The IBD biologics market: current & future landscape
The IBD market is becoming increasingly competitive with the influx of new therapies recently launched and some potential candidates nearing regulatory approvals. The good news for these emerging therapies is that the current established products leave a lot of room for improving standard of care, with high unmet needs. The challenging part though is that new drugs for Ulcerative colitis and Crohn’s disease will have to compete with entrenched brands, like Humira and Stelara, for which biosimilars will also be available in the coming financial years. Yet, anti-TNF biologics, has a serious caveat; as experts point out, that only a fraction of patients achieve remission with such agents and even fewer achieve long-term remission. Currently there are four anti-TNF agents used to treat IBD symptoms - AbbVie's Humira (adalimumab), J&J's Remicade (infliximab) & Simponi (golimumab), and UCB's Cimzia (certolizumab pegol), all slated to go off patent by 2024.
Currently there are about 1.6 million people in the US and the top five EU markets suffering from moderate to severe ulcerative colitis and the prevalence is expected to grow by approx. 2% every year through 2028. Market survey suggests that 40% of the patients are cycling through conventional therapies and most are not satisfied with the treatment outcomes. One of the primary area of concern is convenience and having options of safe oral drugs, which is also being echoed by the HCPs, looking for higher rates of remission, preferably through oral therapies.
The treatment journey of Ulcerative colitis typically begins with oral anti-inflammatory drugs, including both generic and branded corticosteroids, such as budesonide, and 5-aminosalicylic acid (5-ASAs) drugs, like mesalamine, before patients move on to biologic therapies. Anti-TNF mAbs often are the first-line biologic treatment options, after which they could be put on a targeted oral JAK inhibitor - tofacitinib, which is approved for UC. With Pfizer's Xeljanz (tofacitinib), it was the company’s first entrance into the IBD market, representing over 10% of the drug’s global revenue, with good growth opportunities.?Other biologic therapies like J&J’s Stelara and?Takeda’s integrin inhibitor Entyvio (vedolizumab) have good market shares in the IBD space, and could well become potential blockbusters in the category.
Similarly in the Crohn’s disease treatment landscape, biologic therapies are prescribed only after use of corticosteroids, 5-ASAs, antibiotics and other immunomodulatory agents. Apart from the host of TNF inhibitors, Stelara and Entyvio, biologics for CD also include Biogen's integrin inhibitor Tysabri (natalizumab) and AbbVie’s IL-23 inhibitor Skyrizi (risankizumab). Treatment guidelines across UC and CD are similar in the US and EU nations.
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Takeda's Entyvio continues to gain momentum
Takeda’s I.V.-administered biologic Entyvio continues to grow even after eight years since its initial approval in the US in May, 2014. Despite the dominance of anti-TNF agents, Entyvio has managed to make in-roads, especially in patients who are transitioning from conventional medicines to advanced biologic therapies. Entyvio has maintained a leadership position over the past year as the most prescribed biologic therapy for biologic-na?ve IBD patients and also the fastest-growing first-time biologic for CD patients, according to Takeda. The company has shared in its results that the drug is on track to exceed $5bn in fiscal year 2022 revenue and there are plans to seek FDA approval for a subcutaneous version in 2023. Further to that, Takeda enjoys market exclusivity timelines for Entyvio till 2024 in EU and till 2026, in the US. With no Entyvio biosimilars in the horizon and no manufactures announcing any clinical development pipeline plans, it appears that Entyvio may have several years before it will face any biosimilar competition. Plus, Takeda's patents cover many aspects of Entyvio's drug development, including formulation, dosing regimens and the process for manufacturing the integrin inhibitor, which do not expire until 2032 in the US. To date, no manufacturer has challenged any of those patents in an effort to bring a biosimilar version. In addition to that, clinical trial studies in IBD are typically long and complicated – which could take atleast four to five years from early phase to chances of getting regulatory approval.
A promising UC pipeline
There are many active Phase I & II, clinical trial programs covering various mechanisms and modalities, targeting key inflammatory mediators like Interleukins, JAK, and integrins. Some of the promising late stage candidate drugs for UC include: