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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• 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

Report Insights












• 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

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













• 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













• 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













• 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

Report Coverage












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












• 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

Report Details












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pharma companies in india take center stage in complex generics at us and eu markets

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