Bone stabilization system, also known as photodynamic bone stabilization system (PBSS), is a minimally invasive surgical technique used for surgical repair of osteoporotic fractures of long bones. Majority of osteoporotic long bone fractures occur in the metaphyseal area, which presents further difficulties for surgical repair due to high intramedullary volume. In 2014, IlluminOss Medical received conditional approval from the U.S. Food and Drug Administration (FDA) to conduct a clinical trial for the treatment of impending and pathologic fractures in the humerus due to metastatic carcinoma. In January 2018, IlluminOss Medical received the FDA de novo clearance for the IlluminOss Bone Stabilization System for treatment of impending and actual pathological fractures of the humerus, radius, and ulna from metastatic bone disease.
Rise in incidence of osteoporotic long bone fractures, unmet medical needs, unavailability of proper procedures or techniques to treat osteoporotic long bone fractures, and surge in demand for technologically advanced products are expected to drive the market during the forecast period. According to the International Osteoporosis Foundation, globally, osteoporosis causes more than 8.9 million fractures each year, resulting in an osteoporotic fracture every three seconds and osteoporosis affects an estimated 75 million people in Europe, the U.S., and Japan.
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Osteoporosis is estimated to affect 200 million women worldwide, with one-tenth women aged 60, one-fifth women aged 70, two-fifths women aged 80, and two-thirds women aged 90. However, availability of osteoporosis drugs and stringent regulations for medical devices are the major factors likely to hamper the growth of the global bone stabilization system market during the forecast period.
The global bone stabilization system market can be segmented based on end-user and region. In terms of end-user, the market can be classified into hospitals, orthopedic clinic, ambulatory surgical centers, and others. The hospitals segment is expected to account for larger market share due to increase in patient preference for minimally invasive surgical procedures and adoption of technologically advanced products.
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In terms of region, the global bone stabilization system market can be segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America was a significant market for bone stabilization systems in 2017 and the trend is expected to continue during the forecast period. Dominance of North America is attributed to presence of large osteoporosis patient pool, world-class medical infrastructure, rise in awareness about the disease and its treatment, and regulatory approval of new products.
In January 2018, IlluminOss Medical received the U.S. Food and Drug Administration de novo clearance for the IlluminOss Bone Stabilization System for treatment of impending and actual pathological fractures of the humerus, radius, and ulna from metastatic bone disease. Europe was also a significant market for bone stabilization system in 2017, due to increase in economic and health care burden of osteoporotic fractures, rise in government initiatives, and surge in demand to cut down costs related to osteoporotic fractures treatment.
According to the National Center for Biotechnology Information, the economic and health care burden of osteoporotic fractures in the European Union is estimated at US$ 43.8 Bn (EUR 37 Bn) each year, with patients suffering significant pain, disability, and reduction in quality of life. Increaser in number of women suffering from osteoporosis, aging population, surge in awareness about bone disorders and overall health, and rise in health care expenditure are some of the factors projected to boost the bone stabilization system market in Asia Pacific during the forecast period.
According to the United Nations Economic and Social Commission for Asia and the Pacific (UNESCAP), one in four people in Asia Pacific will be 60 years old or older by 2050. The region is experiencing population aging at an unprecedented pace, with the number of older persons expected to more than double, from 535 million in 2015 to about 1.3 billion by 2050. The bone stabilization system market in Latin America and Middle East & Africa is expected to be driven by increase in health care expenditure and new product launch. For instance, in January 2014, IlluminOss Medical launched photodynamic bone stabilization System (PBSS) in Israel. IlluminOss Medical is the only player operating in the global bone stabilization system market.