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子宮マニピュレーション機器の世界市場-2023年~2030年Global Uterine Manipulation Devices Market - 2023-2030 |
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子宮マニピュレーション機器の世界市場-2023年~2030年 |
出版日: 2023年09月06日
発行: DataM Intelligence
ページ情報: 英文 195 Pages
納期: 約2営業日
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子宮マニピュレーション機器の世界市場は、2022年に2億7,040万米ドルに達し、2023-2030年の予測期間中にCAGR 5.9%で成長し、2030年には4億2,510万米ドルに達すると予測されています。
世界の子宮マニピュレーション機器市場を押し上げると予想される主な要因には、女性生殖器系に関連する障害の増加、技術進歩の高まり、低侵襲手術アプローチに対する需要の高まりなどがあります。女性生殖系に関連する代表的な疾患には、子宮頸がん、子宮筋腫、子宮内膜症、多嚢胞性卵巣症候群、間質性細胞症などがあります。
世界保健機関(WHO)によると、2022年2月、子宮頸がんは世界で4番目に典型的ながんと診断され、2020年には604,000人の最近の患者と342,000人以上の死亡が推定されています。2020年における最近の患者数と死亡者数の約90%は、低・中所得国で発生しています。HPV感染は、年間530,000人の子宮頸がん患者と264,000人以上の子宮頸がん死亡の原因であると推定されています。
マッカートニー腟チューブを含む腹腔鏡下女性生殖器外科手術の際の手術成績を高めるために、子宮マニピュレーターの混合物が設計されています。一般的に利用されている子宮マニピュレーション機器には、スポンジスティック、EEAサイザー、ZUMI/HUMI、K-UMIデバイス、Advincula Arch、The RUMI II System、ClearView、Advincula Delineator、V-Careなどがあり、これらは市販または開発中です。
婦人科疾患の増加
女性の生殖器系に関連する代表的な疾患には、子宮頸がん、子宮筋腫、子宮内膜症、多嚢胞性卵巣症候群、間質性細胞症などがあります。上記の疾患の症例数の増加が、予測期間中の世界市場の成長を促進すると予想されます。例えば、National Cancer Registry Programmeによると、乳がんと子宮頸がんは女性に診断されるがんの代表的なものです。子宮頸がんは、インドにおける女性のがん全体の6~29%を占めています。
また、WHOによると、子宮内膜症は、世界中の生殖年齢にある女性と女児の約10%(1億9000万人)に影響を与えています。さらに、PCOSは公衆衛生上の重要な問題であり、生殖年齢の女性に影響を及ぼすホルモン疾患の中で最も一般的に診断されるものひとつです。この疾患は、生殖年齢の女性の8~13%に影響すると推定され、患者の約70%は診断されていません。
さらに、2021年9月から2022年2月にかけて中国南京市の南京医科大学付属病院で実施された横断研究によると、サンプル数は18~52歳の女性977人でした。婦人科疾患では、月経困難症が45.96%を占め、次いで多嚢胞性卵巣症候群(PCOS)が19.04%、子宮筋腫が14.23%、自然流産が13.20%、妊娠困難症が12.59%、卵巣機能不全が11.16%、子宮内膜症が4.09%でした。
高まる女性の健康への取り組み
女性の生殖に関する意識を高め、健康をサポートする取り組みが増加していることも、予測期間中の世界市場の成長を後押ししています。例えば、2022年3月、認知度を高め、教育を後押しし、子宮内膜症研究を支援することにコミットしている非営利団体であるEndometriosis Foundation of America, Inc.は、腹膜子宮内膜症や痛み、より深刻な衰弱状態とその決定的な治療法を含む患者の日を記念して、いくつかの週末の仮想イベントを開催しました。この媒体は、個人が他の人と参加し、自分の状態を理解し、自己体験を共有するのを助けるために開発されました。
さらに、FDA女性健康局は、NIH女性健康調査室と提携し、年齢、人種、民族的背景、健康上の必要性など、さまざまな女性が臨床試験に参加することに関する認識を高めています。さらに、2021年2月から2024年1月までの3年間のプロジェクトであるPRESCRIP-TEC(Prevention and Screening Innovation Project Toward Elimination of Cervical Cancer)は、バングラデシュ、インド、ウガンダ、スロバキアの資源に乏しい、あるいは手が届きにくい環境における子宮頸がん診断の普及を改善することに調査を集中しています。
