Biomaterials Market

Market Overview

The global biomaterials market size was valued at USD 106.51 billion in 2022. It is estimated to reach USD 619.27 billion by 2031, growing at a CAGR of 15.8% during the forecast period (2023–2031).

A biomaterial is a substance designed to interact with biological systems for medical purposes, either restorative (to treat, improve, restore, or supplant a body tissue function) or diagnostic. Fundamentally, biomaterials are synthetic or natural compounds synthesized artificially and employed in the medical and technology fields to help injured tissues or organs work better. Metals, ceramics, plastic, glass, and even living cells and tissue can be employed to create biomaterials.

Biomaterials can be re-engineered into molded or machined parts, coatings, fibers, films, foams, and textiles for biomedical products and devices. They are frequently biodegradable, and some are bioabsorbable, which means they are gradually eliminated from the body when they have served their purpose. These biomaterials work with biological systems to treat issues with the heart, mouth, joints, and nervous system. A wide range of cutting-edge medical technologies, such as tissue engineering, cosmetic surgery, drug delivery systems, and other medical implants, can also benefit from biomaterials science.

Highlights

• Polymers dominate theproduct segment
• Orthopedic dominates the application segment
• North America is the highest shareholder in the global market

Market Dynamics

Market Drivers

Rising Demand as a Consequence of Accidental Injuries and Chronic Conditions

According to WHO, an increase in the total healthcare expenditure has led to improvements in healthcare infrastructure worldwide. Cardiovascular diseases account for approximately 30% of all deaths worldwide. Due to lifestyle and economic development changes, the prevalence of lifestyle disorders and chronic diseases has increased even in developing economies. Biomaterials have been shown to be safer, more reliable, and more cost-effective as research on them has advanced.

Additionally, healthcare expenditure has increased the affordability and accessibility of implants and prosthetics in accidental surgeries and injuries. Rising incidents of accidental injuries, which causes most organ replacement procedures, are observed to hold great growth prospects for this sector. Thus, the biomaterial implants market is expected to grow over the forecast period. Similarly, about 800,000 bone grafting procedures are conducted annually in the U.S., which is expected to generate revenue in this market.

Expansion in the Usage Scope of Biomaterials

The increasing use of biomaterials in drug delivery can be attributed to their use in various healthcare settings, including tissue engineering, 3D printing in medicine, implants, nanomaterials, diagnostic systems, biotechnology, bioimaging, and regenerative medicine. The introduction of nanoscale material has led to improvements in injectable targeted drug delivery systems in the form of inserts. For instance, ophthalmic, vaginal, oral tablets, and polymer-drug conjugates. In addition, biomaterials are used to administer a drug or pharmaceutical product in desired amount or dose in the body for therapeutic effects.

Biomaterials are also used in biosensors and bioelectrodes for various medical and non-medical applications. Implantable devices are substitutes for injured tissues, which aid in performing regular functions such as spine implants and bone allografts. Several scaffold fabrication methods, including 3D-printed biocompatible materials, hydrogels, and tissue-engineered implants, are available. Biomaterials are also under investigation for exploring alternative uses as gene and drug delivery carriers and lab-on-a-chip applications, particularly in cancer studies and stem cell differentiation, thereby driving the market.

Market Restraints

High Expense Associated with the Development of Biomaterials

High research and development costs associated with biomaterials could threaten market growth. Sustainability and maintenance of biomaterials have been a major concern due to high operating costs, low revenue generation, and lack of private investment. Since the testing of biomaterials is highly dependent on biological tissue models and samples, the rapid transformation of biorepositories and improvements in the demand and supply of biospecimens are vital.

Additionally, the cost of raw materials, such as collagen, and the lack of its commercial source is one of the major problems associated with manufacturing biomaterials. The use of natural collagen to manufacture biological implants is still a hurdle in this vertical due to its high cost. However, attempts are being made by biologists to address this challenge. For instance, the use of chitosan (derived from chitin) instead of collagen received great attention due to its low cost and excellent biocompatibility, driving the growth of this market. High capital expenditure for clinical testing grafts and implants continues to increase, causing slow growth of the market.

