According to the World Health Organization, cardiovascular disease (CVD) remains the number one cause of death globally. With the prevalence of CVD set to increase significantly over the next decade and treatment costs escalating, the CVD drug pipeline is robust and diverse. However, the market is currently in a state of transition; the recent launches of generic versions of the most highly prescribed CVD agents have placed increased pressure on drug developers to establish the superiority of new agents over existing treatment options, or to demonstrate increased outcomes benefit when used alongside the standard of care. This pressure is amplified by the increasingly difficult reimbursement and regulatory environment.

To understand where the remaining opportunities lie in CVD, we must first explore the unmet needs in each indication and assess key opinion leader feedback. This report provides an overview of the main areas of unmet need in several key CVD markets. Through the identification of these key areas of unmet need within CVD, we then highlight several areas where the greatest opportunities are for pharmaceutical developers, where innovation can still triumph over genericization.

Questions Answered in This Report:

  • Recent launches of generic versions of the most highly prescribed CVD agents have placed increased pressure on drug developers. This pressure is amplified by the increasingly difficult reimbursement and regulatory environment. What are the key unmet needs in CVD treatment, according to thought leaders? And what are the greatest opportunities in each CVD indication for drug developers?

  • Interviewed thought leaders agree that there is a shortage of safe and effective antiarrhythmic drugs for the management and prevention of atrial fibrillation. What agents are in development to fulfill this unmet need? What are thought leaders’ impressions of these agents and what is their market potential in the major markets we cover in this report?

  • The major unmet need in heart failure treatment relates to the lack of evidence-based treatments and treatment guidelines for heart failure patients with preserved ejection fraction (HFpEF, also known as diastolic HF). What treatments in development are set to fulfill this unmet need? What do surveyed cardiologists make of the prospects for Novartis’s LCZ-696 in this patient population?

  • Thought leaders believe that a significant need exists for novel, efficacious therapies to reduce the high mortality and morbidity rates in heart failure patients. What are the acute and chronic therapies in development that are forecast to meet this unmet need? What is the reaction of surveyed U.S. cardiologists to the results from LCZ-696’s Phase III PARADIGM-HF trial? And how do experts envision future use of this agent?

  • Thought leaders agree that the greatest unmet need in the treatment of pulmonary hypertension (PH) is the development of effective therapies for all forms of PH, and not just pulmonary arterial hypertension (PAH). What are surveyed pulmonologists’ and payers’ assessments of the current levels of off-label prescribing of PAH therapies for PH groups 2?5? What therapies are seeking to expand their labels with clinical trials of patients in PH groups 2-5?

Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, and Japan.

DRG reports: Contains insights from several DRG cardiovascular reports, including Pharmacor, DecisionBase, and Physician & Payer Forum.

Author(s): Conor Walsh, Ph.D., M.Sc.

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