Global Biodegradable Implants Market - 2024-2031

Overview

The global biodegradable implants market reached US$ 5.24 billion in 2023 and is expected to reach US$ 10.31 billion by 2031, growing at a CAGR of 8.9% during the forecast period 2024-2031.

Biodegradable implants are specialized medical devices intended to provide temporary support and stabilization for damaged or diseased tissues, particularly in orthopedic settings. These biodegradable implants gradually break down and are absorbed by the body, which eliminates the need for subsequent surgical removal once they have fulfilled their function.

Biodegradable implants are typically constructed from biocompatible materials, including polymers like polylactic acid (PLA) and polyglycolic acid (PGA), which mimic the mechanical properties of natural bone. This unique characteristic allows them to support the healing process while minimizing complications associated with permanent implants, such as infection, implant loosening, and stress shielding.

Polymers, like polylactic acid (PLA), polyglycolic acid (PGA), and polycaprolactone (PCL), create biocompatible scaffolds that degrade over time, supporting tissue growth and being replaced by new bone.

Market Dynamics: Drivers & Restraints

Advancements in biomaterials

Advancements in biomaterials are anticipated to propel the growth of the global biodegradable implants market significantly. Biomaterials are crucial in the development of medical devices, and the evolution of biodegradable materials has opened new avenues for applications across various fields, including orthopedics, cardiovascular, and dental implants. These biodegradable biomaterials are engineered to naturally decompose within the body over time without causing adverse reactions. Companies are manufacturing biodegradable implants using advanced solutions.

The companies are gaining approvals for implants and solutions that use a variety of biodegradable materials. For instance, in March 2023, Bioretec Ltd. received market authorization for its RemeOs trauma screw in the U.S. The RemeOs trauma screw is the first and currently only bioresorbable metal implant approved by the U.S. Food and Drug Administration (FDA). The approved product range and indication align with the clinical trial conducted on the ankle.

Innovations such as polylactic acid (PLA), polyglycolic acid (PGA), and polycaprolactone (PCL) have enhanced the safety and effectiveness of implants. These materials exhibit excellent biocompatibility, reducing the likelihood of rejection or inflammation which is a common issue associated with permanent implants. As biocompatibility improves, biodegradable implants are gaining wider acceptance in clinical settings, especially among patients seeking temporary solutions that integrate seamlessly with their bodies.

Furthermore, advancements in biodegradable biomaterials are enhancing their efficiency in drug delivery systems, which is expected to improve treatment outcomes and broaden their applications in areas such as oncology, chronic disease management, and tissue engineering. Companies are developing polymers that can be implantable. For instance, in March 2023, Invibio Biomaterial Solutions, part of Victrex, a developer of PEEK biomaterial solutions, launched PEEK-OPTIMA AM Filament, an implantable PEEK polymer that is optimized for additive manufacturing.

Biodegradable materials are also considered more environmentally friendly compared to traditional non-degradable implants, aligning with the growing demand for sustainable medical solutions.

Regulatory bodies like the FDA and the European Medicines Agency (EMA) have approved various biodegradable implants, encouraging further investment in this market and driving growth in both developed and emerging economies. For instance, in March 2021, Inion received the Food and Drug Administration approval for the Inion CompressOn bioabsorbable compression screw. These bioabsorbable screws were developed to meet the needs of surgeons and patients around the world. As these trends continue to develop, the biodegradable implants market is poised for substantial expansion.

Regulatory challenges

The stringent regulatory landscape is expected to hinder market growth. While the regulatory landscape in certain regions may be supportive, navigating the approval processes for new biodegradable implant technologies remains a significant challenge. Manufacturers often face lengthy approval timelines and stringent requirements, which can reduce investment in the development of innovative products. For instance, in the United States, although there are clear guidelines for bioabsorbable implants, the extensive testing required to demonstrate safety and efficacy can prolong the time it takes to bring new devices to market.

In Europe, the Medical Device Regulation (MDR) has introduced more rigorous standards that manufacturers must meet, further complicating the approval process. These regulations require comprehensive clinical evaluations and post-market surveillance, which can be resource-intensive and time-consuming.

Segment Analysis

The global biodegradable implants market is segmented based on product type, material, application, end-user, and region.

Product Type:

Orthopedic implants segment is expected to dominate the global biodegradable implants market share

Due to several factors, the orthopedic implants segment is expected to hold a significant position in the market for biodegradable medical implant devices. The rising demand for advanced solutions in bone healing, the inherent advantages of biodegradable materials, and an increasing preference among patients for minimally invasive treatments are driving this growth.

As the global population ages, there has been a marked increase in bone-related conditions such as osteoporosis, osteoarthritis, and fractures. The elderly demographic, in particular, faces heightened risks of bone fractures and degenerative joint diseases, which fuels the demand for orthopedic implants. For instance, Worldwide, up to 37 million fragility fractures occur annually in individuals aged over 55, the equivalent of 70 fractures per minute.