Market Opportunities

Advancements in Biomaterials Technologies

Demand for novel biomaterials has increased over the years owing to their growing use for replacing and repairing tissues such as bones, teeth, and other injured tissues and organs. Applications of bio-based materials in healthcare range from using polylactic acid as dissolvable drug capsules and as a high-strength bone implant to using sandworm glue as a biocompatible surgical adhesive. They are also used in hip and knee surgeries due to the availability of compatible biomaterials on the market and the growing use of bioplastics due to their biocompatibility and biodegradability.

Additionally, companies play a pivotal role in addressing this challenge by developing new solutions and tools. For instance, in March 2017, Galatea Surgical, a subsidiary of Tepha Inc., launched GalaSHAPE 3D surgical scaffold for aesthetic plastic surgery procedures. Similarly, in January 2015, Integra LifeSciences Corporation introduced the Integra reinforcement matrix to its extremities product catalog. In addition, many research institutes and centers in the UK are developing advanced biomaterial products and services. The University of Nottingham, the University of Cambridge, and Cranfield University are examples of such universities. Such factors create opportunities for market growth.

Regional Analysis

North America Dominates the Global Market

Based on region, the global market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America is the most significant global biomaterials market shareholder and is estimated to exhibit a CAGR of 15.5% during the forecast period. The development of the North American region can be attributed to the high geriatric population, rise in instances of trauma and number of complicated surgeries, favorable reimbursement policies, and high government funding. Moreover, the presence of established players and their efforts in developing technologically advanced and safe biomaterials and devices also contribute to market growth. In addition, the U.S. had the largest market share and is anticipated to expand steadily during the forecast period. This growth can be attributed to advances in life sciences research and favorable government policies.

Furthermore, the country's local presence of several major market players, such as Carpenter Technology Corporation, Inc. and Berkeley Advanced Biomaterials, Inc., drives technological advancements, leading to market growth. These companies are involved in developing advanced biomaterials for healthcare practices and surgeries. The rise in funding for biotechnology research is another factor aiding market growth.

Europe is estimated to exhibit a CAGR of 15.1% over the forecast period. The European biomaterials market has a high growth potential. The development of novel biomaterials for wound healing, plastic surgeries, tissue engineering, ophthalmology, and neurology, as well as an increase in the number of conferences and research-related activities, has fueled the growth of this market. The market is also driven by increased government investments in the biomaterial sector, reimbursements offered by CMS, and a rise in the geriatric population, one of the main end users. The factors hindering the growth of the biomaterials market are challenges in tissue engineering and the effect of the Biomaterials Access Assurance Act on suppliers.

In addition, Germany exhibited significant growth in the biomaterials market, and the considerable market share can be attributed to the investments and innovations by major players, established industrial infrastructure, and supportive government regulations. Several Germany-based organizations support and are focused on providing safer and more biocompatible biomaterials in the coming years. The increase in investments from biopharmaceutical manufacturing companies is also an important growth driver.

The Asia-Pacific biomaterials market is anticipated to grow rapidly during the forecast period. Adoption of biomaterials is still low in the Asia-Pacific region compared to other global markets, leaving significant room for growth. South Korea is the Asia-Pacific region's largest and most active national market. The highest number of implantations are undertaken in the country, resulting in increased demand for biomaterials. In addition, the regional market is fiercely competitive, with many local manufacturers developing low-cost biomaterial products and large multinationals providing well-known, trusted products.

In Latin America, the demand for biomaterials in wound healing, cardiology, neurology, and plastic surgery is growing along with the increase in the elderly population. Significant research for developing advanced technologies, such as medical implants with higher efficiency and hydrogen scaffolding and decellularized dermal matrixes for grafting, and an increase in government grants, investments, and funding are factors driving the Latin American biomaterials market.

The Middle East and Africa biomaterials market is driven by increased research on biomaterials, a rise in older populations, and high per capita income. However, safety issues and lack of compatibility hinder the market's growth. Companies like Corbion N.V. have developed a bioplastic material—Polylactic Acid (PLA)—made from sugarcane and sugar beet, which helps decrease carbon footprints. In addition, the South African market is expected to witness small growth compared to other countries and regions in this market. Due to the developing life science field, rising disease-oriented studies with untapped opportunities are a few factors that are expected to drive segment growth. However, slower economic growth is anticipated to impede market growth in this country in the coming years.

