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儿科医疗器械全球市场规模、份额、行业趋势分析报告(按产品、最终用户(医院、诊所、门诊手术中心等))、区域展望和预测,2022-2028 年Global Pediatric Medical Devices Market Size, Share & Industry Trends Analysis Report By Product, By End User (Hospitals, Clinics, Ambulatory Surgery Centers and Others), By Regional Outlook and Forecast, 2022 - 2028 |
到 2028 年,全球儿科医疗器械市场规模预计将达到 420 亿美元,预测期内復合年增长率为 7.0%。
法规的进步和法律的发展正在推动儿科医疗器械的发展,其影响也体现在产品开发上。 因此,FDA 每年都会收到许多医疗器械申请。 例如,在 2018 年之前,只有大尺寸瓣膜可用于心臟手术,通常不适合儿童心臟。 但允许外科医生治愈需要二尖瓣或主动脉瓣置换术的婴儿和新生儿的最小设备已于 2018 年获得美国 FDA 批准,作为 15 毫米尺寸的旋转人工心臟瓣膜。
联合国儿童基金会报告称,每年有近 70 万五岁以下儿童死于肺炎,比其他任何传染病都多。 此外,监管力度、全球范围内越来越多的儿科医院、儿科医疗设备的技术进步以及越来越多的家长意识活动都在增加。 市场领导者正在推出具有增强功能的新产品。 例如,美敦力 (Medtronic) 宣布推出一款新的儿科监护仪,当患者呼吸时气道可能被阻塞时,该监护仪会向医护人员发出警报。
COVID-19 影响分析
FDA 已协助希望专门配置这些设备以满足儿科患者需求的讚助商。 例如,FDA 已批准 EUA 用于提供连续肾臟替代疗法的设备,用于低血容量、急性肾功能衰竭、液体超负荷或两者兼而有之的患者。 这些患者在急性护理中不能耐受更大的 CPB 量,体重在 8 到 20 公斤之间。 儘管发生了 COVID-19 大流行,但 FDA 强调牢记儿科患者的需求是多么重要。 因此,COVID-19大流行对儿科医疗器械市场产生了积极影响。
市场增长因素
儿童呼吸道疾病和癌症发病率上升
根据美国儿科学会的数据,到 2023 年 2 月,美国将有 1540 万儿童的 COVID-19 检测呈阳性。 因此,儿科医疗器械市场的扩张受到儿童癌症和呼吸系统疾病发病率增加的推动。 早产儿的增加也是推动这个行业扩张的重要因素。 所有这些因素都在推动未来几年市场的增长。
出生率上升和 NICU 利用率
许多孩子一出生就需要 NICU 设施。 由于早产、分娩困难或产后健康问题,需要 NICU 护理的儿童通常会在出生后 24 小时内被转移。 妊娠 37 週之前出生的婴儿被认为是早产儿。 据说早产儿容易患肺炎和败血症等疾病。 因此,市场进入者正在推出一系列设备,以扩大新生儿 ICU 的产品范围。 因此,不断上升的生育率和 NICU 设施正在推动市场的扩张。
市场製约因素
缺乏临床试验,器械製造存在问题
如果儿科医疗设备出现故障,则损害製造商声誉的风险可能过高,企业无法承受。 即使失败率很低,并且父母和看护人不会错过期望孩子受益的机会,这种风险也可能成为市场准入的重大障碍。 儿科成像、筛查和呼吸器在新兴市场不太常见。 因此,领先的公司希望在预测期内提高他们的市场知名度。 然而,预测期内市场认知度低将影响市场总需求。 所有这些因素都极大地制约了市场的增长。
产品展望
儿科医疗设备市场根据产品细分为心脏病设备、体外诊断 (IVD) 设备、成像设备、麻醉和呼吸护理设备、新生儿 ICU 设备等。 2021年,新生儿ICU设备板块在儿科医疗设备市场实现了大幅增长。 由于小婴儿的特殊需要,新生儿重症监护病房 (NICU) 使用了复杂的仪器和设备。 对 NICU 需求的增加解释了这一细分市场的扩张。 NICU 中经常使用的设备包括心臟或心肺监护仪、血压监护仪、温度监护仪和脉搏血氧仪。
最终用户视角
按最终用户划分,儿科医疗器械市场分为医院、诊所、门诊手术中心等。 在2021年的儿科医疗器械市场中,诊所板块将占据较大的收入份额。 此类诊所主要致力于为儿童提供护理这一事实可能是造成这一增长的原因。 儿科诊所提供有关儿童和青少年健康状况的最新临床知识。 儿科诊所提供有关儿童和青少年健康状况的最新临床知识,并提供广泛的解决方案以确保儿童的健康成长。 我们还提供全面的时间表,包括体检、疫苗接种和儿童发育。
区域展望
按地区划分,将儿科医疗器械市场分为北美、欧洲、亚太地区和 LAMEA 进行分析。 2021 年,北美市场在儿科医疗器械市场的收入份额最大。 先进的医疗设备和白血病、哮喘、癌症和先天性心脏病等儿童慢性病患病率上升正在推动该地区的市场扩张。 根据美国疾病控制与预防中心 (CDC) 的数据,在美国,超过 40% 的在校青少年和儿童至少患有一种慢性病。
The Global Pediatric Medical Devices Market size is expected to reach $42 billion by 2028, rising at a market growth of 7.0% CAGR during the forecast period.
