US Orthopaedic Biomaterials Market was valued at USD 3.84 billion in 2019 and is estimated to reach USD 4.1 billion by the end of the year 2020.
It is expected to grow at the CAGR of 8.6% within the time horizon of 2020-2025 because of the increasing bone related disorders and sport related injuries.
Its market value will reach USD 6.29 billion by the year 2025.
- Definition / Scope
- Market Overview
- Market Risks
- Top Market Opportunities
- Market Trends
- Industry Challenges
- Technology Trends
- Pricing Trends
- Regulatory Trends
- Market Size and Forecast
- Market Outlook
- Technology Roadmap
- Distribution Chain Analysis
- Competitive Factors
- Key Market Players
- Strategic Conclusion
Definition / Scope
Orthopaedics is the branch of medicine concerned with the prevention and treatment of the deformities, diseases and injuries of skeleton and associated structures. Biomaterials are either natural or synthetic components that interact with the biological systems, which can be alive or lifeless.
Here, Orthopaedic biomaterials are the synthetic or organic materials of biological composition which are implanted into or near the injured/fractured bone in order to internally fix and heal it. It assists to re-establish the structure of the injured bone (caused by accidents, disease conditions and others).
For this, bone graft replacements, cell therapy, Orthopaedic stem cells, cartilage repair, and bone allografts are done. Orthopaedic biomaterials market is concerned with the production, distribution and sales of the biomaterials used for the correction of Orthopaedic disorders.
The Orthopaedic biomaterials materials are segmented into following segments on the basis of the materials type and applications:
The Orthopaedic biomaterials market in the US is valued at USD 3.84 billion in 2019, increased form USD 2.84 billion in 2015. It is expected to grow at the CAGR of 8.69% within the forecasted time horizon of 2020-2025. Its market value is forecasted to reach USD 6.29 billion by the end of the year 2025.
On the basis of the materials type, the ceramics and bioactive glasses biomaterials segment is dominating the market with the market share of 30.43% of total Orthopaedic biomaterials market in the US because of the excellent affinity of ceramics to integrate with the surface material of bone.
The market size of this segment is valued at USD 1.16 billion in 2019. It is followed by polymers (26%), calcium phosphates cements (21.73%), metal biomaterials (13.04%) and others.
On the basis of the application, the bone morphogenic proteins segment is leading the market share of almost 18% of the total Orthopaedic biomaterials market in the United States. The market size of this segment is valued at USD 0.69 billion in 2019.
Increasing number of sport related injuries and rising prevalence of bone related disorders are driving the growth and development of the Orthopaedic biomaterials in the US.
However, safety and health issues related to bone graft and replacement might restrain the growth of its market. The key market players engaged in the Orthopaedic biomaterials market are Carpenter Technology Corporation, Celanese Corporation, Coors Tek Inc., Berkeley Advanced Biomaterials, etc.
- Safety and risk issues related to bone replacement
Although the bone replacements and grafts are the best treatment procedures for the treatment of the bone related disorders such as osteoporosis, there is a risk for health and life of the affected individual.
According to the American Academy of Orthopaedic Surgeons, almost 2% of cases are at the risk of serious complications. Along with this, almost 1% of the individual experience the postoperative infection and 25 of the individuals are at the risk of blood clot.
The 30-day mortality rate for the knee replacement is about 0.25. Here, the risk for the mortality and serious complication is low. However, it might restrain the growth of the Orthopaedic biomaterials market.
Top Market Opportunities
- Increasing number of sport-related injuries
In the context of the United states, the participation of the Americans in the physical activities and sports is in increasing trend. As a result, the tendency of causing sports related injuries are also in the increasing numbers.
According to the national health statistics report, almost 8.6 million sports and recreation related injuries are occurred annually on average in the context of the United States. The age-adjusted rate of the sports related accidents is about 34.1 per 1,000 population.
Here, almost 50% of these sports and recreation related injuries require the treatment or hospitalization. As per the body parts being injured is concerned, almost 42% of the injury of the lower extremity, 30.3% are of upper extremity and 16.4% of the injuries related to the head and neck.
Along with this, almost one-third of the injuries occurred in the childhood stage are related to the sports in the US. This increasing number of the sports related injuries will create the demand for the injuries related treatment services and will also provide the significant opportunity for the growth of the Orthopaedic biomaterials market
- Growing expenses on health care
The health care spending by the private and governmental organization in the United States in in increasing trend. The health care spending is expected to increase to 19.4% by the year 2027, from 17.9% of the gross domestic product of the country.
It is forecasted to reach USD 6 trillion by the end of the year 2027. Along with this, the governmental health programs such as Medicare are also in growing state. It will provide the opportunity for the financial investment in the sector of the Orthopaedics biomaterials, which will significantly favor the development of its market value and size.
