With the addition of GlobalData resources, PharmSource is interested in satisfying client demand by improving our coverage of the Indian and Chinese markets, which are becoming increasingly important to the supply of pharmaceuticals globally.
Between 2010 and 2015, the Indian generics market grew by 22%, with pharma industry growth being 18% during the same period. China is a major API manufacturer for drug manufacturers around the world, and it heavily supplies the Indian generic sector as well. Recent regulatory changes and industry consolidation inside China will significantly affect global pharma supply.
Maharashtra is India’s third largest and second most populous state. It is located in the south of the country and it is the foundation of India’s pharmaceuticals industry—particularly its capital, Mumbai. The region is globally recognised for manufacturing affordable and high-quality generic medicines.
Large pharma companies have facilities in the area and have been investing recently; for example, GlaxoSmithKline recently upgraded its manufacturing facility in Nashik, near Maharashtra, thereby securing a reliable supply of its tablets, capsules, liquid orals, creams/ointments, and injectable products. There are over 100 pharma CMOs in Maharashtra with either FDA or EU approval, which own 131 related facilities in the region.
In line with the global perception of a strong generics manufacturing industry in India, the majority of these facilities (56%) offer small molecule API manufacturing, with 21% offering solid dose manufacturing. Analytical chemistry and stability services were offered at 35 sites, though 57% of these sites also offered other services, most commonly small molecule API manufacturing.
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The expected growth in the use of both biosimilars and innovator biologics in the future, and continued high demand for small molecule drugs, mean CMOs in Maharashtra and in India generally must invest in biologics capabilities to satisfy anticipated demand.
There is a possibility that India can repeat its generics success with much more complex biosimilars; there are approximately 60 biosimilars on the Indian market and the country’s generics firms, such as Aurobindo and Cipla, have been making investments in biosimilar products and manufacturing capabilities in recent years.
However, it is clear from the lack of Maharashtra facilities manufacturing biologics that there is still a long way to go for the contract manufacturing industry, and with related facilities requiring large investment due to the high cost of product development and regulatory compliance, there are significant challenges in biosimilar manufacturing.
The majority of CMOs (81%) only have one site in Maharashtra. This highlights the nature of the industry with manufacturing facilities for large CMOs regularly being spread across multiple sites internationally, whereas smaller CMOs will typically only have one or two facilities. Wockhardt Contract Manufacturing and Cipla have six and four facilities in the region, respectively, showing a heavy reliance on their manufacturing operations in Maharashtra. Wockhardt has only three facilities located outside of India and Cipla only has one, located in Durban, South Africa, where it will also build a biosimilars plant.
As Figure 3 shows, only 47 facilities in Maharashtra are both FDA and EU-approved. There is a large number of facilities that have only either FDA or EU approval, despite regulatory standards being similar. In October 2017, the FDA even recognised that eight European drug regulators are capable of conducting inspections of manufacturing facilities that meet FDA requirements under mutual recognition agreements with authorities in Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the UK.
In 2018, mutual recognition agreements were extended to authorities in Ireland, Lithuania, Greece, Hungary, Czech Republic, and Romania. India has more FDA-approved manufacturing plants than any country except the US; therefore it is not surprising that the FDA has approved more CMO facilities than the EU.
Although many facilities are approved by only one of the regulators, some CMOs serve both North American and European markets using different facilities. For instance, Fresenius Kabi has an injectables facility in Pune, Maharashtra with only EMA and Indian approval; however, the company also owns another injectables facility in New York, US with FDA approval. CMOs seek facility approval by the regulator(s) of the markets their clients supply the manufactured product to.
If the mutual recognition agreements are further extended to other European states, then in the future more facilities will gain regulatory approval from both the FDA and EMA, as the FDA will recognise drug inspections conducted by more foreign regulatory authorities if they have determined those authorities are capable of conducting inspections that fulfil US requirements.
Industry updates such as this are covered in the Emerging Market Outsourcing Report from PharmSource, a GlobalData product. If you do not subscribe to PharmSource or the Emerging Market Outsourcing Report, please contact a GlobalData sales representative to gain access.