BIO-IMPLANT MARKET ANALYSIS

Global bio-implant market is estimated to be valued at US$ 91.14 Billion in 2023, exhibiting a CAGR of 6.0% during the forecast period (2023-2030). Increasing product launches by key market players is expected to drive the market growth over the forecast period. Moreover, increasing product approvals and inorganic strategies such as collaborations and patnerships are also expected to drive the global bio-implant market growth.

Analysts’ Views on Global Bio-implant Market:

Key market players are focusing on improving patient care by broadening access to high quality test results. Thus, global bio-implant market growth is driven by an increasing product launches by the key market players over the forecast period. For instance, in June 2022, ZimVie, a surgical and medical instrument manufacturing company, announced the launch of its new T3 PRO Tapered Implant and Encode Emergence Healing Abutment. These products are approved by the U.S. Food and Drug Administration (FDA), and will add to ZimVie’s already expansive line of dental implant and abutment solutions. T3 PRO will build on the original T3 Tapered Implant, launched in 2013, while the Encode Emergence Healing Abutment works with ZimVie’s 3-in-1 Encode Impression System.

Figure 1. Global Bio-implant Market Share (%), By Product type, 2023

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Global Bio-implant Market - Driver

Increasing Number of Product Approvals by Regulatory Bodies

Market players are focused on gaining approvals from regulatory bodies, and this is expected to drive the global bio-implant market growth over the forecast period. For instance, in April 2022, The Orthopaedic Implant Company (OIC), a medical device manufacturing company, announced the U.S. FDA approval, and commercial launch of the market’s first and only high-value dorsal spanning plate.

Moreover, in June 2021, Intelligent Implants Ltd., a medical device company, announced that U.S. FDA has granted breakthrough device designation for its SmartFuse orthopedic implant technology. The SmartFuse platform is designed to remotely stimulate, control, and monitor bone growth for real-time clinical decision-making. The product will be indicated for first-use patients who undergo lumbar spinal fusions.

Figure 2. Global Bio-implant Market Share (%), By Region, 2023

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Global Bio-implant Market- Regional Analysis

Among region, North America is expected to dominate the global bio-implant market over the forecast period, owing to North America 35.10% market share. High prevalence of cardiovascular diseases such as coronary heart disease, ischemic heart disease, arrhythmias, and others is expected to drive North America bio-implant market growth. For instance, according to an article published by Circulation Journal, a peer reviewed open access journal, in January 2021, the prevalence of cardiovascular diseases in adults above age of 20 years, in U.S., is around 49.2% (126.9 million in 2018), and increases with age in both males and females. The same source stated that the incidence of valvular heart disease is around 64 per 100, 000 person-years, with aortic stenosis (47.2%), mitral regurgitation (24.2%), and aortic regurgitation (18.0%) contributing most of the valvular diagnoses in 2018, in U.S.

Global Bio-implant Market– Impact of Coronavirus (COVID-19) Pandemic

The coronavirus or COVID-19 outbreak has affected various industries globally. Economy in countries all over the world such as the U.K., India, Italy, Bangladesh, Sri Lanka, the U.S., Morocco, and others has been disrupted due to lockdowns implemented by governments to combat spread of coronavirus since 2020. The COVID-19 pandemic hampered the research and development activities in the field of cardiac implants, due to closure of clinical trial sites and limited in-person reporting of cardiovascular disease adverse events such as cardiac arrest, cardiac implant related infection, and others. According to an article published by the Journal of the American College of Cardiology, in November 2020, the COVID-19 pandemic has adversely affected patient care, and the conduct of clinical trials in all fields of healthcare including cardiology. The same source estimated that, in April 2020, around 90% of clinical trial sites were closed to enrollment worldwide, with a 95% decline in cardiovascular trial activity.

Moreover, according to the same source, most clinical trial sites ceased site-based enrollments and procedures. Adverse event reported declined for enrolled patients and patient mobility in response to governmental orders and fear of infection. Furthermore, changes in patient care include widespread reductions in cardiovascular hospitalizations, and increased numbers of at-home cardiac arrests.

Global Bio-implant Market- Segmentation

Global bio-implant market report is segmented into product type, material type, and end user, and region.

By Product Type, the market is segmented into cardiovascular implants, dental implants, spinal bio-implants, orthopedic implants, ophthalmic implants, and others. Out of which, cardiovascular implants segment is expected to dominate the global bio-implant market during the forecast period, owing to increasing research and development to develop novel cardiac implant products. For instance, in February 2022, Abbott, a medical device company, announced the world's first patient implant of a dual-chamber leadless pacemaker system as part of its AVEIR DR i2i pivotal clinical study. The implant of Abbott's investigational Aveir dual-chamber leadless pacemaker represents a significant technological milestone for leadless pacing technology, and is the first to occur around the world within the pivotal trial.

