New paths to product value: Strategies to optimize the mature product portfolio
Compounding the patent challenge is pressure from payers and health systems on pricing and market access, combined with geopolitical trade pressures.2,3 All these dynamics are pushing biopharma companies to consider how best to handle the management of their mature product portfolio.
As companies assess the best path forward, new strategic outsourcing models for managing these important legacy products are emerging. Rather than reactive outsourcing, companies can adopt more deliberate and more varied paths based on product value, growth potential, and operational and resource capacity. These examples chart our experience in working with companies seeking the best strategies for managing their mature portfolios.
The release model: Scaling back on nonaligned assets
To navigate these “release” strategies, companies typically rely on transitional service agreements (TSAs) to support efficient management of the transition. Often, the seller will retain elements of the portfolio for a defined period, such as handling regulatory filings. TSAs allow the seller to manage these activities through outsourcing while continuing to maintain revenue streams.
The time involved to transfer assets can vary significantly depending on country-specific timelines and complexity, for example, if the portfolio is commercialized in various geographies. By working with external partners to support these activities, organizations can focus on their core objectives.
Another way that companies can choose to scale back is through licensing agreements, which can allow larger companies to continue to generate revenue from a mature product or portfolio, expand into new markets, and at the same time shift the focus to innovation.4
The methods these organizations adopt to scale back on nonaligned assets can vary; however, the objective of shifting the focus to core therapies and innovation remains the same. Engaging outsourcing partners early on to develop a strategic approach that will support the objectives can help any transition to be handled more seamlessly. Not only can it help companies achieve cost savings, but a strategic partner can also provide access to digital innovation, process innovation, and thought leadership.
Retain and proceed with caution
A key driver for outsourcing is to lower the cost of product maintenance while at the same time keeping compliance status of the product from a regulatory, safety, and quality perspective. One model that companies are adopting is outcomes-based where the service provider’s compensation is tied to key results, such as cost savings achieved, cycle times improved, or compliance targets met. This model draws on the provider’s domain expertise – regulatory, quality, etc. – as well as technology capabilities to automate processes, further extending value.5
While mature products might not deliver the profit margins that patented products do, they can still be strategically and financially valuable as long as they are resourced appropriately. Outsourcing allows companies to retain that value and meet compliance requirements while reducing internal overhead. For companies whose mature products are sold in multiple markets, transferring regulatory, safety, quality, and operational maintenance activities to a strategic partner removes much of the complexity of managing the demands of different regions.
Reigniting the mature portfolio
In these scenarios, focused and strategic outsourcing can allow companies to take advantage of that expansion without putting too much burden on internal resources. Outsourcing partners can be used as an operational extension, for example, to support efforts to expand into new markets or to assess data for possible new formulations or indication expansions.
Geographic expansion is an attractive proposition for many companies; nevertheless, there are obstacles to overcome. To safeguard the portfolio companies need to stay ahead of legislative changes and a tightening regulatory environment. Successful geographic expansion should start in early planning and an understanding of the local patient population and medical needs of each market.6
Finding the best path for the mature portfolio
About the authors:
Stefanie Lietsch-Dallwig is Senior Director, Global Program Management Service Solution Lead - Local Affiliate Services, at Cencora. She has held senior regulatory affairs positions in the pharmaceutical industry in international roles, including Director Regulatory International and Emerging Markets, Head of Regulatory Intelligence, and Director Project Management. Stefanie brings a demonstrated track record of registration and launch planning for new applications and variations in EU and non-ICH countries.
Disclaimer:
The information provided in this article does not constitute legal advice. Cencora, Inc., strongly encourages readers to review available information related to the topics discussed and to rely on their own experience and expertise in making decisions related thereto.
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Sources:
1. Next drug patent cliff to challenge Big Pharma strategy, European Pharmaceutical Review, July 2025. https://www.europeanpharmaceuticalreview.com/news/261834/next-drug-patent-cliff-to-challenge-big-pharma-strategy/
2. The Pricing and Market Access Landscape for Multi-Indication Products, Challenges and Opportunities in Europe, KPMG. https://assets.kpmg.com/content/dam/kpmgsites/uk/pdf/2023/10/the-pricing-and-market-access-landscape-for-multi-indication-products.pdf
3. The Most-Favored-Nation Policy: Outlook and Implications Beyond U.S., PharmExec, October 2025. The Most-Favored-Nation Policy: Outlook and Implications Beyond U.S. | PharmExec
4. The Strategic Imperative of Out-Licensing Mature Drugs: A New Lease on Life for Legacy Assets, DrugPatentWatch, Aug 2025. The Strategic Imperative of Out-Licensing Mature Drugs: A New Lease on Life for Legacy Assets - DrugPatentWatch – Transform Data into Market Domination
5. Outsourcing’s Evolution in the Pharma Industry, PharmExec, Sept 2024. Outsourcing’s Evolution in the Pharma Industry | PharmExec
6. Pharmaceutical Globalization - Navigating Opportunities & Obstacles, Drug Development & Delivery, Dec 2023. https://drug-dev.com/pharmaceutical-globalization-navigating-opportunities-obstacles/
