Stephen Ralston, EVP Market Access and Health Economics Outcomes Research (HEOR) at Coronado Research, speaks to Lu Rahman about the latest trends in market access.

LR: What is changing in the market access industry?

SR: Market access is a vibrant industry that has evolved significantly over the past two decades, driven by increasing complexity in global healthcare systems and rising demand for innovative therapies. This growth has been identified as a key factor in the predicted compound annual growth rate (CAGR) of 5% by 2029 in the Global Pharma Contract Commercialisation (CCO) Market¹.

Several factors are driving the increasing demand for market access. Firstly, many major pharmaceutical firms have undergone organisational changes, often reducing their in-house market access teams. This has led to a greater reliance on external partners for market access support, creating opportunities for specialised service providers.

Additionally, the EU Joint Clinical Assessment (JCA) procedure, which is being initiated throughout 2025, is poised to reshape the health technology assessment (HTA) landscape in Europe. This process involves clinical value assessments for medicines covering all 27 EU member states occurring in parallel with the European Medicines Agency (EMA) centralised regulatory procedure, likely increasing demand for market access expertise. 

The US market is also undergoing significant change. The Inflation Reduction Act has already empowered Medicare to negotiate drug prices, potentially shifting the cost dynamics of global drug development. As the current administration explores further reforms, including potential changes to tariffs and vaccine pricing, market access strategies will need to adapt accordingly.

Together, these factors underscore a rapidly changing market access environment, marked by both new challenges and growth opportunities.

LR: Why are pharma companies outsourcing more in areas like health economics and market access?

SR: Historically, pharmaceutical companies have relied on outsourcing for services such as market access and health economics because of the need for expertise in these areas. There are certain disciplines that require highly technical, project-based skills, making it less practical to maintain an internal team. For example, building an economic model may only be needed once per year, making it more efficient to bring in external experts on an as-needed basis.

This trend is likely to accelerate as many companies look to reduce their overall head counts. With companies streamlining their operations, the need for outsourcing will increase. 

LR: How will the EU Joint Clinical Assessment (JCA) affect market access?

SR: The introduction of the EU JCA marks a significant shift in the European HTA landscape. Historically, each of the 27 member states (and previously the UK) conducted independent assessments, requiring manufacturers to submit separate dossiers tailored to national requirements. The rigour and data demands varied by country. In Germany, for example, the Federal Joint Committee (Gemeinsamer Bundesausschuss; G-BA) emphasises clinical value, while the UK’s National Institute for Health and Care Excellence (NICE) focuses on cost-effectiveness, using metrics like cost per quality-adjusted life year (QALY).

This fragmented approach led to inefficiencies, redundancies, and delayed access to innovative therapies. Under the new regulations, the JCA aims to streamline clinical assessments across the EU by creating a single, joint evaluation of a medicine’s clinical benefit that all 27 member states can use. Individual countries will retain autonomy over decisions related to pricing, reimbursement, and cost-effectiveness. 

For manufacturers, the JCA introduces both opportunities and challenges. On one hand, a single clinical dossier could reduce duplication and speed up access across markets. On the other, meeting the JCA’s tight timelines and aligning with PICO (Population, Intervention, Comparator, Outcome) requirements will require greater strategic alignment in evidence generation and submission planning. Moreover, once the JCA is completed, companies must still navigate 27 different national processes to demonstrate local value for money—each with distinct economic models, preferences, and policy environments. 

In this evolving environment, early and sophisticated market access planning will be more critical than ever.

LR: Do you see AI playing a role in market access?

SR: AI has been the buzz word in market access for several years now, but its role remains somewhat limited at this stage. While it can be a useful tool to help human researchers conduct systematic literature reviews more efficiently and with greater quality, AI often misses crucial information or oversimplifies complex findings, which can compromise the quality of the output.

The other big drawback is that many AI platforms can freely search PubMed, but this only covers around 40% of the available medical literature. The remaining literature can often be found in subscription-based databases such as Embase, which are not as easily integrated into AI workflows. This gap forces researchers to conduct parallel searches, undermining the potential time and cost savings of using AI.

Ultimately, while AI has great potential, it is not yet a standalone solution for market access tasks. Instead, it should be seen as a complementary tool that supports, but does not replace, human expertise. 

LR: How does the increase in real-world evidence (RWE) affect market access?

SR: RWE is particularly valuable when launching a new medicine as it enables a manufacturer to characterise the current standard of care across different regions. This is important as standards of care can vary widely worldwide. For example, a trial for a therapy developed with US standard of care data may not be representative of the treatment patterns in the rest of the world. Real-world data can fill these gaps, providing the local data needed to show value in different regions.

Post launch, RWE strengthens pricing and reimbursement negotiations by providing concrete evidence of a medicine’s real-world effectiveness and economic impact. This data can be used to justify the price and reinforce the long-term value of the medicine.

LR: What would help to further optimise market access activity?

SR: To truly optimise market access, we need to start embedding it meaningfully across the entire clinical development cycle. In my experience, while there is growing recognition of the need to involve market access earlier, in practice, it’s still often treated as a downstream or reactive function. In a cross-functional environment, the market access perspective is sometimes seen as overly cautious or a barrier, rather than a critical enabler of long-term success.

I would like to see market access given an equal seat at the cross-functional table from the earliest stages of development. Its insights are valuable, not just for navigating reimbursement and HTA requirements but for shaping clinical trial design, evidence generation, and product positioning in ways that align with payer expectations and patient needs. By integrating market access early on, we can help define leaner, smarter clinical programs that reduce development costs, avoid misaligned endpoints, and improve overall value demonstration. Not only will this accelerate time to market, but also increase the likelihood of successful reimbursement outcomes, ultimately benefiting patients, payers and manufacturer partners.

LR: Finally, in a crowded market, how can clients differentiate between market access vendors?

SR: There are several factors that can set one vendor apart from another. Therapeutic expertise is crucial. When I worked in pharma and was looking to contract a vendor, I needed a partner who immediately understood the clinical and market access challenges my product faced. I didn’t have the time or budget to educate a vendor on the complexities of the therapeutic area. A vendor with real therapeutic depth can hit the ground running, shaping strategies and deliverables from day one.

You also want consultants who are trusted partners; technical credibility and reliability are essential. Whether it’s developing a health economic model, conducting an indirect treatment comparison, or building an external comparator arm, you need to trust that your vendor will deliver a robust, defensible output. If the submission doesn’t stand up to scrutiny by HTA bodies, your entire value proposition – and ultimately access for patients – could be compromised.

Finally, and it may sound simple; look for a vendor with a commitment to quality service throughout the entire engagement – not just until the contract is won. People sometimes ask me why I chose to re-enter this incredibly crowded market. The answer is I always want to bring something better. For me, it’s about bringing experienced, hands-on talent to the table, not just at the start of a project, but throughout its lifecycle. I want a team that’s collaborative, accountable, and genuinely motivated by the impact our work has on patient access to life-changing therapies.

From DDW Volume 26 – Issue 3, Summer 2025 Read the digital issue

References:

1. https://www.pharmiweb.com/press-release/2025-04-02/pharma-contract-commercialization-market-expands-as-demand-for-market-access-compliance-services-rises

Biography:

Stephen Ralston brings over 25 years of experience in delivering high-quality strategic Market Access solutions and HEOR evidence to the pharmaceutical industry. He has held leadership roles within pharmaceutical companies and founded his own Market Access and HEOR consultancy. Ralston’s work includes securing landmark HTA approvals for rare oncology treatments and negotiating with payers to refine decision-making criteria, ultimately improving patient care.