Since quite some time global pharmaceutical majors have been operating within the confines of high risk – high reward R&D based business model with blockbuster drugs (annual sales of over US$ 1 billion).

Blockbuster brands, mostly in the chronic-care segments have been driving the business growth, since long, of the global R&D based pharmaceutical companies. Many such blockbuster drugs are now at the end of their patent life like, Lipitor (Atorvastatin) of Pfizer.

Patent expiry of such drugs, especially in the environment of patent cliff, could make a severe adverse impact on the revenue and profit stream of many companies, leading to drastic cost cut including retrenchment of a large number of employees.

In addition ballooning costs of R&D failure coupled with the decisions of the governments all across the world, including the US , EU and even in Asia, to contain the healthcare cost – the recent examples being Germany, Spain, Korea and China, have become the major cause of concern with the business model of blockbuster drugs.

Availability of low cost and high quality generics coupled with increasing consumerism, growing relevance of outcome-based pricing model are making the global pharmaceutical business models more and more complex.

The need to realign with the new climate:

Accenture in its report titled, “The Era of Outcomes – Emerging Pharmaceutical Business Models for High Performance” had commented, “Unless pharmaceutical companies act now to adjust to the new climate, they will be pressured to sell their proprietary drugs at low profits because the market will no longer bear the premium price”.

‘Blockbuster drugs’ business model is under stress:

Over a period of so many years, the small-molecule blockbuster drugs business model made the global pharmaceutical industry a high-margin/high growth industry. However, it now appears that the low hanging fruits to make blockbuster drugs, with reasonable investments on R&D, have mostly been plucked.

These low hanging fruits mostly involved therapy areas like, anti-ulcerants, anti-lipids, anti-diabetics, cardiovascular, anti-psychotic etc. and their many variants, which were relatively easy R&D targets to manage chronic ailments. Hereafter, the chances of successfully developing drugs for ‘cure’ of these chronic ailments, with value addition, would indeed be a very tough call and enormously expensive.

Thus the blockbuster model of growth engine of the innovator companies effectively relying on a limited number of ‘winning horses’ to achieve their business goal and meeting the Wall Street expectations is becoming more and more challenging. It is well known that such business model will require a rich and vibrant R&D pipeline, always.

The changing scenario with depleting R&D pipeline:

The situation has started changing since quite some time from now. In 2007, depleting pipeline of the blockbuster drugs hit a new low. It is estimated that around U.S. $ 140 billion of annual turnover from blockbuster drugs will get almost shaved off due to patent expiry by the year 2016.

IMS reports that in 2010 revenue of more than U.S. $ 27 billion was adversely impacted due to patent expiry. Another set of blockbuster drugs with similar value turnover will go off patent by the end of 2011.

According to IBIS World, the following large brands will go off patent in 2011 and 2012:

Patent Expiry in 2011	Condition	Company	2010 US Sales $ billion
Lipitor	cholesterol	Pfizer	5.3
Zyprexa	antipsychotic	Eli Lily	2.5
Levaquin	antibiotics	Johnson & Johnson	1.3

Patent Expiry in 2012	Condition	Company	2010 US Sales $ billion
Plavix	anti-platelet	Bristol-Myers Squibb / Sanofi-Aventis	6.2
Seroquel	antipsychotic	AstraZeneca	3.7
Singulair	asthma	Merck	3.2
Actos	type 2 diabetes	Takeda	3.4
Enbrel	arthritis	Amgen	3.3

Proactive shift is required from ‘Blockbuster’ to Niche buster’ model:

Companies with blockbuster-drug business model without adequate molecules in the research pipeline may need to readjust their strategy even if they want to pursue similar R&D focused business model effectively.

Brand proliferation, though innovative, within similar class of molecules competing in the same therapy area, is making the concerned markets highly fragmented with no clear brand domination. In a situation like this, outcome based pricing and competitive pressure will no longer help attracting premium price for such brands anymore.

Being confronted with this kind of situation, many companies are now shifting their R&D initiatives from larger therapy areas with blockbuster focus like, cardiovascular, diabetes, hypertension and more common types of cancer to high value and technologically more complex niche busters in smaller therapy areas like, Alzheimer, Multiple Sclerosis, Parkinsonism, rare types of cancer, urinary incontinence, schizophrenia, specialty vaccines etc.

This trend is expected to continue for quite some time from now.

Generics to continue to drive the growth in the emerging markets:

It is expected that the global pharmaceutical market will record a turnover of US $1.1 trillion by 2014 with the growth predominantly driven by the emerging markets like, Brazil, Russia, India, China, Mexico, Turkey and Korea growing at 14% – 17%, while the developed markets are expected to grow just around 3-6% during that period.

The United States of America will continue to remain the largest pharmaceutical market of the world, with around 3-6% growth.

IMS predicts that over the next five years the industry will have the peak period of patent expiry amounting to sales of more than US$ 142 billion, further intensifying the generic competition.

