...Pharmaceuticals have been around since early 2000 B.C. Since then, the drug market and its vendors have definitely skyrocketed. Pharmaceuticals are regulated by the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) and steps are required to bring new drugs into the market. FDA specific guidelines for new pharmaceuticals are essential because it determines a drug’s safety and effectiveness. To support this thesis an overview of steps required to market a new pharmaceutical will be discussed as well as human testing of drugs, the role of FDA in approving new drugs, and the cost incurred by drug companies when developing new drugs. Pharmaceutical development can be divided into segments. The first segment is the preclinical phase; this is where the drug company attempts to breakdown a disease process into components so it can provide clues for targeting new drug development and usually takes three to four years to complete (Lipsky & Sharp, 2001). Once a new drug has been chosen and developed, the FDA requires that animal tests be performed. In vivo testing, typically done to rodents, demonstrates the safety of the prospective medication and also to notes and evaluates any side or toxic effects, addictions, cancerous tumors, and/or fetal deformities (Turley, 2010, p. 27). The results from the animal studies, indicating no risk to humans, will then be used to support the investigational new drug application (IND) to the FDA to request permission...
Words: 989 - Pages: 4
...The potential risk involved in bringing a new pharmaceutical drug to the market is huge. The actual timescale of the project is longer then a decade, and the success rate is around 1 in a 1000. In fact for every 1000 compounds that are produced only around 30 of these show any sort of promising result. Therefore introducing a new drug into the market does not simply involved one idea and one compound but in fact a complexed process of trial and error so to speak. After years of research on difference compounds have taken place the company can then progress to a stage know as the ‘preclinical stage’. This is where animals are tested upon and it is also the initial stage in the labs. The time scale varies from 3 and a half to four years and the main aim of this stage is to look at the biological activity of the compound and also to evaluate its safety. After the animal testing has been completed they company are not allowed to start testing on humans until their investigational new drug application (IND) has been approved. The company have to file a IND with the FDA, they do so to gain approval to start the next stage, which is on humans. The FDA has 30 days to disapprove. The investigation carried out looks at previous experiments and also information on the new study being evaluated i.e. how is conducting the study, where it is taking place etc. They also look at the chemical structure of the new drug and what its new purpose will be in the market. The next stage of testing...
Words: 827 - Pages: 4
...New Pharmaceuticals and Their Journey to the Market [YOUR NAME] [YOUR SCHOOL] When pharmaceutical companies take on an experimental drug there is a lot of time and money they have to allow for them to maybe make it to market. It’s reported that only 5 in 5,000 drugs that head into preclinical testing even make it to human testing. (Drug approvals - from invention to market, n.d.) A study of the cost has shown that the cost of developing a drug that obtains market approval is $2.6 billion with another $312 million for post-approval development for a life cycle cost of $2.9 billion. (Mullin, Chemical, & News, n.d.) It all begins in preclinical tests, where the pharmaceutical company perform studies before they test on humans. In vitro testing first, where the future drug is tested in a laboratory and after that in vivo tests, where they test on animals. These tests take 3 ½ years. (Drug approvals - from invention to market, n.d. ). The in vivo tests study and record side effects, adverse effects, addictions, cancerous tumors, or fetal deformities. (Turley, 2014) After the animal studies are through, the drug company requests permission for human testing from the FDA by submitting an Investigational New Drug (IND) application. The IND shows information from the animal studies that the drug shouldn’t pose a risk to humans and the chemical structure of the compound along with how it is manufactured. If the IND is approved by the FDA, the drug company may begin sending the...
Words: 668 - Pages: 3
...1.0 Introduction: The pharmaceuticals sector is one of the potential as well as capital oriented sectors in Bangladesh. The pharmaceutical industry in Bangladesh is also one of the most developed sectors within the country's economy. Pharmaceutical industry is technologically the most developed manufacturing industries in Bangladesh and the third largest industry in terms of contribution to government’s revenue. The industry contributes about 1% of the total GDP. The pharmaceuticals market is almost self-sufficient in meeting local demand as 97% of the drugs are manufactured locally while the remaining 3% are imported from abroad. The industry manufactured about 5,600 brands of medicines in different dosage forms. Due to recent development of this sector we are exporting medicines to global market including European market. Square Pharmaceuticals Limited is the largest pharmaceutical company in Bangladesh .The Company was founded in 1958 by Samson H. Chowdhury along with three of his friends as a private firm. It was converted into a public limited company in 1991. It is engaged in the manufacturing of branded generic pharmaceutical products and also other ethical drugs and medicines. The company formulation facilities include Pabna Unit, Dhaka Unit, Pesticide Unit, Cephalosporin Unit and Animal Health Unit. Square Pharmaceuticals Limited has extended its range of services towards the highway of global market. It pioneered exports of medicines from Bangladesh in 1987 and has...
