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市場調查報告書
商品編碼
1712547
全球矯形器具和骨折輔助器市場 - 2025-2033Global Orthopedic Appliances and Fracture Aids Market - 2025-2033 |
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2024 年全球矯形器材和骨折輔助器具市場規模達到 208.5 億美元,預計到 2033 年將達到 323 億美元,在 2025-2033 年預測期內的複合年成長率為 4.7%。
矯形器械和骨折管理工具是旨在為肌肉骨骼系統提供支撐、穩定性和輔助的醫療設備。這些產品主要用於治療影響骨骼和關節的損傷、畸形和疾病。矯形器具,例如支架、夾板和支撐物,是用於特定醫療目的的裝置。它們可以承受重複使用,通常對沒有健康問題的人沒有用。這些器具旨在限制或消除患病、受傷、虛弱或畸形的身體部位的運動,促進癒合並改善功能。
駕駛員和約束裝置
骨科疾病發生率上升
肌肉骨骼疾病,包括骨關節炎、類風濕性關節炎和骨質疏鬆症,正變得越來越普遍,尤其是在老年人口中。根據世界衛生組織 2022 年 7 月的資料,全球約有 17.1 億人患有肌肉骨骼疾病。這些疾病是全世界殘疾的主要原因,其中腰痛被認定為 160 個國家殘疾的主要原因。
此外,體育運動參與度的增加導致需要骨科治療的運動相關傷害增加。隨著人們參與的體能活動越來越多,肌腱病和韌帶扭傷等病症變得越來越普遍。此外,骨科治療和設備的進步、微創手術方法和增強成像技術等創新正在提高診斷的準確性和治療效果,推動市場成長。
行業主要參與者正在推出創新產品和關鍵發展,以推動該市場的成長。例如,2024 年 6 月,Water Orthopedics 自豪地宣布推出革命性的純碳纖維輪椅 WAT950BEF1,這標誌著公司歷史上的一個重要里程碑。這款創新產品是五年夢想的成果,也是受先進技術啟發的開創性製造程序的成果,使其成為業界第一款純碳纖維輪椅。所有這些因素都要求全球矯形器具和骨折輔助器具市場的發展。
嚴格的法規核准
全球矯形器材和骨折輔助器市場面臨的主要挑戰之一是產品開發和商業化所需的嚴格監管批准。由於這些設備直接涉及患者護理和康復,因此必須符合衛生當局製定的嚴格的安全、品質和性能標準。
例如,在美國,食品藥物管理局 (FDA) 將大多數矯形器械歸類為 I 類或 II 類醫療器械,需要進行一般控制或上市前通知 (510(k)) 以證明與合法銷售的器械具有實質等同性。在歐洲,製造商必須遵守醫療器材法規 (MDR),與先前的醫療器材指令 (MDD) 相比,該法規要求更全面的文件、臨床評估和上市後監督。因此,上述因素可能限制全球矯形器具和骨折輔助器具市場的潛在成長。
The global orthopedic appliances and fracture aids market reached US$ 20.85 billion in 2024 and is expected to reach US$ 32.30 billion by 2033, growing at a CAGR of 4.7% during the forecast period of 2025-2033.
Orthopedic devices and fracture management tools are medical equipment designed to provide support, stability, and assistance to the musculoskeletal system. These products are primarily used to treat injuries, deformities, and conditions that affect bones and joints. Orthopedic appliances, such as braces, splints, and supports, are devices that serve a specific medical purpose. They are built to withstand repeated use and are not typically useful for individuals without a medical condition. These appliances aim to restrict or eliminate motion in a diseased, injured, weak, or deformed body part, facilitating healing and improving functionality.
Market Dynamics: Drivers & Restraints
Rising Incidence of Orthopedic Disorders
Musculoskeletal conditions, including osteoarthritis, rheumatoid arthritis, and osteoporosis, are becoming more widespread, particularly among the aging population. As per WHO data in July 2022, around 1.71 billion individuals globally suffer from musculoskeletal conditions. These disorders are the primary cause of disability worldwide, with low back pain recognized as the leading cause of disability in 160 countries.
Moreover, the increase in sports participation has led to a rise in sports-related injuries that necessitate orthopedic care. Conditions like tendinopathies and ligament sprains are becoming more prevalent as individuals take part in more physical activities. In addition, advancements in orthopedic treatments and devices, Innovations such as minimally invasive surgical methods and enhanced imaging technologies are improving diagnostic accuracy and treatment efficacy, driving the market growth.
