Although the future is difficult to predict, if we observe what is happening around us carefully, the tea leaves can be read with enough clarity to make some plausible projections. Most veteran Pharma observers, me included, might say reading such leaves for the companies and others working Pharma’s various segments and then making predictions, is not for the faint-hearted. Nevertheless, looking across the pharma landscape in 2016 there are features, milestones and similar way points that offer the basis for predictions 10 years hence. The following commentary and conclusions are based on the changes we are experiencing right now.
PAST & PRESENT
Over the last century, traditional Brand/ethical global pharmaceutical companies started to serve the needs of patients. Their model had been to discover and produce drugs under the scrutiny of regulators. Patents were their friends. Major markets were patients in the developed countries. High prices of drugs and their availability in the developing countries made wider distribution and consumption rather difficult. Most of the imported drugs were/are for the elite. A void was created. Companies in the developing countries reverse engineered the processes to produce drugs for the needy. These ventures flourished but became painful for the original drug discoverers as sometimes they encroached on their intellectual property and sales. In 1995 the World Trade Organization’s TRIPS guidance was promulgated 1. TRIPS changed the pharmaceutical landscape in 2005 with companies from the developing countries being able to supply generic drugs to the developed countries. Compulsory licensing was part of the negotiated settlement.
Prior to TRIPS, many generic companies in more developed countries produced drugs once their patents had expired and branded pharmaceutical producers accepted this scenario. Entry of generic companies from these developing countries changed the landscape even more but branded Pharma, busy creating blockbuster drugs (more than billion dollar sales per year) and making profits that were/are much higher than similarly capitalized manufacturers in other industries. Those were good times.
In the last few years clouds started appearing. Pharma’s realized the blockbuster drug model will be difficult to sustain and there are few of late, it seems, who want to acknowledge this publicly as they seemingly cling to the old model. Faltering revenues led branded producers to focus their R&D efforts on life style, lipid control, infectious, neglected or orphan diseases and biotech drugs. Revenue and profits spigot ran full force. Negotiated prices in many countries have put a damper on their revenues and profitability. Except for few drugs, most of the orphan and neglected disease drugs are for less than 200,000 patients worldwide. They are very high priced and extend life by few months or have to be taken forever, thus becoming a financial burden even for those who can afford them. Biotech drugs could be for a larger population only if their performances are significantly better than small molecule drugs. One thing is for sure irrespective of the patient population most of the new drugs will be priced much higher than the current drugs for the same diseases.
Over the past five years the FDA 2 approved about 182 new drugs. At this point there’s no telling how many of these would be considered commercial success. It has been forecast that the new launches would have sales of about $80 billion dollars in the next five years 3. Their actual sales are not known. Sales of $80 billion for the 50 of the 182 drugs 3 suggest that average sales per drug per year would not be a celebratory number but a very marginal success at best.
Every year new FDA drug approvals are written about and applauded 4. However, these news items never discuss how many of these drugs are successfully commercialized, their revenue-generating potential and most importantly: how many patients benefit per year.
Pharma’s prevailing business model, even when creating drugs for a limited patient base, has not changed as it generates necessary revenue and profit growth. Significant monies have been made through high prices and raising them5 as often as possible. This cannot continue even in the U.S., the world’s largest pharmaceutical market. Based on the industry’s landscape one would consider sharpening their pencil as days of such largesse could be numbered.
Going forward I see the landscape changing. There are fewer drugs in the pipeline that potentially are significantly better and completely eliminate the use of existing drugs for the same diseases. New drugs are going to be marginally better but at a higher price3,5,6 and used by a limited population. I am not sure of the solution for this quandary, as the drug efficacy cannot be predicted. However, one thing is for sure and that is companies will have to be careful about their drug development model. Unless better than 50 percent of the approved drugs are a commercial success investors and shareholders will start asking many hard and difficult questions.
For every new drug under development, the following questions should be raised:
1. What is the efficacy of the drug over therapies currently available?
2. Are drugs affordable?
3. How many patients have benefited from these drugs?
It’s worth noting that very few new drugs will have patient base of 10 million or more. Orphan/neglected/cancer treatment drugs will be for a limited population and very high priced (i.e., unaffordable to many patients) thus necessitating tougher consumer choices. Many branded drugs of yester-year are set to go off patent soon dampening brand revenues. These represent opportunities for generics manufacturers.
Thus, the waning pipeline and limited patient base are not enough to sustain the current business model (year over year increasing revenue and higher profits) of typical branded pharmaceutical companies. Biopharmaceuticals might replace some of the lost revenue and profits, but not by much for reasons enumerated earlier. There are forecasts 7 of about $70 billion dollar sales increase year-over-year for the next five years. I have serious doubts about this proposed reality as explained 8.