nsclc therapeutics in asia-pacific markets to 2019 · nsclc therapeutics in asia-pacific markets to...

NSCLC Therapeutics in Asia-Pacific Markets to 2019 Personalized Therapies Focus on Untapped Segment of Squamous Cell Carcinoma to Expand Treatment Pool

GBI Research Report Guidance

© GBI Research. This is a licensed product and is not to be photocopied GBIHC326MR / Published MAR 2014

GBI Research Report Guidance

Chapter two provides an overview of the disease, its symptoms, etiology, pathophysiology, diagnosis, classification, epidemiology, prognosis, staging and treatment options.

Chapter three provides a detailed profiling and comparative heat map analysis in terms of safety and efficacy for currently marketed products in the NSCLC market.

Chapter four presents a detailed pipeline analysis for the disease, including individual product profiles, a comparative efficacy and safety profile heat map analysis of the most promising pipeline products as well as analyses on the distribution of molecule types across the NSCLC developmental pipeline, the molecular targets of pipeline mAbs and the developmental program types. In addition, detailed analyses of the clinical trial failure rates, the clinical trial durations by phase and clinical trial sizes, by participant numbers.

Chapter five provides market forecasts for countries across the globe, with special attention given to the APAC countries: India, Australia, China and Japan. The multiple scenario forecasts take into account a range of factors that are likely to vary and provide a clear perspective on the level of the potential degree of variance in the market sizes.

Chapter six covers the major deals that have taken place in the disease market in recent years. Coverage includes co-development deals and licensing agreements, which are segmented on the basis of geography and total value. A concomitant analysis of the licensing deal values for products by molecule types and molecular targets is also provided.


Executive Summary

Executive Summary

Non-Small Cell Lung Cancer Therapeutics Market to Witness Modest Growth over Forecast Period

The launch of premium-priced targeted therapies has changed the Non-Small Cell Lung Cancer (NSCLC) treatment paradigm and elevated the NSCLC market during the past decade. This growth is expected to continue at a moderate pace during the forecast period, culminating in growth from $XX billion in 2012 to $XX billion by 2019, in Asia-Pacific (APAC). In 2012, Japan and China had respective shares of XX% and XX% in the NSCLC market of APAC. India and Australia had much lower shares of XX% and XX% respectively.

An aging population and increasing number of NSCLC incident cases, especially in China and India, drive the growth in the market. The expected launches of premium-priced novel antibodies and immunotherapies in the first and second lines of therapies, targeting both Non-Squamous NSCLC (NOS NSCLC) and Squamous NSCLC (S NSCLC) patients, widen the eligible treatment population, maximize the patient share and ultimately drive market growth. In spite of many expected drug launches, without the risk of generic erosion of currently entrenched therapies, growth is expected to be marginal due to the dominant generic penetration of a few NSCLC drugs in India. A complex and lengthy regulatory pathway and limited reimbursement from national insurance programs, in China, as well as regular price cuts, in Japan, also limit growth in the APAC market.

Non-Small Cell Lung Cancer Therapeutics, Asia-Pacific, Market Size ($bn), 2012 and 2019

2012 2019

Mar

ket s

ize

($bn

)

China India Japan Australia

Source: GBI Research Proprietary Marketed Products Database

Modest growth is driven by the increasing incidence population and expected launch of premium-priced pipeline molecules.


Page 6

Table of Contents

1 Table of Contents

1 Table of Contents ................................................................................................................................. 6 1.1 List of Tables ............................................................................................................................. 8 1.2 List of Figures............................................................................................................................ 8

2 Introduction........................................................................................................................................10 2.1 Symptoms ...............................................................................................................................10 2.2 Etiology ...................................................................................................................................11 2.3 Pathophysiology ......................................................................................................................12 2.4 Co-morbidities and Complications ............................................................................................12 2.5 Diagnosis .................................................................................................................................13

2.5.1 Physical Examination........................................................................................................13 2.5.2 Sputum Cytology ..............................................................................................................13 2.5.3 Imaging Tests...................................................................................................................13 2.5.4 Biopsy ..............................................................................................................................14

2.6 Classification............................................................................................................................15 2.6.1 Adenocarcinoma ..............................................................................................................15 2.6.2 Squamous Cell Carcinoma ................................................................................................15 2.6.3 Large Cell Carcinoma ........................................................................................................15

2.7 Epidemiology ...........................................................................................................................15 2.8 Prognosis and Disease Staging ..................................................................................................16

2.8.1 Staging ............................................................................................................................16 2.9 Treatment Options ..................................................................................................................18

2.9.1 Surgery and Radiation Therapy .........................................................................................18 2.9.2 Pharmacological ..............................................................................................................18 2.9.3 Treatment Algorithms and Prescribing Habits ...................................................................20

3 Marketed Products .............................................................................................................................23 3.1 Therapeutic Landscape ............................................................................................................24

3.1.1 Alimta (pemetrexed disodium) – Eli Lilly and Company ......................................................24 3.1.2 Abraxane (nab-paclitaxel) – Celgene .................................................................................26 3.1.3 Iressa (gefitinib) – AstraZeneca .........................................................................................28 3.1.4 Tarceva (erlotinib hydrochloride) – F. Hoffmann-La Roche .................................................29 3.1.5 Xalkori (crizotinib) – Pfizer ................................................................................................31 3.1.6 Avastin (bevacizumab) – F. Hoffmann-La Roche ................................................................32 3.1.7 Gilotrif (afatinib) – Boehringer Ingelheim ..........................................................................34

