Bone Growth Products Market

Market Overview

The global bone growth products market size was valued at USD 1.21 billion in 2022. It is estimated to reach USD 1.62 billion by 2031, growing at a CAGR of 3.40% during the forecast period (2023–2031). The anticipated rise in the prevalence of spinal fractures is expected to stimulate market expansion during the forecast period. Factors such as growth in target population and rising strategic acquisitions, significantly drives the bone growth products market demand by 2031.

Bone possesses the innate ability to regenerate as part of the reparative process in response to injury, during skeletal development, and during adulthood's continuous remodeling. Bone regeneration involves a well-orchestrated series of biological events of bone induction and conduction involving multiple cell kinds and intracellular and extracellular molecular-signaling pathways, with a predetermined temporal and spatial sequence to optimize skeletal repair and restore skeletal functions.

The most common form of bone regeneration in clinical settings is fracture healing, which recapitulates the path of normal neonatal skeletogenesis, including intramembranous and endochondral ossification. Approximately 5-10% of individuals have undergone orthopedic surgery or have fractured bones that do not recover or heal slowly. Bone growth products, including stimulator devices, bone morphogenetic proteins, and platelet-rich plasma, repair bone injury and accelerate bone healing.

Market Dynamics

Global Bone Growth Products Market Drivers

Growth in Target Population

Bone fractures are a public health concern worldwide and represent a serious financial burden, especially for osteoporosis patients. It is estimated that 200 million people around the globe have osteoporosis. Osteoporosis causes more than two million fractures yearly, and the number continues to grow. In the case of osteoporosis, treatment can also delay bone loss.

According to the US Bone and Joint Initiative, back pain is considered the significant cause of disability in Americans. The increasing prevalence of spinal disorders around the world has also led to a dramatic increase in the number of spinal surgeries. This will increase the demand for spinal devices. A predicted rise in the incidence of spinal fractures is anticipated to drive market growth over the forecast period.

Rising Strategic Acquisitions

The bone growth products market on a global scale has had notable instances of acquisitions during the past decade. Vendors, especially global players, will pursue inorganic growth strategies such as acquisitions and investments in start-ups and small firms to expand their footprint and strengthen their product portfolio and market expertise. Such inorganic initiatives will complement vendors' organic growth strategies, gaining traction among end-users.

Most acquisitions provide significant opportunities to both parties involved in advancements in the respective product portfolio, market expansion, penetration in existing and new markets, and gaining market share quickly. For instance, Smith+Nephew acquired Integra Lifesciences in January 2021 for USD 240 MN. The acquisition supports Smith+Nephew's strategy to invest in higher-growth segments. It will significantly strengthen Smith+Nephew's extremities business by combining a focused sales channel and an exciting new product pipeline. Such strategic acquisitions will likely change the market dynamics and support market growth during the forecast period.

Global Bone Growth Products Market Restraint

Stringent Regulatory Approval Process for Bone Growth Products

Approximately 25% of bone development products are withdrawn from the market within five years. The non-invasive bone growth stimulator was first assigned to Class III of the risk-based classification under the general rules of medical devices marketed after May 28, 1976. Furthermore, it has not been established that bone growth stimulator devices are comparable to any medical devices reclassified into different classes. Therefore, non-invasive bone growth stimulators must comply with pre-marketing approval requirements, hampering market growth.

Global Bone Growth Products Market Opportunities

Next-Generation Mobile Bone Growth Stimulation Devices 

Bone growth stimulation therapy is an effective, safe, and proven treatment for patients with unhealing limb fractures. If the patient follows the prescription, the cure rate will improve. The new mobile app is a great tool for promoting compliance with prescribed treatments by allowing patients to participate actively in recovery. The mobile device is designed as a non-surgical treatment option for patients with a non-union bone fracture in an extremity with no visible signs of healing, using pulsed electromagnetic field US FDA-approved PEMF as an effective and safe treatment for the non-union of bones.

