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市場調査レポート
商品コード
1642681
外科用ナビゲーションシステムの市場レポート:技術、用途、最終用途、地域別2025-2033Surgical Navigation Systems Market Report by Technology, Application, End User, and Region 2025-2033 |
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外科用ナビゲーションシステムの市場レポート:技術、用途、最終用途、地域別2025-2033 |
出版日: 2025年01月18日
発行: IMARC
ページ情報: 英文 141 Pages
納期: 2~3営業日
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外科用ナビゲーションシステムの市場の世界市場規模は2024年に97億米ドルに達しました。今後、IMARC Groupは、市場は2033年までに225億米ドルに達し、2025年から2033年にかけて9.76%の成長率(CAGR)を示すと予測しています。慢性疾患の負担増、高齢化、低侵襲(MI)手技のニーズの高まり、外科用ナビゲーションシステムへの斬新な可視化技術の統合などが、市場成長を促す主な要因となっています。
主な市場促進要因:がん、整形外科疾患、神経疾患などを含む慢性疾患の負担の急増が、主に市場成長の原動力となっています。さらに、画像モダリティの改善、ソフトウェアアルゴリズムの強化、拡張現実との統合など、外科用ナビゲーション技術の進歩が続いていることも市場成長を後押ししています。
主な市場動向:人工知能(AI)と機械学習の統合、ポータブルおよびハンドヘルドナビゲーションシステムの市場開拓への傾斜の高まり、画像モダリティの進歩の高まりなどが、市場の需要を拡大すると予想されます。さらに、医療インフラ投資の増加、先進医療技術に対する需要の高まり、医療従事者の意識の高まりにより、外科用ナビゲーションシステムの市場も拡大しています。
競合情勢:外科用ナビゲーションシステムの市場の主要企業としては、Amplitude Surgical、B. Braun SE、Brainlab AG、Collin Medical、Fudan Digital Medical、Johnson &Johnson、Medtronic PLC、Siemens Healthcare Private Limited、Stryker Corporation、Zimmer Biomet Holdings Inc.などが挙げられます。
地理的動向:報告書によると、北米が最大の市場シェアを占めています。北米は、人口の高齢化、慢性疾患の増加、外科手術の需要の高まり、技術革新の進行など、さまざまな要因によって最も顕著なシェアを獲得しています。北米はヘルスケアにおける技術革新の最前線にあり、これは外科用ナビゲーションシステムにも当てはまる。画像モダリティの向上、ソフトウェアアルゴリズムの強化、他の手術ツールとの統合など、ナビゲーション技術の絶え間ない進歩が、外科用ナビゲーションシステムの市場の需要を押し上げています。
課題と機会:外科用ナビゲーションシステムの初期コストの高さ、統合の複雑さ、専門的なトレーニングの必要性、規制への対応などが、市場が直面している主な課題です。しかし、外科用ナビゲーションシステムとロボット手術プラットフォームおよびデジタル手術技術の統合は、手技の正確性、自動化、手術効率の向上につながる多くの機会をもたらしています。ナビゲーションシステムメーカーとロボット企業の協働は、低侵襲手術の革新的なソリューションにつながり、業界の需要を支えます。
筋骨格系および神経系疾患の急増
世界人口の高齢化に伴い、変形性関節症、椎間板変性症、アルツハイマー病やパーキンソン病などの神経疾患など、加齢に関連した疾患が自然増加します。高齢化社会は、筋骨格系疾患や神経系疾患の増加に大きく寄与しています。例えば、世界保健機関(WHO)が2022年7月に発表した報告書によると、高齢化により約17億1,000万人が筋骨格系疾患に苦しんでいます。これとは別に、画像モダリティの改善、拡張現実との統合、AI主導のナビゲーション・アルゴリズムなど、外科用ナビゲーション技術の継続的な進歩が、複雑な筋骨格系や神経系の症例に対応するこれらのシステムの能力を高めています。外科医は、患者の転帰を改善するために高度な機能を備えたナビゲーション・システムを採用する傾向が強まっています。例えば、2023年12月、精密医療向け画像バイオマーカーの主要企業であるQuibim社は、QP-Brainを発売しました。QP-Brainは、人工知能(AI)を使ってMRI検査のデータを自動的に数値化し、その結果をPACSに直接表示する技術で、神経疾患患者の脳の定量分析を容易にします。これに加えて、各国の政府は、職場における筋骨格系障害に関する意識を高めるためのイニシアチブをとっています。例えば、2024年1月、全米安全評議会(NSC)はアマゾンと提携し、職場における筋骨格系障害(MSD)削減の進捗状況を明らかにする「MSD Solutions Index Pledge Community Report」を発表しました。50社以上の著名企業を対象とした調査に基づくこの分析では、雇用者に年間約170億米ドルの損害を与えている最も一般的な労働災害の防止について、心強い開発と改善すべき点の両方が明らかにされています。これらの要因が外科用ナビゲーションシステムの市場の収益を押し上げています。
