It has been a decade since IQVIA published its first biennial “Launch Excellence” paper, providing insights to our clients on the criteria for Excellence in launch of prescription medicines. In that time we have seen significant changes in the healthcare landscape, and their impact on the key characteristics of Launch Excellence. We define Launch Excellence in prescription medicines as having steep and sustained launch uptake curve, promotional out-performance, and noteworthy market share achievement in the therapy area and by country even in the face of substantial promoted competition.

Our fifth iteration of this paper, Launch Excellence V: Surviving and thriving in a specialized world, we found that the three core elements for success remain the consistent:

1. Alignment behind the launch
2. Powerful value proposition
3. Effective stakeholder engagement

However, many of the criteria that represent Launch Excellence in 2017, vary considerably from previous findings.

The drugs that achieved Launch Excellence in this report had the following characteristics in common:

Launch success is highly geographically focused

Almost 90 percent of the first five years’ sales of New Chemical Entities launched since 2005 came from just seven countries -- US, Japan, Germany, France, UK, Spain and Italy. Organizations need to be laser focused on achieving Excellence in these countries if they wish to achieve global success.

Specialty drugs now dominate

The vast majority of launches (87 percent) that achieved Excellence in our most recent report are for specialty products to treat mostly low-prevalence complex conditions, including cancers and autoimmune diseases, where unmet need is high. These products are generally prescribed by specialists in hospitals rather than primary care physicians; they are expensive and have smaller more targeted patient populations. This is a reversal of the trends we saw in the late 90s, where more than 80 percent of excellent launches were for primary care products.

This shift to specialty products requires companies to be more precise in their efforts. It is no longer a competitive advantage to have vast general purpose sales teams driving launch. To succeed, these companies need a best-in-class specialty commercial model to engage limited numbers of specialists and patients. These strategies should involve a multi-functional integrated team, clearly defined patient focus and compelling real-world evidence to demonstrate the value of the product.

Smaller companies can challenge major players

Because success is driven by a small number of countries and a highly focused set of specialists and patients, smaller companies can now internationally launch, and achieve Excellence for, products themselves. Responding to this broadening competition means larger companies must be more focused and responsive, because smaller companies can often compete with greater speed and agility.

The first six months set the tone

Our data shows the first six months of a launch has a disproportionate influence on later success for at least 80 percent of launches in any country. In other words, whatever trajectory, successful or unsuccessful, products achieve in the first six months, 80 percent or more will continue on that path in the later stages of launch and possibly throughout their protected life. This phenomenon has been consistent across all five Launch Excellence reports, and reinforces the importance of having a fully prepared launch strategy prior to entering the market. While there are undoubtedly launches that are able to recover after a poor start, the majority will stay the course they set from the beginning.

Digital is an important part of the communication effort

There is growing evidence that recent Excellent launches have a higher share of digital activity than non-Excellent launches in their early launch promotion. An effective communication strategy will feature a mature multichannel communication model that includes strong digital components, to enable consistent and seamless communication across a broad spectrum of channels. This is especially important for specialty products, where launch teams cannot afford to lose a single customer, and thus must be able to rapidly adapt to their preferred communication preferences.

Companies struggle to deliver consistent Excellence across multiple launches in compressed timespans

Throughout all of our Launch Excellence studies, we’ve found that the more launches a company executes, the lower the proportion of these launches achieve Excellence. It is a fundamental challenge that exists across companies, across launches and across time, and reflects the multifactorial complexity of a global prescription medicine launch. Companies managing multiple launches often struggle with resource allocation, prioritization and the split focus these high intensity programs demand. With every additional launch the risk of poor results grows. While larger companies cannot avoid multiple launches, they can increase their chances of achieving Excellence by defining and rigorously adhering to a standardized launch strategy that includes:

• A consistent approach to launches across all divisions, geographies and staff.
• Cross-functional global launch teams that can be replicated at a regional and local level, and are integrated around the launch process not the individual function.
• An objective, transparent and quantified focus on performance, measuring results and responding rapidly to issues as they arise.

There are no guarantees of Launch Excellence, but when companies adhere to the core fundamentals of launch success, and take into account the challenges and opportunities in the new specialty-focused marketplace, they can better position themselves to out-perform their competitors and achieve early and continued market success.