CHAPTRE - 2 EMERGING TRENDS IN GLOBAL
Transcription
CHAPTRE - 2 EMERGING TRENDS IN GLOBAL
Chapter 2 CHAPTRE - 2 EMERGING TRENDS IN GLOBAL AND INDIAN PHARMACEUTICAL INDUSTRY SINCE 1991 2.1: INTRODUCTION:The pharmaceutical industry is most advanced, competitive and highly globalized industry. More over the pharmaceutical industry is characterized by high research and development expenditures and extensive regulation of its product compared with other manufacturing sector. The pharmaceutical industry has also been affected by a high number of merger and acquisitions, which have heightened efficiency. The world pharmaceutical industry has grown at a rapid pace during the last three decades due to the tremendous progress made in process technology and high rate of discovery and introduction of new drugs made during the fifties and sixties. 2.2: WORLD PHARMACEUTICAL MARKET:The largest pharmaceutical markets are US, Europe and Japan. The United State accounted for approximately 33 percent of the total world market for ethical (prescription) pharmaceuticals in 1996, while Europe’s share amounted to about 29 percent and Japan,s share was nearly 18 percent.1 In 2006 global pharmaceutical revenues was US$ 643 billion growing by 7 percent over the last year. The share of the global pharmaceutical industry in the global healthcare industry was 15 percent as reported by Indian Credit Rating Agency in January 2004.2 The share of pharmaceutical expenditure in the total global healthcare expenditure varies from country to country. The size of the global pharmaceutical industry was estimated at US$ 400.5 billion and around 88 percent of the market was accounted for by North America, Europe and Japan in the year 2002.3 The global pharmaceutical industry reported a compound 31 Chapter 2 growth rate of 6.8 percent during 1992-2002.4 The pharmaceutical markets in the developed regions witnessed healthy growth rates thereafter with growth rate of around 12 to 15 percent in the US and 8 to10 percent in European countries.5 The pharmaceutical industry which had been concentrated at the top, underwent further consolidation. The top 10 players who together had around 28 percent share of the global market in 1990, accounted for around 46 percent of the market in 2002.6 As in 2004, the top 20 companies accounted for about 66 percent of the global market.7 The industry is truly global as most of the large companies have a presence across the globe. For large European and US pharmaceutical companies, over 40 percent of their total sales came from international operations in 2003.8 Although the demand for pharmaceutical products is high in the developing nations; their lack of purchasing power has skewed the distribution of the market. However, the share of the developing nations in the global pharmaceutical market has increased during the past decade (19902000).9 The global pharmaceutical market is forecasted to grow to US$ 842 billion in 2010, an equivalent compound growth rate of 6.9 percent over the next five years. The global generic medicines market is worth over US$ 80 billion, which is 30 percent of total sales. The turnover of the Indian pharmaceutical industry was estimated close to Rs. 357.5 billion in financial year 2004.10 The industry reported an impressive compounded annual growth rate of 16 percent between financial year 1994 and financial year 2004 to emerge as an attractive segment of the Indian manufacturing sector11. The Indian pharmaceutical industry ranked 13th in value terms and 4th in volume terms globally, as in 2004, due to high volume turnover and low drug prices in the country.12 2.3: WORLD PHARMACEUTICAL PRODUCTION:Pharmaceutical production means whether it is the manufacturing of active ingredients in bulk form, basic chemicals, the preparation of finished new medical entities, or the repacking of imported generic ingredients to make 32 Chapter 2 finished branded or unbranded generic products. Global production is geographically a highly concentrated activity with over 90 percent of world production located in a few high-income countries.13 Two third of the value of medicines produced globally is accounted for by firm with headquarters in just five countries the USA, Japan, Germany, France and UK. Production is also concentrated in a few key products and in a relatively small number of companies, which often have factories and offices in many countries. New medicines with patent protection, which may have resulted from costly research and development processes and where large markets are anticipated, tend to be particularly expensive. Yet price and therapeutic gain are not necessarily related. Large quantities of traditional and generic medicines are manufactured and consumed, particularly in low income countries and the therapeutic value of these is not reflected in available monetary measures. For India and China in particular, the dollar value of medicine transactions bears little relation to the health value of these products. Where available, volume measures such as weight or the number of prescriptions can change the global perspective on production and consumption dramatically. However, they still cannot measure the health value of medicines. India, for example, accounts for about 1 percent of the world’s production by value, but 8 percent by volume (weight). The country ranks thirteenth in world production by value but ranks fourth in the volume of pharmaceuticals produced.14 However, these measures are still no closer to an index of therapeutic value, and the available data are too limited to allow international comparison or analysis of trends. Severity and prevalence of disease is more rampant in poor developing nations where the marginalized and Poor’s access to medicine is low. Herein provision of life saving drugs through not much in value terms has more health volume. The total value of global pharmaceutical production in 1999 was just over 320 billion US dollars.15 33 Chapter 2 Table No. 2.1 shows share of world pharmaceutical production of low, middle and high income countries, following table shows that the high income countries dominated in world pharmaceutical production. These countries share TABLE NO: 2.1 SHARE OF LOW, MIDDLE AND HIGH INCOME COUNTRIES IN WORLD PHARMACEUTICAL PRODUCTION: 1985 TO 1999 (In %) Year 1985 1990 1999 Low Income 3.9 2.6 2.6 Middle Income 7 6.9 4.5 High Income 89.1 90.5 92.9 Source: World Health Organisation estimated based on data reported by UNIDO, OECD Health Data, World Development Indicators 1987, 1992, 2001, International Financial Statistics Yearbook 2002.comparision FIGURE NO: 2.1 DISTRIBUTION OF SHARE OF LOW, MIDDLE AND HIGH INCOME COUNTRIES IN WORLD PHARMACEUTICAL PRODUCTION: 1985 AND 1999 IN % Year 1985 Year 1999 4% 7% 3% 5% 89% Low Income Middle Income High Income 34 92% Chapter 2 of production increased from 89.1 percent in 1985 to 92.9 percent in 1999. The share of middle and Low Countries decreased over the same period. Low income countries share of production from 3.9 percent in 1985 to 2.6 percent in 1999 and the same time middle income countries the share of production from 7 percent in 1985 to 4.5 percent in 1999. Table No. 2.2 shows that the share of total pharmaceutical production of the five top producing countries from 1985 to 1999. The combined share of these countries fell from 78 percent of total production in 1985 to about 67 percent in 1999. The USA remains the biggest single producer accounting almost one third of total production and Japan second largest. The USA share of total pharmaceutical production from 38 percent in 1985 to 31 percent in 1999, during the period total production of USA was decreased but compared to other countries USA is largest pharmaceutical producer in world market. Japan share of total pharmaceutical production from 19 percent in 1985 to 16 percent in 1999. Together these two countries produced 57 percent of the world pharmaceutical in 1985 and 47 percent in 1999. TABLE NO: 2.2 SHARE OF THE TOP FIVE COUNTRIES IN WORLD PHARMACEUTICAL PRODUCTION (In %) Year 1985 1990 1999 USA 38 31 31 Japan 19 20 16 Germany 8 10 6 France 7 8 8 UK 6 7 6 Source: As of Table No.2.1 35 Chapter 2 FIGURE NO: 2.2 DISTRIBUTION OF SHARE OF THE TOP FIVE COUNTRIES IN WORLD PHARMACEUTICAL PRODUCTION: 1985 AND 1999 IN % Year 1985 Year 1999 8% 9% 9% 12% 10% 24% 49% 46% 9% USA Japan 24% Germany France UK The USA lost some of its market share to Japan and Germany between 1985 and 1990. During the period 1985 to 1990, the market share of the Germany was 8 percent to 6 percent. The UK share of total pharmaceutical production from 6 percent in 1985 to 6 percent in 1999. 2.4: GLOBAL PHARMACEUTICAL SALES:Sales and marketing capability are fast becoming an increasingly important source of competitive advantage. In 2007, the total global pharmaceutical sales reached to US$ 712 billion. Among the ten leading international markets combined, which account for 81 percent of world wide sales, audited growth was just 5.7 percent down from 7.2 percent in 2004. Sales provide an additional measure of the consumption of pharmaceuticals. Production measures the output of all manufactures. Consumption means use of domestic pharmaceutical drugs plus import of drugs and minus of pharmaceutical export, it is measurement of output of pharmaceutical product or sales of pharmaceutical product. 