3.2 Comparative Efficacy and Safety...............................................................................................34 4 Pipeline Products ................................................................................................................................37

4.1 Overall Pipeline........................................................................................................................37 4.2 Pipeline Analysis by Molecule Type ..........................................................................................39 4.3 Pipeline Analysis by Mechanism of Action ................................................................................41 4.4 Clinical Trials ............................................................................................................................44

4.4.1 Failure Rate .....................................................................................................................44 4.4.2 Patient Enrollment and Clinical Trial Size ...........................................................................46 4.4.3 Duration ..........................................................................................................................48

4.5 Promising Drug Candidates in the Pipeline ................................................................................50 4.5.1 Ramucirumab (IMC-1121B) – Eli Lilly and Company ...........................................................50 4.5.2 Necitumumab (IMC-11F8) – Eli Lilly and Company .............................................................50 4.5.3 Onartuzumab (MetMab) – F. Hoffmann-La Roche .............................................................51 4.5.4 Ganetespib (STA-9090) – Synta .........................................................................................52 4.5.5 Nintedanib (BIBF1120) – Boehringer Ingelheim .................................................................52 4.5.6 Dacomitinib (PF-00299804) – Pfizer ..................................................................................53 4.5.7 LDK378 – Novartis ............................................................................................................54


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Table of Contents

4.5.8 Yervoy (ipilimumab) – Bristol-Myers Squibb ......................................................................54 4.5.9 Nivolumab (BMS-936558/ONO-4538) – Bristol Myers Squibb ............................................55

5 Market Forecast to 2019 .....................................................................................................................56 5.1 Geographical Markets ..............................................................................................................56

5.1.1 APAC Market ...................................................................................................................56 5.1.2 India ................................................................................................................................57 5.1.3 Australia ..........................................................................................................................60 5.1.4 China ...............................................................................................................................62 5.1.5 Japan ...............................................................................................................................64

5.2 Drivers and Barriers for the Disease Market..............................................................................66 5.2.1 Drivers .............................................................................................................................66 5.2.2 Barriers ............................................................................................................................66

6 Deals and Strategic Consolidations ......................................................................................................68 6.1 Major Co-development Deals ...................................................................................................70

6.1.1 OxOnc Enters Co-development Agreement with Pfizer for Crizotinib ..................................71 6.1.2 SFJ Pharma Enters Co-development Agreement with Pfizer for Dacomitinib .......................71 6.1.3 Merck Enters Co-development Agreement with Endocyte for Cancer Drug .........................72 6.1.4 Roche Enters Co-development Agreement with Clovis .......................................................72 6.1.5 Abbott Laboratories Enters Co-development Agreement with GlaxoSmithKline ..................72

6.2 Major Licensing Deals ..............................................................................................................72 6.2.1 Chugai Enters Licensing Agreement with Roche for Onartuzumab and Lebrikizumab ..........73 6.2.2 Azaya Enters Licensing Agreement with CANbridge Life Sciences for ATI-1123 ...................74 6.2.3 Merck Expands Licensing Agreement with Biomira ............................................................74 6.2.4 Clovis Enters Licensing Agreement with Avila Therapeutics ................................................74

7 Appendix ............................................................................................................................................75 7.1 All Pipeline Drugs by Phase ......................................................................................................75

7.1.1 Discovery .........................................................................................................................75 7.1.2 Preclinical ........................................................................................................................75 7.1.3 IND-filed ..........................................................................................................................77 7.1.4 Phase I .............................................................................................................................78 7.1.5 Phase II ............................................................................................................................80 7.1.6 Phase III ...........................................................................................................................83 7.1.7 Undisclosed......................................................................................................................84

7.2 Market Forecasts to 2019 ........................................................................................................89 7.2.1 APAC ...............................................................................................................................89 7.2.2 India ................................................................................................................................90 7.2.3 Australia ..........................................................................................................................90 7.2.4 China ...............................................................................................................................90 7.2.5 Japan ...............................................................................................................................91

7.3 Market Definitions ...................................................................................................................91 7.4 Abbreviations ..........................................................................................................................91 7.5 Bibliography ............................................................................................................................94 7.6 Research Methodology ............................................................................................................97

7.6.1 Coverage .........................................................................................................................97 7.6.2 Secondary Research .........................................................................................................98 7.6.3 Primary Research .............................................................................................................98 7.6.4 Therapeutic Landscape .....................................................................................................98 7.6.5 Geographical Landscape ................................................................................................ 100 7.6.6 Pipeline Analysis............................................................................................................. 101

7.7 Expert Panel Validation .......................................................................................................... 101 7.8 Contact Us ............................................................................................................................. 101 7.9 Disclaimer.............................................................................................................................. 101


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Table of Contents

1.1 List of Tables

Table 1: Non-Small Cell Lung Cancer Market, Common Symptoms of Non-Small Cell Lung Cancer ..........11 Table 2: Non-Small Cell Lung Cancer Market, Risk Factors of Non-Small Cell Lung Cancer Market ...........12 Table 3: Non-Small Cell Lung Cancer Market, American Joint Committee on Cancer’s Tumor Node

