iq4i research & consultancy pvt. ltd. in various phases ... rna-based therapeutics, but excludes...
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Type II Diabetes Mellitus
IQ4I Research & Consultancy Pvt. Ltd.
Type II Diabetes Mellitus
Pipeline Analysis
CONTENTS� REPORT DESCRIPTION
� INTRODUCTION� Causes & Symptoms
� Diagnosis
� Unmet needs
� Epidemiology
� Current therapies
� HOT TARGETS, MECHANISMS & THERAPIES� Novel Disease mechanisms &
therapies
� Leading & hot targets of T2DM
� SMALL MOLECULES� Pipeline� Competitive Analysis
� LARGE MOLECULE � Pipeline� Competitive Analysis
� MONOCLONAL ABs� Pipeline� Competitive Analysis
� STEMCELL THERAPY� Pipeline� Competitive Analysis
� RNA-BASED THERAPY� Leading & hot targets of T2DM
� Novel targets of Diabetes
� T2D disease progression biomarkers
� MARKET DATA� Forecasting model
� Market dynamics
� Market sizing
� Cost burden
� PIPELINE ANALYSIS� Development stage
� Leading players
� Therapeutic segmentation
� Innovative approaches
� Target analysis
� RNA-BASED THERAPY� Pipeline� Competitive Analysis
� GENE THERAPY� Pipeline� Competitive Analysis
� RECOMBINANT FUSION PROTEINS� Pipeline� Competitive Analysis
� DRUG ANALYSIS BASED ON MECHANISM
� MAJOR PLAYERS� Company Profiles
� Overview, Pipeline & Deals
� REFERENCES
Confidential
� “Type 2 Diabetes (T2D) Pipeline Analysis” gives comprehensive insight on the variousdrugs being developed for the treatment of T2D. The report covers all the drugs beingdeveloped in various phases (Discovery, Preclinical, Clinical & Marketing). The pipelinefocuses on novel pharmacologic drugs & regenerative medicines covering small molecules,monoclonal antibodies, stem cell therapies, Gene therapies, Recombinant proteins andRNA-based therapeutics, but excludes symptom relief drugs, generic combinations. Thereport also covers some of the hot targets in research for T2D treatments and diseaseprogression biomarkers.
� This report enables Pharmaceutical /Biotech companies, Academic institutes, Individualresearchers, Investors, Medical technology companies, Service providers and other
REPORT DESCRIPTION
researchers, Investors, Medical technology companies, Service providers and otherassociated stake holders to identify and analyze the available licensing/collaborativecommercial opportunities in the Type 2 Diabetes (T2D) Drug market. The report alsoprovide strategic insights on medicines that are likely to have an impact on T2D treatmentspace and potentially alter standards of care in T2D in the foreseeable future.
� Current therapies are focused on the treatment of hyperglycemia than on pancreatic Betacell dysfunction and they lose efficacy over time as both endogenous insulin secretion andinsulin sensitivity decrease. There is a need for type 2 diabetes therapies that act in concertwith available agents to provide adequate glycemic control without causing hypoglycemiaand weight gain, which are associated with increase in cardiovascular risk. Hence, itprovides a tremendous opportunity for upcoming therapies specific to T2D such as MAbs,stem cell-based, gene therapies and RNA-based therapies. These modalities may providebeta-cell protection, regeneration, mass increase with additional benefits of weight loss,triglyceride lowering and kidney protection.
