The global trauma fixation market, which includes internal and external fixation devices to treat and manage bone fractures and covers 39 markets, is set to experience a minor increase from approximately $6.4 billion in 2015 to $7.4 billion by 2022, at a Compound Annual Growth Rate (CAGR) of 2.2%, according to research and consulting firm GlobalData.
The company's latest report states that global reimbursement and regulatory limitations, as well as the preference for locally manufactured implants in emerging markets, are demanding obstacles which are curbing potential growth.
Ms Jennifer Ryan, GlobalData's Analyst covering Medical Devices, explains: "Medical device regulation has slowly developed into a more rigorous and taxing process, especially for companies attempting the premarket approval path, which requires heavy development and financial commitment to prove the efficacy and safety of a new product."
Proving the efficacy of orthopedic devices has also been a challenge facing companies trying to bring new products to market.
The US 510(k) regulatory process requires that manufacturers demonstrate a device is substantially equivalent to a predicate device before approval is given by the Food and Drug Administration (FDA).