Hyaluronic Acid Viscosupplementation: The Criticism.
Hyaluronic Acid injections similar to any other medical device and pharmaceutical drug have to undergo rigorous clinical trials to attain regulatory approval. In the last decade, there have been numerous attempts to understand and justify the benefits associated with the use of hyaluronic acid injections. Contrary to it, there have been several clinical trials that have denied the existence of any positive effects with the use of hyaluronic acid injections for the treatment of osteoarthritis. The American Association of Orthopedics has been the strongest critic over the years. The important thing here is to understand the reason for such criticism. The treatment procedure which has been approved by FDA is facing retaliation poses several questions. The best answer to it is the lack of meaningful data to prove clinical efficacy. The clinical trials have not been completely successful because of error in determining the correct sample size, government support and lack of statistical data for making comparison.
So how do we make sure that hyaluronic acid viscosupplementation comes out clean? The first and foremost approach will be to conduct large scale clinical trials across different regions. There is a large patient pool waiting for government reimbursement for hyaluronic acid injections. European countries such as Spain, France and Italy have faced cutbacks or led to an out of pocket market situation due to lack of clinical trials. This will make a major impact on the market dynamics as more companies will enter the market. The patient population will be able to afford the treatment as the cost-benefit relationship attains a realistic balance.
The market for hyaluronic acid viscosupplementation is going to hit saturation in the next 10 years if there is no innovation. The immediate need is to put the question of clinical efficacy to rest. The market will take care of innovation once the approval mechanism becomes crystal clear. We are going to witness an increase in the patient pool that is going to be in need of viscosupplementation. It’s time that we address the elephant in the room.
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