WAYS TO PROSPER IN THE INCREASINGLY COMPETITIVE GLOBAL PHARMACEUTICAL MARKET - WHITE PAPER
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WHITE PAPER WAYS TO PROSPER IN THE INCREASINGLY COMPETITIVE GLOBAL PHARMACEUTICAL MARKET WHICH DIRECTION SHOULD YOU TAKE YOUR COMPANY? AUGUST 2014
ADAPTATION IN CHALLENGING TIMES
IS CRITICAL TO SURVIVAL
The pharmaceutical environment, for both innovative R&D companies and generics manufacturers,
continues to become increasingly competitive. For innovators, the recent patent cliff, higher regulatory
hurdles, competitive pipelines, and the ever increasing cost of R&D are the drivers causing pressure on
their business. Changing market and payer dynamics, increased competition and costs associated with API
production, and regulatory challenges are doing the same for generics companies. Both sides are actively
seeking new ways to alleviate these pressures and find new opportunities for growth.
A number of strategies are deployed across the industry in response to these challenges – anything from
mega-mergers through to portfolio optimization, depending on the situation and objectives of the individual
company in question.
Some strategies are well established across the industry and adopted by the majority of innovator
companies – such as entering into alliances to supplement the existing pipeline or branching into branded
generics.
From the generics perspective, companies are taking approaches such as moving towards “value add”
products. However, this approach, for example in biosimilar development, is not appropriate for all
companies due to existing portfolios or relatively high barriers to entry. A third strategy, expanding into
additional markets and securing new patient populations, has been adopted by the industry as a whole
for some time but has not been appropriate for some small and medium innovator companies or generics
companies.
THAT IS, UNTIL NOW.
Market expansion is a critical strategy for sustaining growth and remaining competitive. Many companies
include market expansion in their overall strategy but the specifics of how this is implemented must be
carefully considered and based around the individual company’s strengths, portfolio, and overall vision.
Due to a variety of pressures, companies cannot continue to rely on the established markets for growth. We
have seen decisive action taken over recent years.
The Global Pharmaceutical Market Could
Be Worth Nearly $1.6 Trillion by 2020
US $Billions
499
500
425
400
337
300
273
205 191 205
200 153
149
127
100
27 31
0
United States Canada EU-Big 5 Japan Growth ROW
Markets
Sales in 2011 Sales in 2020
Source: PWC ConsultingIn 2010, AstraZeneca announced that emerging markets would account for about a quarter of its total
revenue by 2014. Branded generics were tipped to be a part of that success but they will only account for
10 – 15 percent of its emerging market sales by 2014. AstraZeneca’s strategy did not include dramatic price
reductions.1
Pfizer stated that “Off-patent medicines, including branded generics, represent one of the fastest growth
segments in the global pharmaceutical market. This is especially true in emerging markets…” 2
GlaxoSmithKline (GSK) continues to see emerging markets and Japan as critical, stating that in the
Emerging Markets Asia Pacific region they are looking for marketed or late life-cycle products, biosimilar
candidates, and branded generics to take to market - highlighting that partner company compounds will be
promoted alongside flagship GSK brands in the region and will benefit from their strong local presence and
deep market understanding.3
While the opportunities for expansion are vast, they are also complex. A study by Logistics Management
stated that in interviews with more than 250 senior executives of Asian companies “only 28 percent said
their revenues and profits from international markets had fully developed in line with expectations over the
past three years”.4 Clearly, the risk of making an expensive (financially and opportunistically) mistake is high.
HOW WILL YOU SUCCEED?
Defining your strategy is crucial. What best suits your company for the portfolio of drugs at your disposal?
Should you look to regulated markets with the objective of securing some of the growth share (USA)? Or
steer towards static markets but take existing market share from competitors because you have a positively
differentiated drug (EU)? Can you be first to market in an emerging region? Should you develop strategic
relationships with local manufacturers, Fill & Finish Operations, or distributors? Are growth markets really
where your opportunities lie?
Comprehensive, insightful, and directional data can help to ensure your company is among the successful 28
percent. Accessible information relevant to your company and your portfolio is critical to reducing risks and
accelerating your decision making.
KEY QUESTIONS YOU WILL BE ASKING
YOURSELF WILL INCLUDE:
Market Product
• Are there sufficient unmet medical needs and • Will your product be competitive in the new
gaps in the market to support your product(s)? market – against currently marketed products
and those coming through the pipeline?
• Where can we be most competitive with the
opportunity to become market leaders? • Where will your product fit in the existing
market?
• Are the overall market dynamics in those
countries we are considering expanding to • What are the key differentiators of your
conducive to growth for your compound(s)? product(s)?
• Do the market opportunities outweigh the
market requirements for entry?
