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The global cranial orthoses market size is estimated to grow/decline by USD 182.2 million at a CAGR of 10.87% between 2023 and 2028. The rising incidence of cranial deformities has led to increased demand for effective medical solutions. In response, the FDA has approved a range of devices designed to address these conditions, offering new hope for patients requiring intervention. These FDA-approved devices are crafted to improve outcomes and provide safer, more reliable treatments for various cranial deformities. Additionally, favorable reimbursement conditions have been established, easing financial barriers for patients and healthcare providers alike. This supportive reimbursement environment ensures that patients have better access to necessary treatments, while healthcare professionals are incentivized to adopt these advanced technologies. Together, the combination of innovative FDA-approved devices and favorable reimbursement conditions is transforming the management of cranial deformities, ultimately enhancing patient care and treatment success.
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Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market. The report also includes detailed analyses of the competitive landscape of the market and information about key companies, including:
ARMAC, Becker Orthopedic, Bio Medic Appliances Inc., BioSculptor, Boston Orthotics and Prosthetics, Cranial Technologies Inc., Danmar Products Inc, Deccan OrthoPro, Hanger Inc., Human Designs Prosthetics and Orthotics, Invent Medical Group s.r.o, Lawall Prosthetic and Orthotic Services Inc, Leimkuehler Inc., Medicad Implants, Orthomerica Products Inc., Orthotic and Prosthetic Lab Inc, Union Orthotics and Prosthetics Co, and Westcoast Brace and Limb
Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.
The market share growth by the plagiocephaly segment will be significant during the forecast period. It involves forehead flattening or occipital flattening and is relatively more frequent - one out of every 2,000-3,000 births globally. It occurs due to the fusion of the right or left side of the coronal suture, known as coronal synostosis. This results in flattening of the forehead and sometimes even causing a different eye shape on the affected side. The most common reason is sleeping in one position known as positional plagiocephaly.
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The plagiocephaly segment was valued at USD 90.40 million in 2018. An orthotic helmet is the most common and safe means of treatment by restriction of further asymmetric growth. It results in the growth of the forehead in the empty parts of the helmet and then the lightweight foam of the helmet is cut out in layers to accommodate the grown head. Hence all these factors are likely to result in the growth of this segment of the market during the forecast period.
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North America is estimated to contribute 41% to the growth of the global market during the forecast period. Technavio’s analysts have elaborately explained the regional trends and drivers will shape the market during the forecast period.
The market in North America, led by the US, is significant due to high birth rates, particularly those resulting in multiple births and premature infants. These conditions can cause cranial deformities, driving demand for cranial orthoses. Notable market players include Becker Orthopedic, Hanger Clinic, and Boston Brace. Hospitals and clinics provide therapeutic interventions for developmental delays, utilizing medical imaging for early identification and intervention in child neurology. Companies like BioSculptor innovate orthotic solutions to address these needs.
The market encompasses innovative solutions for addressing various cranial disorders such as Deformational Plagiocephaly, Brachycephaly, and Scaphocephaly. Orthotists and Pediatricians play a crucial role in diagnosing and prescribing these orthoses, which include Active Helmets and Passive Helmets. Advanced technologies like Computer-aided design (CAD), 3D scanning, and 3D printing are integral to the production process. New-borns, including those with Premature Deliveries, can benefit from these non-invasive treatment choices. Positional Plagiocephaly, a common condition affecting infants, can significantly impact Quality of Life. Craniofacial Remolding Orthoses offer effective solutions, addressing the asymmetry and promoting proper head development. Reimbursement rules and Financial worries are essential considerations for parents seeking these treatments. Medical imaging is essential for accurate diagnosis and customized orthosis design. Overall, the market represents a significant growth area in Orthotic Technology, addressing the needs of a diverse patient population. Our researchers analyzed the data with 2022 as the base year, along with the key drivers, trends, and challenges.
New FDA-approved devices are expected to drive market growth. The market caters to the production and distribution of medical devices designed to address cranial asymmetry, specifically deformational plagiocephaly and brachycephaly. These conditions result from constant pressure on specific areas of a baby's skull during their growth period. Plagiocephaly causes flattening on one side of the head, while brachycephaly results in a widened back of the head, sometimes accompanied by a bulging forehead. Orthotists and orthotic clinics, in collaboration with pediatricians, offer non-invasive treatment choices such as baby helmets. These devices help correct the skull's shape, improving the quality of life for affected infants. Advanced technologies like computer-aided design (CAD), 3D scanning, and 3D printing are utilized in the manufacturing process.
Premature births and respiratory illnesses increase the risk of positional plagiocephaly and other deformities. Reimbursement regulations and financial worries can impact the adoption of these orthotic solutions. Cranial Asymmetry Orthotic Technology offers various types of helmets, including active and passive, to address different disorders. Major players in the market include Orthomerica, Ballert Orthopedic, and Cranial Technologies. The healthcare infrastructure continues to evolve, with advancements in scanning techniques and the integration of technology, such as 3D printing, to create customized orthoses. Reimbursement regulations and the overall quality of life for newborns and their families remain key considerations in the market. Other related conditions, such as scaphocephaly, are also addressed by this market.