ロボットナビゲーションの普及
ロボットナビゲーションシステムは、手術中に手術器具を誘導する際に高い精度と正確性を提供します。高度な画像技術とリアルタイムのフィードバックを活用することで、これらのシステムは外科医が複雑な解剖学的構造をより高い信頼性と精度でナビゲートすることを可能にし、エラーのリスクを低減して手術結果を改善します。例えば、BLK-Max Super Specialty Hospitalは2022年12月、手術の安全性と正確性を高めるため、脊椎手術用の統合ロボットシステムを発表しました。さらに、ロボットナビゲーションシステムは、外科医に3D画像や拡張現実(AR)オーバーレイなどの強化された視覚化機能を提供します。この視覚化の向上により、空間的な方向と奥行きの知覚が向上し、手術中のより正確なナビゲーションと組織操作が容易になります。例えば、2022年9月、2D/3Dイメージング、外科用ナビゲーション、ロボット工学を組み合わせたシステムを設計・製造するフランスの成長MedTech企業eCential Robotics社は、3Dイメージング、ナビゲーション、ロボット工学ガイダンスシステムのFDA 510(k)認可を発表し、米国での統一ロボットプラットフォームの普及を確実なものにしました。これに伴い、手術用ロボットと複合現実感のビジネスを展開するゼータ・サージカル社は、シンガポールの国立神経科学研究所(NNI)で行われた人体実験において、ゼータ頭蓋ナビゲーション・システムによる最初の患者の治療に成功しました。これらの要因が外科用ナビゲーションシステムの市場のシェアにさらに貢献しています。
低侵襲手術手技の採用増加
低侵襲手術手技では、手術部位への視界やアクセスが限られているため、正確なナビゲーションが必要となります。ナビゲーションシステムはリアルタイムのガイダンスとフィードバックを提供し、外科医がMIS手技中に複雑な解剖学的構造をより正確にナビゲートできるようにします。例えば、2023年8月、脊椎・整形外科の世界企業であるOrthofix Medical Inc.は、7D FLASH Navigation System Percutaneous Module 2.0を使用した最初の症例を米国で開始し、完遂しました。Percutaneous Module 2.0は、Orthofixの7D FLASHナビゲーション・システムに新たなプランニング機能と機能を追加し、低侵襲手術(MIS)脊椎業界により良いサービスを提供できるようにしました。さらに、整形外科、神経外科、心臓血管外科、婦人科など、さまざまな外科専門分野で低侵襲技術がますます活用されるようになっています。ナビゲーション・システムは、こうした専門分野の多様なニーズに対応し、複数の臨床分野にわたって市場の成長を促進しています。例えば、フィリップスは2024年2月、光ファイバーリアルシェイプ(FORS)技術を採用し、血管外科手術でX線放射線を使用しない低侵襲手術を可能にするルミガイドを発売しました。さらに、米国のFDAや欧州のCEマークなどの規制機関が、低侵襲手術に使用するナビゲーション・システムを承認しました。明確な規制経路と承認は安全性と有効性を保証し、低侵襲手術におけるナビゲーション技術の採用を後押しします。例えば、2023年5月、ノバラッドはインドネシア食品医薬品局(FDA)から低侵襲手術用VisAR外科用ナビゲーションシステムの承認を受けました。こうした要因が外科用ナビゲーションシステムの市場予測にプラスの影響を与えています。
The global surgical navigation systems market size reached USD 9.7 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 22.5 Billion by 2033, exhibiting a growth rate (CAGR) of 9.76% during 2025-2033. The rising burden of chronic diseases, the aging population, the growing need for minimally invasive (MI) procedures, and the integration of novel visualization technologies into surgical navigation systems represent some of the key factors driving the market growth.
