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1606532

全球可生物分解植入物市場 - 2024-2031

Global Biodegradable Implants Market - 2024-2031

出版日期: 2024年12月04日 | 出版商:

DataM Intelligence | 英文 176 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

概述

2023年，全球生物可分解植入物市場規模達52.4億美元，預計2031年將達到103.1億美元，2024-2031年預測期間複合年成長率為8.9%。

可生物分解植入物是一種專門的醫療設備，旨在為受損或患病的組織提供臨時支撐和穩定，特別是在骨科環境中。這些可生物分解的植入物逐漸分解並被身體吸收，一旦它們完成其功能，就無需進行後續的手術切除。

可生物分解的植入物通常由生物相容性材料製成，包括聚乳酸 (PLA) 和聚乙醇酸 (PGA) 等聚合物，它們模仿天然骨骼的機械性能。這種獨特的特性使它們能夠支持癒合過程，同時最大限度地減少與永久植入物相關的併發症，例如感染、植入物鬆動和應力屏蔽。

聚乳酸(PLA)、聚乙醇酸(PGA) 和聚己內酯(PCL) 等聚合物可形成生物相容性支架，這些支架會隨著時間的推移而分解，支持組織生長並被新骨取代。

市場動態：

驅動程式和限制

生物材料的進步

生物材料的進步預計將顯著推動全球可生物分解植入物市場的成長。生物材料在醫療器材的開發中至關重要，可生物分解材料的發展為骨科、心血管和牙科植入等各個領域的應用開闢了新的途徑。這些可生物分解的生物材料經過精心設計，可隨著時間的推移在體內自然分解，而不會引起不良反應。公司正在使用先進的解決方案製造可生物分解的植入物。

這些公司正在獲得使用各種可生物分解材料的植入物和解決方案的批准。例如，2023 年 3 月，Bioretec Ltd. 的 RemeOs 創傷螺絲在美國獲得市場授權。核准的產品範圍和適應症與在腳踝上進行的臨床試驗一致。

聚乳酸 (PLA)、聚乙醇酸 (PGA) 和聚己內酯 (PCL) 等創新提高了植入物的安全性和有效性。這些材料表現出優異的生物相容性，減少了排斥或發炎的可能性，這是與永久植入物相關的常見問題。隨著生物相容性的提高，可生物分解的植入物在臨床環境中獲得了更廣泛的接受，特別是在尋求與身體無縫融合的臨時解決方案的患者中。

此外，可生物分解生物材料的進步正在提高其在藥物傳輸系統中的效率，這有望改善治療效果並擴大其在腫瘤學、慢性病管理和組織工程等領域的應用。公司正在開發可植入的聚合物。例如，2023 年 3 月，PEEK 生物材料解決方案開發商 Victrex 旗下的 Invibio Biomaterial Solutions 推出了 PEEK-OPTIMA AM 細絲，這是一種針對積層製造進行了最佳化的植入式 PEEK 聚合物。

與傳統的不可分解植入物相比，可生物分解材料也被認為更環保，符合對永續醫療解決方案不斷成長的需求。

FDA 和歐洲藥品管理局 (EMA) 等監管機構已批准各種可生物分解植入物，鼓勵對該市場的進一步投資，並推動已開發經濟體和新興經濟體的成長。例如，2021 年 3 月，Inion 的 Inion CompressOn 生物可吸收加壓螺絲已獲得美國食品藥物管理局的批准。這些生物可吸收螺絲的開發是為了滿足世界各地外科醫生和患者的需求。隨著這些趨勢的不斷發展，可生物分解植入物市場可望大幅擴張。

監管挑戰

嚴格的監管環境預計將阻礙市場成長。儘管某些地區的監管環境可能會有所支持，但新的可生物分解植入技術的批准流程仍然是一項重大挑戰。製造商通常面臨漫長的核准時間和嚴格的要求，這可能會減少創新產品開發的投資。例如，在美國，儘管生物可吸收植入物有明確的指導方針，但證明安全性和有效性所需的廣泛測試可能會延長新設備上市所需的時間。

在歐洲，醫療器材法規 (MDR) 引入了製造商必須滿足的更嚴格的標準，使核准流程更加複雜。這些法規要求進行全面的臨床評估和上市後監測，這可能會佔用大量資源且耗時。

Biodegradable implants are specialized medical devices intended to provide temporary support and stabilization for damaged or diseased tissues, particularly in orthopedic settings. These biodegradable implants gradually break down and are absorbed by the body, which eliminates the need for subsequent surgical removal once they have fulfilled their function.

