3 things you need to do before launching a pharmaceutical product

– a marketer’s perspective

By Sunil Ramkali, Account Director, Life Science & Pharma

“Give me six hours to chop down a tree,
and I will spend the first four sharpening the axe.”

ABRAHAM LINCOLN

This quote emphasizes the importance of preparation and planning before tackling any task. It also mirrors the marketer mindset required to successfully launch a pharmaceutical product in today’s highly regulated, access – driven marketplace.

What you’re about to read isn’t revolutionary. However, it serves as a timely reminder of what pharma manufacturers must consider to successfully identify and overcome market barriers that could hinder the adoption of a newly launched product. Manufacturers with a well-developed understanding of the market landscape will be the ones that succeed. This article outlines the key areas where strategic investment is essential for a successful global launch.

The growing availability of generic alternatives in major therapeutic areas, combined with increasing cost containment measures from public healthcare systems and private insurers has significantly raised the bar for brand adoption. Today, any new pharmaceutical brand must offer a high level of innovation to justify its use – innovation being defined as delivering clinically meaningful benefits (compared to standard of care) and offering value for money.

Despite the heightened need to justify the value of a new product, the core principles of a successful launch remain unchanged.

Good things come in 3’s

1. Market and Customer Insights – “shape the brand to the market”

Create a differentiated brand strategy by understanding the needs, drivers, and behaviors of your target audience to ensure the brand aligns with market expectations.

2. Market Development – “shape the market to the brand”

Identify the right tactical activities to proactively influence the market landscape through education, stakeholder engagement, and access strategy to support brand adoption at launch and beyond.

3. Resource Availability – “identify the resources required”

Ensure the right capabilities, teams, and funding are in place to execute your launch strategy effectively and sustainably.

1. Market and Customer Insights

Market and customer insight is vital to the success of any brand launch, as it defines the development and evolution of brand strategy over time. Insight is essentially the transformation of primary and secondary market research into actionable knowledge that deepen our understanding of market and customer behavior. This includes identifying prescribing pathways, market access barriers, cost drivers, physician needs and behaviors, clinical and pricing comparators, market dynamics, segmentation, and overall market potential.

Marketing is often defined as the process of adding customer value, which makes effective insight a critical foundation for creating a brand that truly resonates in the marketplace. Once gathered, insights must be systematically applied through a formal brand strategy planning process. This process ultimately leads to the development of a clear, focused brand strategy, i.e. the strategic direction that positions the brand for a successful launch and beyond!

DEVELOPING YOUR BRAND ‘ROAD MAP’ REQUIRES YOU TO KNOW…

  • Where are you now? (situation analysis): understand the current market landscape, including competitive dynamics, customer behavior, and internal capabilities.

  • Where do you want to go? (brand strategy): define the desired future position of the brand, including brand mission and vision, strategic objectives, brand positioning, and target segments.

  • How will you get there? (tactical plan): outline the specific initiatives, channels, and activities required to execute the brand strategy with the target audience.

  • How will you know when you’ve got there? (KPIs): establish measurable outcomes to track progress and success over time.

To effectively answer these four questions, it is essential that we involve all key internal stakeholders – both at headquarters (e.g. marketing, pricing & reimbursement/market access, sales, R&D, medical, clinical and regulatory) and across (prioritized) affiliate markets. A highly engaged cross-functional team ensures alignment and delivers buy-in to the final brand strategy, as it captures the insights from a diverse range of perspectives and customer types (global and local). Such an approach, will help ensure we find the balance between standardization (a need from global marketing) and adaptation/localization (a need from marketing affiliates).

Building the brand strategy – ‘shaping the brand’

To develop a strong brand strategy, a thorough situation analysis is essential. This analysis serves as a foundation for formulating the brand strategy.

