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Type 1 Diabetes - Drug Pipeline Assessment and
Market Forecasts to 2017
Reference Code: GDHC106PRT Publication Date: June 2010
The Type 1 Diabetes Therapeutics Market is Forecast to
Show Moderate Growth until 2017
GlobalData estimated the global type 1 diabetes therapeutics
market to be valued at $XX billion in 2009. It is expected to
grow at a Compound Annual Growth Rate (CAGR) of XX% to
reach $XX billion by 2017. This growth is primarily attributed to
an increase in the average cost of therapy with the existing
treatment options and an increased treatment seeking rate.
Novo Nordisk and Eli Lilly remain the market leaders within the
global type 1 diabetes therapeutics market.
Type 1 Diabetes Therapeutics Market, Global, Revenues ($bn) 2001-2017
CAGR (2009-2017): XX%
diabetes is estimated to increase at a slower rate of XX%
between 2009 and 2017. The number of type 1 diabetes
patients increased at a higher rate of XX% during the period
2001-2009. Therefore, the increase in the average cost of
therapy will be the key to growth in the market. The average
cost of therapy is expected to increase at a CAGR of XX% over
the period 2009-2017. The increase in the average cost of
therapy will be primarily driven by the higher cost of insulin
analogs. The increase in awareness about type 1 diabetes due
to awareness programs held in key countries will continue to
improve the treatment seeking behavior. The increase in people
who seek treatment could lead to an increase in the prescription
population, made
possible by the
effective diagnosis
tests currently
available in the
market.
Sales Value ($ bn)
CAGR (2001-2009): XX%
The Current
Competition is
Strong Due to the
Presence of
Products with
Similar Efficacy and
a Lack of Generics in
the Market
Source: GlobalData
2001 2009 2017
The type 1 diabetes affects only about XX% of the total people
suffering from diabetes. The prevalence of type 1 diabetes is
approximately XX%. This accounted for a total diabetes
affected population of XX million in 2009.
Increase in Average Cost of Therapy Will be the Key Driver
of the Market, Followed by Increased Treatment Seeking
The prevalence rate for type 1 diabetes globally was XX% and
this amounted to approximately XX million people in 2009. Type
1 diabetes is an autoimmune condition and is generally found in
young adults and children. The number of people with type 1
The current market is
dominated by insulin
and insulin analog
products. These
products have similar
efficacy and safety
profiles with only
marginal differences.
This has increased the
competition further in the market. The manufacturers are forced
to compete on pricing or on improving the dosage requirements
of their currently marketed products. In addition, the presence
of a few promising drugs such as Oral-lyn and monoclonal
antibodies in the late stage pipeline means that the competition
will increase further once these products are successfully
launched in the market. The current market also lacks any
generic insulin product despite two insulin products losing
patent protection. This is because of the lack of proper
guidelines for the introduction of biogenerics. In Europe, where
guidelines for the approval of biosimilars exist, an application
Type 1 Diabetes - Drug Pipeline Assessment and
Market Forecasts to 2017
GDHC106PRT /Published JUN 2010
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1 Table of contents
1 Table of contents................................................................................................................................... 3
1.1 List of Tables .................................................................................................................................. 5
1.2 List of Figures ................................................................................................................................. 5
2 Type 1 Diabetes Therapeutics Market: Market Characterization........................................................... 6
2.1 Overview......................................................................................................................................... 6
2.2 Type 1 Diabetes Market Size.......................................................................................................... 6
2.3 Type 1 Diabetes Therapeutics Market Forecast and CAGR........................................................... 7
2.4 Drivers and Barriers for the Type 1 Diabetes Therapeutics Market ................................................ 8
2.4.1 Drivers for the Type 1 Diabetes Therapeutics Market ........................................................... 8
2.4.2 Restraints for the Type 1 Diabetes Therapeutics Market....................................................... 9
2.5 Opportunity and Unmet Need ........................................................................................................10
2.6 Key Takeaway ...............................................................................................................................11
3 Type 1 Diabetes Therapeutics Market: Competitive Assessment ........................................................12
