![]() |
市場調査レポート
商品コード
1606532
生分解性インプラントの世界市場-2024~2031年Global Biodegradable Implants Market - 2024-2031 |
||||||
カスタマイズ可能
適宜更新あり
|
生分解性インプラントの世界市場-2024~2031年 |
出版日: 2024年12月04日
発行: DataM Intelligence
ページ情報: 英文 176 Pages
納期: 即日から翌営業日
|
概要
生分解性インプラントの世界市場は2023年に52億4,000万米ドルに達し、2031年には103億1,000万米ドルに達すると予測され、予測期間2024年~2031年のCAGRは8.9%で成長する見込みです。
生分解性インプラントは、特に整形外科的な環境において、損傷した組織や病気の組織を一時的に支え、安定させることを目的とした特殊な医療機器です。これらの生分解性インプラントは徐々に分解され、体内に吸収されるため、その機能を果たすと外科的に除去する必要がなくなります。
生分解性インプラントは一般的に、ポリ乳酸(PLA)やポリグリコール酸(PGA)のようなポリマーを含む生体適合性材料から作られており、天然骨の機械的特性を模倣しています。このユニークな特性により、感染、インプラントのゆるみ、応力遮蔽など、永久インプラントに関連する合併症を最小限に抑えながら、治癒プロセスをサポートすることができます。
ポリ乳酸(PLA)、ポリグリコール酸(PGA)、ポリカプロラクトン(PCL)などのポリマーは、生体適合性のある足場を作り、時間の経過とともに分解して組織の成長をサポートし、新しい骨に置き換わる。
促進要因と阻害要因
生体材料の進歩
生体材料の進歩は、世界の生分解性インプラント市場の成長を大きく促進すると予測されています。生体材料は医療機器の開発において極めて重要であり、生分解性材料の進化は整形外科、心臓血管、歯科インプラントなど様々な分野での応用に新たな道を開いています。これらの生分解性バイオマテリアルは、副作用を引き起こすことなく、時間の経過とともに体内で自然に分解されるように設計されています。各社は先進的なソリューションを使って生分解性インプラントを製造しています。
各社は、様々な生分解性材料を使用したインプラントやソリューションの認可を取得しつつあります。例えば、2023年3月、Bioretec Ltd.は米国でRemeOs trauma screwの市場認可を取得しました。RemeOs trauma screwは米国食品医薬品局(FDA)により認可された最初で現在唯一の生体吸収性金属インプラントです。承認された製品範囲と適応症は、足首で実施された臨床試験と一致しています。
ポリ乳酸(PLA)、ポリグリコール酸(PGA)、ポリカプロラクトン(PCL)などの技術革新は、インプラントの安全性と有効性を高めてきました。これらの材料は優れた生体適合性を示し、永久インプラントに関連する一般的な問題である拒絶反応や炎症の可能性を低減します。生体適合性が向上するにつれて、生分解性インプラントは臨床の場で、特に自分の身体とシームレスに一体化する一時的な解決策を求める患者の間で、より広く受け入れられるようになってきています。
さらに、生分解性バイオマテリアルの進歩によってドラッグデリバリーシステムの効率が向上しており、治療成績の改善や、腫瘍学、慢性疾患管理、組織工学などの分野での応用拡大が期待されています。企業は移植可能なポリマーを開発しています。例えば、2023年3月、PEEKバイオマテリアル・ソリューションの開発企業であるVictrex社の一部であるInvibio Biomaterial Solutions社は、積層造形用に最適化された移植可能なPEEKポリマーであるPEEK-OPTIMA AM Filamentを発売しました。
生分解性材料はまた、従来の非分解性インプラントと比較して環境に優しいと考えられており、持続可能な医療ソリューションに対する需要の高まりと一致しています。
FDAや欧州医薬品庁(EMA)などの規制機関がさまざまな生分解性インプラントを承認したことで、この市場へのさらなる投資が促進され、先進国、新興経済諸国ともに成長を牽引しています。例えば、2021年3月、InionはInion CompressOn生体吸収性圧迫スクリューの食品医薬品局の承認を取得しました。これらの生体吸収性スクリューは、世界中の外科医と患者のニーズを満たすために開発されました。こうした動向の進展に伴い、生分解性インプラント市場は大幅な拡大が見込まれます。
規制に関する課題
厳しい規制状況が市場成長の妨げになると予想されます。特定の地域の規制状況は支持的かもしれないが、新しい生分解性インプラント技術の承認プロセスを乗り切ることは依然として大きな課題です。メーカーはしばしば、長い承認スケジュールと厳しい要件に直面し、革新的な製品の開発への投資を減少させる可能性があります。例えば米国では、生体吸収性インプラントに関する明確なガイドラインがあるもの、安全性と有効性を実証するために必要な広範な試験により、新しい器具を市場に出すまでの時間が長引く可能性があります。
欧州では、医療機器規制(MDR)が、メーカーが満たさなければならないより厳格な基準を導入し、承認プロセスをさらに複雑にしています。これらの規制は、包括的な臨床評価と市販後サーベイランスを要求しており、資源集約的で時間のかかるものとなっています。
Overview
The global biodegradable implants market reached US$ 5.24 billion in 2023 and is expected to reach US$ 10.31 billion by 2031, growing at a CAGR of 8.9% during the forecast period 2024-2031.
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.
The global biodegradable implants market is segmented based on product type, material, application, end-user, and region.
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.
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.
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.
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.
LIST NOT EXHAUSTIVE