36 Chapter 2 TABLE NO: 2.3 GLOBAL PHARMACEUTICAL SALES, 1997 TO 2007 (Value in US $ Billion) Year Global Sales Annual % Change 1997 289 - 1998 297 2.76 1999 332 11.78 2000 357 7.53 2001 387 8.40 2002 426 10.07 2003 493 15.72 2004 560 13.59 2005 605 8.03 2006 649 7.27 2007 712 9.70 CGR from 10.07 1991-2006 Increase in 2.46 2007 over 1997 Source: IMS Health, Annual World Review Report 2007, www.imshealth.com 37 Chapter 2 FIGURE NO: 2.3 TRENDS OF GLOBAL PHARMACEUTICAL SALES, 1997 TO 2007 (Values in US $ Billion) Values in US$ billion 800 700 600 500 400 300 200 100 Year 07 20 06 20 05 20 04 20 02 03 20 20 00 01 20 20 99 19 98 19 19 97 0 Global Sales Table No. 2.3 shows global pharmaceutical sales during the period under study has increased tremendously. The global pharmaceutical sale was only US$ 289 billions in 1997, which increased to US$ 712 billion in 2007 representing more than 2.46 fold over the period of 11 years. Its compound growth rate was 10.07 percent during the period under study. However, it is found from the following table that the global pharmaceutical sales started to increase rapidly since 1997. Table No. 2.3 gives details of global pharmaceutical sales for the period 1997 to 2007. Data in table reveals that from 1997 to 2007: total sale of the global pharmaceutical industry shows continuous growth the period under study. Total sales of global pharmaceutical industry increased from US$ 289 38 Chapter 2 billion in 1997 to US$ 357 billion in 2000 and further to US$ 560 by 2004. This global sale by 2007 was US$ 712 billion. In 1998 annual average growth rate of global sale was by only 2.76 percent they were rosé to 11.78 percent in 1999. In 2000, global pharmaceutical sales shows decreased annual average growth rate of 7.53 percent. There was wide range of fluctuation in the annual average growth of global pharmaceutical sales during the study period. In 2001 annual average growth rate of global sale was increased by 8.40 percent annually compared to earlier years. Again, they show the decreased annual average growth rate of 13.59 percent in 2004. In 2003 annual average growth rate, increased global sale was highest records by 15.72 percent. Later on period, it was decreased to 7.27percent in 2006. The annual average growth rate of global sale showed ups and down trends during the period under study. Global pharmaceutical sales roes by 2.46 fold in 2007 over 1997. Compound growth rate of global pharmaceutical sales during the period 1997 to 2007 was 10.07 percent. 2.4.1: GLOBAL PHARMACEUTICAL SALES BY REGION:The majority of global pharmaceutical sales originate in the triad (three) means US, EU and Japan with ten key countries accounting for over 80 percentage of global market. North America has been by far the largest pharmaceutical market by volume and value means US$ 304.5 billion in 2007 half of global sales, with the strongest growth among key markets, contributing 51 percentage global market growths in 2002, the US accounted for a 45.9 percentage of blockbuster sales compared with only 8.8 percentages from Japan and 31.1 percentages from Europe. Europe has traditionally been the second largest market for pharmaceutical, with sales of US$ 206.2 billion in 2007. Japan made up the third part of the triad with top five markets (Germany, France, Italy, UK and Spain) to continue contributing sales of EU. European markets each had their 39 Chapter 2 own unique operating environments. The pharmaceutical market in Latin America had proved highly volatile, reflecting underlying economic trends. Table No. 2.4 indicate that global pharmaceutical sales by region means sales of North America, Europe, Japan, Latin America and Asia, Australia and Africa these countries sales from US$. 317.2 billion In 2000, which raised to US$.663.5 billion in 2007. Sale of North America in 2000 was US$ 152.8 billion, which increased to US$ 304.5 billion in 2007 and percentage of sales in total sale from 48.2 percent in 2000, which decreased to 45.9 percent in 2007.The sale of North America shows decreasing trends during the period under the study. The sale of North America has increased 1.99 fold in 2007 over 2000. The compound growth rate was 10.03 percent during the period under study. Sale of European Countries in 2000 was US$ 75.3 billion, which increased to US$ 206.2 billion in 2007. Percentage of sales of European countries was 23.7 percent in 2000, which in creased to 31.1 percent in 2007. It means percentage of sales of European Countries shows increasing trend during the period 2000 to 2007.The sale of European Countries has increased 2.73 fold in 2007 over 2000. Its compound growth rates was16.43 percent during the period under study. In 2000, the Japan sale in world market was US$ 51.5 billion and further rose to US$ 58.5 billion in 2007, came down to US$ 47.6 billion, US$ 46.9 biillion and US$ 56.7 billion in 2001, 2002 and 2006. However, in the next year 2007 went up to US$ 58.5 billion. The sale of Japan has increased 1.13 fold in 2007 over 2000. Its compound growth rates being 3.17 percent during the period under study. Sales of Latin America also indicate the ups and downs in growth trends during 2000 to 2007. In 2000 sales in world, market was US$18.9 billion and they rose to US$ 32 billon in 2007 and decreased to US$ 16.5 billion in 2002. Further increased to US$ 17.4 billion in 2003. In 2000 and 2001 sale of Latin America was same to US$ 18.9 billion. The sale of Latin America has increased 1.69 fold in 2007 over 2000. Its compound growth rates were 8.39 percent. 40 Chapter 2 TABLE NO: 2.4 COMPOSITION AND GROWTH OF GLOBAL PHARMACEUTICAL SALES BY REGION (Value in US $ Billion) Region North Europe America Japan Latin Asia America (excluding Japan), Africa & Australia 152.8 75.3 51.5 18.9 18.7 (48.2) (23.7) (16.2) (6.0) (5.9) 181.8 88 47.6 18.9 27.9 (50) (24) (13) (5) (8) 203.6 90.6 46.9 16.5 31.6 (51) (22) (12) (4) (8) 229.5 115.2 52.4 17.4 37.3 (49) (25) (11) (4) (8) 248 144 58 19 40 (47.8) (27.8) (11.1) (3.8) (7.7) 265.7 169.5 60.3 24 46.4 (47) (30) (10.7) (4.2) (8.2) 289.9 181.8 56.7 27.5 52 2006 (47.7) (29.9) (9.3) (4.5) (8.6) 2007 CGR 304.5 (45.9) 10.03 206.2 (31.1) 16.43 58.5 (8.8) 3.17 32 (4.8) 8.39 62.2 (9.4) 16.38 Increase in 2007 over 2000 1.99 2.73 1.13 1.69 3.32 2000 2001 2002 2003 2004 2005 Source: As of Table No.2.3 Note: Figures into brackets indicate percentage to sale 41 Chapter 2 FIGURE NO. 2.4 DISTRIBUTION OF GLOBAL PHARMACEUTICAL SALES BY REGION IN % Year 2007 Year 2000 6% 6% 9% 5% 9% 16% 46% 48% 11 24% 31% North America Europe Japan Latin America Asia (excluding Japan), Africa & Australia Sales of Asia (excluding Japan), Africa and Australia was to US $ 18.7 billion in 2000, which was increased to US$ 62.2 billion in 2007 and percentage of sales in total sale from 5.9 percent in 2000, which increased to 9.4 percent in 2007.The sale of Asia (excluding Japan), Africa and Australia shows increasing trends during the period under the study. The sale of Asia (excluding Japan), Africa and Australia has increased 3.32 fold in 2007 over 2000. Compound growth rate of sales of this region was 16.38 percent during the period under study. Sales data of this region very apply indicates that this region has large geographical area and population, so markets are large and rise in per capital incomes demand for medicines also is rising and therefore this region is important for sales. 42 Chapter 2 2.4.2: SALES BY GEOGRAPHICAL AREAS: The global pharmaceutical industry is a multinational industry that is highly regulated, capital intensive, and which is driven by large research and development expenditures. The industry is primarily privately owned and is technologically sophisticated. The strong growth in the five European markets that joined the European Union. Emerging markets such as China, South Korea, Brazil, Russia and Turkey experienced double digit growth signaling an important shift occurring in the pharmaceutical industry. As growth in the mature markets flatten, industry attention is shifting to smaller, developing markets that are doing exceptionally well. Many of these developing nations are experiencing significant gross domestic product growth, which helps finance the healthcare systems, increase patient access and fuels the Double digit growth. Pharmaceutical measures are gearing up to the challenges of meeting the unmet needs of these markets. According to IMS Health as stated in the 2004 Annual Report, the United States, the European Union and Japan comprise the three major pharmaceutical markets which together represent 91.5 percent of world sales; and the U.S. market alone accounts for about 70.4 percent of world sales. Not surprisingly, all big Pharmaceutical companies to a significant extent concentrate their resources on these markets, especially on the U.S. market. At the same time, although the share of world pharmaceutical sales in developing countries at this point of time is much lower, India’s and Pakistan sales is very low it is to US$ 628.3 million. Share of world pharmaceutical sales only 0.3 percent. They show much faster growth rate than developed countries do. For example, the China, 9th largest world market, showed a 26 percent sales increase in 2004, followed by Thailand (16% growth) and Egypt (15% growth). Some Latin American countries, such as Mexico, Brazil, Argentina and Venezuela also show much faster sales growth rate than average worldwide. Therefore, developing countries contain a significant potential for further expansion of pharmaceutical industry in the future. 