3.1 Overview........................................................................................................................................12
3.2 Strategic Competitor Assessment..................................................................................................12
3.3 Product Profile for the Major Marketed Products in the Type 1 Diabetes Disease Market.............13
3.3.1 Lantus (Insulin Glargine) ......................................................................................................13
3.3.2 Humulin (Human Insulin) ......................................................................................................16
3.3.3 Humalog (Insulin Lispro).......................................................................................................17
3.3.4 Novolog (Insulin Aspart) .......................................................................................................19
3.3.5 Novolin (Human Insulin) .......................................................................................................20
3.3.6 Apidra (Insulin Glulisine).......................................................................................................21
3.3.7 Levemir (Insulin Detemir)......................................................................................................23
3.4 Key Takeaway ...............................................................................................................................25
4 Type 1 Diabetes Therapeutics Market: Pipeline Assessment ..............................................................26
4.1 Overview........................................................................................................................................26
4.2 Strategic Pipeline Assessment ......................................................................................................26
4.2.1 Technology Trends Analytic Framework ..............................................................................26
4.3 Type 1 Diabetes Therapeutics – Promising Drugs under Clinical Development............................27
4.4 Molecule Profile for Promising Drugs under Clinical Development................................................28
4.4.1 rhGAD65 (Diamyd) ...............................................................................................................28
4.4.2 DiaPep277............................................................................................................................28
4.4.3 Otelixizumab.........................................................................................................................29
4.4.4 Oral-lyn.................................................................................................................................30
4.5 Type 1 Diabetes Therapeutics Market – Clinical Pipeline by Mechanism of Action.......................31
4.6 Type 1 Diabetes Pipeline – Pipeline by Clinical Phases of Development ......................................32
4.6.1 Type 1 Diabetes Therapeutics – Filed and Approved Drugs ................................................32
4.6.2 Type 1 Diabetes Therapeutics – Phase III Clinical Pipeline .................................................33
4.6.3 Type 1 Diabetes Therapeutics – Phase II Clinical Pipeline ..................................................33
4.6.4 Type 1 Diabetes Therapeutics – Phase I Clinical Pipeline ...................................................35
4.6.5 Type 1 Diabetes Therapeutics – Preclinical-Discovery Pipeline...........................................35
4.7 Key Takeaway ...............................................................................................................................36
5 Type 1 Diabetes Market: Implications for Future Market Competition..................................................37
6 Type Diabetes Therapeutics Market: Future Players in the Type 1 Diabetes Therapeutics Market .....39
6.1 Introduction....................................................................................................................................39
6.2 Novo Nordisk .................................................................................................................................39
6.2.1 Business Description ............................................................................................................39
6.2.2 Metabolic Disorders Portfolio................................................................................................40
6.2.3 Type 1 Diabetes Pipeline Portfolio........................................................................................41
6.3 GlaxoSmithKline ............................................................................................................................42
6.3.1 Business Description ............................................................................................................42
6.3.2 Metabolic Disorders Portfolio................................................................................................43
6.3.3 Type 1 Diabetes Pipeline Portfolio........................................................................................43
6.4 Eli Lilly ...........................................................................................................................................44
