The biopharma industry is facing many challenges – and opportunities – at present, including increasing complexity in the market and the continued increasing pressure on managing costs amidst thinner pipelines. This means successful launch planning and execution for new products becomes more critical than ever.
Current challenges in launch planning
Five trends in particular are changing the landscape of new drug launches, creating potential obstacles that must be carefully considered at the launch planning stage (see Figure 1).
Figure 1: Current challenges in new product launches
While companies used to launch a few large products each year, they are now launching many small-to-mid size products instead, with more intense competition. This growing emphasis on small-to-medium-revenue products means that biopharma companies are developing wider and more fragmented product portfolios than ever before. In turn, product launches increasingly need to be tailored and customized to suit diverse product types. Additionally, this means that there is stronger pressure for a quicker return on investment (ROI).
Doing more with less
With continuous pressures on bottom-lines, there is an overwhelming need to ‘do more with less’. Diminishing firm-wide launch capabilities mean launch resourcing is often sub-optimal. Balancing speed-to-market with proper launch preparation is putting more pressure on resources than ever before. In such an environment, adaptability is often the key to success.
Rise in specialty launches
The majority of new launches are increasingly targeted to smaller patient populations, and around half of new drugs approved in the US in 2015 were specialty medicines. By their very nature, specialty drugs require much more targeted launch efforts and a highly customized approach, which means launch teams face a steep learning curve. Biosimilars in particular present a new level of complexity in the specialty market.
Focus on value and outcomes
There has been a strong shift towards a greater focus on value and outcomes, driven by the increasing importance of functions such as Health Economics and Outcomes Research (HEOR), managed care account management, and patient advocacy services. Payers increasingly are putting pressure on coverage and drug reimbursement, sometimes even restricting access for patients.
Acceleration of innovation cycle
As product technology development cycles have shortened over time, companies need to continuously plan to think and stay ahead. This dramatic acceleration of innovation means products typically have less time on the market to recoup investment.
Plus, as shown in the Figure 2, on top of all these challenges, pharma companies are navigating incredibly complex customer landscapes.
Figure 2: The complexity of the customer landscape
This environment shapes the key success factors in launching a new drug
To successfully launch a product in this challenging landscape, pharma companies must build the following success factors into their launch planning efforts:
- A comprehensive and robust launch framework is needed to capture all the key launch activities and structure them in the most effective way.
- Approaches must be customized and tailored for each type of product.
- Initiatives and processes must be prioritized depending on the launch stage and type of product (critical path mapping).
- Resources must be allocated intelligently, particularly when it comes to the flexibility of resource onboarding and offboarding.
- A risk-management and scenario-driven approach is vital.
- Strong PMO support is needed to manage an integrated launch effort across functions, and with stakeholders and external partners.
Providing a three-pillar framework for successful launch planning
At a-connect, we have found that a simple, three-pillar framework helps biopharma companies develop a structured, robust, integrated launch plan, as shown in Figure 3.
Figure 3: Three-pillar framework for launch planning
A foundation of strong capabilities in each of these areas is critical to the success of the launch. With this in mind, across the three pillars, we have identified a set of key modules (20+) of key activity components that encompass multiple functions vital for a successful launch.
a-connect has been supporting several biopharma companies in different capacities for their product launches. Examples of this include:
- Launch preparation support when our clients face critical capacity and capability gaps across key functions, such as marketing, brand planning, pricing and market access, market assessment/research, forecasting, sales, and medical affairs. We deploy seasoned professionals who have real-world pharma launch experience in a variety of complex, cross-functional environments across a range of therapeutic areas to provide hands-on support and leadership.
- Project management/PMO support to drive creation of an integrated plan and robust launch preparation by working together with cross-functional stakeholder teams and driving critical path planning of key launch milestones.
While the shifting biopharma environment no doubt presents challenges for those charged with launching new products, it does present opportunities for those who can proactively adapt their launch planning and execution to suit changing markets and products. Please contact us to learn more about a-connect’s capabilities and how we can support your product launch.