Major players in the industry are launching innovative products and key developments that would propel this market growth. For instance, in June 2024, Water Orthopedics proudly announced the launch of the WAT950BEF1, a revolutionary pure carbon fibre wheelchair that marks a significant milestone in the company's history. This innovative product is the result of a 5-year dream and a pioneering manufacturing process inspired by advanced technology, making it the industry's first purely carbon fibre wheelchair. All these factors demand the global orthopedic appliances and fracture aids market.
Stringent Regulatory Approvals
One of the key challenges in the global orthopedic appliances and fracture aids market is the stringent regulatory approvals required for product development and commercialization. Since these devices are directly involved in patient care and rehabilitation, they must meet rigorous safety, quality, and performance standards set by health authorities.
In the United States, for instance, the Food and Drug Administration (FDA) classifies most orthopedic appliances as Class I or Class II medical devices, which require either general controls or premarket notification (510(k)) to demonstrate substantial equivalence to a legally marketed device. In Europe, manufacturers must comply with the Medical Device Regulation (MDR), which enforces more comprehensive documentation, clinical evaluations, and post-market surveillance compared to the previous Medical Device Directive (MDD). Thus, the above factors could be limiting the global orthopedic appliances and fracture aids market's potential growth.
The global orthopedic appliances and fracture aids market is segmented based on product type, application, distribution channel, and region.
The belts and braces segment in product type is expected to dominate the global orthopedic appliances and fracture aids market with the highest market share
The belts and braces segment of the orthopedic appliances and fracture aids market includes a range of supportive devices aimed at stabilizing, immobilizing, and assisting in the rehabilitation of musculoskeletal injuries and conditions. Moreover, key players in the market are introducing innovative knee caps, back support belts, & knee support belts, and key developments in orthopedic services that would drive this segment's growth in the market.
For instance, in January 2024, Enovis' DJO subsidiary introduced its new DonJoy Roam OA knee brace, designed for patients suffering from osteoarthritis or experiencing other forms of knee pain and instability. Roam OA represents the company's latest advancement in unloader technology, which aims to alleviate the pressure associated with unicompartmental osteoarthritis by redistributing weight away from the affected knee.
Similarly, in January 2022, Ossur introduced the ReLeaf Active knee brace, specifically designed to offer pain relief and support for individuals with osteoarthritis. This brace features a distinctive hinge design that mimics the natural movement of the knee and is constructed from lightweight, breathable materials to ensure comfort for the user. These factors have solidified the segment's position in the global orthopedic appliances and fracture aids market.
North America is expected to hold a significant position in the global orthopedic appliances and fracture aids market, with the highest market share
The region is experiencing a significant increase in its elderly population, especially in countries like the U.S. and Canada. This demographic change results in a higher incidence of orthopaedic conditions, such as osteoporosis and arthritis, which in turn boosts the demand for orthopaedic devices and treatments. As more individuals in the North America region engage in sports and physical activities, there has been a rise in sports-related injuries. This trend requires effective orthopaedic solutions, such as braces and supports, to manage these injuries effectively.
Moreover, key player strategies such as partnerships, collaborations, and product approvals help to drive this market growth. For instance, in February 2023, Breg, Inc., a supplier of high-quality sports medicine products based in Carlsbad, California, is expanding its presence in China through a collaboration with Coreal International. The partnership will enable Chinese physicians and patients to access Breg's extensive range of products starting this spring. Breg offers a diverse selection of sports medicine and rehabilitation products, including braces for knees, hips, shoulders, fracture repair, elbows, wrists, spine, feet, and ankles.
Also, in July 2023, CyMedica Orthopedics rebranded its wearable knee pain treatment as Motive Health and made it available directly to consumers following FDA clearance, allowing anyone experiencing knee discomfort to purchase the device without a prescription. Thus, the above factors are consolidating the region's position as a dominant force in the global orthopedic appliances and fracture aids market.
The major global players in the orthopedic appliances and fracture aids market include Orthosys, GPC Medical Ltd, United Medicare, Modern Medical Aids, Apothecaries Sundries Mfg. Pvt. Ltd., Samsonorthotics.com, TYNOR ORTHOTICS, Collateral Medical Pvt Ltd, Inc., Aapson Orthotics, GWS Surgicals LLP., and ENOVIS CORPORATION, among others.
The global orthopedic appliances and fracture aids market report delivers a detailed analysis with 65 key tables, more than 60 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.
Target Audience 2024
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