6.4.1 Business Description ............................................................................................................44
6.4.2 Metabolic Disorders Portfolio................................................................................................45
6.4.3 Type 1 Diabetes Pipeline Portfolio........................................................................................45
6.5 Sanofi-Aventis................................................................................................................................46
6.5.1 Business Description ............................................................................................................46
Type 1 Diabetes - Drug Pipeline Assessment and
Market Forecasts to 2017
GDHC106PRT /Published JUN 2010
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6.5.2 Metabolic Disorders Portfolio................................................................................................47
6.5.3 Type 1 Diabetes Pipeline Portfolio........................................................................................47
7 Type 1 Diabetes Therapeutics Market: Appendix.................................................................................48
7.1 Definitions......................................................................................................................................48
7.2 Scope of Pipeline Research ..........................................................................................................48
7.3 Abbreviations.................................................................................................................................48
7.4 Research Methodology..................................................................................................................49
7.4.1 Coverage..............................................................................................................................50
7.4.2 Secondary Research ............................................................................................................50
7.4.3 Forecasting...........................................................................................................................50
7.4.4 Primary Research.................................................................................................................52
7.4.5 Expert Panel Validation ........................................................................................................53
7.5 Contact Us.....................................................................................................................................53
7.6 Disclaimer......................................................................................................................................53
7.7 Sources .........................................................................................................................................54
Type 1 Diabetes - Drug Pipeline Assessment and
Market Forecasts to 2017
GDHC106PRT /Published JUN 2010
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1.1 List of Tables
Table 1: Type 1 Diabetes Therapeutics Market, Global, Revenues ($bn), 2001-2009 ............................ 7
Table 2: Type 1 Diabetes Therapeutics Market, Global, Revenue Forecasts ($bn), 2009-2017 ............. 8
Table 3: Type 1 Diabetes Therapeutics Market, Lantus, Clinical Studies Outcome for Efficacy, 2010...14
Table 4:
Type 1 Diabetes Therapeutics Market, Lantus, Adverse Events in 28-Week Clinical Trials of
Adults and Children With Type 1 Diabetes, 2010 .....................................................................14
Table 5: Type 1 Diabetes Therapeutics Market, Lantus, Clinical Studies Outcome for Safety, 2010 .....15
Table 6: Humulin - Glycemic Parameters at the End of Treatment Period in Randomized Patients in
Three Months Cross-Over Studies for Type 1 Diabetes, 2010 .................................................16
Table 7: Humulin – Results of Three Month Cross-Over Studies Comparing Humulin with Humalog in
Type 1 Diabetes, 2010..............................................................................................................17
Table 8: Type 1 Diabetes Therapeutics Market, Humalog, Glycemic Parameters at the End of
Treatment Period in Randomized Patients in Three Months Cross-Over Studies, 2010 ..........18
Table 9: Humalog – Results of a Two Month Study Comparing the Use of Humalog and Humulin With
Sulfonyluria (SU) Therapy, 2010...............................................................................................19
Table 10: Type 1 Diabetes Therapeutics Market, Novolog, Glycemic Parameters at the End of 24 Week
Study, 2010...............................................................................................................................20
Table 11: Apidra – Efficacy Result of 26-Week Study Comparing Apidra with Insulin Lispro, 2010 .........22
Table 12: Apidra – Efficacy Result of 26-Week Study Comparing Apidra with Regular Insulin ................22
Table 13: Apidra – Adverse Reactions Observed in Pooled Studies in Type 1 Diabetic Adults, 2010......22
