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India Pharmaceuticals and Healthcare Report Q4 2009

Business Monitor International, October 2009, Pages: 100

The India Pharmaceuticals and Healthcare Report provides industry professionals and strategists, corporate analysts, pharmaceutical associations, government departments and regulatory bodies with independent forecasts and competitive intelligence on the India's pharmaceuticals and healthcare industry.

In the Q409 update of BMI’s India Pharmaceuticals & Healthcare report, we have introduced our 10-year Drug Expenditure Forecast Model. The country’s US$14.23bn pharmaceutical market is forecast to reach a value of US$44.99bn by 2018, representing a compound annual growth rate (CAGR) of 12.20%. The main drivers of growth are a booming economy, increasing access to medicines, more investment in healthcare infrastructure and a greater incidence of chronic diseases.

India’s intellectual property (IP) regime is far below international standards; however, there are signs that this situation is changing. In August 2009, health activists and some generic drug companies severely criticised the Indian Commerce Ministry’s decision to accept the Mashelkar committee’s recommendations to grant patents to new drugs. The adoption of the recommendations indicates that new patents will be allowed on incremental innovation under Section 3(d) of the Indian Patent Act, in the event that the candidate drug offers enhanced therapeutic efficacy. Patent experts supported the decision as it is in line with international norms.

Pharmaceutical regulations are rapidly improving in India. In July 2009, the Indian Department of Biotechnology (DBT) planned to create a separate regulator for the biotechnology sector. The National Biotechnology Regulatory Board would be responsible for identifying and controlling drugs and vaccines which are developed from natural sources. That same month, the Drug Controller General of India (DCGI) identified six research and development (R&D) centres in which new drugs will be tested before they are launched. Meanwhile, in May 2009 the DCGI decided to withdraw the powers given to state level regulators to issue export quality licences, which are called Certificates of Pharmaceutical Products. The move was designed to centralise and standardise procedures.

Unfortunately, India’s pharmaceutical industry is gradually developing an undesirable reputation for producing sub-standard medicines. During Q309, regulators in the US and UK have blacklisted select batches of drugs made by firms based in the South Asian country. While the scale of the seizures was small, BMI believes the implications are huge. Quality of manufacturing must improve, or demand for Indian-made pharmaceuticals will decrease.

Due to the absence of some form of government-provided universal healthcare, India’s health insurance market is one of the most promising sectors in the world. This was underlined in June 2009, when Indiabased Religare Enterprises signed an agreement with Swiss Re to establish a joint venture with an initial investment of US$100mn. Operations are expected to start in 2010. At that time, Swiss Re was already present in the India health insurance market, holding a 26% stake (the maximum permissible) in TTK Healthcare Services.

EXECUTIVE SUMMARY

SWOT ANALYSIS
India Pharmaceutical Industry SWOT
India Political SWOT
India Economic SWOT
India Business Environment SWOT

INDIA’S PHARMACEUTICAL BUSINESS ENVIRONMENT RATINGS
Table: Asia Pacific Pharmaceutical Business Environment Ratings For Q409
Limits of Potential Returns
Risks to Realisation of Returns

INDIA – MARKET SUMMARY

REGULATORY ENVIRONMENT
Table: Responsibilities Of India’s Department Of Pharmaceuticals
Pharmaceutical Advertising
Pharmacovigilance
Recent Regulatory Developments
IP Regime
Table: History Of The Indian Patent System
Patent Disputes
Counterfeit Medicines
Pricing and Reimbursement

INDUSTRY TRENDS AND DEVELOPMENTS
Epidemiology
Healthcare Sector
Healthcare Funding
Healthcare Insurance
Clinical Trials
Recent Developments in the Clinical Trials Industry
Active Pharmaceutical Ingredients
Biotechnology Sector
Traditional Medicines

INDUSTRY FORECAST SCENARIO
Overall Market Forecast
Table: India – Drug Expenditure Indicators, 2003-2018
Key Growth Factors – Industry
Table: India – Health Expenditure Indicators, 2003-2013
Key Growth Factors – Macroeconomic
Table: India - Economic Activity, 2006-2013
Prescription Drug Market Forecast
Table: India – Prescription Market Indicators, 2003-2018 (INRmn unless otherwise stated)
Patented Product Market Forecast
Table: India – Patented Market Indicators, 2003-2018
Generic Drug Market Forecast
Table: India – Generic Drug Market Indicators, 2003-2018
OTC Medicine Market Forecast
Table: India – OTC Market Indicators, 2003-2018 (US$mn unless otherwise stated)
Pharmaceutical Trade Forecast
Table: India – Pharmaceutical Trade, 2003-2013 (US$mn)
Medical Device Market Forecast
Table: India’s Medical Device Market, 2003-2013
Other Healthcare Data Forecasts
Table: India – Healthcare Data Indicators, 2003-2013
Key Risks to BMI’s Forecast Scenario

COMPETITIVE LANDSCAPE
Top Ten Pharmaceutical Companies In India According To 2008 Sales
Top Ten Pharmaceuticals In India According To 2008 Sales
Retail Pharmacy Sector
Table: Major Players In India’s Retail Pharmacy Sector
Recent Pharmaceutical Retail Developments

COMPANY PROFILES
Leading Multinational Manufacturers
Pfizer
GlaxoSmithKline (GSK)
Novartis
Sanofi-Aventis
Merck & Co
Eli Lilly
Leading Indigenous Manufacturers
Ranbaxy Laboratories
Cipla
Dr Reddy’s Laboratories
Aurobindo Pharmaceutical
Venus Remedies
Granules India
Nicholas Piramal India
Zydus Cadila

COUNTRY SNAPSHOT: INDIA DEMOGRAPHIC DATA
Section 1: Population
Table: Demographic Indicators, 2005-2030
Table: Rural/Urban Breakdown, 2005-2030
Section 2: Education and Healthcare
Table: Education, 2002-2005
Table: Vital Statistics, 2005-2030
Section 3: Labour Market And Spending Power
Table: Employment Indicators, 1996-2001
Table: Consumer Expenditure, 2000-2012 (US$)
Table: Average Annual Manufacturing Wages, 2000-2012

BMI METHODOLOGY
How We Generate Our Pharmaceutical Industry Forecasts
Pharmaceutical Business Environment Ratings Methodology
Ratings Overview
Table: Pharmaceutical Business Environment Indicators
Weighting
Table: Weighting Of Components
Sources

- Pfizer
- GlaxoSmithKline (GSK)
- Novartis
- Sanofi-Aventis
- Merck & Co
- Eli Lilly
- Ranbaxy Laboratories
- Cipla
- Dr Reddy’s Laboratories
- Aurobindo Pharmaceutical
- Venus Remedies
- Granules India
- Nicholas Piramal India
- Zydus Cadila

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