The fluorescence-guided surgery system market is predicted to increase from USD 110.8 million in 2024 to USD 468 million in 2034. Sales are projected to rise at a CAGR of 15.5% over the forecast period between 2024 and 2034.
The revenue generated by fluorescence-guided surgery system in 2023 was USD 92.7 million. The global fluorescence-guided surgery system industry is projected to rise due to increasing regulatory approvals, healthcare expenditure, and surging number of targeted surgical procedures.
Research and development have led to the improvement of fluorescence probes that are highly specific to cancerous cells or target tissues. These probes improve surgeons' visualization of the surgical site during procedures. Clinical data shows that fluorescence-guided surgery enhances patient outcomes, encouraging its adoption by healthcare institutions.
In April 2022, the Imperial Confidence in Concept grant was approved to produce fluorescence probes for tumor visualization during cancer surgery. As more instruments receive regulatory approval, fluorescence-guided surgery devices become increasingly accessible for clinical use.
By application, the fluorescence-guided surgery system market is segmented into cancer surgeries and cardiovascular surgeries, with cancer surgeries holding the leading share in 2023. Increasing incidence of cancer is projected to push demand for fluorescence-guided surgery systems in cancer treatment.
Fluorescence-guided surgery is set to enhance surgery accuracy and potentially improve patient outcomes. As per a report published by the National Institutes of Health (NIH), China witnessed an increase in cancer cases in 2023, with lung cancer being the most prevalent type.
The field of functional genomics (FGS) is undergoing significant developments due to progressions in imaging technology. These include high resolution, improved sensitivity, and real-time imaging, enabling surgeons to visualize target tissues more accurately.
The integration of FGS systems with surgical navigation platforms is becoming more common, providing real-time guidance and enhancing intraoperative decision-making. Leading manufacturers are also prioritizing patient safety and improving surgical outcomes by developing safe, biocompatible fluorescent agents.
| Attributes | Description |
|---|---|
| Estimated Global Fluorescence Guided Surgery System Market Size (2024E) | USD 110.8 million |
| Projected Global Fluorescence Guided Surgery System Market Value (2034F) | USD 468 million |
| Value-based CAGR (2024 to 2034) | 15.5% |
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Growing Need for Minimally Invasive Surgical Techniques to be a Key Trend
Growing demand for minimally invasive surgical techniques is fueling the adoption of FGS systems. These systems enable surgeons to accurately visualize target tissues, minimize damage to healthy tissue, and enhance patient outcomes in minimally invasive procedures.
Improved Surgical Outcomes Push Sales in the Industry
Increasing acceptance and adoption of FGS systems among healthcare providers is spurred by the growing clinical evidence supporting the efficacy. Clinical studies demonstrating improved surgical outcomes, reduced positive margin rates, and low recurrence rates are surging demand for FGS technology.
Stringent Regulatory Approval Process to Hinder Growth
Regulatory approvals for new fluorescent agents and imaging devices are set to be lengthy and complex, necessitating extensive preclinical and clinical testing. Delays are projected to hinder commercialization, limit market access, and slow market growth for manufacturers.
High Implementation and Maintenance Cost to Obstruct Demand
The high cost of fluorescence imaging systems and related equipment, including specialized devices, fluorescent agents, and surgical navigation software, is a significant restraining factor in the FGS system market. The implementation and maintenance of FGS systems are set to be costly for a few healthcare facilities, especially small clinics and resource-limited areas.
The global market recorded a CAGR of 20% during the historical period between 2019 and 2023. Fluorescence imaging, a surgical guidance technique, emerged between 2019 and 2023, using fluorescent dyes or contrast agents to differentiate between healthy and diseased tissue.
Over time, developments in imaging technologies have led to high-resolution images and enhanced tissue penetration, making fluorescence-guided surgery more accurate and reliable. Clinical validation and adoption have led to its acceptance in various surgical specialties, including oncology, neurosurgery, urology, and cardiovascular surgery.
FDA approvals have accelerated the commercialization and widespread adoption of fluorescence-guided surgery systems, allowing companies to offer integrated intraoperative visualization.
Fluorescence-guided surgery has extended into new clinical applications beyond oncology, including sentinel lymph node mapping, perfusion assessment, and organ preservation. Integration with surgical navigation systems has enhanced the accuracy and efficiency of fluorescence-guided procedures, providing real-time guidance.
The development of fluorescent agents is being pursued to improve the specificity of fluorescence-guided surgery. This is a result of binding the agents to specific molecular markers linked to diseases like cancer. By 2034, the industry is projected to reach USD 468 million.
Fluorescence-guided surgery necessitates specialized training and expertise among surgical teams. This encompasses fluorescence imaging techniques, signal interpretation, and integration into workflows. Increasing demand for resources and staff is projected to hinder the growth of healthcare institutions.
Principal Consultant
The following table shows the estimated growth rates of the leading markets. The United States is anticipated to remain at the forefront in North America, with a CAGR of 15.8% through 2034. In East Asia, Japan is projected to witness a CAGR of 17.4% by 2034, followed by China at 16.3%.
| Countries | CAGR 2024 to 2034 |
|---|---|
| United States | 15.8% |
| United Kingdom | 16.8% |
| China | 16.3% |
| South Korea | 18% |
| Japan | 17.4% |
The fluorescence-guided surgery system industry in the United Kingdom is projected to reach USD 18.9 million over the forecast period. The industry is projected to rise due to a huge patient population, presence of reputed manufacturers, high incidence of chronic diseases, and demand for novel surgical treatments.
Furthermore, rapidly developing healthcare expenditure, improving infrastructure, rising geriatric population, and high prevalence of lifestyle diseases are surging growth.
