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SUMMARY
With a particular focus on 12 leading companies, this new, insightful and
data-rich management report examines the evolution of the Indian
pharmaceutical majors in the new era.
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.
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?
TABLE OF CONTENTS
- Foreword
- Executive Summary
- Indian Company Strategies
- Introduction
- Indian bases
- Sales revenue
- The advent of the product patent regime in India
- Background
- The Patents (Amendments) Bill, 2005
- Mashelkar Committee Report, December 2006
- What effect has the advent of the product patent regime had on the
Indian pharmaceutical industry?
- Looking beyond reverse-engineering
- In-licensing and custom manufacturing
- Key markets now and in the future
- Established and emerging generic markets
- The United States
- Authorised generics - threat or opportunity?
- Europe
- South Africa
- Brazil
- Biosimilars
- India's competitive advantage
- Foreign acquisitions
- Company Profiles
- Aurobindo Pharma
- Company Strategy
- Manufacturing
- R&D
- Key Markets
- Major Developments
- Pharmacin acquisition
- Acquisition of US facility
- Milpharm: Aurobindo's first acquisition in Europe
- Products
- APIs
- Domestic Formulations
- International Generics
- US and Canada
- European Union
- South Africa
- Financials
- Cipla
- Company Strategy
- Manufacturing
- R&D
- Key Markets
- Major Developments
- Strategic Alliances & Agreements
- Drug development agreements with Akorn
- Malaria agreement with DNDi
- Akorn
- Divestiture of Cipla Medpro
- Compulsory licensing in Malaysia
- Products
- APIs
- Domestic Formulations
- International Generics
- Antiretrovirals
- US
- Europe
- Financials
- Dr. Reddy's
- Company Strategy
- Manufacturing
- USP's Pharmaceutical Ingredient Verification Programme
- R&D
- Cancer
- Cardiovascular
- Diabetes
- Perlecan
- Key Markets
- Major Developments
- Mergers & Acquisitions
- betapharm
- Roche's Mexico API facility
- Trigenesis Therapeutics
- BMS Laboratories and Meridian Health Care
- American Remedies and Cheminor Drugs
- Joint Ventures
- China - Kunshan Rotam Reddy Pharmaceutical Co., Ltd.
- South Africa - Dr. Reddy's Laboratories (Proprietary) Ltd.
- Agreements
- Dr. Reddy's appointed as Alchemia's partner for synthetic heparin
- Dr. Reddy's and Torrent sign Russian lisinopril agreement
- Dr. Reddy's and ClinTec Co-Development Agreement
- Dr. Reddy's and Argenta announce R&D collaboration
- Dr. Reddy's and Rheoscience announce R&D collaboration
- Dr. Reddy's/Pharmascience sign multi-product agreement
- Dr. Reddy's and ICICI form ANDA partnership
- Pliva
- Leiner Health Products
- Litigation
- Court rules in Eisai's favour over Aciphex ANDA
- Dr. Reddy's/GSK settle Imitrex litigation
- Merck & Co challenges over finasteride ANDA
- Novartis' terbinafine litigation against Dr. Reddy's comes to an end
- Amlodipine
- Products
- APIs
- Domestic Formulations
- International Generics
- Financials
- Glenmark Pharmaceuticals
- Company Strategy
- Manufacturing
- R&D
- Key Markets
- Major Developments
- Mergers & Acquisitions
- Glenmark purchases rights to CHR-1103 and CHR-1201 from Chromos
- Medicamenta of the Czech Republic
- Bouwer Bartlett, South Africa
- Agreements
- R&D agreement with Dyax for therapeutic antibodies
- Merck Generics
- Royalty deal with Paul Capital Partners
- Lehigh Valley Technologies
- Aspen USA
- Generics agreement with InvaGen for US market
- Products
- APIs
- Domestic Formulations
- International Generics
- Financials
- Lupin
- Company Strategy
- Manufacturing
- R&D
- Key Markets
- Major Developments
- Agreements
- GSK Philippines
- Allergan
- Baxter
- Watson Pharmaceuticals
- Products
- APIs
- Domestic Formulations
- International Generics
- Financials
- Matrix Laboratories
- Company Strategy
- Manufacturing
- R&D
- Key Markets
- Major Developments
- Mergers & Acquisitions
- Mylan acquires Matrix
- Aspen and Matrix finalise business relationship
- Matrix gains 43% stake in Explora
- Matrix acquires Docpharma
- Matrix purchases finished dosage facility
- Agreements
- Clinton HIV/AIDS Initiative
- Products
- APIs
- International Generics
- Financials
- Nicholas Piramal
- Company Strategy
- Manufacturing
- R&D
- Key Markets
- Major Developments
- Mergers & Acquisitions
- Boots Piramal Healthcare
- Pfizer's Morpeth facility
- Rhodia's Inhalation Anaesthetics business
- Canere
- Sarabhai Piramal
- ICI Pharmaceutical
- Agreements & Joint Ventures
- Eli Lilly
- Napo Pharmaceuticals
- BioSyntech
- AstraZeneca
- Allergan
- Ethypharm
- Biogen Idec
- Chiesi Farmaceutici
- Products
- APIs
- Domestic Formulations
- International Formulations
- Financials
- Orchid Chemicals & Pharmaceuticals
- Company Strategy
- Manufacturing
- R&D
- Key Markets
- Major Developments
- Agreements
- Actavis
- Alpharma
- Apotex
- Par Pharmaceuticals
- Acquisitions & Joint Ventures
- Bexel Pharmaceuticals Inc.
