The Global Pharmaceutical Industry - Coursework Example

Running Head: Case Study “The global Pharmaceutical Industry" Case Study “The global Pharmaceutical Industry" S. No Table of Contents Page No 1 Pharmaceutical Industry: An Overview 2 2 Pharmaceutical Industry Environmental Forces: An Introduction 4 3 Implications of the Changing business Environment on Pharmaceutical Firms 11 4 Application of Porter’s Five Forces on Pharmaceutical Industry 12 5 Limitations of the Tools in the Analysis 15 6 Pharmaceutical Industry: An Analysis 15 6 Bibliography 19 Pharmaceutical Industry: An Overview The pharmaceutical industry is an extremely complicated uncertain and sustained R&D development, powerful struggle for intellectual property, rigorous government controls and strong consumer demands. The birth of the contemporary pharmaceutical industry can be traced to the late 19th century, when dyestuffs were created to have antibacterial characteristics. The top companies of the world namely Roche, Ciba-Geigy and Sandoz all were setup as family dyestuff companies headquartered near the Rhine in Basel, Switzerland, which started synthetic pharmaceuticals and finally became international players. Penicillin was a most important innovation for the embryonic industry, and throughout the 1940s and 1950s R&D became strongly recognized in the sector. The pharmaceutical industry grew swiftly in the 1960s, deriving benefit from major new innovations with long-term patent safeguards. Regulatory controls on clinical advancement and marketing were simple and healthcare expenditure expanded as market thrived. Consequently, the pharmaceutical market acquired some remarkable character. Management was in the hands of medical practitioners while patients and payers had little awareness or authority. Thus, medical practitioners were inconsiderate to the costs however receptive to the sales endeavors of individual agents. This made possible several ‘me too’ drugs to realize significant profits on investment. It resulted in imitating well-known medicines that cut R&D risk considerably, while the market- place was exposed to products offering slight advantages for example a more suitable dosage type or fewer side effects, although with much the same beneficial effect. There were two major developments in the 1970s in the pharmaceutical industry. Firstly, the Thalidomide tragedy in sickness caused birth defects, initiated much tighter regulatory rules on clinical trials. Secondly, laws were endorsed to establish a permanent period on patent protection – usually 20 years from first report as a research invention. This produced the emergence of ‘generic’ drugs. Generics however have precisely the same dynamic constituents as the original brand, and vie on price. The influence of generic application is exemplified by Bristol Myers Squibb’s brand Glucophage, a cure for diabetes, which produced US sales of $2.1bn in 2001. After the termination of the patent in January 2002, brand sales fell to $69m for the first quarter. Generics legislation had a significant influence on the industry, providing motivation for improvement and for a competitive market. The time during which R&D costs could be recouped was drastically curtailed, putting upward pressure on prices. The introduction of generics, however, was very beneficial for society: valuable medicines became extremely cheap. Indeed, health economists have estimated that the social returns from pharmaceutical R&D exceed that appropriated by firms by at least 50 to 100 per cent. By the end of the 1970s generic entrants and more stringent controls on clinical trials had led to substantial increases in R&D spending. Pharmaceutical Industry Environmental Forces: An Introduction The pharmaceutical industry is remarkable in that a number of countries of the world are dependent on a ‘monopsony’ – there is in fact only one dominant buyer i.e. the government. In the 1980s, governments all over the world started to concentrate on pharmaceuticals as a politically motivated target in their endeavors to regulate increasing healthcare expenses, despite the fact that drugs usually make up below a tenth of that expenses. Several countries initiated some type of cost or compensation control. The industry required the public or political support to oppose these alterations. A different kind of industry player emerged in the 1980s – small biotechnology systems supported by venture capital to take advantage of the numerous prospects heralded molecular biology and genetic engineering. In 2003 there were over 600 publicly traded biotechs all over the world. Nevertheless, biologicals were more difficult to manufacture than conventional pharmaceuticals, creating a worldwide deficiency in production capacity. This increased prices and usually restricted biotech uses to low-volume, high-need areas. While sales doubled in the 5 years to 2002, at $27bn biologicals contribute only 7 % of international market value. Various biotechs initially planned to incorporate and carry out all operations from research to sales. Nevertheless, the majority of biotechs need the funds to deal with the massive hazards implicated and by 2003 only three companies had realized this objective. Besides, only 40 out of 1,466 biotech firms in the US were doing business advantageously. Biotechs had therefore principally discarded endeavors to sell