Neuromodulation Waveforms: A new trend is the creation of complex neuromodulation waveforms, including high-frequency and burst stimulation. These newer waveforms, as opposed to older tonic stimulation, can be delivered with pain relief without the uncomfortable tingling sensation or paresthesia associated with it in many patients. They are also proving to be effective in the management of a wider variety of pain types. The effect is an improved and more comfortable treatment for FBSS patients, resulting in improved outcomes and improved quality of life.
• Closed-Loop and Adaptive Stimulation Systems: The market is shifting toward closed-loop and adaptive stimulation systems that employ a feedback loop to automatically modify stimulation parameters in real-time. These devices perceive the patient's physiological signals and provide a tailored level of stimulation to maximize the relief from pain. This obviates the patient's need to manually control the device. The result is a more effective and consistent treatment, which can result in improved long-term control of pain and patient satisfaction.
• Integration with Digital Health and Remote Monitoring: Integration of FBSS treatment devices with digital health platforms and remote patient monitoring is a significant trend. This enables doctors to remotely monitor how often a patient uses a device, pain level, and activity level, and change the settings of the therapy accordingly. Patients may also monitor progress with mobile apps and exchange messages with their healthcare team. The effect is a more coordinated and data-driven care, which enhances patient-physician conversation and facilitates long-term therapy success.
• Personalized and Targeted Therapies: Personalized and targeted therapies are increasingly being developed. Companies are designing devices to deliver stimulation to discrete nerve targets, like the dorsal root ganglion, in order to treat localized pain more precisely. The emphasis is on developing a treatment plan that is tailored to the individual patient's specific pain profile. The result is a more accurate and effective treatment for the varied group of symptoms experienced in FBSS, away from the one-size-fits-all model.

These trends are transforming the market by turning FBSS treatment devices into advanced, smart, and greatly individualized medical solutions. The market is evolving toward offering an end-to-end, data-based, and patient-focused experience, which is necessary to cover the complicated and long-lasting character of Failed Back Surgery Syndrome.

Recent Developments in the Failed Back Surgery Syndrome Treatment Device Market

Failed back surgery syndrome treatment device market is witnessing a series of recent advancements that are quickly pushing the pain management field forward. These trends are centered on a blend of technology upgrades, growing treatment indications, and strategic partnerships. The ambition is to develop products and services that are more efficient, less disruptive, and better connected to the rest of the healthcare system, which will enhance patient outcomes and make the treatment process simpler.

• FDA Clearances for High-Frequency SCS Systems: One major development is the recent wave of FDA clearances for high-frequency spinal cord stimulation (SCS) systems. These new devices, including devices that utilize 10 kHz stimulation, are established as being able to deliver better pain relief without the paresthesia commonly related to conventional SCS systems. This innovation is increasing the population of patients eligible for SCS therapy. The effect is a very significant contribution to pain relief, providing a new, very effective, and comfortable therapeutic option for FBSS patients.
• Introduction of Closed-Loop Neuromodulation Devices: The industry recently witnessed the introduction of closed-loop neuromodulation devices. This system incorporates a feedback mechanism that automatically feels and adjusts stimulation according to a patient's physiological requirements. This delivers a more stable and individualized therapy experience, maximizing pain relief during the day and evening. The result is a new generation of smart devices that make the patient's experience easier and more effective, long-lasting pain relief.
• Introduction of Dorsal Root Ganglion Stimulation Systems: A new development is the increasing availability and usage of dorsal root ganglion (DRG) stimulation systems. What this device does is target the DRG, a group of nerves that carry pain signals from one region of the body. This delivers extremely targeted and concentrated relief for patients with localized chronic pain, which is an everyday complaint of FBSS. The effect is a more targeted treatment modality for select patterns of pain, which can translate to improved results for a subpopulation of FBSS patients.
• Increased Telehealth and Remote Monitoring Capabilities: Recent advances have involved the establishment of telehealth and remote monitoring capabilities for devices used in treating FBSS. New devices come to market with wireless connectivity permitting physicians to monitor a patient's level of pain, use of device, and therapy settings remotely. This allows clinicians to make timely changes to a patient's treatment plan. The effect is a more integrated and data-informed style of care, which enhances patient-physician communication and facilitates long-term therapy success.
• Emergence of Regenerative Medicine Methods: There has been an evolution in the application of regenerative medicine methods, including stem cell therapy and platelet-rich plasma, along with conventional devices for FBSS management. Though in the infancy stage, this study focuses on alleviating the root tissue injury that can lead to post-surgical pain. The effect is a prospect for a new FBSS treatment paradigm that, in addition to controlling the pain, seeks to heal the injured tissues.

