脊椎非固定デバイスの世界市場：タイプ別、用途別、地域別、予測

脊椎非固定デバイスの市場規模と予測

脊椎非固定デバイス市場規模は、2024年に40億8,000万米ドルと評価され、2026年から2032年にかけてCAGR 4.24%で成長し、2032年には56億8,000万米ドルに達すると予測されています。

脊椎非固定デバイスは、椎骨セグメントの固定を必要としない様々な脊椎疾患の治療に使用される医療器具です。2つ以上の椎骨を結合して脊椎を固定する固定術とは異なり、脊椎非固定デバイスは変性椎間板疾患、脊柱管狭窄症、その他の脊椎疾患を治療しながら脊椎の動きと柔軟性を維持することを目的としています。

脊椎非固定デバイス市場は、脊柱管狭窄症や退行性椎間板疾患などの脊椎疾患の頻度の増加により拡大しています。

脊椎インプラントは、患者の脊椎を安定させ活性化させるだけでなく、脊椎の不均衡を矯正するためにも使用されます。これらの器具は、一般的に脊椎固定デバイスと脊椎非固定デバイスに分類されます。非固定技術を脊椎手術に取り入れることで、患者が脊柱を動かしたり伸ばしたりできるようになり、治療成績が向上しました。

WHOによると、腰痛は子どもから高齢者まで、年齢に関係なくすべての人に影響を及ぼし、医療機関を受診する一般的な理由となっています。腰痛の発生率を推定するのは難しいです。なぜなら、腰痛は成人になる頃にはすでに極めて一般的な症状であり、その症状はずっと繰り返される可能性が高いからです。非特異的な（一般的な）腰痛は、先進工業国では生涯を通じて60％から70％の人が罹患すると予想されています。

脊椎非固定デバイスの世界市場力学

世界の脊椎非固定デバイス市場を形成している主な市場力学は以下の通り：

主な市場促進要因：

低侵襲手術（MIS）治療に対する需要の増加：MIS技術は、標準的な開腹手術よりも切開創が小さく、出血量が少なく、回復時間が早く、不快感が少ないです。脊椎非固定デバイスはMIS治療に適していることが多く、外科医と患者の双方にとって魅力的です。

高齢化人口の拡大：世界の人口は高齢化しており、高齢になればなるほど、椎間板変性症や脊柱管狭窄症などの脊椎疾患を発症しやすくなります。これらの問題は、痛みやこわばり、動くことの障害につながります。脊椎非固定デバイスは、高齢者の症状を緩和し、可動性を維持するのに役立ちます。

転帰と生活の質に焦点を当てる：患者報告による転帰と生活の質の指標は、医療においてますます重要になってきています。脊椎非固定デバイスは、痛みや機能障害を和らげるだけでなく、脊柱の動きや機能を維持することで、患者の全体的な生活の質を維持または向上させることを目的としています。

最小侵襲的アプローチ：多くの非固定手術は低侵襲手技で行うことができ、切開創が小さく、出血量が少なく、回復時間が早いなどの利点があります。低侵襲手術がますます普及するにつれて、これらの手技に対応する脊椎非固定デバイスの需要が高まっています。

主な課題

外科医の訓練と採用：脊椎非固定デバイスを適切に埋め込むには、専門的なトレーニングと技術が必要になることが多いです。外科医は、手術手技に不慣れであったり、学習曲線が険しいと感じたりすると、これらの器具の使用をためらうことがあります。外科医の教育と訓練プログラムを改善することで、この問題に対処し、脊椎非固定デバイスの利用を拡大することができます。

長期的臨床証拠：脊椎非固定デバイスに関する臨床研究では肯定的な結果が得られているが、その安全性、有効性、耐久性に関するより長期的なデータが必要です。長期的な臨床データは、規制上の認可を取得し、支払いを確保し、これらの技術の長期的な利点に対する患者や医療提供者の信頼を得るために不可欠です。

規制上の課題：非固定医療機器の規制プロセスは複雑で時間がかかります。そのため、新規機器の開発と商業化に遅れが生じる可能性があります。

主要動向：

老年人口の増加：世界人口の高齢化に伴い、脊椎疾患を患う人が増える可能性が高いです。大手術に伴うリスクと戦うことができない高齢者には、非固定デバイスが適切な選択肢となる可能性があります。

