The approval of medicines remains a challenge for companies. With the new European MDR, it has also become more difficult for medical devices. It does not matter whether it is the first time for a young company or represents a new market region for an established company. The critical problem is that a marketing authorization does not guarantee a successful market launch.
This issue is experienced by Biogen recently with the launch of its Alzheimer's drug Aduhelm in June 2021. Sales of Aduhelm in Q3 2021 are a disappointing $300,000, just 2% of projected sales for the period (1). Aduhelm is Biogen's hope to stop the decline in sales, a goal that is no longer achievable this year.
Background: The active pharmaceutical ingredient aducanumab is a recombinant human monoclonal antibody that targets defined forms of beta-amyloid. Clinical studies have shown that certain protein deposits in the brain, the so-called beta-amyloid plaques, are reduced by aducanumab in Alzheimer's patients. To determine a reduction of this beta-amyloid load, tedious positron emission tomography (PET) must be used as a diagnostic procedure. However, the extent to which this can actually slow down the deterioration of cognitive abilities in Alzheimer's patients is controversial. Accordingly, Aduhelm has been received skeptically by experts, some of whom have spoken out against its approval.
Challenges of Market Introduction
The Biogen / Aduhelm case is certainly an extreme example. However, it clearly shows that marketing authorization per se does not guarantee a successful market launch. The problem starts when companies focus too much on market approval. This is understandable, if a young company sees the approval process as a huge hurdle because it is uncharted territory. And similarily, the same is true for established companies that want to expand from the EU to Asia or the U.S., for example. However, approval processes, as tricky as they can be in detail, take place within a defined framework, i.e. regulatory requirements must be met. But if a company already feels uncertain about this topic, how much greater will be the challenge of effectively marketing the product in the new target market with different market dynamics, a new competitive environment and the national peculiarities of the healthcare system?
During the market launch of medical products, the hurdles of the market environment are often underestimated or neglected in favor of the approval issues. Worse, if the market launch is understood merely as a task for marketing and the creation of promotional materials. However, it is a mistake to believe that the clinical profile or the innovativeness of the technology is sufficient to successfully introduce a new product.
Good clinical efficacy paired with a positive side effect profile is no longer sufficient for the success of a new drug.
Key factors are good market access, knowledge of the target market, strong differentiation and optimal use of resources (2).
The situation is even more difficult considering the comparatively long development time and the need to get drugs or diagnostic procedures reimbursed by healthcare providers. Those who do not address competition, market structures and reimbursement systems early on and rely too much on innovativeness, on the other hand, will experience a longer time before sales take up.
The Go-To-Market Plan
The first step to a successful market introduction is to understand market launch as a multi-functional project. In addition to regulatory issues and the creation of advertising materials, this also includes decisively medical marketing, dealing with KOLs, setting up sales structures and, in many cases, a suitable business model. All these activities are aimed at winning over customers, i.e. doctors, patients and health insurers, for the product at an early stage. This ensures that the desired revenues are generated more quickly after the product is launched. The dimension should not be underestimated: the time frames for a market introduction project range from at least 2 years until the planned launch and another 1-2 years until the product is established.
For this to succeed, instruments such as the Go-To-Market Plan are necessary to grasp the complexity, address possible weak points at an early stage and steer the project. That sounds like a lot of effort and expense, but how much effort did it take to develop the new product in the first place? In our experience, it is sometimes frustrating to see a company then fluff on the home stretch and deprive itself of its own success. In fact, the success of a launch is not dependent on the size of the company, but on the market-oriented setting of priorities. Even large pharmaceutical companies do not always achieve a successful launch. They have recognized this problem and in many cases organize "launch excellence centers" that take on this interdisciplinary task with the goal of achieving an optimal market launch.
For the example of Aduhelm, it is still too early to make predictions about future success or failure. However, as this is the first new drug for the treatment of Alzheimer's since 2002, it is to be hoped that it will at least be an effective therapy for certain patients.
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