Subsequently, the application of pulsed electromagnetic field (PEMF) stimulation for bone restoration has witnessed significant expansion in both the United States and Europe. In the United States, a survey showed that 72% of hospitals offer bone repair stimulation treatments for fractures that fail to heal. These devices are based on a unique PEMF technology platform. Pulsed Electromagnetic Field (PEMF) therapy uses technology to stimulate and exercise cells to help resolve cellular dysfunction and to support overall wellness. Such developments create opportunities for market growth.

Regional Analysis

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

North America is the most significant global bone growth products market shareholder and is estimated to exhibit a CAGR of 2.88% over the forecast period. The growth rate of North America is expected to be modest, with indications suggesting that this trend would persist over the forecast period. North America dominated the global market for bone growth products due to the relatively higher penetration of spinal fusion than the other regions and the high volume of spinal fusion and non-fusion surgeries. For instance, in the U.S., elective lumbar fusions increased by approximately 62%, from about 122,679 cases in 2004 to about 199,140 in 2015. The expansion of this region is primarily attributed to the increasing number of orthopedic diseases, accidental injuries, and the elderly population. The availability of advanced, safer, and minimally invasive surgical treatments and technological innovations are further accelerating the market growth in the region.

In addition, the number of seniors in the United States is expected to more than double, from 53 million in 2018 to 95 million in 2060. The percentage of people aged 65 and over is expected to increase from 16% to 23%. The rising population is at a high risk of getting orthopedic diseases and bone defects, thereby augmenting regional market expansion.

Europe is expected to exhibit a CAGR of 3.33% over the forecast period. Europe is the second-largest market for bone growth products globally. The market is growing steadily and is anticipated to boost similarly during the forecast period. The region, particularly Western Europe, has a sophisticated and established healthcare infrastructure, and people have access to advanced healthcare services, especially for treating various spinal disorders using fusion and non-fusion procedures. The market is growing because of the surging prevalence of bone disorders and the availability of reimbursement coverage for spinal fusion surgeries in most European countries. In addition, the prevalence of spine disorders increases with age and is mainly prevalent in the 60–69 age group. The percentage of people over 50 comprises approximately 34% of the total population in Europe. This percentage is expected to increase by nearly 10% over the next 20 years. This aging population would require surgical treatment for spinal diseases, contributing to the high demand for market growth.

The Asia-Pacific market is growing faster than other regions and is expected to continue during the forecast period. This region's healthcare system is also enduring a rapid transformation with the support of numerous government agencies. Further, according to WHO, the increase in healthcare expenditure both by public and private entities has contributed to improvement in healthcare infrastructure in the region. In addition, healthcare providers are focused on providing advanced care to patients, thereby increasing the demand for bone growth products. High healthcare expenditure increases patients' accessibility to a wide range of advanced treatment options for several conditions, such as disc herniation and stenosis, thereby driving the demand for bone growth products.

Brazil is the region's top user of medical devices and has one of the biggest economies in Latin America. The market in Brazil is growing at a healthy rate due to the increasing elderly population and life expectancy rates, changing medical device industry dynamics, and rising private and government healthcare expenditures. Mexico is also a major market for bone growth products in the region. The demand for bone growth products in Latin America can be attributed to the growing incidences of bone diseases, mainly in the geriatric population. For instance, people above 60 years, approximately 43 million in 2000, is expected to reach around 100 million by 2025. Evidence of spinal injuries is also increasing in Latin America steadily. Recent amendments in the insurance and healthcare reimbursement policies in countries such as Brazil and Mexico are further predicted to boost the market's growth in the coming years.

Segmental Analysis

The global bone growth products market share is bifurcated into product type, application, and end-user.

Based on the product type, the global bone growth products market is segmented into bone growth stimulator devices, bone morphogenetic protein, and plasma-rich platelets. 

The bone growth stimulator devices segment is the highest contributor to the market and is projected to grow at a CAGR of 3.45% over the forecast period. Bone stimulators come in a variety of sizes, shapes, and technologies. The most frequently used bone stimulators in orthopedics are electrical and ultrasonic stimulators. Most modern bone stimulators are mounted in small battery packs near the fracture or fusion site and are worn daily for minutes or hours. The purpose of the bone stimulator is to stimulate a series of healing-promoting receptors in the body. The bone stimulator activates the pathways that release chemicals in the body. These chemicals are signals in the body that help heal fractures.