43 Chapter 2 TABLE NO: 2.5 SALES BY GEOGRAPHIC AREA*, PhRMA MEMBER COMPANIES 2005 (Value in US $ Million) Area Sales 1- Africa 1- Africa 1177.2 2-Americas 1- U.S 166155.5 2-Canada 5401.4 3-Latin America 5703.3 3- Asia-Pacific 3916.9 1-Asia-Pacific(except Japan) 2-India&Pakistan 628.3 3-Japan 8407.2 4- Australia 1-Austrlia&New Zealand 2682.3 5- Europe 1-France 7196.8 2-Germany 5530.1 3-Italy 5290.0 4-Spain 4268.7 5- U.K 4816.8 8655.6 6-Other Western European nations 7-Central - Eastern European 2366.6 nations 786.8 8-Other Eastern European nations 2027.9 6- Middle East 1025.1 7- Uncategoriesed 236036.5 TOTAL R&D Source: - Pharmaceutical Research Membership Survey, 2007 Share 0.5 70.4 2.3 2.4 1.7 0.3 3.6 1.1 3.0 2.3 2.2 1.8 2.0 3.7 1.0 0.3 0.9 0.4 100.0 and Manufacturers of America, PhRMA Annual *Sales Abroad includes sales generated outside the United States by U.S.-owned PhRMA member companies and sales generated abroad by the U.S. divisions of foreign-owned PhRMA member companies. Sales generated abroad by the foreign divisions of foreign owned PhRMA member companies are excluded. Domestic sales, however, includes sales generated within the United States by all PhRMA member companies. Note: *Central & Eastern European nations includes Cyprus, Czech Republic, Estonia, Hungary, Poland, Slovenia, Bulgaria, Lithuania, Latvia, Romania, Slovakia and Malta, * Other Eastern European nations including Russia, and newly Independent states. *Middle East including Saudi Arabia, Yemen, United Arab Emirates, Iraq, Iran, Kuwait, Israel, Jordan, Syria, Afghanistan, Turkey and Qatar. 44 Chapter 2 Table No. 2.5 gives details of growth of the sales by the geographic area and PhRMA member country above table shows sales value and percentage of sales of member country in the year 2005. Compared to other countries USA sale contribution is high in world sale market. In 2005 sale of USA was to US$166155.5 million and percent of sales in total sale is 70.4 percent in 2005. However, it is from above table that the sale of European Union to US$ 38911.4 million in 2005 and share of sales in total sales is 16.3 percent. Five major countries include under European Union respectively these are France, Germany, Italy, Spain, UK, Other Western European Nations, Central and Eastern European Nations and Other Eastern European Nations. France and other Western European Nations sale was high compared to other European Country respectively it was to US$ 7196.8 million, US$ 8655.6 million in 2005 and share of sales in total sales 3.0 percent and 3.7 percent. 2.4.3: INTERNAL AND EXTERNAL SALE OF USA AND PhRMA MEMBER COUNTRIES:Table No. 2.6 shows the total USA sales and sales of abroad means sales of PhRMA member companies from 1991 to 2006. The total sales of USA and PhRMA member companies have shown a continuous increasing trend since the study period. Total sales to states were US$ 66535.6 million in 1991 increased to US$ 245801 million in 2006. In 1995 sales of USA and PhRMA member companies was US$ 91039 million, which rose to US$ 145958.4 million in 2000 and further went up to US$ 230557.9 million in 2004. The annual average growth rate of sales of USA and PhRMA member companies showed fluctuation trend during the period under study. In 1991, the annual average growth rate of total sales was 14.1 percent, which was rose to 17.1 percent in 1999.However; they showed decreasing total sales of USA and PhRMA member companies’ trend during the period 1992 to 1998 and 2000 to 2006 annual average growth rate of total sales was decreased. The highest 45 Chapter 2 TABLE NO: 2.6 COMPOSITION AND GROWTH OF USA SALES AND SALES OF OTHER COUNTRY**, PhRMA MEMBER COMPANIES: - 1991 TO 2006 (values inUS$ Million) Year 1991 Annual Annual % Sales % USA Sales Change Abroad Change Total 44304.5 15.1 22231.1 12.1 66535.6 Annual % Change 14.1 1992 48095.5 8.6 25744.2 15.8 73839.7 11 1993 48590.9 1 26467.3 2.8 75058.2 1.7 1994 50740.4 4.4 26870.7 1.5 77611.1 3.4 1995 57145.5 12.6 33893.5 **** 1996 64741.4 13.3 36838.7 8.7 101580.1 11.6 1997 71761.9 10.8 39086.2 6.1 110848.1 9.1 1998 81289.2 13.3 43320.1 10.8 124609.3 12.4 1999 101461.8 24.8 44496.6 2.7 145958.4 17.1 2000 115881.8 14.2 45199.5 1.6 161081.3 10.4 2001 130715.9 12.8 47886.9 5.9 178602.8 10.9 2002 139136.4 6.4 53697.4 12.1 192833.8 8 2003*** 148038.6 6.4 60914.4 13.4 208953 13.4 2004*** 160751 8.6 69806.9 14.6 230557.9 14.6 2005 166155.5 3.4 69881 0.1 236036.5 0.1 2006* 174667.4 5.1 71133.6 1.8 245801 1.8 Increase in 2007 over 1991 3.94 CGR 10.98 10.8 3.19 8.17 91039 10.2 3.69 10.08 **** 10.5 *Estimated **Sales Abroad includes sales generated outside the United States by U.S.-owned PhRMA member companies and sales generated abroad by the U.S. divisions of foreign-owned PhRMA member companies. Sales generated abroad by the foreign divisions of foreignowned PhRMA member companies are excluded. Domestic sales, however, includes sales generated within the United States by all PhRMA member companies. ***Recalculated for updated data. ****Sales abroad affected by merger and acquisition activity. Note: Total values may be affected by rounding Source: As of Table No. 2.5 46 Chapter 2 FIGURE NO: 2.5 DISTRIBUTION OF USA SALES AND SALES OF OTHER COUNTRY**, PhRMA MEMBER COMPANIES: - 1991 AND 2006 (Figures in US $ Million) Year 2006 Year 1991 29% 33% 67% 71% USA Sales USA Sales Sales Abroad Sales Abroad annual average growth rate in 1999 was 17.1 percent. Total sales increased 3.69 fold in 2006 over 1991. Compound growth rate of total sales during the study period was 10.08 percent. Table No. 2.6 also explains the growth of USA sales from 1991 to 2006. Sales of USA to states also reported increasing trend. In 1991 total amount of sales of USA to states were US$ 44304.5 million, which rose to US$ 130715.9 million in 2001 and in 2003 sales of USA to states increased to US$ 148038.6 million. They were increased to US$ 166155.5 million in 2005. The annual average growth rate of sales of USA was 12.1 percent in 1991; it got increased to 15.8 percent in 1992 and further decreased to 2.8 percent in 1993. Later on it increased to 14.6 percent in 2004. However, in 47 Chapter 2 2000 annual average growth rate decreased that is 1.6 percent. Sales of USA to states increased to 3.94 fold in 2006 over 1991. Compound growth rate of USA sales to states during the study period was 10.98 percent. Table No. 2.6 also indicates sales in export market mean PhRMA companies sales from 1991 to 2006. In 1991 total amount of sales of abroad to states were US$ 22231.1 million, which rose to US$ 45199.5 million in 2000 and in 2004 sales of PhRMA member companies to states increased to US$ 69806.9 million. They were increased to US$ 71133.6 million in 2006. In 1991 annual average growth rate sales of abroad of PhRMA member companies was 12.1 percent and it was only 1.5 percent in 1994. The annual average growth rate sales of abroad of PhRMA member companies showed ups and downs trend during the period under study. In 2002 annual average growth rate, sales of abroad of PhRMA member companies increased by 12.1 percent and in 2005 sales to states decreased means annual average growth rate of 0.1 percent. Abroad sales to states increased by 3.19 fold in 2006 over 1991. Compound growth rate of abroad sales to states was 8.17 percent during the study period. Thus, the above data analysis reveals that all two components of total sales have shown a rising trends in this growth during the period under study and compound growth rate of all these sales was not more than 10 percent during the period under study. 2.5: RESEARCH AND DEVELOPMENT EXPENDITURE OF USA AND PhRMA MEMBER COUNTRY:Research and Development is the cornerstone of the pharmaceutical industry since the extent and success of company research and development activities largely determine the future pattern of corporate earning and growth. The larger companies in the industry in general and multinational sector in particular are highly research and development intensive. Research and development intensity in terms of sales, net income and cash income (net 48 Chapter 2 income after tax). Research and development from 1991 to 2006 in the USA indicated that the pharmaceutical industry composition of research and development expenditure was 77.7 percent it is higher than world Pharma countries. Table No. 2.7 shows the growth and composition of USA research and development expenditure and PhRMA member companies from1991 to 2006. The table also shows the growth of research and development expenditure both are in absolute terms as well as their annual average growth rate in percentage. Over the past decade, the USA pharmaceutical industry research and development spending has more than doubled. This increase in spending is largely due to the increasing level of attrition, which helped to quadruple the cost of discovering and developing a New Molecular Entity (NME) since 1987. In 2001, the cost to discover and develop a New Molecular Entity ran to roughly US$ 800 million.16 Total research and development expenditure have consistently increased in absolute terms during the period under study. In 1991 research and development expenditure were US$ 9705.4 million and they were increased to US$ 42937.5 million in 2006. In 1999 to research and development