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整形生物製剤の世界市場 - 2024年～2032年

Global Orthobiologics Market - 2024-2032

出版日
ページ情報
英文 185 Pages
納期
即日から翌営業日
カスタマイズ可能
適宜更新あり
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整形生物製剤の世界市場 - 2024年～2032年
出版日: 2024年12月30日
発行: DataM Intelligence
ページ情報: 英文 185 Pages
納期: 即日から翌営業日
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  • 概要
  • 目次
概要

整形生物製剤の世界市場は2023年に52億6,000万米ドルに達し、2032年には78億5,000万米ドルに達すると予測され、予測期間2024年のCAGRは4.6%で成長します。

整形生物製剤は、生物学的ソースに由来し、整形外科疾患の治療を目的とした治療法です。整形生物製剤は再生療法とも呼ばれ、外科的処置に代わる痛みのない治療法です。痛みを軽減し、治癒を早め、患者の全体的な回復を向上させます。最も一般的に使用されているのは、多血小板血漿、自家移植片、同種移植片、骨形態形成蛋白、脱灰骨基質、骨髄濃縮物、幹細胞、粘液サプリメントなどです。

これらの新しい治療法は、変形性関節症、脊椎固定術、外傷手術、再建手術、スポーツ外傷などの整形外科的疾患や手術に用いられます。これらの治療法は比較的新しいものであるため、さまざまな集団における有効性を検証するための適切な臨床的証拠研究が不足しています。しかし、急増する調査と整形外科疾患の有病率の上昇により、市場は1桁台半ばのCAGRで成長すると予想されます。

市場力学：

促進要因と抑制要因

整形外科疾患の有病率の上昇

整形生物製剤は、変形性関節症、外傷性損傷、脊椎損傷、骨折などの整形外科疾患の指定治療法です。その新規性、非侵襲性から、過去10年間、その需要は高まり続けています。これらは整形外科における新しい治療法であり、再生と迅速な治癒を促進するため、非常に重要性を増しており、標準治療に組み込まれつつあります。

さらに、世界の高齢者人口の増加に伴い、いくつかの整形外科疾患の有病率は世界中で上昇しています。このような患者数の増加は、整形生物製剤市場拡大の大きなチャンスです。

例えば、The Lancet Rheumatology Journalに掲載された変形性関節症に関する世界疾病負担調査によると、2020年には世界で5億9,500万人の変形性関節症の症例が報告されました。この研究では、2050年までに変形性関節症の患者は11億人に達すると予測しています。この研究とdataMの推定に基づけば、2030年までに7億3,100万人近くの症例が報告されると予想されます。

高額な費用は、整形生物製剤市場の成長を大きく妨げる可能性があります。

整形生物製剤は、外科的アプローチと比較して、被施術者に無痛の再生療法を提供します。しかし、整形生物製剤の大半は高額であり、通常は医療保険でカバーされないです。整形生物学的治療を受けようとする患者は、ポケットマネーから支出しなければならないです。このことは、特定の患者集団、特に低所得者から中所得者層に経済的負担をもたらす可能性があります。例えば、米国の様々なクリニックや病院の価格を調べてみると、プロテインリッチプラズマのセッションの費用は、1回あたり1300米ドルから2500米ドルの間です。患者が治療効果を得るためには、適応症に応じて複数回のセッションが必要になることもあります。

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
      • 整形外科疾患の罹患率の上昇
      • 整形生物製剤における技術進歩の高まり
    • 抑制要因
      • 整形生物製剤のコストが高い
    • 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
  • パイプライン分析
  • 疫学
  • 特許分析
  • 規制分析

第6章 製品別

  • 多血小板血漿（PRP）
  • 骨形成タンパク質（BMP）
  • 骨髄穿刺液（BMA）
  • 骨髄吸引濃縮物（BMAC）
  • 骨移植
    • 自家移植
    • 同種移植
  • 脱灰骨基質（DBM）
  • 幹細胞
  • 粘性サプリメント
  • その他