治療成績と費用対効果の重視：世界中の医療システムは、価値に基づいたケアを提供し、医療費を削減することにますます重点を置くようになっています。脊椎非固定デバイスは、特に入院期間の短縮、再手術率の低下、長期的な患者満足度の向上といった点で、標準的な固定手術よりも臨床転帰を改善し、コストを削減する可能性があります。

脊椎疾患に対する認識の高まり：脊柱管狭窄症や椎間板変性症などの脊椎疾患に対する認識が高まっています。このため、これらの疾患の治療を求める人が増えており、非固定型脊椎治療装置の需要を押し上げています。

動作保持への注目の高まり：脊椎固定術は患者の可動域を狭める可能性があります。非固定デバイスは脊椎の動きを維持することを目的としており、その結果、患者の長期的な転帰が改善される可能性があります。

目次

第1章 脊椎非固定デバイスの世界市場のイントロダクション

• 市場概要
• 調査範囲
• 前提条件

第2章 エグゼクティブサマリー

第3章 VERIFIED MARKET RESEARCHの調査手法

• データマイニング
• バリデーション
• 一次資料
• データソース一覧

第4章 脊椎非固定デバイスの世界市場展望

• 概要
• 市場力学
  • 促進要因
  • 抑制要因
  • 機会
• ポーターのファイブフォースモデル
• バリューチェーン分析

第5章 脊椎非固定デバイスの世界市場：用途別

• 概要
• 病院

第6章 脊椎非固定デバイスの世界市場：タイプ別

• 概要
• 人工椎間板置換術
• 動的安定化デバイス
• 輪状修復デバイス

第7章 脊椎非固定デバイスの世界市場：地域別

• 概要
• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • その他欧州
• アジア太平洋
  • 中国
  • 日本
  • インド
  • その他アジア太平洋地域
• 世界のその他の地域
  • ラテンアメリカ
  • 中東・アフリカ

第8章 脊椎非固定デバイスの世界市場の競合情勢

• 概要
• 各社の市場ランキング
• 主な発展戦略

第9章 企業プロファイル

• Centinel Spine, LLC
• B. Braun Melsungen
• Johnson & Johnson
• Medtronic PLC
• Pioneer Surgical Technologies
• Synthes Holding AG
• Depuy Spine
• Globus Medical Inc.
• NuVasive, Inc.
• Zimmer Biomet

第10章 主な発展

• 製品上市／開発
• 合併と買収
• 事業拡大
• パートナーシップと提携

第11章 付録

• 関連調査

Non-fusion Spinal Devices Market Size And Forecast

Non-fusion Spinal Devices Market size was valued at USD 4.08 Billion in 2024 and is projected to reach USD 5.68 Billion by 2032, growing at a CAGR of 4.24% from 2026 to 2032.

Non-fusion spinal devices are medical devices used to treat a variety of spine diseases that do not require vertebral segment fusion. Unlike fusion operations, which join two or more vertebrae together to immobilize the spine, non-fusion devices aim to maintain motion and flexibility in the spine while treating degenerative disc disease, spinal stenosis, and other spinal conditions.

The non-fusion spinal devices market is expanding due to the increasing frequency of spinal illnesses such as spinal stenosis and degenerative disc disease.

Spinal implants are used to stabilize and revitalize patients' spines, as well as to right spinal disproportions. These devices are generically categorized as fusion or non-fusion spinal devices. Integrating non-fusion technologies into spinal surgery has improved outcomes by allowing patients to move and stretch their spines.

According to the WHO, back pain affects everyone, regardless of age, from children to the elderly, and is a common reason for medical visits. It is difficult to estimate the incidence of back pain because it is already extremely common by the time a person reaches adulthood, and the symptoms are likely to repeat throughout time. Non-specific (common) back pain is expected to affect 60% to 70% of people in industrialized countries over their lifespan.