Major Market Drivers: The surging burden of chronic diseases, including cancer, orthopedic disorders, neurological conditions, etc., is primarily driving the market growth. Moreover, ongoing advancements in surgical navigation technology, such as improved imaging modalities, enhanced software algorithms, and augmented reality integration, are also propelling the market growth.
Key Market Trends: Integration of artificial intelligence (AI) and machine learning, growing inclination towards the development of portable and handheld navigation systems, rising advancement in imaging modalities, etc., are expected to proliferate the market demand. Furthermore, the surgical navigation system market is also expanding due to increasing healthcare infrastructure investments, rising demand for advanced medical technologies, and growing awareness among healthcare professionals.
Competitive Landscape: Some of the leading surgical navigation systems market companies are Amplitude Surgical, B. Braun SE, Brainlab AG, Collin Medical, Fudan Digital Medical, Johnson & Johnson, Medtronic PLC, Siemens Healthcare Private Limited, Stryker Corporation, and Zimmer Biomet Holdings Inc., among many others.
Geographical Trends: According to the report, North America accounted for the largest market share. North America acquired the most prominent share owing to various factors, such as the aging population, rising incidences of chronic diseases, escalating demand for surgical procedures, ongoing technological innovations, etc. North America is at the forefront of technological innovation in healthcare, and this applies to surgical navigation systems as well. Continuous advancements in navigation technology, such as improved imaging modalities, enhanced software algorithms, and integration with other surgical tools, drive the surgical navigation systems market demand.
Challenges and Opportunities: High initial cost of surgical navigation systems, complexity of integration, need for specialized training, and regulatory compliance are some of the key challenges that the market is facing. However, the integration of surgical navigation systems with robotic surgical platforms and digital surgery technologies presents numerous surgical navigation systems market opportunities for enhanced procedural accuracy, automation, and surgical efficiency. Collaborations between navigation system manufacturers and robotics companies can lead to innovative solutions for minimally invasive surgery, thereby supporting the industry's demand.
Surging Cases of Musculoskeletal and Neurological Disorders
As the global population ages, there's a natural increase in age-related conditions, such as osteoarthritis, degenerative disc disease, and neurological disorders like Alzheimer's and Parkinson's disease. The aging demographic contributes significantly to the rise in musculoskeletal and neurological disorders. For instance, according to the report published by the World Health Organization in July 2022, nearly 1.71 billion people suffer from musculoskeletal disease owing to the aging population. Apart from this, continuous advancements in surgical navigation technology, including improved imaging modalities, augmented reality integration, and AI-driven navigation algorithms, enhance the capabilities of these systems in addressing complex musculoskeletal and neurological cases. Surgeons are more inclined to adopt navigation systems with advanced features to improve patient outcomes. For instance, in December 2023, Quibim, a company leading imaging biomarkers for precision medicine launched QP-Brain. QP-Brain is a technology that uses artificial intelligence (AI) to automatically quantify, and present results based on the data from MRI Scans directly in PACS, making it easier to perform quantitative analysis on patients' brains for neurological disorders. Besides this, governments of various countries are taking initiatives in order to create awareness regarding musculoskeletal disorders in the workplace. For instance, in January 2024, the National Safety Council (NSC), in partnership with Amazon, launched the MSD Solutions Index Pledge Community Report, which highlights progress in reducing musculoskeletal disorders (MSDs) in the workplace. The analysis, based on a survey of over 50 prominent firms, identifies both encouraging developments and places for improvement in preventing the most prevalent workplace accident, which costs employers approximately US$ 17 Billion per year. These factors are bolstering the surgical navigation systems market revenue.