Table 14: Levemir – Efficacy Result in 16-Week Non Blinded Study, 2010..............................................23
Table 15: Major Marketed Products Comparison in the Type 1 Diabetes Therapeutics Market, 2010.....24
Table 16: Type 1 Diabetes Therapeutics – Most Promising Drugs Under Clinical Development, 2010....27
Table 17: Type 1 Diabetes Therapeutics – Filed and Approved Drugs, 2010...........................................32
Table 18: Type 1 Diabetes Therapeutics – Phase III Clinical Pipeline, 2010............................................33
Table 19: Type 1 Diabetes Therapeutics – Phase II Clinical Pipeline, 2010.............................................33
Table 20: Type 1 Diabetes Therapeutics – Phase I Clinical Pipeline, 2010..............................................35
Table 21: Type 1 Diabetes Therapeutics – Preclinical-Discovery Pipeline, 2010 .....................................35
Table 22: Genzyme – Metabolic Disorders Marketed Products, 2010 ......................................................40
Table 23: Novo Nordisk - Metabolic Disorders Pipeline Products, 2010...................................................41
Table 24: GlaxoSmithKline – Metabolic Disorders Marketed Products, 2010...........................................43
Table 25: GlaxoSmithKline - Metabolic Disorders Pipeline Products, 2010..............................................43
Table 26: Eli Lilly – Metabolic Disorders Marketed Products, 2010 ..........................................................45
Table 27: Eli Lilly – Metabolic Disorders Pipeline Products, 2010 ............................................................45
Table 28: Sanofi-Aventis – Metabolic Disorders Marketed Products, 2010 ..............................................47
Table 29: Sanofi-Aventis – Metabolic Disorders Pipeline Products, 2010 ................................................47
1.2 List of Figures
Figure 1: Type 1 Diabetes Therapeutics Market, Global, Revenues ($bn), 2001-2009 ............................ 7
Figure 2: Type 1 Diabetes Therapeutics Market, Global, Revenue Forecasts ($bn), 2009-2017 ............. 8
Figure 3: Opportunity and Unmet Need in the Type 1 Diabetes Therapeutics Market, 2010 ...................10
Figure 4: Strategic Competitor Assessment of the Major Marketed Products in Type 1 Diabetes
Therapeutics, 2010 ...................................................................................................................13
Figure 5: Technology Trends Analytic Framework of the Type 1 Diabetes Therapeutics Pipeline, 2010.26
Figure 6: Technology Trends Analytic Framework of the Type 1 Diabetes Therapeutics
Pipeline – Description, 2010 .....................................................................................................27
Figure 7: Type 1 Diabetes Therapeutics Market – Clinical Pipeline by Mechanism of Action, 2010 ........31
Figure 8: Type 1 Diabetes Therapeutics Pipeline by Phase of Clinical Development, 2010 ....................32
Figure 9: Implications for Future Market Competition in the Type 1 Diabetes Market, 2010....................37
Figure 10: Type 1 Diabetes Therapeutics Market – Clinical Pipeline by Company, 2010 ..........................39
Figure 11: GlobalData Methodology, 2010 ................................................................................................49
Figure 12: GlobalData Market Forecasting Model, 2010............................................................................52
Type 1 Diabetes - Drug Pipeline Assessment and
Market Forecasts to 2017
GDHC106PRT /Published JUN 2010
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2.3 Type 1 Diabetes Therapeutics Market Forecast and CAGR
GlobalData expects the type-1 diabetes therapeutics market to grow at a CAGR of XX% from $XXX billion
in 2009 to $XX billion in 2017.
Figure 1: Type 1 Diabetes Therapeutics Market, Global, Revenues ($bn), 2001-2009
CAGR (2001-2009): XX%
Sales Value ($ bn)
2001 2002 2003 2004 2005 2006 2007 2008 2009
Source: GlobalData
Table 1: Type 1 Diabetes Therapeutics Market, Global, Revenues ($bn), 2001-2009
Year 2001 2002 2003 2004 2005 2006 2007 2008 2009
Sales Value ($bn)
Growth Rate (%)
Source: GlobalData
CAGR 2001-2009
(%)
Type 1 Diabetes - Drug Pipeline Assessment and
Market Forecasts to 2017
GDHC106PRT /Published JUN 2010
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4.5 Type 1 Diabetes Therapeutics Market – Clinical Pipeline by Mechanism of
Action
In terms of the drugs currently under development, insulin products dominated the type 1 diabetes
therapeutics pipeline. This is because type 1 diabetes is dependent on insulin intake due to the body’s
inability to produce insulin. Insulin acts in the body to help in glucose metabolism. Insulin attaches to
insulin receptors in cells to enable the absorption of glucose in cells. Insulin analogs accounted for XX%
of the total number of pipeline products. Together insulin and insulin analogs account for XX% of the total
number of pipeline products. Together, anti-CD3 monoclonal antibodies was the second largest category
and accounted for XX% of the total type 1 diabetes pipeline. Interleukin-1 (IL-1) receptor antagonists, antiinflammatories
and islet implants formed XX% of the total number of pipeline products.
