With a particular focus on 12 leading companies, this report examines the evolution of the Indian pharmaceutical majors in the new era and asks...

What effect has the advent of the product patent regime had on the industry?

What are the key markets for the industry now and in the future?

How does the industry view key issues such as authorised generics and biosimilars?

Does the industry feel its competitive advantage will come under threat from other low cost countries, particularly China?

What foreign acquisitions have been made and what is the potential threat of takeover by foreign firms?

What are the different strategies being adopted by companies with an eye to the future? Opinion driven analysis - available now
The Indian Pharmaceutical Industry: Expansion & Ambitions is a new, insightful and data-rich management report packed with facts and statistics and augmented by comments and input from leading Indian industry commentators.

Published in September 2007, the report provides a complete and detailed review of the Indian market environment and the 12 companies that are leading the way. This online report includes the
INDIAN PHARMA INDUSTRY TRACKER
If you need to stay in touch with the latest developments then you should use this unique online service. Updated on an ongoing basis, the Tracker will keep you up-to-date with the very latest company, product and market developments. The Indian pharmaceutical industry is evolving rapidly. Following a fundamental regulatory change in the Indian market, leading companies have restructured with ambitious plans for domestic domination and foreign expansion already underway. What threat and opportunity will they represent in the future?

In the run up to January 2005, there was much speculation on the future of the Indian pharmaceutical industry in the post product patent regime. From a past deeply rooted in reverse engineering, the industry has been forced to evolve in order to survive.

Leading companies have found a way, not only to exist, but to thrive in the global pharmaceutical market. The route to success has followed a number of paths, from forging alliances with companies outside India for local sales and distribution expertise, contract manufacturing or joint ventures, to the acquisition of foreign companies and the setting up of subsidiaries in their own name. With few exceptions, the chosen route involves the regulated generic markets of the United States and Europe.

Focus on...current and future markets
Geographically, the key markets for the Indian industry are India, the US, Europe, Russia and the former CIS countries, Africa and Latin America, particularly Brazil. In the future, Japan and other Asian markets are likely to be added to this list.

The domestic market is vital...
India remains an important market for the majority of Indian companies. The indigenous industry supplies around 70% of the country's pharmaceuticals. The proportion of revenue derived from India depends largely on the strategy of the individual company and its penetration into overseas markets.

For example, while Zydus Cadila aims to grow rapidly in key generic markets in the US, Europe and Latin America, India remains its most important market, accounting for 67.7% of revenue in fiscal 2006/07. India is also Cipla's key market, generating almost half of the company's revenue in 2006/07, although this percentage has been declining in recent years as the company has increasingly targeted overseas markets. Other companies, such as Dr. Reddy's, are less reliant on the Indian market; in 2006/07, India contributed 14.1% of the company's global revenue. Ambitions lie overseas
But increasingly the major players are looking beyond India. The lucrative US and EU generics markets are currently the major targets for companies following a generic strategy. Others, such as Nicholas Piramal, focus on outsourcing and partnering in drug discovery... Europe
In contrast, the valuable markets of Europe are more important for Wockhardt. In 2006, the company generated 41.4% of its revenue in Europe compared with 9.6% in the US. Growth has been through strategic acquisitions, alliances and new products. During 2006, Wockhardt completed its largest acquisition to date, Pinewood Healthcare, to become a major player in the Irish generics market. The company also has a significant presence in the UK and Germany and has recently purchased a research-based pharmaceutical company, Negma Laboratories in France. In the future, Europe is likely to account for more than 60% of the company's revenue. North America
Ranbaxy is an established player in global generics and the US is the company's largest market. In 2006, 32% of the company's formulations revenue was generated from North America compared with 27% in Europe and the CIS. With regard to formulations sales, the US is by far the most important market for Orchid, with North America contributing 75% of revenue to this segment of the business in fiscal 2006/07; just under one third of the company's total revenue for the year. North America is also the leading revenue generator for Dr. Reddy's, contributing 43.5% of the total in fiscal 2006/07, compared to 22.8% in Europe and 7.3% in Russia and the CIS. AUTHORISED GENERICS
It has been argued that authorised generics in the US are counter to the spirit of Hatch-Waxman, and devalue the 180-day exclusivity period by destroying the incentive for generic companies to challenge patents. On the other hand, some generic companies seem to feel that their best interests are served by deals with patent holders.

An interesting example can be found with Proscar (finasteride) and Zocor (simvastatin). In January 2006, Dr. Reddy's entered into separate agreements with Merck & Co for authorised generics of these two products.

Dr. Reddy's launched its authorised generic 5mg finasteride tablet on 19th June 2006; the day that Teva announced its ANDA for finasteride tablets had been approved by the FDA, with the company gaining the 180-days marketing exclusivity for being the first to file an ANDA.

On 23rd June 2006, Dr Reddy's announced the launch of its authorised generic simvastatin, in 5, 10, 20, 40 and 80mg dosage strengths. On the same day, Ranbaxy's US subsidiary, Ranbaxy Pharmaceuticals and Teva Pharmaceutical Industries announced that the FDA had granted final approval for their respective simvastatin tablets. Teva's application, through its subsidiary, IVAX, was for 5, 10, 20 and 40mg dosages, whilst Ranbaxy's was for 80mg tablets. Both companies gained the 180-days marketing exclusivity for being the first to file ANDAs for their various dosage strengths. Dr. Reddy's was thereby able to immediately - and profitably - compete directly with all of Teva's and Ranbaxy's dosage strengths.