type 2 diabetes - current and future players

REF ER EN CE CO DE GDH C1018F PR | PU BLIC AT ION DAT E JU LY 2013
TYPE 2 DIABETES CURRENT AND FUTURE PLAYERS
TYPE 2 DIABETES CURRENT AND FUTURE PLAYERS
Executive Summary
Sales for Type 2 Diabetes by Region 2012–2022
GlobalData estimates that sales of Type 2
Sales for Type 2 Diabetes by Region, 2012–
2022
Diabetes therapeutics in 2012, the base year of the
5% 1%
in the seven major markets (7MM): US, France,
Germany, Italy, Spain, UK, and Japan. By the end
2012
Total: $28.1bn
9%
forecast period, totalled approximately $28.1 billion
9%
of the forecast period in 2022, Type 2 Diabetes
sales will grow to $68.8 billion at a Compound
Annual Growth Rate (CAGR) of 9.4%.
58%
18%
The major drivers of Type 2 Diabetes market
growth over the forecast period are:

US
5EU
Steadily increased in patient share for each of
7%
the drug classes, including insulins

Increase in the patient pool rapidly due to
worldwide
increasing
in
prevalence
Japan
China
India
2%
Brazil
2022
Total: $68.8bn
14%
and
diagnosis of the disease
7%
56%
The major barriers that will restrict the growth of
14%
the Type 2 Diabetes market during the forecast
period are:

Slow uptake of the branded drugs and make
product launches more difficult because of
US
5EU
Japan
China
India
Brazil
Source: GlobalData.
increased access to affordable medications