These advances are changing the market by placing FBSS treatment devices as a vital piece of a new, tech-based pain management system. The market is transforming fast, with an emphasis on delivering solutions that are not only efficient but also significantly integrated, tailored, and available to more patients.

Strategic Growth Opportunities in the Failed Back Surgery Syndrome Treatment Device Market

The market for failed back surgery syndrome treatment device presents a number of strategic growth opportunities based on an increased demand for sophisticated and affordable pain management options. By concentrating on these primary applications, organizations are not only able to increase their market share but also to inspire meaningful innovation in healthcare. The trick is to capitalize on the intersection of technology and healthcare in terms of solving the unique and usually complicated needs of patients with chronic post-surgical back pain.

• Neuromodulation for Chronic Back and Leg Pain: The neuromodulation segment offers a significant opportunity for growth since it is the most effective and widely used therapy for FBSS. The opportunity lies in developing and selling sophisticated spinal cord stimulation (SCS) systems, such as high-frequency and burst stimulation, which are able to deliver better pain relief with lower side effects. The effect is a large market for devices that provide a long-term solution to opioids and give patients a very good quality of life.
• Targeted Drug Delivery Systems for Pain Management: A second important growth opportunity exists in the design and sale of targeted drug delivery systems, including intrathecal pain pumps. These products release medication directly into the spinal fluid, with much more potent pain relief using much less dose than oral drugs. This minimizes the systemic side effects and risk of opioid addiction. The potential is to offer a highly potent remedy for non-responsive patients.
• Minimally Invasive Interventional Procedures: The market provides tremendous growth opportunity in developing minimally invasive interventional procedures. This involves radiofrequency ablation devices, which are capable of blocking pain signals from individual nerves, and epidural lysis of adhesions, which can disperse scar tissue. The potential is to offer less invasive treatments that are effective in relieving specific causes of FBSS pain. The effect is a market for devices offering targeted and instantaneous pain relief with a reduced recovery period.
• Remote Patient Monitoring and Telehealth Services: Remote patient monitoring and telehealth services are a large growth area. Companies can create connected devices and software platforms enabling physicians to remotely track a patient's pain and device use and set therapy settings appropriately. The opportunity here is to build a seamless ecosystem that delivers a true continuum of care, enhances patient engagement, and provides long-term therapy success.
• Patient-Specific and Personalized Implants: There is an opportunity for growth in creating patient-specific and personalized implants. Through sophisticated imaging and 3D printing, firms can design implants that are customized to a specific patient's anatomy and pain profile. This can result in improved surgical outcomes as well as more efficient relief from pain. The opportunity is to offer a customized solution to a complicated condition, which can be a differentiator in a competitive market.

These opportunities are affecting the market by inducing specialization and developing high-value services. The market is shifting from a broad-based to a highly specific focus on particular applications and patient groups, which is necessary for long-term growth and innovation.

Failed Back Surgery Syndrome Treatment Device Market Driver and Challenges

The market for failed back surgery syndrome treatment device is driven by a set of strong drivers while also being challenged by some strong ones. The drivers stem from an increasing patient population, technological advancements, and a transition away from opioid-based pain relief. The challenges are associated with the high expense of high-end equipment, regulatory entanglements, and greater physician and patient education needs. A precise comprehension of these dynamics is necessary for businesses looking to understand and thrive in this intricate market.

The factors responsible for driving the failed back surgery syndrome treatment device market include:

1. Increasing Rate of Spinal Surgeries: One of the key drivers is the increasing incidence of spinal surgeries worldwide, which in turn leads to an increase in the number of patients at risk for developing FBSS. With increasing incidence of back pain due to population aging and lack of activity levels, a proportionate increase in surgical procedures is taking place, resulting in a greater base for patients to be treated for FBSS. This development translates into a stable and increasing customer base for devices used to treat chronic post-surgical pain.

2. Increasing Movement to Opioid Alternatives: The worldwide opioid epidemic is an important driver. Providers and patients alike are turning to non-opioid pain management alternatives to prevent risks of addiction and side effects. Spinal cord stimulation devices and pain pumps are an excellent, long-term alternative for managing chronic pain, so they are a very attractive option for FBSS patients.