Biodegradable implants are typically constructed from biocompatible materials, including polymers like polylactic acid (PLA) and polyglycolic acid (PGA), which mimic the mechanical properties of natural bone. This unique characteristic allows them to support the healing process while minimizing complications associated with permanent implants, such as infection, implant loosening, and stress shielding.

Polymers, like polylactic acid (PLA), polyglycolic acid (PGA), and polycaprolactone (PCL), create biocompatible scaffolds that degrade over time, supporting tissue growth and being replaced by new bone.

Market Dynamics: Drivers & Restraints

Advancements in biomaterials

Advancements in biomaterials are anticipated to propel the growth of the global biodegradable implants market significantly. Biomaterials are crucial in the development of medical devices, and the evolution of biodegradable materials has opened new avenues for applications across various fields, including orthopedics, cardiovascular, and dental implants. These biodegradable biomaterials are engineered to naturally decompose within the body over time without causing adverse reactions. Companies are manufacturing biodegradable implants using advanced solutions.

The companies are gaining approvals for implants and solutions that use a variety of biodegradable materials. For instance, in March 2023, Bioretec Ltd. received market authorization for its RemeOs trauma screw in the U.S. The RemeOs trauma screw is the first and currently only bioresorbable metal implant approved by the U.S. Food and Drug Administration (FDA). The approved product range and indication align with the clinical trial conducted on the ankle.

Innovations such as polylactic acid (PLA), polyglycolic acid (PGA), and polycaprolactone (PCL) have enhanced the safety and effectiveness of implants. These materials exhibit excellent biocompatibility, reducing the likelihood of rejection or inflammation which is a common issue associated with permanent implants. As biocompatibility improves, biodegradable implants are gaining wider acceptance in clinical settings, especially among patients seeking temporary solutions that integrate seamlessly with their bodies.

Furthermore, advancements in biodegradable biomaterials are enhancing their efficiency in drug delivery systems, which is expected to improve treatment outcomes and broaden their applications in areas such as oncology, chronic disease management, and tissue engineering. Companies are developing polymers that can be implantable. For instance, in March 2023, Invibio Biomaterial Solutions, part of Victrex, a developer of PEEK biomaterial solutions, launched PEEK-OPTIMA AM Filament, an implantable PEEK polymer that is optimized for additive manufacturing.

Biodegradable materials are also considered more environmentally friendly compared to traditional non-degradable implants, aligning with the growing demand for sustainable medical solutions.

Regulatory bodies like the FDA and the European Medicines Agency (EMA) have approved various biodegradable implants, encouraging further investment in this market and driving growth in both developed and emerging economies. For instance, in March 2021, Inion received the Food and Drug Administration approval for the Inion CompressOn bioabsorbable compression screw. These bioabsorbable screws were developed to meet the needs of surgeons and patients around the world. As these trends continue to develop, the biodegradable implants market is poised for substantial expansion.

Regulatory challenges

The stringent regulatory landscape is expected to hinder market growth. While the regulatory landscape in certain regions may be supportive, navigating the approval processes for new biodegradable implant technologies remains a significant challenge. Manufacturers often face lengthy approval timelines and stringent requirements, which can reduce investment in the development of innovative products. For instance, in the United States, although there are clear guidelines for bioabsorbable implants, the extensive testing required to demonstrate safety and efficacy can prolong the time it takes to bring new devices to market.

In Europe, the Medical Device Regulation (MDR) has introduced more rigorous standards that manufacturers must meet, further complicating the approval process. These regulations require comprehensive clinical evaluations and post-market surveillance, which can be resource-intensive and time-consuming.

Segment Analysis

The global biodegradable implants market is segmented based on product type, material, application, end-user, and region.

Product Type:

Orthopedic implants segment is expected to dominate the global biodegradable implants market share

Due to several factors, the orthopedic implants segment is expected to hold a significant position in the market for biodegradable medical implant devices. The rising demand for advanced solutions in bone healing, the inherent advantages of biodegradable materials, and an increasing preference among patients for minimally invasive treatments are driving this growth.

As the global population ages, there has been a marked increase in bone-related conditions such as osteoporosis, osteoarthritis, and fractures. The elderly demographic, in particular, faces heightened risks of bone fractures and degenerative joint diseases, which fuels the demand for orthopedic implants. For instance, Worldwide, up to 37 million fragility fractures occur annually in individuals aged over 55, the equivalent of 70 fractures per minute.

