analysis of the type 2 diabetes therapeutics market

Analysis of the Type 2 Diabetes Therapeutics Market Global Market Opportunities for Differentiated Therapeutics

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July 2013

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This research service examines the global market for type 2 diabetes therapeutics. Topics covered

include the following:

• Market definitions including segmentation and clinical diagnostic criteria

• Important trends, unmet needs, opportunities and risks in the management of type 2 diabetes

Spotlight on companies and pipeline products to watch

• Comprehensive product and pipeline synopses and analyses

• Comparative product profile and clinical efficacy analyses

• Launch timelines and patent expirations

• Cardiovascular outcomes trials timeline

• Segment-level forecasts and discussions of insulin and non-insulin therapeutics

• Regional forecasts and discussions including evaluation of the United States, major European

markets, and select Asia-Pacific markets

Contents

Source: Frost & Sullivan

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• The information contained in this research service was derived from a variety of relevant primary and

secondary information sources.

• Primary interviews were conducted with industry participants in positions such as chairman and CEO,

director of investor relations, director of business development, chief business officer, media relations,

and international key opinion leaders (KOL).

• Secondary data sources include disease and public health organization websites [International

Diabetes federation (IDF), World Health Organization (WHO), American Diabetes Association (ADA)];

company publications (annual reports, U.S. Securities and Exchange Commission (SEC) filings,

investor presentations, earnings transcripts, and press releases); government public sources;

pharmaceutical industry databases; and published articles in scientific and medical journals.

• For the United States, revenue forecasting is performed using a robust, data-driven, bottom-up,

patient-based approach. Marketed drugs and potential new entrants in Phase 3 of development and

beyond are individually forecast, and aggregate figures are provided. For other regions, forecasting is

performed using a top-down model.

Methodology


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Scope and Segmentation


Geographic coverage Global

Study period 2009–2017

Base year 2012

Forecast period 2013—2017

Monetary unit US Dollars

• This research service evaluates the global market for type 2 diabetes therapeutics. It does not

evaluate other diabetes care markets such as glucose meters and supplies, insulin syringes, insulin

pumps, or glucose tablets and other nutritionals.

• Included are insulin and insulin analogues, oral anti-diabetic drugs (OAD) and injectable anti-diabetic

drugs apart form insulin.

• In-depth analysis is provided for the major markets of the United States and Europe. The emerging

markets of China, South Korea, Malaysia, Indonesia, Vietnam, and India are also evaluated with an

emphasis on the regional environment.

• Units are patients. Treated patient numbers, when estimated, are derived from annual sales revenue

and annual cost of therapy.

• The price is the annual cost of therapy. Average annual cost of therapy is based on the average

wholesale price (AWP) per drug, as reported in Thomson Reuters Red Book. Hospital or clinic-

associated expenses are not included in the cost of therapy.

• Indication-specific annual revenue as reported is used when available; otherwise, estimates are used.

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Key Questions This Study Will Answer


Is the market growing, how long will it continue to grow, and at what rate? Which segments and

geographic regions are experiencing the fastest growth?

How will the competitive landscape be affected by new product launches and patent expiries? How

do the product profiles of new products compare to existing products?

What are the remaining unmet needs of diabetes patients? How can participants and emerging

competitors meet these needs?

What are the major trends affecting the growth of this market? What are the biggest risks for

participants or potential participants?

What are the biggest opportunities and risks in emerging markets? What is the relative impact of

social, economic, pricing constraints, and regulatory factors on emerging market penetration?

How competitive is this market? Is this market trending toward increasing or decreasing

competitiveness?

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Insulins

Total Type 2 Diabetes Therapeutics Market

Total Type 2 Diabetes Therapeutics Market: Market Segmentation, Global, 2012

Non-Insulin Therapeutics

Rapid insulin

Add-on to SOC

Premix/

Intermediate insulin

Market Segmentation


Standard of Care

(SOC)

Basal insulin

Biguinides

Sulfonylureas

Meglitinides

Glitazones

Incretins

SGLT2s*

Human Insulin Modern Insulins

*Sodium-glucose co-transporter 2

Regular insulin

Premix/

Intermediate insulin

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New Market Opportunities


Unmet Needs

• The most important unmet need of diabetes

patients remains clinically meaningful

cardiovascular benefit.

• Although improvements in surrogate markers

such as lipids and inflammatory biomarkers are

a step in the right direction, clear demonstration

of reduced risk of a cardiovascular event is

critical for evidence-based medicine.

• Although many newer therapies are able to

more effectively manage blood glucose levels,

impact on disease progression is still lacking,

and most patients must still progress through

an increasingly complicated therapeutic

regimen, usually culminating at insulin therapy.

• The population with prediabetes is estimated to

be approximately three times the size of the

diabetes population. Prophylactic therapy

based on identified precursors to full blown

diabetes is a key unmet need.

Current Participant Strategies

• Novo Nordisk: Meets the diverse needs of

insulin patients by providing a complete insulin

portfolio. Also invests in other biopharma

antidiabetics such as Victoza. Novo Nordisk

focuses on the highly lucrative biopharma

sector where they have considerable capability

and barriers to entry are higher.

• Merck: Achieved market leadership among

non-insulin antidiabetics with a single first-in-

class blockbuster, Januvia. Januvia was the

first add-on oral drug with no weight gain or

other troublesome side effects, allowing it to

rapidly capture a large market share by

addressing a key unmet need of patients.

• Sanofi: Similar to Merck, Sanofi has achieved

the number two spot in the entire diabetes

therapeutics market with the success of their

blockbuster insulin Lantus. Lantus was the first

long-acting basal insulin, greatly increasing the

convenience of insulin therapy.