Cost-effectiveneness pressure in the major
markets specially in 5EU, Japan, India and
China
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TYPE 2 DIABETES CURRENT AND FUTURE PLAYERS
Executive Summary
Patent
Expiration
Challenge
for
Type
2
Diabetes Market Players
Future Leaders in Type 2 Diabetes Market
Future leaders during the forecast period will
Among the companies in this sector, seven large
include: Eli Lilly with its largest portfolio of recently
pharmaceutical companies in this segment had or
launched and late-stage pipeline drugs; Bristol-
will have blockbuster drugs in this therapeutic area,
Myers Squibb/AstraZeneca’s partnership with their
and/or held a large share in the insulin market.
recently launched first-to-market long-acting GLP-1
Several of these companies faced or are currently
analog Bydureon and first-to-the-EU-market SGLT-
facing challenges due to forthcoming patent
2 inhibitor Forxiga; Novo Nordisk with its recently
expirations. GSK’s blockbuster drug Avandia and
launched ultra-long-acting insulin analog as well as
Takeda’s blockbuster drug Actos both lost their
the rich early-stage pipeline that indicates the
patent exclusivity in 2012, Sanofi will be facing a
company’s devotion to future domination; Johnson
patent expiry for its blockbuster insulin analog
& Johnson and a partner in Japan, Mitsubishi
Lantus next year, and Eli Lilly will face a patent cliff
Tanabe, with their potential blockbuster first-to-the-
for Humalog this year, while Merck will lose patent
US-market
exclusivity for its blockbuster drug Januvia during
possibly Takeda with its recently launched trio
the forecast period, in 2017. Some of these
Nesina, Oseni and Kazano, as well as a first-in-
companies are developing strategies to address
class GPR40 inhibitor in late-stage development.
these challenges by funding maturing late-stage
pipeline drugs, while others might lose their
leadership position during the years to come. All
companies are aware of the huge market potential
in the type 2 diabetes arena, and all will certainly
try their best to stay at least as players if not as
leaders.
SGLT-2
inhibitor
Invokana;
and
SGLT-2 Inhibitors in Type 2 Diabetes Market
All pharmaceutical companies are facing big
challenges to advance new drugs for diabetes,
especially after GlaxoSmithKline's Avandia scandal
regarding increased heart attacks. Worldwide,
regulators are on high alert for any safety risks
related to diabetes therapies. However, key areas
for development include drugs that decrease
insulin resistance, target cardiovascular issues and
have limited dosing requirements. The most recent
trend for type 2 diabetes medications is reflected in
the novel class of SGLT-2 inhibitors.
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TYPE 2 DIABETES CURRENT AND FUTURE PLAYERS
Executive Summary
The recently approved AstraZeneca’s and Bristol-
These markets not only represent the strongest
Myers Squibb’s Forxiga could open the door for
opportunities for growth, but also represent an
new type 2 diabetes treatments, and several Big
opportunity
Pharma companies (Eli Lilly and Boehringer
quality in these rising economies.
Ingelheim, Pfizer, Johnson & Johnson, Astellas
Pharma and Chugai Pharmaceuticals) are rushing
to
positively influence
healthcare
What Do the Physicians Think?
to join this market. Considering that they can work
“I think that [the number of] people needing a
independently of insulin, SGLT-2 inhibitors clearly
second and third drug is going to increase
show the biggest promise to take a substantial part
dramatically in the next 10 years and that we will
of the type 2 diabetes market share during the
just see those numbers go up, up, up. Two things
forecast period, although there is still a lack of
are going to drive that up. One is the expectation
long-term safety data for this class, which leaves
that we’ll treat these people fairly aggressively to
some level of uncertainty.
get their A1c down to around 7 to 7.5. The target
appears to be moving based on a few of the
Investment to Emerging Markets
Unfortunately,
Big
generally
after 8.5 and 9 like we used to. That’s going to
decreased its R&D investments into new chemical
drive it, and second is that most people are not
entities due to the high cost and high risk of new
going to have a control over lifestyle, they are
drug development, a decision reinforced by all
going to continue to overeat and under-exercise
other challenges that the industry is currently
and they are going to see their weight continue to
facing,
go
including
Pharma
studies, but we are not going to tolerate people
patent
has
expirations,
pricing
up
and
therefore
their
need
for
more
pressures and increasing regulatory hurdles. In
medications will go up with it. So I think [in this] the
recent years the big companies show a trend of
market, the sky is the limit on how much the
filling their weak pipelines mostly through mergers
market is going to be.”
and acquisitions, in-licensing new compounds, and
developing strategic alliances and partnerships
with
other
pharmaceutical
or
Key Opinion Leader, April 2013
biotechnology
companies. Investment into emerging markets,
such as Brazil, Russia, India, China and Mexico,
represent a very visible trend and attractive
strategic opportunity for major pharma players,
particularly in type 2 diabetes.
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TYPE 2 DIABETES CURRENT AND FUTURE PLAYERS
Executive Summary
“I think over the next 10 years the long-acting GLP-
“The SGLT-2s and the dual PPARs are probably
1 receptor agonist therapies will increase the most,
going to have a better impact long-term… the
because now you know the companies will be
things that increase insulin secretion, somewhat
developing once-a-week treatments… Longer-
are similar to the sulfonylureas, they are going to
acting preparations, if they are proved to be
have hypoglycemic events, or they are going to
effective and safe, will be used more and more
cause people to gain weight, or they are going to
because they really do have a benefit in weight
burn the pancreas out…
loss.”
impressed with them than I am with the SGLT-2s
Key Opinion Leader, April 2013
I am much less
and the dual PPARs.”
Key Opinion Leader, April 2013
“Weight change direction or level and the risk of
hypoglycemia, these are strong determinants for
“The whole concept of individualization of therapy
the choice of the drug today or in the future even
is very important; it is something that we practiced
more.”
for a long time. Each patient is different. We have
Key Opinion Leader, April 2013
“My biggest challenge [with type 2 diabetes] has
to give quite a combination of drugs to each patient
depending on various factors.”
Key Opinion Leader, April 2013
been the lack of long-term efficacy; that the
disease is complicated, the disease is resilient, and
“I think the use of metformin [first-line therapy] will
most of the agents are not potent enough to get
not change. I think it will continue, but the use of
everybody under control long enough. So, lack of
sulfonylureas will decline… I think they will be
efficacy
gradually replaced by newer therapies, some
and
having
therefore
to
combine
medications has been my biggest challenge.”
Key Opinion Leader, April 2013
“We have SGLT-2 inhibitors, we have the long-
available now, some will be available later in the
future.”
Key Opinion Leader, April 2013
acting GLP-1 receptor agonists, DPP-4 inhibitors,
and this will be quite a choice now for physicians to
find the right drugs or right combination of drugs.”
Key Opinion Leader, April 2013
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TYPE 2 DIABETES CURRENT AND FUTURE PLAYERS