Figure 7: Type 1 Diabetes Therapeutics Market – Clinical Pipeline by Mechanism of Action, 2010
Insulin
Anti-CD3 mABs
Islet Implant
Antigen-Specific Immune Modulators
T-lymphocyte Inhibitors
New Islet Formation Inducers
Miscellaneous
Interleukin-1 (IL-1) Receptor Antagonist
Anti-Inflammatory
Insulin Analog
IL12 and STAT 4 Activators
Stem Cell Therapy
SGLT 2 Inhibitor
Source: GlobalData
Type 1 diabetes is an autoimmune disorder and anti-CD3 monoclonal antibodies aim to work by
protecting the insulin-producing pancreatic cells from autoimmune attacks. The drugs in development for
type 1 diabetes can be divided into three major categories of mechanism of action. First, some drugs help
the body’s glucose metabolism by supplying the body with the required insulin. Second, some drugs help
in the generation of new islet cells. Islet cells in the pancreas are primarily responsible for the generation
of insulin. A third category protects the insulin producing islets from autoimmune attacks. The therapies
related to islet implants accounted for XX% of the total products in the pipeline. Antigen-specific immune
modulators, IL12 and STAT 4 activators, t-lymphocyte inhibitors, stem cell therapies, sodium-glucose cotransporter
(SGLT 2) inhibitors and new islet formation inducers each accounted for XX% of the total
pipeline. The rest of the pipeline has products that help to reduce blood glucose level by targeting the
glucose metabolism at different steps, to reduce the destruction of beta cells in the pancreas or induce the
production of healthy insulin producing cells. These products are under the miscellaneous category. It
includes amylinomimetic agents, anti-CD20, anti-IL-1β monoclonal antibodies, products that destructs β
cell and increase insulin levels, granulocyte colony-stimulating factor (G-CSF) receptor inhibitors,
products that convert hepatic glycogen to glucose, DPP-4 inhibitors, enzyme transketolase activators,
GLP1-analogs, glucagon receptors, human LFA-3/IGG1 fusion proteins, CD4+CD25+foxp3+ regulatory T
cells inducers, NF-kB inhibitors, PPAR agonists, products that preserve beta cell functioning, selective costimulation
modulators, CD80 and CD86 blockers, combination products that inhibits 3-hydroxy-3-
methylglutaryl-coenzyme A (HMG-CoA) reductase and reduce LDL cholesterol, Syk kinase inhibitors, and
tumor necrosis factor inhibitors. Some products stimulate intestinal calcium and phosphorus absorption
and bone mineralization and target disease-specific autoagressive T-cells. All these products form part of
the miscellaneous category of mechanisms of action and account for XX% of the total products in the
pipeline.
Type 1 Diabetes - Drug Pipeline Assessment and
Market Forecasts to 2017
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7 Type 1 Diabetes Therapeutics Market: Appendix
7.1 Definitions
Type 1 Diabetes Disorders Market: The type 1 diabetes disorders market is primarily formed of ten
products – Lantus, Symlin, Levemir, CDM1103, NovoMix, Apidra, Humalog, Humulin, Novolin and
Novolog. These products come under the category of insulin, insulin analogs and amylinomimetic agents.
Pipeline analysis: The pipeline candidates fall in the major therapeutic categories such as insulin, anti-
CD3 mABs, interleukin-1 (IL-1) receptor antagonists, anti-inflammatories, islet implants, insulin analogs,
antigen-specific immune modulators, IL12 and STAT 4 activators, T-lymphocyte inhibitors, stem cell
therapies, new islet formation inducers and SGLT 2 inhibitors.
