This blog is part of an ongoing series, A Brave New World: Finding life sciences success in modern markets.

Today’s pharmaceutical companies face unprecedented economic compression across the product lifecycle. A slower path to coverage, increasing rebate demands, and the Inflation Reduction Act (IRA) are significantly impacting a brand’s ability to drive profitability and recoup development costs. The challenges begin at launch as post-pandemic sales are lower across the 3-year launch window compared to earlier years. This revenue gap affects both retail and specialty products and appears in many therapeutic areas. Additional policy changes currently being contemplated will likely exacerbate this situation.

As companies aim to maximize the area under the revenue curve for their assets, a new urgency has emerged: “How can we get a jump on launch?” Today, winning launches are all about reaching patients earlier. Companies are investing sooner in integrated evidence strategies that blend clinical, economic, and real-world data to demonstrate value. Increasingly, “indication stacking” is replacing the conventional approach of “indication sequencing”. By launching multiple indications in rapid succession, especially when they are in related or adjacent markets, brands can create a halo effect that keeps them ahead of the competition in a launch environment that is moving faster than ever before.

In this highly competitive environment, combined with more engaged stakeholders, a well-defined pre-launch strategy isn’t just helpful, it is essential. The months and years leading up to approval are a crucial time to shape perception, build demand, and remove barriers. Today, the most successful drug launches tend to invest earlier and more thoughtfully in pre-launch medical and commercial activities compared to their peers. A recent IQVIA analysis found that the top-performing cohort of launches spent nearly two times more on research and involved twice as many healthcare providers (HCPs) as their competitors.

Similar findings exist on the consumer side; however, with an important nuance—pre-launch direct-to-consumer (DTC) market preparation is often erroneously conflated with unbranded DTC-TV campaigns. While DTC-TV ads can play a role, many brands have found real success with more affordable, non-TV launch activities. By taking a grassroots approach and connecting directly with patients and communities, these teams have demonstrated that effective pre-launch DTC initiatives do not always come with a high price tag.

Patient & Community: Building Early Awareness and Trust

For certain disease states and brands, launch success begins long before a product reaches the market—with a genuine commitment to educating and engaging patients, caregivers, and the broader public. While regulations prohibit direct product advertising prior to launch, there are many compliant ways to educate and engage patients. Strategic partnerships with patient advocacy groups and community health organizations can be invaluable during this phase. By collaborating early, companies can establish themselves as trusted allies by supporting initiatives like public relations campaigns, diagnosis funding, and other efforts that amplify the conversation about the disease. However, not all approaches yield the same results. The most effective brands are those that invest in understanding their patients’ needs.

• For example, a migraine medication that launched in 2018 used a combination of advocacy, public relations, and a multidisciplinary coalition to create pre-launch excitement about an innovative new class of drugs. As a result, the product was able to hit the market with high patient demand. Physicians reported a substantial proportion of patients requested the specific brand by name during its first few months on the market.

• Another example is a specialty product that launched in 2017. Recognizing that there was a wide gap between patient and HCP goals, the company initiated patient listening campaigns. A deep understanding of patient struggles resulted in pre- and post-launch campaigns with attention-grabbing, unbranded content that shone a light on the daily experiences of women suffering with the condition. They also understood the preferred channels for their patient demographic and used social media rather than traditional engagement channels. This primed the market and resulted in an NBRx spike at launch. Compared to other specialty products launched in 2017, this product saw a notable spike in new patient prescriptions. That momentum sustained its elevated trajectory for three years. Further, during its first quarter, this brand garnered the most mentions of drugs in its class across media platforms and achieved a higher positive sentiment from patients.

And of course, while DTC-TV is not the only route to reach patients, it remains one of the most impactful, albeit expensive, channels. Recent IQVIA research reveals a nuanced dynamic in DTC strategies. While unbranded DTC efforts alone may not always drive patient uptake, their true value emerges in therapeutic areas where education is paramount. In these cases, brands that invest in unbranded DTC-TV campaigns lay essential groundwork in cultivating awareness and understanding that can ultimately enhance the impact of subsequent branded messaging. When patients and caregivers are exposed to consistent, informative communications about a condition and the promise of new advances in treatment, they are more receptive and engaged when those innovations finally reach the market.

Additionally, while these initiatives are chiefly designed to reach consumers, their influence often extends far beyond the intended audience. HCPs, payers, and policymakers can also be meaningfully impacted, amplifying the campaign’s reach and shaping perceptions across the broader healthcare landscape.

