US Passes Biosecure Act — A Game Changer For Indian Pharma

India’s CDMO sector, which currently holds just 2.7% of the global market, could see substantial growth.

Colourful medicines arranged for drug. (Source: pxhere)

In a significant development for the global pharmaceutical industry, the US has enacted the Biosecure Act, which bans American companies from partnering with specific Chinese biotech firms. The primary goal of this legislation is to prevent potential misuse of US genomic data, prompting a major shift in the pharmaceutical supply chain.

The ban targets major players like BGI Genomics, MGI Tech, Complete Genomics, WuXi AppTec, and WuXi Biologics, pushing US drugmakers to look towards alternative suppliers. This new law is set to create a ripple effect across the industry, and could particularly benefit Indian contract development and manufacturing organisation companies.

India’s CDMO sector, which currently holds just 2.7% of the global market, could see substantial growth. With China’s CDMO industry dominating 8% of the global market, this change represents a significant opportunity for Indian companies to challenge China’s stronghold and expand their share.

India Rating and Research Report indicated that 60% of listed Indian pharma firms are seeing increased business inquiries, while 33% expect the new legislation will drive substantial business growth. Over the next 12-18 months, Indian companies anticipate a surge in orders from the US, including new pilot projects and higher requests for quote.

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However, Indian firms do have hurdles to clear. The sector is dealing with a lag in experience and a lack of advanced technology compared to their Chinese counterparts. Despite these challenges, the Act’s potential is clear.

Several Indian pharmaceutical companies expect to reap rewards from this new development, as indicated in their first quarter concalls. Syngene International Ltd. noted that US companies are reassessing their supply chains and diversifying away from China, which is a significant opportunity for them. Laurus Labs acknowledges that while the shift will take time, it is a positive development for Indian CDMO opportunities.

Neuland Labs Ltd. reported that US customers are actively seeking alternatives to China, indicating a promising future regardless of the Act’s final form. While, Divis Laboratories Ltd. is seeing a notable increase in opportunities, particularly for products in phases 2 and 3, driven by the passage of the Biosecure Act.

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