Osteoarthritis (OA) is a slowly progressive joint disease that is a major cause of disability and pain among the elderly, second only to cardiovascular disease. The OA space is characterised by a high level of unmet clinical need driven by the limited effectiveness of currently available analgesics and the lack of disease-modifying OA drugs (DMOADs). The current standards of care (SOCs) in OA focus on symptom management and are made up of generic pharmaceuticals, including nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, antidepressants, and intra-articular injections. As such, key opinion leaders (KOLs) interviewed by GlobalData strongly believe that the development of DMOADs is the greatest current unmet need in the OA space.

Increased research into OA over the past decade has led to the identification of new targets, and this progress is reflected in the current OA pipeline. Cell-based therapies have the potential to address this unmet need within the OA space to some degree. Within the OA late-stage pipeline, there are two cell-based therapies that GlobalData believes have significant clinical and commercial potential. These are TissueGene’s Invossa and Organogenesis Holdings’ ReNu, both of which have shown disease-modifying efficacy in clinical trials. Invossa has demonstrated the efficacy and safety of a single shot for up to three years, as outlined by Lew in a 2019 study published in Osteoarthritis and Cartilage (NCT03383471). Similarly, ReNu also showed positive efficacy and safety for up to 12 months from a single intra-articular injection (NCT02318511, NCT03063099).

Commercially, these therapies have the potential to be first-in-class DMOADs and to establish a novel paradigm in OA treatment and management. According to GlobalData’s primary research, while GlobalData initially expects a slow uptake for such cell-based therapies due to their high price, as they will require some time to prove their cost-effectiveness, the uptake is likely to improve following the initial lag period as physicians become accustomed to the therapy and as their cost-effectiveness becomes more apparent. Furthermore, the high price associated with these biologics may lead to reimbursement barriers in the genericised OA market, especially in the five major European markets (5EU: France, Germany, Italy, Spain and the UK), where a greater emphasis is placed on drug pricing and cost-effectiveness compared with the US.

However, even with the entry of cell therapies to the market, the unmet need for improved analgesics will likely continue to be largely unfulfilled, and an abundance of opportunities for the development of novel analgesics and additional DMOADs will remain. OA is considered to be a heterogeneous disease with a complicated pathophysiology and unclear aetiology. As such, distinct OA patient populations exist, and therapies targeting these subgroups are needed. Moreover, OA is most prevalent in elderly patients who often have other comorbid conditions, such as diabetes or hypertension, but the currently available treatment modalities for OA are often contraindicated in these patients. Therefore, one of the remaining unmet needs in this disease area is for therapies that address OA and are appropriate to use despite the comorbidities an elderly patient may have.

Overall, considering the novel analgesics and DMOADs in the OA pipeline, GlobalData expects the OA treatment algorithm to change significantly in the future, with cell therapies garnering significant market share during the next decade.

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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