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EMERGING MARKETS

Growth opportunities aplenty but clear heads and careful steps required


The diversity and size of this Scrip 100 chapter reflects the importance of the one topic guaranteed to lift the spirits of beleaguered pharma execs everywhere, the one ray of light amid the gloom of blockbuster patent expiries and pricing pressures: the emerging markets.


Those two magical words are rolled out with mantra-like predictability at corporate briefings and industry conferences, and it seems no company can be taken seriously these days unless it has a well-defined 'EM strategy'.

In reality of course, the most foresighted firms have been working on theirs for years and at this stage the biggest mid-term opportunities still accrue from Brazil, Russia, India and China and their large and increasingly wealthy populations, and developing healthcare systems.

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Thailand's new govt promises much but can it deliver?


There was a strong sense of déjà vu as voters went to the polls in Thailand's general election earlier this month, which resulted in a landslide victory for a party led by a familiar name.


Following a 75% turnout, the Pheu Thai Party (PTP) headed by Yingluck Shinawatra - the younger sister of deposed former prime minister Thaksin - comprehensively trounced the Democrats and their leader, incumbent prime minister Abhisit Vejjajiva.

In a move to placate its smaller rivals, the PTP then quickly formed an alliance with four minor parties in a coalition that gives it control of around 60% of parliament. Ms Shinawatra, the country's first female prime minister, was helped by the populist appeal of her telecom billionaire brother, who was ousted in the 2006 military coup and now lives in Dubai to avoid a conviction at home over gains from a land deal.

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How to ride the second Chinese biosimilar wave


Today, 40% of China’s recombinant biologic product sales come from biosimilars, which have enjoyed a 25-30% compound annual growth rate (CAGR) over the past 10 years, led by a group of domestic products. What should multinational companies consider when evaluating the biosimilar market in China, and what is the best entry strategy?


As China’s healthcare market continues to expand amid persistent affordability constraints, it is plausible to expect China to become an important market for biosimilars. Recombinant biologics reached approximately $1.5 billion in China in 2010, of which $670 million were biosimilars (excluding peptides). In fact, biosimilars have accounted for a large proportion of recombinant protein based biologics and growth hormones (see Figure 1 below). Overall, the biologic market in China has been growing at 25-30% over the past 10 years.

Such an impressive growth can be attributed to the following reasons. First, disease burden shifts towards those more appropriate for biologics. China’s disease burden is shifting from infectious diseases associated with developing countries (although it is still a significant concern) to chronic diseases associated with diet and environmental changes, such as diabetes, cardiovascular diseases, oncology and rheumatoid arthritis. In these therapeutic areas, biologics are often regarded as the superior therapeutic options.

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Beware your worthy adversaries in Mexico


"Not many companies can say they are doing great right now in Mexico," said Aurelio Martinez candidly, general manager of Mexico and Central America at Cegedim Relationship Management. Lengthy registration processes mean that companies are struggling to get their drugs to a market that has already been hit by increasing generic penetration and a tough economic climate. To survive in Mexico, companies need to lobby regulators and start considering generics companies as worthy adversaries, he advises.


The Mexican market was worth $14.3 billion in 2010, according to Datamonitor. It grew by 8.3% compared with 2009 and its compound annual growth rate between 2006 and 2010 was 2%. However, Mr Martinez says growth of the branded market has been sluggish.

Companies are facing a number of problems. Between 2008 and 2010 the requirements obliging companies to have facilities in Mexico in order to sell their drugs there were gradually removed. It is now enough that imported products come from GMP-certified facilities. However, the move has not made market entry for companies without Mexican facilities easy. "The market is open now, but the problem is that registration is taking too long," said Mr Martinez. It currently takes around two years to register a product, up from around 18 months last year. Datamonitor also points to a lack of transparency in the regulatory process and problems with corruption.

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Confusion reigns in Russia


Just over a year ago, a new Russian law came into force, intended to streamline the drug registration system, including the way that clinical trials are approved. The Law on Circulation of Medicines, which came into effect in September 2010, was part of the Russian government's efforts to open the country up to foreign investment and boost its domestic industrial capability, while reducing its dependency on pharmaceutical imports.


It may have been intended to bring more clarity and certainty to the regulatory system, but where clinical trials are concerned the law can hardly be called a model of regulatory advancement.

True, the law simplified the system so that only one submission for trial approval is now needed rather than two previously. Moreover, trial subjects are now protected by new rules on mandatory health and life insurance. But the new legislation also brought a great deal of confusion and controversy.