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Rapid

Basal

Parenteral

Oral/transmucosal/inhaled

Pre-Mix/Intermediate

Total Type 2 Diabetes Therapeutics Market: Competitive Landscape—Insulin Segment, Marketed

and Pipeline Products by Type, Global, 2012

Competitive Landscape—Insulin Segment

Marketed and Pipeline Products (continued)


Phase 1 Phase 3 Market Preregistration Phase 2

Tresiba (EU, JP)

(NVO)

Tresiba (US)

(NVO)

NN1954

(NVO)

Levemir

(NVO)

Lantus

(SNY)

LY2605541

(BING/LLY)

NN1953

(NVO)

SuliXen

(Xenetic Biosciences)

LAI287 (NN1436)

(NVO) Nodlin

(NOD Pharmaceuticals)

LY2963016

(BING/LLY)

IDegLira

(NVO)

HOE901/AVE0010

(SNY/Zealand)

Humalog

(LLY)

Novolog

(NVO)

Apidra

(SNY) BIOD-238

(Biodel) Novolog Mix 75/25

(NVO)

Humalog 50/50

(LLY)

Humalog25/75

(LLY)

Humulin N

(LLY)

BIOD-123

(Biodel)

Ryzodeg (EU, JP)

(NVO)

Ryzodeg (US)

(NVO)

ORMD-0801

(Oramed)

Afrezza

(Mannkind) BIOD-250

(Biodel)

NN1218

(NVO

Oral-lyn

(Generex)

IN-105

(Biocon/BMY)

Insuman

(SNY)

Humulin R

(LLY)

HM12460A (LAPS-Insulin)

(Hanmi Pharmaceutical)

Insulin glargine U-300

(SNY)

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Pipeline Analysis—Insulin Segment

Products in Late Stage Clinical Development

Product Company MOA/Class Phase Dosing/

Administration Comments

Afrezza

Mannkind,

Emisphere

Technologies

Rapid-acting

insulin analogue Phase 3 Inhalation

Potential first-in-class

inhalable insulin

IDegLira

(insulin degludec +

liraglutide)

Novo Nordisk

Basal insulin +

GLP-1 analogue

fixed combination

Phase 3 SC injection once

daily

Complimentary

combination; potential

superior efficacy among all

anti-diabetics

Insulin glargine U-

300 Sanofi Basal insulin Phase 3

SC injection once

daily

Concentrated formulation

with improved PK/PD

LY2605541

(insulin peglispro) Eli Lilly

Basal insulin

analogue Phase 3

SC injection once

daily

Liver-targeted; potential for

improved outcomes,

particularly for liver-specific

insulin resistance

LY2963016

(insulin glargine)

Boehringer

Ingelheim/Eli

Lilly

Basal insulin

analogue Phase 3

SC injection once

daily Biosimilar Lantus

Oral-lyn Generex Rapid-acting

insulin analogue Phase 3

Transmucosal

(buccal spray)

Needle-less administration,

but multiple sprays per

dose required; possible

absorption issues


Total Type 2 Diabetes Therapeutics Market: Insulin Segment, Late Stage Product Synopsis,

Global, 2012

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Products in Mid–stage Clinical Development



BIOD-123 Biodel

Ultra-rapid-acting

recombinant

human insulin

formulation

Phase 2 SC injection

Absorption 64% faster than

Humalog; improved injection

site reaction profile compared

to first generation formulation

(Linjeta)

FIAsp/NN1218 Novo Nordisk Ultra-rapid –acting

insulin aspart

Phase 1

(Phase 3

ready)

SC injection

Achieved proof-of-concept in

type 1 and type 2 diabetes;

Three Phase 3 trials to be

initiated Q3-2013

HOE901/AVE0010 FC

(Lantus + Lyxumia )

Sanofi,

Zealand

Basal insulin +

GLP-1 analogue

fixed combination

Phase 2 SC injection

once daily

Complimentary combination;

injection device in

development that allows for

adjustment of insulin dose

with a fixed lixisenatide dose

IN-105

Biocon,

Bristol-Myers

Squibb

Prandial insulin

conjugate Phase 2

Oral (single

tablet) Liver-targeted

ORMD-0801 Oramed Basal insulin Phase 2 Oral

(2 pills/day)

Oral GLP-1 also in

development; potential for

insulin + GLP-1 FDC pill


Total Type 2 Diabetes Therapeutics Market: Insulin Segment, Mid–stage Product Synopsis,

Global, 2012

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Products in Early Stage Clinical Development



BIOD-238 Biodel

Ultra-rapid-acting

insulin analogue

(Humalog-based)

Phase 1 SC injection Reduced EDTA and no

MgSO4

BIOD-250 Biodel Ultra-rapid-acting

insulin analogue Phase 1 SC injection MgSO4 added

HM12460A

(LAPS-Insulin)

Hanmi

Pharmaceutical

Ultra-long-acting

insulin Phase 1

SC injection,

once weekly

Preclinical evidence of

comparable glucose

lowering versus daily

basal insulins

NN1436/LAI287 Novo Nordisk Basal insulin

analogue Phase 1

SC injection,

once weekly

Phase 1 trial in type 1

diabetes patients

underway

NN1953/OI338GT

Novo Nordisk,

Merrion

Pharmaceuticals

Basal insulin

analogue Phase 1 Oral (tablet)

Multiple dose Phase 1

trial underway;

developed using

Merrion’s

Gastrointestinal

Permeation

Enhancement

Technology (GIPET)


Total Type 2 Diabetes Therapeutics Market: Insulin Segment, Early Stage Product Synopsis,

Global, 2012

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Products in Early Stage Clinical Development (continued)



NN1954/OI362GT

Novo Nordisk,

Merrion

Pharmaceuticals

Basal insulin

analogue Phase 1 Oral (tablet)

