With over 1,400 products in active development, the innovation pipeline for cardiovascular disease (CVD) is extensive, with four key CVD indications – hypertension, heart failure, dyslipidemia and thrombosis – now accounting for around half of all pipeline innovation, according to GBI Research, a recognized leader in providing business information and analytics.
The company’s latest report on cardiovascular disease looks at the current clinical and commercial landscape and highlights the particularly high level of heart failure pipeline innovation. This reflects efforts by the pharmaceutical industry to remedy the unmet need in treating this disease, which is associated with a five-year mortality rate of 50%.
Currently, CVD therapeutics focus on managing risk factors such as high cholesterol and high blood pressure, and slowing disease progression. However, current treatments are ineffective at reversing damage, which typically relies upon surgical procedure. Anti-dyslipidemic drugs are unable to reverse the build-up of atherosclerotic plaque, and anti-thrombotic drugs only focus on preventing new thrombus from forming rather than dissolving current clots. The current pipeline shows evidence of addressing this challenge with potentially more damage reversal treatments on the horizon.
Heart failure and pulmonary hypertension remain poorly treated, and are associated with poor prognosis. The large pipeline for heart failure includes a high proportion (23%) of first-in-class products relative to other CVD indications, and possesses the potential for breakthroughs in the treatment of this condition.
Tom Jarratt, Associate Analyst for GBI Research, commented:
In this landscape, adopting a strong focus on innovation as a means of adding product value and creating differentiation remains a vitally important component of company strategy. There are 320 first-in-class products in the CVD market that act on a novel molecular target that is not present in an approved product across any indication in the pharmaceutical industry. However, they remain a key product development strategy with the potential to provide the greatest degree of differentiation, extending to a first-mover advantage, and potentially a significant market share.
The clinical and commercial landscape across the pharmaceutical industry is set for significant change over the coming decade and beyond, driven by a number of factors including low R&D productivity and stubbornly high clinical attrition rates.
The net effect is an increasingly challenging, complex and often unpredictable commercial environment which we explore in the report.
GBI Research analysis also indicates that companies across the pharmaceutical spectrum pursue a first-in-class product development strategy, ranging from major pharmaceutical players to start-up biotech firms, despite the typically higher attrition risk of these products. The proportion of first-in-class products in the pipeline for the top 20 major pharmaceutical companies ranges from 20% (for Novo Nordisk) to 60% (for Amgen), indicating a significant focus on breakthrough innovation. Moreover, 41% of start-up biotech companies with no marketed products and up to five pipeline products have at least one first-in-class product in their R&D portfolio.
The data indicates that, despite challenging market conditions, there are reasons for sustained optimism that a stream of clinically and commercially successful first-in-class products will reach the market over the coming decade and beyond.
An analysis of strategic consolidations also revealed a modest level of deal activity in recent years, and a large number of first-in-class products not yet involved in any deals.