Cranial Orthoses Market by Application, Type and Geography - Forecast and Analysis 2023-2027

Cranial Orthoses Market Forecast 2023-2027

The global cranial orthoses market size is estimated to grow by USD 136.94 million at a CAGR of 9.22% between 2022 and 2027. Favorable reimbursement conditions are driving the market growth. For instance, in October 2001, Orthomerica Products started a grassroots campaign to acquire a unique billing code for remolding orthoses. It succeeded in 2002 with the Healthcare Common Procedure Coding System (HCPCS) Alpha-Numeric Panel issuing a new code. For insurance to be available, most companies require a minimum of two months of repositioning techniques to be opted for before choosing a cranial orthotic device for treatment. Additionally, there are other criteria that the infant must meet as per the accurate measurement of the infant's head to verify severe plagiocephaly or the specific problem. This will be conducted by a specifically trained cranial physical therapist. This is to ensure that they are not for treating mild-to-moderate plagiocephaly which would make its usage limited to that of a cosmetic product and not applicable for reimbursement. Hence the increasing trend towards effective coverage for cranial orthoses is likely to have a positive impact on the adoption of such devices, boosting the growth of the global market during the forecast period. This market research and growth report also includes an in-depth analysis of drivers, trends, and challenges. 

What will be the size of the Cranial Orthoses Market During the Forecast Period?

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Market Segmentation

Technavio has segmented the market into Application, Type, and Geography. The market caters to the medical device industry, addressing cranial asymmetry issues such as deformational plagiocephaly and positional plagiocephaly. This condition, affecting approximately 1 in every 2,000-3,000 births, results from coronal synostosis, which halts the growth of the forehead and brow on the affected side. Consequently, baby helmets are employed to correct the condition. Orthotists and orthotic clinics, in collaboration with pediatricians, provide these non-invasive treatment choices. Advancements in technology, including computer-aided design (CAD), 3D scanning, and 3D printing, have revolutionized the production of the asymmetry orthoses. Premature births and respiratory illnesses increase the susceptibility to these disorders. Reimbursement regulations and financial worries are significant concerns for families seeking treatment. Orthotic technology offers craniofacial remolding orthoses for various disorders, including brachycephaly, plagiocephaly, and scaphocephaly. Healthcare infrastructure and reimbursement regulations play a crucial role in ensuring access to quality of life-enhancing treatments. 

Application Analysis 

Plagiocephaly segment

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 82.77 million in 2017 and continued to grow by 2021. 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.

Regional Analysis

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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 which 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.

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Market Dynamics and Customer Landscape

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. 

Key Market Drivers

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 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.

Significant Market Trends

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 the 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 the asymmetry disorders in the early stages.

Major Market Challenges

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. 

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Customer Landscape

The market 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 report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their growth strategies.

Customer Landscape

Key Market Players 

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 20 market companies, including:

Align Clinic - The company offers cranial orthoses to treat Plagiocephaly, Brachycephaly, Scaphycephaly in babies.

• ARMAC
• Becker Orthopedic
• Bio Medic Appliances Inc.
• BioSculptor
• Boston Orthotics and Prosthetics
• CranialTechnologies 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
• 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.

Market Analyst Overview

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.

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.

Segment Overview

The market report forecasts market growth by revenue at global, regional & country levels and provides an analysis of the latest trends and growth opportunities from 2017 to 2027. 

• Application Outlook 
  • Plagiocephaly
  • Scaphocephaly
  • Brachycephaly

• Type Outlook 
  • Active helmets
  • Passive helmets

• Region Outlook 
  • North America
    • The U.S.
    • Canada
  • Europe
    • U.K.
    • Germany
    • France
    • Rest of Europe
  • Asia
    • China
    • India
  • Rest of World (ROW)
    • Australia 
    • Argentina
    • Brazil

Market Scope
Report Coverage	Details
Page number	152
Base year	2022
Historic period	2017-2021
Forecast period	2023-2027
Growth momentum & CAGR	Accelerate at a CAGR of 9.22%
Market growth 2023-2027	USD 136.94 million
Market structure	Fragmented
YoY growth 2022-2023(%)	9.18
Regional analysis	North America, Europe, Asia, and the Rest of the World (ROW)
Performing market contribution	North America at 41%
Key countries	US, Canada, Germany, UK, and China
Competitive landscape	Leading companies, Market Positioning of companies, Competitive Strategies, and Industry Risks
Key companies profiled	Align Clinic, ARMAC, Becker Orthopedic, Bio Medic Appliances Inc., BioSculptor, Boston Orthotics and Prosthetics, CranialTechnologies 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 growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, and Market condition analysis for the forecast period.
Customization purview	If our 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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What are the Key Data Covered in this Market Research Report?

• CAGR of the market during the forecast period
• Detailed information on factors that will drive the market growth and forecasting between 2023 and 2027
• Precise estimation of the market and its contribution to the market in focus on the parent market
• Detailed analysis of customer landscape covering Diver of price sensitivity, Adoption of the lifecycle, and key purchase criteria 
• Vendor landscape comparing criticality of inputs and factors of differentiation
• Exclusive Matrix on vendor position and Classification
• Accurate predictions about upcoming trends and changes in consumer behavior
• Market growth analysis across North America, Europe, Asia, and the Rest of the World (ROW)
• A thorough analysis of the market’s competitive landscape and detailed information about companies
• Market forecasting of factors that will challenge the growth of the key market companies

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