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Pharma presentation by Balaji Roy
- 1. Balaji Roy
- 2. Pharmaceutical Industry in India is one of the largest and most advanced among the developing countries. Around 70% of the country's demand for bulk drugs, drug intermediates, pharmaceutical formulations, chemicals, tablets, capsules, orals and vaccines is met by IPI. The Indian pharmaceutical industry has come a long way from waiting for imports of bulk drugs from global players to breaking new grounds in medical research worldwide.
- 4. Phase V Phase IV Innovation and Growth Phase Research Phase III Development Rapid expansion of New IP law Phase domestic market Discovery Research Phase II Process International Convergence Government Control development market Phase I development Indian Patent Act Production Early Years 1970 infrastructure Research orientation Market share Drug prices capped creation domination by Local companies Export initiatives foreign begin to make an companies impact Relative absence of organized Indian companies 1970 1980 1990 2000 2010
- 5. VALUE Innovative Products Specialty Generic Generic Products exports to exports to developed under- countries developed & API developing Exports countries TIME
- 6. Pharmaceutical Industry Two percent of the world's pharmaceutical market. Estimated market value of about US $12.26 billion. 3rd rank in terms of total pharmaceutical production volume. 14th in terms of value. Growing at an average rate of 8-9 %. Expected to grow to US $ 20-23 billion by 2015. The pharmaceutical industry grows at about 1.5-1.6 times the Gross domestic product growth.
- 7. INDIAN PHARMACEUTICAL MARKET DOMESTIC MARKET OVERSEAS MARKET Ethical drugs The Export generic drugs Over the counter (OTC) and APIs drugs Contracted Research and Active pharmaceutical Manufacturing Services ingredient (API) market (CRAMS)
- 8. A patent is a limited monopoly granted in respect of an invention. A patent confers the right to exclude others from making, using or selling the invention. This right is granted to the inventor (or his/her successor in title) by a national or regional authority. This right is limited in terms of territory and duration. The scope of this right is defined by the patent claims.
- 9. A patent does not confer the "positive" right to use the invention. The use of an invention, whether patented or not, is subject to other national laws and regulations.
- 10. Territorial scope : National patents Both granting procedure and effect are national. European patents - The granting procedure is European, the effect is national International patent applications (PCT): The application and examination procedure is international, the granting procedure is European/national, the effect is national. Term 20 years from filing
- 11. Product Broadest protection. It covers all uses of the product, even those not explicitly disclosed. Method The protection for a method of manufacture also covers the products obtained by that method. Relatively narrow scope of Use protection - second medical use
- 13. Generic medications are: A copy of the original (bioequivalent) and interchangeable with the innovator drug. Manufactured without a license from the innovator company. Marketed after expiry of patent or other exclusive rights .
- 15. Patented Off Patent Product Introductory Growth Maturity Decline Development Stage Stage Stage Stage Off Patent Scenario A Scenario B Scenario C Time
- 16. MAJOR PLAYERS AS PER NET SALES IN INDIA 9000 8000 7686.59 6977.5 IN CRORE 7000 6686.3 6000 5364.37 5000 4284.63 4015.56 4000 3152.2 3000 2641.07 2560.16 2352.59 2000 1000 0 COMPANY
- 17. CURRENT GROWTH SCENARIO FACTORS LEADING TO THE GROWTH OF PHARAMACEUTICAL INDUSTRY Economic Growth Population growth Increase in chronic diseases Healthcare infrastructure growth Growth of health insurance Low manufacturing costs
- 19. Anti- infective Gastrointestine Cardiac Respiratory Vitamin/minerals/nutrients Pain /analgesis Dermatologics gynaecology Neuro psychiatry Antidiabetics Othologicals others 11% 16% 4% 2% 5% 11% 5% 10% 11% 6% 10% 10%
- 20. 40000 35000 34741 US $ IN MN(APR 2011- MAR 2012) 30000 25000 20000 16857 15000 12931 8589 9151 10000 7942 5769 5000 2702 2411 1778 0 COUNTRY
- 21. SRILANKA 6% SOUTH AFRICA UNITED 10% STATES 20% MEXICO 8% PAKISTAN GERMANY 7% 17% BRAZIL UNITED 10% KINGDOM INDIA CHINA 9% 8% 5%
- 22. EFFECT OF RECESSION Recession Proof Business. Career in the pharmaceutical industry as evergreen. Fastest growing manufacturing industries.
- 23. Contract manufacturing for Global Supply of APIs Quality Generic Products Process Technologies Pharmaceutical Manufacturing Equipment Alternate Medicines - Ayurvedic & Herbal
- 24. SWOT ANALYSIS STRENGHTS WEAKNESSES Cost Competitiveness Low investments in innovative R&D Strong manufacturing base Lack of resources to compete with Established network of laboratories and R&D MNCs infrastructure Highly trained scientists Inadequate regulatory standards Strong marketing and distribution network Production of spurious and low quality Rich biodiversity drugs spoils the image of the industry in Largest number of US FDA approved plants international arena Opportunities Threats Product patent regime poses serious Significant export potential challenge unless it invests in R&D Licensing deals with MNCs DPCO puts unrealistic ceilings on Marketing alliances to sell MNC products product in Indian market prices & profitability & prevents in Contract manufacturing agreements with generating investible surpluses the MNCs Export effort hampered by procedural Potential for developing India as a centre hurdles & non tariff barriers imposed for international clinical trials abroad Lowering of tariff protection
- 25. FINDINGS AND CONCLUSION Expected to grow to US $ 20-23 billion by 2015. Export market is growing much faster than the domestic market. Future will see strong growth in the specialty branded generics and patented drug segments. Drugs for diabetes and cardiovascular diseases are expected to see the fastest growth among all therapy areas .
- 26. Vast opportunity exists for the organized market. Cipla, Ranbaxy and GlaxoSmithKline are controlling the top three positions in the Indian pharmaceutical market. Pharma industry being a growth industry unaffected by the business cycle India has: Competitive strength in research services. Availability of low cost skilled doctors and scientists. Large patient population with diverse disease characteristics. VLSS agencies recommends investment in this industry to be a wise decision.
- 27. RECOMMENDATIONS Selecting right product-mix. Focusing on core competencies. More of merger and acquisition. Reengineering and investing heavily in R&D. Advances in biotechnology and Information technology.
- 28. The obligations imposed on India are going to have a significant impact on Indias successful bulk and formulation-oriented pharmaceutical industry. Indian companies could focus on producing patented drugs under license from foreign companies .
- 29. THANK YOU