高まる研究活動
明確な子宮筋腫における子宮マニピュレーターの安全性を高めるための研究活動の増加が、世界市場の成長を後押ししています。例えば、2022年1月には、「後天性子宮筋膜仮性動脈瘤の超音波イメージング」という調査が行われました:The Role of Manipulators as an Unusual Cause during Laparoscopic Surgery"(腹腔鏡手術中の異常な原因としてのマニピュレーターの役割)により、婦人科手術におけるClearView Uterine Manipulator, 7 cm tipの承認結果が示され、手術中に安全に使用できることが示されました。
さらに2023年6月、Universitat Jaume Iのバイオメカニクス・人間工学研究機関のアソシアシオンRUVID研究者、カステッロ総合病院腹骨盤腫瘍外科紹介ユニット(UR-COAP)、フィサビオ財団は、低侵襲婦人科手術用の無外傷子宮マニピュレーターを設計しました。最初の腫瘍への傷害を回避し、子宮の操作による害を低減し、潜在的な発がん物質の移動を減少させることが評価されました。
不適切な使用による合併症
子宮マニピュレーターの利点にもかかわらず、子宮マニピュレーターの使用に危険がないわけではありません。子宮マニピュレーターの不適切な使用や設置は、子宮や子宮周囲の組織の損傷を引き起こし、出血や感染症などの複雑な事態を引き起こす可能性があります。腹腔鏡子宮マニピュレーターが正確に設置されていなかったり、マニピュレーター操作中に広範囲に圧力がかかりすぎたりすると、子宮穿孔の可能性があります。これは出血や隣接臓器の損傷につながる可能性があります。
また、腹腔鏡子宮マニピュレーターを使用する前に適切な滅菌を行わないと、その部位に感染を起こす危険性があります。これは術後感染の原因となり、さらなる治療が必要となることもあります。腹腔鏡下子宮マニピュレーターによる子宮の操作は、特に子宮筋腫やその他の子宮異常がある場合、出血を誘発することがあります。このような複雑な事態は、骨盤がすぐに見える状態で子宮内にマニピュレーターを適切に挿入することで回避できます。
外科専門医の不足
産婦人科医の需要と供給のギャップが拡大しているため、予測期間中の市場成長は鈍化すると予想されます。例えば、March of Dimesによると、米国では220万人以上の出産適齢期の女性が「マタニティ・ケア・デザート」に住んでおり、約690万人が婦人科ヘルスケアへのアクセスが十分でないか、全くない状況にあります。米国の半数の国には産婦人科がありません。
さらに、米国保健社会福祉省は2021年に、産婦人科医の数が50,850人から47,490人(7%)に減少すると推定しているが、2030年までに必要数は50,850人から52,660人(4%)に増加すると推定しています。さらに、米国医科大学協会(AAMC)は、2032年までに約12万2,000人の医師が不足すると推定しており、産婦人科医も例外ではありません。米国医科大学協会による2023年の初期データでは、産婦人科レジデンスプログラム1つあたりの適度な応募者数は、2022年の663人から2023年には650人に減少しています。
Global Uterine Manipulation Devices Market reached US$ 270.4 million in 2022 and is expected to reach US$ 425.1 million by 2030, growing with a CAGR of 5.9% during the forecast period 2023-2030.
The primary factors expected to boost the global uterine manipulation devices market include the growing disorders associated with the female reproductive system, rising technological advancements, and growing demand for minimally invasive surgical approaches. Typical disorders associated with the female reproductive system includes cervical cancer, uterine fibroids, endometriosis, polycystic ovary syndrome, and interstitial cytosis, among others.