Bone morphogenetic proteins (BMP) are multifunctional growth elements that are members of the superfamily of transforming growth factor-beta (TGF-beta). They were introduced in the medical field to promote bone healing to reduce morbidity compared to the usual methods of bone graft harvest. Bone morphogenetic proteins (BMP) also promote bone growth naturally in the human body. These endogenous proteins can be synthesized, concentrated, and afterward administered within the spinal region to facilitate spinal fusion.

Based on application, the global bone growth products market is segmented into spinal fusion surgeries, oral and maxillofacial surgeries, delayed union and non-union bone fractures, and others. 

The spinal fusion surgeries segment is the largest contributor to the market and is projected to exhibit a CAGR of 3.54% over the forecast period. Spinal fusion is performed to stop the movement of the spine and prevent neurological defects. During the surgical operation, an instrument is utilized to fuse two or more vertebral bodies in conjunction with the application of a bone graft. Bone grafts may include the patient's bone (autologous graft), donor bone (allograft), or other types of grafts. In case of prolonged recovery, bone growth products are used.

During the surgical procedure known as spinal fusion, a medical device called an internal bone growth stimulator is surgically placed. The device is very small and is embedded in a soft tissue pocket under the skin of the lower back on the side of the spine. It supplies a small electric current directly to the area of the spine where bone growth (spinal fusion) occurs.

Non-union of bone following a fracture is an orthopedic condition with high morbidity and clinical burden. Long fractures heal without complications in most patients. Delayed healing or non-unions are observed in a relatively modest proportion of fractures, ranging from 2% to 10%. The fracture healing process involves several stages, including an inflammatory response, soft callus production, hard bone formation, and remodeling. In addition, the delayed union is defined by clinical examination as a lack of radiographic progression of healing or fracture instability within 4-6 months after injury. Non-unions are fractures that do not heal within 9-12 months or prolong the healing process beyond the expected rate.

Based on end-users, the global market for bone growth products is bifurcated into hospitals and clinics, specialty orthopedic and spine centers, and ASCs. 

The hospitals and clinics segment owns the highest market share and is expected to exhibit a CAGR of 2.87% during the forecast period. Hospitals are the first point of treatment for various bone-related issues. Hospitals largely invest in equipping themselves with advanced materials that will help them treat patients better. Increasing lifestyle changes, a growing elderly population, and a rising prevalence of spinal disorders, such as low back pain, spinal stenosis, and degenerative spine disorders, are the major aspects contributing to the increasing volume of spine surgeries in hospitals.

Additionally, physician offices and clinics are the first contact points for people in remote and rural areas. Physicians and doctors recommend advanced treatments and refer patients to large multi-specialty hospitals. The utilization of advanced treatment modalities in clinical settings is subject to some limitations. However, these modalities play a crucial role in the provision of treatment recommendations to patients.

Ambulatory surgical centers (ASCs) are outpatient surgery centers that are an alternative to hospital-based outpatient procedures and provide advanced healthcare facilities to patients. These centers are cost-effective and offer quality care with minimal indirect treatment costs. Although ASCs are the fastest-growing segment compared to hospitals and specialty orthopedic centers, this end-user segment accounts for a minimal market share. This is mainly because most public insurance providers offer limited reimbursements for all orthopedic or spinal implant procedures performed in ASCs.

Recent Developments

• April 2023- Bone Biologics, a developer of orthobiologic products, received approval from the Human Research Ethics Committee in Australia to begin the NB1 bone graft pilot study. Monash Health has been authorized as the initial site for a planned multi-center pilot clinical trial to evaluate the NB1 bone graft.
• October 2022- Theragen confirmed the issuance of a second U.S. patent for its ActaStim-S, a wearable and app-compatible postoperative bone growth stimulator for spinal fusion patients.