A Study on Factors Attributed to Failure of Pharmaceutical Products


  • Alkesh S. Mourya B. Pharma, 4th Year Sem. VIII Student, SSR College of Pharmacy, India
  • Dr. Rajesh Kumar Pandey Associate Professor, SSR IMR, Silvassa, Permanently Affiliated to SPPU, Pune, India




pharma marketing, pharma crisis, pharma products, pharmaceutical industry, product withdrawal


The Pharmaceutical Industry plays a pivotal role in healthcare by developing, manufacturing, and marketing drugs to treat a myriad of medical conditions. However, despite rigorous research, development, and testing processes, a significant number of pharmaceutical products fail to meet the expected standards or gain market acceptance. This study aims to explore the multifaceted factors that contribute to the failure of pharmaceutical products, focusing on the product life cycle as a framework for analysis. The product life cycle of a pharmaceutical product encompasses several stages, including research and development, clinical trials, regulatory approval, launch, and post-marketing surveillance. At each stage, various factors can influence the success or failure of a product. These factors range from scientific challenges and regulatory hurdles during the R&D phase to manufacturing issues, competitive pressures, and post-market safety concerns.

Through a comprehensive theoretical reviews and authors understanding of the subject, this study identifies key factors attributed to the failure of pharmaceutical products. These include but are not limited to Scientific Challenges: Inherent complexities in drug discovery and development, including target identification, drug design, and optimization, can lead to unforeseen efficacy or safety issues. Regulatory Hurdles: Stringent regulatory requirements and evolving guidelines can delay approvals, increase development costs, and limit market access for new drugs. Manufacturing Issues: Quality control failures, supply chain disruptions, and manufacturing inconsistencies can compromise the integrity, efficacy, and safety of pharmaceutical products. Competitive Pressures: Intense competition from generic drugs, biosimilars, and innovative therapies can erode market share and profitability, especially for products with limited differentiation. Post-Market Safety Concerns: Adverse events, drug interactions, and long-term side effects discovered after product launch can result in recalls, litigation, and damage to the brand reputation. By understanding and addressing these factors proactively, pharmaceutical companies can mitigate risks, enhance product quality, and improve the likelihood of success throughout the product life cycle. This study underscores the importance of comprehensive risk management, continuous monitoring, and adaptive strategies to navigate the complexities and challenges inherent in the pharmaceutical industry.


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How to Cite

Alkesh S. Mourya, & Dr. Rajesh Kumar Pandey. (2024). A Study on Factors Attributed to Failure of Pharmaceutical Products. Applied Science and Biotechnology Journal for Advanced Research, 3(2), 12–21. https://doi.org/10.5281/zenodo.10976869