Autoimmune Drug Market Could Take Off

The global immunology market-which covers autoimmune diseases such as rheumatoid arthritis, psoriasis, lupus, and ankylosing spondylitis-is set to rise from $57.7 billion in 2015 to $75.4 billion by 2022. This represents a compound annual growth rate of almost 4%, according to UK-based business intelligence provider GBI Research.

The United States accounts for approximately half of the global immunology market and is expected to account for a similar proportion toward the end of the forecast period.

“A key reason for the continuous growth in the market is the large, chronically affected patient population,” said GBI’s Managing Analyst Dominic Trewartha. “Because these conditions, which generally affect older patients, are debilitating and carry a high economic burden, the treatments are able to command high prices,” he said. 

“But the main driver of growth has been newer therapies that offer iterative improvements upon the already strong existing therapies, adding to the range of options patients have,” he said.   

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In a written release, the company reported that disease-modifying antirheumatic drugs –a highly genericized class of systematic small molecule-based agents–are used in the first-line treatment of immunological disorders. However, as these therapies often fail to elicit an adequate long-term response, a large second-line therapy has emerged in these markets, which began with the approval of Remicade (infliximab) and Enbrel (etanercept) in 1988. This segment consists largely of premium system monoclonal antibodies (mAbs), which have been highly commercially successful over the past decade.

“Generally, the first-line therapies are off-patent nonbiologic drugs such as methotrexate, corticosteroids, and sulfasalazine, which have been approved for decades and are heavily genericized,” Trewartha told Drug Topics. They are not expensive, he said, and are “generally effective in the general autoimmune population. They are unlikely to be shifted from this position for many years to come.”

“The second and third lines of therapy are far more dynamic and competitive. The tumor necrosis factor inhibitor mAbs have constituted a strong second line of therapy across the key autoimmune disorders and have been difficult to displace. There are a number of promising upcoming late-stage pipeline products that are expected to compete with them and drive market growth in the second line of therapy.  In other cases, the new agents will constitute a strong third line of therapy,” Trewartha said.

There is currently a large pharmaceutical pipeline for immunology, consisting of 2,054 products in active development, almost 100 of which are in phase III clinical trials. The majority of these fall into similar therapeutic categories to the current market, with interleukin and tumor necrosis factor inhibition remaining key therapy types.

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Some drugs, however, indicate a move away from this trend, according to GBI Research. Drugs such as ozanimod (a sphingosine-1-phosphate inhibitor), baricitinib, and upadacitinib (both JAK inhibitors), point to emerging new classes of agents. Xeljanz (tofacitinib) is already approved as a JAK inhibitor, noted Trewartha.

Renee Baiano, PharmD, CSP, Clinical Program Manager for Walgreens Specialty Pharmacy, agreed that many of those receiving treatment do not achieve the targeted outcome of low disease activity or remission with conventional therapy and need to move on to a biologic medication, such as a TNF-alpha factor inhibitor. Clinical factors may make a provider choose a biologic medication early in therapy for better disease control, she added. For example, if a newly diagnosed patient with psoriasis presents with a rash covering a large body surface area, psoriatic lesions on the hands or face, or disease that is impacting quality of life, a biologic medication may be selected as first-line therapy.

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“Over-the-counter products ... are sometimes used concomitantly with prescribed medications or during early/mild phases of various autoimmune diseases,” Baiano told Drug Topics. “If a pharmacist finds that a patient is self-treating their condition, he or she should encourage the patient to discuss their symptoms with their physician. Even if a patient feels they are properly managing their condition on their own, there could be smoldering effects of the disease of which the patient is not aware,” she said.

Patients may also misinterpret disease improvement to mean that they do not need to take medication, Baiano added. “The error in perception of a reduced need for medication and the fear of side effects are major factors to consider when counseling on compliance,” she said.

“At Walgreens Specialty Pharmacy, we take a proactive approach to encourage medication adherence and help patients manage their therapy,” said Baiano. “Monthly outreach assessments are conducted to follow up with the patient and schedule delivery of their refills.”