By Payam Moghimi-Bidhendi and Jesse Spicer – iData Research Inc.
The European orthopedic biomaterials market is broadly driven by the aging population and for being an attractive alternative for patients looking to avoid surgical implantation of permanent devices or hardware. Orthopedic surgeries are generally complicated, multi-stage procedures that result in longer recovery times and increased blood loss. Biomaterials that are currently offered in the market aim to treat orthopedic conditions or complications through regeneration as opposed to surgery. In particular, bone marrow concentrates and synthetics are promising agents for the treatment of orthopedic disorders. Hence, the treatments that are experiencing the fastest growth in the European orthopedic biomaterials market coincide with these treatment segments. Furthermore, within other moderate growth areas of the market, such as the hyaluronic acid (HA) segment, consumer preference for single-injection treatments is growing, mainly due to the convenience of single-injection in comparison to the traditional five-injection treatments.
The orthopedic cell therapies market which consists of platelet rich plasma (PRP) and bone marrow aspirate concentration (BMA) is gaining more popularity in Europe. The growth is attributed to demand outpacing the decline in average selling price (ASP) and more surgeons becoming familiar with its benefits. Products classified as using PRP or BMA are preferred in order to increase the fusion between the grafts and the proprietary bone. Some markets such as Italy will experience higher growth than more conservative markets in Scandinavia, which prefer to wait until more clinical evidence justifies the use of orthopedic cell therapy products. Thus, due to a lack of clinical evidence and high ASP, these products are expected to grow only moderately across Europe in the next several years.
The HA market is suffering from price deflation. While cycles sold are expected to grow slowly, this growth is outweighed by decreasing ASPs across all cycle variations. These opposing forces have stalled the entire HA market, leading to minimal growth prospects.
Shifting Hyaluronic Acid Market
The hyaluronic acid (HA) market represents the largest segment in the European orthopedic biomaterials market. This segment is expected to remain stable over the next several years. The single and three-injection cycles were the fastest growing segments in the HA market, albeit very slightly compared to the U.S. HA market over the same time period. However, the five-injection cycle segment was growing in Germany but declining in almost every other market in the region. As mentioned above, the average selling prices (ASP) of HA products will offset any significant growth in the number of cycles sold, and thus the overall market will remain very stable in years to come.
The growth of these markets is greatly influenced by the reimbursement structures for the products. Although most brands are considered medical devices, in some countries such as Germany, Italy, Greece and Scandinavia, some products are classified as pharmaceuticals. Reimbursement policies in each region can directly affect the ASP and patient preference in the HA market.
Patients who suffer from osteoarthritis experience acute joint pain, tenderness, stiffness, creaking, locking of the joints and inflammation. Hyaluronic acid treatment can delay knee replacement for up to a year. Sometimes, consecutive cycles of hyaluronic acid treatment can provide even longer relief. If relief can be provided with fewer injections, therefore fewer visits to a doctor are needed. Five injection products were the first on the market and have lost share to three-injection treatments. More recently, three-injection products have been losing share to single-injection treatments. There can be difficulties involved in using single-injection products such as inflammation or stiffness in the knee. Also, some patients simply do not gain relief from single or three-injection products. For these reasons, it is unlikely that single-injection treatments will become the sole hyaluronic acid treatment method.
The growth of single-injection products has been one of the most significant trends in the market. Sanofi Genzyme’s Synvisc-One® is the leader in the fastest growing HA segment, the single-injection cycle market. However, Fidia Farmaceuticals has retained its leading spot in the overall HA market for Europe as well as introducing its relatively new and unique two injection products, Hymovis®. Fidia Farmaceuticals was one of the pioneers of the HA business, and with this new two-injection cycle product, they will maintain growth over the next several years as the overall market trends towards the lower injection treatment cycle options.
Resurgence in Orthopedic Growth Factor
The orthopedic growth factor market was the third largest segment in the European orthopedic biomaterials market and it is expected to grow over the next several years. Orthopedic growth factors are a group of small, soluble proteins that bind onto cell surface receptors, triggering a series of signals that regulate the body’s ability to grow, renew and heal. Due to the regenerative properties of growth factors, they have been exploited for bone healing in orthopedic applications. The BMP market received a boost both from Olympus’s exit and an increase in approved indications. Back in 2014, Medtronic’s InductOS® received approval to be used in every surgical approach to the spinal column and cage. While this market suffered in previous years from negative publicity regarding adverse effects from off-label BMP use, it is expected to grow after several studies have verified its safety. This will lead to an increase in quantities demanded across the entire European Union.
The European orthopedic biomaterials market has experience a change in focus in terms of aligning products with the fluctuations of consumer driven demand. These include the trend for HA single and triple injection treatments over the traditional five injections. Moreover, price erosion in the bone graft substitute market threatened to send the market into contraction had it not been for the rise of synthetics. Overall, the European orthopedic biomaterials market has experienced fluctuations in quantities, units sold, ASPs, and competitors have been rapidly changing in response to these various market forces. Changes in regulations, reimbursement policies, and approved indications for some products, such as Medtronic’s InductOS®, are the drivers for growth in the European market.
Payam Moghimi-Bidhendi is a market research analyst at iData Research and was the lead researcher for the 2016 U.S. orthopedic biomaterials report. His current work includes the 2017 European orthopedic biomaterials and the U.S. small bone and joint orthopedic devices market.
Jesse Spicer, is a senior analyst team leader at iData Research and has been heavily involved with the company’s endoscopy division throughout his tenure. As a research analyst, he led several research projects on key global medical device markets including soft tissue reinforcement and regeneration, laparoscopy, video integration, operating room equipment and wound care.
Europe Market Report Suite for Orthopedic Biomaterials 2017 – MedSuite – iData Research Inc.