Rising Penetration of Robotic Navigation
Robot navigation systems offer high levels of precision and accuracy in guiding surgical instruments during procedures. By leveraging advanced imaging technologies and real-time feedback, these systems enable surgeons to navigate complex anatomical structures with greater confidence and precision, reducing the risk of errors and improving surgical outcomes. For instance, in December 2022, BLK-Max Super Specialty Hospital launched an integrated robotic system for spine surgeries in order to increase the safety and accuracy of the surgery. Moreover, robot navigation systems provide surgeons with enhanced visualization capabilities, including 3D imaging and augmented reality overlays. This improved visualization allows for better spatial orientation and depth perception, facilitating more precise navigation and tissue manipulation during surgery. For instance, in September 2022, eCential Robotics, a French growth MedTech company that designs and manufactures a system that combines 2D/3D imaging, surgical navigation, and robotics, announced FDA 510(k) clearance for its 3D imaging, navigation, and robotics guidance system, securing the penetration of its unified robotic platform in the United States. In line with this, Zeta Surgical, a surgical robotics and mixed reality business, successfully treated its first patient with the Zeta Cranial Navigation System during its first-in-human study at Singapore's National Neuroscience Institute (NNI). These factors are further contributing to the surgical navigation systems market share.
Increasing Adoption of Minimally Invasive Surgical Techniques
Minimally invasive surgical techniques require precise navigation due to limited visibility and access to the surgical site. Navigation systems provide real-time guidance and feedback, enabling surgeons to navigate complex anatomical structures with greater accuracy during MIS procedures. For instance, in August 2023, Orthofix Medical Inc., a global spine and orthopedics company, launched and completed the first cases in the United States using the 7D FLASH Navigation System Percutaneous Module 2.0. The Percutaneous Module 2.0 adds new planning capabilities and capability to Orthofix's 7D FLASH Navigation System, allowing it to better serve the Minimally Invasive Surgery (MIS) spine industry. Moreover, minimally invasive techniques are being increasingly utilized across various surgical specialties, including orthopedics, neurosurgery, cardiovascular surgery, and gynecology. Navigation systems accommodate the diverse needs of these specialties, driving the market growth across multiple clinical areas. For instance, in February 2024, Philips launched LumiGuide, which uses Fiber Optic RealShape (FORS) technology to enable minimally invasive surgery without the use of X-ray radiation for vascular surgery. Furthermore, regulatory agencies, such as the FDA in the United States and the CE mark in Europe, approved navigation systems for use in minimally invasive surgeries. Clear regulatory pathways and approvals provide assurance of safety and efficacy, encouraging the adoption of navigation technology in minimally invasive procedures. For instance, in May 2023, Novarad received approval from Indonesia's Food and Drug Administration (FDA) for VisAR surgical navigation system for minimally invasive surgery. These factors are positively influencing the surgical navigation systems market forecast.
