The global bone biopsy market size was valued at USD 228.1 million in 2022 and is projected to reach USD 405.4 million by 2031, registering a CAGR of 6.6% during the forecast period (2023-2031). The increased cancer prevalence is driving the bone biopsy market growth.
A bone biopsy is a medical procedure involving removing a small sample of bone tissue for diagnostic or investigative purposes. This procedure is typically used to investigate potential bone-related diseases, analyze bone disorders, and identify the cause of abnormalities. Biopsies of the bone are essential for determining the nature of bone lesions, detecting infections, and diagnosing bone cancers or metabolic bone diseases.
Additionally, the increasing prevalence of bone malignancies and the increasing acceptability of bone marrow biopsy for diagnosis and treatment of lymphoma and leukemia illness are driving the growth of the worldwide bone biopsy market share. Furthermore, improved healthcare infrastructure throughout emerging markets presents a profitable opportunity for the business. Conversely, stringent regulatory regulations are likely to limit market expansion.
The increasing prevalence of bone-related disorders such as cancer, metabolic bone diseases, and infections drives the demand for bone biopsy procedures. As the global population ages, the prevalence of bone conditions is expected to rise, contributing to the market trend. Osteoporosis, a common metabolic bone disorder characterized by decreased bone density, affects a large proportion of the elderly population. According to the International Osteoporosis Foundation, osteoporosis affects an estimated 200 million women and 75 million men aged 50 and older worldwide. As the prevalence of osteoporosis rises, so does the demand for bone biopsies to assess bone health and diagnose related conditions.
Furthermore, according to the NCBI, approximately 1.5 million people suffer a bone disease-related fracture each year. Fracture risk rises with age and is highest in women. According to the American Cancer Society, there will be 1.9 million new cancer cases and 609,360 cancer deaths in the United States in 2022. Each year, over 3,200 people in the United States are diagnosed with primary cancer of the bones and joints. Bone cancer is a type of sarcoma that begins in the bone. The rising prevalence of these bone disorders emphasizes the importance of accurate and timely diagnosis via procedures such as bone biopsies. Early detection allows for quicker intervention and treatment, which results in better patient outcomes. The incidence of bone disorders is expected to remain a driving force behind the demand for bone biopsy procedures as healthcare systems implement preventive strategies and awareness campaigns. Diagnostic technology advancements will improve the ability to detect and diagnose these disorders earlier, influencing the bone biopsy market trend.
Stringent regulatory regulations can limit the growth of the market significantly. While regulatory processes are necessary to ensure patient safety and the efficacy of medical procedures, they can sometimes cause delays in the approval and adoption of new technologies or methodologies in bone biopsy. These delays can impede the timely introduction of innovative solutions and limit healthcare providers' options. Bone marrow cell separators in India must register as of April 1, 2021. Before being imported into India, all medical devices must have an MD-14/MD-15 Import License from the CDSCO as of October 1, 2023. Non-measuring/sterile Class A devices do not require an Import License but must be registered online. Similarly, the FDA will acknowledge receipt of a submission for approval within 60 days. Still, the average time to receive clearance is 177 days (nearly six months), with only 19% cleared within three months. However, the time required for clearance can vary depending on the type of device submitted.
In addition, the European Medicines Agency (EMA) conducts a thorough evaluation process. Approval can take several months to over a year, depending on the type of regulatory procedure and the evidence the manufacturer provides. As a result, the longer regulatory approval timelines may delay the market entry of innovative bone biopsy technologies. This delay may impact the adoption of improved diagnostic methods, potentially limiting access to advanced and more efficient biopsy procedures for healthcare providers and patients.
Biopsy device advancements continue to provide opportunities to improve the precision, safety, and efficiency of bone biopsy procedures. Imaging guidance, automation, and real-time monitoring advancements can all help to improve diagnostic accuracy and patient outcomes. Nanotechnology is being used to create new sensors and devices for the detection and analysis of liquid biopsy biomarkers, which have the potential to be more sensitive and specific than existing technologies. Furthermore, to improve accuracy, advanced imaging technologies such as magnetic resonance imaging (MRI) and computed tomography (CT) are increasingly being integrated into biopsy procedures. Siemens Healthineers opened a new CT scanner production unit in India in 2022 to meet the growing demand for CT scanners and strengthen its market position.
Additionally, technological advances improve the accuracy of bone biopsies, procedural efficiency, and patient comfort. These advancements can lead to more precise diagnoses, shorter procedure times, and improved overall safety, propelling the use of advanced biopsy devices in clinical settings. Future trends in technology include incorporating artificial intelligence (AI) algorithms for real-time image analysis, further enhancing the diagnostic capabilities of bone biopsy devices. Furthermore, developing innovative biopsy tools with connectivity features may allow seamless communication between devices and healthcare systems, streamlining data management and analysis.
| Study Period | 2019-2031 | CAGR | 6.6% |
| Historical Period | 2019-2021 | Forecast Period | 2023-2031 |
| Base Year | 2022 | Base Year Market Size | USD 228.1 million |
| Forecast Year | 2031 | Forecast Year Market Size | USD 405.4 million |
| Largest Market | North America | Fastest Growing Market | Asia-Pacific |
The global bone biopsy market analysis is conducted across North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.
