日本の手術器具市場-2024～2031年

概要

日本の手術器具市場は、2023年に8億5,982万米ドルに達し、2031年には17億2,348万米ドルに達すると予測され、予測期間2024年～2031年のCAGRは10.6%で成長する見込みです。

日本の手術器具市場には、複数の医療専門分野にわたる外科手術の実施に不可欠な多種多様な機器や器具が含まれます。この市場は、いくつかの主要製品カテゴリーによって特徴付けられます。鉗子、はさみ、メス、リトラクター、拡張器、把持器、補助器具などのハンドヘルド器具は、外科手術の基幹をなします。これらの器具は、組織の把持、正確な切断、手術中の視認性確保などの作業に不可欠です。さらに、電気外科用器具は、電気エネルギーを使って組織を切開・凝固させることで重要な役割を果たしており、出血を最小限に抑え、手術中の精度を高めるのに役立っています。

さらに、低侵襲手術のために特別に設計された腹腔鏡手術器具も市場の特徴です。トロッカーや腹腔鏡などの器具は、外科医が小さな切開創から手術を行うことを可能にし、患者の回復時間の短縮や術後の痛みの軽減につながります。最後に、縫合糸やステープラーなどの創傷閉鎖器具は、手術後の切開や創傷を効果的に閉鎖し、適切な治癒を確保するために極めて重要です。これらの多様な製品タイプの組み合わせは、伝統的な手術手技と低侵襲手術手技の両方を促進し、最終的に日本の医療制度における患者の転帰を改善するという手術器具市場の重要性を強調しています。このような要因が、日本の手術器具市場拡大の原動力となっています。

市場力学：

促進要因と抑制要因

低侵襲手術に対する需要の高まり

低侵襲手術に対する需要の高まりは、日本の手術器具市場の成長を大きく後押ししており、市場予測期間中も牽引していくと予想されます。

低侵襲手術（MIS）に対する需要の高まりは、日本の手術器具市場の主要な促進要因であり、患者の転帰と全体的なヘルスケア効率を高めるいくつかの要因の影響を受けています。低侵襲手術は小さな切開が特徴で、従来の開腹手術に伴う外傷を軽減します。このアプローチは、回復時間の短縮、術後の痛みの軽減、合併症リスクの低減につながり、結果として入院期間の短縮につながります。

世界経済フォーラムが2023年9月に発表した記事によると、現在、日本の人口の10％以上が80歳以上であり、65歳以上の人口は総人口の約33.33％です。この著しい人口動態の変化は、潜在的な患者プールが大きいことを示し、日本の手術器具需要を押し上げると予想されます。

日本では、高齢者が慢性疾患のために外科的介入を必要とする可能性が高いため、高齢化がMISへの嗜好の高まりに大きく寄与しています。人口の約33％が65歳以上であり、効果的でありながら侵襲性の低い手術ソリューションに対する大きな需要が生まれています。さらに、ロボット支援システムや強化された画像技術などの手術技術の進歩は、手術の精度と結果を向上させることで、この動向をさらに後押ししています。ヘルスケアプロバイダーがこうした革新的な技術をますます採用するようになるにつれ、低侵襲手術用に調整された特殊な手術器具に対する需要が高まり、市場の成長が促進されると予想されます。このシフトは、外科手術の進化を反映しているだけでなく、コストを効果的に管理しながら患者ケアを強化することを目的とした、より広範なヘルスケア目標とも一致しています。

さらに、この日本の手術器具市場の成長を後押しするのは、業界の主要企業の製品投入です。例えば、2022年2月、スミス・アンド・ネフューはCORIサージカルシステムを日本に導入し、特に膝関節形成術の手術器具分野で大きな飛躍を遂げました。この革新的な製品は、手術精度を向上させ、患者の予後を改善することを目的としており、低侵襲手術手技の増加傾向に合致しています。

また、2022年9月、オリンパス株式会社は、様々な医療分野の内視鏡手術に携わる医療従事者（HCP）のニーズに対応した最先端の手術可視化プラットフォームであるVISERA ELITE IIIを発売しました。この革新的なシステムは、複数の高度な画像処理機能を単一のプラットフォームに統合することで、腹腔鏡下大腸切除術や腹腔鏡下胆嚢摘出術などの低侵襲手術の機能を強化するように設計されています。

さらに、日本国内の新興市場における需要の高まりが、日本の手術器具市場の拡大に寄与しています。

厳しい政府規制

厳しい政府規制は日本の手術器具市場の大きな制約となっており、医療機器の市場開発、承認、販売に影響を及ぼしています。規制の枠組みは独立行政法人医薬品医療機器総合機構（PMDA）と厚生労働省（MHLW）によって管理されており、これらの機関は医療製品の安全性と有効性を確保するために厳しい基準を設けています。

