Over the next five years, pharmaceutical consulting could be positioned to play an increasingly critical role, according to the latest estimates from the Business Monitor International’s Pharmaceuticals & Healthcare Business Environment Ratings.

Although the US pharmaceuticals market is currently ranked first both regionally and internationally, projections for the fourth quarter of 2010 and beyond indicate that industry growth is likely to be meager at best. Indeed, the compound annual growth rate (CAGR) is projected to be only 1.76% over the next five years. This slowdown is the result of several factors, including patent expirations, increasing FDA scrutiny, pending healthcare reform, the overall economic climate, and decreased demand for medications and medical services. In this difficult environment, pharmaceutical consultants could prove to be the key factor that enables many drug manufacturers to maintain a competitive edge.

Intimately bound together, the economic climate and healthcare reform strategies will also play a role – one that also opens the door wider for pharmaceutical consulting – in the projected five-year industry slowdown. Real Gross Domestic Product (GDP) is expected to decline from 2.8% in 2010 to 1.8% in 2011, and the weakening economy combined with a dismal labor market has resulted in fewer patients choosing to fill prescriptions, and a decreasing rate of medical services being used by insured people.

Additionally, developments in the third quarter of 2010 will almost certainly result in even heavier compliance and regulatory burdens for drug manufacturers, especially with respect to the OTC segment. The events included the recall of 21 lots of medications – among them certain Tylenol products, as well as Benadryl and Motrin – by Johnson & Johnson. In addition, the FDA recently initiated a new program that will make the safety evaluations for recently approved drugs and vaccines available online. Finally, in August major groups in the consumer, physician, and chemical manufacturing arenas pledged to support a proposed bill intended to protect the US drug supply by allowing the FDA to expand its authority to “safeguard” pharmaceutical supply chains. What this means is that pharmaceutical manufacturers stand to benefit more than ever from the services of knowledgeable pharmaceutical consultants.

Despite everything that is happening, however, the outlook is far from bleak. Pharmaceutical spending in the US was nearly $306 billion in 2009, and the market is expected to reach $334 billion in value at consumer prices by 2014. Still, competition in a market hampered by decreasing growth and a growing presence of state is ever increasing, so ensuring a competitive edge becomes that much more important. Preventive treatment for both patients and the industry is crucial right now.

The best consultants possess the ability and willingness to examine each situation and problem from every perspective then, through analysis and testing, formulate multiple possible solutions. Management and consultants then work together to determine the best solution. Some of the critical areas that pharmaceutical consultants can provide assistance with are:

  • Quality and compliance
  • Good manufacturing practices (GMP)
  • FDA regulatory concerns and adherence
  • Laboratory services
  • Lean manufacturing
  • Training and coaching

Smart Pharmaceutical Consulting is comprised of highly qualified pharmaceutical consultants with extensive industry-specific experience who can guide companies through the upcoming years of slowing market growth, and help them sustain profitability. Their goal is to “provide the competitive edge you need to be the market leader in medical products.”