Metastasis Staging System, 2010 .............................................................................................17 Table 4: Non-Small Cell Lung Cancer Market, Global, Pharmaceutical Pipeline (Discovery), 2013 ............75 Table 5: Non-Small Cell Lung Cancer Market, Global, Pharmaceutical Pipeline (Preclinical), 2013 ...........75 Table 6: Non-Small Cell Lung Cancer Market, Global, Pharmaceutical Pipeline (IND-filed), 2013 .............77 Table 7: Non-Small Cell Lung Cancer Market, Global, Pharmaceutical Pipeline (Phase I), 2013................78 Table 8: Non-Small Cell Lung Cancer Market, Global, Pharmaceutical Pipeline (Phase II), 2013 ...............80 Table 9: Non-Small Cell Lung Cancer Market, Global, Pharmaceutical Pipeline (Phase III), 2013 ..............83 Table 10: Non-Small Cell Lung Cancer Market, Global, Pharmaceutical Pipeline (Undisclosed), 2013 ........84 Table 11: Non-Small Cell Lung Cancer Market, Asia-Pacific, Market Forecast, 2012–2019 ........................89 Table 12: Non-Small Cell Lung Cancer Market, India, Market Forecast, 2012–2019 ..................................90 Table 13: Non-Small Cell Lung Cancer Market, Australia, Market Forecast, 2012–2019 ............................90 Table 14: Non-Small Cell Lung Cancer Market, China, Market Forecast, 2012–2019 .................................90 Table 15: Non-Small Cell Lung Cancer Market, Japan, Market Forecast, 2012–2019 .................................91

1.2 List of Figures

Figure 1: Non-Small Cell Lung Cancer Market, Asia-Pacific, Distribution of Prevalence Population, 2012–2019 .......................................................................................................................................16

Figure 2: Non-Small Cell Lung Cancer Market, Treatment Algorithm for Early and Advanced Localized Tumors Stages IIIA and IIIB, 2013 .............................................................................................20

Figure 3: Non-Small Cell Lung Cancer Market, Treatment Algorithm for Early and Advanced Localized Tumors Stages IIIA and IIIB, 2013 .............................................................................................21

Figure 4: Non-Small Cell Lung Cancer Market, Treatment Algorithm for Advanced Metastatic Tumors, 2013 .......................................................................................................................................22

Figure 5: Non-Small Cell Lung Cancer Market, Global, Annual Sales, 2012 ...............................................24 Figure 6: Non-Small Cell Lung Cancer Market, Global, Alimta (pemetrexed disodium) Annual Sales ($bn),

2004–2012 .............................................................................................................................25 Figure 7: Non-Small Cell Lung Cancer Market, Global, Abraxane (nab-paclitaxel) Annual Sales ($m), 2009–

2012 .......................................................................................................................................27 Figure 8: Non-Small Cell Lung Cancer Market, Global, Iressa (gefitinib) Annual Sales ($m), 2005–2012 ....28 Figure 9: Non-Small Cell Lung Cancer Market, Global, Tarceva (erlotinib) Annual Sales ($bn), 2006–2012 30 Figure 10: Non-Small Cell Lung Cancer Market, Global, Xalkori (crizotinib) Annual Sales ($m), 2012–2013 .31 Figure 11: Non-Small Cell Lung Cancer Market, Global, Avastin (bevacizumab) Annual Sales ($bn), 2006–

2012 .......................................................................................................................................33 Figure 12: Non-Small Cell Lung Cancer Market, Global, Comparative Safety and Efficacy of Marketed

Products (Heat Map), 2013......................................................................................................35 Figure 13: Non-Small Cell Lung Cancer Market, Global, Pipeline by Stage of Development, Program Type

and Route of Administration, 2013 ..........................................................................................38 Figure 14: Non-Small Cell Lung Cancer Market, Global, Pipeline by Molecule Type and Stage of

Development, 2013.................................................................................................................40 Figure 15: Non-Small Cell Lung Cancer Market, Global, Pipeline by Mechanism of Action, 2013 ................42 Figure 16: Non-Small Cell Lung Cancer Market, Global, Pipeline by Mechanism of Action, Molecule Type

and Stage of Development (Number), 2013 .............................................................................43 Figure 17: Non-Small Cell Lung Cancer Market, Global, Clinical Trial Failure Rate (%), 2013 .......................45 Figure 18: Non-Small Cell Lung Cancer Market, Global, Clinical Trial Size (Participants), 2013 ....................47 Figure 19: Non-Small Cell Lung Cancer Market, Global, Pipeline Clinical Trial Duration (months), 2013 .....49 Figure 20: Non-Small Cell Lung Cancer Market, Asia-Pacific, Market Size, 2012–2019 ...............................57 Figure 21: Non-Small Cell Lung Cancer Market, India, Market Size, 2012–2019 .........................................59 Figure 22: Non-Small Cell Lung Cancer Market, Australia, Market Size, 2012–2019 ...................................61 Figure 23: Non-Small Cell Lung Cancer Market, China, Market Size, 2012–2019 ........................................63 Figure 24: Non-Small Cell Lung Cancer Market, Japan, Market Size, 2012–2019 ........................................65


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Table of Contents

Figure 25: Non-Small Cell Lung Cancer Market, Global Deals by Value, Year and Stage of Development, 2006–2013 .............................................................................................................................69

Figure 26: Non-Small Cell Lung Cancer Market, Global, Deals by Phase, Molecule Type and Mechanism of Action, 2006–2013 ..................................................................................................................70

Figure 27: Non-Small Cell Lung Cancer Market, Global, Co-development Deals by Geography, 2006–2013 71 Figure 28: Non-Small Cell Lung Cancer Market, Global, Licensing Deals by Geography, 2006–2013 ...........73 Figure 29: GBI Research Market Forecasting Model (Example) ............................................................... 100


Page 10

Introduction

2 Introduction

Non-Small Cell Lung Cancer (NSCLC) is a leading cause of cancer morbidity and mortality worldwide, with an alarming increase in developing countries. Lung cancer is the most common cancer for males, accounting for XX% of all new cancer cases and XX% of all cancer deaths. It accounts for XX% of cancer-related deaths among females (Jemal et al., 2011).