TYPE II DIABETES - INTRODUCTIONType 2 Diabetes Mellitus formerly known as noninsulin-dependent diabetes mellitus(NIDDM) and adult-onset disease is a metabolic disorder which is characterized by reducedinsulin sensitivity, insulin resistance and pancreatic β-cell dysfunction
Prevalence
Urban ,
64%
Rural, 36%
Diabetes Affects
Diabetes Facts
•Globally, around 371 millionpeople are living with diabetes andtype 2 diabetes accounts for 90% ofall diabetes cases.•Currently, highest number of
•Non Hispanic Whites= 7.6%•Asian Americans = 9%•Hispanics = 12.8%•Non Hispanic Blocks = 13.2%•American Indians/Alaska Natives = 15.9%
People at major risk
Africa-13.5M
Europe–49.5 M
South East Asia-63M
North America-34.2M
South & Central America–23.4M Western Pacific-
118.8M
Middle East & North Africa– 30.6 M
Prevalence•Currently, highest number ofpeople with diabetes occurs in 40-59 years age group.•As of March 2013, approximately23 million children & adultswere observed with T2D.•Expenditure on diabetes in NorthAmerican region was higher thanother region. And by 2050, 1 in 3American adults will havediabetes.•In 2013, International DiabetesFederation (IDF) estimated 10million people with diabetes inChina, India, USA, Brazil &Russian Federation .
TYPE II DIABETES - CAUSES AND SYMPTOMS
Causes Symptoms
� Overweight
� Obesity
� Genetic susceptibility
� Increased thirst & hunger
� Dry mouth
� Polyurination
� Unexplained weight loss
� Fatigue
� Blurred vision
Risk factors
Family history of diabetes � Blurred vision
� Headache
� Loss of consciousness
� Slow healing sores/cuts
� Decreased vision
� Impotency
� Frequent yeast infections
� Acanthosis nigricans
� Numbness & tingling of hands & feet
� Family history of diabetes
� Unhealthy diet
� Increasing age
� Overweight/Obese
� Physical activity
� Ethnicity
� Poor nutrition during pregnancy
� Impaired glucose tolerance
� Pre-diabetes condition
� Polycystic ovary syndrome
� Genetic susceptibility
TYPE II DIABETES - DIAGNOSIS
BLOOD TEST
BLOOD TEST
BLOOD BLOOD
DIAGNOSISDIAGNOSIS HEMOGLOBIN A1C
HEMOGLOBIN A1C
LIPID TESTLIPID TEST
BLOOD CREATINI
NE & URINE
MICROALBUMIN
BLOOD CREATINI
NE & URINE
MICROALBUMIN
TYPE II DIABETES - UNMET NEEDS
Current type 2 diabetes therapies are focused on the treatment of hyperglycemia, a symptom, and not the direct cause of the disease, which is pancreatic Beta cell dysfunction.
Existing agents lose efficacy over time as both endogenous insulin secretion and insulin sensitivity decrease.
There is a need for type 2 diabetes therapies that act in concert with available agents to provide adequate glycemic control without causing hypoglycemia and weight gain, which are associated with increases in cardiovascular risk.
Need for new glucose-lowering drugs that act independently of insulin, have benefits beyond glucose-lowering actions, and provide improved tolerability compared with traditional medications for T2DM.
TYPE II DIABETES - COUNTRY-WISE PREVALENCE
USA X MN
Russia Federation X MN
Japan X MN
PakistanX MN
EgyptX MN
{MN: Million}
Fig 1
India X MN
ChinaX MN
BrazilX MN
MexicoX MN
IndonesiaX MN
X MN
Globally, the rate of prevalence is higher in men than in women and increases as age progresses.