Global Non-fusion Spinal Devices Market Dynamics

The key market dynamics that are shaping the global non-fusion spinal device market include:

Key Market Drivers:

Increasing Demand for Minimally Invasive Surgery (MIS) Treatments: MIS techniques are associated with smaller incisions, less blood loss, faster recovery times, and less discomfort than standard open operations. Non-fusion spinal devices are frequently well-suited for MIS treatments, boosting their appeal to both surgeons and patients.

Expanding Aging Population: The global population is aging, and as people get older, they are more susceptible to developing spine diseases such as degenerative disc degeneration and spinal stenosis. These problems can lead to pain, stiffness, and trouble moving. Non-fusion spinal devices can help relieve symptoms and maintain mobility in older persons.

Focus on Outcomes and Quality of Life: Patient-reported outcomes and quality of life metrics are becoming increasingly important in healthcare. Non-fusion spinal devices are intended not just to relieve pain and dysfunction, but also to maintain or improve patients' overall quality of life by maintaining spinal motion and function.

Minimally Invasive Approaches: Many non-fusion operations can be performed with minimally invasive techniques, which have advantages such as smaller incisions, less blood loss, and faster recovery times. As minimally invasive procedures become increasingly popular, there is a greater demand for non-fusion spinal devices that work with these techniques.

Key Challenges:

Surgeon Training and Adoption: Non-fusion spinal devices frequently necessitate specialized training and skill to properly implant. Surgeons may be hesitant to use these devices if they are unfamiliar with the surgical techniques or see a steep learning curve. Improving surgeon education and training programs can help to address this issue and enable greater utilization of non-fusion spinal devices.

Long-Term Clinical Evidence: While clinical studies on non-fusion spinal devices have provided positive results, more long-term data on their safety, efficacy, and durability are required. Long-term clinical data is critical for obtaining regulatory clearance, securing payment, and instilling patient and healthcare provider confidence in these technologies' long-term advantages.

Regulatory Challenges: The regulation process for non-fusion devices can be complicated and time-consuming. This might cause delays in the development and commercialization of new devices.

Key Trends:

Growing Geriatric Population: As the world's population ages, more people are likely to have spine disorders. Non-fusion devices may be an appropriate choice for older individuals who are unable to fight the risks involved with major surgery.

Focus on Outcomes and Cost-Effectiveness: Healthcare systems around the world are increasingly focused on providing value-based care and reducing healthcare costs. Non-fusion spinal devices have the potential to improve clinical outcomes and cost savings over standard fusion surgeries, particularly in terms of shorter hospital stays, lower rates of revision surgery, and better long-term patient satisfaction.

Growing Awareness of Spinal Disorders: There is a growing awareness of spinal disorders, such as spinal stenosis and disc degeneration. This is leading to more people seeking treatment for these conditions, which is driving up the demand for non-fusion spinal devices.

Increasing Focus on Motion Preservation: Spinal fusion surgery might reduce a patient's range of motion. Non-fusion devices aim to maintain motion in the spine, which can result in better long-term outcomes for patients.

Global Non-fusion Spinal Devices Market Regional Analysis

Here is a more detailed regional analysis of the global non-fusion spinal device market:

North America:

The benefits of non-fusion spinal devices corresponds in North America have seen a quick adoption of modern medical technology, particularly non-fusion spinal devices, because of variables such as high healthcare spending, a robust research and development infrastructure, and a strong demand for new treatment choices. Patients and healthcare providers in the region are increasingly embracing minimally invasive procedures that enable quicker recovery periods and better outcomes.

Government activities and policies in North America have contributed significantly to the introduction of non-fusion spinal devices. Efforts to improve the quality of life for people suffering from spinal problems have resulted in increasing funding for R&D and healthcare infrastructure. Furthermore, regulatory authorities such as the FDA in the United States have simplified the approval procedure for these devices, enabling fast market access and encouraging innovation in the industry.

Overall, a favorable regulatory environment, innovations in technology, and government assistance have pushed North America to the forefront of the spinal non-fusion device market. As the region continues to prioritize healthcare innovation and quality improvement measures, its dominance in this industry is projected to last for the foreseeable future.