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How to get more 'wag' from the tail – managing mature brands in immature markets


In the good old days of pharma, when pipelines were plentiful, Western markets were a haven for strong prices and double digit growth was a given, little thought or focus was given to those teams working with mature brands or those trying to get difficult 'emerging' markets on the radar.


Managing mature brands has often been a thankless 'caretaking' task, focused on managing the risk in a portfolio far too large to actively drive with as little investment as possible, and in many cases even less resources. Meanwhile, driving emerging markets has been a battle to get the global business to understand (and even care) that local dynamics, stakeholder expectations, business models and growth profiles are different, and thus need to be catered for differently.

However, in today's less rosy world, where sources of top line growth, and just as importantly cash flow, are proving more challenging to find, these two deprioritised areas of pharma's past are converging to form one of the fundamental principles of the next decade's growth. With the much vaunted patent cliff redressing the relative size and contribution from mature brands and growth markets, companies that can successfully marry the two will be those that are best positioned to survive the coming tempests.

So why are these two business areas becoming so closely interlinked? Fundamentally, it boils down to two key factors – growth dynamics and portfolio expectation. In terms of the former, the growth dynamics of brands in new markets are often very different to those in the traditional focus regions.

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Partnering to maximise rewards in pharmerging markets

In the past so-called "pharmerging" markets have been the hottest growth area for biopharmaceutical drugs. With large populations, growing disposable income and unmet medical needs, these markets have seen double-digit growth rates. James Featherstone, vice-president of global commercialisation for Quintiles, examines the best practice for entering these markets

Facing dwindling growth opportunities in more developed markets, it is no surprise that multinational biopharma companies turned their attention to promising emerging regions. But success has been mixed and nearly all top global biopharmaceutical companies are under-performing in these markets. According to IMS, while pharmerging markets accounted for 17% of the global pharma market in 2009, the top 15 companies derived only 9.4% of their sales from them.

Succeeding in these markets depends on moving quickly and adapting global strategy through local insights and experience. No defined strategic blueprint exists that can be applied uniformly across these extremely heterogeneous countries. Allying with a partner with local expertise is often the best approach to establish a presence. Alliances enable companies to gain regional expertise in a short amount of time while limiting resource commitments and risks.

Geographical shift in drug spending
According to IMS Health, global drug spending will reach nearly $1.1 trillion by 2015, reflecting an annual sales growth rate of 3-6%. Hidden behind this overall number are unprecedented dynamics at play, which are shifting the mix of spending between branded products and generics and between mature and pharmerging markets.

Mature western markets are seeing slowing growth due to market saturation, economic slowdown, health care cost containment efforts, patent expiry of key blockbuster drugs and increased generic competition. Pharmerging markets, on the other hand, are expected to grow quickly, driven by a large population base with unmet medical needs, economic growth and increased prevalence of chronic diseases.

These dynamics will result in a significant geographical shift in drug spending. The US’s share of global drug sales is expected to drop to 31% in 2015, down from 41% in 2005. The share of the top five European countries, which accounted for 20% of spending in 2005, will make up only 13%. But 17 pharmerging markets, led by China, will account for 28% of total spending by 2015, up from only 12% in 2005. No surprise then, that biopharma wants to tap these markets where the growth potential could offset stagnating sales in mature markets, ensure further growth and cover increasingly expensive R&D cost.

Challenges of highly diverse markets
Although pharmerging markets offer tempting opportunities, they are associated with huge challenges. Market opportunity is scattered among a host of countries and to take full advantage of growth, drug makers will have to enter numerous, enormously diverse markets.

Pharma companies need to ensure their product portfolios match local needs and understand all the subtleties that go with pharmerging markets, and create market entry strategies with balanced portfolios of branded, patent-protected products and lower cost generics.

Despite a growing middle class, per capita income remains significantly lower than in developed markets and the ability to pay for medicines varies significantly. This forces companies to tailor pricing strategies and product mix. The majority of drug spending is out-of-pocket, margins are often low and biopharma is facing stifling competition with power often in the hands of local companies familiar with the operating environment. Negotiating or lobbying for price or reimbursements is often a necessity and constitutes a huge challenge for an outsider.