CURRENT THERAPIES OF TYPE II DIABETES MELLITUSCurrent therapies for T2DM are relatively effective in controlling hyperglycemia. Some examples include:
Current Therapies
• Thiazolidinediones • Insulin secretagogues
•Sulfonylurea derivatives • SGLT-1/2 inhibitors
• α-glucosidase inhibitors • Insulin sensitizers
• Glucagon-like peptide-1 receptor agonists • Pyruvate dehydrogenase inhibitors
• Dipeptidyl peptidase-4 inhibitors • Fibroblast growth factors
• Long-acting DPP-4 inhibitors • Glucokinase activators • Long-acting DPP-4 inhibitors • Glucokinase activators
DIABETES: HOSPITAL READMISSION RATES IN U.S. (2011)
30-day readmission rate for patients aged 18-64 years (2011):
Type Total Readmission rate (%) Total cost of readmission rate (%)
Medicaid Patient 3.5% 3.3%
Privately insured patient 2.1% 1.7%
Uninsured patient 4.6% 4.1%
T2D MARKET: FORECASTING MODEL
Historical Data
and trends of
T2D Market
Evolution
Company
Developments
Applications
Download Pattern
Regulatory
Landscape
Pipeline
Evolution
T2D Costs of
Burden
Hospitalization
Pattern
Readmission
Pattern
Market ShareEpidemiology
Pattern
Geographical
Usage
Market Restraints
� High cost of drugs and
innovative therapies
Market Drivers� High unmet need
� Increasing incidence of
Market Opportunities� Acquisitions/collaborations
of companies and research
institutes
Fig 2
Factors Influencing
Market Growth
innovative therapies
including stem cell
and gene therapies
Investments�In 2011, Eli lilly and Boehringer Ingelheim formed a diabetes
alliance whereas in 2013, both the partners adjusted the scope of
diabetes alliance with respect to LY2605541 for commercialization.
Increasing incidence of
diabetes and diabetes related
disorders
� Increasing aged population
� Alteration in lifestyle
.
Historical Market Data
Impact Analysis of Market
Trends
Market Size & Forecast by
Region
Major Players Profiling and
Strategies
Global T2D Market Size
2013 and Forecast to 2018Market Trends and
Forecasting
Market Penetration
�Innovative drug discovery
platforms
institutes
�Demand for novel drugs to
increase revenue of pharma
industry
T2D : MARKET DYNAMICS
�High cost of drugs and innovative
therapies (stem cell and gene
therapies)
�Risk of pancreatitis, pancreatic &
thyroid cancer associated with
incretin based therapies
RESTRAINTS
�High unmet need
� Increasing incidence of diabetes and
diabetes related disorders
� Increasing aged population & obese
� Alteration in lifestyle
DRIVERS
Fig 3
Confidential
thyroid cancer associated with
incretin based therapies
� Patent expiration of small
molecules
�Entry of basal insulin biosimilars
pose significant threat
THREATS
diagnosis� Acquisitions/collaborations of
companies and research institutes
�Demand for T2D drugs in emerging markets
�Innovative drug delivery platforms
OPPORTUNITIES
Global T2D
Market
T2D - MARKET SIZING
Global T2D Drugs Market Global T2D Drugs Market by Region
Fig 4 Fig 5M
ark
et s
ize
($B
illi
on
)
Mar
ket
siz
e ($
Bil
lio
n)
2014
2021
Confidential
• The global T2D market is estimated to be $XX billion in 2014 and is expected to reach $XX billion
by 2021 with a CAGR of X% (2015-2021).
• The market growth is attributed to increasing incidence of diabetes and diabetes related
disorders, high unmet need which led to development of innovative drugs in the market, emergence of
novel therapeutics.
2014 2015 2016 2017 2018 2019 2020 2021
Mar
ket
siz
e ($
Bil
lio
n)
Year
NA EU AP ROW
Mar
ket
siz
e ($
Bil
lio
n)
Region
T2D PIPELINE BY PHASESFig 6
No
. of
mo
lecu
les
•Pipeline analysis reveals that there are XX molecules in various stages of pipeline (focusedon Discovery, Pre-clinical, Phase I, II, III and Marketed candidates)
•The Pre-clinical stage commanded the pipeline analysis with XX molecules, followed by phase IIwith around XX molecules.
•PR, REG & APP ---- Pre-Registered, Registered & Approved
Discovery Pre-clinical Phase I Phase II Phase III PR, REG & APP
Marketed
No
. of
mo
lecu
les
T2D PIPELINE BY LEADING PLAYERS
Fig 7N
o. o
f m
ole
cule
s
• GSK is leading with X molecules in T2D followed by Merck & Ember with X molecules each
• Companies such as Poxel and Eli Lilly are holding X molecules each
• Amgen and Connexios are holding X molecules each
No
. of
mo
lecu
les
GLOBAL T2D DRUG MARKET BY THERAPEUTIC SEGMENTATION
Small molecules
Large molecules
Monoclonal antibodies
Recombinant Proteins
Stem cell therapy
RNA based therapy
Fig 8
Confidential
The T2D pipeline is commanded by pharmacological drugs, accounting for XX molecules. Large molecules
accounting for XX molecules followed by Monoclonal antibodies, Recombinant proteins, Stem cell therapy, RNA
base therapy, Gene therapy and others.
