Critical success factors for a biopharmaceutical product launch

Forty percent of worldwide drug launches between 2009 and 2019 failed to meet their five-year sales forecasts.1 Approximately 50% of all products launched over the past 15 years failed to reach peak U.S. sales of $250 million1.

Drugs miss revenue expectations due to six primary reasons – limited market access, inadequate understanding of customer needs, poor product differentiation, unfavorable safety profile and low resource allocation.

A successful launch must overcome a series of barriers, including intense competition, pricing pressure, and access challenges.

As pharmaceutical companies reshape their commercial models in the VUCA (volatile, uncertain, complex, ambiguous) world, six success factors will be crucial to launch success: early strategic planning, continuous readiness assessment, personalized content, superior customer experience, analytics enabled engagement, and post launch surveillance.


Early strategic planning

Biopharma companies should implement a well-defined launch excellence approach that guides the process along a clear path from situation assessment to planning and readiness, through to performance monitoring until the brand transitions to in-line.

Launch excellence framework has three main dimensions (market, product and organization).


Prepare the market:

  • Understand market to refine launch success factors
  • Evaluate competitive environment and implications on product
  • Build Key Opinion Leader (KOL) advocacy
  • Build Payer advocacy


To prepare for launch, the team needs to interact with broad number of stakeholders including regulators, payers, physicians, patients and advocacy groups to understand their needs at a fundamental level and communicate information in highly tailored ways.


Prepare the product:

  • Demonstrate product value
  • Ensure regulatory approval
  • Collect stakeholder (payer, physician, patient) insights to inform product strategy
  • Generate competitive evidence that translates to clinical advantage
  • Develop product value proposition and market access materials
  • Develop positioning and promotional messaging


To prepare for launch, the team needs to get ahead of access barriers by generating and communicating evidence of the differentiated clinical and economic value of their new therapies. Value evidence generation needs to start early, with medical and commercial input into clinical study design, even earlier than pivotal Phase II-III studies. Engaging with payers and other stakeholders also needs to start early to educate on the disease and unmet needs as well as understand what value means to each stakeholder.


Prepare the organization:

  • Set up launch assessment to deliver successful launch
  • Prepare effective customer interface (sales reps, MSLs)
  • Optimize supply chain for launch
  • Post launch surveillance and data collection


To prepare for launch, the team should conduct regular launch readiness reviews around key milestones such as the decision to file, filing, positioning, marketing authorization, pricing and reimbursement approval, training of sales reps and MSLs, and supply chain readiness. Companies should put a post-launch evidence-generation plan before the launch to generate a steady stream of real-world-data after the launch that supports the drug’s efficacy.


Continuous readiness assessment

During the initial launch planning assessment, the core launch team uses market and product information (e.g., product forecasts, competitive dynamics, key product dimensions, R&D timelines) to determine the success factors that will drive the product in the chosen market. Based on the success factors identified, this team can select critical deliverables and map them to the defined timeline, adding owners and expected levels of completion that will later help establish the launch readiness assessment process.

To help participating countries prepare for launch and facilitate collaboration with global representatives, the team should conduct regular in-depth readiness reviews around key milestones such as the decision to file, filing, positioning, marketing authorization, pricing and reimbursement approval, training of sales reps and MSLs, and supply chain readiness.

Developing a rigorous methodology to define the probability of technical, regulatory, and market access success for each product, and revisiting incentives will minimize the tension in resource allocation, and help achieve functional and enterprise goals.

Perhaps the biggest difference between earlier launch planning and today is the use of personalized content delivery, agile working and advanced analytics to create competitive advantage not only for the launch but for the business as a whole.


Personalized content

With varying HCP preferences and changing prescribing habits, pharma companies need up-to-date perspectives on physician interests so they can tailor messages to individual needs, and not aggregate them based on physician segments. Partnering with a company to assemble accurate prescriber profiles is integral to successful prescriber targeting.

Physician profiles are created through careful exploration of prescriber needs, gained from interviews and quantitative surveys conducted with a sample of physicians within a therapeutic area. Prescriber personas encapsulate the needs and characteristics of particular segment. Additionally, historical HCP preferences from data sources such as CRM systems and sales records are used to inform the segment view.

Companies can employ dashboards that show an aggregate segment view to an individual doctor. The profiles can uncover prescriber trends, which can help develop targeted sales and marketing campaigns.

As the product launch progresses, physi­cian feedback on unmet needs, sources of dissatisfaction and prescription sales volumes are used to update the picture. The assessments can enable global management to modify education initiatives, update messaging, and push tactical recommendations to sales reps to help them update engagement plans for HCPs.


Superior customer experience

Physicians today consider a much wider set of factors beyond clinical data when deciding which drug to prescribe, including clinical protocols, drug price, the type of patient to whom a drug can be prescribed and overall treatment regimen. And they are rapidly shifting to a broader array of information sources, especially online sites and peers.

Physician’s brand preference is attributable to customer experience factors beyond the product, including, for example, how well pharma companies support physicians by providing answers to medical questions, identifying patients and connecting physicians with peers.

Physician’s overall customer experience is a sum of individual interactions with a pharma company. Every interaction or episode is an opportunity to engage in a positive dialogue. One example is providing easy and accurate medical science liaison contacts within 24 hours of the physician’s request. Some of these interactions have a greater impact on prescribing behavior than others.


Analytics enabled engagement

Lack of understanding of patient segments who would respond well to the therapy, physician segments who would be high versus low prescribers for the new drug, and difficulty in converting customers (physicians and patients) from existing therapies to the new drug due to availability of competitive drugs or generic treatments leads to missed sales forecasts.

With the increasing penetration of electronic medical records (EMRs), and the emergence of prescriber data, companies can use data and analytics to improve the returns on their commercial activities.

Using real-world data from EMRs and prescription records to complement customer-relationship-management data can build better picture of patient treatment.

For example, a biopharma company turned to advanced analytics to boost its commercial effectiveness. To help it refine customer engagement and messaging, it built a new physician segmentation based on responsiveness to calls, with variations by channel and conversation topic. It then reallocated 30 percent of its calls to 90 prescribers who contributed 55 percent of new growth. In parallel, it applied analytics to enable regular refreshing of call allocation to focus on the physicians with the greatest potential.


Post launch surveillance and data collection

Companies should conduct post-launch studies to close any remaining gaps in data and ensure superior data quality over competing products and new entrants. High-quality data enhances market access. Successful companies put a post-launch evidence-generation plan in place 18 months before the launch to generate a steady stream of data after the launch that supports the drug’s efficacy. For example, Celgene produced almost twice as many post-launch studies for its multiple myeloma drug Revlimid, as compared with its closest competitor drug Velcade. Celgene’s steady stream of fresh evidence has given Revlimid a competitive advantage by keeping it at the forefront of hematologist’s mind.


Image Credit:

  1. EvaluatePharma

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