- Increasing aged population
In the context of the United States, the proportion of the aged population is in increasing trend. Over the past decade, the population of the age 65 and above has been increased by 33% from 37.2 million to 49.2 million.
It is estimated to be doubled by the year 2060 and will reach 98 million. Along with this, it has also been estimated that out of every five US citizens, one Us citizens will be of the retirement age.
As the age progresses, the cartilages of the human body is prone to strain and fatigue as well as the flexibility of the connective tissues such as ligaments are declined due to less water content, which leads to arthritis and bone related complications.
So, with the increment of age, the risk of the bone fracture increases. This increasing trend of aging population will drive the market for the treatment of the bone fractures and other bone related disorders, which will ultimately favor the growth and development of the Orthopaedic biomaterials.
- Increase prevalence of bone disorders and degenerative diseases
The bone related disorders such as osteoporosis, osteopenia are in increasing frequency in the US. On average, almost 1.5 million osteoporotic fractures are occurred annually. Here, more than a half of the affected US citizens are hospitalized for treatment.
The chances of occurrence of these bone degenerative diseases is the most common among aged women. On average, four out of every ten women aged more than 50 years experiences either hip, spine or wrist fracture.
Besides this, about 10 million US population over 50 years of age have osteoporosis of the hip. It has been expected that one in every Americans will be at risk for the development of the osteoporosis of hip by the end of the year 2020. The rising number of bone related issues id driving the growth and development of the Orthopaedic biomaterials market.
- Product recall of Orthopaedic replacement products
The product manufacturers sometimes request the consumer or seller to return the product after the discovery of the product defects and safety issues associated with it.
About 1,000 implants parts used for the purpose of the knee surgeries are affected by the recalls of the products because of its faulty design, improper fit, loosening and early wear.
In the context of the United States, almost 485 recalls are made by the Depuy Synthes, 355 by Zimmer Biomet and 125 recalls by Stryker within the time period of 15 years(2003-2018). This recalls might influence the demand for these products, which will ultimately restrain the growth of the Orthopaedic biomaterials market.
- High research and development costs
The research and development activities in the field of Orthopaedics require the biological infrastructures, technical expertise, and finance. The cost required for the development of the Orthopaedic research laboratory is quite high.
Its costs ranges from USD 500 thousand to USD 1 million for the development of the well-established experimental based biomechanics program in the context of the United States.
This high level of cost required for the research and development is quite challenging for the key market players engaged in the research and development activities of the Orthopaedics.
The technological advancement is widening the scope for the development of Orthopaedic biomaterials market. Some of the key technological changes in Orthopaedic biomaterials market are as follows:
- 3D printed Orthopaedic implants: 3D printing is the new additive manufacturing technique which support to form the 3D structures in the controllable manner in the field of the Orthopaedics, tissue engineering, regenerative medicine, etc. It has been estimated that almost ten thousand 3D replacement parts for the hops, knees, ankles, parts of spines and skulls will be used.
- Smart biomaterials: These biomaterials are capable of converting energy from one form into another in response to the stimuli present in the environmental conditions (temperature, pH, moisture, electricity, magnetic fields, etc). The most popular biomaterials are ceramic, alloy, gel and polymers.
- Surface bio-functionalization techniques: This technique helps to enhance the surface coverage of biosensor in order to improve the sensitivity and linear response in the wide dynamic range.
- Biodegradable metallic biomaterials: These metals dissolves completely and assists the tissue healing process with no implant residues.
The price of the products of this Orthopaedic biomaterials market depends upon the type of materials, end users, type of the bone disorders, type of services and technological applications.
The cost of the knee replacement is quite high in the US, its costs almost three times more than that of Mexico.
In the context of the United States, the price of the total knee replacement ranges from USD 45,000 to USD 70,000. On average, cost required for the total knee replacement is USD 49,599 while the price of the partial knee replacement is almost 10% to 20% less than the complete one.
The cost required for the ankle replacement ranges from USD 14730 to USD 40,507. The national average cost of the ankle replacement is USD 23,936. Along with the application, the price of the bone replacements differs in accordance to the location of the country.
For instance, the average cost of the GA ankle replacement costs USD 10,200 to USD 28,000 while it costs USD 13,700 to USD 37,600 in Phoenix.
In the context of the United States, FDA regulates the tissues and living cells including Orthopaedics biomaterials. The key regulations directly or indirectly related to the Orthopaedics biomaterials market are discussed as follows:
Public health service Act: According to this act, HCT shouldn’t cause the systemic effect on the recipient and is not dependent on the metabolic activity of living cells for its primary function.