7.2 Scope of Pipeline Research
Pipeline products covered within the report are sourced from;
Top 200 companies (by number of molecules in pipeline)
Clinical trial.gov
WHO registry, which is covering around 6 different registries such as
India, Australia, Germany and Japan
7.3 Abbreviations
CAGR: Compound Annual Growth Rate
CDC:
CNS:
EBV:
Centers for Disease Control and Prevention
Central Nervous System
Epstein-Barr virus
EMEA: Europe by European Medicines Agency
FPG:
GAD:
Fasting Plasma Glucose
Glutamic Acid Decarboxylase
G-CSF: Granulocyte Colony-Stimulating Factor
GHb:
GSK:
Glycated Hemoglobin
GlaxoSmithKline
HbA1c: Glycosylated Haemoglobin
HMG-CoA: 3-Hydroxy-3-Methylglutaryl-Coenzyme A
Hsp60: Human Heat Shock Protein 60
IDMC:
IL:
Independent Data Monitoring Committee
Interleukin
LADA: Latent Autoimmune Diabetes in Adults
OAD:
NAID:
Oral Anti-Diabetic products
National Institute of Allergy and Infectious Diseases
NCRR: National Center for Research Resources
NIAID: National Institute of Allergy and Infectious Diseases
NICHD: Eunice Kennedy Shriver National Institute of Child Health and Human Development
NIDDK: National Institute of Diabetes and Digestive and Kidney Diseases
Type 1 Diabetes - Drug Pipeline Assessment and
Market Forecasts to 2017
GDHC106PRT /Published JUN 2010
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NIH:
NPH:
National Institutes of Health
Neutral Protamine Hagedorn
mABs: Monoclonal Antiobodies
R&D:
rDNA:
Research and Development
recombinant DNA
rhGAD65: Recombinant Human Glutamic Acid Decarboxylase
SGLT 2: Sodium-Glucose Co-Transporter
SIBA:
SU:
VLD:
WHO:
Soluble Insulin Basal Analog
Sulfonyluria
Very Low Dose
World Health Organization
7.4 Research Methodology
GlobalData’s dedicated Research and Analysis Teams consist of experienced professionals with a
pedigree in marketing, market research, consulting backgrounds in the pharmaceutical industry and
advanced statistical expertise.
GlobalData adheres to the Codes of Practice of the Market Research Society (www.mrs.org.uk) and the
Society of Competitive Intelligence Professionals (www.scip.org).
All GlobalData databases are continuously updated and revised. The following research methodology is
followed for all databases and reports.
Figure 11: GlobalData Methodology, 2010
Data Update
Taxonomy
Update
Expert
Panel
Validation
Secondary
Research
Forecasts
Primary
Research
Source: GlobalData
Modeling and
benchmarking
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7.4.1 Coverage
The objective of updating GlobalData’s coverage is to ensure that it represents the most up to date vision
of the industry possible.
Changes to the industry taxonomy are built on the basis of extensive research of company, association
and competitor sources.
Company coverage is based on three key factors: Revenues, products and media attention/innovation/
market potential.
The estimated revenues of all major companies, including private and governmental, are gathered
and used to prioritize coverage; and
Companies which are making the news, or which are of particular interest due to their innovative
approach are prioritized.
GlobalData aims to cover all major news events and deals in the pharmaceutical industry, updated on a
daily basis.
The coverage is further streamlined and strengthened with additional inputs from GlobalData’s Expert
Panel (see below).
7.4.2 Secondary Research
The research process begins with exhaustive secondary research on internal and external sources being
carried out to source qualitative and quantitative information relating to each market.
The secondary research sources that are typically referred to include, but are not limited to:
Company websites, annual reports, financial reports, broker reports, investor presentations and SEC
filings;
Industry trade journals, scientific journals and other technical literature;
Internal and external proprietary databases;
Relevant patent and regulatory databases;
National government documents, statistical databases and market reports;
Procedure registries; and
News articles, press releases and web-casts specific to the companies operating in the market.
7.4.3 Forecasting
GlobalData uses an epidemiology-based treatment flow model to forecast the market size for therapeutic
indications. GlobalData reports cover seven major geographies namely the US, the UK, Germany,
France, Spain, Italy and Japan.
