PCSK9 Inhibitors Set to Achieve Blockbuster Status Despite Constraints on Use

BURLINGTON, Mass., Dec. 16, 2015 /PRNewswire/ -- Decision Resources Group finds that the recently launched proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor class will be a key driver in the growth of the dyslipidemia and acute coronary syndrome (ACS) markets over the 2014-2024 forecast period. PCSK9 inhibitors are injectable monoclonal antibodies that are highly efficacious for lowering low-density lipoprotein (LDL)-cholesterol, an important modifiable risk factor for cardiovascular (CV) diseases, such as ACS. These novel agents have been enthusiastically received by lipid and cardiology experts, and there is an almost universal belief that the PCSK9 inhibitors will help prevent CV events. The high prices of the PCSK9 inhibitors and the availability of orally administered competition will limit their use to later lines of therapy in patients at very high CV risk, as payers seek to control the impact on healthcare budgets. However, when, as expected, CV outcomes benefits are demonstrated, access to PCSK9 inhibitors is likely to increase and lead to multi-billion dollar annual sales for this class.

Other key findings from the "Dyslipidemia" and "Acute Coronary Syndrome" Pharmacor reports:

• The market for lipid-modifying therapies is expected to grow from approximately $20 billion in 2014 to more than $25 billion in 2024; much of this growth will be driven by the launch of the PCSK9 inhibitors. Together, these drugs will capture more than 20 percent market share in 2024.
• Given the lack of clinical differentiation between the PCSK9 inhibitors, the race to market and gaining physician familiarity are particularly important for these drugs' developers. The class effect perceived for the PCSK9 inhibitors could result in relatively equal distribution of patient share unless other differentiating factors arise.
• Pharmaceutical companies believe that the market can support additional PCSK9 inhibitors. Despite the three late-stage candidates, several PCSK9 inhibitors are in early-stage development, highlighting the potential that the pharmaceutical industry sees in this class.
• Physicians interviewed are apprehensive about adding yet another agent to current post-hospital ACS pharmacological strategies because of the added cost and inconvenience, especially because ACS patients already carry the burden of a large polytherapeutic regimen. Nevertheless, the relatively infrequent dosing of the PCSK9 inhibitors may play in their favor.

Comments from Decision Resources Group Senior Director Conor Walsh, Ph.D.:

• "The broad label (especially in Europe) for the approved PCSK9 inhibitors was largely unexpected; the relatively quick development timeline, limited patient exposure and lack of CV outcomes data had led most analysts to forecast greater prescribing restrictions. However, these labels reflect how these agents can meet the significant gap in the market for second-line LDL cholesterol-lowering therapies and suggest a considerable belief in the ability of these agents to safely deliver CV benefits."

Comments from Decision Resources Group Senior Analyst Tim Blackstock, M.B. Ch.B.:

• "PCSK9 inhibitors dominate the hopes of experts in lipid management and CV disease prevention. The dramatic reduction in LDL-cholesterol and the relatively clean safety profile associated with these agents suggest an important role for them in the future, although it will initially be only for a limited population."

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About Decision Resources Group

Decision Resources Group offers best-in-class, high-value data, analytics and insights products and services to the healthcare industry, delivered by more than 900 employees across 14 global locations. DRG provides the pharmaceutical, biotech, medical device, financial services and payer industries with the tools, insights and advice they need to compete and thrive in an increasingly complex and value-based marketplace. DecisionResourcesGroup.com.

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SOURCE Decision Resources Group