Regenerative Medicine Advanced Therapy Designation: It is the new category of FDA which includes the designations for cell therapies, gene therapies and therapeutic tissue engineering products, human cell & tissue products and combination products.
According to it, the drug is eligible for the sale if the drug in intended to treat, modify, reverse, and cure a serious or life threatening conditions.
Market Size and Forecast
The total market size of the Orthopaedic biomaterials market is the US is valued at USD 3.84 billion in 2019, increased form USD 2.84 billion in 2015.
It is expected to grow at the CAGR of 8.69% within the forecasted time horizon of 2020-2025. Its market value is forecasted to reach USD 6.29 billion by the end of the year 2025.
On the basis of the materials type
- The ceramics and bioactive glasses biomaterials segment is dominating the market with the market share of 30.43% of total Orthopaedic biomaterials market in the US because of the excellent affinity of ceramics to integrate with the surface material of bone. The market size of this segment is valued at USD 1.16 billion in 2019.
- The polymers segment account for the market share of almost 26% with the market value of USD 1 billion in 2019.
- The calcium phosphates cements segment account for the market share of almost 22% with the market value of USD 0.83 billion in 2019.
- The metal biomaterials segment account for the market share of almost 13.04% with the market value of USD 0.5 billion in 2019.
- The remaining 9% is accounted by the composites segment with the market size of 0.33 billion in 2019.
On the basis of the application
- The bone morphogenic proteins segment is leading the market share of almost 18% of the total Orthopaedic biomaterials market in the United States. The market size of this segment is valued at USD 0.69 billion in 2019.
- The hip implants segment also account for 18% of the total Orthopaedic biomaterials market in the United States with the market share of 0.69 billion in 2019.
- The knee implants segment accounts for 11% of the total Orthopaedic biomaterials market in the United States with the market share of 0.42 billion in 2019.
- The resorbable products segment accounts for 7% of the total Orthopaedic biomaterials market in the United States with the market share of 0.26 billion in 2019.
- The growth factors segment accounts for 2% of the total Orthopaedic biomaterials market in the United States with the market share of 0.07 billion in 2019.
The US Orthopaedic biomaterials market is expected to grow at the CAGR of 8.6% within the forecasted time period of 2020-2025 because of the increasing trend of the bone related disorders and rising aging population. It will reach USD 6.29 billion by the end of year 2025.
The technological changes such as adoption of 3D printing technology, sensors occurring in this Orthopaedics biomaterials market are creating the favorable environment for the development of its market.
Advancing technology is driving the development of the innovation solutions for the Orthopaedic disorders through a variety of research and development activities in the experimental biological laboratories.
Distribution Chain Analysis
The key stakeholders involved in the operation of the Orthopaedic biomaterials market are product manufacturers, distributors, sales, and end users.
As first, research and development institutions engaged in the field of the Orthopaedics and other therapeutic procedures identify the innovation solutions for the Orthopaedic disorders then it is verified by the concerned governmental authority.
After the approval, the biomaterials are manufactured by the product manufacturers and distributors sell it to the consumer through various distribution channels such as hospital, rehabilitation centers, etc.
The key market players (product manufacturing companies, research and development organization) engaged in the Orthopaedics biomaterials market are competing for the improvement of the designs of nanophase materials to improve reliability and functionalities of implants.
Along with this, they are focused on the development of the smart biomaterials for the treatment of the Orthopaedic disorders.
Key Market Players
Short profile of the key market players engaged in the Orthopaedics biomaterials market are discussed as follows:
- Carpenter Technology Corporation: It manufactures and distributes stainless steels and corrosion- resistant alloys as the biomaterials for the purpose of the Orthopaedics treatment and others. Its market revenue is USD 2.38 billion in 2019.
- Berkeley Advanced Biomaterials: It is the specialized company engaged in the production of the hydroxyapatite, tricalcium phosphate and calcium based products.
- Celanese Corporation: It is the global company, which develops and manufactures the chemicals and specialty materials including the Orthopaedic biomaterials.
- Coors Tek Inc.: It is the global company which manufacturers ceramics for the multiple purposes such as aerospace, automotive, chemical, electronics, medical, etc. Its revenue is valued at USD 820 million in 2019.
US Orthopaedic Biomaterials Market is growing at the rate of 8.6% because of the rising aging population, increasing sports related injuries and bone related disorders. However, the product recalls and health risks associated with the bone replacement might restrain the growth of its market.
So, the market players engaged in the Orthopaedic biomaterials market must be focused on the development of the smart and biodegradable biomaterials.
- HCT= Human cells and tissue based products
- FDA= Food and Drug Administration
- USD= United States Dollar
- CAGR= Compound Annual Growth Rate