Single dose Phase 1

study completed;

developed using

Merrion’s GIPET

technology

Nodlin NOD

Pharmaceuticals Basal insulin

Phase 1

(China) Oral

Technology

encapsulates

macromolecules into bio-

adhesive nano-particles

SuliXen Xenetic Biosciences Basal insulin

analogue Phase 1 SC injection

Potentially less

immunogenic

BIOD-530 Biodel

Ultra-rapid-acting

concentrated

insulin

Preclinical SC injection or

pump; U-400

Potential to be the only

concentrated insulin for

pump use


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Parenteral

Oral Generics are not included. Source: Frost & Sullivan

Total Type 2 Diabetes Therapeutics Market: Competitive Landscape—Non–Insulin Segment, Late

Stage and Marketed Products by Drug Class, Global, 2012

Competitive Landscape—Non–Insulin Segment

Late Stage and Marketed Products

TZD/PPAR

DPP-4

GLP-1

FDC

Miglitinide Other*

SGLT2

Januvia

(MRK)

Nesina

(Takeda/

Furiea)

Onglyza

(BMY/AZN)

Galvus

(NVS)

Tradjenta

(BING/LLY)

Zemiglo

(LG Life Sciences)

Tenelia

(Mitsubishi

Tanabe/Daiichi

Sankyo) Kazano

(Takeda/Furiex)

Avandamet

(GSK)

Janumet /

Janumet XR

(MRK)

Kombiglyze

(BMY/AZN)

Avandaryl/Avaglim

(GSK)

Oseni/Liovel

(Takeda)

Actoplus Met/Actoplus Met

XR/Competact XR

(Takeda)

Juvisync

(MRK)

Duetact

(Takeda)

Jentadueto

(BING/LLY)

Eucreas/GalvusMet

(Novartis)

Forxiga (EU)

(BMY/AZN) Prandin/NovoNorm

(NVO)

Starlix

(Novartis)

Glufast

Kissei Pharmaceutical

Cycloset

(Santarus)

Symlin

(BMY/AZN)

Avandia

(GSK)

Actos

(Takeda)

Bydureon

(BMY)

Victoza

(NVO)

Lyxumia

(SNY)

Byetta

(BMY)

Pre-registration

Phase 3

Market

Tandemact+alogliptin

(Takeda)

Forxiga + MET

(BMY/AZN)

Empagliflozin + linagliptin

(BING/LLY)

Glimepiride +

atorvastatin

(GSK)

Canagliflozin/MET (US)

(JNJ)

Dulaglutide

(LLY)

Albiglutide (EU)

(GSK) Canagliflozin/MET (EU)

(JNJ)

Empagliflozin + MET

(BING/LLY)

IDegLira

(NVO)

Tradjenta + PIO

(BING/LLY)

Gemigliptin + MET

(LG Life Sciences)

ITCA 650

(Intarcia

Therapeutics)

Trelagliptin (JP)

(Takeda/Furiex)

MK-3102

(MRK)

Semaglutide

(NVO) Empagliflozin

(BING/LLY)

Aleglitazar

(Roche)

Albiglutide (US)

(GSK)

TAK-875

(Takeda)

Ipragliflozin

(Astellas/Kotobuki

Pharmaceutical)

Luseogliflozin

(Taisho/NVS)

Invokana (EU)

(JNJ)

Tofogliflozin

(Chugai/Kowa/SNY)

Invokana (US)

(JNJ)

Forxiga (US)

(BMY/AZN)

* Classes other than

those listed or

undisclosed

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Marketed Product Synopsis—Non–insulin Segment

Add–on Products

Product Company MOA/Class First Launch Markets US Patent

Expiry

Actos

(pioglitazone) Takeda TZD 1999 Worldwide Expired

Actoplus Met

(pioglitazone/ metformin

IR)

Takeda FDC (TZD + MET) 2005 Worldwide Expired

Actoplus Met XR/

Competact XR

(pioglitazone/ metformin

XR)

Takeda, Watson FDC (TZD + MET) 2010 Worldwide 2026

Avandia (rosiglitazone) GlaxoSmithKline TZD 1999 Worldwide Expired

Avandamet

(rosiglitazone/

metformin IR)

GlaxoSmithKline FDC (TZD + MET) 2002 Worldwide Expired

Avandaryl/Avaglim

(rosiglitazone/

glimepiride)

GlaxoSmithKline,

Sanofi FDC (TZD + SU) 2006 Worldwide Expired

Bydureon

(exenatide XR)

Bristol-Myers

Squibb/Eli Lilly GLP-1 2011 Worldwide 2025


Total Type 2 Diabetes Therapeutics Market: Non-insulin Segment, Add-on Marketed Product

Synopsis, Global, 2012

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Add–on Products (continued)

Product Company MOA/Class First

Launch Markets

US Patent

Expiry

Byetta (exenatide) Bristol-Myers Squibb GLP-1 2005 Worldwide 2017

Cycloset

(bromocriptine

mesylate)

Santarus Other (dopamine

receptor agonist) 2010 Worldwide 2015

Duetact

(pioglitazone/

glimepiride)

Takeda FDC (TZD + SU) 2006 Worldwide Expired

Eucreas/GalvusMet

(vildagliptin/

metformin)

Novartis FDC (DPP-4 +

MET) 2007 Worldwide ex-US Unknown

Forxiga (dapagliflozin) Bristol-Myers Squibb,

AstraZeneca SGLT2 2012

Europe (US

approval pending) 2020

Galvus

(vildagliptin) Novartis DPP-4 2007 Worldwide ex-US Unknown

Glufast

(mitiglinide)

Kissei

Pharmaceutical Meglitinide — APAC Unknown

Invokana

(canagliflozin) Johnson & Johnson SGLT2 2013

US (EU approval

pending) 2024


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Expiry

Janumet XR

(sitagliptin +

metformin XR)

Merck, Depomed FDC (DPP-4 +

MET) 2012 Worldwide 2022

Janumet

(sitagliptin/metformin) Merck

FDC (DPP-4 +


Januvia (sitagliptin) Merck DPP-4 2006 Worldwide 2022

Jentadueto

(linagliptin/metformin)