第7章 用途別

  • 変形性関節症および変性関節炎
  • 脊椎固定術
  • 骨折の回復
  • 軟部組織損傷
  • 顎顔面および歯科用途
  • その他

第8章 エンドユーザー別

  • 病院
  • 整形外科クリニック
  • 歯科医院
  • その他

第9章 地域別

  • 北米
    • 米国
    • カナダ
    • メキシコ
  • 欧州
    • ドイツ
    • 英国
    • フランス
    • スペイン
    • イタリア
    • その他欧州地域
  • 南米
    • ブラジル
    • アルゼンチン
    • その他南米
  • アジア太平洋地域
    • 中国
    • インド
    • 日本
    • 韓国
    • その他アジア太平洋地域
  • 中東・アフリカ

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

  • Stryker
    • 会社概要
    • 製品ポートフォリオと概要
    • 財務概要
    • 主な発展
  • Zimmer Biomet.
  • Arthrex, Inc.
  • Sanofi
  • Anika Therapeutics, Inc.
  • Ferring
  • Bioventus LLC
  • SeaSpine
  • Globus Medical
  • Biotech
  • Xtant Medical
  • Isto Biologics
  • LocateBio
  • Kuros Biosciences A.G.
  • OssDsign AB
  • Octane Medical Group Inc.

第12章 付録

目次
Product Code: MD1073

The global orthobiologics market reached US$5.26 billion in 2023 and is expected to reach US$7.85 billion by 2032, growing at a CAGR of 4.6% during the forecast period 2024-2032.

Orthobiologics are therapies that originate from biological sources and are aimed at treating orthopedic conditions. Orthobiologics sometimes referred to as regenerative therapies are painless alternatives to surgical procedures. They help reduce the pain, accelerate healing, and improve the overall recovery of the patient. The most commonly used orthobiologics include platelet-rich plasma, autografts, allografts, bone morphogenetic proteins, demineralized bone matrix, marrow concentrates, stem cells, and viscosupplements.

These novel therapies are used in orthopedic conditions and procedures like osteoarthritis, spinal fusion surgery, trauma surgery, reconstructive surgery, sports injuries, etc. Since these therapies are relatively new, the majority of them lack proper clinical evidence studies to validate their efficacy in different population groups. However, with the burgeoning research, and rising prevalence of orthopedic conditions, the market is expected to grow in the mid-single digit CAGR.

Market Dynamics: Drivers & Restraints

Rising prevalence of orthopedic conditions

Orthobiologics are the designated therapies for several orthopedic conditions such as osteoarthritis, traumatic injuries, spinal injuries, bone fractures, etc. Due to their novelty, and non-invasive nature, their demand has been rising for the past decade. These are the newer therapies in orthopedics, and as they promote regeneration and quick healing, they are gaining huge importance and are being integrated into the standard of care.

Moreover, with the growing elderly population worldwide, the prevalence of several orthopedic conditions is rising across the globe. This rising patient population is a significant opportunity for orthobiologics market expansion.

For instance, as per the global burden of disease study conducted on osteoarthritis and published in The Lancet Rheumatology Journal has stated that in 2020, globally 595 million cases of osteoarthritis were reported. The study projected that by 2050, osteoarthritis cases are expected to reach 1.1 billion. Based on the study and dataM estimates, by 2030, nearly 731 million cases are expected to be reported.

The high costs can significantly hinder the orthobiologics market growth.

Orthobiologics offer pain-free and regenerative therapy for the recipient, as compared to the surgical approaches. However, majority of the orthobiologics are expensive and are not usually covered under medical insurance. Patients, who are opting to get the orthobiologic treatment must spend out of their pockets. This can pose an economic burden on certain patient populations, especially those in the low- to middle-income category. For instance, upon review of prices from various clinics and hospitals in the U.S., the cost of a protein-rich plasma session can vary between US$1300 to US$2500 per session. A patient may need multiple sessions based on their indication, to get the therapeutic benefits.

Segment Analysis

The global orthobiologics market is segmented based on product, application, end-user, and region.

Platelet-rich plasma (PRP) in the product segment is dominating with the highest market share.

Platelet-rich plasma (PRP) is derived from the blood of the patient, by centrifuging the patient's whole blood. The concentrated plasma is rich in platelets which contain growth factors essential for tissue healing, regeneration, and inflammation modulation. In orthopedics, platelet-rich plasma (PRP) is widely used as an orthobiologic due to its ability to heal musculoskeletal tissues. t is commonly used in chronic tendinopathies like tennis elbow and patellar tendinitis, where it stimulates collagen production and repairs tendon damage. PRP also shows promise in managing osteoarthritis (OA) by reducing inflammation, alleviating pain, and slowing cartilage degradation. In fracture healing and bone grafts, PRP aids in bone regeneration by activating osteoblasts. Its anti-inflammatory properties help mitigate chronic swelling, contributing to improved joint function and mobility.