The use of 3D scanning for cranial orthoses is a key trend in the market. The market in the medical device industry is experiencing growth due to advancements in technology, specifically the implementation of 3D scanning and 3D printing in the production of cranial orthotic devices. Cranial asymmetry disorders, such as deformational plagiocephaly and positional plagiocephaly, are common in infants and can be addressed through the use of baby helmets. Orthotists and orthotic clinics, in collaboration with pediatricians, utilize computer-aided design (CAD) and 3D scanning to create customized orthotic solutions. 3D scanning provides increased accuracy compared to traditional plaster molds and significantly boosts productivity. Affordable, handheld 3D optical scanners, like Spectra by Vorum Research Corp., are becoming popular for capturing 3D data of infant head shapes. Cranial asymmetry disorders, including brachycephaly and scaphocephaly, affect a significant number of newborns, particularly those born prematurely. Reimbursement regulations and financial worries can impact the adoption of these orthoses.
Non-invasive treatment choices, such as asymmetry remolding orthoses, offer a better quality of life for affected individuals. Healthcare infrastructure and reimbursement regulations continue to evolve, providing opportunities for companies like Orthomerica, Ballert Orthopedic, and Cranial Technologies to innovate and expand their offerings in the market. Respiratory illnesses and other health concerns can complicate the use of these orthoses, necessitating close collaboration between orthotists, pediatricians, and pharmaceutical companies to ensure the best possible outcomes for patients. The market is expected to grow as the demand for non-invasive treatment choices increases, driven by advancements in technology and a growing awareness of the importance of addressing asymmetry disorders in the early stages.
The availability of alternative methods to cranial orthoses is challenging market growth. In the medical device industry, cranial asymmetry, specifically deformational plagiocephaly and positional plagiocephaly, can lead to abnormal head shapes. This condition is often observed in newborns, including those born prematurely, and is often associated with torticollis. While cranial orthoses, such as baby helmets, are one treatment option, physical therapy and home exercise programs are recommended. Orthotists in orthotic clinics and pediatricians teach parents stretching techniques to strengthen neck muscles and correct head positioning. Advancements in technology, including computer-aided design (CAD), 3D scanning, and 3D printing, have improved the production of cranial asymmetry orthotic technology.
Cranial remolding orthoses, including active and passive helmets, are used to treat disorders like plagiocephaly, brachycephaly, and scaphocephaly. Reimbursement regulations and financial worries can impact the use of these non-invasive treatment choices. Quality of life for affected infants can be significantly improved through these treatments. Craniofacial remolding orthoses are essential for correcting head shape deformities and addressing associated conditions. Premature deliveries and respiratory illnesses can increase the risk of cranial asymmetry.
The market forecast report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the market report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market forecasting and growth strategies.
Customer Landscape
The market research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD million " for the period 2024-2028, as well as historical data from 2018 - 2022 for the following segments.
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The market is a significant industry that caters to the production and distribution of medical devices designed to support and protect the skull and brain. These orthoses are essential for managing various conditions such as craniosynostosis, traumatic brain injury, and other skull deformities. The market is driven by the increasing prevalence of these conditions, particularly in the pediatric population. Additionally, technological advancements in the design and materials used to manufacture cranial orthoses have led to improved patient comfort and outcomes. The market is also influenced by regulatory approvals and reimbursement policies.
Moreover, key players in the market include OrthoHelm, Medtronic, and Stryker. The market is expected to grow at a steady pace due to the rising demand for effective and innovative solutions in the healthcare industry. The market is segmented by product type, application, and end-user. Product types include rigid and semi-rigid orthoses, while applications include congenital and acquired conditions. End-users includes hospital, clinics, and home care settings. The hospital must do an early intervention in the case of skull deformities or any other orthoses, for which abundant hospital supplies are paramount.
Market Scope |
|
Report Coverage |
Details |
Page number |
158 |
Base year |
2023 |
Historic period |
2018 - 2022 |
Forecast period |
2024-2028 |
Growth momentum & CAGR |
Accelerate at a CAGR of 10.87% |
Market growth 2024-2028 |
USD 182.2 million |
Market structure |
Fragmented |
YoY growth 2023-2024(%) |
9.53 |
Regional analysis |
North America, Europe, Asia, and Rest of World (ROW) |
Performing market contribution |
North America at 41% |
Key countries |
US, Germany, UK, China, and Canada |
Competitive landscape |
Leading Vendors, Market Positioning of Vendors, Competitive Strategies, and Industry Risks |
Key companies profiled |
Align Clinic, ARMAC, Becker Orthopedic, Bio Medic Appliances Inc., BioSculptor, Boston Orthotics and Prosthetics, Cranial Technologies Inc., Danmar Products Inc, Deccan OrthoPro, Hanger Inc., Human Designs Prosthetics and Orthotics, Invent Medical Group s.r.o, Lawall Prosthetic and Orthotic Services Inc, Leimkuehler Inc., Medicad Implants, Orthomerica Products Inc., Orthotic and Prosthetic Lab Inc, Union Orthotics and Prosthetics Co, and Westcoast Brace and Limb |
Market dynamics |
Parent market analysis, Market Forecasting, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, Market condition analysis for market forecast period. |
Customization purview |
If our market report has not included the data that you are looking for, you can reach out to our analysts and get segments customized. |
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1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation by Application
7 Market Segmentation by Type
8 Customer Landscape
9 Geographic Landscape
10 Drivers, Challenges, and Opportunity/Restraints
11 Competitive Landscape
12 Competitive Analysis
13 Appendix
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