expenditure were US$ 22690.7 million, which was increased to US$ 39857.6 million in 2005. The annual average growth rate of research and development expenditure of USA and PhRMA member companies showed fluctuation trend during the period under study. In 1991, the annual average growth rate of total research and development expenditure was 15.3 percent, however; they showed decreasing total research and development expenditure of USA and PhRMA member companies. The decreased growth rate of 5.6 percent in 1994. In 1996 total research and development, expenditure increased annually 11.2 percent. In 1998, these research and development expenditure again showed decreased an annual average growth rate of 10.8 percent. In 2000, annual average growth rate of total research and development expenditure was 14.7 percent. However, 49 Chapter 2 TABLE NO: 2.7 COMPOSITION AND GROWTH OF US RESEARCH AND DEVELOPMENT AND RESEARCH AND DEVELOPMENT ABROAD, PhRMA MEMBER COMPANIES: - 1991 TO 2006 (Dollar figures in Million) Annual Annual % Abroad*** % Change R and D Change 16.5 1776.8 9.9 Total R and D 9705.4 Annual % Change 15.3 Year 1991 US R and D 7928.6 1992 9312.1 17.4 2155.8 21.3 11467.9 18.2 1993 10477.1 12.5 2262.9 5 12740 11.1 1994 11101.6 6 2347.8 3.8 13449.4 5.6 1995 11874 7 3333.5 *** 15207.5 *** 1996 13627.1 14.8 3278.5 -1.6 16905.6 11.2 1997 15466 13.9 3492.1 6.5 18958.1 12.4 1998 17127.9 11 3839 9.9 20966.9 10.8 1999 18471.1 7.4 4219.6 9.9 22690.7 8.2 2000 21363.7 15.7 4667.1 10.6 26030.8 14.7 2001 23502 10 6220.6 33.3 29722.6 14.4 2002 25655.1 9.2 5357.2 -13.9 31012.3 4.2 2003 27064.9 5.5 7388.4 37.9 34453.3 11.1 2004 29555.5 9.2 7462.6 1 37018.1 7.4 2005 30969 4.8 8888.6 19.1 39857.6 7.7 2006* 33967.9 9.7 9005.6 1.3 42973.5 7.8 Increase in 2007 over 1991 CGR 4.28 10.19 12.8 5.06 11.44 16.6 4.42 10.44 13.4 Sources: - As of Table No. 2.5 * Estimated **R and D Abroad includes expenditures outside the United States by U.S.owned PhRMA member companies and R and D conducted abroad by the U.S. divisions of foreign-owned PhRMA member companies. R and D performed abroad by the foreign divisions of foreign-owned PhRMA member companies is excluded. Domestic R and D, however, includes R and D expenditures within the United States by all PhRMA member companies.***R and D Abroad affected by merger and acquisition activity 50 Chapter 2 FIGURE NO: 2.6 DISTRIBUTION OF US RESEARCH AND DEVELOPMENT AND RESEARCH AND DEVELOPMENT ABROAD, PhRMA MEMBER COMPANIES: - 1991 AND 2006 (Dollar figures in Million) Year 2006 Year 1991 18% 21% 79% 82% US R and D US R and D Abroad*** R and D Abroad*** R and D FIGURE NO: 2.7 TRENDS OF US RESEARCH AND DEVELOPMENT AND RESEARCH AND DEVELOPMENT ABROAD, PhRMA MEMBER COMPANIES: - 1991 TO 2006 (Dollar figures in Million) 50000 45000 40000 35000 25000 20000 15000 10000 5000 Year US R and D 51 2006 2005 2004 2003 2002 2001 2000 1999 1998 1997 1996 1995 1994 1993 1992 0 1991 Value 30000 Abroad R and D Chapter 2 2002 these total research and development expenditure again showed decreased growth rate of 4.2 percent. During 2003, annual average growth rate of total research and development expenditure increased to 11.1 percent and again in 2004 this expenditure shows the very less annual average growth rate it was 7.4 percent. In 2006, annual average growth rate these research and development expenditure increased to 7.8 percent. Total research and development expenditure of USA and PhRMA member companies increased 4.42 fold in 2006 over 1991. Compound growth rate of Total research and development expenditure of USA and PhRMA member companies during the study period was 10.44 percent. As successive research and development expenditure are favorable to USA and PhRMA member companies and shows continuously increasing trend. In 1991, the total amount of USA research and development expenditure was US$ 7928.6 million, which was rose to US$ 11101.6 million in 1994. In 2004, the USA research and development expenditure increased to US $ 29555.5 million and further raised US$ 33967.9 million in 2006. In 1991, the annual average growth rate of US research and development expenditure was 16.5 percent, however; they showed decreasing US research and development expenditure. The decreased growth rate of 12.5 percent in 1993. In 1994, there was very less annually growth of 6 percent. Again in 1996 it increased by 14.8 percent. In 1998 annual average growth rate of research and development expenditure was decreasing that is 11 percent and in 2000 annual average growth rate increased by 15.7 percent. Later on period, it was decreasing. In 2001, annual average growth rate of research and development expenditure increased to 10 percent. In 2004, annual average growth rate of research and development expenditure increased to 9.2 percent, which was declined to 4.8 percent in 2005.The annual average growth rate of US research and development expenditure showed ups and downs trend during 52 Chapter 2 the period under study. Total US research and development expenditure of USA increased 4.28 fold in 2006 over 1991. Compound growth rate of Total research and development expenditure of USA during the study period was 10.19 percent. Table No. 2.7 also shows that research and development expenditure of abroad means PhRMA member companies from 1991 to 2006. In 1991 total amount of research and development expenditure of PhRMA member companies were US$ 1776.8 million and they increased to US$ 9005.6 million in 2006. Abroad research and development expenditure was continuous increasing trend during the period under study. In 1991 annual average growth rate of abroad research and development expenditure was by only 9.9 percent they were rose to 21.3 percent in 1992. In 1993 and 1994, research and development expenditure decreased annual average growth rate of 5 percent and 3.8 percent. There was wide range of fluctuation in the annual average growth of abroad research and development expenditure during the study period. In 1996, research and development expenditure shows a negative annual average growth rate of -1.6 percent. In 2001 they increased by 33.8 percent annually compared to earlier years. Again they shows negative annual average growth rate of -13.6 percent in 2002. In 2003 average growth rate, increased research and development expenditure was highest record by 37.3 percent. Later on year 2004, it decreased of 1 percent. In 2005 annual average growth of abroad research and development expenditure increased to 19.1 percent which was declined to 1.3 percent in 2006. Total abroad research and development expenditure increased 5.06 fold in 2006 over 1991. Compound growth rate of total abroad research and development expenditure during the study period was 11.44 percent. Table No.2.8 indicates research and development as a percentage of sales. Following table shows research and development expenditure as a percentage of sales of USA and PhRMA member companies from 1991 to 2006. In this period, data gives details of USA and PhRMA member 53 Chapter 2 companies’ research and development expenditure as a percentage of sales. USA research and development expenditure as a percentage of sales increased from 17.9 percent in 1991 to 21.9 percent n 1994 further increased to 19.4 percent in 2006. In 1995, USA research and development expenditure was 20.7 percent compared to previous year it was less, however they showed increased investment of research and development expenditure of 21 percent to 21.6 percent in 1996 and 1997. In the year 1998 to 1999, 2000 to 2001 and 2002 to 2003 investment of research and development expenditure of USA was ups and downs, its rang 21.1 percent , 18.4 percent and 18.3 percent. In 2005 research and development expenditure as a percentage of sales of USA was 18.6 percent. USA research and development expenditure investment shows fluctuating trend during the period under study. Table No.2.8 reports the percentage of the total research and development expenditure as a percentage of sales of PhRMA member countries for the period 1991 to 2006. PhRMA member research and development expenditure also show a trend of growth. However, it has some fluctuation in it. PhRMA member companies research and development expenditure less than USA Pharmaceutical companies. It was 7.99 percent in the initial period of study to 8.54 percent in 1993 and again it increased 9.83 percent in 1995. But in 1996, it decreased to 8.89 percent. However, since 1996 it indicates decline with fluctuations in contrast in some years it show high and less of Research and development expenditure of PhRMA member companies. In 1996, it was to 8.93 percent, which declined in the next year to 8.86 percent. Table No.2.8 also reveals research and development expenditure as a percentage of sales of PhRMA member companies during the period under study and this table explains the percentage of research and development expenditure to total sales of USA and PhRMA member companies. It was 14.6 percent in 1991, which was increased 17.5 percent in 2006. The percentage of research and development as a percentage of sales shows ups and downs trend during the period under study. However, as successive research and 54 Chapter 2 development investments are favorable to USA and PhRMA member companies. TABLE NO: 2.8 RESEARCH AND DEVELOPMENT AS A PERCENTAGE OF SALES PhRMA MEMBER COMANIES 1991 TO 2006 (%) Total R and D as a % of Total Sales Year US R and D as a% of US Sales PhRMA member R and D as a% of PhRMA member Sales 1991 17.9 7.99 14.6 1992 19.4 8.37 15.5 1993 21.6 8.54 17 1994 21.9 8.73 17.3 1995 20.7 9.83 16.7 1996 21 8.89 16.6 1997 21.6 8.93 17.1 1998 21.1 8.86 16.8 1999 18.2 9.48 15.5 2000 18.4 10.32 16.2 2001 18.3 12.99 16.7 2002 18.4 9.97 16.1 2003 18.3 12.12 16.5 2004 18.4 10.69 16.1** 2005 18.6 12.719 16.9** 2006 19.4 12.66 17.5 Sources: - As of Table No. 2.5 In 1992, 1993, 1994 total research and development expenditure of USA and PhRMA member companies was increased. Its range of 15.5 percent to 17.3 percent, but from 1995 to 2005 fluctuating trend. 