市場調查報告書
商品編碼
1245528
兒科醫療器械全球市場規模、份額、行業趨勢分析報告(按產品、最終用戶(醫院、診所、門診手術中心等))、區域展望和預測,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,全球兒科醫療器械市場規模預計將達到 420 億美元,預測期內復合年增長率為 7.0%。
法規的進步和法律的發展正在推動兒科醫療器械的發展,其影響也體現在產品開發上。 因此,FDA 每年都會收到許多醫療器械申請。 例如,在 2018 年之前,只有大尺寸瓣膜可用於心臟手術,通常不適合兒童心臟。 但允許外科醫生治愈需要二尖瓣或主動脈瓣置換術的嬰兒和新生兒的最小設備已於 2018 年獲得美國 FDA 批准,作為 15 毫米尺寸的旋轉人工心臟瓣膜。
聯合國兒童基金會報告稱,每年有近 70 萬五歲以下兒童死於肺炎,比其他任何傳染病都多。 此外,監管力度、全球範圍內越來越多的兒科醫院、兒科醫療設備的技術進步以及越來越多的家長意識活動都在增加。 市場領導者正在推出具有增強功能的新產品。 例如,美敦力 (Medtronic) 宣布推出一款新的兒科監護儀,當患者呼吸時氣道可能被阻塞時,該監護儀會向醫護人員發出警報。
COVID-19 影響分析
FDA 已協助希望專門配置這些設備以滿足兒科患者需求的讚助商。 例如,FDA 已批准 EUA 用於提供連續腎臟替代療法的設備,用於低血容量、急性腎功能衰竭、液體超負荷或兩者兼而有之的患者。 這些患者在急性護理中不能耐受更大的 CPB 量,體重在 8 到 20 公斤之間。 儘管發生了 COVID-19 大流行,但 FDA 強調牢記兒科患者的需求是多麼重要。 因此,COVID-19大流行對兒科醫療器械市場產生了積極影響。
市場增長因素
兒童呼吸道疾病和癌症發病率上升
根據美國兒科學會的數據,到 2023 年 2 月,美國將有 1540 萬兒童的 COVID-19 檢測呈陽性。 因此,兒科醫療器械市場的擴張受到兒童癌症和呼吸系統疾病發病率增加的推動。 早產兒的增加也是推動這個行業擴張的重要因素。 所有這些因素都在推動未來幾年市場的增長。
出生率上升和 NICU 利用率
許多孩子一出生就需要 NICU 設施。 由於早產、分娩困難或產後健康問題,需要 NICU 護理的兒童通常會在出生後 24 小時內被轉移。 妊娠 37 週之前出生的嬰兒被認為是早產兒。 據說早產兒容易患肺炎和敗血症等疾病。 因此,市場進入者正在推出一系列設備,以擴大新生兒 ICU 的產品範圍。 因此,不斷上升的生育率和 NICU 設施正在推動市場的擴張。
市場製約因素
缺乏臨床試驗,器械製造存在問題
如果兒科醫療設備出現故障,則損害製造商聲譽的風險可能過高,企業無法承受。 即使失敗率很低,並且父母和看護人不會錯過期望孩子受益的機會,這種風險也可能成為市場准入的重大障礙。 兒科成像、篩查和呼吸器在新興市場不太常見。 因此,領先的公司希望在預測期內提高他們的市場知名度。 然而,預測期內市場認知度低將影響市場總需求。 所有這些因素都極大地制約了市場的增長。
產品展望
兒科醫療設備市場根據產品細分為心髒病設備、體外診斷 (IVD) 設備、成像設備、麻醉和呼吸護理設備、新生兒 ICU 設備等。 2021年,新生兒ICU設備板塊在兒科醫療設備市場實現了大幅增長。 由於小嬰兒的特殊需要,新生兒重症監護病房 (NICU) 使用了複雜的儀器和設備。 對 NICU 需求的增加解釋了這一細分市場的擴張。 NICU 中經常使用的設備包括心臟或心肺監護儀、血壓監護儀、溫度監護儀和脈搏血氧儀。
最終用戶視角
按最終用戶劃分,兒科醫療器械市場分為醫院、診所、門診手術中心等。 在2021年的兒科醫療器械市場中,診所板塊將佔據較大的收入份額。 此類診所主要致力於為兒童提供護理這一事實可能是造成這一增長的原因。 兒科診所提供有關兒童和青少年健康狀況的最新臨床知識。 兒科診所提供有關兒童和青少年健康狀況的最新臨床知識,並提供廣泛的解決方案以確保兒童的健康成長。 我們還提供全面的時間表,包括體檢、疫苗接種和兒童發育。
區域展望
按地區劃分,將兒科醫療器械市場分為北美、歐洲、亞太地區和 LAMEA 進行分析。 2021 年,北美市場在兒科醫療器械市場的收入份額最大。 先進的醫療設備和白血病、哮喘、癌症和先天性心髒病等兒童慢性病患病率上升正在推動該地區的市場擴張。 根據美國疾病控制與預防中心 (CDC) 的數據,在美國,超過 40% 的在校青少年和兒童至少患有一種慢性病。
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