Key Challenges Of The Pharma Industry

There are multiple health concerns worldwide and more and more drugs are needed every day. Many drugs however, are extremely expensive to develop, test, and produce. According to the Tufts Center for the Study of Drug Development (2002), it costs up to $802 million to bring a new drug to the market. In 2002, pharmaceutical companies spent $34 billion in research and development (Center-Watch, 2003). In addition to the costs, the overall time from the discovery to approve and market the drug can take up to 15 years.

Some pharmaceutical companies are feeling grief from a decline in research slump but the issues are more serious in reference to the United States intellectual property laws on which these same companies need to inflate their profits. Maybe the focus should be on an idea that came about several years ago. Give drug patents a shorter term of 15 years but don’t start the clock until the FDA approves the drug.

Improvements in health care and life sciences are an important source of gains in health and longevity globally. The development of innovative pharmaceutical products plays a critical role in ensuring these continued gains. To encourage the continued development of new drugs, economic incentives are essential. These incentives are principally provided through direct and indirect government funding, intellectual property laws, and other policies that favor innovation. Without such incentives, private corporations, which bring to market the vast majority of new drugs, would be less able to assume the risks and costs necessary to continue their research and development (R&D). In the United States, government action has focused on creating the environment that would best encourage further innovation and yield a constant flow of new and innovative medicines to the market. The goal has been to ensure that consumers would benefit both from technological breakthroughs and the competition that further innovation generates. The United States also relies on a strong generic pharmaceutical industry to create added competitive pressure to lower drug prices. Recent action by the Administration and Congress has accelerated the flow of generic medicines to the market for precisely that reason. By contrast, in the Organization for Economic Cooperation and

Extremely risky drug discovery and development, lengthening development times which increase development cost, return on investments, and generic competitors.

Market failure appears when there is a failure in allocation of goods and services. When the market is unsuccessful, the government is called to intervene and correct the failure. Over the years, government participation in the pharmaceutical market has been more wide-ranging than any other good or service. With the government’s ability to regulate, mandate, inform, finance and provide, their intervention to overcome market failure can be beneficial for the economy. Market failure plays a significant role in today’s economy.

The most important issue that can impact Pharm Universe is if any of their formula is stolen by hacking into their information systems. Such an incident will have a negative effect on the company and it won’t be able to meet its goals like increasing market share to 10 percent

The Pharmaceutical industry has been in the spotlight for decades due to the fact that they have a reputation for being unethical in its marketing strategies. In The Washington Post Shannon Brownlee (2008) states, “We try never to forget that medicine is for the people. It is not for the profits. The profits follow.” This honorable statement is completely lost in today’s world of pharmaceutical marketing tactics. These tactics are often deceptive and biased. Big Pharma consistently forgets their moral purpose and focuses primarily on the almighty dollar. Big Pharma is working on restoring their reputation by reforming their ethical code of conduct.

Recently, there has been a debate about the high prescription drug prices in the United States. Accounting for 9.7% of the national health expenditure, $329.2 billion was spent on prescription medications ($931 per person) in 2011 (Linton, 2014). So what exactly is the average American getting with their $931? Well, because there is an extraordinary amount of time, effort, and energy that goes into creating, manufacturing, and distributing a new drug, it’s no wonder the prices are so high. But what other costs are folded into the prices of your prescribed medications? This review looks beyond just the research and development costs needed to take a new drug from idea to shelf by examining several journals and other credible, secondary sources, to shed some light on how much pharmaceutical companies are spending to develop, advertise, and sell their drugs.

At Eli Lilly and Company (Lilly), patent expiration is part of everyday business. However, Prozac, Lilly’s flagship product and market leader in the most popular class of pharmaceuticals used to treat depression – the selective serotonin reuptake inhibitors (SSRIs) was definitely a cause for concern (Ofek & Laufner, p.1). Patent expiration meant that generics would flood the market and Prozac’s current $2 billion in annual sales would create a huge revenue gap (Ofek & Laufner, p.1). Although management at Lilly was actively seeking a successor to Prozac the road to pharmaceutical breakthroughs is

In recent years, the pharmaceutical drug industry as a whole has faced declining research and development productivity, a rapidly changing healthcare landscape and a lot competition from generic drugs resulting in lower growth and profit margins. Typically, Genentech’s drug development project life cycle focused on clinical trial management and the outcomes of those trials. Now however, the company is looking at more holistic approaches to improve processes of bringing new products to the pharmaceutical market that can accelerate product development while lowering operational costs for Genentech. This is challenging for Genentech because of the complex value chain and business processes required in this highly regulated

One weakness that Merck has confronted is the duration of the drug development, the value of the drug being evaluated and the length of the FDA application for drug approval. For example, of the 5,000 molecules that are discovered, only couple of hundred are investigated, only one enters into the market and only a third becomes a marketable success (Gilbert and Sarkar 3). A drug development time may take on average over 15 years and expenditure R & D total costs of about $880 million (Gilbert and Sarkar 2) (Exhibit 3). The length for and FDA application is at least 100,000 pages, which details the potential drug's usage, production, formula and labeling.

The pharmaceuticals industry is one of the most profitable business sectors. The implications of this business can be observed on individual, corporate, and national level. The actions that companies make determine significant effects on different categories of stakeholders.

Pfizer is one of the world’s largest research-based pharmaceutical and biomedical companies that is dedicated to discovering, developing, manufacturing, and marketing prescription medications for both humans and animals. Pfizer was founded by cousins Charles Pfizer and Charles Erhart in 1849. Its top prescription products include Lipitor, Celebrex, and Lyrica, Prevnar, Viagra, Enbrel, Zyvox, and Norvasc.

Pharmaceutical industry is facing intense competition and enormous challenge in the recent year, mainly due to the threat from generics drugs and competitors enhance ability and adoption of new technology (Taylor, 2015). For AstraZeneca, they

Achieve a median composite eight-year product development cycle by 2010. Deliver two new molecular entity (NME) launches on average per year from 2010. In order to achieve the above objective, ensure that we have 10 or more NMEs in Phase III development by 2010. Development cycle times and quality for small molecules and biologics. Number of NME launches per year. Attrition rates. Number of development projects by phase. Number of in-licensing deals, alliances and acquisitions. R&D investment levels. Improving R&D quality and speed through leading-edge science, effective risk management and decision-making and overall business efficiency. Maximising the value of our biologics business and continuing to build a major presence in this fast-growing sector. Investing in external opportunities to enhance our internal innovation through in-licensing, alliances and acquisitions. 2008 target exceeded for small molecule development cycle times. NME and life-cycle management progressions