- Biotechnological Chemical Development Ltd.
- Mano Pharmaceuticals & Sali Healthcare
- NCPC Orchid Pharmaceuticals Ltd.
- Products
- APIs
- Domestic Formulations
- International Generics
- Financials
- Ranbaxy
- Company Strategy
- Manufacturing
- R&D
- Key Markets
- Major Developments
- Mergers & Acquisitions
- Ranbaxy acquires dermatology brands from Bristol-Myers Squibb
- Ranbaxy acquires Be-Tabs for US$71 million
- Ranbaxy acquires GSK's Mundogen generic business in Spain
- Ranbaxy acquires Terapia
- Ranbaxy acquires generic product portfolio from Efarmes
- RPG (Aventis)
- Bayer
- Ohm Laboratories
- Agreements
- Ranbaxy signs first biosimilars agreement
- R&D Agreement with GlaxoSmithKline
- Ipca and Ranbaxy sign deal for US market
- Ranbaxy signs Canadian licensing and supply agreements with
Janssen-Ortho
- Ranbaxy to market Lupin's TB brands in Africa
- Ventiv Health
- Merck and Thembalami
- Atrix Laboratories
- Mallinckrodt Baker
- Medicines for Malaria Venture
- Nippon Chemiphar
- Signature Pharmaceuticals
- Schwarz Pharma
- Veratide
- Wockhardt
- Litigation
- Lipitor
- Atorvastatin in Denmark
- Australian court upholds basic Lipitor patent
- Dutch court upholds basic Lipitor patent but invalidates '281 patent
- US CAFC upholds Pfizer's basic atorvastatin patent but invalidates
second
- UK Court of Appeal upholds Pfizer patent
- Pfizer gains preliminary injunction in Finland
- Ranbaxy gains Norwegian atorvastatin litigation success
- UK SFO investigation; charges brought
- UK Department of Health legal action settled
- Products
- APIs
- Domestic Formulations
- International Generics
- Financials
- Sun Pharma
- Company Strategy
- Manufacturing
- R&D
- Key Markets
- Major Developments
- Mergers & Acquisitions
- Taro Pharmaceutical Industries
- Able Laboratories
- Valeant
- Women's First Healthcare brands
- Phlox Pharma
- Pradeep Drug Company Ltd
- Milmet Labs
- MJ Pharma
- Caraco
- Tamil Nadu Dadha Pharma
- Gujarat Lyka Organics
- Litigation
- Caraco gains tramadol/acetaminophen appellate court ruling
- Products
- APIs
- Domestic Formulations
- International Generics
- Financials
- Wockhardt
- Company Strategy
- Manufacturing
- R&D
- Key Markets
- Major Developments
- Acquisitions
- Negma Laboratories
- Pinewood Laboratories
- CP Pharmaceuticals Ltd
- Merind Ltd
- Wallis Laboratory
- Agreements & Joint Ventures
- Wockhardt Mexico
- Wockhardt South Africa
- Wockhardt Rhein Biotech
- Li-Taka Pharmaceuticals
- Ranbaxy
- Bayer
- Products
- APIs
- Domestic Formulations
- International Generics
- Financials
- Zydus Cadila
- Company Strategy
- Manufacturing
- R&D
- Key Markets
- Major Developments
- Mergers & Acquisitions
- Quimica e Farmaceutica Nikkho do Brasil
- Nippon Universal Pharmaceutical
- Liva Healthcare
- Alpharma France
- Merger into Cadila Healthcare
- Banyan Chemicals
- German Remedies
- Recon Healthcare
- Agreements & Joint Ventures
- Evolupharn and Aerocid
- Bharat Serums and Vaccines
- Venus Remedies
- Mallinckrodt
- Mayne Group
- Zambon Group
- Zydus Byk Healthcare
- Litigation
- Three Rivers sues Zydus Cadila for ribavirin patent infringement
- Products
- APIs
- Domestic Formulations
- International Generics
- Financials
- SOURCES
- Espicom Sources
- Others
List of Tables
- Indian Company Sales, 12 months ended 31st March 2007
- Indian Pharmaceutical Companies' US Subsidiaries
- FDA ANDA Approvals, January 2005 - July 2007
- Indian Pharmaceutical Companies' EU Subsidiaries
- UK Marketing Authorisations, 2006