Words: 4423 - Pages: 18
...The Global Pharmaceutical Industry: Conduct an external analysis Introduction The pharmaceutical industry is described by high levels of risky and lengthy R&D process, tough competition for intellectual property, tighter government regulations and powerful pressures on buying power. (Johnson, 2006) In 2011, several blockbuster drugs patent like Lipitor will expire, possibly endangering the revenues of the pharmaceutical industry for the next three to five years. On the global level, the historical supremacy of the US was being challenged with the highest market growth rates recorded in emerging markets. The industry more than ever need to get a handle on the slippery business by offering a true step change in strategy. This case study will critically analyse the Global Pharmaceutical Industry with PESTEL, Porter’s five forces, SWOT analysis and plausible views of industry in the future. PESTLE PESTLE analysis used to help organisation to understand in depth that what is the current status of the organisation and the external factors which are effecting. It also helps to the Management to make strategy for the future and overcome the weak areas of the organization. PESTLE is comprises of political, Economical, Social, Technological, Legal and Environmental factors. Political The both policies (domestic and foreign) of government have a great effect on the industry innovation as compare to the other factors. To get the attentions of firms due to increase the economic...
Words: 2635 - Pages: 11
...Hikma Pharmaceuticals: an Emerging Markets Multinational By : Radi Haloub and John Anchor Industry Background The emergence of the pharmaceutical industry, in the late 1850s, was a breakthrough during which drug makers created the slogan “You Have a Problem, We Have a Pill” (Lynn, 1993: 5). This slogan reflected that fact that the pharmaceutical business was one of the world's largest industries, in addition to being one of the most profitable ones. Since that time, developments in medicine have not ceased to continue to serve humanity and prevent diseases through manufacturing, developing and promoting medications. The industry is highly controlled by healthcare authorities and governmental regulations, due to medical and safety concerns. For example, governments and authorities obligate firms to obey manufacturing and registration laws, storage conditions, labelling and packaging, product marketing, distribution, public awareness, prescription and patenting (John, et al. 2007), and this is what makes pharmaceuticals unique at the industry level. Pharmaceutical companies are classified according to their level of investment in Research and Development (R&D): the “Principal Companies” are the companies which have large investments in R&D to produce patented drugs, whereas “Generic Companies” produce offpatent drugs. Generic drugs (Generics or Branded Pharmaceuticals) are defined by Brems et al. (2011) as off-patent drugs which are not offered by the original manufacturer...
Words: 4085 - Pages: 17
...c) Demand d) Competition- The Rise of the Generics e) Market Failure, Government Intervention and Price 4) Performance page 7 5) Impact of the Global Economic Downturn page 9 6) Summary page 10 7) Conclusion page 11 Bibliography page 12 8) 1. Introduction This paper briefly examines the current state of the pharmaceutical industry, as well as the economic characteristics, performance, and the impact of the global recession. The industry is made up of several enterprises engaging in the research, development, manufacture and marketing of medicines, vaccines, medical devices, and nutritional products for humans and animals. Though, this multi-billion dollar industry includes large ethical drug multi-nationals (often referred to as Big Pharma), mid-sized specialty pharmaceutical companies, manufacturers of generics, small biotechnology and biopharmaceutical firms, and service companies, 1 for the purpose of this paper, the emphasis will be mainly on drug makers. 2. History/Overview of the Industry The pharmaceutical industry of today is a far cry from its humble beginnings in the nineteenth century of physicians mainly prescribing plant extracts to being technology intensive, dominated by a few large companies with significant research and development (R&D) budgets, and significant government oversight. Over the past five years, the industry has been characterized by mega-mergers and acquisitions...
Words: 2796 - Pages: 12
...| Porter’s Analysis: Pharmaceutical Industry | Submitted to Dr. Grace Khoury | By: Asem Masri. Student No. 1125420 | 11/6/2014 | 1. Contents Introduction 1 Porter’s Five Forces Analysis 1 Threat of new entrants 1 Rivalry among existing firms 2 Threat of substitute products 2 Bargaining power of buyers 3 Bargaining power of suppliers 4 Relative Power of other stakeholders 4 Conclusion 5 References 5 Introduction The pharmaceutical industry in Palestine is one of the most profitable industries, with the Palestinian companies owning 55% and 30% market share of the private and public sectors respectively, and high potential of growth even more, in a market estimated at around USD 100 million. All these companies mostly reproduce generics that are seen as commodities rather than differentiated, and highly depend on preferred agreements with pharmacies, doctors, hospitals and medical centers to serve both as their marketing and distribution channels. All operating firms in the industry are publicly traded companies, are highly controlled and regulated, depend heavily on technology and require vast financial resources. Because of the large size , high complexity and vast financial requirements of the industry, it won’t be a straight forward task to decide on whether this industry is attractive to enter or not, without performing proper STEEP and industry analysis. In this case, we will focus on performing pharmaceutical industry analysis using...
Words: 1927 - Pages: 8
...Student Name : Singh, R. : Hariram, E. : Marimuthu, V.K. Student Number : 20054057 : 20101233 : 19852274 Assignment Title : The Global Pharmaceutical Industry. Date : 10 March 2012 Programme : BTECH-MANAGEMENT IV Question 1 Identify the main environmental forces currently affecting the global pharmaceutical industry? PESTEL analysis of the global pharmaceutical industry: Political * Governments set stringent regulation and is a powerful purchaser. * Governments around the world focus on pharmaceuticals as a politically easy target in their efforts to control rising health care expenditure. * Inter-country pricing disparities. Economic * European free trade agreements. * Deregulation of market to allow foreign drugs to compete. Social * Ageing population puts pressure on healthcare systems. * Epidemic of chronic diseases. * Rising consumer expectations. * Payers choosing generic drugs for first-line treatment of common ailments. Technological * Increase productivity, decrease costs and develop new treatment modalities to enhance profitability. * Impact of Internet on traditional business models. * Impact of genetic research on industry. Environmental * Industry operations are becoming more stringent with increasing standards and requirements for environmental protection. Legal * Rigorous regulatory scrutiny governed by legislation. * Legislation enacted to set a...
Words: 1594 - Pages: 7
...) External Environment: The Pharmaceutical Industry is dependent on political and legal conditions of general environment. In pharmaceutical industry we have two kind of medications which are generic or innovative. Innovative pharmaceutical industry success depends on the patent protection in the industry. For example, in United States innovative industry can have 10 to 12 years of patent protection life from the time that product is for sale in the market. Success of the generic pharmaceuticals which are bioequivalent to innovative pharmaceutical is also related to the political and legal environment of their market. If we look at pharmaceutical industry globally we can see that regulations toward generic pharmaceutical are different in different countries. For example, in United States they have the Hatch-Waxman ACT 1984including Abbreviated New Drug Application which reduce the drugs approval period and give the chance to Generic companies to have a 180 day exclusivity period if the generic company can submit an abbreviated new drug application before other generic competitors. In Europe regulations are different in each country for example, United Kingdom and the Netherlands are very similar to USA, and countries such as Germany and France are more physician-driven or branded generics market and the cost of sale for generic products are higher in these countries. Market for generic drugs in the rest of the world...
Words: 298 - Pages: 2
...History The history of the United Kingdom as a unified sovereign state began with the political union of the kingdoms of England, which included Wales, and Scotland. On the new kingdom, the historian Simon Schema said, "What began as a hostile merger would end in a full partnership in the most powerful going concern in the world... it was one of the most astonishing transformations in European history. A further Act of union in 1800 added the Kingdom of Ireland to create the United Kingdom of Great Britain and Ireland. Introduction: The United Kingdom (official name United Kingdom of Great Britain and Northern Ireland) consists of four countries united under one monarch and government. The countries are England, Scotland, Wales and Northern Ireland. Each have a distinct culture and feel of their own with some in Northern Ireland wishing to split from the United Kingdom and join the Republic of Ireland, with which the UK shares its only land border. England has traditionally been the dominant nation within the UK has over 80 percent of the share of the total population. People in Scotland and Wales have proud national traditions and languages. Scottish Gaelic is mainly spoken in the north west of the country, by a small proportion of the population. Welsh has a much bigger number of people speaking the language and all public signs in Wales are displayed in both Welsh and English. Economy Of Uk: Statistical Data Economy of the United Kingdom | Canary Wharf business district...
Words: 3671 - Pages: 15
...activities of “Big Pharma,” or the commercial pharmaceutical industry of the United States. In this article the author highlights some market strategies used by the industry, which suggest corrupt practices. The article criticizes the actions of the pharmaceutical industry beginning in the 1980s to the present, asserting that the industry compromises the integrity of the process of medical research and that it pressures consumers and doctors to use its products and that it falsifies data regarding the capabilities and dangers of its drugs (Harriet A. Washington, American Scholar, Summer 2011, vol. 80). Drug makers do not just comprise doctors; they also undermine the top medical journals and skew the findings of medical research. Identifying unethical business research involved in this article is given. Evaluating the article will also show how unethical behavior affects the industry, injured party, and society. A proposition of how unethical behavior can be avoided is proposed. The article is based on how pharmaceutical companies use medical research in medical journals and advertising (Washington H., 2011). Medical advertising has an influence on medical articles in medical journals along with supplying journals with financial support to keep publishing (Washington H., 2011). Health care professionals use medical journals when diagnosing and treating patients. This is not the only issue the article speaks about. Pharmaceutical companies also use techniques in the medical...
