Blog | 5/19/2025

The Secret Sauce: Keys to Success in Diagnostics Market Access

By Donna Hochberg, PhD, Chris Karras, Peter Origenes, Martha O'Neill, Ivan Hristov, Alfonso Barrios, PhD,  Shun Hang (Henry) Chan, PhD

In today's rapidly evolving landscape, the importance of a robust market access strategy for diagnostics cannot be overstated (see our recent discussion here). The right approach can make or break a product's commercial success and safeguard value in an environment where intellectual property protection is often limited. In this discussion, we explore top-level keys to market access strategy success, offering valuable lessons to both new market entrants and established players. 
_______________________________________________________

start-early.png

Before investing in the development of a novel diagnostic, it is crucial to validate that you will be able to receive payment for the test and that these payments will be sufficient to support the test’s commercialization. An early understanding of what is required to obtain these payments is essential to maximize return on investment (ROI) and drive rapid product adoption. By ‘early’, we mean at the moment of product/test ideation. 

secret-sauce-1.png

 

create-product.png

A data-driven value story is vital to gaining buy-in from clinicians, payers, labs, patients, and other clinical and economic stakeholders. Simply presenting the conceptual clinical answer that your test provides, no matter how seemingly obvious or compelling its impact may be, is not sufficient. The true impact of the value story lies in demonstrating clinical utility – showing how the test or technology will change patient management, lab operations, and, ultimately, outcomes. 

secret-sauce-2.png

Stakeholders are unlikely to accept the value of a new test based solely on previous studies. Each test presents unique challenges and requires a tailored story. A robust market access strategy must include the collection of data specific to your test, comparing it to the existing standard of care and potentially competitors. While leveraging already available data can be a good starting point, it is the tailored data that will substantiate your test’s value claim and differentiate your product in the market. By focusing on the unique benefits and outcomes associated with your test, you can effectively support its value, maximize adoption, and ensure a competitive advantage.

 

make-cross.png

A common error in market access is viewing it as a specific independent function rather than as part of a broader whole including R&D, medical affairs, and commercial teams. The reality is stakeholders from across the organization are critical to the development and execution of a successful market access strategy and must be coordinated at the highest levels.

secret-sauce-3.png

 

optimized-nimble.png

Structuring a market access organization effectively is fundamental for companies of all sizes:

  • For larger organizations, this includes where the market access and medical affairs functions sit within the organization. There is no one right answer as the market access requirements and the most effective organizational structure to support them can vary significantly from one product launch to another and look very different depending on the number of products and clinical areas covered in the portfolio. 
  • Smaller organizations, particularly those with a single product, should focus on the unique needs of bringing that one product to market and might not require all the tools and resources that larger organizations use right away. Engaging outside consultants can be a cost-effective solution for developing and executing parts of the strategy without building an entire internal team.

Regardless of size, all organizations must be willing to shift personnel to different tasks as needed and conduct periodic reviews of organizational structure to remain agile and responsive to the evolving market landscape.

 

right-size.png

A market access strategy must both right-size the investment in market access for an individual product and the allocation of resources across the portfolio, functions, and activities. One tip is for organizations to develop a framework or decision tree that can be applied to any new product introduction and support evaluation of ROI. This framework should consider the ‘essential characteristics’ of a test to determine the level and type of investment required. For example, not every test holds the same potential for a value-based price, the data required to support testing can vary significantly, and some tests enter markets where favorable codes, coverage, and rates are already established. The framework should also be tailored to your organization based on factors such as risk sensitivity, access to capital, and the significance of product within the portfolio. By tailoring the framework to your organization's specific needs, you can effectively manage resources and make informed decisions to drive success.

Conclusion

Understanding and implementing these market access keys to success is crucial for diagnostic companies aiming to thrive in today's competitive environment. A well-crafted market access plan not only facilitates smoother market entry but also solidifies the value of your product, driving both customer acceptance and financial success. In our next blog post, we will delve deeper into the specifics of crafting a market access strategy and translating it into actionable steps that yield real-world results. 

If you’re interested in learning more on successful commercial and market access strategy for your products, please contact us at diagnostics@healthadvances.com. 

Share this: