From Pipeline to Payers: How to Build a Bulletproof Market Access Strategy

In today’s competitive healthcare landscape, the journey from drug development to gaining payer approval is more complex than ever. An innovative product doesn’t automatically guarantee access to the market. With rising competition, stringent regulations, and payers increasingly focused on value-based care, a strong market access strategy is no longer a luxury—it’s a necessity. With nearly half of life sciences leaders (47%) expecting pricing and access to significantly affect their strategies in 2025 (Deloitte, 2025), payers’ expectations for value, evidence, and affordability have never been higher. Payers are seeking better value for healthcare spend. With increasing financial pressures, payers are focusing on optimizing the value in healthcare spending. But how can you ensure that your strategy is bulletproof and paves the way for success?

In this blog, we’ll break down the key elements of building a market access strategy that takes your product from the research and development (R&D) phase to payer approval with confidence and clarity.

Start Early: Integrate Market Access in R&D

The dominant stakeholders in major pharmaceutical markets, payers, are seeking better value for healthcare spending. With increasing financial pressures, payers are focusing on optimizing the value of healthcare spending.

One of the most common mistakes companies make is treating market access as an afterthought, when in fact it should be treated as a critical component integrated early in the development process. Deloitte revealed that nearly 60% of drug launches failed due to limited market access, followed by nearly 50% lacking adequate understanding of the market and customer needs, and 41% lacking clear product differentiation. By considering payer needs and market dynamics during the R&D phase, you can build a stronger case for your product from the start.

During the early stages of drug development, focus on the following:

• Unmet needs analysis: Ensure your product addresses a critical gap in the current therapeutic landscape. Payers are more likely to approve drugs that fill unmet needs and improve outcomes over existing treatments.

• Value proposition: Define the clinical and economic benefits of your drug. What sets it apart from competitors? Will it reduce hospitalizations, improve patient quality of life, or cut overall healthcare costs?

Develop a Robust Evidence Generation Plan

Evidence is everything when it comes to payer approval. A well-rounded evidence generation plan should go beyond traditional clinical trials to include real-world evidence (RWE) and health economics and outcomes research (HEOR).

Key elements of your evidence plan should include:

• Clinical efficacy and safety data: Demonstrate that your drug works and that it’s safe for patients.

• Real-world data: Payers want to know how your product will perform outside the controlled environment of clinical trials. Incorporating RWE from early on helps build a more comprehensive case for your product’s effectiveness in diverse patient populations. The global RWE market is projected to hit $48B by 2032. Pharma companies that invest in real‑time and scalable RWD infrastructure today will dominate access conversations tomorrow.

• Cost-effectiveness studies: With healthcare budgets tightening, payers are increasingly focused on cost-effectiveness. Show how your product will provide long-term savings or offer better outcomes for the same cost.

Understand Payer Expectations and Priorities

Different payers have different priorities, and understanding these nuances is crucial. While some focus on cost-effectiveness, others may prioritize clinical innovation, patient outcomes, or reducing healthcare resource use. To build a winning market access strategy, you must tailor your approach to each payer's needs. Research each payer group, focusing on:

• Payer guidelines: Understand how each payer evaluates new treatments and what their key decision criteria are.

• Value frameworks: Familiarize yourself with value assessment frameworks like ICER (Institute for Clinical and Economic Review) in the U.S. or NICE (National Institute for Health and Care Excellence) in the UK. Tailor your submission to meet these frameworks' specific criteria. Compelling access strategies no longer just focus on clinical benefit, but connect the dots between efficacy, real‑world performance, health equity, patient quality of life, and financial sustainability.

• Negotiation tactics: Payers have power in pricing negotiations, and understanding their concerns can help you navigate these discussions successfully. Be ready to justify your price with a clear value proposition backed by strong evidence.

Build Relationships with Key Stakeholders

Engaging stakeholders early and often is a vital part of any market access strategy. This includes not only payers but also healthcare providers, patient advocacy groups, and even policymakers. These relationships can help you build support for your product before it even reaches the market.

