市场调查报告书
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1190456
角膜植入物市场——增长、趋势、COVID-19 的影响和预测 (2023-2028)Corneal Implant Market - Growth, Trends, and Forecasts (2023 - 2028) |
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在预测期内,角膜植入物市场的复合年增长率预计为 6.1%。
COVID-19 大流行的迅速出现对全世界的眼科手术产生了重大影响。 由于眼科手术被视为择期手术,疫情期间择期手术的暂停减少了全球接受眼科手术的患者数量。 同样在 2020 年 3 月,作为该国应对 COVID-19 的一部分,CMS 建议停止择期手术。 此外,在 2020 年 3 月,AAO 公布了临床指南,建议眼科医生停止除紧急和急诊医疗以外的医疗。 此外,正如国际环境研究与公共卫生杂誌在 2021 年 8 月宣布的那样,在放宽大流行限制措施后,没有看到反弹效应。 双侧同步白内障手术 (SBCS) 占 2019 年 5 月至 2021 年 3 月进行的白内障手术的 0.77%,而 2021 年 4 月至 2021 年 5 月为 6.5%。 因此,随着 COVID-19 病例开始消退,在大流行早期影响市场的 COVID-19 大流行已经得到了显着覆盖。
市场的增长主要归功于角膜植入技术的进步、老年人口的增加以及全球眼病发病率的增加等因素。 这些因素导致医疗机构对角膜植入物的大量需求。 老年人口易患 Fuchs 营养不良,可通过内皮角膜移植术 (EK) 进行治疗。 根据 2020 年 3 月发表在《视网膜和眼部研究进展》上的一篇论文,晚发性 Fuchs 内皮营养不良在美国很常见,影响了大约 4% 的 40 岁以上人群。 大疱性角膜病变也是接受白内障手术的老年人中最常见的疾病。 对于此类患者,建议进行 EK 手术。 此外,根据联合国 2022 年世界人口老龄化报告,世界 65 岁及以上人口的比例预计将从 2022 年的 10% 增加到 2050 年的 16%。 到 2050 年,世界 65 岁及以上人口将是 5 岁以下儿童人数的两倍多,与 12 岁以下儿童人数几乎持平。 因此,人口老龄化的增加将带动整体市场的增长。
此外,由于对胶原蛋白人工角膜的生物相容性和低成本进行了评估,因此对胶原人工角膜的需求正在增加,从而导致生物工程人工角膜的发展。 此外,该领域研发活动的增加也促进了市场增长。 例如,2020 年 7 月,CorNeat Vision 开发了一种易于植入且价格低廉的人工角膜 CorNeat KPro。 CorNeat KPro 旨在替换受损、变形或混浊的角膜,有望为没有角膜的患者提供完整和即时的视力康復。 该产品预计将于 2022 年获得 CE 标誌和美国 FDA 批准。 同样在 2021 年 6 月,以色列眼科初创公司 EyeOn Medical 的旗舰产品 EndoArt 获得了 CE 标誌,这是世界上第一个用于对抗角膜水肿的合成角膜植入物。 通过这种方式,上述技术发展有助于增加对角膜植入物的需求。
此外,全球范围内眼病发病率的上升也导致了对角膜植入物的大量需求。 角膜植入物用于治疗圆锥角膜、角膜混浊、角膜失明和其他眼部疾病。 根据美国角膜研究基金会 2020 年的统计,普通人群中每 10 万人中就有 50 到 200 人患有圆锥角膜疾病。 由此,预计随着圆锥角膜疾病患者人数的增加,角膜植入物的需求也会增加。 而根据 RNIB 2020 的统计数据,估计到 2050 年英国将有 410 万人受到失明的影响。 此外,根据2021年WHO统计,2020年全球将有近视或远视约22亿人,角膜混浊将有420万人。 如此庞大的数字表明对角膜植入物的需求很高。 因此,上述所有因素目前都在促进角膜植入物市场的增长。
然而,外科手术和眼科设备的高成本以及替代疗法的可用性是抑制市场增长的因素之一。
推动侵入性角膜移植增长的一个主要因素是越来越多的人患有眼外伤和眼部疾病。 穿透性角膜移植术用于治疗患有眼部疾病(例如角膜溃疡和感染性角膜炎)的患者。 此外,穿透性角膜移植术(penetrating keratoplasty,PKP)是治疗角膜外翻的首选方法,是治疗角膜不耐受和矫正视力患者的标准,光学和视觉效果显着,已成为一种技术。
此外,穿透性角膜移植手术数量的增加表明对角膜植入物的需求不断增长。 根据 EBAA 的 2021 年眼库统计报告,美国分配给角膜移植的供应组织(包括长期储存组织)总数为 79,641 份,比 2020 年的 66,278 份增加了 20.2%。 2021 年,美国移植了 49,110 个半保留角膜,22,928 个出口到国外。 根据同一份文件,美国的渗透性角膜移植术 (PK) 移植数量为 16,269(增长 5.6%),EK 数量为 30,098,增长 15.3%。 因此,角膜移植手术数量的增加预示着角膜移植需求的增长。 由于这些原因,预计该部门在预测期内将显着增长。
在北美地区,美国所占份额最大,预计在预测期内仍将占据主导地位。 该地区日益增长的奉献意识和多个组织的存在是该地区市场增长的一些关键驱动力。 例如,EBAA 每年 11 月举办眼球捐赠月活动,以提高人们对角膜捐赠和移植的认识。 预计这些努力将增加该国进行的眼科手术的数量。
此外,圆锥角膜患病率的增加预计将增加对角膜植入物的需求,这有望在预测期内推动市场增长。 例如,根据 EBAA 2021 报告,每 2,000 名美国人中就有 1 人患有圆锥角膜。 症状通常出现在生命早期,在青少年和成人中最为普遍。 这可能会产生对该产品的需求。
此外,根据CDC 2020年6月的统计数据,2020年美国约有1200万40岁以上的人患有视力障碍。 因此,该地区视力障碍的高发率增加了眼科手术的数量,这进一步导致了对角膜植入物的需求增加。
因此,在预测期内,上述所有因素都有望提振该地区的市场。
