Osteoarthritis

Knee Osteoarthritis (lead indication)

Osteoarthritis of the knee is one of the most common forms of osteoarthritis, affecting tens of millions of people in the United States.  Knee osteoarthritis prevalence can range from ~10% up to ~35% depending on age groups.  One common standard of care procedure for the treatment of osteoarthritis is intra-articular administration of sodium hyaluronate, or hyaluronic acid (HA).  We have built upon the well proven benefits of HA by adding chondroitin sulfate and n-acetyl-d-glucosamine.  The video to the right explains the use of HA in patients with osteoarthritis.

Existing Viscoelastic Market

Hyaluronic acid injections (i.e. visco-supplementation) are considered a first-line treatment for osteoarthritis.  Some estimates value the current market in excess of $3 billion USD.  Given the aging population, combined with obesity and other lifestyle conditions, this market is projected to continue to increase over the next few decades.

The rise in the osteoarthritic population, along with increasing awareness across the globe, is a key driver for hyaluronic acid visco-supplementation’s market demand.  Knee osteoarthritis treatment comprises nearly 60% of total market revenue in 2015 and is projected to grow to $2.3 billion in 2021 with an estimated CAGR 7.8%. The sales and revenue of the market is expected to increase during 2015-2020 at a CAGR of 6.5%.  According to the American Orthopaedic Society for Sports Medicine, around 4 million people undergo knee arthroscopies, whereas the number of patients undergoing shoulder arthroscopies is 1.4 million annually.  Based on the product, the market can be segmented into a single injection, three injections, and five injections. Due to growing demand for shorter regimen, single-injection cycles are expected to grow at the highest CAGR over the forecast period, which is the target injection schedule for ADH-01.

ViscoElastic Comparators

In the USA, there are under 6 primary competitors in the intraarticular injection, visco-supplementation market. Each competitive product is substantially the same [non-differentiated], with the primary difference being formulaic – the type or amount of HA in the composition. MONOVISC® from Anika Therapeutics is a single-injection hyaluronic acid that received FDA approval in early 2014. Another single-injection product, CINGAL®, from the same company is in the pipeline. Gel-One® (Zimmer Holdings) and Synvisc-One® (Sanofi) are other convenient single injections available in the market, which together, hold the majority of the overall market share. ADH-01 is a new and substantial improvement over these existing formulations because it comprises a patented mixture of hyaluronic acid, sodium chondroitin and N-acetyl-D-glucosamine. The in vivo and in vitro studies, along with performance data from the veterinary market, have demonstrated a substantial advantage over existing products.