Asia Pacific:

The Asia Pacific area offers promising market opportunities for spinal non-fusion devices, due to factors such as rising awareness of healthy living, growth of medical facilities, and a significant increase in elderly people. With an increasing emphasis on preventative healthcare and greater access to medical services throughout the region, people are becoming more aware of the necessity of preserving spinal health. This increased knowledge, combined with a rise in healthcare infrastructure development, presents a favorable climate for the adoption of innovative spinal treatment options, such as non-fusion devices.

Furthermore, the Asia Pacific region is undergoing a large demographic shift, with a substantial increase in aged people. According to the United Nations Economic and Social Commission for Asia and the Pacific demographic statistics sheet from 2016, 12.4% of the region's population was 60 years or older, a proportion that is anticipated to rise even higher by 2050.

This demographic trend highlights the increased demand for innovative solutions to age-related spinal disorders, which is driving the regional non-fusion spinal device market. As Asia Pacific's healthcare systems modernize and focus on meeting the demands of an aging population, the market for spinal non-fusion devices is expected to rise significantly.

Global Non-fusion Spinal Device Market: Segmentation Analysis

The Global Non-fusion Spinal Device Market is Segmented on the basis of Type, Application, And Geography.

Non-fusion Spinal Device Market, By Type

• Artificial Discs Replacement
• Dynamic Stabilization Devices
• Annulus Repair Devices

Based on the Component, the market is bifurcated into Artificial Discs Replacement, Dynamic Stabilization Devices and Annulus Repair Devices. Growing markets in the non-fusion spinal device sector. It's difficult to say for certain which is growing the fastest, but annulus repair devices are a relatively new technology that may be enjoying the fastest growth due to an increased emphasis on motion preservation methodologies.

Non-fusion Spinal Device Market, By Application

• Hospitals
• Ambulatory Surgical Centers

Based on Application, the market is segmented into Hospitals and Ambulatory Surgical Centers. However, Ambulatory Surgical Centers are predicted to increase quicker due to the growing preference for minimally invasive treatments and outpatient care. These operations are less expensive and require shorter recovery times, making ASCs a more appealing alternative for both patients and insurance.

Non-fusion Spinal Device Market, By Geography

• North America
• Europe
• Asia Pacific
• Rest of the World
• On the basis of Geography, the Global Non-fusion Spinal Device Market is classified into North America, Europe, Asia Pacific, and the Rest of the world. North America accounted for the largest market share of non-fusion spinal device followed by Europe. Growing demand for effective emergency care and increasing adoption of mobile surgery centers are anticipated to drive the industry during the forecast period.

Key Players

The "Global Non-fusion Spinal Device Market" study report will provide valuable insight with an emphasis on the global market. The major players in the market are Centinel Spine, LLC, B. Braun Melsungen, Johnson & Johnson, Medtronic PLC, Pioneer Surgical Technologies, Synthes Holding AG, Depuy Spine, Globus Medical Inc., and NuVasive, Inc. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

• Non-fusion Spinal Device Market Recent Developments
• In June 2024, Premia Spine got FDA approval for its Total Posterior Spine (TOPS) facet joint replacement system. The TOPS System previously received the FDA's Breakthrough Designation and has now successfully completed its Premarket Approval (PMA) application. The TOPS(TM) System replaces anatomical elements destroyed during spinal decompression treatment, such as the lamina and facet joint, to relieve pain.
• In November 2022, Spinal Stabilization Technologies Ltd announced that it has begun the LOPAIN2 clinical trial to assess the effectiveness of the PerQdisc Nucleus Replacement Device (NRD). The trial is expected to take place in South America, with 72 patients participating.
• In August 2021, Orthofix US LLC announced the first patient implant in the M6-C Artificial Cervical Disc 2-Level Investigation Device Exemption (IDE) Study. The FDA authorized the M6-C artificial cervical disc in 2019 for single-level implantation from C3 to C7 as an alternative to cervical fusion.
• In April 2021, NuVasive Inc received 510k approval from the US FDA for the use of Simplify Disc, a two-level cervical complete disc replacement.

