Article preview reprinted from Medtech Insight - January 2010
Injectable products that can alleviate pain and even reverse the disease process are on the horizon for treating degenerative orthopedic and spinal conditions, such as damaged articular joint cartilage and deteriorated spinal discs. With no available long-term treatment options for these conditions short of invasive surgical procedures like joint replacement or spinal fusion, injectable technologies that offer the possibility of being used upstream in the continuum of care are potential billion-dollar market opportunities. In fact, in a post health care reform environment, injectable therapies may prove to be the most cost-effective way for treating many degenerative conditions. Read more...
Injectable Solutions for Joint and Back Pain
Article preview reprinted from Medtech Insight - January 2010
Injectable products that can alleviate pain and even reverse the disease process are on the horizon for treating degenerative orthopedic and spinal conditions, such as damaged articular joint cartilage and deteriorated spinal discs. With no available long-term treatment options for these conditions short of invasive surgical procedures like joint replacement or spinal fusion, injectable technologies that offer the possibility of being used upstream in the continuum of care are potential billion-dollar market opportunities. In fact, in a post health care reform environment, injectable therapies may prove to be the most cost-effective way for treating many degenerative conditions.
HA Therapy: $1B+ OpportunityOne injectable therapy that has been on the market for more than a decade and today represents a $1+ billion market opportunity worldwide is hyaluronic acid (HA) intra-articular injection. Used for alleviating joint pain associated with osteoarthritic (OA) disease, HA injection therapy has expanded into a $700+ million market in the US and is growing at a rate of 10% per year—and this does not take into account end-user sales.
About half of the patients currently treated with HA injections are covered by Medicare and the other half by private payers. For the Medicare patient, the orthopedic surgeon typically buys the product and bills Medicare. CMS then reimburses the surgeon at a rate equivalent to the average selling price plus 6%. For private pay patients, the surgeon generally writes a prescription and the patient can go to the pharmacy or even purchase the product online. Patients typically receive weekly injections of HA over a period of three to five weeks and can experience pain relief and increased mobility for up to six months.
Concern regarding a possible placebo effect has surrounded HA therapy for some time and meta-analyses of available clinical studies have shown only modest effects across populations; however, anecdotally, most clinicians have seen individual patients who have had a remarkably good response to the treatment irrespective of the stage of arthritic disease. Thus, the therapy is generally well accepted in the physician community; however, the problem facing clinicians is identifying a priori who will benefit from treatment.
While HA products can vary according to source (avian, bacterial, synthetic), molecular weight, concentration, and even reimbursement, perhaps the most differentiating feature among products is the treatment regimen. First-generation products such as Genzyme Biosurgery/Genzyme Corp.'s Synvisc, Depuy Mitek Inc. (a division of Johnson & Johnson)/Anika Therapeutics Inc.'s ORTHOVISC, Bioniche Pharma/Bioniche Life Sciences Inc.'s Suplasyn, and Ferring Pharmaceuticals AS's Euflexxa, require three weekly injections whereas Sanofi-Aventis' Hyalgan and Seikagaku Corp.'s SUPARTZ (distributed by Smith & Nephew Inc., a division of Smith & Nephew PLC) require five. Recently, single injection treatment regimens using a tripled dose of HA have gained US Food & Drug Administration (FDA) approval and should boost usage and sales of HA therapy in the US.
Single Injection RxGenzyme Biosurgery is the leading shareholder in injectable HA therapy with approximately 35% of the US market. (See Exhibit 1.) The company is expected to retain its first place position with the recent introduction of Synvisc-One, a second-generation HA product approved in February 2009 as a single-injection treatment for patients with OA knee pain, which performed well in a 253-patient Investigational Device Exemption (IDE) trial. Synvisc-One utilizes the same formulation as Synvisc, but is packaged in a larger syringe with the total treatment volume identical to the three-injection regimen recommended for the original product. At January's JP Morgan conference, Genzyme reported that the successful introduction of Synvisc-One increased Synvisc sales by 25% in 2009 to $329 million compared with $263 million in 2008. Synvisc sales for the fourth quarter of 2009 were $90 million, representing a 40% increase over $69 million in the fourth quarter of 2008. This has resulted in an increase in market share from 38% to 56%, according to the company.
by Sharon O'Reilly
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