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The Changing Oncology Market Scenario in India The Indian oncology market is forecast to grow strongly in the next

decade, driven by the rise in cancer incidence and diagnosis, improved access to cancer therapies, better health insurance coverage, and higher pharmaceutical spending, particularly among the growing middle class. But while pharmaceutical companies are keen to establish a strong presence in India, a number of challenges remain Cancer is one of the ten leading causes of death in India and accounts for 8% of the main causes of deaths in the country. Cancer of the oral cavity and lung cancers are the leading cancer types in Indian males while cervix and breast cancer are the predominant cancer types in females. These cancer types account for over 50% of all cancer deaths in India. Rising disposable income has lead to various lifestyle changes such as increasing rates of smoking, decline in physical activity among affluent, increase in the consumption of red meat and fast food in urban areas. These trends have lead to increase rates of various cancers in India.

Increased rates of incidence of various cancer types prevailing in India and a booming economy has made India one of the key emerging markets for various multinational pharmaceutical companies with an oncology portfolio. Treatment Scenario

The diagnosis and treatment of cancer has progressed a lot in the last few decades in India. Almost all major cities in India have a 500 to 1000 bedded specialized oncology centers. These centers have state of the art facilities for diagnosis and treatment of cancer. In addition almost all large hospitals in India have oncology units. The talent pool of medical, surgical, and radiation oncologists continue to grow though the demand far outstrips the supply. Market Overview The oncology market in India is about $186 million, and is expected to reach $693 million by 2012, a Compound Annual Growth Rate (CAGR) of nearly 30%. More than 30 drug companies are active in Indian oncology market. The current market is largely generic and dominated by regional players. In the last few years many multinational drug companies have entered the Indian oncology market. Pfizer, GlaxoSmithKline, AstraZeneca, Novartis, BMS, Sanofi-Aventis, Schering Plough, Baxter, Johnson & Johnson, Merck and Amgen are some of the large Pharmaceutical companies who have launched products in the Indian market. These companies are targeting a small but significant proportion of Indian cancer patients who will be able to afford the newer and premium-priced anti-cancer treatments. The medical insurance sector has become stronger over the last decade and provides an ever increasing opportunity to the MNCs.

Indian pharmaceutical companies are currently dominating the conventional chemotherapy market. Dr.Reddys, Shanta Biotech, Dabur, Natco, Sun pharma have strong R & D oncology setup and are key manufacturers in the Indian Market. The challenge they pose is the increasing ability to genericize small molecules products. Additionally, Indian companies like Dr. Reddys, Ranbaxy, and some other leading biotech companies are also looking at manufacturing biologics and may pose a serious threat for MNCs manufacturing targeted agents. Challenges for Pharma Companies

Multiple hurdles face a Pharmaceutical company entering the Indian market. Epidemiological surveillance is weak and forecasting future epidemiological figures is challenging. Forecasting the market potential is even more challenging with multiple complexities unique to the Indian market.

While the economy is booming more than one-third of the Indian population lives below the poverty line. The highly priced innovator products are out of reach of most of the patients. The current IP and regulatory scenario in India is weak but offers the hope of becoming stronger in the near future. However decades may pass before the secure environs of stable North American and European markets is achieved. The Indian market is attractive but targeting the right patient and physician customer with an innovative sales force strategy will be critical to achieving growing sales and high ROI.

Highlights A large part of the Indian population lacks access to appropriate cancer care. A number of reasons contribute to this including inadequate healthcare infrastructure, low health insurance coverage, poor education and low cancer awareness. While domestic companies dominate the market with branded generics, all major multinational pharmaceutical companies have a presence in India, targeting a small but significant part of the population that can afford the price premium associated with global brands. As the Indian economy continues to grow, more people will gain the financial ability to seek cancer treatment, while the growing middle class will drive demand for innovative branded therapies. Plans to increase government expenditure on health and improve access to cancer drugs will also drive the uptake of cancer therapeutics in the future

SUCCESS

The high level of commercial success experienced by the key companies in the oncology market makes it extremely attractive to drug developers. However, the shift toward a more personalized approach means fewer drugs will achieve blockbuster status. The evolution of a fragmented oncology market will decrease the value of the top 20 branded therapies by $8.6 billion between 2010 and 2020.

In 2020, targeted therapies will dominate the top 20, but as developers focus on niche subsets of patients with specific genetic mutations the market will fragment. As a result, the total sales of the top 20 branded therapies in the seven major markets will decrease from $36.6 billion in 2010 to just over $28 billion in 2020. Generic erosion of multiple key brands in the cytotoxic class will be the key driver in decreasing its share of the top 20 branded sales in the seven major markets from 21% in 2010 to 3% in 2020. However, differing brand loyalty means patent expiries will have varying effects on the top 20 in individual markets. Roche dominated the top 20 in 2010, with combined seven major market sales of $13.2 billion. Avastin, Rituxan, and Herceptin look set to maintain the top three positions in 2020 and Roche looks set to consolidate its leading position in the oncology market.

The Indian government has granted marketing licenses for about 25 recombinant protein therapeutics. Some of the recombinant products already approved by the Genetic Engineering Approval Committee (GEAC) are:

Insulin Interferon alpha Interferon gamma Interleukin-2 Gm-CSF G-CSF Hepatitis B vaccine

Erythropoietin Strptokinase EGF Chymotrypsin

Traditionally India has been a very strong player in conventional generics due to established track record of process engineering skills and capability to set up comparable manufacturing units at a fraction of the capital cost utilized overseas. Companies such as Shantha biotech, which started with just one product, are now effectively using this experience to launch other products like plasminogen activators, interferons, sophisticated vaccines etc. Following the suit of globalization many multinationals like Monsanto, Pfizer, Unilever, Dupont, Bayer, have set up their businesses in India. Eli Lilly- Ranbaxy 50:50 joint venture in India has been marketing a range of biotech products such as Humalog and Huminsulin for diabetes. Hoechst Roussel Vet has developed a cow abortion IBH vaccine in India. ChironBoehringer is setting up a vaccine venture in India.