Executive Summary
“The endocrinologist recognized that being overly
So, me and other colleagues, what we have been
conservative can hurt the patients, so in other
doing really for years is that we know what works
words if you say that there is no long-term data for
and we know what doesn’t work … we know that
new drug that can prevent complications, you can’t
we don’t have data but we really need to prescribe
wait. I am not going to wait for 10 years for
certain therapies without data, knowing what the
randomized controlled trials to show me that
advantages are. I think that the newer guidelines
injection will dispel. If I know that it prevents
fully
complications, I am happy. We are not going to
endocrinologists are doing, I think the guidelines
have 300 randomized controlled trials checking all
didn’t set up anything new, they are just catching
possible combinations because now it’s so many
up with what physicians are doing already.”
combinations of drugs you could test.
acknowledge
the
reality,
that’s
what
Key Opinion Leader, April 2013
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TYPE 2 DIABETES CURRENT AND FUTURE PLAYERS
Table of Contents
1
Table of Contents
1 Table of Contents .......................................................................................................................... 7
1.1 List of Tables.......................................................................................................................... 10
1.2 List of Figures ........................................................................................................................ 11
2 Introduction ................................................................................................................................. 12
2.1 Catalyst .................................................................................................................................. 12
2.2 Related Reports ..................................................................................................................... 13
2.3 Upcoming Related Reports .................................................................................................... 16
3 Market Outlook ............................................................................................................................ 17
3.1 Global Markets ....................................................................................................................... 17
3.1.1
Forecast ......................................................................................................................... 17
3.1.2
Drivers and Barriers – Global Issues............................................................................... 23
4 Current and Future Players ......................................................................................................... 25
4.1 Overview ................................................................................................................................ 25
4.2 Trends in Corporate Strategy ................................................................................................. 28
4.3 Company Profiles................................................................................................................... 29
4.3.1
Eli Lilly ............................................................................................................................ 29
4.3.2
Bristol-Myers Squibb....................................................................................................... 32
4.3.3
Novo Nordisk .................................................................................................................. 35
4.3.4
Sanofi ............................................................................................................................. 38
4.3.5
GlaxoSmithKline ............................................................................................................. 41
4.3.6
AstraZeneca ................................................................................................................... 43
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TYPE 2 DIABETES CURRENT AND FUTURE PLAYERS
Table of Contents
4.3.7
Merck & Co ..................................................................................................................... 45
4.3.8
Boehringer Ingelheim...................................................................................................... 47
4.3.9
Takeda ........................................................................................................................... 49
4.3.10 Roche ............................................................................................................................. 51
4.3.11 Pfizer .............................................................................................................................. 53
4.3.12 Johnson & Johnson ........................................................................................................ 55
5 Appendix ..................................................................................................................................... 57
5.1 Bibliography ........................................................................................................................... 57
5.2 Abbreviations ......................................................................................................................... 59
5.3 Methodology .......................................................................................................................... 62
5.4 Forecasting Methodology ....................................................................................................... 62
5.4.1
Diagnosed Type 2 Patients ............................................................................................. 62
5.4.2
Percent Drug-Treated Patients ....................................................................................... 63
5.4.3
Drugs Included in Each Therapeutic Class ..................................................................... 63
5.4.4
Launch and Patent Expiry Dates..................................................................................... 64
5.4.5
General Pricing Assumptions.......................................................................................... 65
5.4.6
Individual Drug Assumptions .......................................................................................... 66
5.4.7
Generic Erosion .............................................................................................................. 75
5.4.8
Pricing of Pipeline Agents ............................................................................................... 75
5.5 Physicians and Specialists Included in this Study................................................................... 77
5.6 About the Authors .................................................................................................................. 79
5.6.1
Analyst II – CVMD .......................................................................................................... 79
5.6.2
Therapy Director – CVMD and Infectious Disease .......................................................... 79
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TYPE 2 DIABETES CURRENT AND FUTURE PLAYERS
Table of Contents
5.6.3
Global Head of Healthcare.............................................................................................. 80
5.7 About GlobalData ................................................................................................................... 81