Segmental Analysis

The global market is segmented by product and application.

Based on product, the global market is bifurcated into metallic, natural, ceramics, and polymers. 

The polymers segment dominates the global market and is predicted to exhibit a CAGR of 14.7% over the forecast period. Polymeric biomaterials are used during medical procedures and surgeries and can be retained in the body long. Thus, polymeric biomaterials have properties that render them compatible to be used as replacements for different types of tissues. Polymers could be natural or synthetic, and the main types of biopolymers are biosynthetically derived proteins and polyesters. A few examples of natural biopolymers are collagen, elastin, and chitosan. In contrast, synthetic biopolymers include Poly Glycolic Acid (PGA), Poly Lactic Acid (PLA), and Poly (ɛ-caprolactone) (PCL). The polyesters obtained by chemical synthesis are considered better alternatives than biosynthetic polymers since they can be modified and pose a lower risk of inducing an immune response in the body.

Bioceramics have been transforming the biomedical field to a large extent. Bioceramics are used to manufacture implants used in surgeries and medical procedures. Advancements in the healthcare field have improved implant materials' biocompatibility and mechanical strength. Mostly, implants made of bioceramics and composites are used to repair and replace damaged tissues and parts of the musculoskeletal system. Examples of bioceramics currently used by healthcare professionals are alumina, graphite, vitreous carbon, and more. These bioceramics are used for developing devices and parts such as orthodontic anchors, bone plates, artificial hip, and knee and spinal fusions.

Based on application, the global market is segmented into cardiovascular, ophthalmology, dental, orthopedic, wound healing, tissue engineering, plastic surgery, neurology, and others. 

The orthopedic segment owns the highest market share and is estimated to exhibit a CAGR of 16.4% during the forecast period. Bone and joint degenerative and inflammatory problems affect a considerably large population base. The different types of biomaterials utilized for orthopedic patients are categorized into first-generation, second-generation, and third-generation biomaterials. The first generation includes metallic materials, ceramics, and bioinert polymers. The second generation includes bioactive and biodegradable ceramics, cement, metals, and polymers. Lastly, the third generation includes biomaterials designed to stimulate a specific response at molecular levels.

In many other circumstances, like fractures, large resections, joint malfunctions, spinal pathologies, and other situations, repair or substitution will be the main requirement; therefore, the demand for medical devices and biomaterials in the field will increase over the forecast period. In addition, the orthopedic application segment is further bifurcated into joint replacement, biomaterials, ortho biologics, bioresorbable tissue fixation products, viscosupplementation, spine biomaterial, and other applications.

Advanced solutions are given to patients for chronic wounds and interventions therapies for wound care, such as foam dressings, hydrocolloids, antimicrobial dressings, film dressings, alginate dressings, collagen products, and hydrogels, are key product segments within the segment. As technology advances and becomes more practical, tissue engineering and regenerative medicines have increased in the field. Furthermore, cellular therapies and biomaterials such as elastin, collagen, and chitosan have increased for wound management. These factors are anticipated to drive market adoption and demand. The wound healing segment is further bifurcated into fracture healing devices, adhesion barriers, skin substitutes, internal tissue sealants, surgical hemostats, etc.

Recent Developments

• January 2023- RevBio, Inc. announced that it had received permission from the Italian Ministry of Health and the Ethics Committee of the University "G.D.Annunzio" of Chieti-Pescara to initiate a 15-patient pilot clinical trial. The primary objective of this study is to determine how long it takes for the adhesive biomaterial Tetranite® to repair bone in the mandibular and maxillary dental arches.
• May 2023- CJ Biomaterials, a manufacturer of bioplastics, collaborated with Dongil Platech, a manufacturer of drinking straws in South Korea, to develop a bioplastic straw composed of a combination of PLA and amorphous polyhydroxyalkanoates (aPHA). This will be the first product to incorporate Phact aPHA from CJ Biomaterials.