Medical equipment or tools used to diagnose or treat illnesses and problems in children under the age of 21 are referred to as pediatric devices. Infants, children, and adolescents are the focus of the medical specialty known as pediatrics, which deals with their health and medical care. Since children are more active and physically smaller than adults, these medical devices are built specifically with their needs in mind.
One of the main factors propelling the growth of the pediatric medical devices market is the increase in the prevalence of chronic diseases and infectious diseases among the pediatric population. The demand for pediatric medical devices is also influenced by the increased demand for anesthetic and respiratory equipment due to their efficiency in treating conditions like asthma and the rising occurrence of preterm births worldwide. Additionally, in recent times technical developments and new product launches in the field has grown significantly owing to the high demand.
Regulatory and legislative developments have aided in the development of pediatric medical devices, effects of which are also seen in the development of products. As a result, the FDA receives a number of applications for medical devices each year. For example, prior to 2018, only larger-sized valves could be utilized for heart surgery, which is frequently inappropriate for children's hearts. However, the tiniest device that enables surgeons to heal infants and neonates needing mitral or aortic valve replacement was approved by the U.S. FDA in 2018 and is a rotatable prosthetic mechanical heart valve of size 15 mm.
According to a UNICEF report, approximately 700,000 children under the age of five die from pneumonia each year, surpassing any other infectious ailment. Additionally, there have been more regulatory organization initiatives, more pediatric hospitals worldwide, technological advancements in pediatric equipment, and expanding parental awareness campaigns. The biggest players in the market have introduced new goods with enhanced capabilities. For example, Medtronic introduced a new pediatric monitor that warns medical professionals when a patient's airways might be blocked during breathing.
COVID-19 Impact Analysis
The FDA supported sponsors who wanted to make sure that these devices were set up to specifically cater to pediatric patients' needs. For instance, the FDA granted a EUA for a device that delivers continuous renal replacement treatment and can be used in patients with lower blood volumes or those with acute renal failure, fluid overload, or both. These patients were unable withstand a greater extracorporeal circuit volume in an acute care setting and weigh 8 to 20 kilograms. Despite the COVID-19 outbreak, the FDA emphasized how crucial it is to keep in mind the needs of pediatric patients. Therefore, the COVID-19 pandemic had a favorable impact on the pediatric medical devices market.
Market Growth Factors
Rising respiratory disorder and cancer incidences in children
According to the American Academy of Pediatrics, 15.4 million kids in the US tested COVID-19 positive in February 2023. As a result, the expansion of the pediatric medical devices market is driven by the increasing frequency of cancer and respiratory disorders among children. In addition, the rise in the number of premature babies is another important element driving the expansion of this industry. All these factors are promoting the growth of the market in the coming years.
Increasing birth rate and NICU availability
Many children require NICU facilities upon birth. Children who need NICU care are typically transferred there within 24 hours of birth due to difficulties during early birth, delivery, or health problems following birth. If a child is born before 37 weeks of pregnancy, it is considered preterm. Premature babies are more vulnerable to conditions like pneumonia, sepsis, etc. As a result, market participants have launched a number of devices that would broaden the selection of goods accessible in the neonatal ICU. Hence, the increasing birth rate and NICU devices are promoting the expansion of the market.
Market Restraining Factors
Lack of clinical trials and problems in device manufacture
The danger to a manufacturer's reputation when pediatric medical devices malfunction may be too high for the business to bear. Even if the failure rate is low and parents or other carers are ready to take the chance in the hopes that their kid will benefit, this risk might acts as a significant barrier to entry into the market. In emerging markets, pediatric imaging, screening, and respiratory equipment are less common. Therefore, the leading players are raising the market's profile during the forecast period. However, the lack of market awareness during the forecast period impacts the market's total demand. All these factors significantly hamper the growth of the market.
