Pharmaceutical companies are facing major headwinds due to loss of exclusivity as product patents expire. They are navigating multiple macroeconomic pressures, such as inflation, pricing pressures, and fluctuating capital markets.
Although data shows more products are entering late-stage development, barriers to future pipelines remain. Among the issues faced are competition, a heavy focus on saturated therapy areas[1], and concerns over future investments in early research amid significant funding cuts to the US National Institutes of Health (NIH)[2]. Investment remains a major concern in the Europe Union, with several reports emphasizing the critical importance of funding programs and developments that will make the region more competitive[3],[4].
At the same time, the mature product portfolio remains an important, if declining, source of revenue and financial stability for pharmaceutical companies. According to analysts, revenue returns from drugs currently under patent will fall in 2031 and even more so by 2034[5].
Given these competing challenges, companies are looking for ways to better manage the existing portfolio even as these products face loss of exclusivity1. Integral to this will be implementing greater efficiencies in how companies support and manage their legacy portfolios.
Retaining value while cutting costs
Too many companies are managing their legacy portfolios with resources and infrastructure designed to support earlier stage research and development. As a result, internal teams spend their time and expertise focused on mature products rather than on driving innovation.
Instead, what they should be doing is adopting a more efficient and sustainable approach to managing the regulatory and pharmacovigilance activities that are needed to ensure continued access of mature therapies to patients.
This requires deep understanding of the current global marketplace – both from a regulatory and reimbursement perspective – and an ability to extract the greatest value from the mature product portfolio. And that will require a flexible, scalable, and nimble mature product management strategy.
These needs are prompting more and more pharma companies of all sizes to turn to outsourcing, not only as a cost-cutting measure, but also as a strategic lever to unlock options.
Local and global market knowledge
Managing the in-market activities required to keep legacy assets on the market requires both local and global expertise. It requires navigating multiple regulatory environments, each with its own requirements. Such complexity can strain internal resources, particularly when companies attempt to manage these processes in-house.
Requirements at the local level – such as responsible persons (RPs) and qualified persons for pharmacovigilance (QPPVs) – can place an enormous burden on local affiliates.
By outsourcing critical and resource-intensive functions, such as regional and local regulatory affairs, PV, and supply chain management, company leaders free up internal resources while ensuring compliance on global markets.
Since a mature portfolio typically will span multiple markets and regions, these products will require label updates, safety reporting, product supply and other product management activities. Having a strategic partner helps to ensure these companies can continue to support the global portfolio and manage regional requirements around variation filings, renewal coordination, and safety reporting.
When dealing with a global portfolio, an outsourcing model that combines centralized oversight with local execution is key to drive compliance, efficiency, and scalability across regions. The most effective partners apply outcome-based models with shared risk/reward structures. This approach enables IP continuity, scalability, and supports financial predictability and forecasting.
Reigniting the mature portfolio
Looking beyond product maintenance, in some instances there are opportunities to breathe new life into a brand – for example, through new formulations, fixed-dose combinations, or even secondary indications if clinically relevant. Alternatively, expanding into underpenetrated regions or new customer segments could also revitalize a brand and unlock revenue growth.
As concerns over patent cliffs as well as funding cuts intensify, the opportunity to reignite some mature brands is gaining momentum.
Here again, strategic outsourcing can create value by enabling focused expansion without overtaxing internal capacity. Whether a company is seeking new marketing authorizations, repurposing data for indication expansion, or launching supplemental clinical studies, an outsourcing partner can act as an operational extension, accelerating execution while internal teams focus on scientific and strategic inputs.
Dedicated models, such as short business review cycles and adjustable resource allocations, can help companies to expand or contract the portfolio as needed.
Extending or expanding the life and profitability of mature products will require companies to invest in reformulations, new delivery systems, or line extensions while managing ongoing regulatory maintenance.
Another key avenue being pursued by companies is expansion into Asia, Latin America, and Africa. These markets are growing quickly, but at the same time they are rapidly updating their legislation, making it difficult for companies to enter and increasingly more expensive to manage product maintenance.
By assessing each target market’s regulatory, reimbursement, and policy environment early, companies can determine risk and opportunity. Equally important is optimizing channel strategy and ensuring cross-functional coordination across regulatory, patient access, and logistics functions. Integrated commercialization partners can help streamline the complexity to reduce internal burden while helping companies tap into new income opportunities.
Seeing the big picture with the mature portfolio
Managing the mature portfolio requires a multi-faceted and strategic approach – one that balances product extension, product expansion, and cost-efficient product maintenance. All these approaches require a balance of operational agility, deep knowledge of regulations, and the infrastructure to execute across pathways without disrupting product continuity or compliance.
Mature products can still retain strategic and financial value, as long as they are resourced appropriately. Bringing in a global strategic partner to oversee maintenance of a mature portfolio can ensure those compliance requirements are met while freeing internal employees to focus their attention on high-value innovation.
About the author:
Ursula Schickel, Ph.D., is Senior Director Regulatory Affairs. She leads regulatory submission and procedure management at PharmaLex and supports clients with marketing authorization applications and life-cycle management of different product portfolios in global markets. With more than 20 years of experience in regulatory affairs and a master’s degree in regulatory affairs, Ursula has dealt with a broad range of regulatory activities covering development projects and global maintenance of mature product portfolios in various markets.
[1] Be brave, be bold. Measuring the return from pharmaceutical innovation, EY. March 2025. https://www.deloitte.com/ch/en/Industries/life-sciences-health-care/research/measuring-return-from-pharmaceutical-innovation.html
[2] Potential Trade-Offs of Proposed Cuts to the US National Institutes of Health, JAMA, July 2025. https://jamanetwork.com/journals/jama-health-forum/fullarticle/2836433
[3] The future of European competitiveness, Mario Draghi, European Commission. https://commission.europa.eu/topics/eu-competitiveness/draghi-report_en#paragraph_47059
[4] Align, Act, Accelerate: Research, technology and innovation to boost European competitiveness. European Commission. https://op.europa.eu/en/publication-detail/-/publication/2f9fc221-86bb-11ef-a67d-01aa75ed71a1/language-en
[5] Biopharma’s Patent Cliff Puts Costs Front and Center, BCG, Feb 2025. https://www.bcg.com/publications/2025/patent-cliff-threatens-biopharmaceutical-revenue