Boehringer

Ingelheim/Eli Lilly

FDC (DPP-4 +


Juvisync (sitagliptin/

simvastatin) Merck

FDC (DPP-4 +

statin)

2009 (JP)

2011 (US) Worldwide 2026

Kazano

(alogliptin/metformin) Takeda

FDC (DPP-4 +

MET) 2013 US 2016

Kombiglyze XR

(saxagliptin/metformin

XR)

Bristol-Myers

Squibb/ AstraZeneca

FDC (DPP-4 +


Lyxumia

(lixisenatide) Sanofi GLP-1 2013

Europe (US

approval

pending)

2020

Nesina (alogliptin) Takeda DPP-4 2010 Japan, US 2016




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Expiry

Onglyza (saxagliptin) Bristol-Myers

Squibb/ AstraZeneca DPP-4 2009 Worldwide 2021

Oseni/Liovel

(alogliptin/

pioglitazone)

Takeda FDC (DPP-4 +

TZD) 2011 Japan, US 2016

Prandin/NovoNorm

(repaglinide) Novo Nordisk Meglitinide 1998 US, Europe Expired

Starlix (neteglinide) Novartis Meglitinide 2000 Worldwide Expired

Symlin (pramlintide

acetate)

Bristol-Myers

Squibb, AstraZeneca

Other (amylin

receptor

antagonist)

2005 Worldwide 2019

Tenelia

(Teneligliptin/MP-513) Mitsubishi Tanabe DPP-4 2012 Japan Unknown

Tradjenta (linagliptin) Boehringer

Ingelheim/Eli Lilly DPP-4 2011 Worldwide 2025

Victoza (liraglutide) Novo Nordisk GLP-1 2009 Worldwide 2022

Zemiglo (gemigliptin) LG Life Sciences DPP-4 2012 Turkey, Korea,

China Unknown




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Timeline of Product Launches

2018 2017 2016 2015 2014 2013 2010 2011 2012

Japan launch EU launch

Total Type 2 Diabetes Therapeutics Market: Timeline of Product Launches, Global, 2010–2018

The base year is 2012. Source: Frost & Sullivan

Key Takeaway: The diabetes market will see a steady stream of new product launches over the next

six years.

FIAsp

Affrezza

IDegLira

Semaglutide

Aleglitazar

Empagliflozin

Dulaglutide

Albiglutide

ITCA 650

Invokana

MK-3102 TAK-875 Lyxumia Lyxumia

Bydureon

Janumet XR Tradjenta

Jentadueto

Juvisync

Nesina

Nesina

Kazano

Oseni

Forxiga

Note: Product launches after mid-2013 are estimated based on

regulatory filing dates and/or publically communicated estimates

US launch First Global

Launch

Invokana

Invokana

Empagliflozin

Bydureon Bydureon

Nesina

Forxiga

Forxiga

Tradjenta

Tradjenta

Lyxumia

Albiglutide

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2005 2010 2015 2020 2025 2000 2030

Patent Expirations

Total Type 2 Diabetes Therapeutics Market: Patent Expirations, Insulin Segment,

Global, 2000–2030

Source: Frost & Sullivan Year

Patent Expirations

Insulin Segment P

rod

uct

Humulin

2000

Humalog

2013

Novolog/NovoRapid

2014

Lantus

2015

Afrezza

2020

Apidra

2023

Levemir 2019

Insulin/insulin analogue

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2005 2010 2015 2020 2025 2000 2030

Patent Expirations

Total Type 2 Diabetes Therapeutics Market: Patent Expirations, Non-insulin Segment,

Global, 2000–2030


Year

Patent Expirations

Non–insulin Segment

* Market exclusivity to 2018

Pro

du

ct

Other class TZD GLP-1 DPP-4 SGLT2

Amaryl

2005

Glucophage XR

2003

Glucotrol XL

2003

Glucobay

2007

Nesina

2016*

Cycloset

2015

Starlix

2009

Avandia

2012

Prandin

2011

Actos

2011

Glumetza

2016

Juvisync

2026

Forxiga

2020

Galvus

2020

Symlin

2019

Fortamet

2018

Byetta

2017

Victoza

2022

Januvia

2022

Onglyza

2021

Lyxumia

2020

Jentadueto

2025

Tradjenta

2025

Bydureon

2025

Invokana

2024

Kombiglyze XR

2023

Actoplus Met XR

2026

21 NC67-52

Card

iova

sc

ula

r O

utc

om

es

Tri

al

2015 2020 2005

Patent Expirations

Total Type 2 Diabetes Therapeutics Market: Cardiovascular Outcomes Trials Timeline, Global, 2012

Source: Clinicaltrials.gov and Frost & Sullivan analysis Year

Cardiovascular Outcomes Trials Timeline

2010

TECOS (N = 14,000) Sitagliptin

EXAMINE (N = 5,400) Alogliptin

CANVAS (N = 4,330) Canaglifozin

EXSCEL (N = 9,500) Exenatide

ELIXA (N = 6,000) Lixisenatide

N = 7,000 Empagliflozin

REWIND (N = 9,622) Dulaglutide

(N = 5,000) TAK-875

MK-3102-018 AM5 (N = 4,000) MK-3102

AleCardio (N = 19,000) Aleglitazar

SUSTAIN (N = 3,260) Semaglutide

(N = 2,000) ITCA 650

DECLARE (N = 17,150) Dapagliflozin

CAROLINA N = 6,000 Linagliptin

LEADER N = 9,340 Liraglutide

SAVOR (N = 16,500) Saxagliptin

ORIGIN (N = 12,537)

Insulin glargine

22 NC67-52

Comparative Product Profiles of Promising Late-stage

Candidates


Drug (Company) Advantages Disadvantages

IDegLira

(Novo Nordisk)

• Superior efficacy versus all known

antidiabetics

• Physician acceptance of the insulin/GLP-

1 combination

• Regulatory delay

ITCA 650

(Intarcia Therapeutics)