7.4.3.1 Epidemiology-based Forecasting
The forecasting model used at GlobalData makes use of epidemiology data gathered from research
publications and primary interviews with physicians to represent the treatment flow patterns for individual
diseases and therapies. The market for any disease segment is directly proportional to the volume of units
sold and the price per unit.
Sales = Volume of Units sold X Price per Unit
The volume of units sold is calculated on the average dosage regimen for that disease, the duration of
treatment and the number of patients who are prescribed drug treatment (prescription population). The
prescription population is calculated as a percentage of the population diagnosed with a disease
(diagnosis population). The diagnosis population is the population diagnosed with a disease expressed as
a percentage of the population that is seeking treatment (treatment seeking population). The prevalence
of a disease (disease population) is the percentage of the total population who suffer from a
disease/condition.
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Data on the treatment seeking rate, diagnosis rate and prescription rate, if unavailable from research
publications, are gathered from interviews with physicians and are used to estimate the patient volumes
for the disease under consideration. Therapy uptake and compliance data are fitted in the forecasting
model to account for patient switching and compliance behavior.
To account for differences in patients’ ability to afford drugs across various geographies, macroeconomic
data such as inflation and GDP and healthcare indicators such as healthcare spending, insurance
coverage and average income per individual are used.
The average cost of treatment is calculated using product purchase frequency and the average price of
the therapy. The product purchase frequency is calculated from the dosage data available for the
therapies and drug prices are gathered from public sources.
The epidemiology-based forecasting model uses a bottom-up methodology and it makes use of
estimations in the absence of data from research publications. Such estimations may result in a final
market value different from the actual value. To correct this ‘gap’ the forecasting model uses ‘triangulation’
with the help of base year sales data (from company annual reports, internal and external databases) and
sales estimations.
Analogous Forecasting Methodology
An analogous forecasting methodology is used to account for the introduction of new products, the patent
expiries of branded products and the subsequent introduction of generics. Historic data for new product
launches and generics penetration are used to arrive at robust forecasts. The increase or decrease of the
prevalence rate, treatment seeking rate, diagnosis rate and prescription rate are fitted into the forecasting
model to estimate market growth rate.
The proprietary model enables GlobalData Research to account for the impact of individual drivers and
restraints in the growth of the market. The year of impact and the extent of impact are quantified in the
forecasting model to provide close-to-accurate data sets.
Diseased Population
The diseased population for any indication is the prevalence rate. The prevalence rates are usually
obtained from various journals, online publications, sources such as World Health Organization (WHO) or
associations and foundation websites for that particular disease.
Treatment Seeking Population
The treatment seeking population is always calculated as a percentage of the prevalence population. The
number denotes the actual number of patients who are going to hospitals to get diagnosis for any
disease. The treatment seeking population is primarily driven by the onset of symptoms, patient
awareness and the severity of the disease.
Diagnosis Population
Of the patients who undergo diagnostic tests to confirm a disease, only a few people get diagnosed with
the disease. This number as a percentage of the treatment seeking population is the diagnosis rate. The
diagnosis population is primarily driven by the sensitivity of the diagnostic tests, state-of-the-art
technology, patient access to these diagnostic tests and cost of the diagnostic tests.
Prescription Population
For any disease, multiple treatment options exist. For example, in cancer treatment various treatment
options such as surgery, radiation therapy, and drug therapy are available. The prescription population is
defined as the number of patients who are prescribed drug therapy. This is calculated as a percentage of
the diagnosis population. The prescription population is primarily driven by the age at which the disease is
diagnosed, the disease stage, patient health and the cost of drug treatment.