Here’s how to make stakeholder engagement work:

• Payers: Build a dialogue early with payers, sharing data and insights that demonstrate the value of your product. The sooner you engage, the more opportunity you have to address any potential concerns.

• Healthcare providers: Physicians and specialists are key influencers in the healthcare ecosystem. Engage them through education and value communication initiatives that demonstrate the clinical benefits of your drug.

• Patient advocacy groups: Advocacy groups can be powerful allies in building awareness and demand for your product. Working with these groups also adds credibility to your value proposition and can amplify your message to payers.

Master Pricing and Reimbursement Negotiations

Over one-third of newly launched products fail to meet projected revenue forecasts, and for more than half of these, limited market access is the primary culprit. Payers face constant pressure to manage costs, making pricing negotiations a potential sticking point. A clear, data-driven pricing strategy is therefore essential to securing and sustaining market access.

Strategies for successful pricing and reimbursement include:

• Value-based pricing: Align your pricing with the value your product delivers. Highlight both the clinical benefits and the economic savings it offers to the healthcare system.

• Risk-sharing agreements: Consider offering innovative pricing models, such as risk-sharing or outcome-based agreements, where reimbursement is tied to the drug’s performance in the real world. These agreements demonstrate your confidence in the product’s efficacy and reduce payer risk. Amidst regulatory uncertainty, 2025 has brought more precision therapeutics, warranty‑based contracts and biosimilar growth.

• Tiered pricing strategies: In cases where affordability is a concern, offering tiered pricing based on the patient's ability to pay or regional healthcare budgets can help you gain broader market access.

Prepare for Post-Launch Market Dynamics

Market access doesn’t stop once your drug is approved. Post-launch strategies are just as important to maintain and expand access. Keep monitoring real-world outcomes, gather post-market data, and be ready to adjust as necessary.

Focus on:

• Ongoing data collection: Continue to collect real-world evidence to support your product’s long-term success.

• Post-launch marketing: Engage payers and healthcare providers with ongoing education and updates about your product’s real-world performance. In 2025, the Medical Group Management Association (MGMA) said they seek to ‘eliminate or significantly reduce the volume of prior authorizations’ through ‘greater health plan transparency, uniform national standards and increased automation in prior authorization

• Adaptability: Stay flexible to adjust your market access strategy in response to new payer concerns, emerging competitors, or changing regulations.

Build a Strategy That Lasts

In the race to bring new drugs to market, a bulletproof market access strategy is your best chance for success. From the early R&D phase to post-launch market dynamics, each step of the journey is an opportunity to strengthen your product’s value proposition and secure payer approval.

By starting early, building a solid evidence base, understanding payer needs, engaging stakeholders, and mastering pricing negotiations, you can confidently guide your drug from pipeline to payer approval—and ultimately into the hands of the patients who need it most.

At PFG MedComm, we specialize in crafting comprehensive market access strategies that address every stage of the product lifecycle. Let us help you navigate the complexities and drive your product to success in today’s competitive healthcare environment.

Looking Forward

In the race to bring new drugs to market, a bulletproof market access strategy is no longer optional—it is the decisive factor for success. For 2026, payers will focus on delivering value by containing escalating healthcare costs, weighing evidence for new high-cost treatments, and pushing affordability onto consumers and providers. The impending expiration of enhanced Affordable Care Act (ACA) premium tax credits at the end of 2025 further intensifies these priorities.

From the early R&D phase to post-launch dynamics, every stage is now an opportunity to demonstrate real-world performance, anticipate payer concerns, and adapt to evolving frameworks. The global RWE market alone is projected to reach $48B by 2032, signaling that robust data infrastructure and long-term evidence generation are essential, not optional.

By starting early, investing in scalable evidence, engaging stakeholders with transparency, and embracing innovative pricing models such as warranty-based or outcomes-linked agreements, you can position your product not only for approval but for sustainable access.

‍

Maximize Your Strategy

At PFG MedComm, we partner with clients to design future-ready market access strategies that adapt to regulatory shifts and competitive pressures. We ensure innovative products reach the patients who need them the most and create lasting value in a rapidly changing healthcare landscape.