North America is the most significant global market shareholder and is estimated to grow at a CAGR of 6.4% over the forecast period. The United States has one of the most well-established healthcare infrastructures in the world, which will also benefit the bone biopsy systems market. Low bone mass is thought to be responsible for over 1.5 million fractures in the United States each year, resulting in 500,000 hospitalizations and nearly 200,000 nursing home placements, increasing the country's demand for bone biopsy systems. The impressive growth of America's healthcare industry offers significant opportunities for bone biopsy system suppliers. Growing government and end-use industry initiatives, funding for the healthcare sector, and ongoing research will likely create several opportunities for bone biopsy device manufacturers shortly.
Asia-Pacific is anticipated to exhibit a CAGR of 6.7% over the forecast period. This is due to factors such as improved healthcare infrastructure, government initiatives, and an increasing patient population with bone cancer, bone infection, osteoporosis, chronic kidney disease, and other bone disorders. According to the International Osteoporosis Foundation, by 2050, Asia is expected to account for more than half of all osteoporotic hip fractures worldwide. Moreover, according to a World Health Organization (WHO) report, several Asia-Pacific countries, including China, Japan, and India, have steadily increased healthcare expenditures. This spending increase helps develop and improve healthcare infrastructure, including facilities for advanced diagnostic procedures like bone biopsies. According to the World Health Organization's 2019-2020 report, India's total health expenditure (THE) was Rs 6,55,822 crores, or 3.27% of GDP and Rs 4,863 per capita.
Furthermore, some Asian countries, such as Singapore and Thailand, are emerging as medical tourism hotspots. Patients from other regions travel to these countries for healthcare services, including specialized procedures such as bone biopsies. This trend contributes to the expansion of the region's bone biopsy industry.
Europe accounted for 28% of the global bone biopsy systems market. Europe has settled mainly on three systems: single-payer, socialized, and privatized but regulated, creating a sizable market opportunity for bone biopsy system manufacturers. Government initiatives and more favorable reimbursement conditions are expected to boost the market in the region, particularly in the United Kingdom, Germany, and Italy. In Italy, for example, the government has authority over industry providers and health insurance. The national healthcare system covers every citizen, and government-employed doctors provide free services, creating a highly lucrative and affordable market for bone biopsy systems.
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Needle Biopsy accounts for the largest share of the bone biopsy market. Needle biopsy is a minimally invasive procedure in which a small tissue sample is extracted using a thin, hollow needle. This type of biopsy is commonly used for bone biopsies because it is less invasive and less complicated than open biopsies. To precisely target the area of interest, needle biopsies can be performed under imaging guidance, such as X-ray, CT scan, or ultrasound. This technique is frequently used for needle-accessible lesions or abnormalities, allowing for accurate diagnosis with minimal trauma to surrounding tissues.
The surgical removal of a more extensive section of bone tissue involves open biopsy, also known as surgical or incisional biopsy. This procedure is more invasive than needle biopsy and necessitates a small incision to access the affected area directly. Open biopsies may be used when a larger sample is required for a more comprehensive analysis or when the lesion is in a location that is difficult to reach with a needle biopsy.
The market can be further bifurcated into MRI-guided and CT-guided. MRI-Guided, An MRI-guided biopsy is a specialized technique that uses magnetic resonance imaging (MRI) technology to guide a biopsy. This imaging modality provides precise guidance during the biopsy by giving detailed and real-time images of the targeted area. MRI-guided biopsies are especially useful for lesions or abnormalities that may not be visible using other imaging methods. MRI-guided biopsies are commonly used when investigating bone abnormalities, particularly in regions requiring highly detailed imaging for accurate targeting. Using other imaging techniques, this method helps collect samples from areas that are difficult to visualize.
A CT-guided biopsy is a procedure that uses computed tomography (CT) imaging to guide it. CT scans produce detailed cross-sectional images of the body, allowing healthcare providers to visualize the targeted area in three dimensions. CT-guided biopsies are helpful for pinpointing lesions and abnormalities visible on CT scans.
Hospitals and Clinics, Bone biopsy procedures are widely used in hospitals and clinics, where they play an essential role in diagnosing and treating various bone-related conditions. Bone biopsies are performed regularly in hospitals, including extensive medical facilities and smaller clinics. Hospitals have the infrastructure and resources to handle many bone biopsy cases, from routine diagnostic procedures to more complex interventions.
Compared to traditional hospitals, surgical centers, also known as ambulatory surgery centers (ASCs), focus on providing outpatient surgical procedures in a more specialized and efficient setting. These facilities are intended to offer same-day surgical interventions, such as bone biopsies, while reducing the need for overnight stays. Advanced equipment and specialized staff dedicated to specific procedures are standard features of surgical centers. Bone biopsy procedures performed in surgical centers contribute to streamlined processes, lower costs, and increased patient convenience, particularly in cases where hospitalization is not required.