Words: 796 - Pages: 4
...Applying Porter’s Five Forces to Pharmaceutical Industry in Egypt The power of buyers is the impact that customers have on a producing industry. Like in any pharmaceutical industry throughout the world, key buyers from the manufacturers distributors of the products, which are mainly hospitals, pharmacies, general stores, and supermarkets (El-Khatib, 2011). The Egyptian pharmaceutical market is fairly fragmented with the pharmacies and drugstores forming the most important distribution channel for medicines in this market. The small independent pharmacies and drugstores have less buyer power than the larger supermarkets and general store chains. Also, large pharmaceutical companies with recognized brands have considerable power over smaller drugstores and pharmacies, thus reducing the buyer power. Usually retailers have significant power in supply chains, but consumer preference also has a significant part in this market. Of course drugs and medicines are much more important to the life of a pharmacy or drugstore than a supermarket; therefore, buyers’ switching costs can differ slightly in this market. If any backward integration happens, it increases pressure on the manufacturing pharmaceutical companies and increases buyer power at the same time. So, overall buyer power is moderate to weak. Suppliers to the pharmaceutical market are mainly the active pharmaceutical ingredients (API) manufacturers. The drug manufacturing companies, who are the main players in this market...
Words: 856 - Pages: 4
...AN EXPLORATORY STUDY ON THE EXPORT POTENTIAL AND STRATEGIES OF BEXIMCO PHARMACEUTICALS LTD. [pic] [pic] [pic] AN EXPLORATORY STUDY ON THE EXPORT POTENTIAL AND STRATEGIES OF BEXIMCO PHARMACEUTICALS LTD. Submitted To: Professor Golam Mohammed Chowdhury Chairman Internship and Placement Program Supervised By: Mr. Ridwanul Huq Lecturer Submitted by: Md. Shoeb-Bin-Mananan MBA 38th Day Roll-38D Institute of Business Administration University of Dhaka July 08, 2010 July 08, 2010 Professor Golam Mohammed Chowdhury The Chairperson Internship and Placement Committee Institute of Business Administration University of Dhaka Subject: Submission of Internship Report. Dear Sir, It is my pleasure to submit the internship report, which is done as a part of academic curriculum, to you for your kind evaluation. The report is prepared on “The Export Potential and Strategies of BEXIMCO Pharmaceuticals Ltd”. My organizational supervisor assigned me to prepare a report on the above mentioned subject and later my faculty advisor also approved it. I have put my best effort in preparing this report and to make it a worthy one. Each aspect of the problem is considered and studied as required. I shall try my best and shall be obliged to provide you with any kind of clarification concerning this report. Sincerely yours, ____________ Md. Shoeb-Bin-Mananan Roll No.: 38 Batch : 38th (Day) Major:...
Words: 10200 - Pages: 41
...manufacturing laboratory with the Bulgarian Pharmaceutical Cooperative Society in 1942, the company grew into Galenus Factory, the first modern pharmaceutical enterprise on the Balkan Peninsula. After its nationalization in 1953, Galenus Factory was renamed to Chemical-Pharmaceutical Plant. After the successful privatization in September 2000, Sopharma has become a private pharmaceutical company with priorities aimed at the establishment of the world standards for quality and efficiency. In 2000, 67% of Sopharma was privatized by Elpharma - a consortium between Unipharma and Electroimpex. Bulgarian pharmaceutical company Unipharma was just privatized by the present CEO of Sopharma Ognian Donev while Electroimpex was owned by Bulgarian businessman and entrepreneur Borislav Dionisev. After Privatization Sopharma modernized and increased its production capabilities. At present Sopharma is the main unit in the structure of the group “Sopharma Industries”. As of September 2009 Sopharma owns 16 subsidiaries - 8 in Bulgaria and 8 abroad. Most of them operate in the field of medicine and produce different types of products for medicine and cosmetics or support the main activity. Some Bulgarian subsidiaries are publicly traded and are listed on the Bulgarian Stock exchange. 2. Environment a. GDP, inflation, exchange rate, current account deficit b. Products and Markets Sopharma is currently active in three areas: • production of pharmaceuticals, including medicines, mainly generics...
Words: 7368 - Pages: 30