Approximately XX–XX% of lungs cancers are NSCLCs. Adenocarcinoma is the dominant histologic sub-type of NSCLC, accounting for about XX% of all lung cancers. Other sub-types are Squamous Cell Carcinoma (SCC), which accounts for XX–XX% of all lung cancers, and Large Cell Carcinoma (LCC), which accounts for about XX–XX% of all lung cancers (ACS, 2013). The majority of NSCLC cases are diagnosed in the advanced stages after the disease has invaded locally or after metastasis to distant sites. Diagnosed patients have an extremely poor prognosis and low survival rates.

Conventional treatment options for advanced-stage NSCLC patients have been dominated by platinum-based chemotherapy regimens. However, the advent of targeted therapies such as Iressa (gefitinib), Tarceva (erlotinib), Xalkori (crizotinib) and Gilotrif (afatinib) for specific molecular sub-populations that have distinctive gene mutations has remodeled the NSCLC treatment landscape. During the forecast period, the competitive landscape will continue to evolve with the expected launch of potential new targeted therapies.

The robust NSCLC pipeline and promising drug candidates are capable of addressing the many unmet needs in the NSCLC market. The expected launch of pipeline candidates ramucirumab, necitumumab and Yervoy, during the forecast period, will address the treatment options for SCC, which currently has targeted therapy. In addition, the launch of the first-in-class Programmed Cell Death Protein (PD) 1 immunotherapy, nivolumab, will be a significant contributor to market growth during the forecast period.

The NSCLC market will continue to grow during the forecast period, driven by the aging population and the increasing incidence in the Asia-Pacific (APAC) region, as well as the expected launch of premium-priced pipeline agents.

2.1 Symptoms

The signs and symptoms of NSCLC are not usually manifested during the early stages of the disease. However, the symptoms develop to be recognizable as the disease aggravates. The onset of symptoms is not immediate, and they typically take a long time to progress. The most common symptoms of lung cancer include:

Chest pain

Coughing, which may present as hemoptysis (coughing up blood)

Dyspnea (shortness of breath)

Weight loss

Hoarseness

Infections such as bronchitis and pneumonia

Additional symptoms can be caused due to primary local invasion into thoracic structures or distant metastases, which include:

Dysphagia (difficulty in swallowing)

Facial edema

Bone pain

Neurological defects, such as weakness or numbness of limbs, dizziness, balance problems, or seizures

Pulmonary fibrosis

Supraclavicular lymphadenopathy

Lung cancer is the most common cancer accounting for XX% and XX% of all cancer deaths in males and females repectively.


Page 28

Marketed Products

3.1.3 Iressa (gefitinib) – AstraZeneca

Iressa was the first EGFR-TK inhibitor to be approved for use in lung cancer treatment. Similar to Tarceva, Iressa is a kinase inhibitor that selectively targets EGFR. It is designed to specifically target the tumor with no need to use maximum tolerated dose.

Iressa was approved by FDA under accelerated approval regulations in May 2003 for the treatment of advanced or malignant NSCLC. The Australian TGA also approved the product, in the same year. However, due to its failure to provide superior OS compared with standard chemotherapy in all patients, regardless of EGFR mutation, Iressa’s marketing status was revoked in the US by the FDA in 2005. Iressa received its first approval for NSCLC in Japan in 2002. It received the regulatory approval in 2004 and 2005 in India and China respectively. The EU approved the drug in 2009, and it is also reimbursed for conditional first-line treatment in the UK (NICE, 2010). In 2012, the Pharmaceutical Management Agency, or Pharmac, announced that it would be funding gefitinib (Iressa) for lung cancer, also.

Iressa has been marketed by AstraZeneca since its launch in 2002. It is also being investigated in Phase III trials for treatment of breast cancer and SCC of the head and neck. The following figure displays the annual sales of Iressa from 2005 to 2012, as well as market approvals and important events in the life cycle of Iressa.

Figure 8: Non-Small Cell Lung Cancer Market, Global, Iressa (gefitinib) Annual Sales ($m), 2005–2012

2005 2006 2007 2008 2009 2010 2011 2012

Rev

enue

($m

)

2005: Approval in China for NSCLC

2009: EC approval for NSCLC with EGFR mutations

2010: NICE approval for NSCLC

2012: Pharmac approval forfunding

2002: Approval in Japan to treat locally advanced or metastatic NSCLC2003: FDA and TGA approval for locally advanced or metastatic NSCLC2004: Approval in India for NSCLC

Source: GBI Research, Proprietary Marketed Products Database

Note: NICE: National Institute for Health and Care Excellence


Page 39

Pipeline Products

4.2 Pipeline Analysis by Molecule Type

The developmental pipeline of NSCLC appears to be highly active with diverse molecule types. The pipeline is dominated by small molecules with XX drug candidates or XX% of the overall pipeline. When segregated on the basis of stage of development, the number of small molecules is highest in Phase II trials, which account for XX% of the Phase II product candidates, followed by the preclinical stage (XX%) and Phase I (XX%). The share of small molecules is markedly higher (XX%) in the confirmatory Phase III trials also, in comparison with other molecule types.