Among the other orthobiologics, PRP is the preferred choice in many conditions, as its autologous pose no immunogenic, infectious threat to patients, and is a safe and painless solution. For instance, as per the article published in the Journal of Arthroscopic Surgery and Sports Medicine in September 2024, platelet-rich plasma (PRP) has widely emerged as the most commonly used orthobiologic agent for knee osteoarthritis as it directly influences the cartilage microenvironment.

Geographical Analysis

North America is expected to hold a significant share of the Orthobiologics market.

North America region dominates the global orthobiologics market due to its advanced healthcare infrastructure, high adoption rates of innovative medical technologies such as orthobiologics, and strong research and development activities by market players. Additionally, the prevalence of orthopedic conditions, such as osteoarthritis, and sports injuries, spinal injuries are steadily rising in the region.

North America also has a significant patient population who are aware of and demand minimally invasive procedures, supported by skilled healthcare professionals who adopt emerging therapies rapidly.

According to the Centers for Disease Control and Prevention (CDC), osteoarthritis affects approximately 32.5 million adult population in the U.S. which is approximately 10% of the total population in 2023. This population is expected to rise steadily in the future due to the aging population.

Moreover, a robust pipeline of orthobiologics and collaborations between industry and academic institutions further reinforce the region's market leadership.

For instance, the American Academy of Orthopaedic Surgeons released a new 2024-2028 Strategic Plan. It focuses on collaboration efforts in the musculoskeletal (MSK) community and encourages partnerships with specialty societies, digital health organizations, etc. For orthobiologics, this collaboration can improve the development and adoption.

These are some of the factors that position North America as the leading region in the global orthobiologics market.

Competitive Landscape

The major global players in the orthobiologics market are Stryker, Zimmer Biomet., Arthrex, Inc., Sanofi, Anika Therapeutics, Inc., Ferring, Bioventus LLC, SeaSpine, Globus Medical, and Biotech among others.

Emerging Players

The emerging players in the orthobiologics market include Xtant Medical, Isto Biologics, LocateBio, Kuros Biosciences A.G., OssDsign AB, and Octane Medical Group Inc. among others.

Key Developments

  • In September 2024, Xtant Medical Holdings, Inc. launched OsteoVive Plus, an extensive portfolio of viable bone grafts aimed for use in various grafting procedures. This advanced portfolio of bone grafts is featured with Xtant's proprietary Purloc Fiber Technology which produces a cohesive and moldable allograft containing a high concentration of elongated cortical fibers.
  • In June 2024, Octane Medical Group announced the acquisition of B. Braun's global orthobiologics business. The acquisition is composed of two subsidiaries of B. Braun- TETEC AG in Germany and Aesculap Biologics, LLC. in the United States. The current orthobiologics portfolio includes NOVOCART 3D and NOVOCART Inject which are aimed for cartilage repair.
  • In August 2024, LifeNet Health launched PliaFX Pak in the U.S. in collaboration with Johnson & Johnson MedTech. PilaFX Pak is a bone allograft made with a combination of mineralized bone chips, and moldable mineralized fibers. This advanced bone allograft finds its application in orthopedic spine and trauma procedures, including fractures, fusions, and osteotomies.
  • In September 2023, Elutia Inc. announced the sale of its Orthobiologics business to Berkeley Biologics LLC, a wholly owned subsidiary of GNI Group Ltd. Elutia received US$15 million upfront payment at closing, and will receive US$20 million over the period of 5 years.
  • Why Purchase the Report?
  • Pipeline & Innovations: Reviews ongoing clinical trials, and Product pipelines, and forecasts upcoming pharmaceutical advancements.
  • Product Performance & Market Positioning: Analyzes Product performance, market positioning, and growth potential to optimize strategies.
  • Real-world Evidence: Integrates patient feedback and data into drug-enzyme-type 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 global orthobiologics market report would provide approximately 80 tables, 68 figures, and 185 pages.