5.8 Disclaimer .............................................................................................................................. 81
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TYPE 2 DIABETES CURRENT AND FUTURE PLAYERS
Table of Contents
1.1
List of Tables
Table 1: Global Sales Forecasts ($m) for Type 2 Diabetes, 2012–2022 ......................................................... 20
Table 2: Type 2 Diabetes Market – Drivers and Barriers, 2012 ....................................................................... 23
Table 3: Key Companies in the Type 2 Diabetes Market, 2012....................................................................... 26
Table 4: Other Companies in the Type 2 Diabetes Market, 2012 .................................................................... 27
Table 5: Eli Lilly’s Type 2 Diabetes Portfolio Assessment, 2013 ..................................................................... 31
Table 6: Eli Lilly SWOT Analysis, 2012 .......................................................................................................... 32
Table 7: Bristol-Myers Squibb’s Type 2 Diabetes Portfolio Assessment, 2013 ................................................ 34
Table 8: Bristol-Myers Squibb SWOT Analysis, 2012 ..................................................................................... 35
Table 9: Novo Nordisk’s Type 2 Diabetes Portfolio Assessment, 2013 ........................................................... 37
Table 10: Novo Nordisk SWOT Analysis, 2012 .............................................................................................. 38
Table 11: Sanofi’s Type 2 Diabetes Portfolio Assessment, 2013 .................................................................... 40
Table 12: Sanofi SWOT Analysis, 2012 ......................................................................................................... 40
Table 13: GSK’s Type 2 Diabetes Portfolio Assessment, 2013 ....................................................................... 42
Table 14: GSK SWOT Analysis, 2012 ............................................................................................................ 42
Table 15: AstraZeneca’s Type 2 Diabetes Portfolio Assessment, 2013 .......................................................... 44
Table 16: AstraZeneca SWOT Analysis, 2012 ............................................................................................... 44
Table 17: Merck’s Type 2 Diabetes Portfolio Assessment, 2013..................................................................... 46
Table 18: Merck SWOT Analysis, 2012 .......................................................................................................... 46
Table 19: Boehringer Ingelheim’s Type 2 Diabetes Portfolio Assessment, 2013 ............................................. 48
Table 20: Boehringer Ingelheim SWOT Analysis, 2012 .................................................................................. 48
Table 21: Takeda’s Type 2 Diabetes Portfolio Assessment, 2013................................................................... 50
Table 22: Takeda SWOT Analysis, 2012........................................................................................................ 51
Table 23: Roche’s Type 2 Diabetes Portfolio Assessment, 2013 .................................................................... 52
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TYPE 2 DIABETES CURRENT AND FUTURE PLAYERS
Table of Contents
Table 24: Roche SWOT Analysis, 2012 ......................................................................................................... 52
Table 25: Pfizer’s Type 2 Diabetes Portfolio Assessment, 2013 ..................................................................... 54
Table 26: Pfizer SWOT Analysis, 2012 .......................................................................................................... 54
Table 27: J&J’s Type 2 Diabetes Portfolio Assessment, 2013 ........................................................................ 55
Table 28: J&J SWOT Analysis, 2012 ............................................................................................................. 56
Table 29: Key Launch Dates.......................................................................................................................... 64
Table 30: Key Patent Expiries ........................................................................................................................ 64
Table 31: Number of High-Prescribing Physicians Surveyed .......................................................................... 78
1.2
List of Figures
Figure 1: Global Sales for Type 2 Diabetes by Region, 2011–2022 ................................................................ 22
Figure 2: Company Portfolio Gap Analysis in Type 2 Diabetes, 2012–2022 .................................................... 27
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TYPE 2 DIABETES CURRENT AND FUTURE PLAYERS
Introduction
2
Introduction
2.1
Catalyst
The American Diabetes Association’s 73rd Scientific Sessions, held in June 2013, represented an
opportunity for the major industry players with a stake in the type 2 diabetes market to showcase
their diabetes drugs’ latest results. In particular, Eli Lilly presented new data on its investigational
drugs, dulaglutide and empagliflozin, as well as confirmed its development and regulatory
timescale for biosimilar insulin products, including a version of Sanofi's Lantus. Another key
takeaway from the ADA sessions was Sanofi’s encouraging data on its Lantus follow-on product,
aimed at protecting its Lantus franchise.
While the global type 2 diabetes market is crowded with inexpensive generics and marked by a
pipeline filled with me-too drugs, GlobalData expects this market to undergo substantial growth
between 2012 and 2022, more than doubling over this period. The main driver of this enormous
expansion will be the dramatic increase in disease prevalence, which is attributable to increased
life expectancy and an increasingly sedentary and stressful lifestyle. The second largest driver will
be the physicians’ efforts to delay disease progression and reduce the costly burden of diabetic
complications through the use of combination therapies and novel branded drugs. In the emerging
markets in particular, uptake of branded drugs will increase due to rapid economic growth.
Despite the high number of marketed therapies, this market is still experiencing large unmet needs
and it has a significant growth opportunity for new patent-protected products. Metformin will remain
the first-line therapy for type 2 diabetes due to physicians’ familiarity with it and the availability of
long-term data, but the usage of sulfonylureas, another front-line therapy, will gradually be replaced
over the next 10 years by novel therapies with improved side-effect profiles. The battle for secondor third-line therapy will involve DPP-4 inhibitors, GLP-1 receptor agonists, SGLT-2 inhibitors and
other upcoming novel therapies. Of all currently marketed classes, GLP-1 receptor agonists will
experience the fastest growth due to their weight-loss effects and the skyrocketing epidemic of
obesity. With the recent therapeutic guidelines putting emphasis on a patient-tailored approach in
treating type 2 diabetes, pharmaceutical companies will achieve considerable success with their
me-too drugs. In the future, companies may choose to focus not on blockbuster medicines, but
rather on niche drugs that are aimed at smaller groups.
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TYPE 2 DIABETES CURRENT AND FUTURE PLAYERS
Introduction
2.2