drugs themselves and in its place used the global contacts of the research-based international companies to influence return on R&D via out-licensing and strategic groupings. As stock market financial support ended, the sector started to strengthen revenue streams with potential conduits. In the UK, for example, British Biotech united with drug company Vernalis, at the same time as Celltech got Oxford Glycoscience. Business Environment As major economies declined in 2002, experiments in support of healthcare progress remained. Ageing populations produced further strains, as the ‘over-65s’ used four times as much healthcare per person as those under 65. This along with more costly high technology results and growing patient hopes produced untenable conditions. On the one hand, total coverage systems as in UK were time-consuming or incapable to initiate the modern treatments. In contrast, insurance-funded systems were capable to present the modern innovations however were incapable to share those gains with a growing part of the populace. In 2002 the number of US citizens with no health insurance increased by 5.7 % to 43.6 million, the major single annual increase in a decade. In reaction to these pressures, payers employed an extensive range of methods to restrict expenses on pharmaceuticals. A number of payers put the importance on the supply side. Some payers give emphasis to the demand side. Other methods influenced both. No country depended upon a single method. Kinds of control showed inherent cultural disparities with supply-side measures were supported by more centralised, less market-oriented economies. The option of approach was also influenced by the significance or if not of the national pharmaceutical industry as a provider of GDP, balance of trade and employment. In countries with supply-side controls, agreed price or repayment sanction could take takes six months or a year. In countries with demand-side controls, there was similar waiting time in realizing market access, as a result of the need to negotiate product, or approval by organizations for example the National Institute for Clinical Excellence (NICE) in the UK. Generics create a unique danger. A number of key markets introduced low volume utilization of generics i.e. just 6 %. Nevertheless, generics were being enthusiastically supported in all EU markets and fast access was expected. Computer systems allowed medicines to be printed in their generic instead of branded form, thus making it possible the pharmacist to offer the cheapest generic drug. Pharmaceutical costs controls were intended to recompense true progress. Price recompense levels were founded on apparent innovativeness and advantages and penalizing ‘me too’ drugs. Thus, there was a competition to market with each new drug type, in view of the fact that only the first to market would gain. Competition was engaged most intensely at the level of drug class and being late to market with an undifferentiated product was a modus operandi for failure. The industry embraced several strategic responses to these challenges. A number of pharmaceutical firms introduced ‘disease management’ programs. A new common response was to perform pharmacoeconomic assessments, studies that tried to show the additional value presented by a new drug due to enhanced usefulness, protection, acceptability or availability. Government price controls produced another test for the pharmaceutical industry in the shape of ‘parallel trade’. The principle of free movement of commodities across the Single European Market implied that distributors were free to obtain drugs in low price markets and export them to high price markets, taking the difference. There was little advantage to governments or customers, however a considerable harm for the industry. This arbitrage profit went to the parallel importers. Parallel imports were aggravated when pharmaceutical merchants strengthened globally through cross-border mergers and acquisitions, making it even simpler to purchase in one country and distribute in another. In 2002, parallel imports had acquired 17 % of the UK, 7 % of the German market and were estimated to comprise a 3.5bn of returns a year across the EU. Moreover, the expansion of the EU was estimated to worsen parallel trade, as prices in Central and Eastern Europe have a tendency to be low. Parallel trade was also common in the Far East and there was even an underlying problem in the important US market given the price disparities with Canada. On the contrary, the US had no recognized price controls and price increases were traditional. Eventually, this caused large differences in prices. Cross-border trade was pushed by the quick increase in drug cost, the 25 % of US seniors with no drug treatment, the economic difficulties, and the simplicity of long-distance trade over the internet and improved knowledge of price discrepancies. In 2003, state governors and Congress representatives were advocating to institutionalize and encourage imports, in spite of resistance from the FDA and the Justice Department. Storefront import pharmacies and drug-sale parties in care homes were developing throughout the USA and workers activism was common. The true danger to the industry was not the real level of imports; however the dangers created by free pricing in the USA from the public criticism. The circumstances