3. Technological Advances in Neuromodulation: Leading driver is rapid technological advances. Advances in high-frequency, burst, and closed-loop stimulation systems are enhancing the efficacy and user comfort of neuromodulation systems. These advances are broadening the patient population able to be treated with these therapies and driving their acceptance among physicians looking to provide their patients with the best results.

4. Expanding Reimbursement Policies: Positive reimbursement policies in developed nations are one of the principal drivers. As government payers and insurance companies acknowledge the cost-effectiveness of long-term treatment with FBSS treatment devices over constant medical treatment and re-operations, they continue to increase their reimbursement coverage. Such reimbursement support makes these therapies more affordable for a larger patient population.

5. Growing Awareness of FBSS and Options for Treatment: There is growing awareness of FBSS as a specific clinical syndrome and greater recognition of the treatment devices that are available. Patient advocate organizations and professional medical associations are making patients and physicians aware of the condition and the variety of therapeutic approaches that are available, which is causing treatment to be provided in a more timely and effective manner.

Challenges in the failed back surgery syndrome treatment device market are:

1. Exorbitant Price of Sophisticated Devices: One of the major challenges is the exorbitant price of sophisticated FBSS treatment devices, including spinal cord stimulation systems. The prohibitive initial price of the devices and the surgery can act as an obstacle for healthcare systems and patients, particularly in areas with poor insurance coverage. This financial barrier can restrict the market penetration of these new therapies.

2. Burdensome and Complex Regulatory Process: There is a burdensome and complex regulatory process in the market. Gaining approvals from organizations such as the FDA for new innovative devices is a time-consuming and costly process that involves extensive clinical trials. This might decelerate the rate of innovation and complicate entry into the market by small companies. The process of regulation also differs significantly across countries, contributing to the complexity.

3. Physician Training and Education Requirement: One challenge is that specialized training and education for physicians are required to implant and adjust these sophisticated devices. The procedures and the device programming are intricate and need high levels of expertise. Insufficiency of trained doctors and the high learning curve involved in new technologies can be a hindrance to adoption. This also emphasizes the necessity for continued manufacturer support and training.

In conclusion, the FBSS treatment device market is growing owing to a convergence of favorable drivers such as the rise in the patient population, a decline in opioid use, and technological advancements. Its growth is, however, hindered by important constraints like device costs being very high, the presence of a complicated regulatory framework, and more physician training being required. The future of the market will rely on its capacity to overcome these challenges while also continuing to deliver efficient and patient-focused solutions for chronic pain.

List of Failed Back Surgery Syndrome Treatment Device Companies

Companies in the market compete on the basis of product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leverage integration opportunities across the value chain. With these strategies failed back surgery syndrome treatment device companies cater increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the failed back surgery syndrome treatment device companies profiled in this report include-

• Boston Scientific Corporation
• Medtronic
• Stryker Corporation
• Johnson & Johnson
• Avanos Medical Devices
• Abbott Laboratories
• Cosman Medical

Failed Back Surgery Syndrome Treatment Device Market by Segment

The study includes a forecast for the global failed back surgery syndrome treatment device market by type, application, and region.

Failed Back Surgery Syndrome Treatment Device Market by Type [Value from 2019 to 2031]:

• Spinal Cord Stimulators
• Radiofrequency Ablation Devices

Failed Back Surgery Syndrome Treatment Device Market by Application [Value from 2019 to 2031]:

• Hospitals
• Ambulatory Surgery Centers

Country Wise Outlook for the Failed Back Surgery Syndrome Treatment Device Market

Failed back surgery syndrome treatment device market is growing rapidly with a rising number of spinal operations and a greater percentage of patients suffering from ongoing pain after surgery. This market, ranging from spinal stimulators to pain pumps, is changing fast. New developments are targeted towards more individualized, less invasive, and better solutions to treat chronic pain. The market is also moving towards sophisticated neuromodulation technologies and increased focus on providing long-term relief to a sophisticated patient population.