日本の手術器具の承認取得までの道のりは複雑であり、時間がかかることもあります。医療機器は、関連するリスクレベル（クラスIからクラスIV）に基づいて4つのクラスに分類され、リスクの高い機器ほど、より厳格な評価が行われます。例えば、患者へのリスクが最も高いクラスIVの医療機器は、市場参入前にPMDAによる徹底的な審査に合格しなければならないです。このような複雑さは、製品上市の遅れやメーカーのコスト増につながる可能性があります。

日本で医療機器を販売しようとする外国企業は、外国製造業者登録（FMR）証明書を確保しなければならないです。このプロセスには、包括的な書類作成と現地規制への準拠が必要であり、日本の規制状況に不慣れな企業にとっては特に困難な課題となりうる。さらに、提出された書類はすべて日本語に翻訳されなければならず、複雑さがさらに増します。したがって、上記の要因が日本の手術器具市場の潜在的成長を制限している可能性があります。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

• 影響要因
  • 促進要因
    • 低侵襲手術の需要の高まりと
  • 抑制要因
    • 厳格な政府規制
  • 機会
  • 影響分析

第5章 産業分析

• ポーターのファイブフォース分析
• サプライチェーン分析
• 価格分析
• 特許分析
• 規制分析
• SWOT分析
• アンメットニーズ

第6章 製品タイプ別

• ハンドヘルドデバイス
  • 鉗子
  • はさみ
  • メス
  • リトラクター
  • 拡張器
  • グラスパー
  • 補助器具
• 腹腔鏡装置
  • トロカールとアクセスデバイス
  • 腹腔鏡
• 電気手術器具
• 創傷閉鎖器具
  • 縫合糸
  • ホッチキス
• その他

第7章 カテゴリ別

• 再利用可能な手術器具
• 使い捨て手術器具

第8章 用途別

• 婦人科・泌尿器科
• 心臓病学
• 整形外科
• 神経学
• その他

第9章 エンドユーザー別

• 病院
• 専門クリニック
• 外来手術センター
• その他

第10章 競合情勢

• 競合シナリオ
• 市況・シェア分析
• M&A分析

第11章 企業プロファイル

• Olympus
  • 会社概要
  • 製品ポートフォリオと概要
  • 財務概要
  • 主な発展
• Terumo Corporation
• B. Braun SE
• Medtronic
• CONMED Corporation.
• Smith+Nephew
• Johnson & Johnson Services, Inc.
• Boston Scientific Corporation
• Stryker
• Aspen Surgical Products, Inc.

第12章 付録

Overview

The Japan surgical equipments market reached US$ 859.82 million in 2023 and is expected to reach US$ 1,723.48 million by 2031, growing at a CAGR of 10.6 % during the forecast period 2024-2031.

The Japan surgical equipment market includes a wide variety of devices and instruments that are critical for performing surgical procedures across multiple medical specialties. This market is characterized by several key categories of products. Handheld instruments, such as forceps, scissors, scalpels, retractors, dilators, graspers, and auxiliary tools, form the backbone of surgical operations. These instruments are essential for tasks like grasping tissues, making precise cuts, and providing visibility during surgery. Additionally, electrosurgical devices play a vital role by using electrical energy to cut and coagulate tissue, which helps minimize blood loss and enhances precision during procedures.

Furthermore, the market features laparoscopic tools, specifically designed for minimally invasive surgeries. Instruments like trocars and laparoscopes allow surgeons to perform operations through small incisions, leading to quicker recovery times and reduced postoperative pain for patients. Lastly, wound closure devices, including sutures and staplers, are crucial for effectively closing incisions or wounds after surgery, ensuring proper healing. The combination of these diverse product types underscores the importance of the surgical equipment market in facilitating both traditional and minimally invasive surgical techniques, ultimately improving patient outcomes in Japan's healthcare system. These factors have driven Japan surgical equipments market expansion.

Market Dynamics: Drivers & Restraints

Rising Demand for Minimally Invasive Surgical Procedures

The rising demand for minimally invasive surgical procedures is significantly driving the growth of the Japan surgical equipments market and is expected to drive throughout the market forecast period.

The increasing demand for minimally invasive surgical procedures (MIS) is a key driver in the Japan surgical equipment market, influenced by several factors that enhance patient outcomes and overall healthcare efficiency. Minimally invasive surgeries are characterized by smaller incisions, which reduce the trauma associated with traditional open surgeries. This approach leads to quicker recovery times, less postoperative pain, and a lower risk of complications, resulting in shorter hospital stays an essential consideration in a healthcare system that prioritizes efficiency and cost-effectiveness.