where US citizens endured the largest part of the universal cost of pharmaceutical R&D by way of high prices seemed untenable. Either US prices would drop, harming R&D investment, or other rich countries required to bear a reasonable part of the burden. However with their domestic pharmaceutical industries in degeneration, there was little encouragement for other governments to alter their systems. Key Markets The bulk of worldwide pharmaceutical sales start in the Triad countries i.e. US, EU and Japan with ten major countries justifying over 80 % of the international market. The US has been definitely the largest pharmaceutical market by volume and value, with the powerful increase amongst main markets, contributing 65 % of international market growth. In 2002, the US justified an amazing 70 % of blockbuster sales, compare with only 4 % from Japan and 12 % from the European Union. Non-Triad countries were estimated to retain about 11 % share between them. By and large, the global market was set to become especially US-centric, leaving the industry greatly exposed to variations there. After regulatory changes in 1997, pharmaceutical companies were allowed to sell directly to US customers. Direct-to-consumer (DTC) advertising revolutionized the market and stimulated quick sales increase. European markets on the other hand, had their own distinctive operating environments however they were usually described by strong payer pressures and as a result reduced prices than the US or Japan. The slowing economies forced EU market increase to 8 % in 2002. Growth of the EU, nevertheless, offered prospects for expansion, particularly in Poland and central Europe, however also brought new challenges from generics and low-priced parallel imports. Despite the fact that least developed countries were not in a position to present a major market prospects, they did offer the industry with vital strategic options in the area of corporate social responsibility which had international implications. Sales and Marketing Sales and marketing competence became an ever more important basis of viable advantage in pharmaceutical industry. A company that developed a strong global franchise with its customers could capitalize on return on its internal products and was in a good niche to draw the best in-licensing contenders. In 2002, firms spent nearly $9.4bn on marketing in the US. A key factor that drove up costs was the growth in DTC advertising, where spending reached $2.7bn by 2002. Companies recognized that well-informed patients were prepared to ask for drugs by name, creating a powerful new ‘pull’ strategy. DTC could be very costly because of the vast target audience and expensive television advertising. It also required new marketing skills –both Pfizer and Novartis employed consumer marketers to smarten up their DTC promotion and branding. DTC also rendered drug advertising much more visible and risked creating a backlash against the industry. Successful drug promotion correlated strongly with product superiority, high prices and high promotional spend. An interesting trend began to emerge where drugs that were second to market were more successful than the original pathfinder drug. Evidently, it proved relatively easy to identify flaws in the first drug and deliver a follow-up positioned as ‘best in class’ or targeted at specific sub-populations. Implications of the Changing business Environment on Pharmaceutical Firms The new developments in pharmaceutical industry will espouse critical significance if medicine becomes more personalised. At present the implications of the blockbuster sales focus on mass patient markets. The influence of genomics and other industrial developments as delineated in Kim Sweeny’s paper (Sweeny 2002) expected to make possible an echelon of fairly targeted customised medicine. Particularly the mapping of the human genome has initiated the prospects of personalised drugs to be appropriate each patient’s hereditary composition. Probably the new world will have characteristics of new organisational structures in addition to new network alignments. The task of pharmaceutical companies in such a change is hard to envisage. Alterations would be needed at nearly all parts of the value chain, from innovation, during the progress stages to delivery. The pharmaceutical companies would concentrate on the management and financing of these tasks. This outlook is supported by the growing costs of R&D, the very small number of prospective blockbusters and the operatives decreasing the profits on those drugs. Despite the fact that the dynamics of change, both technological and requirements created seems devastating, it is a frequent mistake to envisage in advance, the collapse of large corporations. Whatever the composition of the pharmaceutical industry, it is expected that large pharmaceutical companies will have an important role in shaping that composition. Application of Porter’s Five Forces on Pharmaceutical Industry According to Porter’s model the structure of an industry is determined by five basic forces which are as follows: 1. Rivalry among existing firms 2. Threat of new entrants 3. Threat of substitute products or services 4. Bargaining power of suppliers 5. Bargaining power of customers Rivalry among existing firms The rivalry among existing firms can be assessed from various outlooks. Several mergers