On December 9-11, 2025, Informa Connect’s Trade and Channel Strategies’ Mastering the Complexities of Pharmacy and Distribution Models to Accelerate Market Access conference in Philadelphia took a deep dive into the current landscape of innovative distribution, integrated pharmacy models, and the future of trade for the pharmaceutical and biotechnology industries. This conference has become a gathering spot for market access professionals over the last 20 years, featuring discussions on new distribution models, analysis of the latest market dynamics, global trade tariffs, and drug supply serialization.
After three days of insights, here are a few key takeaways for industry stakeholders as we enter a new year in which the market continues to evolve.
Disruption in Pharmaceuticals
IntegriChain’s Senior Vice President and Managing Partner Bill Roth provided the opening keynote presentation, “Navigating Disruption in the Pharmaceutical Channels,” where he provided a vision of a seismic change in 2026 from the past 40-50 years of pharmaceuticals moving from cash-pay to insurance-pay and segments are now returning to cash-pay in response to market demands and industry failures to address those demands. As retailers struggle to survive on their current market mix that sees a majority of patients (over 60%) paying out of pocket (OOP) for at least one medication, Roth observed that the number and user base of cash-pay pharmacies has grown in response. But cash pay does not work for many products, particularly new-to-market, innovative therapies. As a result, we now live in a multimodal payer, pricing, and channel model. Roth’s advice for adapting to this shift? Talk to your lawyers (note that AI is not advanced enough to respond with appropriate nuance and accuracy) to build payment/payor programs that work in today’s rapidly changing landscape, where you cannot simply copy another similar product’s model.
Decoding Policy and Legal Vigilance
These authors took center stage immediately after the kick-off keynote to present a view of how various states have responded to market access and safety concerns (such as safety, cost for payers and patients, access of local and independent pharmacies, and funding for safety-net health care) that have not been addressed federally – by design and by inaction – by enacting their own laws and enforcement measures. For manufacturers, it is important to navigate this increasingly complex state-by-state activity when designing market access strategies and expectations for their products, particularly at launch. Layering in the approaches to trade and the pharmaceutical industry taken by the federal government through executive orders and social media posts increases the chaotic experience of manufacturers in the context of the increased local differentiation. Such changes have made it increasingly important for companies to work with trusted advisers to navigate the state-by-state patchwork landscape, a message similar to what was echoed during a recent conference on FDA enforcement and compliance.
The FDA’s post-market study requirements may lead to opportunities for patent protection or new exclusivities, and we discussed the impact of compounding pharmacies on access to popular medications like glucagon-like peptides (GLP-1s), especially when a shortage exists for a time period and the adjustments thereafter. Several types of market access studies may be helpful or required for innovative companies to support product pricing, especially with the Inflation Reduction Act looming and comparative advantage pricing models in other countries. This makes it increasingly important for manufacturers to collaborate with physicians and patient advocacy groups early in product development to support pricing warranted by research and development needs and market growth.
Other Areas of Note
Additional speakers addressed more specific topics such as channel strategies, partnerships for more effective market access, new pharmacy and distribution models including how independent pharmacies are making an impact, the direct-to-patient “revolution” and how that is reshaping distribution models such as “white label” pharmacies, complex therapy requirements navigating to more comprehensive patient support and distribution through alternative sites of care, cell and gene therapy logistics and dispensing, digital health and health system collaborations, IRA impact, drug shortages, specialty channel distribution models, the impact of generics and biosimilars, pricing strategies and 340B logistics, and market dynamics from Wall Street.
This blog was drafted by Spencer Fane attorneys Brian Malkin and Beth Siemer, attorneys in the Washington, D.C., and St. Louis, Missouri, offices of Spencer Fane, respectively. For more information, visit spencerfane.com.
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