Without question, what impressed me the most is the big bet the Indian pharmaceutical industry is making on the opportunity presented by patent expirations. Most generic-drug companies I visited have 20–30 products in development for which they anticipate filing abbreviated new drug applications in the next several years. The US and European markets are major targets for their generic products, but these companies ship products all over the world and also have significant sales in Africa, Latin America, and other Asian countries.The generic-drug companies are in high-gear and are investing in large state-of-the-art manufacturing and development facilities to meet the anticipated demand. One executive of a CMO of active pharmaceutical ingredients (APIs) I talked with cited an anticipated three-fold increase in unit volumes for generic APIs and formulations. The new manufacturing facilities that these generic-drug companies are building are impressive; facilities of 200,000 ft2 or more with state-of-the-art design and equipment are typical. In addition to the new facilities around Hyderabad, the traditional center of the Indian pharmaceutical industry, large, new pharmaceutical clusters are being developed in areas, such as Vizag, a coastal city in Andhra Pradesh state, and Ahmedabad, in Gujarat. State governments are setting up special economic zones with subsidies and tax incentives to attract development.
One of the most interesting characteristics of these facilities is the predominance of equipment made within India; the displays of the Indian equipment manufacturers at CPhI India were truly impressive. One brand-new injectables facility we visited had vial washing and prep equipment made in India, fillers made in Europe, and a freeze dryer made in China. The availability of high-quality locally made equipment is an important source of cost advantage for Indian manufacturers as it lowers their capital-investment requirements.
Contract development and services are a significant part of the business for these generic-drug companies, around 30% in some cases, but they are not the driver of their near-term growth strategies. Contract services are seen as a way to leverage existing capacity, build relationships, and support a deepening scientific base. The focus of these companies is on the opportunities in generic drugs, and I don't see them becoming a disruptive force in the CMO industry in the foreseeable future.
The big risk to CMOs is generic-drug companies may be building too much capacity as they seek to cash in on patent expirations. If this proves to be the case, we could see some Indian generic-drug companies turn more aggressively to contract manufacturing to fill their underutilized facilities. Were this to happen, it could create pricing chaos in the CMO industry and put European and North American CMOs at a considerable disadvantage.