According to World Health Organization, in February 2022, cervical cancer was the fourth highly typical cancer diagnosed in females globally, with an assesed 604,000 recent patients and over 342,000 deaths in 2020. Approximately 90% of the recent cases and deaths worldwide in 2020 surfaced in low- and middle-income nations. The HPV infection is accountable for an assessed 530 000 cases of cervical cancer and over 264 000 cervical cancer deaths annually.
A mixture of uterine manipulators has been designed to enhance surgical performance during laparoscopic female reproductive system surgical procedures, including the McCartney vaginal tube. The commonly utilized uterine manipulation devices include sponge stick, EEA sizer, ZUMI/HUMI, and K-UMI devices, Advincula Arch, The RUMI II System, ClearView, Advincula Delineator, and V-Care, among others available on the market or under development.
Growing Cases of Gynecological Disorders
Typical disorders associated with the female reproductive system include cervical cancer, uterine fibroids, endometriosis, polycystic ovary syndrome, and interstitial cytosis, among others. The growing cases of the abovementioned disorders are expected to drive global market growth during the forecast period. For instance, according to the National Cancer Registry Programme, the cancer of breast and cervix uteri was the highly typical cancer diagnosed in females. Cervical cancer makes up for 6-29% of all cancers among females in India.
Also, according to the WHO, Endometriosis impacts approximately 10% (190 million) of reproductive-age women and girls worldwide. Moreover, PCOS is a significant public health problem and is among the most commonly diagnosed hormonal disorders impacting females of reproductive age. The disorder impacts an assessed 8-13% of females of reproductive age, and around 70% of patients are undiagnosed.
Moreover, according to a cross-sectional study conducted at a hospital affiliated with Nanjing medical university in Nanjing, China between September 2021 and February 2022, with a sample size of 977 women aged 18-52 years. The highly predominant gynecological condition was dysmenorrhea with 45.96% of cases, heeded by polycystic ovary syndrome, PCOS accounting for 19.04% of cases, uterine fibroids with 14.23% of cases, spontaneous abortion with 13.20% of cases, 12.59% cases of trouble conceiving, ovarian dysfunction accounting for 11.16% cases and endometriosis accounting for 4.09% of cases.
Increasing Female Health Initiatives
The increasing initiatives to promote awareness and support female reproduction health also drive the global market growth during the forecast period. For instance, in March 2022, the Endometriosis Foundation of America, Inc., a non-profit organization committed to increasing awareness, boosting education, and supporting endometriosis research hosted several weekends of virtual events to mark Patient Day, including peritoneal endometriosis and pain and more serious debilitating condition and its conclusive therapy. This medium is developed to assist individuals to join with others, understand their condition, and share their self-experiences.
Moreover, the FDA Office of Women's Health partnered with the NIH Office of Research on Women's Health to increase awareness regarding various females of distinct ages, races, ethnic backgrounds, and health necessities partaking in clinical trials. Further, the Prevention and Screening Innovation Project Toward Elimination of Cervical Cancer (PRESCRIP-TEC), a three-year project from February 2021 - January 2024 concentrates its investigation on improving the adoption of cervical cancer diagnoses in resource-poor or hard-to-reach environments of Bangladesh, India, Uganda and Slovakia.
Growing Research Activities
The increasing research activities to increase the saftey of uterine manipulators in distinct uterine sugeries are boosting the global market growth. For instance, in January 2022, the investigation "Ultrasound Imaging of Acquired Myometrial Pseudoaneurysm: The Role of Manipulators as an Unusual Cause during Laparoscopic Surgery" demonstrated approving outcomes for ClearView Uterine Manipulator, 7 cm tip in gynecological surgery, exhibiting that they are secure to be utilized during surgical operations.