According to an article published by the World Economic Forum in September 2023, more than 10% of Japan's population is now aged 80 or older, while approximately 33.33% of the total population is 65 years or older. This significant demographic shift indicates a large potential patient pool, which is expected to drive up the demand for surgical equipment in the country.

In Japan, the aging population significantly contributes to the rising preference for MIS, as older individuals are more likely to require surgical interventions for chronic conditions. Approximately 33% of the population is aged 65 or older, creating a substantial demand for effective yet less invasive surgical solutions. Additionally, advancements in surgical technologies, such as robotic-assisted systems and enhanced imaging techniques, further support this trend by improving precision and outcomes during surgeries. As healthcare providers increasingly adopt these innovative techniques, the demand for specialized surgical equipment tailored for minimally invasive procedures is expected to rise, driving growth in the market. This shift not only reflects evolving surgical practices but also aligns with broader healthcare goals aimed at enhancing patient care while managing costs effectively.

Furthermore, key players in the industry product launches that would drive this Japan surgical equipment market growth. For instance, in February 2022, Smith & Nephew introduced the CORI Surgical System in Japan marking a significant leap forward in the surgical devices sector, especially for knee arthroplasty procedures. This innovative product aims to improve surgical accuracy and enhance patient outcomes, aligning with the increasing trend toward minimally invasive surgical techniques.

Also, in September 2022, Olympus Corporation launched the VISERA ELITE III, a cutting-edge surgical visualization platform tailored to meet the needs of healthcare professionals (HCPs) involved in endoscopic procedures across various medical disciplines. This innovative system is designed to enhance the capabilities of minimally invasive surgeries, such as laparoscopic colectomy and laparoscopic cholecystectomy, by integrating multiple advanced imaging functions into a single platform.

Moreover, the rising demand for emerging markets within Japan contributes to Japan surgical equipment market expansion.

Stringent Government Regulations

Stringent government regulations act as a significant constraint in the Japan surgical equipment market, influencing the development, approval, and marketing of medical devices. The regulatory framework is governed by the Pharmaceutical and Medical Devices Agency (PMDA) and the Ministry of Health, Labor, and Welfare (MHLW), which enforce rigorous standards to ensure the safety and efficacy of medical products before they can be marketed.

The pathway to obtaining approval for surgical equipment in Japan is intricate and can be time-consuming. Medical devices are categorized into four classes based on their associated risk levels (Class I to Class IV), with higher-risk devices undergoing more stringent evaluations. For instance, Class IV devices, which present the highest risk to patients, must pass a thorough assessment by the PMDA before market entry. This complexity can lead to delays in product launches and increased costs for manufacturers.

Foreign companies seeking to sell their devices in Japan must secure a Foreign Manufacturer Registration (FMR) certificate. This process entails comprehensive documentation and compliance with local regulations, which can be particularly challenging for those unfamiliar with Japan's regulatory landscape. Furthermore, all submitted documents must be translated into Japanese, adding another layer of complexity. Thus, the above factors could be limiting the Japan surgical equipments market's potential growth.

Segment Analysis

The Japan surgical equipments market is segmented based on product type, category, application, and end-user.

Product Type:

The wound closure devices segment is expected to dominate the Japan surgical equipments market share

The wound closure devices segment holds a major portion of the Japan surgical equipments market share and is expected to continue to hold a significant portion of the Japan surgical equipments market share during the forecast period.

The wound closure devices segment within the Japanese surgical equipment market is vital for ensuring effective surgical outcomes by properly closing incisions and wounds. This segment primarily consists of surgical sutures and staplers, both of which are crucial for facilitating healing and minimizing complications after surgery.

Surgical sutures are threads used to stitch tissues together following an incision or injury. They are available in various types, including absorbable and non-absorbable materials, enabling surgeons to select the most suitable option based on the specific needs of the procedure and the patient's condition. Sutures are widely utilized across multiple surgical specialties, such as general surgery, orthopedic surgery, and gynecology.

Furthermore, key player's strategies such as partnerships and collaborations would drive this segment growth in the Japan surgical equipments market growth. For instnace, in August 2023, Asensus Surgical, Inc. announced a significant partnership with First Towakai Hospital to lease and utilize its Senhance Surgical System in their urology and gynecology centers, as well as the gastroenterology department. This collaboration highlights the growing trend of integrating advanced robotic surgical systems into healthcare facilities to enhance surgical capabilities and patient outcomes.