Worldwide, 1 in 3 women over age 50 will experience osteoporosis fractures, as will 1 in 5 men aged over 50. Osteoporosis affects approximately 6.3% of men over the age of 50 and 21.2% of women over the same age range globally. Based on the world population of men and women, this suggests that approximately 500 million men and women worldwide may be affected.

Biodegradable implants, such as screws, pins, and plates offer a temporary solution that provides essential support during the healing process while eliminating the need for future surgeries to remove permanent implants.

Unlike traditional permanent implants, biodegradable options naturally degrade as bone heals, which is especially beneficial for elderly patients or those with compromised health. This feature reduces the overall healthcare burden by minimizing the risk of complications and lowering healthcare costs associated with additional surgeries.

Moreover, because biodegradable orthopedic implants break down over time, patients often experience shorter recovery periods and reduced hospital stays compared to those with permanent implants that may require follow-up procedures. This contributes to an overall improved patient experience and encourages greater adoption of biodegradable implants in orthopedic surgeries. With faster recovery times and fewer complications, these implants can lead to better surgical outcomes and decreased hospitalization durations, ultimately alleviating the healthcare burden on both patients and healthcare systems.

As awareness of these benefits continues to grow among healthcare providers and patients alike, the biodegradable orthopedic implants segment is expected to expand significantly in the coming years.

Geographical Analysis

North America is expected to hold a significant position in the global biodegradable implants market share

North America holds a dominant position in the global biodegradable implants market and is expected to hold the major portion of the market during the forecast period. This dominance is governed by the rising advanced medical infrastructure and the increasing research and development of innovative solutions in the region.

The increasing research and development of innovative solutions in the region also contributes to the region's market growth. For instance, in June 2021, researchers at Northwestern and George Washington Universities (GW) developed the first-ever transient pacemaker which is a wireless, battery-free, fully implantable pacing device that disappears after it's no longer needed.

The prevalence of chronic diseases, particularly cardiovascular conditions and orthopedic issues, is significantly impacting the demand for biodegradable implants in the United States. For instance, ankle fractures are one of the most frequently occurring fracture types among the adult patient population. There are 3.4 million patients treated each year in the U.S. for ankle fractures. Single-isolated ankle (malleolar) fractures are the most common type, accounting for 70% of the yearly incidence of all ankle fractures. This rising incidence of fractures increases the demand for biodegradable implants as patients are interested particularly in innovative solutions which do not require further surgeries.

The National Institute of Health in 2024 stated that, after reviewing data from more than 29 million adults receiving hospital care in California, researchers found that 2 million adults (6.8%) had atrial fibrillation, an irregular heart rhythm. When they extrapolated these data to statewide data and the U.S. population, they found that at least 10.55 million American adults (4.48%) are predicted to have atrial fibrillation. As these health concerns escalate, there is an increasing need for bioabsorbable implants that can enhance patient outcomes while minimizing complications associated with traditional permanent implants.

Unlike their non-biodegradable counterparts, biodegradable implants are designed to gradually dissolve in the body, which helps to reduce risks such as inflammation and infection. As the aging population continues to grow, the demand for these innovative solutions is expected to rise, making biodegradable implants a vital component of advanced treatments.

Companies are innovating advanced implant solutions by utilizing advanced biodegradable materials which is expected to increase the demand for these implants. For instance, in July 2021, Stryker received the FDA clearance of the first balloon implant for arthroscopic treatment of massive irreparable rotator cuff tears (MIRCTs). Market players in the region are collaborating with the established players to expand the biodegradable implants portfolio.

Asia Pacific is growing at the fastest pace in the global biodegradable implants market

The Asia-Pacific (APAC) region is emerging as one of the fastest-growing markets in the global biodegradable implants, which is governed by several critical factors. Countries such as China, India, Japan, and South Korea are making substantial investments in healthcare infrastructure, leading to hospitals and clinics becoming increasingly equipped with advanced technologies. These advancements allow for a greater adoption of innovative treatments and implants.

Additionally, the aging population in countries like Japan, China, and South Korea significantly contributes to market growth. As the elderly demographic expands, there is a heightened incidence of bone fractures, joint diseases, and dental issues, which escalates the demand for both orthopedic and dental implants. For instance, the National Institute of Health in 2023 reported that osteoporosis affects 10-30% of women aged above 40, and up to 10% of men in 7 developed economies in Asia Pacific. Fractures affect 500-1000 adults aged above 50 per 100,000 person-years.

Thus, increasing orthopedic conditions increase the demand for biodegradable implants as more patients are seeking for sustainable medical solutions.