The situation analysis typically consists of an external environmental review – such as a PEST analysis (Political, Economic, Social, and Technological), followed by a SWOT analysis (Strengths and Weaknesses (internal); Opportunities and Threats (external))

From the SWOT, key issues should be identified, typically around 4–5 for each quadrant. These key issues ae based on grouping common themes, which will define the brand’s Critical Success Factors (CSFs) or Strategic Imperatives. These are usually 3–5 action-oriented statements that guide the brand’s strategic direction and inform the brand operational plan. Not delivering the CSFs will make achieving the brand strategy difficult at best, and impossible at worst.

The situation analysis should look to address the following key criteria for a successful brand launch:

  • Sales presence – potential share of voice or promotional spend
  • Patient potential – epidemiological data on the number of patients eligible for the brand
  • Launch sequence – order of launch relative to competitive brands
  • Market satisfaction/differentiation – level of unmet medical need or dissatisfaction with current treatment options
  • Brand innovation/value – clinical profile of the brand in comparison to clinical competitors
  • Cost – relative cost or cost-effectiveness of the brand in comparison to pricing comparators

To align the organisation, a series of brand strategy statements should be developed based on the insights from the situation analysis. These statements must be effectively communicated and adopted across the organisation to ensure that all initiatives, regardless of function, are aligned.

BRAND VISION

– an aspirational statement of where we want the brand to be in the future, assuming unlimited resources. It defines the brand’s ultimate destination – our ‘roadmap.’

STRATEGY OVER TIME

– how we will realise the brand vision over time.

BRAND POSITIONING

– the tactical expression of the brand strategy over time. It represents the DNA of the brand, differentiating it from competitors by uniquely positioning it in the minds & hearts of target customers. In order to influence customer behaviour.

 

A useful approach to crafting the positioning statement is to define:

 

  • Who – the target customer
  • What – the brand
  • Why – the unique proposition of the brand
  • How – the key brand messages

2. Market DEVELOPMENT

The brand strategy development process also plays a critical role in identifying potential opportunities and barriers to the successful adoption of our brand. Once identified, these factors must be proactively addressed during clinical and market development and the pre-launch phase of the brand lifecycle, well before they become actual obstacles.

For example, if the process uncovers potential safety concerns likely to be raised by regulatory authorities, we can address them early through adjustments to the clinical development program or by implementing a Patient Risk Management Plan as part of the pre-launch and launch activities. Or if we know the key cost drivers and/or pricing comparators, we can look to generate health economic data prior to launch. Anticipating such challenges allows us to manage them proactively, reducing delays and ensuring a smoother path to market access and physician adoption.

KOL/KEE DEVELOPMENT

Increased budgetary constraints and the growing influence of payers have significantly reduced physicians’ prescribing freedom in recent years. Many are now required to closely manage drug budgets and adhere strictly to treatment guidelines and formulary listings. Despite these restrictions, developing and shaping the market at the Key Opinion Leader (KOL) or Key External Expert (KEE) level remains critical. These individuals play a vital role in cascading key brand messages down to the broader prescriber base through treatment guidelines, educational programs and through manufacturer sponsored events. As such, building strong KOL advocacy continues and will always be a major factor in the successful acceptance and adoption of any new therapeutic class and/or brand.

KOL development, whether led by R&D or marketing must be fully aligned with the brand strategy and be initiated during the pre-launch phase. Early alignment ensures that engagement activities are strategically relevant and support the long-term positioning of the brand.

In addition to traditional KOL engagement tactics such as scientific exchange, advisory boards, congress participation, publications, and symposia, the implementation of accredited Continuing Medical Education (CME) programs should also be considered. CME programs are a powerful tool for influencing KOL perceptions and shaping clinical thinking during the pre-launch period.

In many markets, physicians are required to stay current in their specialty areas and must complete a minimum number of CME hours annually. A well-designed CME program that is both engaging and educational can add real value, as they can communicate key brand messages, highlighting limitations of current treatments, and reinforce the need for innovation, especially in areas like rare diseases. This, in turn, helps build a foundation for acceptance of new therapies at launch.

