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Bionic Devices Market size surpassed USD 4.7 billion in 2020 and is projected to grow at a CAGR of over 8.1% billion from 2021 to 2027. Growing incidence of chronic diseases including hearing loss is one of the key variables fostering the market growth. Furthermore, technological developments in bionic devices and the rising disposable income in emerging economies will promote the market expansion.
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However, high cost associated with bionic devices and opaque reimbursement coverage may negatively impact the market progression. Bionic devices are relatively novel modalities, one of the emerging technologies in the medical field with constant innovations and developments. Recent years have witnessed advancements in terms of materials, manufacturing methods, functionality and other parameters owing to significant R&D investments.
Moreover, the U.S. FDA is responsible for regulations and approval related to the medical devices. It closely monitors the development, market approval and post-approval adverse events concerned with the medical devices including bionic prosthetics. Due to wide classification and implantable nature, these devices are classified as Class I, II & III medical devices. Majority of the Class II devices and (all) Class III devices are mandated to undergo a series of examinations and technical documentation. Premarket notification (510k), premarket approval (PMA), or investigational device exemption (IDE), depending on device class are mandatory for commercial use of the product. The U.S. FDA regulates these approvals that are often quoted as tedious, stringent, time consuming, etc.
The COVID-19 pandemic arose as an unparalleled health crisis that has negatively affected the bionic devices market. The coronavirus outbreak has affected millions of individuals globally, further inflicting significant mortalities, disease burden, and financial adversities. Owing to tremendous patient influx, the healthcare system and facilities were under extreme pressure.
The COVID-19 affected patients were prioritized that led to delay in other medical procedures and affected the industry growth. This delay impacted the several elective procedures that further reduced the product adoption. Orthopedic bionic devices are extensively used post amputation surgery and helps in partially or fully restoring the movement in limbs or arms. However, the reduced number of amputation procedures during the outbreak affected the industry expansion, as device acceptance rate dropped down.
Report Coverage | Details |
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Base Year: | 2020 |
Market Size in 2020: | USD 4,692.9 million |
Forecast Period: | 2021 to 2027 |
Forecast Period 2021 to 2027 CAGR: | 8.1% |
2027 Value Projection: | USD 7,955.6 million |
Historical Data for: | 2016 to 2020 |
No. of Pages: | 150 |
Tables, Charts & Figures: | 181 |
Segments covered: | Product, Fixation, and Region |
Growth Drivers: |
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Pitfalls & Challenges: |
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Rising prevalence of chronic conditions that promote amputations is predicted to augment the need for bionic devices. Several chronic conditions such as diabetes, peripheral arterial disease, trauma, and malignant tumours among others are responsible for amputation. Patients suffering with diabetes are exposed to 30 times higher risk of undergoing an amputation and is responsible for significant economic strain on healthcare systems. Trauma is another chronic conditions that is associated with rising incidence of amputation for lower extremity. Trauma causes amputation in more than 20% patients that are affected with critical wound contamination and feature substantial soft tissue loss. Further, battle-associated explosive events promotes the incidence of amputation in 93% cases and around 2% of combat casualties lead to limb amputation.
The incidence of these chronic conditions is directly proportional to the rise in the number of amputations. Due to the high prevalence of chronic conditions, the number of amputations is constantly surging. Moreover, several clinical studies suggest that in developing economies, the adverse impact of major lower extremity amputations has surged, further increasing the market potential. This surge is mainly credited to limited resources and high prevalence of diabetes-associated foot complications.
The auditory bionics/cochlear implants segment was valued at around USD 1.46 billion in 2020 led by the increasing prevalence of auditory conditions and hearing disorders causing deafness & hearing loss. With aging population, the number of individuals suffering with hearing loss is set to increase. The key drivers for rising incidence of hearing loss includes demographic transition, improved life expectancy, occupational, and recreational noise among others.
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The implantable bionic devices market is expected to reach USD 5.04 billion by 2027 impelled by the growing number of road accidents and high patient preference for bio-implants. According to the World Health Organization statistics, published in 2021, road accidents approximately account for 1.3 million mortalities globally. Around 20 to 50 million people suffer owing to non-fatal injuries during road accidents, with many among them incurring a disability and leading to traumatic amputation.
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U.S. dominated the North American bionic devices market and will exceed USD 3.09 billion by 2027. This majority market share is mainly attributed to numerous factors including high acceptance of advanced bionic devices, rise in incidence of chronic ailments and high healthcare expenditure across the country. High prevalence of chronic ailments such as peripheral arterial disease, trauma, and hearing impairment in the U.S. is set to prove conducive for the industry value. The rise in chronic diseases are anticipated to fuel the adoption rate of bionic devices in the country. Further, presence of prominent market participants including Medtronic, Abbott, and Syncardia among others launch advanced products that will propel the industry demand in the U.S.
Some of the major companies operating in the market are Sonova, Demant, Cochlear Ltd., MED-EL Medical Electronics, Touch Bionics (Ossur), Ekso Bionics, Scheck & Siress, Medtronic, Abbott, Boston Scientific, and Syncardia. These prominent leaders emphasize on implementing strategic initiatives such as vertical integration, research collaboration, new product development, and commercialization for business growth. Furthermore, these participants invest in R&D activities that enables them to launch advanced products featuring novel technologies and gain maximum revenue share.
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Market, By Product, 2016 - 2027 (USD Million)
Market, By Fixation, 2016 - 2027 (USD Million)
The above information is provided for the following regions and countries: