Osteoarthritic (OA) pain is one of the most prevalent chronic pain conditions, affecting 87 million patients throughout the major pharmaceutical markets (United States, France, Germany, Italy, Spain, United Kingdom, Japan) and is responsible for $4.2 billion in pharmaceutical sales in these markets in 2016. This market continues to be of intense interest due to the increasing prevalence of this condition—owing largely to the aging of the population and growing obesity rates. Despite the multitude of available prescription analgesics, OA-related pain is not well-controlled in all patients. Novel therapies on the horizon have the potential to bring better pain relief, but obstacles to their use exist.
Currently, treatment of OA pain utilizes nonsteroidal anti-inflammatory drugs (NSAIDs), COX-2-selective NSAIDs, opioid analgesics, acetaminophen/opioid analgesic combinations, dual-acting opioid analgesics, and local anesthetics as well as intra-articular injections and joint replacement surgery, typically in an escalation pattern. Despite recent launches of abuse-deterrent formulations (ADFs) of long-acting opioid analgesics and of fixed-dose combinations (FDCs) of NSAIDs with gastrointestinal protective compounds, the treatment paradigm of OA pain has remained relatively unchanged for more than a decade and relies heavily on the variety of generically available analgesics. Current market-leading classes—opioid analgesics and NSAIDs—will continue to maintain the majority of patient share and consistent sales in the major markets through 2026, underscoring their central role in the treatment of OA pain. However, chronic use of opioid analgesics and NSAIDs are associated with growing safety concerns. Prolonged use of NSAIDs are associated with gastrointestinal or cardiovascular side effects while chronic opioid analgesic use can lead to addiction and abuse/misuse in many patients. In the United States, there has been and continues to be much public and political focus on curbing opioid analgesic abuse.
The expected launch of first-in-class anti-nerve growth factor (NGF) biologic therapies beginning in 2020 will be the most substantial change to the OA pain market in the foreseeable future. The launch of these agents will drive significant growth of the OA pain market due to the anticipated high price of these monoclonal antibodies, although, of note, prices are expected to be lower than those of biologic therapies used in other indications because of cost sensitivity in the pain space. Due largely to the anticipated high prices relative to that of existing analgesics—which will presumably result in third-party payers imposing access hurdles—use of these agents are expected to be limited to patients with severe pain who are either not surgical candidates or are looking to postpone surgery. Developers of these agents will also likely have to provide supportive pharmacoeconomic data in order to gain favorable health technology assessment (HTA) reviews and formulary placement. Results from ongoing Phase III trials should continue to demonstrate impressive efficacy while hopefully at least partially assuaging physicians’ and regulators’ safety concerns that led to a prior FDA-imposed clinical hold on development of this class. Even with use restricted to a small percentage of the OA pain patient population, these anti-NGF therapies are expected to generate blockbuster sales of $17 billion in the major markets in 2026, driven primarily by their premium pricing and the large OA pain population.
Experts interviewed by DRG are unanimous in their opinion that, despite the variety of analgesics currently available to treat OA pain, there remain unmet needs that will not be fully addressed by any emerging therapy currently in late stages of development. Of note, physicians would like to see a disease-modifying therapy for OA that reduces the need for analgesics. Without that therapeutic option becoming available in the near future, however, increased analgesic efficacy with a concomitant improved safety profile remains the most important unmet need. Physicians also desire more potent non-narcotic options or opioid analgesics with stronger abuse-deterrent features to avoid the risk of dependence, abuse, and/or overdose from chronic opioid analgesic use. These residual needs provide opportunities for pharmaceutical developers pursuing unique mechanisms of action for analgesia to capture a segment of the OA pain market, the total of which will rise to approximately $23.5 billion in the major markets in 2026.
Further insights and analysis on OA pain, including how the prescription treatment landscape will evolve over the next ten years, are available in our 2017: Osteoarthritic Pain Disease Landscape and Forecast content (published in August 2017).