In the overall pipeline, mAbs also occupy a major share, followed by small molecules. Of the investigational products, XX drug candidates (XX%) are found to be mAbs. The share of mAbs is highest in the Phase I stage of development (XX%) followed by Phase III (XX%), Phase II (XX%) and the preclinical stage (XX%). Of the XX NSCLC pipeline products that are currently IND/CTA-filed, one molecule is a mAb.

As well as these two major molecule types, vaccines also occupy a significant share (XX%, XX molecules). The number of molecules which are categorized as biosimilars, proteins and peptides is significantly less in comparison with small molecules and mAbs.


Page 40

Pipeline Products

Figure 14: Non-Small Cell Lung Cancer Market, Global, Pipeline by Molecule Type and Stage of Development, 2013

Dis

cove

ry

IND

/CTA

-file

d

Pre

clin

ical

Pha

se I

Pha

se II

Phas

e III

Pre

-regi

stra

tion

Pip

elin

e m

olec

ules

(num

ber)

Biosimilar Cell therapy Gene therapy Monoclonal antibody

Peptide Protein Small molecule Vaccine

B) NSCLC pipeline by molecule type and by phase

Biosimilar

Cell therapy

Gene therapy

Monoclonal antibody

Peptide

Protein

Small molecule

Vaccine

A) NSCLC pipeline by molecule type

Source: GBI Research, Proprietary Pipeline Products Database


Page 48

Pipeline Products

4.4.3 Duration

The mean clinical trial duration for Phase III NSCLC clinical trials was slightly higher than the average for oncology and the overall industry average. At Phases I and II, it was comparable. This implies that the cost of running clinical trials for NSCLC cancer products might be moderately higher than for oncology, and the industry as a whole. The average duration of a macular degeneration clinical trial was found to be XX, XX and XX months for Phase I, Phase II and Phase III respectively.

In all the stages of development, the mean clinical trial durations differed among molecule types. The clinical trial duration for the two prominent molecule types (small molecules and mAbs) are comparable across all the phases. The duration for small molecules was slightly higher when compared with mAbs in Phase II and III and vice-versa for Phase I clinical trials. As seen in Figure 19, in comparison with all other molecule types, clinical trial duration is found to be longer for vaccines and shorter for peptides and proteins.


Page 49

Pipeline Products

Figure 19: Non-Small Cell Lung Cancer Market, Global, Pipeline Clinical Trial Duration (months), 2013

Overall Small molecules Monoclonal antibodies

Vaccines Peptides

Tria

l dur

atio

n (m

onth

s)

Third quartile Second quartile Indiction averageIndustry average Therapy area average

A) Phase I


Vaccines Peptides

Tria

l dur

atio

n (m

onth

s)

Third quartile Second quartile Indication averageIndustry average Therapy area average


Vaccines Peptides

Tria

l dur

atio

n (m

onth

s)

Third quartile Second quartile Indication averageIndustry average Therapy area average

B) Phase II

C) Phase III

Source: GBI Research, Proprietary Clinical Trials Database


Page 58

Market Forecast to 2019

5.1.2.2 Annual Cost of Therapy

The Annual Cost of Therapy (ACoT) for NSCLC in India is estimated to have been $XXm in 2012. Among all the APAC markets, the Indian market is considered to have the lowest ACoT. Though the ACoT for NSCLC in India is low compared with other regions it is expected to grow at a rapid pace, at a CAGR of XX%, reaching $XXm by the end of the forecast period.

The key reason for the low ACoT in India is due to the entrenchment of generic drugs and recent patent rulings that allow for the marketing of generic versions of NSCLC drugs in India. Another factor for its having the lowest cost of treatment is the price reductions, due to new pricing regulations. The recent price regulations, made possible by the Drug Price Control Order, regulate the price of the products that are included in India’s 2011 National List of Essential Medicines. This meant dominant cytotoxic cancer drugs, such as cisplatin, gemcitabine hydrochloride, paclitaxel and carboplatin, and a few other drugs by both local and international pharmaceutical companies, reducing their prices by up to XX%.

The expected launch of promising small molecules in the pipeline, including nintedanib, Gilotrif, dacomitinib and LDK378, and the increasing incidence population will contribute to the growth of overall treatment costs during the forecast period.

5.1.2.3 Market Size

The availability of generic chemotherapies, including pemetrexed (Alimta) and the generic targeted therapies erlotinib (Tarceva) and gefitinib (Iressa), downsizes the NSCLC market in India. The market for NSCLC in India is estimated to have been $XXm in 2012 and is expected to grow to $XXm in 2019, at a CAGR of XX%. In a best-case scenario, it is expected to grow at a CAGR of XX% to $XXm by the end of 2019, while in a worst-case scenario it is expected to grow at a CAGR of XX% to $XXm by the end of the forecast period.