and acquisitions have been influential in the internal rivalry among pharmaceutical companies. The two most prominent movements of mergers were in 1989-1990 and in 1994-1995. In the first movement SmithKline Beckman and Beecham merged into SmithKline Beecham, Bristol-Meyers and Squibb into Bristol-Myers Squibb, Marion Laboratories and Merrel Dow with Marion Merrel Dow. Moreover Rhone Poulenc and Rorer merged into Rhone Poulenc Rorer. There have been a mega-merger of Glaxo and Welcome merged into Glaxo-Welcome, and the Hoechst, Roussel and Marion Merrel Dow merged into Hoechst Marion Roussel; Pharmacia and Upjohn merged into Pharmacia & Upjohn and the acquirement of Fisons by Rhone-Poulenc Rorer. In 1996, two big companies from Switzerland, Sandoz & Ciba declared that they would merge into a new company called Novartis. Rivalry at the Product Market Level At the level of particular product markets the pharmaceutical industry’s two-tier structure with new brands and generics has to be considered. The former vie generally on non-price profits, provided they are patent protected, though it has to be pointed out that at present careful health care environment is becoming a growing topic. The Threat of new Entrants The pharmaceutical industry is a quite an interesting industry for potential new entrants. As a sign of the profitability of the industry, 12 US based companies are highlighted amongst the top 50 Fortune 500 companies in return on sales. In addition, position of industries by productivity, in terms of equity or profit margin on sales, the pharmaceutical industry emerges at, or very close to the top. The Threat of Substitute Products Three key varieties of substitutes impact the principled pharmaceutical industry: alternative therapies, the health perception of the clients and generics. Alternative therapies, for example joint replacements for arthritis or organ transplant for organ malfunction reduce the potential development of the pharmaceutical industry. The Bargaining Power of Customers Many client groups have significant bearing on the existing and future composition of the pharmaceutical industry. Prescribers, HMOs, hospitals and patient pressure groups produces types of clientele that will increasingly put more emphasis on drug companies to develop genuinely new, effective and useful drugs and to enlighten the customer better about the significance of the existing drugs. Moreover, focus in the prescriber population will have critical outcomes for the marketing of pharmaceutical products. In particular, pharmaceutical companies will be vying for less direct customers with diverse needs and outlooks. In the USA, the increase of the careful MCO can virtually make or break a firm by their formularies, a development that will expectedly access the European market. Pharmaceutical companies will also have to alter the extent and the part of their exorbitantly expensive sales forces in view of a more focused prescribers market. The Bargaining Power of Suppliers The bargaining power of suppliers is a somewhat minor force in the pharmaceutical industry. The big pharmaceutical firms are generally vertically integrated backward, and thus do not confront great risks from suppliers. The bulk of pharmaceutical products raw materials supply is not an obstruction. The exception is bio-technology and genome technology, where supply is usually a trouble due to the highly focused character of the efforts. One more subject where the supply might be a significant limitation is, for instance, the shortage of donor organs which radically restricts the development of immunity medicines. Limitations of the Tools in the Analysis Following are the salient limitations of tools employed in the analysis: Life cycle issues The embryonic stage is sometimes skipped or short Industry growth is not fully accounted The time span of the stages fluctuates radically Innovation and change Innovation in pharmaceutical can unfreeze and reshape industry structure An industry may be hypercompetitive, with permanent and ongoing change It is vital to ensure that the tools employed are dependable and applicable to the existing circumstances of the pharmaceutical industry. They should be viable, reliable and valid, so as to make ways a high-quality analysis of the model. For this reason, the collected data and information should be checked and be useful to the existing pharmaceutical business conditions. More limitations are present in the environment of market forces that decrease the applicability of the information sources to the existing conditions; and the quantity of meticulous information needed. This can be unreasonable to its realistic use. For instance, the level of competitor information needed is very comprehensive and may not always be obtainable. Pharmaceutical Industry: An Analysis It is apparent in the USA that there is a growing demand for healthcare products as a result of an ever-increasing ageing population and government resources can no more pay for these expenses. As stated by Jaffe (2006), the US expends 16% of GDP on healthcare, and increase of 6% in 1960 and spending is projected to rise by another 4% by 2020. Many countries are also facing an ageing population and declining birth rate (see Lasserre and Schutte, 2006). Japan uses up 6% of its GDP on health care, although people have a tendency to live a little