The OA pipeline is rapidly evolving due to improved understanding of the disease’s pathophysiology and recent biomarker development
The Osteoarthritis (OA) market is expected to increase from $1.6 billion in 2016 to $3.5 billion by 2026 in the seven major markets (7MM), at a compound annual growth rate (CAGR) of 8.1 per cent, according to GlobalData.
The company’s latest report: ‘OpportunityAnalyzer: Osteoarthritis Opportunity Analysis and Forecasts to 2026’ reveals that this rapid market growth will be driven by a rise in the aging population and the launch of novel biologic therapies priced at a substantial premium to the generics and small-molecule therapies. The OA market is largely genericised and no product is anticipated to lose patent protection during the forecast period.
At the end of 2026, the US will continue to dominate the OA market as its share of sales increases further from its current 68.2 per cent to 75 per cent across the 7MM, while the 5EU and Japan will account for around 15 per cent and 10 per cent of sales, respectively.
The higher sales numbers for the US can be attributed to a large OA population, which will continue to grow to over 274 million by 2026, as well as a higher than anticipated high annual cost of therapy (ACOT) of biologic analgesics including Pfizer’s tanezumab and Regeneron’s fasinumab as well as DMOADs including TissueGene’s Invossa and Samumed’s SM04690, in the US market.
The OA pipeline is rapidly evolving thanks to improved understanding of the disease’s pathophysiology and recent biomarker development. Current R&D strategies in OA are characterised by a trend towards developing new analgesics with novel MOAs and drugs with disease-modifying effect, reflecting market demand for these therapies.
Analgesics with innovative MOAs — including anti-nerve growth factors (anti-NGFs), a new class of opioids (CR845), an intra-articular formulation of capsaicin (CNTX-4975), and improved and novel formulations of marketed therapies (Zilretta, SI-613, and X-0002)—continue to be studied in clinical trials.
In addition, with developments in biomarkers and magnetic resonance imaging (MRI) techniques, several potential DMOADs are now in development. These drugs include a small molecule therapy, SM04690, and two cell-based DMOADs, Invossa and ReJoin.
Maria Sudul, Healthcare Analyst, GlobalData commented, ‘‘The OA market provides an abundance of opportunities for the development of novel analgesics and DMOADs. OA is considered a heterogeneous disease and as such, distinct OA patient populations exist and therapies targeting these subgroups are much needed. We anticipate that with the rapid evolution of OA pipeline products, the OA market landscape will change radically over the next 20 years.’’
Current treatments for OA are symptomatic therapies that aim to provide pain relief and improve function as well as offer a disease-modifying effect; however, available treatment modalities have limited therapeutic effect, and more than half of OA patients are unable to achieve adequate pain relief with any of the current treatments.
OA is also primarily a disease associated with aging and elderly patients often have other comorbid conditions alongside OA, such as diabetes or hypertension. As a result of this, many treatment modalities currently available for OA are often contraindicated in these patients.
Sudul continued, ‘‘We anticipate that clinical unmet need in the OA market will remain largely unfulfilled over the forecast period. There is a pressing need for alternative analgesics with the ability to adequately address pain in OA patients at all severity levels. In addition, OA is considered a heterogeneous disease due to its complicated pathophysiology and unclear etiology. As such, distinct OA patient populations exist and therapies targeting these subgroups are much needed. There also remains a need for therapies that simultaneously address the OA and comorbidities a patient may have.’’
The current OA therapy landscape offers a large opportunity for pharmaceutical companies to develop drugs with new MOAs and disease-modifying effects including novel analgesics with the ability to adequately address all severity levels of OA-associated pain. A novel class of analgesics, anti-NGFs, under development for OA pain among other indications, is expected to provide an attractive treatment option for moderate-to-severe knee and hip OA patients. In GlobalData’s competitive assessment of the late-stage OA pipeline, anti-NGFs, especially Pfizer’s tanezumab, emerged as the most clinically and commercially attractive analgesic treatment option.
Sudul added, ‘‘Anti-NGFs are likely to become the most attractive new treatment option, especially for moderate and severe patients. We also believe that anti-NGFs will provide a commercial advantage over DMOADs as they face less-daunting reimbursement barriers.’’