Moreover, in June 2023, the Asociacion RUVID Researchers from the Biomechanics and Ergonomics research body of the Universitat Jaume I, the Abdomino-Pelvic Oncology Surgery Referral Unit (UR-COAP) of the General University Hospital of Castello and the Fisabio Foundation have designed an atraumatic uterine manipulator for minimally invasive gynecological procedures. Assessed to avert injury to the initial tumor, lower the harm done by manipulating the uterus and decrease the potential migration of potential carcinogens.
Complications Induced by Inapropriate Use
Despite the benefits offered by uterine manipulators, the use of uterine manipulators is not without hazards. Inappropriate usage or placement of the manipulator can provoke damage to the uterus or encompassing tissues and may direct intricacies like bleeding or infection. There is a chance of uterine perforation in the case if laparoscopic uterine manipulator is not placed accurately or too extensive pressure is applied during manipulation. This can guide to bleeding or damage to adjacent organs.
Also, there is a peril of infection at the site if the laparoscopic uterine manipulator is not sterilized properly prior to use. This can lead to postoperative infection, which may need further treatment. The manipulation of the uterus with the laparoscopic uterine manipulator can induce bleeding, particularly if there are fibroids or other uterine anomalies present. These sorts of intricacies can be averted by the appropriate application manipulator into the uterus underneath immediate pelvic visualization.
Lack of Surgical Specialists
The increasing gap in the demand and supply of Obstetricians and Gynecologists is expected to slow the market growth in the forecast period. For instance, according to the March of Dimes, over 2.2 million U.S. females of childbearing age living in "maternity care deserts," and around 6.9 million have undersized or no access to gynecological healthcare. Half of the nations in the United States do not have any obstetrics and gynecology (OB/GYN) establsihments.
Moreover, the U.S. Department of Health and Human Services in 2021, estimated that the number of OB-GYNs to drop from 50,850 to 47,490 (7%), however the need is estimated to grow from 50,850 to 52,660 (4%) by 2030. Further, the Association of American Medical Colleges (AAMC) estimated a shortage of around 122,000 medics by 2032, and OB/GYN is no anomaly. The initial 2023 data from the American Association of Medical Colleges discloses that the moderate number of applications per obstetrics and gynecology residence program dropped from 663 in 2022 to 650 in 2023.
The global uterine manipulation devices market is segmented based on product type, type, application, end-user and region.
Increasing Number of Hysterectomy Procedures Conducted
Hysterectomy is surgery to extract the uterus/womb, out of the procedures specific to females, hysterectomies are the second most performed surgery in the U.S. (after cesarean sections). NIH, estimations indicate that one out of nine females will experience a hysterectomy in their lifetime and that roughly 600,000 operations are conducted annually in the United States. Moreover, according to NIH, in India, the preponderance of hysterectomy procedures was 3.2%, the highest in Andhra Pradesh (8.9%) and the lower in Assam (0.9%). Rural India had elevated a preponderance than urban India.
Further, one out of three women in the U.S. have had a hysterectomy by age 60. Therefore, the growing female geriatric population will also contribute to the segment growth in the forecast period. For instance, according to the National Statistical Office (NSO)'s Elderly in India 2021 report, India's geriatric residents (aged 60 and above) were estimated to brush 194 million in 2031 from 138 million in 2021, a 41 percent growth over a decade.
Geographical Penetration
North America Accounted for Approximately 37.1% of the Market Share in 2022 Owing to the Growing Cases of Gynecological Disorders
The growing demand for gynecological surgeries owing to increasing cases of gynecological disorders in this region. For instance, according to the American Cancer Society's 2023, estimations around 13,960 fresh cases of invasive cervical cancer are expected to be diagnosed and, over 4,310 females are expected to die from cervical cancer by the end of 2023. Moreover, according to the US Department of Health and Human Services, Endometriosis is estimated to affect over 11% of American females between 15 and 44. It is extremely typical among females in their 30s and 40s and may cause it more difficult to acquire pregnancy.