longer than those in the USA, perhaps as a result of diet and lifestyle. Merger & Acquisitions Studies in the pharmaceutical industry also support the growing activity of alliances and mergers where expertise can be shared. Hassan (2007), for instance, points out those big pharmaceutical companies generally acquire small companies for strategic grounds and markets respond encouragingly. Franchises make sure the greatest collection of talent will be used in the expansion stage, although alliances also entail high negotiation expenses and a greater level of ambiguity than in the case for subsidiaries (see Buckley, 1985). Innovations Generally about 30 new medicines emerge per year and there are over 100 in the developmental stage as far as the international pharmaceutical industry is concerned (see IMS 2005). Leading drugs in the market have been in the fields of cancer, arthritis, statins, diabetes and Aids. With a raise in competition and global players, studies are becoming more crucial as the product life cycle gets faster (see Vernon, 1966). Improved technology and communications are promoting globalization of the industry. Gurau (2005) asserts that more than 17 million Americans had been online to care about pharmaceutical products. Porter (1990) also asserted that dynamic conditions are also significant in rationalizing global production. Patenting Scherer and Ross (1990) observe that patenting is of specific significance to the pharmaceutical industry owing to the extremely high cost of product development against the remarkably inexpensive product duplication. A study by Henry Grabowski (2002) reckons that pharmaceutical R&D expenses would be curtailed by 64% without patent protection. Grossman and Lai (2002) points out that the rewards which are presented by patenting spur added R&D, and therefore enhance future wellbeing. Lanjouw (2005) examines the pace at which companies with patented drugs want to enter new markets. Empirical evidence clearly shows that patents cause a major loss as a result of the pharmaceutical company’s capacity to function as a monopolist. Kremer (2002) as well as Danzon and Towse (2003) study global welfare perception by assessing the scope to new treatments that is both available and affordable. Upon carrying out their own study of the impacts of differential pricing and price ceilings in Europe, Grossman and Lai (2006) supported the accomplishment of parallel importation policies by governments to provide greater access to pharmaceuticals whilst disincentivizing the application of unduly low price ceilings. Kyle (2007) on the other hand, describes the methods in which pharmaceutical companies respond to undue government involvement, and suggests improved product differentiation offset the apparent gains of parallel imports. Shavell (2003) presents an outline of the patent system’s shortcomings. Of the potential, either an incentive or patent-buyout system seems probably to persist to inspire improvement at the same time as removing some of the loss related with patenting. Maurer and Scotchmer (2003) study the advantages of these challenging mechanisms in contrast to the existing intellectual property system. Bibliography Buckley, P 1985, The Economic Theory of the Multinational, Macmillan. Danzon, PM & Towse, A 2003, “Differential Pricing for Pharmaceuticals: Reconciling Access, R&D and Patents” International Journal of Health Care Finance and Economics Vol. 3, p. 183-205. Grabowski, H 2002, “Patents, Innovation and Access to New Pharmaceuticals,” Journal of International Economic Law p. 849-860. Grossman, GM and Lai, EL-C 2002, “International Protection of Intellectual Property” NBER Working Paper 8704, January. Grossman, GM and Lai, EL-C 2006, “Parallel Imports and Price Controls” NBER Working Paper 12423 August. Gurau, C 2005, “Pharmaceutical Marketing on the Internet,” Journal of Consumer Marketing, Vol 22, No 7. Hassan, 2007, “Do Mergers and Acquisitions Create Shareholder Wealth in the Pharmaceutical Industry,” International Journal of Pharmaceutical Management, Vol 1, No 1. IMS Report 2005, Global Pharmaceutical Perspectives. Jaffe, R 2006, “Healthcare Transparency,” Journal of Management Development, Vol 25, No 10. Kremer, M 2002, “Pharmaceuticals and the Developing World” The Journal of Economic Perspectives, Vol. 16, No. 4, Autumn p. 67-90. Kyle, MK 2007, “Strategic Responses to Parallel Trade” NBER Working Paper 12968 March. Lanjouw, JO 2005, “Patents, Price Controls and Access to New Drugs: How Policy Affects Global Market Entry” NBER Working Paper 11321 May. Lasserre, P & Schutte, H 2006, Strategies for Asia Pacific 3rd edition, Palgrave Macmillan. Maurer, SM & Scotchmer, S 2003, “Procuring Knowledge” NBER Working Paper 9903 August. Porter, M 1990, Competitive Advantage of Nations, Free Press. Scherer, FM & Ross, D 1990, Industrial Market Structure and Economic Performance, Boston: Houghton Mifflin Company. Shavell, S 2003, “Economic Analysis of Property Law” NBER Working Paper 9695 May. Sweeny, K 2002, ‘Technology Trends in Drug Discovery and Development: Implications for the Development of the Pharmaceutical Industry in Australia’, Draft Working Paper No. 3, Pharmaceutical Industry Project, CSES, Victoria University, Melbourne. Vernon, R 1966, “International Investment and Trade under the Product Life Cycle,” Quarterly Journal of Economics, 80. Read More