市场调查报告书
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全球骨科生物材料市场 - 2023-2030Global Orthopedic Biomaterials Market - 2023-2030 |
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生物材料是一种为了医疗目的(治疗或诊断测试)而与生物系统相互作用的物质。生物材料可以在实验室中使用多种化学技术使用金属或聚合物成分、陶瓷或复合材料来製造,生物材料也可以从自然界中获得。
骨科生物材料用于固定骨骼的暂时植入物、永久植入材料和生物可吸收植入物。常见的骨科生物材料包括磷酸钙水泥、生物活性玻璃、聚合物、金属和复合材料。
骨科手术数量的增加是市场成长的重要动力。在骨科手术中,生物材料可用于替换或再生受损或患病的组织,以改善其生理性能。
例如,美国关节置换登记处(AJRR) 发布的2022 年年度报告显示,与前一年相比,整体累积手术量增加了14%,其中包括自2012 年以来来自1,250 多家医院的超过280 万例髋关节和膝关节手术、门诊手术中心和私人执业团体。因此,对可用于骨科手术的生物材料的需求增加。
此外,据世界卫生组织称,每年约有 2000-5000 万人因道路伤亡而受到非致命伤害。同样,根据 CDC 的数据,2020 年报告了大约 2,885,545 例非致命性损伤需要手术的门诊病例。因此,由于这些损伤,骨科生物材料的使用增加,这有助于提振市场。
此外,类风湿性关节炎和骨关节炎等慢性疾病病例数量的增加以及产品的推出等重要的成长动力预计将在预测期内推动市场。
上市前批准和漫长的临床试验是适用于骨科生物材料市场的严格监管标准之一。这些昂贵且耗时的监管程序增加了整体开发成本,同时延迟了新型生物材料产品进入市场的时间。上述因素预计将阻碍市场成长。
A biomaterial is a substance that has been engineered to interact with biological systems for a medical purpose, either a therapeutic or a diagnostic test. Biomaterials can be created in the lab using a number of chemical techniques using metallic or polymeric components, ceramics, or composite materials, and biomaterials can also be obtained from nature.
Orthopedic biomaterials are used from temporary implants to fix bone to permanent implant materials and bioabsorbable implants. Common orthopedic biomaterials include calcium phosphate cements, bioactive glasses, polymers, metals, and composites.
The increasing number of orthopedic surgeries acts as a significant driver for market growth. In orthopedic surgeries, biomaterials can be utilized to replace or regenerate damaged or diseased tissues in order to improve their physiological performance.
For instance, the American Joint Replacement Registry (AJRR), published its 2022 annual report that demonstrates an overall cumulative procedural growth of 14% compared to the previous year and includes over 2.8 million hip and knee procedures since 2012 from over 1,250 hospitals, ambulatory surgery centers, and private practice groups. Hence, the demand for biomaterials increases that can be used in orthopedic surgeries.
Also, according to the WHO, approximately 20-50 million people get non-fatal injuries because of road casualties yearly. Likewise, according to the CDC, roughly 2,885,545 ambulatory cases were reported with non-fatal injuries requiring surgery in 2020. Thus, due to these injuries, the use of orthopedic biomaterials increased which help to boost the market.
Furthermore, significant growth drivers such as the growing number of cases of chronic diseases like rheumatoid arthritis, and osteoarthritis, and, product launches are expected to drive the market in the forecast period.
Pre-market approval and lengthy clinical trials are among the strict regulatory criteria that apply to the orthopedic biomaterial market. These expensive and time-consuming regulatory procedures raise the overall cost of development while delaying the release of novel biomaterial products into the market. The above factors are expected to hamper the market growth.
The global orthopedic biomaterials market is segmented based on material type, application, end users and region.
Calcium phosphate cement is a bioactive and biodegradable grafting material in the form of powder and liquid. Calcium phosphate cements are expected to hold the largest market share over the period forecast owing to increasing new orthopedic biomaterial launches and technical advancements.
For instance, in July 2022, Curasan AG launched the CERASORB CPC (Calcium Phosphate Cement) Bone Void Fillers for maxillofacial, orthopedic, and trauma surgery. CERASORB CPC is a synthetic, biocompatible, osteoconductive, and bioresorbable mineral bone cement composed of calcium and phosphate salts finely dispersed in a biocompatible oil.
Additionally, in May 2022, Granulab (M) Sdn Bhd launched Malaysia's first halal-certified synthetic bone cement called Prosteomax. It is an innovative calcium phosphate-based synthetic bone cement that has been certified halal by the Islamic Development Department Malaysia.
The global orthopedic biomaterials market is segmented into North America, Europe, Asia Pacific, South America, Middle East, and Africa.
North America has maintained a significant market proportion due to factors such as the rising prevalence of orthopedic surgeries, and product launches, this trend is anticipated to continue throughout the forecast period.
For instance, in April 2023, Abyrx, Inc. received U.S. FDA clearances for the MONTAGE Settable, Resorbable Bone Putty as both a bone void filler and cranial bone cement. MONTAGE is a hand-moldable, hardening putty that, within minutes after mixing, develops bone-like characteristics and offers a unique intraoperative application.
Additionally, in February 2022, Orthofix Medical Inc. launched the Opus BA, a synthetic bioactive bone graft solution for cervical and lumbar spine fusion procedures. Opus BA can be used to fill skeletal system gaps or holes that are not essential to the stability of the bony structure.
The COVID-19 pandemic has had a significant impact on the global orthopedic biomaterials market. The onset of the pandemic in early 2020 led to widespread lockdowns and restrictions, impacting regular diagnoses, treatments, biomaterial launches, and consultations worldwide. With the outbreak of the pandemic, many pharmaceutical or medical device manufacturing units faced labor shortages and were unable to travel to work due to lockdown restrictions. Therefore, owing to the above factors, the orthopedic biomaterials market is expected to be moderately affected over the forecast period.
The major global players in the market include: Stryker Corporation, Koninklijke DSM N.V., Evonik Industries AG, Globus Medical, Zimmer Biomet Holdings Inc., Medbone, Invibio Ltd., CAM Bioceramics B.V., Exactech Inc., DePuy Synthes among others.
The global orthopedic biomaterials market report would provide approximately 61 tables, 63 figures, and 185 Pages.