Viscosupplementation is a procedure in which hyaluronic acid (HA) is injected into the knee joint for the treatment of osteoarthritis (OA) of the knee. HA is a naturally occurring glycosaminoglycan and an integral component of synovial fluid and cartilage matrix present in the joints.
Europe viscosupplementation market is estimated to account for US$ 241.8 Mn in terms of value and is expected to reach US$ 343.6 Mn by the end of 2027.
Europe Viscosupplementation Market: Drivers
Increasing prevalence of OA is expected to propel growth of the Europe viscosupplementation market over the forecast period. For instance, according to the study, ‘Prevalence and development of hip and knee osteoarthritis according to American College of Rheumatology criteria in the CHECK cohort’, published in January 2019, in BMC Arthritis Research & Therapy, 63% of the participants in the Netherlands suffered from hip OA and 92% of participants with knee complaints were classified as having knee OA.
Moreover, increasing geriatric population is also expected to aid in growth of the market. For instance, according to Office of National Statistics, U.K. 2018, there are nearly 12 million people aged 65 and above in the U.K. of which 5.4 million people are aged over 75, 1.6 million are aged over 85, over 500,000 people are over 90, and 14,430 are centenarians.
Three injection cycle held dominant position in Europe viscosupplementation market in 2019, accounting for 59.5% share in terms of value, followed by five injection cycle, and single injection cycle, respectively
Figure 1. Europe Viscosupplementation Market Share (%), by Value, by Type, 2019
Europe Viscosupplementation | Coherent Market Insights
Europe Viscosupplementation Market: Restraints
Side effects of viscosupplementation are expected to hinder growth of the market. These side effects include, temporary injection-site pain, swelling, and bruising around the joint.
Moreover, European market is highly segmented with a lot of regional players entering the market. The competition in the region is especially huge in case of the five cycle injections. Europe is a mature market in terms of generic medical devices and as a result of the relative ease of obtaining a CE mark in Europe as compared to the U.S. FDA approval, the intensity of competition in the region has been observed to be immense. Such regional competition is expected to limit the market growth.
Europe Viscosupplementation Market: Opportunities
R&D related to viscosupplements is expected to offer lucrative growth opportunities for players in Europe viscosupplementation market. For instance, in May 2018, researchers from Humboldt-Universität zu Berlin and Berlin Institute of Health, Germany, reported that HA can influence the cartilage metabolism via upregulation of Metalloproteinase inhibitor 3 in OA-like condition.
In Europe, there has been a rise in the number of osteoarthritis patients seeking alternate options to knee replacement in view of avoiding the side effects associated with NSAID and corticosteroids injections. This factor has changed the overall scenario in the pharmaceuticals industry, propelling the inclination of the players in the market towards the viscosupplementation-based therapy.
Europe viscosupplementation market was valued at US$ 230.4 Mn in 2019 and is forecast to reach a value of US$ 343.6 Mn by 2027 at a CAGR of 5.0% between 2020 and 2027.
Figure 2. Europe Viscosupplementation Market Value (US$ Mn), and Y-o-Y Growth (%), 2019-2027
Europe Viscosupplementation | Coherent Market Insights
Market Trends/Key Takeaways
Viscosupplementation is done on an outpatient basis. It has low recovery time, which makes it best fit for the patients who want to resume work as soon as possible.Viscosupplementation is a convenient procedure for both elderly and young people as the procedure uses single-injection treatments, which helps improve patience compliance.
The European market for viscosupplementation products is fairly mature. In fact, at the global level, the market is now saturated with various categories of HA-based products with changes in their molecular weight. The new trend in this industry is the introduction of new combination products in the market. The product pipeline of major players involves the combination of HA and corticosteroid-based injections, which combine the pain relieving effect of corticosteroids with the long lasting effect of HA that lasts for nearly 6 months.
Regulations
Medical Device Type:
As per European guidelines, viscosupplementation products are classified as Class III type
Definition of Class III: A medical device incorporating medical substance as an integral part, where the action of the medical substance is ancillary
This class is categorized as high risk and premarket approval is required
Parameters considered in Europe:
Standard for approval: Safety and technical performance
Evidences required: Limited data is sufficient, which includes literature review, laboratory testing, and small clinical trials
Approval granted by: Notified bodies including private organizations recognized by EFTA countries. Approval by any notified body authorizes and marketing of the product throughout EU.
Transparency of approval: Neither approval data nor evidence-based data is disclosed to public
Post approval requirements: Side effects are reported to notified bodies and not to any government body
Europe Viscosupplementation Market: Competitive Landscape
Major players operating in Europe Viscosupplementation market include, Sanofi S.A., Anika Therapeutics, Inc., Seikagaku, Zimmer Biomet Holdings Inc., Meda AB (Mylan), Fidia Farmaceutici S.p.A., Bioventus LLC, Ferring B.V, Lifecore Biomedical, and LG Life Sciences.
Europe Viscosupplementation Market: Key Developments
Major players in the market are focused on launching new products to expand their product portfolio. For instance, in December 2019, Fidia Farmaceutici S.p.A. launched TRILURON (sodium hyaluronate), a HA-based intra-articular viscosupplement indicated for the treatment knee OA.
Major players in the market are focused on adopting various strategies to enhance their market share. For instance, in November 2019, Anika Therapeutics Inc. participated in the MEDICA 2019 International Trade Fair (Germany) and the International Cartilage Regeneration and Joint Preservation Society Focus Meeting (Austria).