Competitive Landscape

The major global players in the biodegradable implants market include Evonik, Johnson & Johnson, Medtronic, Stryker, Smith+Nephew, Boston Scientific Corporation, Inion, Bioretec, Arthrex, Inc, Syntellix among others.

Why Purchase the Report?

Pipeline & Innovations: Insights into clinical trials, product pipelines, and upcoming advancements.
Market Positioning: Analysis of product performance and growth potential for optimized strategies.
Real-World Evidence: Integration of patient feedback for enhanced product outcomes.
Physician Preferences: Insights into healthcare provider behaviors and adoption strategies.
Regulatory & Market Updates: Coverage of recent regulations, policies, and emerging technologies.
Competitive Insights: Analysis of market share, competitor strategies, and new entrants.
Pricing & Market Access: Review of pricing models, reimbursement trends, and access strategies.
Market Expansion: Strategies for entering new markets and forming partnerships.
Regional Opportunities: Identification of high-growth regions and investment prospects.
Supply Chain Optimization: Assessment of risks and distribution strategies.
Sustainability & Regulation: Focus on eco-friendly practices and regulatory changes.
Post-Market Surveillance: Enhanced safety and access through post-market data.
Value-Based Pricing: Insights into pharmacoeconomics and data-driven R&D decisions.

The Global Biodegradable Implants market report delivers a detailed analysis with 60+ key tables, more than 50 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.
Technology & 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.

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 Material
3.3. Snippet by Application
3.4. Snippet by End-User
3.5. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
  - 4.1.1.1. Advancements in biomaterials
- 4.1.2. Restraints
  - 4.1.2.1. Regulatory challenges
- 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. Orthopedic Implants*
- 6.2.1. Introduction
- 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
6.3. Cardiovascular Implants
6.4. Dental Implants
6.5. Others

7. By Material

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
- 7.1.2. Market Attractiveness Index, By Material
7.2. Polymer*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
- 7.2.3. Polyglycolic Acid (PGA)
- 7.2.4. Polylactic Acid (PLA)
- 7.2.5. Poly-B-hydroxybutyrate (PHB)
- 7.2.6. Poly (lactic acid-co-glycolic acid) (PLGA)
- 7.2.7. Poly-ε-caprolactone (PCL)
7.3. Metal
- 7.3.1. Magnesium
- 7.3.2. Zinc
- 7.3.3. Iron
7.4. Ceramics

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. Orthopedic Surgeries*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Cardiovascular Procedures
8.4. Dental Procedures
8.5. 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. Ambulatory Surgical Centers
9.4. Specialty Clinics

10. By Region

10.1. Introduction
- 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 10.1.2. Market Attractiveness Index, By Region
10.2. North America
- 10.2.1. Introduction
- 10.2.2. Key Region-Specific Dynamics
- 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
- 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 10.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.2.7.1. U.S.
  - 10.2.7.2. Canada
  - 10.2.7.3. Mexico
10.3. Europe
- 10.3.1. Introduction
- 10.3.2. Key Region-Specific Dynamics
- 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
- 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 10.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.3.7.1. Germany
  - 10.3.7.2. U.K.
  - 10.3.7.3. France
  - 10.3.7.4. Spain
  - 10.3.7.5. Italy
  - 10.3.7.6. Rest of Europe
10.4. South America
- 10.4.1. Introduction
- 10.4.2. Key Region-Specific Dynamics
- 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
- 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 10.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.4.7.1. Brazil
  - 10.4.7.2. Argentina
  - 10.4.7.3. Rest of South America
10.5. Asia-Pacific
- 10.5.1. Introduction
- 10.5.2. Key Region-Specific Dynamics
- 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
- 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 10.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.5.7.1. China
  - 10.5.7.2. India
  - 10.5.7.3. Japan
  - 10.5.7.4. South Korea
  - 10.5.7.5. Rest of Asia-Pacific
10.6. Middle East and Africa
- 10.6.1. Introduction
- 10.6.2. Key Region-Specific Dynamics
- 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
- 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

11. Competitive Landscape

11.1. Competitive Scenario
11.2. Market Positioning/Share Analysis
11.3. Mergers and Acquisitions Analysis

12. Company Profiles

12.1. Johnson & Johnson*
- 12.1.1. Company Overview
- 12.1.2. Product Portfolio and Description
- 12.1.3. Financial Overview
- 12.1.4. Key Developments
12.2. Evonik
12.3. Medtronic
12.4. Stryker
12.5. Smith+Nephew
12.6. Boston Scientific Corporation
12.7. Inion
12.8. Bioretec
12.9. Arthrex, Inc
12.10. Syntellix

LIST NOT EXHAUSTIVE