Related Reports
GlobalData (2013). Actos (Type 2 Diabetes) –Forecast and Market Analysis to 2022, July,
2013, GDHC214DFR.

GlobalData (2013). Byetta (Type 2 Diabetes) –Forecast and Market Analysis to 2022, July,
2013, GDHC2165DFR.

GlobalData (2013). Victoza (Type 2 Diabetes) –Forecast and Market Analysis to 2022, July,
2013, GDHC216DFR.

GlobalData (2013). Bydureon (Type 2 Diabetes) –Forecast and Market Analysis to 2022, July,
2013, GDHC217DFR.

GlobalData (2013). Lyxumia (Type 2 Diabetes) –Forecast and Market Analysis to 2022, July,
2013, GDHC219DFR.

GlobalData (2013). Januvia (Type 2 Diabetes) –Forecast and Market Analysis to 2022, July,
2013, GDHC220DFR.

GlobalData (2013). Onglyza (Type 2 Diabetes) –Forecast and Market Analysis to 2022, July,
2013, GDHC221DFR.

GlobalData (2013). Tradjenta (Type 2 Diabetes) –Forecast and Market Analysis to 2022, July,
2013, GDHC222DFR.

GlobalData (2013). Galvus (Type 2 Diabetes) –Forecast and Market Analysis to 2022, July,
2013, GDHC223DFR.

GlobalData (2013). Nesina (Type 2 Diabetes) –Forecast and Market Analysis to 2022, July,
2013, GDHC224DFR.

GlobalData (2013). Forxiga (Type 2 Diabetes) –Forecast and Market Analysis to 2022, July,
2013, GDHC225DFR.
Type 2 Diabetes - Current and Future Players
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13
TYPE 2 DIABETES CURRENT AND FUTURE PLAYERS
Introduction

GlobalData (2013). Invokana (Type 2 Diabetes) –Forecast and Market Analysis to 2022, July,
2013, GDHC226DFR.

GlobalData (2013). Humalog (Type 2 Diabetes) –Forecast and Market Analysis to 2022, July,
2013, GDHC227DFR.

GlobalData (2013). Lantus (Type 2 Diabetes) –Forecast and Market Analysis to 2022, July,
2013, GDHC228DFR.

GlobalData (2013). Levemir (Type 2 Diabetes) –Forecast and Market Analysis to 2022, July,
2013, GDHC229DFR.

GlobalData (2013). Novolog (Type 2 Diabetes) –Forecast and Market Analysis to 2022, July,
2013, GDHC230DFR.

