Changing competitive landscape set to expand overall market
With few options available for treating OA pain, joint fluid injections have become a standard part of the treatment regimen for patients with painful arthritic knees. Even though it is not possible to 
predict which knee pain sufferers will respond to viscosupplementation therapy, commonly administered as a series of injections of hyaluronic acid, most patients seeking treatment will at least give it a “try” as an alternative to non-steroidal anti-inflammatory drugs (NSAIDs) and before resorting to joint replacement.
BioMedGPS estimates that nearly 2 million Americans will receive hyaluronic acid injections for knee OA this year resulting in a market valued at more than $1 billion in 2016. Robust growth is projected over the next 5 years as high-priced single injection products take hold; new companies enter the market —some with differentiated products used earlier in the treatment continuum; and longer-lasting combination products make their way through the FDA. By 2020, the market is projected to reach over $1.2B in revenues, according to the recently published SmartTRAK US Joint Fluid Market Overview.
Shifts In Shares
Sanofi remained the market leader in the US Joint Fluid market but experienced a loss of share in 2014, according to SmartTRAK Financial Dashboard. The big winner was DePuy Synthes whose strategy of promoting MONOVISC without cannibalizing ORTHOVISC, led to strong gains in both the single and 3-injection segments DePuy Synthes' overall share increased in 2014 followed by Ferring; Bioventus; Fidia and Zimmer Biomet.
Strong Uptake of Single Injection Products
New entrants in the single injection space with unique "J' codes, specifically J&J's DePuy Synthes Mitek division with MONOVISC and Zimmer Biomet which worked out its distribution challenges with Gel-One, propelled overall market expansion in 2015. With list prices ~$1,000, strong growth is expected in single injection products in spite of increased pricing pressure.
With 75% of Synvisc sales attributed to Synvisc One, Sanofi, still controls the single injection segment but lost ground to DePuy Synthes and Zimmer Biomet which posted solid gains in MONOVISC and Gel-One sales. DePuy Synthes' MONOVISC overtook Zimmer Biomet's Gel-One as the No. 2 player..
Competition Heats Up in 3-Injection Market
Still the largest US Joint Fluid segment is the 3-injection market accounting for nearly 50% of total US revenues in 2016. With the launch of newly approved 3-injection products later this year, competition is expected to heat up as well-entrenched players, such as DePuy Synthes, Ferring and Sanofi, fight to maintain share.
In this arena, DePuy Synthes' experienced the greatest YoY share increases; followed by Ferring and Sanofi according to SmartTRAK Financial Dashboard. Revenues in the 3-injection segment increased 3.8% reaching ~$432.0MM in revenues in 2015.
With Bioventus, which struck a distribution deal with IBSA for GELSYN-3, and Seikagku with Visco-3 joining the 3-injection playing field, the question that arises is how differentiated are these products? Also, not known is what happens if one of these newcomers decides to go “generic” particularly if there is little differentiation among products. What is certain is that the 3-injection market will expand at the demise of 5-injection products, now that both Fidia and Bioventus, the sole competitors, shift focus to the 2- and 3-injection segments. Even with the entry of OrthogenRx with GENVISC 850, a 5-injection product, BioMedGPS forecasts the 5-injection segment will decline by -4.0% CAGR in procedures and by -9.6% in dollars over the 2015-2020 time period. This shift along with increased competition will result in a healthy CAGR in the 3-injection segment over the 2016-2020E forecastt period.
Emerging 2-Injection Segment
With recent PMA approval of Hymovis, a 2-injection viscoelastic gel, Fidia is poised to gain share in this unique segment of the market. Launched in March in 2016 via their US sales organization, Hymovis will boost Fidia's presence in the overall Joint Fluid market with a differentiated offering offsetting flat and/or declining sales of Hyalgan, its 5-injection product. Fidia is banking on Hymovis taking share from all segments of the joint fluid market. Effective April 1st, Hymovis was granted a "C" code by CMS allowing pass through status. The product will be reimbursed at ASP plus 6% for CY2016. Hymovis lists at $880 for a 2-syringe pack and will be sold at $932/pack to pharmacies and ASC's.
New Differentiated Injectables
There are 12 approved Joint Fluid products currently approved on the US market for knee OA—three single injection; one 2-injection; five 3-injection and three 5-injection products—and this does not include "Human Tissue” products (PRP, amniotic fluid or adipose tissue) also being injected into osteoarthritic joints to a largely self-pay patient population. While largely untested, these products are under increased scrutiny by the FDA since they may not fulfill the “homologous use” criteria put forth in regulatory guidelines. Companies such as MiMedx and Liventa have clinical studies in progress evaluating injections of amniotic fluid for OA.
In the US, Joint Fluid products are approved for use in the knee joint, however, Anika with partner DePuy Synthes commenced an IDE trial evaluating MONOVISC for hip OA potentially expanding the overall market.
Also, on the horizon are longer-acting combination products in various phases of Phase III trials expected to appear on the US market in the next 5 years. Among the companies with products in clinicals include: Carbylan with Hydros, a dual mode viscosupplement which houses a long-acting steroid inside hydrogel beads; Flexion with an intra-articular sustained release steroid for moderate to severe OA pain; and Anika with CINGAL, a single injection hyaluronic acid plus steroid product that could potentially be used in patients with mild-to-moderate OA.
Anika announced plans for selling CINGAL via its own sales network rather than via partner DePuy Synthes and have hired ex-Sanofi executives to lead its commercialization efforts.
However, establishing a distribution network to market a joint fluid product is complex as overtook Zimmer Biomet, the largest orthopedic company, found out when it ran into challenges with Gel-One . Today, most suppliers have direct sales forces focused almost exclusively on selling joint fluid products complemented by large wholesale distributors and specialty pharmacies. While several new entrants, Anika, Seikagku, OrthogenRx are setting up contract sales organizations to promote their products, tapping into specialty pharmacies and securing unique "J" codes for reimbursement takes time which may end up being the major differentiator among products.
