India’s contract research and development manufacturing organization (CRDMO) sector is on the cusp of significant growth, with potential to expand seven-fold to $22-25 billion by 2035. The sector, which is currently valued at $35-40 billion, is expected to play a crucial role in the global pharma industry, which is valued at $140-145 billion.
India’s CRDMO sector has gained from global companies’ efforts to diversify their supply chain away from China, following the pandemic and a US bill restricting federal contracts with certain Chinese biotech firms on national security grounds. However, Indian firms are still facing regulatory hurdles, which are hindering their growth.
Companies such as Sai Life Sciences, Piramal Pharma, and Syngene have urged the government to remove regulatory hurdles and grant faster clearance for vital raw material imports. They have called for a more business-friendly policy environment, with a centralized digital single-window clearance system, easy export and import capabilities, and more investment in the sector.
The industry is also facing challenges such as prolonged approval times, demanding regulatory requirements, lack of customs warehouses, and delays in clearing certain raw material imports. The government’s inaction on these issues has hindered India’s CRDMO sector’s growth potential.
Despite the challenges, India’s CRDMO sector has received significant investment, with over $2.86 billion invested in the local biotech industry. Industry leaders are calling for more investment and support to help India become a major hub for contract manufacturing and research and development. With the right policies and investment, India could emerge as a leading player in the global CRDMO sector, providing a major fillip to the country’s economy.