Moreover, according to CDC, PCOS is among the highly typical reasons for female infertility, impacting 6% to 12%, accounting for around 5 million US females of reproductive age. Interstitial cystitis (IC) is highly typical, the disorder is estimated to impact 3 million to 8 million women and between 1 million to 4 million men in the United States. Further, the Centers for Disease and Prevention (CDC) reports that roughly 600,000 hysterectomies are conducted in the United States annually.
Similarly, according to Behavioral Risk Factor Surveillance System (BRFSS) or the National Health Interview Survey (NHIS), analysis of growing trends in hysterectomy prevalence by age and directional differences by race and ethnicity were observed with less than 2% of women aged 20-29 years and over 4 in 10 females aged 70-79 years documented undergoing hysterectomy. Furthermore, the increasing initiatives and availability of reimbursement policies in the United States ensures the North America's uterine manipulation devices market growth in the forecast period.
For instance, the Medicare covers a doctor considered medically necessary hysterectomy. Again, the U.S. Preventive Services Task Force (USPSTF) suggests screening for cervical cancer every 3 years with a Pap test in females aged 21 to 29 years, and for women ages 30 to 65 years, a Pap test screening every 3 years with high-risk human papillomavirus (hrHPV) testing every 5 years, or every 5 years with both types of tests. Again, the NCI Cervical Cancer 'Last Mile' Initiative, a public-private collaboration getting together federal agencies, industry associates, and professional associations to contribute proof regarding the precision and clinical significance of self-sampling-based HPV testing for cervical cancer screening.
The major global players in the market include CooperSurgical Inc., MEDGYN PRODUCTS, INC., CONMED Corporation, Peters Surgical., Zhejiang Geyi Medical Instrument Co.,Ltd, Laborie, HTKD Medical, Bissinger Medizintechnik, Purple Surgical, Ningbo Xinwell Medical Technology Co., LTD., Utah Medical Products, Inc., and Panpac Medical Corp. among others.
According to an article titled, "Gynecological Surgery and COVID-19" published in July 2020, an estimated 28 million procedures were delayed or withdrawn globally because of the pandemic, forcing a hold on the diagnosis and treatment of over 2 million cancer patients. In Brazil, both the National Health Agency (ANS) and National Health Surveillance Agency (ANVISA) advised the postponement of elective and non-essential procedures, caused a significant impact on the number of surgical procedures that decreased by 33.4% in this period.
Moreover, according to a nationwide survey by the Japan Society of Obstetrics and Gynecology, the whole number of surgeries dropped from 129,648 in 2019 to 118,565 in 2020, accounting for 8.5%, for all surgical operations. Nevertheless, there was steep growth in the number of robotic procedures conducted in 2020 corresponded to that in 2019 for all inhabitants. The number of entire hysterectomies declined markedly from 15,385 in 2019 to 12,531 in 2020, a demonstrating a drop of 10.1%.
Again, earlier during the pandemic, ambulatory visitings at some medical centers in the U.S. dropped significantly, with a concurrent growth in telehealth visits. Yet, the transformation of in-person care to telemedicine care was inconsistent across experties. Procedure volumes were even dropped throughout the multiple specialties.
Surprisingly, actually volumes for some sorts of emergency department care were attenuated, including for some gynecologic disorders. COVID-19 has altered clinical and surgical approaches in benign gynecology. It has directed medics to begin employing telemedicine for gynecologic care more readily, and considerable gynecologists have continued to employ this approach of health care even when the pandemic has subsided.
By Product Type
By Type
By Application
Partial Hysterectomy
Total Hysterectomy
Radical Hysterectomy
By End-User
By Region
U.S.
Canada
Mexico
Germany
UK
France
Italy
Spain
Rest of Europe
Brazil
Argentina
Rest of South America
China
India
Japan
Australia
Rest of Asia-Pacific
The global uterine manipulation devices market report would provide approximately 61 tables, 58 figures and 186 Pages.
LIST NOT EXHAUSTIVE