由于多个区域和全球市场参与者的存在,角膜植入物市场高度分散。 这些参与者专注于增长战略,例如新产品发布、现有产品创新和併购。 一些市场参与者也专注于为人眼提供角膜,重点是眼球捐赠。 在全球市场上运营的主要参与者包括 CorneaGen、CorNeat Vision、Aurolab、KERAMED Inc. 和 Price Vision Group。
The corneal implants market is projected to register a CAGR of 6.1% during the forecast period.
The rapid emergence of the COVID-19 pandemic has had a significant impact on ophthalmic surgery across the globe. The suspension of elective procedures during the pandemic reduced the number of patients undergoing ophthalmic surgery globally, as ophthalmic procedures are considered elective procedures. Also, in March 2020, CMS recommended the cancellation of elective surgery as part of the national response to COVID-19. Moreover, in March 2020, the AAO released practice guidelines advising ophthalmologists to cease providing any treatment other than urgent and emergent care. Moreover, as per August 2021 published by the International Journal of Environmental Research and Public Health, no rebound effect was observed once the pandemic restrictions were eased. Simultaneous bilateral cataract surgeries (SBCS) constituted 6.5% of cataract procedures performed in April 2021 and May 2021 compared with 0.77% carried out between May 2019 and March 2021. Hence, the COVID-19 pandemic impacted the market at the initial stages of the pandemic but then started to cover significantly as the COVID-19 cases started to subside.
The market growth can be largely attributed to the factors such as technological advancements in corneal implants, the increasing prevalence of the geriatric population, and growing incidences of eye disorders worldwide. These factors are leading to a huge demand for corneal implants in healthcare facilities. The geriatric population is prone to suffer from Fuchs' dystrophy which is treated with endothelial keratoplasty (EK). According to a March 2020 article published in Progress in Retinal and Eye Research, the late-onset form of Fuchs' endothelial dystrophy is a common condition, affecting approximately 4% of people above 40 years of age in United States. In addition, bullous keratopathy is the most common condition among older people who undergo cataract surgery. Such patients are recommended to undergo an EK procedure. Moreover, as per the World Population Ageing 2022 report by the UN, the share of the global population aged 65 years or above is projected to rise from 10% in 2022 to 16% in 2050. By 2050, the number of persons aged 65 years or over worldwide is projected to be more than twice the number of children under age 5 and about the same as the number of children under age 12. Thus, the increase in the geriatric population will fuel overall market growth.