• Convenience of once yearly implantation

• Physician familiarity with mechanism

• Inconvenience of removal if immediately

necessary

Forxiga

(Bristol-Myers

Squibb/AstraZeneca)

and

Invokana

(Johnson & Johnson)

• Weight loss and BP lowering

• Convenience of once-daily oral therapy

• Ease of combination therapy

• Unknown long term safety profile

• Potential for dapagliflozin cancer signal to

be class effect

• Genitourinary side effects

• Contraindicated in certain patient types

(renal insufficiency)

LY2605541

(Eli Lilly)

• Liver-targeted action

• Improved efficacy in liver-insulin

resistance

• Weight loss

• Unknown long term safety/efficacy profile

Total Type 2 Diabetes Therapeutics Market: Comparative Product Profiles of Promising Late-stage

Candidates, Global, 2012

23 NC67-52

Included below please find the detailed Table of Contents for Analysis of the Type 2 Diabetes

Therapeutics Market: Global Market Opportunities for Differentiated Therapeutics

If interested in more information, contact: Jennifer C...“

Additional sources of information on diabetes:

• European Diabetes Diagnostics Market

• Indian Diabetes Market

• European Diabetes Therapeutics Market

• 2010 U.S. Type 2 Diabetes Patients' Choice: Awareness, Usage, and Preferences of Injection Pens

•Additional Frost & Sullivan offerings:

• Talk to an analyst

• Take our DNA Survey

• Arrange a Growth Workshop

• Explore the Growth Excellence Matrix 2.0

• Attend a relevant live or virtual event

• Explore Healthcare Growth Consulting opportunities

Learn More—Next Steps


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24 NC67-52

Research Team

Debbie Toscano Senior Industry Analyst

Life Sciences

Lead Analyst Europe Analyst

Gulifeiya Abuduxike Industry Analyst

Life Sciences

Aiswariya Chidambaram Senior Research Analyst

Life Sciences

Blair Dong Consulting Analyst

Life Sciences

APAC Analyst China Analyst

Research Director

Jennifer Lazar Brice Global Program Director

Life Sciences

Manisha Rawat Research Analyst

Life Sciences

India Analyst

Strategic Review Committee Leader

Greg Caressi Senior Vice President

Healthcare & Life Sciences

Ankita Kothari Research Associate

Life Sciences

India Analyst

25 NC67-52

Contents

Section Slide Number

Executive Summary 39

• Key Findings 40

• Scope and Segmentation 42

• Key Questions This Study Will Answer 43

• Market Engineering Measurements 44

• CEO’s Perspective 46

• Key Companies to Watch 47

• Executive Summary—3 Big Predictions 48

Market Overview 49

• Market Background 50

• Market Segmentation 52

• Market Segmentation Discussion 53

• Global Market Perspective 56

• Defining Healthcare Trends in the Future 57

26 NC67-52

Contents (continued)


Competitive Playbook 58

• New Market Opportunities 59

• Merger, Acquisition, and Partnership Assessment 61

Driver, Restraints, and Trends—Total Market 62

• Market Drivers 63

• Market Restraints 64

Forecasts and Trends—Total Market 65


• Forecast Assumptions and Definitions 68

• Revenue Forecast 69

• Revenue Forecast Discussion 70

• Percent Revenue Forecast by Region 72

• Revenue Forecast by Region 73

27 NC67-52


Section Slide

Number

Competitive Environment 74

• Competitive Landscape—Insulin Segment: Marketed and Pipeline Products 75

• Marketed Product Synopsis—Insulin Segment 77

• Marketed Product Profiles—Insulin Segment: Rapid-acting Insulin 79

• Marketed Product Profiles—Insulin Segment: Intermediate-acting/Premix Insulin 80

• Marketed Product Profiles—Insulin Segment: Basal Insulin 81

• Pipeline Analysis—Insulin Segment: Products in Late Stage Clinical Development 82

• Pipeline Analysis—Insulin Segment: Products in Mid-stage Clinical Development 83

• Pipeline Analysis—Insulin Segment: Products in Early Stage Clinical Development 84

• Competitive Landscape—Non–insulin Segment: Count of Marketed and Pipeline Products 86

• Competitive Landscape—Non–Insulin Segment: Late Stage and Marketed Products 87

• Competitive Landscape—Non–Insulin Segment: Early Stage Pipeline Products 88

• Marketed Product Synopsis—Non–insulin Segment: First Line Standard of Care Products 89

• Marketed Product Synopsis—Non–insulin Segment: Add–on Products 90

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• Marketed Product Profiles—Non-insulin Segment: DPP-4 Class 94

• Marketed Product Profiles—Non-insulin Segment: GLP-1 Class 96

• Marketed Product Profiles—Non-insulin Segment: SGLT2 Class 98

• Pipeline Analysis—Non–Insulin Segment: Products in Late Stage Clinical

Development

99

• Pipeline Analysis—Non–Insulin Segment: Products in Mid-stage Clinical

Development

101

• Pipeline Analysis—Non–Insulin Segment: Products in Early Stage Clinical

Development

105

• Market Share Evolution 110

• Market Share Analysis 111

• Top Competitors 112

• Timeline of Product Launches 113

• Patent Expirations: Insulin Segment 114

• Patent Expirations: Non–insulin Segment 115

• Exclusivity Periods of Key Products: Insulin Segment 116

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• Exclusivity Periods of Key Products: Non–insulin Segment 117

• Cardiovascular Outcomes Trials Timeline 119

• Comparative Product Profiles of Promising Late-stage Candidates 120

• Comparative Efficacy Analysis 121

• Comparative Efficacy Analysis Discussion 123

Insulin Segment Breakdown 124

• Insulin Segment Key Findings 125




Non–insulin Segment Breakdown 129

• Non-insulin Segment Key Findings 130




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United States Breakdown 134

• Insulin Segment Revenue Forecast 135

• Insulin Segment Revenue Forecast by Class 136

• Insulin Segment Revenue Forecast Discussion 137

• Insulin Segment Type 2 Diabetes Prevalence and Treated Patient Forecast 138

• Insulin Segment Type 2 Diabetes Prevalence and Treated Patient Forecast

Discussion

139

• Non-insulin Segment Revenue Forecast 140

• Non-insulin Segment Revenue Forecast by Class 141

• Non-insulin Segment Revenue Forecast Discussion 142

• Non-insulin Segment Type 2 Diabetes Prevalence and Treated Patient Forecast 143