The dominance of generics in India limits the launch of premium-priced branded drugs by pharma giants. For example, crizotinib was approved for ALK-positive NSCLC by the Indian Central Drugs Standard Control Organization (CDSCO) in 2011; however, Pfizer has not yet launched Xalkori on the Indian market. The expected launch of promising pipeline targeted therapies, including Gilotrif, Novartis’ LDK378, Lilly’s necitumumab, Boehringer Ingelheim's nintedanib, is also expected to be delayed. Drug manufacturers may even prevent the launch of branded drugs in Indian market to avoid patent litigations and generic competition.


Page 59

Market Forecast to 2019

Figure 21: Non-Small Cell Lung Cancer Market, India, Market Size, 2012–2019

2012 2013 2014 2015 2016 2017 2018 2019P

opul

atio

n (‘

000)

Prevalance population Treatment population

A) Treatment usage pattern

2012 2013 2014 2015 2016 2017 2018 2019

Mar

ket s

ize

($m

)

Low variance Medium variance High variance Projected

C) Revenue

2012 2013 2014 2015 2016 2017 2018 2019

Ann

ual c

ost o

f tre

atm

ent (

$)

Low variance Medium variance High variance Projected

B) Annual cost of treatment

Source: GBI Research, Proprietary Marketed Products Database

Note: The projected figure is taken to be the most likely scenario, with a high probability of minor variance from that point. Higher variance outcomes are believed to be plausible but less likely.


Page 75

Appendix

7 Appendix

7.1 All Pipeline Drugs by Phase

7.1.1 Discovery

Table 4: Non-Small Cell Lung Cancer Market, Global, Pharmaceutical Pipeline (Discovery), 2013

Drug/project name Company Molecule type MOA

BB-003

bevacizumab biosimilar


BV-6

ImmTAC Targeting MAGE A3

JPI-283

THR-53

VI-14442

ZSG-101

ZSG-102

BB-003


7.1.2 Preclinical

Table 5: Non-Small Cell Lung Cancer Market, Global, Pharmaceutical Pipeline (Preclinical), 2013

Drug/project name Company Molecule type MOA

AIK-4

AL-8326

ALT-802

Anti Ferritin Gemcitabine Paclitaxel NanomAbs

ARN-5032

AZ-64

AZD-3463

BAL-27862



BL-8040

CBI-701g

CBL-0137

CEP-28122

CEP-37440

Ceramide Analogues

Certax

CFAK-Y15

CGEN-25008


Page 76

Appendix

CNVN-202 in combination with MK-2206

CNX-222

Compound-13d

COTI-2

docetaxel

docetaxel

Drug Targeting Carbonic Anhydrase IX

Drug Targeting Netrin-1

Drug Targeting Pan-PIM Kinase

Drug Targeting Phosphofructokinase-2

Drug-Resistant Lung Cancer Program

Drugs Targeting RAS Mutant Tumors

EDC-1

gemcitabine

GH-501a

GO-203-2c

GT-468iMABs

HIF-143

hMABs For Cancer

IC-1207

IL-17E

IMA-930

iMAB-027

ImmTAC Targeting MAGE-A3 HLA-A1

Interferon Lambda-1 Linked Fab Dimer

LOR-253

MDX-1 Vaccine

MG-516

MiR-Rxlet-7

MPT-0B098

MT-103

MT-477

NT-113

NUC-3373

NUC-3641

ORIL-007

paclitaxel

paclitaxel


Page 77

Appendix

Pseudovirions For Cancer

Revercom

SGI-7079

SIMM-559

SL-052

STP-801

SVC-112

TAS-2913

TF-011-Monomethyl Auristatin E

Tri-Specific Anti-Her-1/Her3 Zybodies

Tumor Vaccine

Vaccine For Non-Small Cell Lung Cancer

VE-822

X-379


7.1.3 IND-filed

Table 6: Non-Small Cell Lung Cancer Market, Global, Pharmaceutical Pipeline (IND-filed), 2013

Drug name Company Molecule type MOA

BACPT DP

bevacizumab Biosimilar

IMGN-289

OSI-930

QBI-139



Page 78

Appendix

7.1.4 Phase I

Table 7: Non-Small Cell Lung Cancer Market, Global, Pharmaceutical Pipeline (Phase I), 2013


AEOL-10150

AL-3818

AL-6802

antroquinonol

AT-13387

AT-406

AZD-4547

AZD-8186

AZD-9291

BIIB-022

carfilzomib

CC-223

Celecoxib in combination with RT

cetuximab biobetter

CHP-MAGE-A4 Vaccine

CO-1686

CRS-207

CST-101

CUDC-101

CV-9202

dalotuzumab

DCVax-Lung

Debio-0932

demcizumab

docetaxel

docetaxel liposomal

doxorubicin

EMD-521873

foretinib

HM-61713

HMPL-309

HMPL-504

imgatuzumab

IMGN-853

IMO-2055

INC-280

KML-001

L-DOS-47


Page 79

Appendix

LY-2812176

margetuximab

marizomib

MEDI-4736

MEK-162

melflufen

mepacrine

MGA-271

MGCD-265

MGN-1703

MM-10001

MORAb-066

NMS-E628

NRC-AN-019

orantinib

PankoMab GEX

panobinostat

PB-357

Peptide Based Therapeutic Cancer Vaccine

PR-509

PR-610

PRAME Vaccine

radretumab

resminostat

RG-7599

rilotumumab

romidepsin

Semi-Allogeneic Human Fibroblasts Transfected With DNA

Simotinib Hydrochloride

solitomab

trebananib

TSR-011

vinorelbine tartrate liposomal

X-396

XMT-1001

levoleucovorin calcium



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Appendix

7.1.5 Phase II

Table 8: Non-Small Cell Lung Cancer Market, Global, Pharmaceutical Pipeline (Phase II), 2013