55 Chapter 2 TABLE NO: 2.9 RESEARCH AND DEVELOPMENT BY GEOGRAPHIC AREA*, PhRMA MEMBER COMPANIES 2005 (Values in US$ Million) Area 1- Africa 1- Africa 2-Americas 1- U.S 2-Canada 3-Latin America 3- Asia-Pacific 1-Asia-Pacific(Japan) 2-India&Pakistan 3-Japan 4- Australia 1-Austrlia&New Zealand $ 28 28 Shares 0.1 31624.1 30969.9 479.3 174.9 77.7 1.2 0.4 1153.8 117.5 10.9 1025.4 144.6 144.6 0.3 0 2.6 0.4 3688.8 5- Europe 1-France 2-Germany 3-Italy 4-Spain 5- U.K 6-Other Western Country 7-Central&Eastern Europe 8-Other Eastern Europe 6- Middle East 7- Uncategoriesed TOTAL R AND D 498.8 548.2 342.1 208.8 2090.9 2835.9 131.2 113.4 37.7 101.3 39857.9 1.3 1.4 0.9 0.5 5.2 7.1 0.3 0.3 0.1 0.3 100.00% Source: As of Table No. 2.5 *Sales Abroad includes sales generated outside the United States by U.S.-owned PhRMA member companies and sales generated abroad by the U.S. divisions of foreignowned PhRMA member companies. Sales generated abroad by the foreign divisions of foreign owned PhRMA member companies are excluded. Domestic sales, however, includes sales generated within the United States by all PhRMA member companies. Note: *Central & Eastern European nations includes Cyprus, Czech Republic, Estonia, Hungary, Poland, Slovenia, Bulgaria, Lithuania, Latvia, Romania, Slovakia and Malta, * Other Eastern European nations including Russia, and newly Independent states. *Middle East including Saudi Arabia, Yemen, United Arab Emirates, Iraq, Iran, Kuwait, Israel, Jordan, Syria, Afghanistan, Turkey and Qatar. 56 Chapter 2 Table No.2.9 indicates research and development expenditure of PhRMA member companies. United State alone account for about 77.7 percent of world research and development expenditure. At the same time, although the share of world pharmaceutical research and development expenditure in developing countries at this point of time is much lower, India’s and Pakistan research and development expenditure is very low means it is to US$ 10.9 million. Share in world pharmaceutical research and development expenditure only 0 percent. They show negative growth rate than developed countries do. However, it is found above table that the research and development expenditure of European Union to US$ 6769.3 million in 2005 and share of research and development expenditure in total research and development expenditure is 17 percent. Five major countries include under European Union respectively these are France, Germany, Italy, Spain, UK, Other Western European Nations, Central and Eastern European Nations and Other Eastern European Nations. In 2005 Africa’s research and development, expenditure to US$ 28 million and share has only 0.1 percent at the same time Australia research and development expenditure to US$144.6 million and share in total research and development 0.4 percent. 2.6: GLOBAL TRADE IN PHARMACEUTICALS:During the 1990s, trade in pharmaceuticals grew substantially faster than production. Table No.2.10 shows that, in constant price terms, the international trade in pharmaceuticals has expanded dramatically since 1980, growing three times faster than current prices indicate. International trade in pharmaceuticals is dominated by the high-income industrialized countries. In 1999, they accounted for 93 percent of global exports and 80 percent of global imports, by value. This concentration in trade has increased since 1980. Between 1980 and 1999, middle income countries’ share of world exports fell, and the shares of both low and middle income countries in world imports dropped significantly. With the notable exception of 57 Chapter 2 TABLE NO: 2.10 GLOBAL TRADE IN PHARMACEUTICAL 1980 TO 1999 (Value in US$ Billion) Direction of trade 1980 1990 1999 Exports (current price) 14.53 36.04 104.22 Exports (constant 1995 price) 5.35 28.79 117.86 Imports(current price) 13.54 34.64 104.80 Imports (constant 1995 price) 4.98 27.67 118.53 Source: World Health Organisation Annual Report 2004, The World Medicines Situations, Commodity Trade Statistics Section, ITSB, United Nation Statistic Division, New York, US pharmaceutical price index, P.No.22 Japan, the countries, which contribute most to world, trade both in exports and in imports are the world’s major producers: the USA, UK, Germany and France. Japan, the world’s second largest producer, continues to produce primarily for the domestic market and since 1980 has reduced its share of the world’s pharmaceutical imports. 2.6.1: PHARMACEUTICALS EXPORT PATTERN:Table No. 2.11 shows the shares of countries by income level in world pharmaceutical exports from 1980 to 1999. The share of high-income countries rose from 1980 to 1999. In 1980 share of high income countries was to 90.5 percent to 91.8 percent in 1985 of the world total again in 1990 it was increased to 92.8 percent but in 1995 it was decreased to 91.5 percent of the world total. High income countries export increased steadily from 1980 to 1999. While middle income countries exports dropped from 8.3 percent to 4.2 percent. Middle-income countries export share was fluctuating from 1980 to 58 Chapter 2 TABLE NO: 2.11 SHARE OF LOW, MIDDLE AND HIGH INCOME COUNTRIES IN WORLD PHARMACEUTICAL EXPORETS (In %) Year 1980 1985 1990 1995 1999 Low Income 1.1 1.1 3.3 3.6 2.9 Middle Income 8.3 7.1 3.9 4.9 4.2 High Income 90.5 91.8 92.8 91.5 92.9 Source: As of Table No.2.10 FIGURE NO: 2.8 DISTRIBUTION OF SHARE OF LOW, MIDDLE AND HIGH INCOME COUNTRIES IN WORLD PHARMACEUTICAL EXPORETS (IN %) Year 1980 Year 1999 3% 1% 8% 91% 4% Low Income Middle Income High Income 59 93% Chapter 2 1999. In 1990 Middle income countries, export share was very low compared to other year. The export share of some low income countries such as India, Pakistan and Indonesia more than doubled from 1.1 percent to 2.9 percent. In 1990 export share was to 3.3 percent to 3.6 percent in 1995. 2.6.2: LEADING PHARMACEUTICAL EXPORTING COUNTRIES:Table No.2.12 shows leading pharmaceutical export countries from 1980 onwards. Only eight countries 70 percent of the world pharmaceutical exports. In 1999 world pharmaceutical exports was 79.8 percent. Germany, Switzerland, USA and UK these countries are also among the top five producers of pharmaceutical, only Japan missing from the major export group. Table No.2.12 also indicates that the Germany contributed largest share of world pharmaceutical exports in 1980 export of Germany was to US$ 2.272 billion and share of export in world market was 15.6 percent, which was increased in 1990 it was US$ 5.8612 billion and share 16.3 percent. In 1999, export was to 14.978 billion and share of export in world market was 14.5 percent. The export of Germany has increased more than 6 fold in 1999 over 1980. Export of world market of Switzerland was to US$ 1.615 million in 1980 and share of export in world market was 11.1 percent, which was increased in 1999 it was US$ 11.452 billion and share of export of Pharmaceutical 11.1 percent. The export of USA was to US $ 2.020 billion in 1980 to US$ 11.071 billion in 1999, the export of Switzerland and USA was representing more than 7.09 fold and 5.48 fold in 1999 over 1980. However, it is found the above table that the top exporting countries export state to increase rapidly since 1980. However, it is found from the same table that export of Italy had increased to US$ 0.688 billion in 1980 to US$ 5.607 billion in 1999 and share of export of Italy in world market was 4.7 percent in 1980 to 5.4 percent in 1999. The export of Italy was increased more than 8 fold in 1999 over 1980. 