GlobalData (2013). Apidra (Type 2 Diabetes) –Forecast and Market Analysis to 2022, July,
2013, GDHC231DFR.

GlobalData (2013). Tresiba (Type 2 Diabetes) –Forecast and Market Analysis to 2022, July,
2013, GDHC232DFR.

GlobalData (2013). Albiglutide (Type 2 Diabetes) –Forecast and Market Analysis to 2022, July,
2013, GDHC233DFR.

GlobalData (2013). Dulaglutide (Type 2 Diabetes) –Forecast and Market Analysis to 2022,
July, 2013, GDHC234DFR.

GlobalData (2013). Semaglutide (Type 2 Diabetes) –Forecast and Market Analysis to 2022,
July, 2013, GDHC235DFR.

GlobalData (2013). Trelagliptin (Type 2 Diabetes) –Forecast and Market Analysis to 2022, July,
2013, GDHC236DFR.

GlobalData (2013). MK-3102 (Type 2 Diabetes) –Forecast and Market Analysis to 2022, July,
2013, GDHC237DFR.

GlobalData (2013). Empagiflozin (Type 2 Diabetes) –Forecast and Market Analysis to 2022,
July, 2013, GDHC238DFR.
Type 2 Diabetes - Current and Future Players
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14
TYPE 2 DIABETES CURRENT AND FUTURE PLAYERS
Introduction

GlobalData (2013). Tofogliflozin (Type 2 Diabetes) –Forecast and Market Analysis to 2022,
July, 2013, GDHC239DFR.

GlobalData (2013). Ipragliflozin (Type 2 Diabetes) –Forecast and Market Analysis to 2022,
July, 2013, GDHC240DFR.

GlobalData (2013). Fasiglifam (Type 2 Diabetes) –Forecast and Market Analysis to 2022, July,
2013, GDHC241DFR.

GlobalData (2013). LY2409021 (Type 2 Diabetes) –Forecast and Market Analysis to 2022,
July, 2013, GDHC242DFR.

GlobalData (2013). LY2605541 (Type 2 Diabetes) –Forecast and Market Analysis to 2022,
July, 2013, GDHC243DFR.

GlobalData (2013). Type 2 Diabetes – United States Drug Forecast and Market Analysis to
2022. GDHC133CFR.

GlobalData (2013). Type 2 Diabetes – France Drug Forecast and Market Analysis to 2022.
GDHC134CFR.

GlobalData (2013). Type 2 Diabetes – Germany Drug Forecast and Market Analysis to 2022.
GDHC135CFR.

GlobalData (2013). Type 2 Diabetes – Italy Drug Forecast and Market Analysis to 2022.
GDHC136CFR.

GlobalData (2013). Type 2 Diabetes – Spain Drug Forecast and Market Analysis to 2022.
GDHC137CFR.

GlobalData (2013). Type 2 Diabetes – United Kingdom Drug Forecast and Market Analysis to
2022. GDHC138CFR.

GlobalData (2013). Type 2 Diabetes – Japan Drug Forecast and Market Analysis to 2022.
GDHC139CFR.

GlobalData (2013). Type 2 Diabetes – China Drug Forecast and Market Analysis to 2022.
GDHC140CFR.
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TYPE 2 DIABETES CURRENT AND FUTURE PLAYERS
Introduction

GlobalData (2013). Type 2 Diabetes – India Drug Forecast and Market Analysis to 2022.
GDHC141CFR.

GlobalData (2013). Type 2 Diabetes – Brazil Drug Forecast and Market Analysis to 2022.
GDHC142CFR.
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TYPE 2 DIABETES CURRENT AND FUTURE PLAYERS
Appendix
5.7
About GlobalData
GlobalData is a leading global provider of business intelligence in the Healthcare industry.
GlobalData provides its clients with up-to-date information and analysis on the latest developments
in drug research, disease analysis, and clinical research and development. Our integrated business
intelligence solutions include a range of interactive online databases, analytical tools, reports and
forecasts. Our analysis is supported by a 24/7 client support and analyst team.
GlobalData has offices in New York, Boston, London, India and Singapore.
5.8
Disclaimer
All Rights Reserved.
No part of this publication may be reproduced, stored in a retrieval system or transmitted in any
form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior
permission of the publisher, GlobalData.
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