Blog | 5/28/2025

Market Access Execution: Have You Covered Your Bases?

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

In prior installments, we highlighted the role of market access as an MVP (both minimum viable product and most valuable player) of diagnostic commercialization success and provided overarching keys to success for developing and executing market access strategies. For the final installment of our market access blog series, we explore the design and execution of a complete program across five major components by posing the critical questions the cross functional market access team needs to answer to optimize the strategy and tactical plan.

Successful diagnostic tests are supported by strategies including all components of market access, calibrating each to the product’s value story, relevant stakeholders, and competitive environment.

Clinical and economic evidence is the foundational component of market access. Analytical and clinical validity studies alone do not generate the insights needed to support a compelling value message or secure optimal coverage, rates, and customer adoption. Particularly for tests providing new clinical insights, clinical utility and economic evidence are also required. The design of a robust evidence generation strategy must take into consideration not just the clinical value story but incorporate endpoints and approaches that address needs for the coding, pricing, and stakeholder engagement plans. Key questions to answer while developing the evidence generation strategy include:

Which specific endpoints (as identified from advisory boards and market studies) will be required to best fill gaps and create a compelling value story?
How do evidence needs differ across geographies? Which countries will require local evidence generation?
How should the patient population be defined to balance ease of recruiting with the degree of impact on market access/opportunity size?
Is there any existing data that can be leveraged?
What market access endpoints can and should be integrated into regulatory submission registration trials?
To what degree can and should investigator-initiated studies be conducted and incorporated into the plan?
Should studies compare outcomes head-to-head against competitors or just against the standard of care? (e.g., POC versus lab or POC versus other POC)
How many studies will be needed, as benchmarked against comparators?
To what extent can observational and decision impact studies be incorporated into the plan in place of prospective cohort studies and randomized controlled trials?
How should trials be designed: how many centers and patients?
How many peer-reviewed publications are required to drive strong payer coverage?

Coding strategy is another core pillar of market access that determines whether a diagnostic test will be reimbursed, at what rate, and under what conditions. Without appropriate coding, even clinically valuable tests may face barriers to adoption.

Is a code even relevant for this test or is testing primarily for inpatient use (which is bundled under a DRG) or covered under some other capitated payments system (e.g., global budget rather than fee for service coverage of diagnostics in a particular geography)?
Is testing performed professionally and reimbursed with a code, or is testing paid for by patients directly as an out-of-pocket cost?
In which countries are codes required? How do coding requirements differ across geographies?
Is there an existing code that can be leveraged for this test, or is there a reason to pursue the creation of a new code?
If not, what type of code is best suited to the test? (e.g., in the US, choice between a traditional Category I CPT code versus a PLA code)
What are the risks and timelines of pursuing the chosen coding strategy and how can these be mitigated?

Developing a robust pricing strategy is essential to unlocking the full value of a novel diagnostic. When setting the price for an IVD test, manufacturers must balance clinical value, competitive positioning, and expected reimbursement. Key considerations include the test’s impact on clinical decision-making, cost savings or outcomes improvement, existing alternatives in the market, customer willingness to pay, and payer willingness to cover the test at a given rate. Pricing must also account for production costs and the distribution model. Without a robust pricing strategy, even the most promising technologies risk underperformance due to misaligned incentives or access barriers.

At minimum, what level of margin will be required by labs in order to cover labor and overhead?
How does the price point compare to the standard of care? To competitor benchmarks or other analog products?
To what extent is there evidence to support budget impact or health-economic cost savings that could drive a higher price point? Is there potential to price at a premium?
How should different distribution strategies (e.g., direct vs. distributor) impact the pricing decision?
How do different contracting strategies such as reagent rental impact assay pricing?
Given all of the above, relative to expected reimbursement rate and coding strategy, how should the test be priced?

Instrument access through pilot or beta test sites plays a critical role in market access strategy by enabling early clinical adoption, generating real-world performance data (RWD), and building advocate users. These placements help validate the instrument’s utility in diverse settings, support evidence generation for reimbursement, and create reference accounts that influence broader market uptake. Strategically selected sites can also uncover feedback, help refine positioning, and accelerate commercial traction post-launch. This strategy can help secure long-term contractual commitments and foster customer loyalty in competitive or cost-sensitive environments.

How does the instrument cost and workflow (only one test on the instrument), influence the value story for the customer? Is it adding a hurdle to adoption (e.g., crosses a purchasing decision threshold, adds too much cost to the equation for the first test on the menu, etc.)?
For both new and installed instruments, how is total cost of ownership reflected in the value proposition to labs as new assays are introduced?
Will standard instrument placement tactics (i.e., reagent rental or capital purchase) be sufficient to achieve desired placements, or will a more aggressive (or creative) strategy be needed to drive market penetration?
Should a subset of instruments be strategically placed at no upfront cost to drive long-term assay revenue?
Is there an opportunity to partner with key customers as early adopters to accelerate evidence generation and contribute real-world data?
Are risk-sharing (savings from implementation split between customer and manufacturer/price per test adjusted based on savings) strategies a good approach to early-access and collecting RWD? How difficult will it be for partners in these agreements to collect the needed data?

A strong evidence package alone is not enough to drive adoption—early and sustained engagement with key stakeholders is essential to achieving market access. By actively involving KOLs, guideline bodies, policy makers, clinicians, lab professionals, and payers, diagnostics manufacturers can build support, address concerns and ensure the value of the test is clearly understood. Strategic stakeholder engagement helps accelerate uptake and lays the foundation for long-term success.

Which stakeholders are the highest priority for building relationships?
How should investment in stakeholder engagement vary across the tactical mix and key geographies?
What are the most effective communication channels (e.g. publications, field force, continuing medical education, conference participation) to maximize impact and uptake?
How are all communication channels—across medical affairs, public and government affairs, marketing, and field sales—strategically aligned to convey critical evidence and reinforce product value?
How can guidelines bodies and professional organizations be integrated to proactively disseminate evidence and generate greater awareness of the test and its benefits?
Which government agencies are considered priority stakeholders that should be integrated into the overall engagement strategy?
Which clinician specialties require the most education on test utilization and what are the most effective tactics for delivering that information?
How early should payers be included in discussions of evidence and pricing in order to ensure positive coverage at launch?
What role should direct-to-patient engagement play in the overall strategy, and which channels—such as PR, advertising, or other marketing approaches—are best suited to reach and influence this audience?
When in the product life cycle should stakeholder engagement begin?
How many FTEs will be needed to maintain existing relationships as launch approaches?

Conclusion

As we reflect on the full scope of this blog series, our aim has been to underscore the critical role of market access in driving commercial success of diagnostic products and to elevate your perspective on what it takes to execute effectively.

In summary:

Ongoing trends and evolving market dynamics are raising the bar for market access strategy as a core element of any diagnostic offering
Each diagnostic product requires a uniquely crafted approach to market access to effectively demonstrate value and drive commercial success in the professional testing market
Achieving meaningful results requires early planning, cross-functional alignment, and dedicated resources to ensure high-impact execution

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