Early collaboration with non-prescribing decision makers is vital

Collaboration of clinical stakeholders isn’t enough. It is vital that budgetary barriers put in place by non-prescribing decision makers are also addressed through effective, realistic, and evidence-based pricing strategies. As marketers we have key role in this work and can provide a vital support to our market access colleagues by understanding the budgeting processes and prescribing pathways at both the national and regional levels in key markets.

We cannot underestimate the influence of payers on the adoption and long-term success of a new brand. It is essential to fully understand how funding and prescribing decisions are made across different healthcare systems, so our pricing strategies align with payer expectations and constraints. In many markets, achieving and maintaining reimbursement will require robust cost-effectiveness data. And with an increasing need to generate such data before launch, engaging with payers well before launch is critical to understand their specific requirements and to address potential concerns early.

To achieve this the clinical development program must be designed in close collaboration with internal and external pricing and market access stakeholders. This ensures the generation of relevant health economic outcomes data, or at a minimum, data that can be used to model economic value to support pricing and reimbursement submissions.

In addition to such activities, lobbying through patient advocacy groups can be a powerful enabler in supporting access to new pharmaceutical products, both pre- and post-launch. As part of a well-structured Managed Entry Program (MEP), patient groups can help raise awareness of unmet needs, highlight the value of innovation, and influence decision-makers to support early access and favorable reimbursement decisions.

Market access is not a individual, a function or a department. It must be a way of doing business.

3. Resource Availability

Identifying how to shape the brand to the market and how to shape the market to the brand is meaningless unless sufficient resources are available at every stage of the product lifecycle.

There is no one-size-fits-all solution when it comes to determining the appropriate level of investment during the pre-launch phase or how to allocate resources across the marketing mix. However, one thing is clear: a significant portion of resources must be dedicated to gathering market and customer insights. This is the foundation of a competitive and differentiated brand strategy. If we cut corners at this stage, we substantially reduce our chances of success.

Once we have sufficiently invested in shaping both the brand and the market, we will be in a strong position to launch. At this point, the baton is passed to our sales colleagues. However, their success is still heavily reliant on the ongoing support from marketing throughout the product’s promotional lifecycle.

This support includes:

  • Development and localization of promotional materials
  • Campaign briefing and product knowledge training
  • Sales training & objection handling strategies
  • Targeting and segmentation guidance
  • Physician and patient profiling
  • Creating customer access tools
  • Digital and omnichannel engagement
  • Presence at international events
  • Most importantly, ensuring strong buy-in to the brand strategy

Cross-functional collaboration is essential to avoid strategic leakage, i.e., the inconsistent delivery of brand messaging to your target audience. Without alignment, execution suffers, and long-term brand success is compromised.

It goes without saying, a motivated and convinced sales force is mandatory throughout the brand lifecycle – ‘enthusiasm sells’

DEFINE, DELIVER AND DRIVE THE BRAND STRATEGY

In summary, successful product launches require in-depth market and customer insight to develop a highly differentiated brand strategy. Without sufficient resources, even the best strategy will struggle to succeed!

If we know where we want to be, then defining how we get there is much easier!

THE AUTHOR

As the pharmaceutical industry continues to evolve, navigating the complexities of today’s market can be challenging.

That’s where Sunil Ramkali, CEO & Account Director, Life Science at W, comes in. With over 35 years of experience in global and local sales, marketing, and market access/pricing, Sunil brings a wealth of knowledge to his clients. His insights have been published in numerous articles, including PharmaVoice, and he lectures at Lund University on “Commercial considerations in early drug development”.

If you’re seeking guidance in the pharmaceutical industry, Sunil’s expertise can help you achieve success.

Contact: sunil@wcommunicationagency.com

THE AGENCY

W creates strong brands and business opportunities for international B2B corporations and companies. We make complex products and processes within Life Science, Technology and Industry understandable, inspiring and attractive.

Our mantra is Turning complexity into clarity.