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White Paper
Launch Excellence VI
Launch Excellence in a disrupted world: challenges and opportunity
Sep 10, 2019

Introduction

It is now very clear that the global pharmaceutical industry is in a period of significant change, and with it the environment for innovative product launch. Molecular innovation is being supplemented, and in some instances could be replaced, by other forms of innovation, including highly individualised and procedure-like cell and gene therapies, prescription digital therapeutics, or innovation on existing, off-patent molecules.

The rise of specialty as the key value growth driver of the developed markets, has already created a situation where most launches, and almost 100% of the most successful launches, are for globally small, sometimes tiny, patient populations. 2018 was the first year in which both the FDA and the EMA approved more Orphan medicines, for rare diseases, than mainstream products. Mass market common, chronic diseases of the elderly don’t drive pharmaceutical value growth anymore; increasingly, the pipeline, the launches, and the pharmaceutical industry’s value growth is a product of high value therapies for small patient populations.

IQVIA is in the unique position of having the largest global database on past launch performance available, giving us an unmatched quantitative evidence base in research on Launch.		 In this white paper, we make extensive use of our core MIDAS database of global launch sales, as well as, when we search into the past of launch, the MIDAS based World Review. In all cases, note that the value figures provided are at list price, pre-rebates and discounts, and at ex-manufacturer level.

For our white paper, we focus on innovative, protected new products, defining these as New Active Substances (NAS). New Active Substances are novel and innovative active ingredients, small molecule, biologic or other, which have been launched on the global pharmaceutical market for the first time.
In our Launch Excellence series, we have defined the launch period as the first two years of a launch’s commercial life in a country, from the point sales first appear in MIDAS. Some argue the launch period can only start once a certain level of market access is obtained, although since market access processes and outcomes are highly variable by country this makes objective agreement on when “proper” launch has started across countries complex. For Thought Leadership, we’ve chosen objectivity and simplicity. However, we accept that the two-year initial launch period is only the start of many launches, albeit, because of the six-month window of opportunity which we will discuss later, an extremely important one.

For multi-indicational products, launch is no longer a one-off event. In addition, faster approvals on earlier clinical data and longer journeys to full market access, because of extended real world assessment, create an extended launch period. 		 There’s also consideration of the full lifetime value of a pharmaceutical launch. Unusual patterns of uptake, as for Hepatitis C products, create spectacular early launch performance but also rapid declines in performance. These products may have the steepest uptakes ever, but they are not the most valuable launches ever.

The core of the Launch Excellence series examines the launches, which have been the most commercially successful in the recent timeframe, relative to their contemporaneous launch peers to each major launch country. By using largely consistent data and analytics since 2007 we build a unique, quantified view of the way in which commercial success has changed over years. Examining launches on a country by country basis means that we can understand the most common reasons why launches do not reach their full potential.

OF THE TOP 20 PRODUCTS WITH THE GREATEST LIFE-TIME SALES

12 are specialty products

specialty is winning in the long term, even amongst older products

The Past: The Most Successful Launches Of All Time

What is the ultimate measure of a Launch’s Excellence? Steep initial uptake curves, consistency of performance across major markets, and optimisation on the available opportunity are all extremely important. In the long view, however, the final assessment may be the total revenues the launch accrues during its full lifetime on the market.

IQVIA can undertake this final assessment using its very long running World Review, published since the 1970s. More recent launches have an incomplete life, so we chose only launches for which we had a minimum of ten year’s World Review recorded sales.

Despite the rise of specialty as the key launch value driver, it is still Lipitor, with an estimated $160bn of gross lifetime sales, that sits in the leader position of best-selling product of all time. But of the top 20, eight are primary care, and twelve specialty- even with these necessarily older products, specialty is winning in the long term. The world’s current largest selling product, Humira, is second in absolute lifetime sales and a specialty product ($145bn).

Although the very best top sellers were also Excellent by our Launch Excellence criteria, the top sellers of all time can be either tortoises or hares - Launch Excellence uncovers, in the two-year evaluation period, the hares. 
 Slower burn “tortoises” are also among the biggest selling products ever, notably Crestor, with an estimated $75bn of gross lifetime sales. Very commercially successful “tortoises” fail on Excellence criteria most often on measures of promotional out-performance, suggesting exceptionally high levels of promotional investment in the first two years of launch. This investment may also be accompanied by significant investment elsewhere. Crestor was not, by our two-year uptake criteria of previously Launch Excellences, an excellent launch. Consistent, careful investment over a period of a decade, including the GALAXY series of clinical trials which was, at the time, the largest patient number set of trials around a single product, have, in the longer term, paid off. However, such a lengthy and sustained level of investment will delay profitability.

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Download to read more and get the bonus appendix 

Learn from past, present and future pharmaceutical launches in Launch Excellence in a disrupted world: Challenges and Opportunity

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