• United States: The United States is a prominent market, with high volume of spinal surgeries and high uptake of advanced medical devices. New products include FDA clearances of next-generation spinal cord stimulation (SCS) systems, such as those with high-frequency and burst stimulation waveforms, that deliver greater pain relief with fewer side effects. There is also significant interest in closed-loop SCS systems that adjust the stimulation automatically using real-time feedback. The market is also being pushed by emerging reimbursement policies that are increasing access to these new therapies, specifically as a non-opioid pain management option.
• China: China's market is expanding sharply, driven by a huge patient base and a focused effort to modernize its healthcare infrastructure. Emerging developments are centered on domestic innovation as well as an emerging demand for advanced imported devices. Chinese firms are investing heavily in the establishment of local neuromodulation technology and minimally invasive surgical device development. Government initiatives to increase access to advanced healthcare and an increase in health consciousness are also driving growth in specialist clinics and the implementation of FBSS treatment devices.
• Germany: The German market is dominated by scientific research and precision-based medical device production. Advances are focused on highly clinically tested advanced neuromodulation devices. German players are leading the development of devices that are not just effective but also have better patient safety features. The market is fueled by a high priority on long-term patient outcomes and an existing reimbursement system that favors the use of high-quality, advanced devices. There is also emphasis on research into the root causes of FBSS to make more specific therapies.
• India: India's market is in its emerging stage, with recent activity concentrating on affordability and expanding access to care. The market is experiencing a mixture of high-end devices imported and an increasing number of domestically produced, cost-saving alternatives. Increased incidence of back pain and spinal procedures, as well as a rising middle class, is propelling demand. Expansion is also centered on establishing a larger network of pain clinics and the training of physicians to use novel, less invasive treatment devices.
• Japan: Japan's market is characterized by strong stresses on technological advanced Ness and concern with an aging population. Recent advances involve the development of small, rechargeable spinal cord stimulation systems that are more patient-friendly. It is Japanese firms that are leading the way in embedding advanced sensors and AI in neuromodulation devices to enable tailored and adaptive treatment. The market is fueled by the aged population of the country and the resultant demand for long-term, effective remedies of chronic pain that can enhance quality of life and independence.

Features of the Global Failed Back Surgery Syndrome Treatment Device Market

• Market Size Estimates: Failed back surgery syndrome treatment device market size estimation in terms of value ($B).
• Trend and Forecast Analysis: Market trends (2019 to 2024) and forecast (2025 to 2031) by various segments and regions.
• Segmentation Analysis: Failed back surgery syndrome treatment device market size by type, application, and region in terms of value ($B).
• Regional Analysis: Failed back surgery syndrome treatment device market breakdown by North America, Europe, Asia Pacific, and Rest of the World.
• Growth Opportunities: Analysis of growth opportunities in different types, applications, and regions for the failed back surgery syndrome treatment device market.
• Strategic Analysis: This includes M&A, new product development, and competitive landscape of the failed back surgery syndrome treatment device market.

Analysis of competitive intensity of the industry based on Porter's Five Forces model.

This report answers following 11 key questions:

• Q.1. What are some of the most promising, high-growth opportunities for the failed back surgery syndrome treatment device market by type (spinal cord stimulators and radiofrequency ablation devices), application (hospitals and ambulatory surgery centers), and region (North America, Europe, Asia Pacific, and the Rest of the World)?
• Q.2. Which segments will grow at a faster pace and why?
• Q.3. Which region will grow at a faster pace and why?
• Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?
• Q.5. What are the business risks and competitive threats in this market?
• Q.6. What are the emerging trends in this market and the reasons behind them?
• Q.7. What are some of the changing demands of customers in the market?
• Q.8. What are the new developments in the market? Which companies are leading these developments?
• Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?
• Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or product substitution?
• Q.11. What M&A activity has occurred in the last 5 years and what has its impact been on the industry?

Table of Contents

1. Executive Summary

2. Market Overview

• 2.1 Background and Classifications
• 2.2 Supply Chain

3. Market Trends & Forecast Analysis

• 3.2 Industry Drivers and Challenges
• 3.3 PESTLE Analysis
• 3.4 Patent Analysis
• 3.5 Regulatory Environment

4. Global Failed Back Surgery Syndrome Treatment Device Market by Type

• 4.1 Overview
• 4.2 Attractiveness Analysis by Type
• 4.3 Spinal Cord Stimulators: Trends and Forecast (2019-2031)
• 4.4 Radiofrequency Ablation Devices: Trends and Forecast (2019-2031)

5. Global Failed Back Surgery Syndrome Treatment Device Market by Application

• 5.1 Overview
• 5.2 Attractiveness Analysis by Application
• 5.3 Hospitals: Trends and Forecast (2019-2031)
• 5.4 Ambulatory Surgery Centers: Trends and Forecast (2019-2031)

6. Regional Analysis

• 6.1 Overview
• 6.2 Global Failed Back Surgery Syndrome Treatment Device Market by Region