The experts believe that the growth in the emerging markets will continue to come primarily from the generic drugs.

Integrated combo-business model with ‘niche busters’ and generic drugs:

Some large companies have already started imbibing an integrated combo-business model of innovative niche busters and generic medicines, focusing more on high growth emerging pharmaceutical markets.

The global generic drug market was worth US $107.8 billion USD in 2009 and is estimated to be of US$ 129.3 billion by 2014 with a CAGR of around 10%. However, there are some companies, who are still ‘sticking to knitting’ with the traditional R&D ‘blockbuster drugs’ based business models.

The process of innovative and generic drugs ‘combo-business model’ was initiated way back in 1996, when Novartis AG was formed with the merger of Ciba-Geigy and Sandoz. At that time the later became the global generic pharmaceutical business arm of Novartis AG, which continued to project itself as a research-based global pharmaceutical company. With this strategy Novartis paved the way for other innovator companies to follow this uncharted frontier, as a global ‘combo-business strategy’. In 2009 Sandoz was reported to have achieved 19% of the overall net sales of Novartis, with a turnover of US$ 7.2 billion growing at 20%.

Other recent example of such consolidation process in the emerging markets happened on June 10, 2010, when GlaxoSmithKline (GSK) announced that it has acquired ‘Phoenix’, a leading Argentine pharmaceutical company focused on the development, manufacturing, marketing and sale of branded generic products, for a cash consideration of around US $ 253 million. With this acquisition, GSK gained full ownership of ‘Phoenix’ to accelerate its business growth in Argentina and the Latin American region.

Similarly another global pharma major Sanofi is now seriously trying to position itself as a major player in the generics business, as well, with the acquisition of Zentiva, an important player in the European generics market. Zentiva, is a leading generic player in the markets like, Czechoslovakia, Turkey, Romania, Poland  and Russia, besides the Central and Eastern European region. In addition to Zentiva, in the same year 2009, Sanofi also acquired other two important generic players, Medley in Brazil and Kendrick in Mexico.

With this Sanofi announced, “Building a larger business in generic medicines is an important part of our growth strategy. Focusing on the needs of patients, Sanofi has conducted a regional approach in order to enlarge its business volumes and market share, offering more affordable high-quality products to more patients”.

Keeping a close vigil on these developments, even Pfizer, the largest pharmaceutical player of the world, has started curving out a niche for itself in the global market of fast growing generics, following the footsteps of other large global players like, Novartis, GlaxoSmithKline, Sanofi, Daiichi Sankyo and Abbott.

Yet another strategy – splitting the company for greater focus on both generic and innovative pharmaceuticals:

In the midst of the above trend, on October 19, 2011 Chicago based Abbott announced with a ‘Press Release’ its plan to separate into two publicly traded companies, one in diversified medical products and the other in research-based pharmaceuticals. The announcement said, the diversified medical products company will consist of Abbott’s existing diversified medical products portfolio, including its branded generic pharmaceutical, devices, diagnostic and nutritional businesses, and will retain the Abbott name. The research-based pharmaceutical company will include Abbott’s current portfolio of proprietary pharmaceuticals and biologics and will be named later. Both companies will be global leaders in their respective industries, the Press Release said.

Such splits are based on the belief of many that in the pharmaceutical business two entirely different business models of new drug discovery and generics will need different kind of business focus, which may not complement each other for the long term growth of the overall business.

OTC Switch of prescription drugs will continue:Prescription to ‘Over the Counter (OTC)’ switch of pharmaceutical products is another business strategy that many innovator companies have started imbibing from quite some time, though at a much larger scale now.This strategy is helping many global pharmaceutical companies, especially in the Europe and the US to expand the indication of the drugs and thereby widening the patients’ base.Recent prescription to OTC switches will include products like, Losec (AstraZeneca), Xenical (Roche), Zocor (Merck), etc. Perhaps Lipitor (Pfizer) will join this bandwagon soon.

Conclusion:

PwC in its publication titled “Pharma 2020: The Vision” articulated:

“The current pharmaceutical industry business model is both economically unsustainable and operationally incapable of acting quickly enough to produce the types of innovative treatments demanded by global markets. In order to make the most of these future growth opportunities, the industry must fundamentally change the way it operates.”

Quite in tandem a gradually emerging new ‘pharmaceutical sales and marketing model’ has started emphasizing the need for innovative collaboration and partnership within the global pharmaceutical industry by bundling medicines with patient oriented services. In this model, besides marketing just the medicines, as we see today, the expertise of a company to effectively deliver some key services like, patient monitoring and disease management could well be the cutting edge for business excellence. In this evolving scenario, those companies, which will be able to offer better value with an integrated mix of medicines with services, are expected to be on the winning streak.

Be that as it may, effective transition from ‘blockbuster’ to an integrated ‘niche buster’ plus ‘generic drugs’ business model, is expected to be “The Game Changer’ in the new ball game of the global pharmaceutical industry in the years ahead.

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.