Generic Giants Strategize to Exploit Massive Patent Cliff Potential
Huge rewards and strong competition are prompting generic drug manufacturers to closely examine the best way to maximize market share as the industry patent cliff approaches its peak, states a new report from business intelligence analysts GBI Research.
According to the firm’s latest report*, the revenues of drugs subject to patent expiration between 2013 and 2020 are valued at over US$100 billion, offering producers of generics and biosimilars a fantastic opportunity to substantially bolster their own sales.
However, while the next few years hold great promise for these companies, fierce competition exists not only from rival generics manufacturers, but also from major pharmaceutical players looking to maintain market dominance with ‘Authorized Generics’ (AG). In response, generics firms are re-evaluating their approach to the market.
GBI Research states that companies such as Hospira are reaching out to new locales in order to build a global presence, while targeting governments looking to bring down healthcare costs. Exploiting pharmaceutically underdeveloped economies may allow generics firms to launch products first, challenging the intellectual property of proprietary pharmaceutical majors.
Generics producers also hope to capitalize on expiring patents by manufacturing complex generics that are difficult to reproduce. These “super generics” have high barriers to entry, a greater price than most other generics and incur greater Research and Development (R&D) costs; however, there is significant potential for super generics within specific therapeutic areas, such as cancer and conditions involving the central nervous system.
GBI Research expects demand for high-quality generics to increase in the future, as key drugs lose patent protection and governments are offered opportunities to provide vital treatments at significantly reduced costs.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Funding Cuts Threaten Diversity in Clinical Research
June 27th 2025In this video interview, Kyle McAllister, co-founder, CEO, Trially, discusses how recent federal funding cuts are likely to undermine research focused on underrepresented populations, and why long-term investment in community-based studies is essential to closing persistent health equity gaps.