60 Chapter 2 TABLE NO: 2.12 TOP EXPORTING COUNTRIES 1980 TO 1999 (US$ Billion) Country 1980 (in 1999 rank order) 1990 1999 Increase in 2007 over 1980 Val ue % Value % Ra Value % wor wor nk wor ld ld ld Germany 2.27 15.6 5.861 16.3 1 14.97 14.5 2 2 8 Switzerl 1.61 11.1 4.359 12.1 2 11.45 11.1 and 5 USA 2.02 5 13.9 0 UK 1.73 1.49 11.9 0.67 10.3 0.68 4.040 3.665 4.6 1.632 11.07 7.09 10.7 1 11.2 4 10.05 5.48 9.7 3 10.2 5 2 0 Italy 3 4 7 Belgium 11.4 2 2 France 4.103 2 10.04 5.80 9.7 3 4.5 6 6.438 6.70 6.2 9 4.7 8 1.516 6.59 9.60 4.2 7 5.607 5.4 9 8.14 Ireland - - - - 8 5.122 4.9 Sweden - - - - 9 4.010 3.9 Netherla 0.61 4.3 1.377 3.8 10 3.852 3.7 nds 9 Top Countrie s World Export 11.1 13 76.5 26.55 4 73.7 82.62 6 79.8 14.5 26 100 36.03 7 100 103.6 19 100 1 - 6.22 Source: As of Table No. 2.10, Pn.23 61 7.43 7.13 Chapter 2 FIGURE NO:2.9 DISTRIBUTION OF TOP EXPORTING COUNTRIES 1980 AND 1999 IN % Year 1980 Year 1999 10% 9% 7% 7% 9% 50% 7% 8% 51% 6% 7% 6% 3% 4% 3% 3% 0% 3% 0% 2% 3% Germany USA France Italy Sweden Top Countries Export 2% Switzerland UK Belgium Ireland Netherlands Table No.2.12 also reveals that the export of UK has also increased tremendously. It was US$ 1.372 billion in 1980, which was increased to US $10.053 billion in 1999. The export of UK has increased 5.8 fold in 1999 over 1980, the share of export of world market of UK was 11.9 percent in 1980, and which was decreased 9.7 percent in 1999. The export of France and Belgium in world market was to US$ 1.497 billion and US$ 0.670 billion in 1980, which rose to US$ 10.043 billion to US$ 6.438 billion in 1999. However, share of export in world market it was less from 1980 to 1999. It was 10.3 percent and 4.6 percent in 1980 to 9.7 percent 62 Chapter 2 and 6.2 percent in 1999. The export of France and Belgium was increased more than 6.7 fold and 9.7 fold in 1999 over 1980. From 1999, Ireland and Sweden were included in top exporting countries. In 1999 export of Ireland in world market was US$ 5.122 billion and Sweden was US$ 4.010 billion. Share of export 4.9 percent and 3.9 percent. In 1999 export of Netherlands was to US$ 3.852 billion and share of export was 3.9 percent it decreased compared to 1980s share of export. The export of Netherlands has increased more than 6.22 fold in 1999 over 1980. In 1980 top countries export was to US$ 11.113 billion, which increased to US $ 82.626 in 1999. Top countries share in 1980, which was 76.4 percent to 79.8 percent in 1999, and fold growth more than 7 fold. The low income manufacturing countries produce predominantly for the local market. Even in India, with over 20000 pharmaceutical manufacturers, where the export share of local production has tripled since 1985 less than 20 percent of total production enters international trade. Major pharmaceutical exports from low and middle-income countries in 1998 have been analyzed according to their destination, with the results shown in Table No.2.13 China is the only country in this group to export most of its pharmaceuticals to industrialized countries; all the other exporters supply mainly developing country markets. Table No 2.13 gives details about the pharmaceutical exports from low and middle income countries. It is found above table that the export to industrialized countries and exports to developing countries and export to developing countries as percentage of total. China is the largest exports to industrialized country as well as developing country in 1998 export of Chain to industrialized country to US$ 1079 billion and export of Chain to developing country to US$ 592 billion. India’s export to industrialized country as well as developing country to US$ 288 billion to US$ 576 billion in same year. 63 Chapter 2 TABLE NO: 2.13 PHARMACEUTICAL EXPORT FROM LOW AND MIDDLE INCOME COUNTRIES 1998 (Values in US$ Billion) Exporter Exports to Exports to Exports to industrialized developing developing countries countries countries as % of total China 1079 592 35.4 India 288 576 66.7 Mexico 304 410 57.4 Argentina 25 277 91.7 Korea 85 204 70.6 Brazil 64 183 74.1 Colombia 10 173 94.5 Source: Consumption and trade in off-patent medicines, Commission on Macroeconomics and Health, Working Paper WG4:3, May 2001. http://www.cmhealth.org/cmh_papers &reports.htm# Working Group 4. Mexico, Argentina, Korea Republic, Brazil and Colombia all these countries exports to developing countries higher than industrialized countries. Mexico’s export to industrialized country as well as developing country to US $304 billion to US $410 billion. Brazil and Colombia industrialized country and developing country to US$ 64 billion to US$ 183 billion and US$ 10 billion to US$173 billion in the same year. 64 Chapter 2 FIGURE NO: 2.10 TRNDS OF PHARMACEUTICAL EXPORT FROM LOW AND MIDDLE INCOME COUNTRIES 1998 (Dollar figures in US $ Billion) 1200 Values in US $ Billion 1000 800 600 400 0 Exports to industrialized countries Ch in a In di M a ex A ico rg en tin K a or ea Br Co azi lo l m bi a 200 Exports to developing countries Countries 2.6.3: PHARMACEUTICALS IMPORT PATTERN:Table No.2.14 that the shows the shares of countries, by income level, in world pharmaceutical imports from 1980 to 1999. The share of high-income countries rose from 69.9 percent of total imports to 79.3 percent. The shares of both low and middle income countries fell over the same period from a combined 30.1 percent of the world market to 20.7 percent. As with exports, trade became increasingly concentrated among the high-income countries in these two decades. The share of high income countries rose from 72.4 percent of total imports to 79.2 percent from 1985 to 1990. Following table shows value of 65 Chapter 2 TABLE NO: 2.14 SHARE OF LOW, MIDDLE AND HIGH INCOME COUNTRIES IN WORLD PHARMACEUTICAL IMPORTS (In %) Year 1980 1985 1990 1995 1999 Low Income 7.2 7.5 6.1 5.2 3.4 Middle Income 22.9 20.1 14.7 16.7 17.3 High Income 69.9 72.4 79.2 78.2 79.3 Source: World Health Organisation Report 2004, The World Medicines Situations, Commodity Trade Statistics Section, ITSB, United Nation Statistic Division, New York, US pharmaceutical price index, P.No.25 FIGURE NO: 2.11 DISRIBUTION OF SHARE OF LOW, MIDDLE AND HIGH INCOME COUNTRIES IN WORLD PHARMACEUTICAL IMPORTS IN % Year 1999 Year 1980 3% 7% 17% 23% 70% Low Income Middle Income High Income 66 80% Chapter 2 pharmaceutical imports, conforming relatively weak growth of middle income country as well as low income country imports. 2.6.4: LEADING PHARMACEUTICAL IMPORTING COUNTRIES:Table No.2.15 identifies the principal importing countries, which include the five principal producers. The combined imports of these 11 industrialized countries accounted for 54 percent of world imports in 1980 and 66 percent in 1999. Germany was the world’s leading importer in 1980 and 1990. Japan’s position as an importer has fallen since 1990. Table No.2.15 shows leading pharmaceutical importing countries from 1980 to 1999. Imports of USA were to US$ 803.1 billion in 1980, which increased to US$ 13649 billion in 1999. The share of import of USA in world market was 5.9 percent in 1980 to 13 percent in 1999. A USA import has increased more than 16.99 fold in 1999 over 1980. However, it is found from following table that the import of USA state started to increase rapidly since 1980. In 1980, Imports of Germany were to US$ 1291 billion in 1980, which increased to US$ 8669.6 billion in 1999. The share of import of Germany in world market was 9.5 percent in 1980 but they showed decreased growth of 8.3 percent in 1999. It was decreased compared to earlier period. An import has increased by 6.71 fold in 1999 over 1980. In 1980, an import of France was to US $700.8 billion, which increased to US$ 7748.7 billion in 1999. It indicates an import was increasingly tremendously. The share of import of France in world market was 5.2 percent in 1980 to 7.4 percent in 1999. A France import has increased by11.05 fold in 1999 over 1980. In 1980, imports of UK were less compared to Italy and France it was to US$ 516.9 billion in 1980, which rose to US$ 7746.6 billion in 1999. The share of import of UK in world market was 3.8 percent in 1980 to 7.4 percent in 1999. A UK import has increased more than 14.98 fold in 1999 over the year 1980. 67 Chapter 2 TABLE NO: 2.15 TOP IMPORTING COUNTRIES 1980 TO 1999 (Values in US$ Billion) Countr 1980 y (in 1999 rank order) Valu e USA 1990 1999 % Valu worl e d 803.1 5.9 2540 % Ra Valu worl nk e d 7.3 1 1364 9 9.8 2 8669. 6 7.6 3 7748. 7 6.0 4 7746. 7 8.1 5 6195. 8 3.4 6 5050. 5 4.4 7 5023. 6 8.2 8 4593. 4 4.2 9 4174. 6 2.8 10 3509. 0 2.5 11 3237. 6 64.3 6959 9 German 1291. 9.5 y 0 France 700.8 5.2 3396 UK 516.9 3.8 2064 Italy 652.6 4.8 2817 Switzer land Belgiu m Japan Netherl ands Spain 411.0 3.0 654.9 4.8 2646 1193 1510 1074. 7.9 2 568.9 4.2 2836 245.2 1.8 975. 7 860. 3 2228 6 Canada 356.2 2.6 11 top pharm. importi ng countrie s World importe rs 7274. 53.5 8 1447 Incre ase in 2007 over 1980 % worl d 13.0 16.99 8.3 6.71 7.4 11.05 7.4 14.98 5.9 9.49 4.8 12.28 4.8 7.67 4.4 4.27 4.0 7.33 3.3 14.31 3.1 9.08 66.4 9.56 1354 3.2 Source: As of Table 100 3463 6 100 1048 01 100 7.73 No. 2.14, Pn.26 68 Chapter 2 FIGURE NO: 2.12 DISTRIBUTION OF TOP IMPORTING COUNTRIES 1980 AND 1999 IN % Year 1999 Year 1980 4% 6% 3% 8% 2% 5% 3% 4% 2% 4% 3% 4% 5% 3% 3% 3% 1% 3% 2% 66% 2% 60% 2% 2% USA Germany France UK Italy Switzerland Belgium Japan Netherlands Spain Canada World importers Table No.2.15 also shows that the imports of Italy and Switzerland, imports of these two countries was to US$652.6 billion and US$ 411 billion in 1980, which increased to US$ 6195.8 billion and US$ 5050.5 billion in 1999. 69 Chapter 2 These countries share in 1980 was 4.8 percent of Italy and 3.0 percent of Switzerland and in 1999 it was 5.9 percent and 4.8 percent. The imports of Italy and Switzerland increased more than 9.49 fold and 12.48 fold in 1999 over 1980. In 1980, an import of Belgium was to US$ 654.9 billion, which increased to US$ 5023.6 billion in 1999. The share of import of Belgium in world market was 4.8 percent in 1980 to 74.8 percent in 1999. A Belgium import has increased by 7.67 fold in 1999 over 1980. Netherlands, Spain and Canada’s share of imports in world imports it was less means not more than 4.0 percent in world imports. In 1980 top 11 countries imports was to US$ 7274.8 billion, which increased to US $ 69599 billion in 1999. Top11 countries share in 1980, which was 53.5 percent to 66.4 percent in 1999, and fold growth more than 9.56 fold. Total world import was to US$ 13543.2 billion in 1980, which raised to US$ 104801billion in 1999 and fold growth more than 7 fold in 1999 over 1980. Table No. 2.16 shows that the pharmaceutical imports from other lowor middle-income countries account form a minority share in each of these countries. Brazil is the largest imports to other low and Middle-income TABLE NO: 2.16 PHARMACEUTICAL IMPORTS FROM LOW AND MIDDLE INCOME COUNTRIES: 1998 (Values in US$ Billion) Exporter Exports to industrialized countries Exports to developing countries Brazil Mexico Argentina Korea China Colombia 1325 955 638 463 423 294 263 109 139 92 103 202 Exports to developing countries as % of total 16.6 10.2 17.9 16.6 19.6 40.7 Source: Consumption and trade in off-patent medicines, Commission on Macroeconomics and Health, Working Paper WG4:3, May 2001. http://www.cmhealth.org/cmh_papers &reports.htm# Working Group 4. 