Product Outlook
Based on product, the pediatric medical devices market is categorized into cardiology devices, in vitro diagnostic (IVD) devices, diagnostic imaging devices, anesthesia & respiratory care devices, neonatal ICU devices, and others. The neonatal ICU devices segment procured a considerable growth rate in the pediatric medical devices market in 2021. For the special requirements of little infants, complicated instruments and devices are used in neonatal intensive care units (NICUs). The increasing demand for NICU are accountable for the expansion of the segment. Heart or cardiorespiratory monitors, blood pressure monitors, temperature monitors, and pulse oximeters are a few of the instruments frequently utilized in the NICU.
End User Outlook
On the basis of end user, the pediatric medical devices market is divided into hospitals, clinics, ambulatory surgical centers, and others. The clinics segment witnessed a significant revenue share in the pediatric medical devices market in 2021. The fact that such clinics are primarily devoted to providing care for children can be accountable for the increase. The pediatric clinics offer the most recent clinical knowledge on children's and adolescents' health conditions. It provides a broad range of solutions to guarantee a child's healthy upbringing. These clinics also offer a comprehensive schedule of check-ups, vaccines, and a child's general growth.
Regional Outlook
Based on region, the pediatric medical devices market is analyzed across North America, Europe, Asia Pacific, and LAMEA. The North America segment garnered the maximum revenue share in the pediatric medical devices market in 2021. Advanced medical equipment and the rising prevalence of pediatric chronic disorders such as leukemia, asthma, cancer, and congenital heart disease are driving the market's expansion in this region. In America, more than 40% of adolescents and children in school have at least one chronic condition, according to figures from the Centers for Disease Control and Prevention (CDC).
The market research report covers the analysis of key stake holders of the market. Key companies profiled in the report include Medtronic PLC, Abbott Laboratories, Cardinal Health, Inc., GE HealthCare Technologies, Inc., Hamilton Medical AG (Hamilton Bonaduz AG), TSE spol. s.r.o. (TSE Medical), Fritz Stephan GmbH, Phoenix Medical Systems Pvt. Ltd., Trimpeks, and Atom Medical Corporation.
Strategies Deployed in Pediatric Medical Devices Market
Sep-2022: Medtronic received an expanded FDA clearance for pediatric use of the LINQ II system, a wireless, small Insertable Cardiac Monitor system. The broadened indication consists of children aged two years and above, who have heart rhythm abnormalities and need continuous monitoring for a long period.
Apr-2022: Cardinal Health collaborated with Innara Health, a company engaged in feeding development for newborns and infants born prematurely. Under this collaboration, both companies would redesign the Ntrainer system. The Ntrainer system is an FDA-approved medical device for better prefeeding skills in newborns and preterm infants. Additionally, Cardinal Health would support the development and commercialization of the next-generation NTrainer.
Feb-2022: Medtronic plc got FDA approval for Freezor™ and Freezor™ Xtra Cardiac Cryoablation Focal Catheters, an ablation catheter to treat the growing prevalence of pediatric Atrioventricular Nodal Reentrant Tachycardia. The products are single-use, flexible devices used to block unnecessary electrical signals and freeze cardiac tissue within the heart.
May-2021: Medtronic introduced SonarMed™ airway monitoring system, a device that utilizes acoustic technology to check for endotracheal tube obstruction and confirm position at the same time, delivering clinicians critical information needed to make a better decision for the smallest patients. Additionally, the product is an FDA-approved airway monitoring system that delivers in-time notifications and particular measurements that help allow a structured response to address possible vital events including migration and ETT movement.
Dec-2020: Medtronic unveiled Carpedim, a cardio-renal pediatric dialysis emergency machine, across the United States. The Carpedim machine would deliver continuous renal replacement therapy (CRRT) to patients between 2.5 kg and 10 kg. Moreover, the product is intended to address challenges associated with current machines for neonatal patients.
Jan-2019: Abbott got FDA approval for The Amplatzer Piccolo Occluder, a medical device that can be implanted in babies weighing as little as 700 gm. The product's size is smaller than a pea, which provides hope to premature newborns and infants for corrective treatment. Moreover, the product is created to enable the physician to place it through the pulmonary or aortic artery and also to redeploy or retrieve the device for ideal placement.
Mar-2018: Abott got FDA approval for the Masters HPTM 15mm rotatable mechanical heart valve, the world's smallest mechanical heart valve. The Masters HPTM 15mm rotatable mechanical heart valve would allow doctors to treat toddlers and babies in need of aortic or mitral valve replacement.
Market Segments covered in the Report:
By Product
By End User
By Geography
Companies Profiled
Unique Offerings from KBV Research
List of Figures