In the United States alone, more than $100 billion is spent annually on pharmaceutical research and development. The pharmaceutical industry has a higher level of expenditures than any other manufacturing sector in the nation’s economy. Advances in technology and longer lifespans have resulted in a litany of diagnoses across the population, which has led to the soaring need for therapeutic drugs. Despite the growing need, escalating health care costs, the hefty research and development costs and lengthy timespan that is takes for one single drug attain FDA approval pose a challenge to consumers when it comes to filling their medicine cabinets.
Pharmaceutical Industry Giants
The United States holds the largest share of the worldwide drug industry, in number and in income. Out of over 200 pharmaceutical companies, half of the leading 12 are based within the United States, and the remaining six are located in several western European countries.
• Johnson & Johnson (United States)
• Pfizer (United States)
• GlaxoSmithKline (United Kingdom)
• Hoffmann-La Roche (Switzerland)
• Sanofi-Aventis (France)
• Novartis (Switzerland)
• AstraZeneca (United Kingdom)
• Abbott Laboratories (United States)
• Merck (United States)
• Bayer (Germany)
• Bristol-Myers Squibb (United States)
• Eli Lilly & Company (United States)
From the research and development laboratories across the United States, only an average of 23 drugs ultimately makes it to the medicine cabinets of consumers each year. Johnson & Johnson and Pfizer, whose figures average $64.2 billion, currently yield the highest pharmaceutical company revenues within the United States.
From Concept to Consumer
Once a new drug idea enters the research and development process, it undergoes several stages on its journey from concept to consumer. Out of 5,000 compounds, as the drug ideas are called, only an average of 250 will enter the first stage.
During this stage, which can last from one to six years, toxicology screenings on the compounds take place in order to purify a synthesized formulation of the drug. Once this is achieved, an investigational new drug application is submitted for approval by the Food and Drug Administration (FDA). Once the application is approved, then the drug moves into the clinical phases of its development and production. This advancement occurs in only an average of five out of the 250 drugs that entered the preclinical testing stage.
This stage involves three phases of clinical trials to determine the drug’s effect on the human body. The initial phase evaluates and maximizes the safety level of the drug. The second phase tweaks the dosage to achieve the highest possible efficacy of the drug. During the third phase, the most costly and extensive chapter in the drug’s development, side effects are determined while safety concerns and levels of efficacy continue to be analyzed. The entire clinical testing process can last anywhere from six to eleven years.
Application and Approval
Once the clinical trials are complete, a new drug application is submitted to the FDA for approval to enter the consumer market. During this time, the FDA conducts its own meticulous research while consulting with panels of experts to ensure the safety of the drug. This can last from six months to two years before approval is granted.
Pharmacy Shelves: The Monitoring Continues
Once the drug enters distribution, it continues to be monitored for an average period of 12 years to detect long-term side effects and any unforeseen potential safety compromises that develop.
Only approximately one out of 5,000 new drug ideas will make it through the above sequence of research and development stages to make its debut on the pharmacy shelves. The average time duration for this process lasts 12 years, and the average cost for the research and development of that drug is over $1.2 billion.
Current Focus and Future Trends
Throughout the world, more than 3,000 drugs are presently in development. Nearly half of these drugs are treatment hopefuls for cancer patients. The second largest chunk targets mental illness and behavioral disorders, including Alzheimer’s and other dementias. The escalation of obesity has prompted still more drugs in development to combat diabetes, cardiovascular and respiratory diseases. The increasing number of senior patients has given rise to a focus on more effective arthritic remedies.
Due to longer life expectancies and a surge in the aging baby boomer population, the future trends will continue to focus on oncology drugs, pain-relieving medications, diabetic drugs and medications for central nervous conditions and mental health. Also on the rise is the development of specialty medicines that will be ordered by specialists to treat their patients who suffer from complex, chronic and highly specialized diseases. Increasing drug costs are also spurning the need for the development of a more extensive lineup of generic drugs.
As long as the need for continued research to treat and cure existing diseases prevails and new illnesses are discovered, the pharmaceutical industry will be one of continued growth and career opportunity.
by Eszter Hazai, PhD Google+