Disease Analysis: Hepatitis C
発行: Datamonitor Healthcare
ページ情報: 英文 46 Pages
当レポートでは、世界のC型肝炎向け治療薬の治験情勢と市場動向見通しについて分析し、疾患の概要や疫学的予測、現在の主な治療薬 (上市済み／パイプライン製品) や治験の進行状況、現在のアンメットニーズと将来的な市場機会、治験／市場の先行きに関する専門家の見解、といった情報を取りまとめてお届けいたします。
Datamonitor Healthcare estimates that in 2018, there were 72.2 million prevalent cases of hepatitis C worldwide.
Therapeutic strategies for chronic hepatitis C have evolved rapidly over the last six years. Following the debut of Sovaldi in 2013, direct-acting antiviral (DAA) combination regimens containing at least two modes of action (nucleotide NS5B inhibitors, NS5A inhibitors, and NS3/4A protease inhibitors) have rapidly become the standard of care, replacing older interferon-based regimens. The drastic shift to DAA regimens is due to their significant advances in cure rates (≥95%), greatly improved tolerability profiles, and shortened treatment durations (down from 48 weeks to 8-12 weeks for most patients).
Since peaking in 2015, the sales value of the hepatitis C market has entered a protracted decline as intensifying competition has slashed treatment costs, and patient numbers have fallen sharply in the US, Japan, and five major European markets (France, Germany, Italy, Spain, and the UK). Despite significant improvements in patient access to treatment as payers lifted treatment restrictions in response to lower treatment costs, the patient pool is expected to continue to shrink as the influx of newly diagnosed patients fails to offset the high number of patients exiting the treatment algorithm due to cure. Thus, investment in initiatives to improve screening uptake and linkage to care will be critical in softening the pace of this decline.
The launch of AbbVie's Mavyret in 2017 shook up the hepatitis C market and led to AbbVie capturing market-leader status from Gilead, which had previously dominated the field with rival regimens Harvoni (mainly genotype 1 [GT-1]) and Epclusa (all genotypes). Both Mavyret and Epclusa possess pan-genotypic activity, which positions them as one-size-fits-all regimens and provides a strategic advantage in payer negotiations versus Merck & Co's Zepatier, which is only efficacious in GT-1/4 patients. However, Mavyret possesses the advantage of a shorter eight-week duration in most treatment-naive patients versus Epclusa's 12-week dosing, and AbbVie also priced Mavyret at an aggressive discount to Epclusa to rapidly capture market share. Datamonitor Healthcare believes that market dynamics in the hepatitis C space will remain relatively stable, with Mavyret expected to continue to command the majority of market share and Epclusa continuing to hold out in second place.
The 2017 launch of Gilead's Vosevi has addressed the final clinical unmet need for an effective treatment option in the small minority of patients who fail treatment with first-line DAA regimens. Such patients commonly develop resistance-associated substitutions (RASs), particularly to NS5A inhibitors, which render them less likely to respond to repeated treatment. Notably, Vosevi displayed comparable cure rates in patients with RASs to those without RASs in the POLARIS-1 study, positioning it as an ideal therapy for prior treatment failures. While Vosevi faces minimal competition in this niche, its sales potential is limited by the small (and decreasing) size of the salvage population. With no major clinical unmet needs remaining and the value of the hepatitis C market continuing to decline, there is a scarcity of agents in the late-phase development pipeline. Indeed, while there are 18 drugs in the pipeline, only one has reached Phase III, and the continued development of early-phase compounds is unlikely given their ever-diminishing commercial potential and very limited ability to show clinical differentiation from currently available options.
The overall likelihood of approval of a Phase I hepatitis C drug is 8.4%, and the average probability a drug advances from Phase III is 69.6%. Hepatitis C drugs, on average, take 6.7 years from Phase I to approval, substantially shorter than the average of 9.1 years in the overall infectious disease space.