3D printing i.e. additive manufacturing involves a layer by layer process to create physical objects out of digital 3D blueprints. It was mainly used for rapid prototyping in the late 1980’s. However, it has now become a next-generation technology which can produce localised, on-demand final products or even spare parts. 3D printing is possible with a range of thermoplastics, metal alloys, ceramics & various foodstuffs. It has seen an application in diverse areas like aerospace, retail, supply chain optimisation, & the medical industry. The 3D printed Hip & Knee Implants Market could dramatically improve both the effectiveness of surgery along with reducing the time taken to recover.
It was pioneered by Dr Susannah Clarke and has already been used in hundreds of hip & knee surgeries across the world. It uses CAT scans to create a 3D blueprint of the damaged hip or knee joint to be replaced. Surgeons can then use this to practice the operation on a computer, deciding beforehand where to make incisions or how to realign the bone. The 3D printed hip & knee implant market will help to make replacement surgery much safer & quicker in the long run.
An ageing population in developed countries & China are expected to be the biggest driver of the 3D printed hip & knee implant market. Millions of people worldwide have to undergo either hip or knee replacement surgery every year. It is not people above 60 years but those between ages 45-54 who have shown the largest increase in percentage terms. This is because of improved implant quality and awareness of how they improve mobility and quality of life. Some of these initial surgeries fail due to contracting infections & patients then have to undergo another surgery to replace the implant. This has a much lower success rate & also causes significant pain & inconvenience.
A second driver is that 3D printing is a minimally invasive procedure preferred by patients. Surgeons can rehearse the operation with the help of 3D models beforehand which allows them to make smaller incisions, reduce blood loss & assures an easier recovery. The 3D printed hip & knee implant market helps to reduce costs & inefficiencies as these parts will be an exact fit for an individual patient.
3D printed Hip & Knee Implants Market Restraints, Key Regions and Key Players
While the 3D printed hip & knee implant market has a tremendous scope with the pace at which 3D printing is advancing, there are still major challenges faced today. The first one is long term performance. 3D printed parts are inherently weaker than forged parts which are how traditional metal implants are made today. They are stronger than cast parts, but they wear down much faster than forged parts in lab tests. The second main concern is the lack of regulation. At present, more than 70 3D printed devices have been approved by 510(k) of the U.S. FDA Act and this includes medical implants as well.
While those drafts have been approved, FDA technical guidance is still some time away. It is an open question how restrictive the guidelines will be once published. And this just pertains to the U.S as there is no governing body or standard worldwide. This means that the 3D printed hip & knee implant market will have to go through separate approvals in each country, increasing the effort and time taken by manufacturers.
The largest 3D printed hip & knee implant market is the U.S as half of all joint replacements worldwide take place there. China is the fastest growing market. Implants are heavily regulated there as the country currently imports a majority of them. Greater government pressure to manufacture indigenously is encouraging companies to enter the domestic 3D printed hip & knee implant market. The China Food And Drug Administration has also approved 3D printed hip plants for medical use there. Some companies in the 3D printed hip & knee implant market are Medtronic, DePuy, 3D Systems, Embody Orthopaedics & Smith & Nephew.
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