Electromagnetic Navigation Systems
Optical Navigation Systems
Others
Electromagnetic navigation systems dominates the market
Electromagnetic navigation systems are valuable tools used in surgical navigation systems across various medical fields. These systems utilize electromagnetic fields to track the position of instruments or devices within the body, providing real-time guidance to surgeons during procedures. Moreover, surgeons can use electromagnetic navigation systems during the pre-operative phase to plan surgical approaches and trajectories. By overlaying imaging data (such as CT scans or MRI) onto a computer-generated model of the patient's anatomy, surgeons can simulate the procedure and determine the optimal path for instrument insertion. For instance, in May 2024, Centerline Biomedical, Inc., was awarded a MedTech Outlook Award as a 2024 top surgical devices company. The company is known for Revolutionizing Interventional Procedures with IOPS Technology. Endovascular surgeries benefit from IOPS's innovative 3D visualization, electromagnetic navigation, and radiation safety features.
Neurosurgery
Orthopedic
ENT
Dental
Others
Neurosurgery hold the largest share in the market
As per the surgical navigation systems market outlook, surgical navigation systems have revolutionized neurosurgery by providing neurosurgeons with advanced tools for precise planning and execution of complex procedures involving the brain and spine. It assists neurosurgeons in accurately locating and delineating brain tumors, even those deep within the brain. By overlaying pre-operative imaging onto the patient's anatomy in real-time, surgeons can precisely navigate to the tumor, minimizing damage to surrounding healthy brain tissue. For instance, in January 2024, Zeta Surgical, a surgical robotics and mixed reality firm, received FDA special 510(k) clearance for increased features and expanded compatibility with their cranial navigation system for neurosurgery.
Hospitals
Ambulatory Surgical Centers
Hospitals accounts for the majority of the market share
Surgical navigation systems are increasingly being used in hospitals for various procedures, especially those involving delicate or intricate surgeries. Surgeons can use surgical navigation systems to plan the surgery before entering the operating room. This involves reviewing medical images such as CT scans, MRI scans, or ultrasound to map out the procedure and identify critical structures. In addition, during surgery, navigation systems provide real-time feedback to the surgeon, helping them navigate through complex anatomical structures with precision. This guidance can be particularly useful in minimally invasive procedures where the surgeon's direct line of sight may be limited. For instance, in January 2024, AdventHealth for Children, a nationally recognized children's hospital and pediatric specialty network situated in Central Florida, successfully completed cranial vault reconstruction for craniosynostosis using the VisAR augmented reality surgical navigation system.
North America
United States
Canada
Asia-Pacific
China
Japan
India
South Korea
Australia
Indonesia
Others
Europe
Germany
France
United Kingdom
Italy
Spain
Russia
Others
Latin America
Brazil
Mexico
Others
Middle East and Africa
North America exhibits a clear dominance in the market
The market research report has also provided a comprehensive analysis of all the major regional markets, which include Europe (Italy, Germany, France, Spain, the United Kingdom, Russia, and others); North America (the United States and Canada); Asia Pacific (China, Japan, Australia, South Korea, Indonesia, India, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America accounted for the largest market share.
According to the surgical navigation systems market overview, North America is a hub for technological innovation in healthcare. Continuous advancements in surgical navigation technologies, such as the integration of artificial intelligence (AI), augmented reality (AR), and machine learning algorithms, are enhancing the precision, efficiency, and safety of surgical procedures. These innovations drive demand for advanced surgical navigation systems in the region. Moreover, the rising prevalence of chronic diseases, such as cardiovascular diseases, cancer, and orthopedic disorders, is driving the demand for surgical interventions. Surgical navigation systems play a crucial role in performing complex surgeries with greater accuracy and precision, leading to better patient outcomes and reduced post-operative complications. For instance, in May 2023, Novarad, a U.S.-based medical device company, received approval from Indonesia's Food and Drug Administration (FDA) for VisAR surgical navigation system for minimally invasive surgery.
Amplitude Surgical
B. Braun SE
Brainlab AG
Collin Medical
Fudan Digital Medical
Johnson & Johnson
Medtronic PLC
Siemens Healthcare Private Limited
Stryker Corporation
Zimmer Biomet Holdings Inc.
Kindly note that this only represents a partial list of companies, and the complete list has been provided in the report.