Moreover, the demand for collagen-based artificial corneas is increasing owing to their biocompatibility and low cost which has led to the development of bio-engineered artificial corneas. In addition, increased R&D activities in this area are contributing to market growth. For instance, in July 2020, CorNeat Vision developed an easily implantable and affordable artificial cornea, CorNeat KPro. The CorNeat KPro has been designed to replace scarred, deformed, or opacified corneas and is anticipated to fully and immediately rehabilitate the vision of corneally blind patients. The product is expected to achieve CE marking and US FDA clearance in 2022. Also, in June 2021, Israeli ophthalmology startup, EyeOn Medical, received a CE Mark for its flagship product EndoArt, the world's first synthetic corneal implant designed to counteract corneal edema. Thus, the aforementioned technological developments are contributing to the rising demand for corneal implants.
Also, due to the growing incidence of eye disorders worldwide, there is a huge demand for corneal implants. Corneal implants are used in the treatment of keratoconus, corneal opacity, corneal blindness, and other eye disorders. As per the 2020 statistics by the Cornea Research Foundation of America, 50 to 200 out of every 100,000 people in the general population were affected by keratoconus disorder in 2020. This indicates that an increase in several people suffering from keratoconus disorder is expected to increase the demand for corneal implants. In addition, as per the 2020 statistics by the RNIB, an estimated number of 4.1 million people in United Kingdom will be affected by blindness by 2050. Furthermore, as per the WHO statistics of 2021, globally, approximately 2.2 billion people had near or distant vision impairment and 4.2 million people had corneal opacities in 2020. Such a huge number indicates a high demand for corneal implants. Thus, all the above-mentioned factors are currently augmenting the growth of the corneal implant market.
However, the high costs of surgical procedures and ophthalmic devices and the availability of alternative treatments are some of the factors impeding the market growth.
The major factors attributed to the growth of invasive keratoplasty are the increasing number of people suffering from eye-ball injuries and eye disorders. Penetrating keratoplasty procedures are performed to treat patients suffering from eye disorders such as corneal ulcers and infectious keratitis. In addition, penetrating keratoplasty (PKP) is preferred for treating ectatic corneal disease and has been the standard procedure for the treatment of keratoconus patients with remarkable optical and visual outcomes for keratoconus patients that are contact lens intolerant or have corrected visual acuity.
Moreover, an increasing number of penetrating keratoplasty procedures indicates the rising demand for corneal implants. According to the 2021 Eye Banking Statistical Report by the EBAA, the total number of United States-supplied tissue distributed for keratoplasty (including long-term preserved tissue) was 79,641, a 20.2% increase from 66,278 in 2020. 49,110 intermediate-term preserved corneas were transplanted in United States, and 22,928 were exported internationally in 2021. As per the same source, the number of penetrating keratoplasty (PK) grafts in United States was 16,269 (a 5.6% increase), while EK numbers increased by 15.3% to 30,098. Hence, the increasing number of penetrating keratoplasty surgeries indicates the rising demand for corneal implants. Thus, given the above-mentioned factors, the segment is anticipated to grow significantly during the forecast period.
Within North America, United States has held the major share of the market and is expected to dominate during the forecast period. The increasing awareness about eye donation in the region and the presence of several organizations are a few of the major factors accounting for the growth of the market in the region. For instance, the EBAA celebrates eye donation month each November to raise awareness about cornea donation and transplantation. Such initiatives are likely to increase the number of eye surgeries performed in the country.
Additionally, the increasing prevalence of keratoconus is expected to increase the demand for corneal implants, which is expected to boost the growth of the market during the forecast period. For instance, according to the EBAA 2021 report, keratoconus affects one in every 2,000 Americans. It generally manifests early in life and is most prevalent among teenagers and adults. This is likely to create demand for the product.
Moreover, as per the June 2020 statistics by the CDC, approximately 12 million people aged 40 years and above suffered from vision impairment in United States in 2020. Thus, the high prevalence of vision impairment in the region has boosted the number of ophthalmic surgeries that further contribute to the rising demand for corneal implants.
Thus, all the aforementioned factors are expected to boost the market in the region during the forecast period.
The corneal implants market is highly fragmented due to the presence of several regional and global market players. These players focus on growth strategies such as new product launches, innovations in existing products, and mergers and acquisitions. Some of the market players are also focusing on the provision of human eye corneas while maintaining a focus on eye donations. Key players operating in the global market are CorneaGen, CorNeat Vision, Aurolab, KERAMED Inc., and Price Vision Group, among others.