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全球骨科生物製品市场 - 2024-2032

Global Orthobiologics Market - 2024-2032

出版日期: 2024年12月30日 | 出版商:

DataM Intelligence | 英文 185 Pages | 商品交期: 最快1-2个工作天内

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简介目录

2023年，全球骨科生物製品市场规模达52.6亿美元，预计2032年将达到78.5亿美元，2024-2032年预测期间复合年增长率为4.6%。

骨科生物製剂是源自生物来源的疗法，旨在治疗骨科疾病。骨生物製剂有时被称为再生疗法，是外科手术的无痛替代方案。它们有助于减轻疼痛、加速癒合并改善患者的整体康復。最常使用的骨生物製剂包括富含血小板的血浆、自体移植物、同种异体移植物、骨形态发生蛋白、脱矿骨基质、骨髓浓缩物、干细胞和黏性补充剂。

这些新疗法用于骨关节炎、脊椎融合手术、创伤手术、重建手术、运动伤害等骨科疾病和手术。的疗效。然而，随着研究的蓬勃发展以及骨科疾病盛行率的上升，预计市场将以中个位数的复合年增长率成长。

市场动态：

驱动程式和限制

骨科疾病盛行率上升

骨生物製剂是治疗骨关节炎、创伤性损伤、脊椎损伤、骨折等多种骨科疾病的指定疗法。这些是骨科领域较新的疗法，随着它们促进再生和快速癒合，它们变得越来越重要，并正在纳入护理标准。

此外，随着全球老年人口的不断增长，全球多种骨科疾病的盛行率正在上升。患者人数的增加是骨科生物製品市场扩张的重要机会。

例如，《柳叶刀风湿病学杂誌》发表的针对骨关节炎的全球疾病负担研究表明，2020年全球报告了5.95亿例骨关节炎病例。该研究预计，到2050年，骨关节炎病例预计将达到11亿人。根据研究和 dataM 估计，到 2030 年，预计将报告近 7.31 亿例病例。

高成本会严重阻碍骨科生物製品市场的成长。

与手术方法相比，骨生物製剂为接受者提供无痛和再生治疗。然而，大多数骨科生物製剂价格昂贵，通常不在医疗保险范围内。选择接受骨科生物治疗的患者必须自掏腰包。这可能会给某些患者群体带来经济负担，尤其是中低收入群体。例如，根据美国各诊所和医院的价格审查，富含蛋白质的血浆疗程的费用可能在每次 1300 美元至 2500 美元之间。根据其适应症，患者可能需要多次治疗才能获得治疗效果。

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.

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.