70 Chapter 2 FIGURE NO: 2.13 TRENDS OF PHARMACEUTICAL IMPORTS FROM LOW AND MIDDLE INCOME COUNTRIES: 1998 (Values in US$ Billion) 1400 Values in US $ Billion 1200 1000 800 600 400 200 0 Brazil Mexico Argentina Korea China Colombia Countries Exports to industrialized countries Exports to developing countries countries account for a minority share in each of these countries. Brazil is the largest imports to industrialized country as well as developing country in 1998 import of Brazil from industrialized country to US$ 1325 billion and import of Brazil to developing country to US$ 263 billion. Mexico, Argentina, Korea Republic, China and Colombia all these countries imports to developing countries higher than industrialized countries. Mexico’s import from industrialized country as well as developing country to US$ 955 billion to US$ 109 billion. Argentina and Colombia industrialized country and developing country to US$ 638 billion to US$139 billion and US $294 billion to US$ 202 billion in the same year. 71 Chapter 2 2.7: MAJOR PLAYERS OF THE WORLD PHARMACEUTICAL MARKET:U.S. companies play a key role in the world pharmaceutical industry 8 out of 15 leaders of this market are headquartered in the United States; moreover, the largest world pharmaceutical company, NJ-based Pfizer, has sales of pharmaceutical products that are approximately 1.5 times higher than those of its closest competitor. The pharmaceutical industry is characterized by a high level of concentration with fifteen multinational companies dominating the Industry. Several factors are worth mentioning. First, for almost all companies presented in the table, the pharmaceutical segment is the largest; and only for one of them, world giant Johnson and Johnson, sales of pharmaceutical segment are below 50 percent. Table No. 2.17 contains information about these major pharmaceutical companies that are sorted in the order of their 2004 revenues from the sales of pharmaceutical products. Numbers provided in this table include sales of all subsidiaries and affiliated companies that are consolidated in annual reports of the corresponding companies. As Table No. 2.17 shows, the majority of the largest pharmaceutical companies are not diversified. They are either concentrated exclusively on pharmaceutical products, (Eli Lilly and Astra Zeneca are good examples with virtually 100 percent of their revenues coming from sales of pharmaceutical products) or, although they develop and manufacture other health care products, they still have pharmaceutical divisions as the core of their business that provide more than 50 percent of their revenues. Other products manufactured by these companies usually include medical devices, nutritional products, consumer healthcare products and products for animal health. Only two out of these 15 major pharmaceutical companies have revenues from sales of pharmaceutical products that are lower than 50 percent of their total sales. These companies are world giants Johnson and Johnson (which besides pharmaceutical products manufactures consumer goods and medicaldevices) 72 Chapter 2 TABLE NO: 2.17 REVENUE AND SALES OF MAJOR PHARMACEUTICAL COMPANIES (Values in US Million) Company HQ, location Revenue of Total Share of pharmaceutical sales, mln pharmac segment, mln USD USD eutical segment, % Pfizer NY, U.S. 46,133 52,516 87.85% GlaxoSmithKline UK 31,434 37,324 84.22% Johnson NJ, U.S. 22,190 47,348 46.87% Merck NJ, U.S. 21,494 22,939 93.70% AstraZeneca UK 21,426 21,426 100% Johnson& Switzerlan Novartis d 18,497 28,247 65.48% Sanofi-Aventis France 17,861 18,711 95.46% Roche Switzerlan 17,460 25,168 69.37% Bristol-Myers Squibb Wyeth NY, U.S. NJ, U.S. 15,482 13,964 19,380 17,358 79.89% 80.45% Abbott IL, U.S. 13,600 19,680 69.11% Eli Lilly IN, U.S. 13,059 13,858 94.23% Takeda Japan 8,648 10,046 86.09% Schering-Plough Bayer NJ, U.S. Germany 6,417 5,458 8,272 37,013 77.57% 14.75% Source: Larry Davidson and Gennadiy Greblov, (2005) “The Pharmaceutical industry in the Global Economy”. Information Services via the World Trade Atlas, U.S. State Export Edition,www.bus.indiana.edu/davidso/lifesciences/lsresearchpapers/pharmaceutical%20ind ustryaug12.doc and Bayer, which has only about 15 percent of its revenues from the sales of pharmaceutical products. 73 Chapter 2 Eli Lilly’s US$ 13.1 billion sales figure made it the twelfth largest company – with Pharmaceutical sales considerably larger than Bayer’s US$ 5.5 billion but a lot less than Pfizer’s US$ 46.1 billion. Geographical headquarters of major pharmaceutical companies are approximately evenly distributed between the U.S. In addition, Western Europe with only one Asian company in the list. Indiana is home to one of these companies, Eli Lilly. 2.8: MERGER AND ACQUISITION OF WORLD PHARMACEUTICAL COMPANIES: The pharmaceutical industry is currently undergoing a period of very significant transformation. The majority of big Pharmaceutical companies generate high returns, thus providing them with excess cash for further rapid growth whether organic or through mergers and acquisitions. Although size of the company on its own does not guarantee success, it gives a significant advantage, especially in pharmaceutical industry. Besides economies of scale in manufacturing, clinical trials and marketing, bigger companies can allow investments in more research and development (R&D) projects that diversify their future drugs portfolio and make them much more stable in the long term. As the result, top companies in the industry were active participants of mergers and acquisitions, new joint ventures and spin-offs of non-core businesses. The largest acquisitions in the industry during last years were the acquisition of Pharmacia by Pfizer (purchase price US$58 billion), and acquisition of Guidant by Johnson and Johnson (purchase price $25 billion). Both acquisitions allowed these two U.S.-based companies to solidify their places among the elite of the pharmaceutical industry. European companies were even more aggressive in merger and acquisitions activity than their American competitors were 3 out of 6 major European companies underwent mergers during the last severalyears: GlaxoSmithKline (merger of Glaxo 74 Chapter 2 TABLE NO: 2.18 MERGER AND ACQUISITIONS OF THE TOP PHARMACEUTICAL COMPANIES (Values in US Billion) Company acquired Pfizer Johnson & Johnson Merck Bristol-Myers Squibb Eli Lilly Abbott Core business of targets Prescription pharmaceutical products, Pharmacia consumer healthcare products and animal healthcare products Biopharmaceutical Esperion company with no Therapeutics approved products Treatment of cardiac and Guidant vascular disease Non-prescription Consumer pharmaceutical products Pharmaceuticals (former JV of J&J and Merck) R and D in synthesis of DNA sequences, gene Egea assembly and Biosciences construction of large synthetic gene libraries Biapharm SAS Skin care products Micomed Spinal implants Development of novel Aton Pharma treatments for cancer and other diseases R and D, manufacturing Banyu and sales of drugs for Pharmaceutical cardiovascular diseases and antibiotics Materials for Wound Acordis Therapies products Applied Treatment of nonMolecular Hodgkin's lymphoma and Evolution rheumatoid arthritis Advanced diabetes TheraSense management technology i-Stat Diagnostic testing Spine Next SA Spine-care business 75 Purchase price US billion $56.0 $1.3 $25.4 $0.6 $0.1 $1.5 $0.2 $0.4 $2.3 Chapter 2 GlaxoSmithKline Merger of Glaxo Wellcome and SmithKline Megrer of two major pharmaceutical companies (registered in 2000) Beecham Block Drug AstraZeneca - Oral care and over-thecounter medicines Megrer of two major Merger of Astra pharmaceutical and Zeneca companies (registered in 843 mln GBP - 1999) Novartis Generic manufacturer Sabex with a leading position in generic injectables Mead Johnson's adult nutrition 385 mln nutrition USD Idenix Pharmaceuticals Inc Igen International Disetronic Sanofi-Aventis Bayer Merger of SanofiSynthelabo and Aventis Roche's overthe-counter business USD Global adult medical business Roche 565 mln Biotechnology Human in-vitro diagnostics Insulin pumps and injection systems for the treatment of diabetes. Merger of two major pharmaceutical companies (registered in 2004) Gustafson 76 255 mln USD + up to 357 mln USD in possible additional payments 1,823 mln CHF 1,132 mln CHF - Over-the-counter medicines 206 mln EUR Seed treatment 100 mln EUR Chapter 2 Source: as of Table No: 2.17 Wellcome and SmithKline Beecham), AstraZeneca (merger of Astra and Zeneca) and Sanofi-Aventis (merger of Sanofi-Synthelabo and Aventis). Another form of structural change in the industry was establishing of new strategic alliances and joint ventures. So far as the research and development process for each drug take many years and requires significant investments, and the outcome of these investments of time and financial resources remains unclear until the final approval of the drug, big Pharmaceutical companies are constantly looking for synergies that they can get from cooperation with their competitors. Last few years give multiple examples of such initiatives. For example cooperation of Sanofi-Aventis and Bristol-Myers Squibb resulted in production of Plavix, which is currently one of the top-selling products for each of these companies. Finally, big Pharmaceutical companies in order to maintain strong sales growth and to meet profitability expectations of their shareholders were actively selling low-profitability or non-core businesses. For example, in 2003 Merck sold its low-profitability Medco Health Solutions that helped to increase its profitability margin. Massive sales of non-pharmaceutical businesses by Takeda also were compatible with its strategy to concentrate its financial resources on its core pharmaceutical business. 