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Forecasting Model for Therapeutic Areas
Figure 12: GlobalData Market Forecasting Model, 2010
GlobalData Market Sizing Model
Disease Population
General Population 743,535,048
Qualifying condition 1
Qualifying condition 2
Prevalence neuropathic pain 2.7% 19,926,739
Qualifying condition (complication, severity)
DISEASED POPULATION 19,926,739
Treatment Flow Patterns
Treatment Seeking Rate (Symptoms/Dis Awareness) 90%
Diagnosis Rate (Clinical and Diagnostic Tests)
Prescription Rate (Physician Perception, Treatment Effectiveness)
CVS Disease 78%
Other Treatments for Valve (Surg/Med/None)
Fulfillment
Availability
NA
Willingness to Use (Patient Perceptions)
NA
Ready to Use (Surgery eligibility, Reuse etc)
NA
Affordability at Price
HE as % of GDP spend
Average US Income (per capita)
Patient Out-of-pocket Budget (Annual)
Budget allocation to one-time surgery
Budget allocation to other health needs
Average Payor Coverage
Patient Liability
Target Price (@20% pat liab)
ASP for Cost of Therapy
TOTAL PATIENT VOLUMES
Product Purchase Frequency
TOTAL UNIT VOLUMES
Pricing per Unit
Inflation
Price Decrease due to competition
Market Value
Source: GlobalData
7.4.4 Primary Research
GlobalData conducts hundreds of primary interviews a year with industry participants and commentators
in order to validate its data and analysis. A typical research interview fulfills the following functions:
It provides first-hand information on the market size, market trends, growth trends, competitive
landscape, future outlook etc;
Helps in validating and strengthening the secondary research findings; and
Further develops the Analysis Team’s expertise and market understanding.
Primary research involves E-mail correspondence, telephone interviews as well as face-to-face interviews
for each market, category, segment and sub-segment across geographies.
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The participants who typically take part in such a process include, but are not limited to:
Industry participants: CEOs, VPs, marketing/product managers, market intelligence managers and
national sales managers;
Hospital stores, laboratories, pharmacies, distributors and paramedics;
Outside experts: investment bankers, valuation experts, research analysts specializing in specific
pharmaceutical markets; and
Key opinion leaders: physicians and surgeons specializing in different therapeutic areas
corresponding to different kinds of pharmaceuticals.
7.4.5 Expert Panel Validation
GlobalData uses a panel of experts to cross verify its databases and forecasts.
GlobalData expert panel comprises marketing managers, product specialists, international sales
managers from pharmaceutical companies; academics from research universities, KOLs from hospitals,
consultants from venture capital funds and distributors/suppliers of pharmaceuticals and supplies.
Historic data and forecasts are relayed to GlobalData’s Expert Panel for feedback and adjusted in
accordance with their feedback.
7.5 Contact Us
If you have any queries about this report or would like further information, please contact at the below
given telephone numbers or email address.
North America: +1 646 395 5460
Europe: +44 207 753 4298 (OR) +44 161 227 0666
Asia Pacific: +91 40 6616 6700
Email: info@globaldata.com
7.6 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.
The facts of this report are believed to be correct at the time of publication but cannot be guaranteed.
Please note that the findings, conclusions and recommendations that GlobalData delivers will be based
on information gathered in good faith from both primary and secondary sources, whose accuracy we are
not always in a position to guarantee. As such GlobalData can accept no liability whatever for actions
taken based on any information that may subsequently prove to be incorrect.
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7.7 Sources
http://dialogpro.dialog.com/
www.who.com
http://www.rxlist.com/script/main/hp.asp
www.pharmacychecker.com
www.drugstore.com
http://www.medicinpricer.dk/Default.aspk?Ing=2
http:/www.ic.nhs.uk/statistics-and-data-collections/primary-care/prescriptions
www.medicalnewstoday.com
http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm
www.drugs.com
http://www.fiercepharma.com/
http://www.nice.org.uk/
Type 1 Diabetes - Drug Pipeline Assessment and
Market Forecasts to 2017
GDHC106PRT /Published JUN 2010
Page 54
© GlobalData. This report is a licensed product and is not to be photocopied