Pharma companies in India take center stage in complex generics at US and EU markets

Report: Global Pharmaceutical and Biotechnology Outlook 2014 - India Pharma Category: Healthcare

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Report: Global Pharmaceutical and Biotechnology Outlook 2014 - India Pharma Report Insights

• Indian companies are taking center stage in complex generics at US and EU markets • In Bio-similars, Indian companies will have perhaps the largest basket

aimed at emerging countries in 2014-2016 and later for developed countries • Though few but is the beginning of NCE/mAb development by Indian companies is a sign of Indian generics moving up in the chain • The uncertainty of clinical and regulatory pathways in the US helps Asian biopharma and biotech companies to be in forefront in developing and marketing biosimilars www.researchonglobalmarkets.com

Report: Global Pharmaceutical and Biotechnology Outlook 2014 - India Pharma Report Insights (Continued)

• Biopharma or biotech companies in India, South Korea and China may have significant advantages of low-cost manufacturing, colossal markets, and healthy government support over potential peers from

other regions • The cost barriers in the biosimilar market lead regulated marketed giants to tie up with Asian companies to gain access to these advantages and hedging their bets through a joint-venture strategy • Reimbursement remains a concern as no countries provide full reimbursement - patient pay total cost out-of-pocket in India

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Report: Global Pharmaceutical and Biotechnology Outlook 2014 - India Pharma Report Insights (Continued)

• However, with well defined regulatory pathways, it is believed that Indian biopharma companies who keep leveraging their strength of low cost manufacturing along with skilled workforce, would support

them to gain global recognition • Factories at India continue to have lions share of US Generics market, despite a couple of plants at India facing scrutiny from US FDA • It is to be noted that one fourth of FDA inspection outside the US is conducted in India, but Indian plants have received very less Import alerts or warning letters by FDA which indicates strong quality consciousness of Indian drug manufacturers www.researchonglobalmarkets.com

Report: Global Pharmaceutical and Biotechnology Outlook 2014 - India Pharma Report Insights (Continued)

• Only 21 warning letters have been issued to Indian companies which is far less than other Ex-US countries such as Mexico with 74%; Canada and British with 30% import alerts

• With a robust outlook, companies continue to invest in sales force to target more doctors and more focus per brand • The implementation of quality norms with vigor has helped companies with better quality perception to charge high prices • Every company has invested in increasing the sales force to capture the market that has consolidated at the tail end

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Report: Global Pharmaceutical and Biotechnology Outlook 2014 - India Pharma Report Insights (Continued)

• With tiny companies getting out of business importance of branding has increased drastically which is leading all companies to increase their focus per brand

• Policy makers in India will start the process of strict audit of marketing practices followed by pharma companies in India

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Report: Global Pharmaceutical and Biotechnology Outlook 2014 - India Pharma Report Coverage

• Uniform Code on Sales and Marketing Practices in India • Issuance of warning letters to Indian facilities by USFDA • Biosimilar perspective for Indian market

• New drug discovery development in India

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Report: Global Pharmaceutical and Biotechnology Outlook 2014 - India Pharma Table of Contents

• Domestic sales as percent of total sales • Alleged nexus among doctors & pharma companies • Uniform code for marketing practices – Deliberations versus Ground

reality • Various promotional ways to incur as expenses by pharma companies • India pharma: FDA warning letter review 2010-2013 • Approved biosimilars in India • Select biosimilars collaborations till date • NCE-mAb pipeline Indian companies

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Report: Global Pharmaceutical and Biotechnology Outlook 2014 - India Pharma Report Details

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Publish date: Jan 20, 2014 Number of slides: 66 Geographic coverage: India Available format: PDF, CD, Hardcopy Price for Single User License: USD 2,500 Price for Site License: USD 5,000 Price for Global User License: USD 7,500 Delivery Time: Within 1 business day Payment Modes: Credit/Debit Card, RTGS/Wire Transfer, Google Wallet, PayPal www.researchonglobalmarkets.com

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