Industry Odisha Bureau, Sep 2: Indian pharmaceutical companies have evolved substantially beyond their traditional domestic branded formulations. The industry now operates globally across APIs, generics, vaccines, speciality products, and biosimilars. This expansion has positioned several Indian companies as meaningful participants in regulated markets.
Multiple business models now characterize the Indian pharma industry simultaneously. Some companies maintain significant domestic branded formulation businesses alongside international operations. Others have built API operations and generic export franchises across developed economies.
Participation in regulated markets requires capabilities that extend far beyond manufacturing domestically. Markets such as the United States demand regulatory compliance and manufacturing excellence. The pathway to success differs fundamentally from domestic branded formulation business models.
The next pharmaceutical opportunity increasingly involves biosimilars rather than conventional generics. A conventional generic reproduces the same active ingredient after patent expiry. Biosimilars represent far more complex products developed through sophisticated living systems.
Developing and manufacturing biosimilars requires specialised facilities and scientific expertise. The development process takes years with substantial capital commitment before sales. Manufacturing must consistently meet demanding quality standards that regulators demand globally.
Regulatory expertise represents another critical hurdle for Indian pharma companies. Approval processes in regulated markets differ significantly from domestic regulatory frameworks. Companies must navigate complex, time-consuming procedures before they commercialise internationally.
Approval alone does not guarantee commercial success in regulated pharmaceutical markets. Many complex products require hospital relationships, insurer agreements, and purchasing contracts. Commercialisation often requires infrastructure that companies may not possess internally themselves.
Indian pharma companies pursue different routes to participate in this opportunity. Dr. Reddy’s developed biosimilar manufacturing capability while licensing commercialisation rights externally. Lupin manufactures its biosimilar while partnering for US market distribution.
Biocon acquired Viatris’ biosimilars business to build integrated commercial capabilities. This approach provides greater control over value but requires substantial capital. Different companies choose different models based on their specific capabilities.
The coming pharmaceutical opportunity depends as much on product selection. Companies must choose molecules worth pursuing years before markets open. Capital allocation, regulatory expertise, and market timing determine which companies succeed.
How many Indian pharma companies possess the capability to scale remains unclear. Entry barriers create both challenges and potential protective economics for successful entrants. The next couple of years will reveal which companies capitalise effectively.