alisertib

AP-26113

apatorsen

AUY-922

axitinib

AXL-1717

bavituximab

belinostat

BMS-690514

buparlisib

cabozantinib (S)-malate

CADI-05

CAP-7.1

CBP-501 in combination with [cisplatin] in combination with [pemetrexed disodium]

cisplatin

cixutumumab

CNVN-202

cositecan

CRLX-101

CV-9201

CYC-202

dabrafenib

docetaxel targeted nanoparticles

dovitinib lactate

DPV-001

entinostat

etirinotecan pegol

farletuzumab

ficlatuzumab

fosbretabulin disodium

GI-4000

GlutaDON


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Appendix

GSK-2302032A

HBI-8000

HS-110

ISIS-EIF4ERx

ixabepilone

lambrolizumab

lenvatinib

linifanib

linsitinib

LY-2875358

MelCancerVac

MK-2206 in combination with selumetinib sulfate

neratinib

NGR-hTNF

olaratumab

ORA-101

paclitaxel-loaded polymeric micelle

palbociclib

parsatuzumab

patritumab

pegdinetanib

Pegylated Endostatin

pelareorep

pentamidine isethionate

pertuzumab

PGG beta-glucan

pictilisib

ponatinib

poziotinib

pralatrexate

PT-107

PX-866

retaspimycin hydrochloride

RG-7446

RG-7853

S-488410


Page 82

Appendix

sabarubicin

salirasib

sapacitabine

SAR-256212

selumetinib sulfate

SPI-1620

suramin hexasodium

tamibarotene

tergenpumatucel-L

TG-4010

tigatuzumab

tivantinib

trametinib dimethyl sulfoxide

veliparib

vintafolide

volasertib

Vx-001

letrozole

dasatinib



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Appendix

7.1.6 Phase III

Table 9: Non-Small Cell Lung Cancer Market, Global, Pharmaceutical Pipeline (Phase III), 2013


(tegafur in combination with gimeracil in combination with oteracil potassium)

ardeparin sodium

belagenpumatucel-L

bevacizumab


BV-NSCLC-001

canfosfamide hydrochloride

celecoxib in combination with [carboplatin] in combination with [gemcitabine hydrochloride] in combination with [pemetrexed disodium]

cisplatin liposomal

crizotinib

custirsen sodium

dacomitinib

dimesna

eribulin mesylate

erlotinib hydrochloride

ganetespib

GSK-1572932A

GSK-2132231A

ipilimumab

KD-019

LDK-378

motesanib diphosphate

necitumumab

nimotuzumab

nintedanib

nivolumab

onartuzumab

racotumomab

ramucirumab

Recombinant Human Endostatin in combination with [cisplatin] in combination with [vinorelbine tartrate]

sorafenib tosylate

tacedinaline


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Appendix

tecemotide

tertomotide

vandetanib

YN-968D1


7.1.7 Undisclosed

Table 10: Non-Small Cell Lung Cancer Market, Global, Pharmaceutical Pipeline (Undisclosed), 2013


ABT-510

ABT-751

AC-480

acridine carboxamide

AE-941

AEG-35156

agatolimod sodium

alanosine

amatuximab

anatumomab mafenatox

AP-11014

apaziquone

apricoxib

aprinocarsen sodium

AT-101

Autologous Dexosomes Loaded With Tumor-Specific Peptides

AV-412

batabulin sodium





BI-2536

BKT-RP3

BMS-184476

BMS-275183

bortezomib

brivanib alaninate

brostallicin

canertinib dihydrochloride


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Appendix

cantuzumab mertansine

CDP-791

cediranib maleate

celecoxib

celecoxib in combination with zileuton in combination with [carboplatin] in combination with [gemcitabine hydrochloride]

