Abstract

Complex generics are becoming the most widely manufactured pharmaceutical product, giving cost-effective alternatives at the same time pose challenges to various stakeholders. In this study, we are focused on the market growth barriers and facilitators in the top two complex generic markets. A mixed-method market dynamic study was employed. 4Ps analysis (Product, price, place, and promotion) study was conducted quantitatively to know the market share and trends of complex generics in the United States and India. Strength, weakness, opportunities, and challenges analysis is employed to analyze internal and external strengths to develop strategic planning and management techniques to achieve market success. Data were collected from regulatory agency reports, online registered pharmacy websites, government retail pharmacy websites, IQVIA databases, and published literatures. Nonbiologic complex oral API products were seen to be more in US and Indian markets. Chemotherapeutic agents (capsule, tablets, and injectables) and respiratory agents (aerosols) are the leading complex generics. Price study shows an average 45%–60% reduction in selling price compared to innovator drugs. Promotional activities fully depend on the physician. The increasing demand for complex generics, driven by their affordability compared to name-brand equivalents, is highlighted in the strength section. The weakness section involves the regulatory obstacles, such as potential delays in drug approval and complexity of the manufacturing process, such as difficulty in establishing bioequivalence (BE), increased production costs, and so on. The opportunities section looks at ways to grow the industry, such as developing strategic relationships with new technologies like continuous manufacturing procedures and model-informed formulation development. Finally, the challenges, such as stringent BE requirements and a lack of regulatory guidelines, which delay the approval and market entry of complex generics, are highlighted. The evolving complex generic market requires a well-defined technology-driven approach for substantial growth. This article highlights the dynamic nature of the complex generics market and provides stakeholders with helpful information for making strategic decisions to effectively navigate the complex nature of this particular market sector and achieve long-term growth.

Key words: Super generics, Hybrid drugs, Descriptive statistics, GDUFA, Challenges, Market dynamics