Understanding how to energize, extend and capitalize the lifespan of mature drugs

As the pharmaceutical and biopharma sector increasingly focuses on value-based pricing, sustained profitability and expanding market access, the need to leverage products as they mature has intensified.

What has also increased is the need for strategic collaborations with partners that have the experience and knowledge to manage the complexities of product lifecycle maintenance.

The arduous and costly journey of developing a drug, supporting clinical trials and meeting regulatory approvals can take between 6 to 10 years and cost as much as $2.3 billion dollars in 2023.¹ That journey and the costs don’t end after the threshold of commercialization is crossed.

Once a product is commercialized, the manufacturer can begin to recoup costs incurred during the early stages of development. As the product begins to mature in the ensuing years—most brand-name drugs experience between 12 to 16 years without competition from generics²—it begins to reach market maturity.

Maximizing a drug’s ‘Golden Years’

During this period, maintenance plays a vital role as a manufacturer's product can be in the market for a number of years, leading to significant changes impacting both local operations and corporate functions. Understanding and knowing how to approach these adjustments are essential to optimize and increase revenue from mature drugs. By doing so, revenue brought in by an established product can go toward the company’s bottom line or be reinvested in new products that might be under-resourced.

A mistake drugmakers often make is assuming they have already invested enough money at the front end of a launch, thinking the product will gain a level of success along with the ability to self-promote and continue to achieve the level of sales without developing a new product strategy.

“Having a global and local outsourcing solution can provide a pathway to address all of the challenges,” Kirsten Jacobs, Chief Service Strategy Officer for global consulting services at Cencora (formerly AmerisourceBergen), said. “Through a collaboration, companies can concentrate on internal priorities like innovation, efficiency and ROI and not have to keep their eye on managing the complexities of product lifecycle maintenance.”

Cencora’s Optimal Patient Access (OPA) outsourcing solution offers a comprehensive approach that blends pharmacovigilance, regulatory affairs, and quality assurance to aid operational efficiency, support profitability and help ensure revenue sustainability and growth.

Having the right solutions on hand

According to Jacobs, Cencora's solutions enable the optimization of global data oversight from local markets to assure patient safety and access to up-to-date patient information. Jacobs also emphasized the importance of refining manufacturing strategies, distribution channels and pricing tactics for achieving success.

Through a strategic partnership, Cencora offers consulting services for risk management, change management, and regulatory affairs functions throughout the entire product development process. Additionally, the company provides a comprehensive strategy for commissioning, qualification and validation (CQV) to ensure that a drugmaker's facilities, systems and equipment meet all necessary requirements. Moreover, its pharmacovigilance and medical information services oversee compliance with constantly evolving global regulatory standards to ensure the highest quality of safety data collection and processing.

“Most, if not all, of these activities lead to global regulatory dossier updates as well as the establishment of global processes within our pharmacovigilance and GxP affected areas,” said Jacobs.

With more than 500 associates globally and representing more than 235 brands, Cencora has vast experience and access to numerous data silos that can help unlock insights that can become relevant strategies. By using AI and machine learning, the knowledge uncovered allows drugmakers to navigate market challenges more quickly.

“We take a holistic approach that allows our partners to focus on what is important to them as they look to maximize the lifespan of a product,” Jacobs said.

By leveraging expertise and addressing key aspects at each stage of development, manufacturers can enhance their chances to extend the lifespan of their products through the right collaborative partnerships with experienced partners possessing global and local expertise. Connect with us to learn more information on how to navigate the commercialization journey.

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