Target Audience 2023

  • Manufacturers: Pharmaceutical, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
  • Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
  • Technology & Innovation: 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
  • 3.2. Snippet by Application
  • 3.3. Snippet by End User
  • 3.4. Snippet by Region

4. Dynamics

  • 4.1. Impacting Factors
    • 4.1.1. Drivers
      • 4.1.1.1. Rising prevalence of orthopedic conditions
      • 4.1.1.2. Rising technological advancements in orthobiologics
    • 4.1.2. Restraints
      • 4.1.2.1. High cost of orthobiologics
    • 4.1.3. Opportunities
    • 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. Pipeline Analysis
  • 5.5. Epidemiology
  • 5.6. Patent Analysis
  • 5.7. Regulatory Analysis

6. By Product

  • 6.1. Introduction
    • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
    • 6.1.2. Market Attractiveness Index, By Product
  • 6.2. Platelet-Rich Plasma (PRP)*
    • 6.2.1. Introduction
    • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 6.3. Bone Morphogenetic Proteins (BMP)
  • 6.4. Bone Marrow Aspirate (BMA)
  • 6.5. bone Marrow Aspirate Concentrate (BMAC)
  • 6.6. Bone Grafts
    • 6.6.1. Autograft
    • 6.6.2. Allograft
  • 6.7. Demineralized Bone Matrix (DBM)
  • 6.8. Stem cells
  • 6.9. Viscosupplements
  • 6.10. Others

7. By Application

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 7.1.2. Market Attractiveness Index, By Application
  • 7.2. Osteoarthritis & Degenerative Arthritis*
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.3. Spinal Fusion
  • 7.4. Fracture Recovery
  • 7.5. Soft Tissue Injuries
  • 7.6. Maxillofacial & Dental Applications
  • 7.7. Others

8. By End User

  • 8.1. Introduction
    • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 8.1.2. Market Attractiveness Index, By End User
  • 8.2. Hospitals*
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.3. Orthopedic Clinics
  • 8.4. Dental Clinics
  • 8.5. Others

9. By Region

  • 9.1. Introduction
    • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
    • 9.1.2. Market Attractiveness Index, By Region
  • 9.2. North America
    • 9.2.1. Introduction
    • 9.2.2. Key Region-Specific Dynamics
    • 9.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
    • 9.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 9.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 9.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.2.6.1. U.S.
      • 9.2.6.2. Canada
      • 9.2.6.3. Mexico
  • 9.3. Europe
    • 9.3.1. Introduction
    • 9.3.2. Key Region-Specific Dynamics
    • 9.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
    • 9.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 9.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 9.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.3.6.1. Germany
      • 9.3.6.2. U.K.
      • 9.3.6.3. France
      • 9.3.6.4. Spain
      • 9.3.6.5. Italy
      • 9.3.6.6. Rest of Europe
  • 9.4. South America
    • 9.4.1. Introduction
    • 9.4.2. Key Region-Specific Dynamics
    • 9.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
    • 9.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 9.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 9.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.4.6.1. Brazil
      • 9.4.6.2. Argentina
      • 9.4.6.3. Rest of South America
  • 9.5. Asia-Pacific
    • 9.5.1. Introduction
    • 9.5.2. Key Region-Specific Dynamics
    • 9.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
    • 9.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 9.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 9.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.5.6.1. China
      • 9.5.6.2. India
      • 9.5.6.3. Japan
      • 9.5.6.4. South Korea
      • 9.5.6.5. Rest of Asia-Pacific
  • 9.6. Middle East and Africa
    • 9.6.1. Introduction
    • 9.6.2. Key Region-Specific Dynamics
    • 9.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
    • 9.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 9.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User

10. Competitive Landscape

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

11. Company Profiles

  • 11.1. Stryker*
    • 11.1.1. Company Overview
    • 11.1.2. Product Portfolio and Description
    • 11.1.3. Financial Overview
    • 11.1.4. Key Developments
  • 11.2. Zimmer Biomet.
  • 11.3. Arthrex, Inc.
  • 11.4. Sanofi
  • 11.5. Anika Therapeutics, Inc.
  • 11.6. Ferring
  • 11.7. Bioventus LLC
  • 11.8. SeaSpine
  • 11.9. Globus Medical
  • 11.10. Biotech
  • 11.11. Xtant Medical
  • 11.12. Isto Biologics
  • 11.13. LocateBio
  • 11.14. Kuros Biosciences A.G.
  • 11.15. OssDsign AB
  • 11.16. Octane Medical Group Inc.

LIST NOT EXHAUSTIVE

12. Appendix

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