TABLE OF CONTENTS

1 INTRODUCTION OF GLOBAL NON-FUSION SPINAL DEVICES MARKET

• 1.1 Overview of the Market
• 1.2 Scope of Report
• 1.3 Assumptions

2 EXECUTIVE SUMMARY

3 RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH

• 3.1 Data Mining
• 3.2 Validation
• 3.3 Primary Interviews
• 3.4 List of Data Sources

4 GLOBAL NON-FUSION SPINAL DEVICES MARKET OUTLOOK

• 4.1 Overview
• 4.2 Market Dynamics
  • 4.2.1 Drivers
  • 4.2.2 Restraints
  • 4.2.3 Opportunities
• 4.3 Porters Five Force Model
• 4.4 Value Chain Analysis

5 GLOBAL NON-FUSION SPINAL DEVICES MARKET, BY APPLICATION

• 5.1 Overview
• 5.2 Hospitals

6 GLOBAL NON-FUSION SPINAL DEVICES MARKET, BY TYPE

• 6.1 Overview
• 6.2 Artificial Discs Replacement
• 6.3 Dynamic Stabilization Devices
• 6.4 Annulus Repair Devices

7 GLOBAL NON-FUSION SPINAL DEVICES MARKET, BY GEOGRAPHY

• 7.1 Overview
• 7.2 North America
  • 7.2.1 U.S.
  • 7.2.2 Canada
  • 7.2.3 Mexico
• 7.3 Europe
  • 7.3.1 Germany
  • 7.3.2 U.K.
  • 7.3.3 France
  • 7.3.4 Rest of Europe
• 7.4 Asia Pacific
  • 7.4.1 China
  • 7.4.2 Japan
  • 7.4.3 India
  • 7.4.4 Rest of Asia Pacific
• 7.5 Rest of the World
  • 7.5.1 Latin America
  • 7.5.2 Middle East and Africa

8 GLOBAL NON-FUSION SPINAL DEVICES MARKET COMPETITIVE LANDSCAPE

• 8.1 Overview
• 8.2 Company Market Ranking
• 8.3 Key Development Strategies

9 COMPANY PROFILES

• 9.1 Centinel Spine, LLC
  • 9.1.1 Overview
  • 9.1.2 Financial Performance
  • 9.1.3 Product Outlook
  • 9.1.4 Key Developments
• 9.2 B. Braun Melsungen
  • 9.2.1 Overview
  • 9.2.2 Financial Performance
  • 9.2.3 Product Outlook
  • 9.2.4 Key Developments
• 9.3 Johnson & Johnson
  • 9.3.1 Overview
  • 9.3.2 Financial Performance
  • 9.3.3 Product Outlook
  • 9.3.4 Key Developments
• 9.4 Medtronic PLC
  • 9.4.1 Overview
  • 9.4.2 Financial Performance
  • 9.4.3 Product Outlook
  • 9.4.4 Key Developments
• 9.5 Pioneer Surgical Technologies
  • 9.5.1 Overview
  • 9.5.2 Financial Performance
  • 9.5.3 Product Outlook
  • 9.5.4 Key Developments
• 9.6 Synthes Holding AG
  • 9.6.1 Overview
  • 9.6.2 Financial Performance
  • 9.6.3 Product Outlook
  • 9.6.4 Key Developments
• 9.7 Depuy Spine
  • 9.7.1 Overview
  • 9.7.2 Financial Performance
  • 9.7.3 Product Outlook
  • 9.7.4 Key Developments
• 9.8 Globus Medical Inc.
  • 9.8.1 Overview
  • 9.8.2 Financial Performance
  • 9.8.3 Product Outlook
  • 9.8.4 Key Developments
• 9.9 NuVasive, Inc.
  • 9.9.1 Overview
  • 9.9.2 Financial Performance
  • 9.9.3 Product Outlook
  • 9.9.4 Key Developments
• 9.10 Zimmer Biomet
  • 9.10.1 Overview
  • 9.10.2 Financial Performance
  • 9.10.3 Product Outlook
  • 9.10.4 Key Developments

10 KEY DEVELOPMENTS

• 10.1 Product Launches/Developments
• 10.2 Mergers and Acquisitions
• 10.3 Business Expansions
• 10.4 Partnerships and Collaborations

11 Appendix

• 11.1 Related Research