7. North American Failed Back Surgery Syndrome Treatment Device Market

• 7.1 Overview
• 7.2 North American Failed Back Surgery Syndrome Treatment Device Market by Type
• 7.3 North American Failed Back Surgery Syndrome Treatment Device Market by Application
• 7.4 United States Failed Back Surgery Syndrome Treatment Device Market
• 7.5 Mexican Failed Back Surgery Syndrome Treatment Device Market
• 7.6 Canadian Failed Back Surgery Syndrome Treatment Device Market

8. European Failed Back Surgery Syndrome Treatment Device Market

• 8.1 Overview
• 8.2 European Failed Back Surgery Syndrome Treatment Device Market by Type
• 8.3 European Failed Back Surgery Syndrome Treatment Device Market by Application
• 8.4 German Failed Back Surgery Syndrome Treatment Device Market
• 8.5 French Failed Back Surgery Syndrome Treatment Device Market
• 8.6 Spanish Failed Back Surgery Syndrome Treatment Device Market
• 8.7 Italian Failed Back Surgery Syndrome Treatment Device Market
• 8.8 United Kingdom Failed Back Surgery Syndrome Treatment Device Market

9. APAC Failed Back Surgery Syndrome Treatment Device Market

• 9.1 Overview
• 9.2 APAC Failed Back Surgery Syndrome Treatment Device Market by Type
• 9.3 APAC Failed Back Surgery Syndrome Treatment Device Market by Application
• 9.4 Japanese Failed Back Surgery Syndrome Treatment Device Market
• 9.5 Indian Failed Back Surgery Syndrome Treatment Device Market
• 9.6 Chinese Failed Back Surgery Syndrome Treatment Device Market
• 9.7 South Korean Failed Back Surgery Syndrome Treatment Device Market
• 9.8 Indonesian Failed Back Surgery Syndrome Treatment Device Market

10. ROW Failed Back Surgery Syndrome Treatment Device Market

• 10.1 Overview
• 10.2 ROW Failed Back Surgery Syndrome Treatment Device Market by Type
• 10.3 ROW Failed Back Surgery Syndrome Treatment Device Market by Application
• 10.4 Middle Eastern Failed Back Surgery Syndrome Treatment Device Market
• 10.5 South American Failed Back Surgery Syndrome Treatment Device Market
• 10.6 African Failed Back Surgery Syndrome Treatment Device Market

11. Competitor Analysis

• 11.1 Product Portfolio Analysis
• 11.2 Operational Integration
• 11.3 Porter's Five Forces Analysis
  • Competitive Rivalry
  • Bargaining Power of Buyers
  • Bargaining Power of Suppliers
  • Threat of Substitutes
  • Threat of New Entrants
• 11.4 Market Share Analysis

12. Opportunities & Strategic Analysis

• 12.1 Value Chain Analysis
• 12.2 Growth Opportunity Analysis
  • 12.2.1 Growth Opportunities by Type
  • 12.2.2 Growth Opportunities by Application
• 12.3 Emerging Trends in the Global Failed Back Surgery Syndrome Treatment Device Market
• 12.4 Strategic Analysis
  • 12.4.1 New Product Development
  • 12.4.2 Certification and Licensing
  • 12.4.3 Mergers, Acquisitions, Agreements, Collaborations, and Joint Ventures

13. Company Profiles of the Leading Players Across the Value Chain

• 13.1 Competitive Analysis
• 13.2 Boston Scientific Corporation
  • Company Overview
  • Failed Back Surgery Syndrome Treatment Device Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.3 Medtronic
  • Company Overview
  • Failed Back Surgery Syndrome Treatment Device Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.4 Stryker Corporation
  • Company Overview
  • Failed Back Surgery Syndrome Treatment Device Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.5 Johnson & Johnson
  • Company Overview
  • Failed Back Surgery Syndrome Treatment Device Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.6 Avanos Medical Devices
  • Company Overview
  • Failed Back Surgery Syndrome Treatment Device Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.7 Abbott Laboratories
  • Company Overview
  • Failed Back Surgery Syndrome Treatment Device Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.8 Cosman Medical
  • Company Overview
  • Failed Back Surgery Syndrome Treatment Device Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing

14. Appendix

• 14.1 List of Figures
• 14.2 List of Tables
• 14.3 Research Methodology
• 14.4 Disclaimer
• 14.5 Copyright
• 14.6 Abbreviations and Technical Units
• 14.7 About Us
• 14.8 Contact Us