• How are you able to obtain a concise overview
of challenges, opportunities, and suggested
priorities across markets to inform your
expansion strategy?200 153
149
127
100
Barriers to Entry Route27 to31Market
0
United States Canada Japan Growth
• What are the regulatory requirements for filing; • Who couldEU-Big 5
we collaborate with that hasROW
Markets local
can we anticipate any regulatory challenges? Sales in 2011 infrastructure
Sales in 2020 and knowledge?
• What are the clinical requirements for market • Who has done deals in this area previously,
Source: PWC Consulting
entry – what clinical trial data packages are and who is currently open to partnering?
required for submission in each country? What
studies are required to determine bioequivalence
standards for generics?
What are the
• What are the existing pricing and reimbursement regulatory
(P&R) models in each market – are there any requirements in
regulatory or P&R hurdles that would reduce each country I am
the attractiveness or that could provide a Is there evaluating? What are
sufficient unmet the clinical
competitive advantage? need in the requirements for
markets I’m my product in
considering? each country?
Which
Is my product
Market
competitive Should I Which market
WHERE CAN YOU TURN verses currently
marketed Prioritize?
is likely to
offer the most
TO FIND STRATEGIC products? opportunity?
INTELLIGENCE? Who could I
Do market
potentially
Gain a strategic business partner with a proven dynamics match
partner with to
my strategic
record of supporting pharmaceutical companies. intent?
support market
We are a partner with experience, expertise, entry?
global presence, and client focus. For today’s
challenges, and those yet ahead, Thomson Reuters
is uniquely positioned to understand what you are
facing – and help you manage, adapt, and prosper.
When undertaking such important decisions, high level general reports do not provide the necessary
detailed information that is relevant to your specific needs, portfolio and strategy. The Thomson Reuters
Market Assessment Report is different. This service will support your market expansion objectives in light
of your overall company strengths, your strategy, the compounds within your portfolio, and for markets that
you specify.
By engaging Thomson Reuters you will:
• Secure access to relevant, proprietary • Receive consolidated insights across up to four
competitive intelligence, regulatory information, independent, selected markets for a specified
incidence & prevalence data, clinical trial and compound or compounds
un-redacted deals data not available through • Receive professional direction and insight about
any other individual source which market(s) offer the largest opportunity,
• Capitalize on Thomson Reuters experience in specifically considering your compound(s)
Key Opinion Leader identification, engagement
and interviewing to provide “real time” industry
insight to key advantages and challenges your
compound(s) may face in each market
Engagement with Thomson Reuters will enable clients to make more efficient, informed decisions relating
to your market expansion strategy than ever before. Supported by data driven analysis and industry insight,
you will be better positioned to positively influence the strategy of your company – by securing insight on
how and where you are likely to succeed.INTEGRATED SOURCES OF INTELLIGENCE
12,000 active ingredients, 140,000 products, and 66,000 companies are covered with worldwide data on:
• API development and manufacturing status
• Routes of synthesis from patents and literature
• Patent families and country patents owned by innovators, generics, and API manufacturers
with estimated expiry dates
• Patent and non-patent exclusivities
• GMP certifications from several countries
• Regulatory filings, including drug master files for US, Japan, and Korea
• Finished dose form sales, kilogram consumption, and worldwide launches of drugs
UNIQUE, PROVEN TIME-SAVING ANALYTICS
Unique proprietary analytics estimate generic launch dates in more than 30 countries; characterize
company capabilities and allow you to rapidly assess the strength of your competition; and target APIs with
minimal competition or with limited or no availability for use in specific world markets.
COMPETITIVE INTELLIGENCE
Competitive intelligence integrating more than 40 pharmaceutical data sources, unique abstracts,
commentaries and analysis, covering in excess of 55,000 drugs, over 13,000 targets, and more than
178,000 clinical trials
REGULATORY INTELLIGENCE
Regulatory framework, requirements, and P&R processes for 70 countries across the globe.
DEAL MAKING AND PARTNERING
Combined data on drugs in development, the companies developing them, the partnering deals being done
around them, and their market potential. More than 39,000 deals documented.
PRIMARY RESEARCH CAPABILITIES
Access to a leading primary market research capability covering all aspects of patient, physician and payer
attitudes to drugs. The capability covers quantitative and qualitative research and allows for fully informed
market and landscape analysis.
References
1. http://blogs.wsj.com/health/2010/03/16/astrazeneca-maps-selective-expansionin-emerging-markets/
2. http://www.fiercebiotech.com/press-releases/pfizer-expands-its-genericsportfolio-through-innovative-licensing-deals-increasing-a
3. http://www.gsk.com/partnerships/business-development/pharmaceuticalscollaborations/ commercial-opportunities.html
4. http://www.logisticsmgmt.com/article/global_logistics_challenges_for_expansion_into_emerging_marketsYou can also read