Modes of market entry
No single strategy can be successfully applied to entering all countries. Developing true understanding of the markets is a process which takes time. Fundamentally, there are only three ways to enter new markets: organic internal growth (build), mergers/acquisitions (buy), or partnerships (ally). No approach is inherently superior and the best option depends on the specific market and company situation.

Most pharmerging markets are characterised by high environmental uncertainty, competition, and complex distribution systems. Biopharma companies that want to enter these markets often seek speed to profit from the remaining patent life. These are all circumstances that indicate the corporate development mode. Allying with a partner who has an established presence and regional expertise allows a company to accelerate market access and an understanding of local conditions while limiting resource commitments and risks.

Strategic alliances can create synergy effects; they offer benefits in addressing local government concerns about foreign ownership and the tendency for local firms to receive preferential treatment. They can provide on-the-ground experience of non-transparent state or country regulatory systems and of the most appropriate infrastructure to build.

Variety of alliance structures
Alliances are defined as any voluntarily initiated and enduring relationship between two or more companies that involves the sharing, exchange, or co-development of resources for mutual gain. Partners remain separate businesses. Alliances can be either equity or non-equity based and typically start with one cooperative agreement that evolves into a portfolio of arrangements built over time. The choice of legal structure should be driven by strategy. Some common types of strategic commercialisation alliances are:

  • Co-promotion or co-marketing: an alliance focused on the best commercialisation of an already approved product.
  • Licensing: form of partnering with local expertise. “Out-licensing” involves the transfer of marketing and distribution rights from the licensor to the licensee. The licensor usually receives a combination of an up-front licensing fee and royalties based on sales.
  • Equity strategic alliances: two or more firms own different percentages of the company they have formed by combining some of their resources and capabilities to create a competitive advantage.
  • Risk-or investment based alliance: contractual relationship to share some unique resources, capabilities and capital to create a competitive advantage.
  • Joint ventures: entail the creation of a new entity by two or more partners who retain equity in the new entity and exercise control.

The choice of alliance structure depends on the development phase of the market a company wants to enter. According to McKinsey, emerging markets typically evolve through four evolutionary stages: nascent, frenzied, turbulent and mature. The nascent stage is characterised by strict government regulations with alliance activity often limited to licensing agreements. Countries that start to deregulate enter the frenzied stage with companies forming many joint ventures to comply with local ownership provisions. Further deregulation leads to a period of turbulence where joint ventures are dissolved as alternative structures become available. Eventually, as markets stabilise, they reach the mature stage, which is similar to developed markets with a full set of available alliance structures.

Chosing the right alliance partner
Careful partnership selection is crucial. The winners will be companies that select their alliance partners based on the experience of emerging markets and cross-functional depth. Equally important criteria are adeptness in alliance management and demonstrated ability to overcome pitfalls. Ideal partners will have an extensive network of relationships and established presence in several markets, allowing entering different countries with one single contact. They should be able to leverage local expertise while maintaining the same international standards across all countries.

Shorter-term contracts allow companies to test new markets and business models with the flexibility to respond to new market conditions. Ideal partners would have complementary skills and offer flexibility in partnership design. They would be open to arrangements where the biopharmaceutical company retains IP rights and full brand control. Working with a partner who is not a current or potential competitor helps avoid competing interests.

Importance of alliance management
One of the most important criteria for partner selection is expertise in managing alliances. Many alliances fail because of a lack of uniformity or a scattershot approach to governance. Working with an experienced partner with a formalised approach to alliance management can alleviate the risk of failure. The practice of alliance management benefits the partnership by introducing more rigour to the decision-making process and improving communication. This practice applies systematic elements across all relationships, allowing the alliance to be driven forward aggressively and effectively, which in turn accelerates commercial opportunities.

Committed leadership and resources is the key to the success of any alliance. A joint governance framework with integrated operational control ensures a successful execution, keeping the long-term objectives in mind. Meeting in person on a regular basis allows clear oversight, issue escalation and continuous improvements.

Partnership success relates but to the cultural framework in which it is delivered. Organisations need to have a collaborative alliance mindset and culture. An alliance-enabled culture is built on trust, open communication, and a singular focus on achieving results.

Emerging markets represent a growth opportunity for the biopharmaceutical industry, but entering new regions requires a comprehensive strategy that includes much more than a sales force. A successful strategy will incorporate a balance of market access considerations, regional outcomes data, physician and pharmacist buy-in and knowledgeable sales reps familiar with the local distribution channel. Only then can a biopharmaceutical company create an effective campaign within an emerging market.