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Pharmaceutical industry
Develops, produces, and markets drugs licensed for use as medications
These companies are allowed to deal in generic and /or brand medications and medical devices
They are subject to a variety of laws and regulations regarding the patenting, testing and ensuring safety and efficacy and marketing of drugs
Orphan drugs
Patents
Phase IV
Phase III Development Phase Phase I Early Years Market share domination by foreign companies Relative absence of organized Indian companies Process Government Control development Phase II Indian Patent Act 1970 Drug prices capped Local companies begin to make an impact Production infrastructure creation Export initiatives Growth Phase
Rapid expansion of New IP law domestic market Discovery Research International Convergence market development Research orientation
1970
1980
1990
2000
2010
Types of competition
Highly competitive Top 5 players have mere 18% of market share Lower fixed cost and high working capital Concentration ratio is very low High growth prospects Entry barriers are very low
Types of competition
End user different from influencer Govt. Plays important role in price regulation through NPPA Low bargaining power of suppliers Advances in biotechnology threat to synthetic pharma industry
Rank
1 2 3
Company
Cipla Ranbaxy(Taken over by Daiichi Sankyo in 2008) Dr. Reddy's Laboratories
Revenue 2010 (Rs Revenue 2010 (Rs crore) billion) 4,198.96 4,162.25 3,763.72 41.989 41.622 37.637
4
5 6 7 8 9
Sun Pharmaceutical
Lupin Ltd Aurobindo Pharma GlaxoSmithKline(British company) Cadila Healthcare Aventis Pharma(Swedish company)
2,463.59
2,215.52 2,081.19 1,773.41 1,613 983.80
24.635
22.155 20.801 17.734 16.13 9.838
Markets big players start to leverage on R&D and form cartels or merge
As large players begin to dominate, the competition takes the face of oligopoly with high entry barriers
Indian perspective
BIG BRANDS FORM CARTELS OR MERGE MARKET IS DIVIDED BY ENTRY BARRIERS AND R&D SMALL FIRMS
Imports
The imports of pharmaceuticals are estimated at 10 to 12 percent of the total market. The major suppliers are Switzerland, China, USA, Germany, Italy, Denmark, France, and UK USA accounts for 14% of total world imports, followed by Switzerland (4.8%), Japan and Canada (3%) Imports include raw materials and finished products.
Some major pharmaceuticals which are imported include provitamins and vitamins, cortisones, hydrocortisone, insulin, penicillin, oesetrogen, progesterone and other hormones, erythromycin and other antibiotics, antisera other blood fraction, and glycosides. The imports from Switzerland, US and Germany primarily consist of finished medicament in dosage forms for retail sales
Exports
Indian pharmaceutical industry ranks 17th with respect to exports value of actives and dosage
Exports constitute nearly 40 per cent of the production, with formulations contributing 55 per cent and bulk drugs 45 per cent
The overall pharmaceutical exports are estimated to increase at a CAGR of 30-32 % and reach us$ 18.3 billion in 2011-2012
This act is the third of three amendments to the patents act of 1970, to bring Indias patent regime into compliance with the WTO TRIPS agreement.
The patents (amendment) act, 2005 extends the product patent protection to the areas of pharmaceuticals and agricultural chemicals.
FDI in Pharma
Sought out destination for foreign players Industrial licensing has been abolished Ministry of Chemicals and Fertilizers permits 100% FDI Exemption from DPCO if product is patented under the Indian Patent Act and developed through indigenous R&D in India
Ranbaxy
Shanta Biotech Orchid Chemicals Piramal Health Care
Daiichi Sankyo
Sanofi Aventis Hospira Abott
Negatives of acquisition
Reducing domestic availability of drugs Reduce competition Oligopolistic market and cartelization Cases of emergency Sustainable growth of economy
DPCO
The drugs price control order (DPCO), 1995 is an order issued by the government of India under section 3 of the essential commodities act, 1955 to regulate the prices of drugs.
The order inter alia provides the list of price controlled drugs, procedures for fixation of prices of drugs, method of implementation of prices fixed by government and penalties for contravention of provisions among other things.
Drugs and formulations have been subjected to price control for more than three decades now.