2.10: CONCLUSIONS:At present leading global pharmaceutical players in world market in terms of sales, production, import and export and research and development expenditure. USA, Europe and Japan are the largest pharmaceutical market, approximately share of United State 33 percent of the total world market. During the study period developed countries pharmaceutical production shares increased from 89.1 percent in 1985 and 92.9 percent in 1999. Global pharmaceutical production located in five developed countries the USA, Japan, Europe, UK and Germany. 77 Chapter 2 The global pharmaceutical sale has increased during the period under study. The global pharmaceutical sales was only US$ 289 billion in 1997 which increased to US$ 712 billion in 2007 representing more than 2.46 fold over the period and compound growth rate is 10.07 during the study period. The majority of global pharmaceutical sales originate in the USA, Europe and Japan accounting for 80 percent of market. The North America has been by far the largest pharmaceutical market by volume and value means US$ 304.5 billion in 2007 half of global sales, with the strongest growth among key markets, contributing 51 percentage global market growths in 2002, the US accounted for a 45.9 percentage of blockbuster sales compared with only 8.8 percentages from Japan and 31.1 percentages from Europe. . The sale of North America has increased 1.99 fold in 2007 over 2000. The Compound rate was 10.03 percent during the period under study but compared to EU countries it has decreased. The sale of European Countries has increased 2.73 fold in 2007 over 2000. Its Compound rates was16.43 percent during the period under study. The sale of Asia (excluding Japan), Africa & Australia shows increasing trends during the period under the study. The sale of Asia (excluding Japan), Africa & Australia has increased 3.32 fold in 2007 over 2000. compound growth rate of sales of this region was 16.38 percent during the period under study. Table No. 2.5 indicates sales by geographic area of PhRMA member companies, the share of world pharmaceutical sales in developing countries at this point of time is much lower, India’s and Pakistan sales is very low it is to US$ 628.3 million. Share of world pharmaceutical sales only 0.3 percent. Internal and external sales of USA and PhRMA member companies shown continuous increasing trend since the study period. Sales of USA to states increased to 3.94 fold in 2006 over 1991. Compound growth rate of sales of USA is 10.98 percent during the period under study. Sales of PhRMA member companies to states increased to 3.19 fold in 2006 over 1991. Compound Growth Rate of sales of USA is 8.17 percent during the period under study. Global pharmaceutical industry is highly Research and development intensive. US alone account for about 77.7 percent of world Research and 78 Chapter 2 development expenditure. At the same time, although the share of world pharmaceutical research and development expenditure in developing countries at this point of time is much lower, India’s and Pakistan research and development expenditure is very low means it is to US$ 10.9 million. Share in world pharmaceutical research and development expenditure only 0 percent. They show negative growth rate than developed countries do. Developed countries are dominating in international trade because of high income countries trade increased from 1980 to 1999 share of these countries to increased 90.5 percent to 92.9 percent during the study period. They are interested in Asian market because of wide area and population. In 1999 total world export was to US$ 103.19 billion. The low income manufacturing countries produce predominantly for the local market. Even in India, with over 20000 pharmaceutical manufacturers, where the export share of local production has tripled since 1985 less than 20 percent of total production enters international trade. The pharmaceutical industry is changing fast. To survive and to prosper involves managing drug pipelines as drugs come off patents they no longer bring in enough revenues and must be replaced quickly by other drugs with durable patents. This means that the companies have to think ahead, something that sounds easy but involves great risks. Huge sums must be invested in uncertain in-house research and development and/or must go toward mergers and acquisitions with other promising companies. Strategic alliances can be used to augment opportunities as well. As companies develop their new pipelines, they must be mindful of changes caused by regulations and deregulations in countries all over the globe. While most of drug consumption and sales is a U.S.,European, Japanese affair deregulation means sales opportunities are growing rapidly in the developing world. China, Thailand, Egypt, Mexico, Argentina, Brazil, and Venezuela have been increasing their imports of pharmaceuticals products at rapid rates. Of course, where there is growing demand there is also growing supply and competition. Many new drug companies are springing up in developing 79 Chapter 2 countries and the biggest global firms are moving into those territories. However, even this has more than the usual global risk for drug companies because of the importance of intellectual property protection. Picking places and partners takes more than the usual scrutiny or a company can lose valuable resources. Speaking of places we noted that the U.S. is the largest market for pharmaceutical sales and therefore will continue to be a hotbed of competition for Lilly and the other U.S. producers. Non U.S. companies have been very active in mergers and acquisitions and will be more formidable competitors on U.S. soil. This global competitive environment creates challenges and opportunities for the companies with equal importance for the communities in which they reside. If size matters in the drug industry then both domestic and foreign mergers, acquisitions, and strategic alliances will continue to be critical. Such changes always have implication for location requiring communities around the globe to think harder about their roles as globalization unfolds. Communities that desire to maintain or build pharmaceutical clusters must be mindful that investment is always a two-way street. Building strong and growing pharmaceutical clusters at home will entail both inbound and outbound investments since whatever companies locate or stay in their areas they will be compelled by global competition to own production facilities abroad. This research offers no new insights into what it takes to build a viable pharmaceutical cluster but it surely underlines two facts that it is worth doing in Indiana and that it will involve retaining and attracting companies that need to take sizeable financial risks. This suggests an infrastructure that supports not only the usual needs for top-flight talent and communications/transportation advantages but it suggests an environment that allows for flexibility and risk taking. While clusters bring to mind new facilities and higher employment, global competition suggests that drug companies will survive and prosper sometimes by shedding unprofitable lines of business. It is always painful for any community when firms restructure. It is tempting to regulate firms so that 80 Chapter 2 the blows to the community are softer. However, the truth of the drug industry is that competitiveness and growth will require many actions on the parts of these firms and not all of them will seem to be in the best short-run interest of the community.17 81 Chapter 2 References:1 - PhRMA Industry Profile, 1998, p. 70 2 - Drugs and Pharmaceuticals: International Pharmaceutical Industry-A Snapshot, Jan 2004, ICRA 3– Ibid 4 – Ibid 5 – Ibid 6 – Ibid 7 – Ibid 8 – Ibid 9 – Ibid 10 – Ibid 11 – Ibid 12 - Ibid 13 - Pharmaceuticals: The Indian Pharmaceutical Industry, Feb 2005, ICRA (Indian Credit Rating Agency) 14 - World Health Organasation Report 2004 15 - European Federation of Pharmaceutical Industries and Association (EFPIA) 16 - PhRMA 2004 Pharmaceutical Industry Profile 17 - Larry Davidson and Gennadiy Greblov, (2005) “The Pharmaceutical industry in the Global Economy”. Information Services via the World Trade Atlas, U.S. State Export Edition, pn.29-30 82 Chapter 2 83