- Indian Company Registrations of Generic Medicines in Brazil, January 2007
- Indian Companies' Foreign Acquisitions
- Aurobindo Pharma: Manufacturing Facilities
- Aurobindo Pharma: Key Subsidiaries
- Aurobindo Pharma: ANDA Approvals, 2004-2007
- Cephazone Pharma: FDA ANDA Approval, 2007
- Aurobindo Pharma: Financial Results, 2003-2007
- Cipla: Manufacturing Facilities
- Cipla: FDA ANDA Approvals, 2007
- Cipla: Tentative FDA ANDA Approvals
- Cipla: Tentative FDA NDA Approvals
- Cipla: Financial Results, 2003-2007
- Dr. Reddy's: Manufacturing Facilities
- Dr. Reddy's: Regional Headquarters and Key Subsidiaries
- Dr. Reddy's: Key API Products by Sales, 2005-2006
- Dr. Reddy's: Top 10 Brands in India, 2005-2007
- Dr. Reddy's: FDA ANDA Approvals, 2002-2007
- Dr. Reddy's: Financial Summary, 2003-2007
- Glenmark: Manufacturing Facilities
- Glenmark: Key Subsidiaries
- Glenmark: FDA ANDA Approvals, 2006-2007
- Glenmark: Financial Results, 2003-2007
- Lupin: Manufacturing Facilities
- Lupin: Leading Brands in India, 2007
- Lupin: FDA ANDA Approvals
- Lupin: Tentative FDA Approvals
- Lupin: Financial Results, 2003-2007
- Matrix: Manufacturing Facilities
- Matrix: Tentative FDA ANDA Approvals
- Matrix: Financial Results, 2003-2007
- NPIL: Manufacturing Facilities
- NPIL: Financial Results, 2003-2007
- NPIL: Branded Formulations Revenue by Therapeutic Area, 2006-2007 (Rs.
Million)
- Orchid: Manufacturing Facilities
- Orchid: Key Subsidiaries and Joint Ventures
- Orchid: Top Ten Brands
- Orchid: FDA ANDA Approvals, 2005-2007
- Orchid: Financial Results, 2003-2007
- Ranbaxy: Manufacturing Facilities
- Ranbaxy: Regional Headquarters & Key Subsidiaries
- Ranbaxy Laboratories: FDA ANDA Approvals, 2002-2007
- Ohm Laboratories: FDA ANDA Approvals, 2006-2007
- Ranbaxy: Financial Results, 2003-2006
- Ranbaxy: Formulations Sales by Country/Region, 2006 (US$ Million)
- Sun Pharma: Manufacturing Facilities
- Sun Pharma: Key Subsidiaries
- Sun Pharma: FDA ANDA Approvals, 2006-2007
- Caraco Pharmaceutical: ANDA Approvals, 2002-2007
- Sun Pharma: Financial Results, 2003-2007
- Wockhardt Manufacturing Facilities
- Wockhardt: Key Subsidiaries
- Wockhardt: FDA ANDA Approvals, 2003-2007
- Wockhardt: Financial Results, 2003-2006
- Wockhardt: Sales by Region, 2006
- Zydus Cadila: Manufacturing Facilities
- Zydus Cadila: Key Subsidiaries
- Zydus: ANDA Approvals, 2005-2007
- Zydus Cadila: Consolidated Results, 2006-2007
- Cadila Healthcare: Financial Results, 2003-2007
- Zydus Cadila: Domestic Formulations Sales by Therapy Area, 2006
List of Figures
- Map: Indian Pharmaceutical Company Headquarters
- Map: Manufacturing Locations in India
- Map: Indian Companies in the US
- Map: Indian Companies in the UK and Ireland
- Map: Indian Companies in Continental Europe
- Map: Indian Companies in Brazil
- Map: Indian Companies in China
- Cipla: Exports by Region, 2007 (%)
- Dr. Reddy's: Sales by Region, 2006 (%)
- Dr. Reddy's: Sales by Region, 2007 (%)
- Glenmark: Formulations Sales by Region, 2007 (%)
- Lupin: Domestic & Export Sales, 2007
- Matrix: Sales by Region, 2006 (%)
- NPIL: Domestic Formulations Revenue by Therapeutic Area, 2007 (%)
- Orchid: API Sales by Region, 2007 (%)
- Orchid: Formulations Sales by Region, 2007 (%)
- Ranbaxy: Formulations Sales by Region, 2006 (%)
- Sun Pharma: Domestic & Export Sales, 2007
- Wockhardt: Sales by Region, 2006 (%)
- Zydus Cadila: Sales by Region, 2007 (%)
- Zydus Cadila: Domestic Formulations Sales by Therapy Area, 2006 (%)
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