RNA based therapy
Gene therapy
Others
SMALL MOLECULES MOLECULE PHASE MOA COMPANY SUMMARY
Anagliptin MarketedDPP-4
inhibitorKowa Research
Institute
Anagliptin is an orally active DPP-4 inhibitor, for thetreatment of type-2 diabetes. In April 2013, the companylaunched oral anagliptin in Japan for the treatment of type-2diabetes mellitus.
XX XX XX XX XX
XX XX XX XX XX
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XX XX XX XX XX
XX XX XX XX XX
LARGE MOLECULES MOLECULE PHASE MOA COMPANY SUMMARY
Lixisenatide Marketed GLP-1 agonist SanofiLixisenatide is a glucagon like peptide 1 receptor agonist, forthe treatment of T2D. In October 2014, the company launchedthe drug Lyxumia (brand name) for T2D in Brazil.
XX XX XX XX XX
XX XX XX XX XX
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XX XX XX XX XX
XX XX XX XX XX
TYPE 2 DIABETESTYPE 2 DIABETESMONOCLONAL ANTIBODIESMONOCLONAL ANTIBODIESMONOCLONAL ANTIBODIESMONOCLONAL ANTIBODIES
MONOCLONAL ANTIBODIES
MOLECULE PHASE MOA COMPANY SUMMARY
Gevokizumab Phase IIInterleukin 1
beta inhibitorXOMA
Corporation
Gevokizumab, a monoclonal antibody administeredsubcutaneously for the treatment of type 1 and 2 diabetes. Asper clinical trial data, the drug completed phase II trial inpatients with type 1 and 2 diabetes.
XX XX XX XX XX
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XX XX XX XX XX
XX XX XX XX XX
TYPE 2 DIABETESTYPE 2 DIABETESSTEM CELL BASED THERAPYSTEM CELL BASED THERAPYSTEM CELL BASED THERAPYSTEM CELL BASED THERAPY
STEM CELL THERAPYMOLECULE PHASE MOA COMPANY SUMMARY
XX XX XX XX XX
Confidential
XX XX XX XX XX
XX XX XX XX XX
RNA-BASED THERAPY
MOLECULE PHASE MOA COMPANY SUMMARY
XX XX XX XX XX
XX XX XX XX XX
Confidential
XX XX XX XX XX
TYPE 2 DIABETESTYPE 2 DIABETESRECOMBINANT FUSION PROTEINRECOMBINANT FUSION PROTEINRECOMBINANT FUSION PROTEINRECOMBINANT FUSION PROTEIN
RECOMBINANT PROTEINS THERAPY
MOLECULE PHASE MOA COMPANY SUMMARY
XX XX XX XX XX
Confidential
XX XX XX XX XX
XX XX XX XX XX
COMPANY-ADDEX THERAPEUTICS
OVERVIEWHEADQUARTERS
Addex therapeutics is a biotechnological company founded in the year 2002and is headquartered in Switzerland. The company mainly focus ondiscovering and developing orally available small molecule drugs calledallosteric modulators, to treat broad range of diseases. The company usesits proprietary discovery platform to address receptors and other proteinsthat have been undruggable for conventional drug discovery methodsincluding GPCR, receptor tyrosine kinases and cytokine receptors. Manytargets have been widely recognized as attractive for modulation ofimportant diseases with unmet medical needs.
SWITZERLAND
Confidential
PIPELINEPIPELINE
Discovery Pre-Clinical Phase I Phase II Phase III Marketed
ADX-91886
important diseases with unmet medical needs.
XX
XX
XX
XX
XX
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