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市场调查报告书
商品编码
1712547
全球矫形器具和骨折辅助器市场 - 2025-2033Global Orthopedic Appliances and Fracture Aids Market - 2025-2033 |
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2024 年全球矫形器材和骨折辅助器具市场规模达到 208.5 亿美元,预计到 2033 年将达到 323 亿美元,在 2025-2033 年预测期内的复合年增长率为 4.7%。
矫形器械和骨折管理工具是旨在为肌肉骨骼系统提供支撑、稳定性和辅助的医疗设备。这些产品主要用于治疗影响骨骼和关节的损伤、畸形和疾病。矫形器具,例如支架、夹板和支撑物,是用于特定医疗目的的装置。它们可以承受重复使用,通常对没有健康问题的人没有用。这些器具旨在限製或消除患病、受伤、虚弱或畸形的身体部位的运动,促进癒合并改善功能。
驾驶员和约束装置
骨科疾病发生率上升
肌肉骨骼疾病,包括骨关节炎、类风湿性关节炎和骨质疏鬆症,正变得越来越普遍,尤其是在老年人口中。根据世界卫生组织 2022 年 7 月的资料,全球约有 17.1 亿人患有肌肉骨骼疾病。这些疾病是全世界残疾的主要原因,其中腰痛被认定为 160 个国家残疾的主要原因。
此外,体育运动参与度的增加导致需要骨科治疗的运动相关伤害增加。随着人们参与的体能活动越来越多,肌腱病和韧带扭伤等病症变得越来越普遍。此外,骨科治疗和设备的进步、微创手术方法和增强成像技术等创新正在提高诊断的准确性和治疗效果,推动市场成长。
行业主要参与者正在推出创新产品和关键发展,以推动该市场的成长。例如,2024 年 6 月,Water Orthopedics 自豪地宣布推出革命性的纯碳纤维轮椅 WAT950BEF1,这标誌着公司历史上的一个重要里程碑。这款创新产品是五年梦想的成果,也是受先进技术启发的开创性製造工艺的成果,使其成为业界第一款纯碳纤维轮椅。所有这些因素都要求全球矫形器具和骨折辅助器具市场的发展。
严格的监管审批
全球矫形器材和骨折辅助器市场面临的主要挑战之一是产品开发和商业化所需的严格监管批准。由于这些设备直接涉及患者护理和康復,因此必须符合卫生当局製定的严格的安全、品质和性能标准。
例如,在美国,食品药物管理局 (FDA) 将大多数矫形器械归类为 I 类或 II 类医疗器械,需要进行一般控製或上市前通知 (510(k)) 以证明与合法销售的器械具有实质等同性。在欧洲,製造商必须遵守医疗器材法规 (MDR),与先前的医疗器材指令 (MDD) 相比,该法规要求更全面的文件、临床评估和上市后监督。因此,上述因素可能限制全球矫形器具和骨折辅助器具市场的潜在成长。
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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