Also, in January 2023, MiMedx Group, Inc. announced an exclusive distribution agreement with Gunze Medical Limited, a subsidiary of Gunze Limited, to facilitate the sales of its product EPIFIX in Japan. This partnership is significant as Gunze Medical is a prominent distributor of medical products used in various wound and surgical settings, including bioabsorbable devices and materials such as sutures and sheet products. These factors have solidified the segment's position in the Japan surgical equipments market.

Competitive Landscape

The major players in the Japan surgical equipments market include Olympus, Terumo Corporation, B. Braun SE, Medtronic, CONMED Corporation., Smith+Nephew, Johnson & Johnson Services, Inc., Boston Scientific Corporation, Stryker, and Aspen Surgical Products, Inc. among others.

Key Developments

• In September 2024, Olympus Corporation announced the launch of its new 4K camera head, designated CH-S700-08-LB, specifically designed for endoscopic urology and gynecology procedures. This product is compatible with the VISERA ELITE III video system center, which is a comprehensive platform for surgical endoscopy. The camera head will initially be introduced in Europe and is set to launch in Japan, Hong Kong, and Singapore, pending compliance with local regulations.

Why Purchase the Report?

• Pipeline & Innovations: Reviews ongoing clinical trials, and product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
• Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
• Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
• Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
• Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
• Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
• Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
• Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
• Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
• Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
• Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
• Post-market Surveillance: Uses post-market data to enhance product safety and access.
• Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The Japan surgical equipment's market report delivers a detailed analysis with 40+ key tables, more than 30 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2023

• Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
• Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
• Category & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
• Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
• Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
• Supply Chain: Distribution and Supply Chain Managers.
• Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
• Academic & Research: Academic Institutions.

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

• 3.1. Snippet by Product Type
• 3.2. Snippet by Category
• 3.3. Snippet by Application
• 3.4. Snippet by End-User

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Rising Demand for Minimally Invasive Surgical Procedures and
  • 4.1.2. Restraints
    • 4.1.2.1. Stringent Government Regulations
  • 4.1.3. Opportunity
  • 4.1.4. Impact Analysis

5. Industry Analysis

• 5.1. Porter's Five Force Analysis
• 5.2. Supply Chain Analysis
• 5.3. Pricing Analysis
• 5.4. Patent Analysis
• 5.5. Regulatory Analysis
• 5.6. SWOT Analysis
• 5.7. Unmet Needs

6. By Product Type

• 6.1. Introduction
  • 6.1.1. Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 6.1.2. Market Attractiveness Index, By Product Type
• 6.2. Handheld Devices*
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 6.2.3. Forceps
  • 6.2.4. Scissors
  • 6.2.5. Scalpels
  • 6.2.6. Retractors
  • 6.2.7. Dilators
  • 6.2.8. Graspers
  • 6.2.9. Auxiliary instruments
• 6.3. Laparoscopic Devices
  • 6.3.1. Trocars and access devices
  • 6.3.2. Laparoscopes
• 6.4. Electrosurgical Devices
• 6.5. Wound Closure Devices
  • 6.5.1. Sutures
  • 6.5.2. Staplers
• 6.6. Others

7. By Category

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Category
  • 7.1.2. Market Attractiveness Index, By Category
• 7.2. Reusable Surgical Equipment*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Disposable Surgical Equipment

8. By Application

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 8.1.2. Market Attractiveness Index, By Application
• 8.2. Gynecology and Urology*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Cardiology
• 8.4. Orthopedics
• 8.5. Neurology
• 8.6. Others

9. By End-User

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 9.1.2. Market Attractiveness Index, By End-User
• 9.2. Hospitals *
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Specialty Clinics
• 9.4. Ambulatory Surgical Centers
• 9.5. Others

10. Competitive Landscape

• 10.1. Competitive Scenario
• 10.2. Market Positioning/Share Analysis
• 10.3. Mergers and Acquisitions Analysis

11. Company Profiles

• 11.1. Olympus*
  • 11.1.1. Company Overview
  • 11.1.2. Product Portfolio and Description
  • 11.1.3. Financial Overview
  • 11.1.4. Key Developments
• 11.2. Terumo Corporation
• 11.3. B. Braun SE
• 11.4. Medtronic
• 11.5. CONMED Corporation.
• 11.6. Smith+Nephew
• 11.7. Johnson & Johnson Services, Inc.
• 11.8. Boston Scientific Corporation
• 11.9. Stryker
• 11.10. Aspen Surgical Products, Inc.

LIST NOT EXHAUSTIVE

12. Appendix

• 12.1. About Us and Services
• 12.2. Contact Us