Healthcare Providers: Engaging the Medical Community Early

If patients are the heart of launch, healthcare providers are its backbone. To gain their support, it’s not enough to demonstrate that a new therapy works; they must also understand why it matters and how it fits into their clinical practice. One practical and effective strategy is early engagement of key clinical stakeholders through research. Involving HCPs in clinical studies offers hands-on, experiential learning that builds familiarity and confidence. When paired with the right experience, these clinicians can become early adopters and advocates for the product, helping to ensure it’s used appropriately and reaches the patients who will benefit most.

Once pivotal trials are complete, spotlight what makes your data stand out. If it is not immediately obvious, mining for the meaningful differentiator is key to crafting a compelling narrative. Beyond headline differences in efficacy, safety, or tolerability, other attributes, such as a novel mechanism of action, convenience improvements, a different risk-benefit profile, or superior outcomes for a specific patient sub-group can become powerful drivers of your product’s success.

Effectively surfacing and communicating these qualities can set your molecule apart and ignite enthusiasm among stakeholders. Medical Affairs teams often take the lead here, rolling out carefully constructed plans for publications and presentations in the pre-launch window. Products that are most successful steadily contribute to the scientific dialogue, particularly in the 2 years prior to launch.

The final step of effective pre-launch preparation for HCP stakeholders is building field teams that truly stand out. Beyond having experience in the therapeutic area, team members must also possess the technical expertise, background, and genuine passion needed to spark interest and build trust. These field professionals become ambassadors for the brand, adept at identifying gaps in the current treatment landscape and, once the product launches, clearly communicating how it can bridge those gaps. When you choose the right people, even the most skeptical HCPs can learn to see the value the therapy brings to their patients.

Payers & Market Access: Clearing the Path to Adoption

Even if patients request a specific drug and providers are willing to prescribe it, a launch can stumble without timely payer approval. Payer control is tightening for modern launches, as rejection rates in the first year have increased from 40% to 64% over the past 6 years.

Engaging payers with concrete evidence and giving them enough lead time to evolve their thinking is crucial. Wherever possible, payers should be exposed to health economic and outcomes insights well before launch. Pre-Approval Information Exchange (PIE) engagements are a newly available tool to facilitate these discussions. Authorized by the 21st Century Cures Act, these engagements allow pharmaceutical manufacturers to share scientific and health economic information with healthcare decision-makers 6-18 months before FDA approval. If you can demonstrate to payers before launch that the therapy will reduce hospitalizations or enable people to work more days, it makes a strong case for favorable formulary positioning on day one.

Timing: How Early Is Early Enough?

When it comes to pre-launch investments, the common practice is to start as early as possible. But the reality is more nuanced. The ideal timing depends on how much education your market needs, how quickly stakeholders can grasp new concepts, and just how much status quo thinking needs to change. Some brands facing major scientific or logistical challenges have begun laying the groundwork as far as six years before launch. More typically, companies ramp up their efforts over a three-year window, with activity accelerating in the final 18 to 24 months before approval. Interestingly, the data show that about 65% of DTC pre-launch advertising spend occurs in the last quarter before launch.

While this is the current practice, it isn’t necessarily the best approach. Instead, gradual, consistent investment in the six months before approval tends to outperform a last-minute spending surge. The key is to maintain the right balance: starting early doesn’t mean peaking early. You want to build momentum, not burn out interest. A well-planned timeline will leave stakeholders feeling like they’ve been carried along on the journey and can’t wait for the finish line.

How to measure success

When deciding which pre-launch initiatives to prioritize, it is important to ask, “How do we measure success?” The good news is that depending on the specific stakeholder needs and drivers of perception and behavior, there are many key performance indicators (KPIs) that may apply. Physician digital search data is one way to gauge awareness and interest. For example, an analysis of an oncology brand showed that online searches for the brand and its new indication peaked around the time of approval. This data can be further segmented to identify specific prescribers and create advanced segmentations. While there are many indicators that can be assessed, the bad news is there are no industry-wide benchmarks for comparison. While this is not an insurmountable challenge, it is one that requires a careful selection of measures and different approaches for assessing success.

Conclusion: Launch Day

By the time approval day arrives, an effective pre-launch strategy will ensure that your new product is stepping into an ecosystem that’s been primed for it. Patients have heard about the promise and are eager to learn if it’s an option for them. Providers are educated and are already thinking about how the brand will fit into their practice. Payers recognize the value and are willing to support its use for the right patients. The groundwork has been laid to ensure the whole operation will run as smoothly as possible.

We are in the golden age of scientific innovation, from gene therapies to personalized medicines, but with that comes greater scrutiny on cost and outcomes. To succeed, a new treatment needs more than just good clinical trial results; it requires a strategy to navigate the real-world market dynamics from day one. Pre-launch strategy is what builds the bridge from laboratory success to marketplace triumph. Please contact your IQVIA representative for more information.