• Non-insulin Segment Type 2 Diabetes Prevalence and Treated Patient Forecast

Discussion

144

• Pricing Analysis 145

• Market Analysis 146

• PESTLE Analysis 147

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United Kingdom Breakdown 148

• The United Kingdom Diabetes Outlook 149





• Regulatory Policy Framework 154

• Pricing and Reimbursement 155

• Type 2 Diabetes Prevalence Forecast 156

• Type 2 Diabetes Prevalence Forecast Discussion 157


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Germany Breakdown 160

• Germany Diabetes Outlook 161










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France Breakdown 172

• France Diabetes Outlook 173










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Italy Breakdown 184

• Italy Diabetes Outlook 185










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Spain Breakdown 196

• Spain Diabetes Outlook 197










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Benelux Breakdown 208

• Benelux Diabetes Outlook 209










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Scandinavia Breakdown 224

• Scandinavia Diabetes Outlook 225










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China Breakdown 242

• Market Overview 243






• Type 2 Diabetes Prevalence and Treated Patient Forecast 249

• Type 2 Diabetes Prevalence and Treated Patient Forecast Discussion 250


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South Korea Breakdown 252

• South Korea Diabetes Outlook 253









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Malaysia Breakdown 264

• Malaysia Diabetes Outlook 265









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Indonesia Breakdown 276

• Indonesia Diabetes Outlook 277









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Vietnam Breakdown 287

• Vietnam Diabetes Outlook 288









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India Breakdown 299









Customer and End-user Analysis 308

• KOL Commentary 309

Key Companies to Watch 310

• Companies to Watch 311

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The Last Word 316

• The Last Word—3 Big Predictions 317

• The Last Word—Discussion 318

• Legal Disclaimer 321

Appendix 322

• Drivers Explained 323

• Restraints Explained 327

• Decision Support Database 331

• Additional Sources of Information on Diabetes 337

• Market Engineering Methodology 338

• Learn More—Next Steps 339

45 NC67-52

List of Exhibits

Exhibit Slide Number

Total Type 2 Diabetes Therapeutics Market: Market Engineering Measurements, Global,

2012 44

Total Type 2 Diabetes Therapeutics Market: Market Segmentation, Global, 2012 52

Total Type 2 Diabetes Therapeutics Market: Growth Rate Breakdown by Geographic

Region, Global, 2012 56

Total Type 2 Diabetes Therapeutics Market: Market Outlook, Global, 2012 and 2022 57

Total Type 2 Diabetes Therapeutics Market: Game-changing Strategies, Global, 2012 60

Total Type 2Diabetes Therapeutics Market: Market Outlook, Global, 2007–2013 61

Total Type 2Diabetes Therapeutics Market: Key Market Drivers, Global, 2013—2017 63

Total Type 2Diabetes Therapeutics Market: Key Market Restraints, Global, 2013—2017 64

Total Type 2 Diabetes Therapeutics Market: Market Engineering Measurements, Global,

2012 66

Total Type 2 Diabetes Therapeutics Market: Revenue Forecast, Global, 2009–2017 69

Total Type 2 Diabetes Therapeutics Market: Major New Product Launches, Global, 2013–

2017 71

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List of Exhibits (continued)


Total Type 2 Diabetes Therapeutics Market: Percent Revenue Forecast by Region, Global,

2009–2017 72

Total Type 2 Diabetes Therapeutics Market: Revenue Forecast by Region, Global, 2009–

2017 73

Total Diabetes Therapeutics Market: Competitive Landscape—Insulin Segment, Count of

Marketed and Pipeline Products by Type and Phase, Global, 2012 75

Total Diabetes Therapeutics Market: Competitive Landscape—Insulin Segment, Marketed

and Pipeline Products by Type, Global, 2012 76

Total Type 2 Diabetes Therapeutics Market: Insulin Segment, Marketed Product Synopsis,

Global, 2012 77

Total Type 2 Diabetes Therapeutics Market: Insulin Segment Marketed Product Profiles,

Rapid-acting Insulin, Global, 2012 79


Intermediate-acting/Premix Insulin, Global, 2012 80


Basal Insulin, Global, 2012 81

Total Type 2 Diabetes Therapeutics Market: Insulin Segment, Late Stage Product

Synopsis, Global, 2012 82

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Total Type 2 Diabetes Therapeutics Market: Insulin Segment, Mid–Stage Product


Total Type 2 Diabetes Therapeutics Market: Insulin Segment, Early Stage Product


Total Diabetes Therapeutics Market: Competitive Landscape—Non–insulin Segment,

Count of Marketed and Pipeline Products by Type and Phase, Global, 2012 86

Total Diabetes Therapeutics Market: Competitive Landscape—Non–Insulin Segment, Late

Stage and Marketed Products by Drug Class, Global, 2012 87

Total Diabetes Therapeutics Market: Competitive Landscape—Non–Insulin Segment,

Number of Early Stage Pipeline Products by Drug Class, Global, 2012 88

Total Type 2 Diabetes Therapeutics Market: Non-insulin Segment, Standard of Care

Marketed Product Synopsis, Global, 2012 89

Total Type 2 Diabetes Therapeutics Market: Non-insulin Segment, Add-on Marketed

Product Synopsis, Global, 2012 90

Total Type 2 Diabetes Therapeutics Market: Non-insulin Segment Marketed Product

Profiles, DPP-4s, Global, 2012 94


Profiles, GLP-1s, Global, 2012 96

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Profiles, SGLT2s, Global, 2012 98