By  Material Type, the market is segmented into Biomaterial Metal, Ceramic, Alloys, and Polymer. Out of which, the ceramic segment is expected to hold second largest share in market over the forecast period, owing to increasing ceramic product approvals by the regulatory bodies. For instance, in December 2021, DentalPoint, the pioneer in two-piece ceramic implants, announced that it has received U.S. FDA approval for its latest productnamed ZERAMEX XT. ZERAMEX XT is a 100 % metal-free alternative to titanium implants that is designed for highly cosmetic tooth replacement, especially in the esthetic zone.

By End User, the market is segmented into hospitals and clinics, ambulatory surgical centers, and  others. Out of which, hospitals and clinics segment is expected to dominate the market over the forecast period. For Instance, in July 2021, Duke University Hospital, announced that a surgical team has successfully implanted a new-generation artificial heart in a 39-year-old man with heart failure, and thus, become the first center in North America to perform the procedure.

Global Bio-implant Market- Cross Sectional Analysis

In the product type, cardiovascular implants segment hold a dominant position in the Europe region due to increasing research and development activities by key market players. For instance, in February, 2022, Abbott, announced the world's first patient implant of a dual-chamber leadless pacemaker system as part of its AVEIR DR i2i pivotal clinical study. The implant of Abbott's investigational Aveir dual-chamber leadless pacemaker represents a significant technological milestone for leadless pacing technology, and is the first to occur around the world within the pivotal trial.

Global Bio-implant Market-Key Developments

In October 2021, ScottCare Cardiovascular Solutions, a medical solutions manufacturer, announced that it has signed an agreement with Ninety One Holding, Inc., to become a principal distributor for Ninety One's cloud software platform for cardiac implanted device monitoring, effectively expanding the partnership between the two firms. The will allow ScottCare Cardiovascular Solutions  to offer Ninety One’s cloud platform directly to clinics that choose to monitor and manage patient data with their own staff. Ninety One's platform combines advanced data science with the latest technologies to assist with the analysis and management of complex medical data for implanted cardiac device patients.

On February 23, 2023, CurvaFix, Inc., a developer of medical devices to repair fractures in curved bones, announced the launch of its smaller-diameter, 7.5mm CurvaFix IM Implant that is designed to simplify surgery, and to provide strong, stable fixation in small-boned patients.

Global Bio-implant Market- Key Trends

Increasing Number of Product Approvals By Regulatory Bodies

Key market players are focused on organic growth strategies such as gaining product approvals from regulatory bodies, and this is expected to drive the bio-implant market growth over the forecast period. For instance, in August 2021, Zimmer Biomet Holdings, Inc., a global medical technology leader, and Canary Medical, a medical data company, announced that the U.S. Food and Drug Administration (FDA) has provided De Novo classification grant and authorization to market the tibial extension for Persona IQ, the world's first and only smart knee cleared by the U.S. FDA for total knee replacement surgery. Persona IQ combines Zimmer Biomet's proven and trusted knee implantnamed Persona The Personalized Knee with Canary Medical's proprietary implantable canturioTMte tibial extension sensor technology that measures and determines range of motion, step count, walking speed, and other gait metrics. Persona IQ will work together with Zimmer Biomet's remote care management platform, mymobility with Apple Watch, as well as other components of the ZBEdge Connected Intelligence Suite.

Global Bio-implant Market- Restraint

Product Recalls and Cardiac Implant Related Infection

The major factors that can hamper growth of the global bio-implant market over the forecast period include product recalls of cardiac implants. For Instance, in February 2021, Medtronic, a U.S.-based medical device company, announced that it had recalled its Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter Defibrillators (ICDs), and Cardiac Resynchronization Therapy (CRT-Ds) devices due to an unexpected and rapid decrease in battery life. This decrease in battery life is caused by a short circuit in some devices to produce first warning that the battery is low earlier than expected. There have been 444 complaints regarding these ICDs and CRT-Ds in the U.S.

Global Bio-implant Market- Key Players

Major players operating in the global bio-implant market include Abbott., Dentsply Sirona Plc., Medtronic, Stryker Corporation, Zimmer Biomet, B.Braun, Cook Medical, C.R. Bard, Edwards Lifesciences, Wright Medical Technology, and Boston Scientific Corporation.

*Definition:  Bio-implants are prosthesis or artificial medical devices that replace missing tissues, and supports a damaged biological structure to improve biological functions of the body, and are made up of material obtained of human or animal origin or biosynthetic materials. Bio-implant is used to assist and regularize human physiological functions.