Worldwide, 1 in 3 women over age 50 will experience osteoporosis fractures, as will 1 in 5 men aged over 50. Osteoporosis affects approximately 6.3% of men over the age of 50 and 21.2% of women over the same age range globally. Based on the world population of men and women, this suggests that approximately 500 million men and women worldwide may be affected.

Biodegradable implants, such as screws, pins, and plates offer a temporary solution that provides essential support during the healing process while eliminating the need for future surgeries to remove permanent implants.

Unlike traditional permanent implants, biodegradable options naturally degrade as bone heals, which is especially beneficial for elderly patients or those with compromised health. This feature reduces the overall healthcare burden by minimizing the risk of complications and lowering healthcare costs associated with additional surgeries.

Moreover, because biodegradable orthopedic implants break down over time, patients often experience shorter recovery periods and reduced hospital stays compared to those with permanent implants that may require follow-up procedures. This contributes to an overall improved patient experience and encourages greater adoption of biodegradable implants in orthopedic surgeries. With faster recovery times and fewer complications, these implants can lead to better surgical outcomes and decreased hospitalization durations, ultimately alleviating the healthcare burden on both patients and healthcare systems.

As awareness of these benefits continues to grow among healthcare providers and patients alike, the biodegradable orthopedic implants segment is expected to expand significantly in the coming years.

Geographical Analysis

North America is expected to hold a significant position in the global biodegradable implants market share

North America holds a dominant position in the global biodegradable implants market and is expected to hold the major portion of the market during the forecast period. This dominance is governed by the rising advanced medical infrastructure and the increasing research and development of innovative solutions in the region.

The increasing research and development of innovative solutions in the region also contributes to the region's market growth. For instance, in June 2021, researchers at Northwestern and George Washington Universities (GW) developed the first-ever transient pacemaker which is a wireless, battery-free, fully implantable pacing device that disappears after it's no longer needed.

The prevalence of chronic diseases, particularly cardiovascular conditions and orthopedic issues, is significantly impacting the demand for biodegradable implants in the United States. For instance, ankle fractures are one of the most frequently occurring fracture types among the adult patient population. There are 3.4 million patients treated each year in the U.S. for ankle fractures. Single-isolated ankle (malleolar) fractures are the most common type, accounting for 70% of the yearly incidence of all ankle fractures. This rising incidence of fractures increases the demand for biodegradable implants as patients are interested particularly in innovative solutions which do not require further surgeries.

The National Institute of Health in 2024 stated that, after reviewing data from more than 29 million adults receiving hospital care in California, researchers found that 2 million adults (6.8%) had atrial fibrillation, an irregular heart rhythm. When they extrapolated these data to statewide data and the U.S. population, they found that at least 10.55 million American adults (4.48%) are predicted to have atrial fibrillation. As these health concerns escalate, there is an increasing need for bioabsorbable implants that can enhance patient outcomes while minimizing complications associated with traditional permanent implants.

Unlike their non-biodegradable counterparts, biodegradable implants are designed to gradually dissolve in the body, which helps to reduce risks such as inflammation and infection. As the aging population continues to grow, the demand for these innovative solutions is expected to rise, making biodegradable implants a vital component of advanced treatments.

Companies are innovating advanced implant solutions by utilizing advanced biodegradable materials which is expected to increase the demand for these implants. For instance, in July 2021, Stryker received the FDA clearance of the first balloon implant for arthroscopic treatment of massive irreparable rotator cuff tears (MIRCTs). Market players in the region are collaborating with the established players to expand the biodegradable implants portfolio.

Asia Pacific is growing at the fastest pace in the global biodegradable implants market

The Asia-Pacific (APAC) region is emerging as one of the fastest-growing markets in the global biodegradable implants, which is governed by several critical factors. Countries such as China, India, Japan, and South Korea are making substantial investments in healthcare infrastructure, leading to hospitals and clinics becoming increasingly equipped with advanced technologies. These advancements allow for a greater adoption of innovative treatments and implants.

Additionally, the aging population in countries like Japan, China, and South Korea significantly contributes to market growth. As the elderly demographic expands, there is a heightened incidence of bone fractures, joint diseases, and dental issues, which escalates the demand for both orthopedic and dental implants. For instance, the National Institute of Health in 2023 reported that osteoporosis affects 10-30% of women aged above 40, and up to 10% of men in 7 developed economies in Asia Pacific. Fractures affect 500-1000 adults aged above 50 per 100,000 person-years.

Thus, increasing orthopedic conditions increase the demand for biodegradable implants as more patients are seeking for sustainable medical solutions.

Competitive Landscape

The major global players in the biodegradable implants market include Evonik, Johnson & Johnson, Medtronic, Stryker, Smith+Nephew, Boston Scientific Corporation, Inion, Bioretec, Arthrex, Inc, Syntellix among others.

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• Pipeline & Innovations: Insights into clinical trials, product pipelines, and upcoming advancements.
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• Post-Market Surveillance: Enhanced safety and access through post-market data.
• Value-Based Pricing: Insights into pharmacoeconomics and data-driven R&D decisions.

The Global Biodegradable Implants market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.

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