Total Type 2 Diabetes Therapeutics Market: Insulin Segment, Late Stage Product


Total Type 2 Diabetes Therapeutics Market: Insulin Segment, Mid–Stage Product


Total Type 2 Diabetes Therapeutics Market: Insulin Segment, Early–Stage Product


Total Type 2 Diabetes Therapeutics Market: Absolute Market Share Trend by Revenue,

Global, 2009 and 2012 110

Total Type 2 Diabetes Therapeutics Market: Company Market Share Analysis of Top 5

Participants, Global, 2012 111

Total Type 2 Diabetes Therapeutics Market: SWOT Analysis, Global, 2012 112

Total Type 2 Diabetes Therapeutics Market: Timeline of Product Launches, Global, 2010–

2018 113

Total Type 2 Diabetes Therapeutics Market: Patent Expirations, Insulin Segment, Global,

2000–2030 114

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Total Type 2 Diabetes Therapeutics Market: Patent Expirations, Non-insulin Segment,

Global, 2000–2030 115

Total Type 2 Diabetes Therapeutics Market: Exclusivity Periods of Major Products,

Modern Insulins, Global, 2000–2030 116

Total Type 2 Diabetes Therapeutics Market: Exclusivity Periods of Major Products, Non–

insulin Classes, Global, 2000–2030 117

Total Type 2 Diabetes Therapeutics Market: Cardiovascular Outcomes Trials Timeline,

Global, 2012 119

Total Type 2 Diabetes Therapeutics Market: Comparative Product Profiles of Promising

Late-stage Candidates, Global, 2012 120

Total Type 2 Diabetes Therapeutics Market: Comparative HbA1c Lowering of Selected

Marketed Drugs, Global, 2012 121

Insulin Segment: Percent Sales Breakdown, Global, 2012 125

Insulin Segment: Market Engineering Measurements, Global, 2012 126

Insulin Segment: Revenue Forecast, Global, 2009–2017 127

Non–insulin Segment: Percent Sales Breakdown, Global, 2012 130

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Non–insulin Segment: Market Engineering Measurements, Global, 2012 131

Non–insulin Segment: Revenue Forecast, Global, 2009–2017 132

Insulin Segment: Revenue Forecast, US, 2009–2017 135

Insulin Segment: Revenue Forecast by Class, US, 2009–2017 136

Insulin Segment: Prevalence and Treated Patient Forecast, US, 2009–2017 138

Non-insulin Segment: Revenue Forecast, US, 2009–2017 140

Non-insulin Segment: Revenue Forecast by Class, US, 2009–2017 141

Non–insulin Segment: Evolution of Market Share by Drug Class, US, 2012 and 2017 142

Non–insulin Segment: Prevalence and Treated Patient Forecast, US, 2009–2017 143

Total Type 2 Diabetes Therapeutics Market: Pricing Analysis, US, 2012 145

Diabetes Therapeutics Market: PESTLE Analysis, US, 2012 147

Diabetes Therapeutics Market: Diabetes Outlook, The United Kingdom, 2012 and 2030 149

Insulin Segment: Revenue Forecast, the United Kingdom, 2009–2017 150

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Non-insulin Segment: Revenue Forecast, the United Kingdom, 2009–2017 152

Type 2 Diabetes Therapeutics Market: Regulatory Policy Framework, the United

Kingdom, 2012 154

Type 2 Diabetes Therapeutics Market: Prevalence Forecast, the United Kingdom, 2009–

2017 156

Type 2 Diabetes Therapeutics Market: Diabetes Prevalence and Patient Forecast by Age

Groups, The United Kingdom, 2012 and 2017 158

Type 2 Diabetes Therapeutics Market: Diabetes Prevalence and Patient Forecast by

Gender, The United Kingdom, 2012 and 2017 158

Type 2 Diabetes Therapeutics Market: Diabetes Outlook, Germany, 2012 and 2030 161

Insulin Segment: Revenue Forecast, Germany, 2009–2017 162

Non-insulin Segment: Revenue Forecast, Germany, 2009–2017 164

Type 2 Diabetes Therapeutics Market: Regulatory Policy Framework, Germany, 2012 166

Type 2 Diabetes Therapeutics Market: Prevalence Forecast, Germany, 2009–2017 168


Groups, Germany, 2012 and 2017 170

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Gender, Germany, 2012 and 2017 170

Type 2 Diabetes Therapeutics Market: Diabetes Outlook , France, 2012 and 2030 173

Insulin Segment: Revenue Forecast, France, 2009–2017 174

Non-insulin Segment: Revenue Forecast, France, 2009–2017 176

Type 2 Diabetes Therapeutics Market: Regulatory Policy Framework, France, 2012 178

Type 2 Diabetes Therapeutics Market: Prevalence Forecast, France, 2009–2017 180


Groups, France, 2012 and 2017 182


Gender, France, 2012 and 2017 182

Type 2 Diabetes Therapeutics Market: Diabetes Outlook, Italy, 2012 and 2030 185

Insulin Segment: Revenue Forecast, Italy, 2009–2017 186

Non-insulin Segment: Revenue Forecast, Italy, 2009–2017 188

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Type 2 Diabetes Therapeutics Market: Regulatory Policy Framework, Italy, 2012 190

Type 2 Diabetes Therapeutics Market: Prevalence Forecast, Italy, 2009–2017 192


Groups, Italy, 2012 and 201 194


Gender, Italy, 2012 and 2017 194

Type 2 Diabetes Therapeutics Market: Diabetes Outlook, Spain, 2012 and 2030 197

Insulin Segment: Revenue Forecast, Spain, 2009–2017 198

Non-insulin Segment: Revenue Forecast, Spain, 2009–201 200

Type 2 Diabetes Therapeutics Market: Regulatory Policy Framework, Spain, 2012 202

