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Growth opportunities aplenty but clear heads and careful steps required
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'. Thailand's new govt promises much but can it deliver?
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. How to ride the second Chinese biosimilar wave
Beware your worthy adversaries in Mexico
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.
Confusion reigns in Russia
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.
How to get more 'wag' from the tail – managing mature brands in immature 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:
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.