The United States is anticipated to record a CAGR of 15.8% during the evaluation period. The country is growing due to factors such as increasing cancer prevalence, launch of minimally invasive surgical techniques, and demand for precision-guided interventions.
The United States is a hub for technological innovation in healthcare, with companies investing heavily in research and development to advance fluorescence imaging technologies. Fluorescence-guided surgery has been widely adopted across various surgical specialties in the United States, including oncology, neurosurgery, urology, and cardiovascular surgery.
The United States Food and Drug Administration (FDA) plays a key role in regulating these systems and agents, ensuring safety and efficacy for clinical use. The market is highly competitive, with leading manufacturers and small companies vying for high shares.
China is projected to showcase a CAGR of 16.3% in the forecast period. The country is a hub for clinical research and collaboration in fluorescence-guided surgery, involving academic institutions and healthcare providers in clinical trials and technology development.
Reimbursement policies and coverage for fluorescence-guided procedures vary depending on the specific application and healthcare provider. Efforts are ongoing to secure broad reimbursement coverage for fluorescence-guided procedures.
China is projected to continue growth and innovation with developments in imaging technology, targeted fluorescent agents, and surgical navigation systems.
The section below analyzes the leading segment of the market. In terms of type, the SPY system segment accounted for a share of 34% in 2023. Based on surgery, the open surgery segment held a share of 65% in 2023.
| Segment | SPY System (Type) |
|---|---|
| Value Share (2023) | 34% |
The SPY system segment, which uses fluorescence-guided surgery (FGS) to improve surgical results, held the leading share in 2023 due to the increasing incidence of heart disorders.
FGS systems, like the SPY system, use real-time tissue perfusion monitoring and specific biological targets during surgery. The system enables surgeons to perform operations with few challenges and better patient outcomes.
| Segment | Open Surgery (Surgery) |
|---|---|
| Value Share (2023) | 65% |
The fluorescence-guided surgery system market is divided into open surgery and laparoscopy/endoscopy, with open surgery holding the leading share in 2023. This segment includes oncology, neurosurgery, cardiovascular, and gastrointestinal surgeries.
The industry is growing due to the need for efficient and precise operations. Fluorescence-guided surgery uses indocyanine green (ICG) to highlight specific tissues or structural components. This makes the open surgery a significant segment for those treatments not suitable with minimally invasive methods.
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Stryker Corporation, Olympus Corporation, Medtronic PLC, OnLume Inc., and Getinge AB are key fluorescence-guided surgery system manufacturers listed in the report. The market evaluates leading companies in the industry based on product offerings, financial statements, key developments, strategic approach, position, and geographical penetration.
Strengths, weaknesses, opportunities, winning imperatives, current focus, strategies, and threats from competitors are also analyzed for key companies.
Several companies in the industry are focusing on partnerships, mergers and acquisitions, new product launches, and regional footprint extensions. Leading manufacturers of fluorescence-guided surgery systems are continuously refining existing products to meet evolving consumer expectations and demands.
Key manufacturers also employ strategies such as partnerships, distribution agreements, collaborations, advertisements, and celebrity endorsements to stay ahead of the competition. These strategies help several companies to enhance brand visibility, establish credibility, and gain a competitive advantage in the dynamic landscape.
Industry Updates
The industry is segregated into SPY system, PDE system, VS3 iridium system, and others.
In terms of surgeries, the industry is divided into open surgery and laparoscopy/endoscopy.
A few of the important applications include cancer surgeries, cardiovascular surgeries, and others.
Key countries of North America, Latin America, East Asia, South Asia and Pacific, Western Europe, Eastern Europe, and the Middle East and Africa are covered.
The industry is set to witness a CAGR of 15.5% by 2034.
The industry witnessed a CAGR of 20% from 2019 to 2023.
In 2034, the industry is anticipated to reach USD 468 million.
The United Kingdom is estimated to lead through 2034.
Stryker Corporation, Olympus Corporation, Medtronic PLC.
The market is set to reach USD 110.8 million by 2024.
1. Executive Summary 2. Industry Introduction, including Taxonomy and Market Definition 3. Market Trends and Success Factors, including Macro-economic Factors, Market Dynamics, and Recent Industry Developments 4. Global Market Demand Analysis 2019 to 2023 and Forecast 2024 to 2034, including Historical Analysis and Future Projections 5. Pricing Analysis 6. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034 6.1. Type 6.2. Surgery 6.3. Application 7. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Type 7.1. SPY System 7.2. PDE System 7.3. VS3 Iridium System 7.4. Others 8. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Surgery 8.1. Open Surgery 8.2. Laparoscopy/Endoscopy 9. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Application 9.1. Cancer Surgeries 9.2. Cardiovascular Surgeries 9.3. Others 10. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Region 10.1. North America 10.2. Latin America 10.3. Western Europe 10.4. South Asia 10.5. East Asia 10.6. Eastern Europe 10.7. Middle East & Africa 11. North America Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 12. Latin America Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 13. Western Europe Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 14. South Asia Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 15. East Asia Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 16. Eastern Europe Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 17. Middle East and Africa Sales Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 18. Sales Forecast 2024 to 2034 by Type, Surgery, and Application for 30 Countries 19. Competition Outlook, including Market Structure Analysis, Company Share Analysis by Key Players, and Competition Dashboard 20. Company Profile 20.1. Stryker Corporation 20.2. Hamamatsu Photonics K.K. 20.3. Olympus Corporation 20.4. Medtronic PLC 20.5. OnLume Inc. 20.6. Getinge AB 20.7. Curadel LLC 20.8. PerkinElmer, Inc. 20.9. Karl Storz SE & Co. KG 20.10. Irillic Pvt. Ltd 20.11. Shimadzu Corporation
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Fluorescence Guided Surgery System Market