Type 2 Diabetes Therapeutics Market: Prevalence Forecast, Spain, 2009–2017 204


Group, Spain, 2012 and 2017 206


Gender, Spain, 2012 and 2017 206

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Type 2 Diabetes Therapeutics Market: Diabetes Outlook, Benelux, 2012 and 2030 209

Insulin Segment: Revenue Forecast, Benelux, 2009–2017 210

Non-insulin Segment: Revenue Forecast, Benelux, 2009–2017 212

Type 2 Diabetes Therapeutics Market: Regulatory Policy Framework, Belgium, 2012 214

Type 2 Diabetes Therapeutics Market: Regulatory Policy Framework, the Netherlands,

2012 215

Type 2 Diabetes Therapeutics Market: Regulatory Policy Framework, Luxembourg, 2012 216

Type 2 Diabetes Therapeutics Market: Prevalence Forecast, Benelux, 2009–2017 220


Groups, Benelux, 2012 and 2017 222


Gender, Benelux, 2012 and 2017 222

Type 2 Diabetes Therapeutics Market: Diabetes Outlook, Scandinavia, 2012 and 2030 225

Insulin Segment: Revenue Forecast, Scandinavia, 2009–2017 226

Non-insulin Segment: Revenue Forecast, Scandinavia, 2009–2017 228

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Type 2 Diabetes Therapeutics Market: Regulatory Policy Framework, Norway, 2012 230

Type 2 Diabetes Therapeutics Market: Regulatory Policy Framework, Sweden, 2012 231

Type 2 Diabetes Therapeutics Market: Regulatory Policy Framework, Denmark, 2012 232

Type 2 Diabetes Therapeutics Market: Regulatory Policy Framework, Finland, 2012 233

Type 2 Diabetes Therapeutics Market: Prevalence Forecast, Scandinavia, 2009–2017 238


Groups, Scandinavia, 2012 and 2017 240


Gender, Scandinavia, 2012 and 2017 240

Insulin Segment: Revenue Forecast, China, 2009–2017 244

Non-insulin Segment: Revenue Forecast, China, 2009–2017 246

Type 2 Diabetes Therapeutics Market: Pricing Analysis, China, 2012 248

Type 2 Diabetes Therapeutics Market: Prevalence and Treated Patient Forecast, China,

2009–2017 249

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Type 2 Diabetes Therapeutics Market: Range of Reported Disease Prevalence

Estimates, China, 2012 250

Type 2 Diabetes Therapeutics Market: Diabetes Outlook, South Korea, 2012 and 2030 253

Insulin Segment: Revenue Forecast, South Korea, 2009–2017 254

Non-insulin Segment: Revenue Forecast, South Korea, 2009–2017 256

Type 2 Diabetes Therapeutics Market: Pricing Analysis, South Korea, 2012 258

Type 2 Diabetes Therapeutics Market: Prevalence and Treated Patient Forecast, South

Korea, 2009–2017 259

Type 2 Diabetes Therapeutics Market: Diabetes Prevalence by Age Groups, South Korea,

2012 and 2030 261

Type 2 Diabetes Therapeutics Market: Diabetes Prevalence by Gender, South Korea,

2012 and 2030 261

Type 2 Diabetes Therapeutics Market: Diabetes Outlook, Malaysia, 2012 and 2030 265

Insulin Segment: Revenue Forecast, Malaysia, 2009–2017 266

Non-insulin Segment: Revenue Forecast, Malaysia, 2009–2017 268

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Type 2 Diabetes Market: Pricing Analysis, Malaysia, 2012 270

Type 2 Diabetes Market: Prevalence and Treated Patient Forecast, Malaysia, 2009–2017 271

Type 2 Diabetes Therapeutics Market: Diabetes Prevalence by Age Groups, Malaysia,

2012 and 2030 273

Type 2 Diabetes Therapeutics Market: Diabetes Prevalence by Gender, Malaysia, 2012

and 2030 273

Type 2 Diabetes Therapeutics Market: Diabetes Outlook, Indonesia, 2012 and 2030 277

Insulin Segment: Revenue Forecast, Indonesia, 2009–2017 278

Non-insulin Segment: Revenue Forecast, Indonesia, 2009-2017 280

Type 2 Diabetes Market: Prevalence and Treated Patient Forecast, Indonesia, 2009–2017 283

Type 2 Diabetes Therapeutics Market: Diabetes Prevalence by Age Groups, Indonesia,

2012 and 2030 285

Type 2 Diabetes Therapeutics Market: Diabetes Prevalence by Gender, Indonesia, 2012

and 2030 285

Type 2 Diabetes Therapeutics Market: Diabetes Outlook, Vietnam, 2012 and 2030 288

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Insulin Segment: Revenue Forecast, Vietnam, 2009–2017 289

Non-insulin Segment: Revenue Forecast, Vietnam, 2009–2017 291

Type 2 Diabetes Therapeutics Market: Pricing Analysis, Vietnam, 2012 294

Type 2 Diabetes Market: Prevalence and Treated Patient Forecast, Vietnam, 2009–2017 295

Type 2 Diabetes Therapeutics Market: Diabetes Prevalence by Age Groups, Vietnam,

2012 and 2030 297

Type 2 Diabetes Therapeutics Market: Diabetes Prevalence by Gender, Vietnam, 2012 and

2030 297

Insulin Segment: Revenue Forecast, India, 2009–2017 300

Non-insulin Segment: Revenue Forecast, India, 2009–2017 302

Type 2 Diabetes Market: Pricing Analysis, India, 2012 304

Type 2 Diabetes Market: Prevalence and Treated Patient Forecast, India, 2009–2017 305

Decision Support Database: Prevalence of Type 2 Diabetes in Thousands, Global, 2008–

2018 331

Decision Support Database: Prevalence Percent of Type 2 Diabetes, Global, 2008–2018 334

analysis of the type 2 diabetes therapeutics market

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