Global Prescription Drug Market
The worldwide market for prescription drugs is forecast to reach almost $900 billion by 2015, according to research from Global Industry Analysts.
The prescription drug industry has been affected by the economic crisis in so far as health cutbacks have resulted in pricing pressure. Expiring patents and the subsequent availability of cheaper generic alternatives add further pressure.
The market involves the sale of medication that necessitates a prescription from a medical professional. These medicines require a license and are regulated by law. They are separate from over-the-counter drugs, which do not require a prescription.
Market Challenges
Drug safety and efficacy being of utmost priority to the industry, careful attention to quality and testing along with safety standard surveillance are ongoing efforts required to meet the challenges of changing legislations and to avoid penalties from regulatory bodies as well as the threat of lawsuits from patients.
Another industry issue to manage is the long development time required for prescription drugs, for which clinical trials for new drugs can last up to 11 years. This is followed by regulatory body review and approval, which can add another two years before the drug can be launched on the market.
Safety is also a major concern in the marketing and sale of prescription drugs, with ongoing risk management equally having an impact. The US Federal Drug Administration (FDA)’s Risk Evaluation and Mitigation Strategy addresses the abuse of opioid drugs used for pain management and available by prescription. The FDA scheme promotes responsible prescriptions and use of opioid painkillers, including oxycodone, morphine and methadone. With the US government underlining the widespread abuse of prescription medication and associated deaths, the FDA’s strategy attempts to clamp down on the over-prescription of opioids to prevent the surplus from being sold through illegal routes. The FDA’s initiative includes a push for manufacturers of opioid painkillers to list information on the use, disposal and prescription of their products for medical professionals.
Leading Prescription Drugs
The top spot in the global prescription drugs market is held by oncology drugs for the treatment of cancer, followed by respiratory agents such as anti-inflammatory drugs, lung fluid replacement, decongestants, biologics and inhaled corticosteroids.
Lipid regulators are in third place but are likely to see a fall in growth as the segment’s top drug, Pfizer’s cholesterol treatment drug Lipitor, along with others in this category, is to see its patent expire paving the way for generic drugs.
Regional Market Share
The worldwide market is slowing in some regions but showing greater growth in others such as the Asia-Pacific area where growth to 2015 is forecast to be more dynamic than in current leading regions like the US, according to Global Industry Analysts.
Today, the number one region for prescription drugs is the US. The US prescription drug market is characterized by fragmentation with no company outside of the top five enjoying revenue from sales of more than 5%.
Global market weight is likely to reposition itself to see greater growth in developing markets, with India and China leading the way with an expected 17% annual growth through 2014, Bloomberg reports.
Leading Prescription Drugs
- Headquartered in New York with over 110,000 employees, pharmaceutical giant Pfizer saw 2010 revenue hit nearly $68 billion, a 36% jump on 2009. It manufactures the 2010 number-one selling prescription drug in the US – the cholesterol treatment drug Lipitor – for which sales reached $7.2 billion and represented 18% of the company’s biopharmaceutical revenue in 2010. About to come off patent, this drug is likely to see fierce competition from generic competitors.
- Novartis, based in Switzerland, is a leader in the global prescription drugs market, with one of its top-selling drugs, Gleevic, used to treat chronic myeloid leukemia. The company recorded a 27% rise in its second quarter net sales in 2011 to nearly $15 billion, and its core operating income climbed 29% to $4.2 billion.
- AstraZeneca, a prescription drug market leader with 61,000 staff in 100 countries, invests over $4 billion annually in its 14 R&D centers across 8 countries. In 2011, it saw product liability lawsuits drag down profits to some degree, paying nearly $650 million to settle more than 28,000 lawsuits concerning its drug Seroquel, reports Bloomberg. AstraZeneca is involved in the manufacture and/or distribution of over 93 drugs in the US, 9 of which were among the top 200 drugs sales in the US in 2010.
The Future of Prescription Drugs
The global market for prescription drugs is growing in tandem with chronic diseases linked to unhealthy lifestyles and an aging global population: With 170 million children overweight or obese the trend looks set to continue, in which case a whopping 50% of the US population will be classified as obese as soon as 2030 leading to just short of 7 million cases of cardiovascular disease and heart stroke, almost 8 million cases of diabetes and more than 500,000 additional cancer sufferers.
The UK will not be far behind the US with over 25% of the population currently classified as obese. With developing countries set to follow suit, the global obesity epidemic and increasing age profiles mean that the demand for prescription drugs should steadily increase. Other chronic diseases boosting demand for prescription drugs - apart from cancer and obesity-related diseases - are HIV and multiple sclerosis.
Going against the growth grain are the issues of expiring patents, strict regulations, lengthy pre-market reviews and lawsuits. According to Bloomberg, a $136 billion yearly loss is expected until 2014 due to expiring drug patents.
Leading Associations
- International Pharmaceutical Federation www.fip.org
- International Federation of Pharmaceutical Manufacturers and Associations www.ifpma.org
- World Drug Information Association www.diahome.org
- Pharmaceutical Research and Manufacturers of America www.phrma.org
- US Food and Drug Administration (FDA) www.fda.gov
- European Federation of Pharmaceutical Industries and Associations www.efpia.org
- European Pharmaceutical Market Research Association www.ephmra.org
- Central Drugs Standards Control Organization (India) http://cdsco.nic.in/
