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Emerging markets such as China, India, and Japan are the key areas of opportunity for players in this market. However, stringent clinical & regulatory processes and unfavorable healthcare reforms in the US are expected to restrain the growth.
Increased funds and grants by government bodies and universities for the
development of novel biomaterials
The demand for and usage of biomaterials in various medical applications has increased significantly across the globe over the last few years. Also, several government bodies and universities have extended their help in the form of investments, funds, and grants to promote research into the development of novel biomaterials.
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Stringent clinical & regulatory processes
Biomaterial-based medical devices are stringently regulated in several regions, including North America, Europe, and Asia, to ensure their quality and efficacy. This is primarily attributed to the fact that most biomaterial-based medical devices are implantable. All new biomaterials require proof that they are safe and effective before they can be approved for marketing. In the US, the process for approval follows strict guidelines and regulations set by the FDA. According to the FDA, biomaterial-based products such as implantable pacemakers, stents, and heart valves are classified as Class III devices, which pose the highest potential risk of illness or injury. Thus, these devices are subjected to the premarket approval application pathway (which is the most stringent type of device marketing application).
The development of biomaterials involves time-consuming processes and expensive clinical trials. As these products have to be implanted inside the human body, they need to be biocompatible and have to undergo the ISO biocompatibility testing standards. However, it is difficult to anticipate the biocompatibility until the later stages of clinical trials, making companies and investors apprehensive of investing in this market. In addition, regulatory procedures are complicated, restrictive, and depend on biomaterial composition and future application. These factors are expected to restrain market growth to a certain extent in the coming years.
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Shortage of skilled surgeons
According to the Lancet Commission on Global Surgery, ~2.2 million more surgeons, anesthetists, and obstetricians are required in low- and middle-income countries (LMICs) each year. Also, major healthcare markets such as the US, Germany, and the UK are witnessing a dearth of surgeons in their respective healthcare systems. For instance, according to the Association of American Medical Colleges, a deficit of 41,000 general surgeons is estimated in the US by 2025. Similarly, Ohio State University has projected that there would be about 3,000 cardiothoracic surgeons available to cover about 854,000 cases by 2030. Similarly, in the UK, there is 1 vascular surgeon per 137,000 individuals (Source: Survey conducted by the Vascular Society of Great Britain & Ireland in 2016).
The significant shortage of surgeons available to handle the increasing demand for procedures is expected to affect the uptake of implantable devices in the coming years. This is considered as a major challenge for the growth of the biomaterials market.
Key Market Players
Prominent players in the market are Royal DSM (Netherlands), BASF SE (Germany), Corbion (Netherlands), Carpenter Technology Corporation (US), Evonik Industries (Germany), Berkeley Advanced Biomaterials (US), Cam Bioceramics B.V. (Netherlands), Celanese Corporation (US), CoorsTek Inc. (US), CeramTec (Germany), and GELITA AG (Germany).
Royal DSM offers coatings, drug delivery platforms, and a wide range of biomedical materials, such as bioceramics, biomedical polyethylenes, biomedical polyurethanes, collagens, and ophthalmic biomaterials for various applications, such as orthopedics, sports medicine, ophthalmology, general surgery, and cardiology. The company offers polyethylenes under the brand names—Dyneema Purity Woven, Dyneema Purity Black Fiber, Dyneema Purity Radiopaque Fiber, Dyneema Purity SGX Fiber, Dyneema Purity TG Fiber, Dyneema Purity UG / VG Fiber, and Dyneema Purity Membrane.
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Neurological disorder is associated with dysfunction in any part of the brain or nervous system, resulting in physical and/or psychological symptoms. Various neurological disorders are congenital, which emerge during the early years of embryo developmental and may be diagnosed at birth. Whereas, acquired neurological disorders develop after the birth due to traumatic brain injuries, immune disorders, postnatal injections, spinal cord injuries, neoplasm, and exposure to environmental chemicals or toxins, among others.