CEP-9722

cetuximab

CG-201

CG-8123

CI-1040

cilengitide

CIMAvax-EGF Peptide Vaccine

clazakizumab

conatumumab

conatumumab

crenolanib

CT-47609

CT-47613

CU-903

DHA-Paclitaxel

dinaciclib

docetaxel

docetaxel liposomal

DRF-1042

drozitumab

Drug Targeting TREM-1

dulanermin

edrecolomab

efatutazone

elesclomol

elisidepsin

enzastaurin hydrochloride

EP-2101

everolimus

exisulind

Ferritizumab

figitumumab

ganitumab


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Appendix

gataparsen sodium

gemcitabine elaidate

GSK-249553

ILX-295501

imetelstat sodium

INGN-401

iniparib

INNO-305

IRX-4204

ISIS-EIF4ERx

ispinesib

Kahalalide F

KOS-1584

KOS-862

KW-2170

L-Vax

lapatinib ditosylate

lenalidomide

litronesib

lometrexol sodium

lonafarnib

LY-2584702

LY-355703

mapatumumab

marimastat

matuzumab

matuzumab

milataxel

mitomycin microparticle

MKC-1

ML-133

mAb Targeting Epidermal Growth Factor Receptor



motexafin gadolinium

MPI-443803

muparfostat

naptumomab estafenatox

NBI-3001

NOV-002


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Appendix

NRX-194204

NTX-250

NTX-400

NTX-420

NTX-500

NTX-800

NY-ESO-1 Plasmid DNA Cancer Vaccine

oblimersen sodium

ombrabulin

ONS-1010

ONS-1020

ortataxel

OSI-632

OSI-817

OSI-930

P-2045

paclitaxel

paclitaxel

paclitaxel SR

padeliporfin

panitumumab

patupilone

pazopanib hydrochloride

PB-357

PD-0325901

pelitinib

pelitrexol

perifosine

PFK-015

pivanex

PKI-166

plinabulin

PR-104

prinomastat

PRLX-93936

PRX-321

R-100

R-440

rabusertib

ranpirnase

rebimastat

Recombinant


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Appendix

Angiostatin Protein

regorafenib

RG-4733

Rh-Apo2L

ridaforolimus

rubitecan

S-3304

sagopilone

satraplatin

sepantronium bromide

serdemetan

SGN-15

SHT-00268C

soblidotin

SRL-172

sulofenur

talactoferrin alfa

talotrexin ammonium

tamibarotene

tariquidar

TAS-106

tasidotin hydrochloride

tasisulam sodium

temozolomide

teprotumumab

tirapazamine

tirapazamine in combination with [carboplatin] in combination with [paclitaxel]

tivantinib

tivozanib

TLC-178

tosedostat

tovetumab

tozasertib

tremelimumab

TriAb

Triapine

tucotuzumab celmoleukin

tyroservatide

UNBS-1450

UNBS-3078


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Appendix

UNBS-3243

urelumab

V-930

V-934

V-935

vadimezan

vatalanib

vinflunine ditartrate

vinorelbine tartrate

vinorelbine tartrate nanoliposomal

volociximab

vorinostat

vosaroxin

XL-999

Zaltrap

zalutumumab

zibotentan


7.2 Market Forecasts to 2019

7.2.1 APAC

Table 11: Non-Small Cell Lung Cancer Market, Asia-Pacific, Market Forecast, 2012–2019

Year 2012 2013 2014 2015 2016 2017 2018 2019 CAGR (%)

Incidence per 100,000

Five-year prevalence population (‘000)

Treatment population (‘000)

Maximum revenue ($bn)

Projected revenue ($bn)

Minimum revenue ($bn)

Source: GBI Research, Proprietary Database


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Appendix

7.2.2 India

Table 12: Non-Small Cell Lung Cancer Market, India, Market Forecast, 2012–2019

Year 2012 2013 2014 2015 2016 2017 2018 2019 CAGR

(%)


Five-year prevalence population (‘000)


ACoT ($)

Maximum revenue ($m)

Projected revenue ($m)

Minimum revenue ($m)


7.2.3 Australia

Table 13: Non-Small Cell Lung Cancer Market, Australia, Market Forecast, 2012–2019

Year 2012 2013 2014 2015 2016 2017 2018 2019 CAGR (%)


Prevalence population (‘000)


ACoT ($)





7.2.4 China

Table 14: Non-Small Cell Lung Cancer Market, China, Market Forecast, 2012–2019

Year 2012 2013 2014 2015 2016 2017 2018 2019 CAGR (%)




ACoT ($)






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Appendix

7.2.5 Japan

Table 15: Non-Small Cell Lung Cancer Market, Japan, Market Forecast, 2012–2019

Year 2012 2013 2014 2015 2016 2017 2018 2019 CAGR (%)




ACoT ($)





7.3 Market Definitions

Market coverage: Non-Small Cell Lung Cancer (NSCLC) in four countries in the Asia-Pacific (APAC) region: Australia, China, India and Japan.

Prevalence population: The estimated number of people at any given point of time who are affected by lung cancer.

Prescription rate: The percentage of the Non-Small Cell Lung Cancer (NSCLC)-suffering population that has been prescribed any drug therapy.

Prescription population: The number of people taking any drug for Non-Small Cell Lung Cancer (NSCLC).

7.4 Abbreviations

-ve: negative

+ve: positive

ACoT: Annual Cost of Therapy

ALK: Anaplastic Lymphoma Kinase

ALT: Alanine Aminotransferase

APAC: Asia-Pacific

ASCO: American Society of Clinical Oncology

ATP: Adenosine Triphosphate

BMS: Bristol-Myers Squibb

CAGR: Compound Annual Growth Rate

CD: Cluster of Differentiation

CDSCO: Central Drugs Standard Control Organization

CFDA: China Food and Drug Administration

cm: centimeters

COPD: Chronic Obstructive Pulmonary Disease

CT: Computed Tomography

CTA: Clinical Trial Application

CTLA: Cytotoxic T-Lymphocyte Antigen

DHFR: Dihydrofolate Reductase


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Appendix

EBRT: External Beam Radiation Therapy

EBUS: Endobronchial Ultrasound

EGFR: Epidermal Growth Factor Receptor

EMSI: EGFR Mutant-Selective Inhibitor

EURTAC: European Tarceva vs Chemotherapy

FDA: Food and Drug Administration

FGFR: Fibroblast Growth Factor Receptor

FNAB: Fine Needle Aspiration Biopsy

GBM: Glioblastoma Multiforme

GF: Growth Factor

GFR: Growth Factor Receptor

GI: Gastrointestinal

GSK: GlaxoSmithKline

HDAC: Histone Deacetylases

HER: Human Epidermal Growth Factor Receptor

HGF: Hepatocyte Growth Factor

HGFR: Hepatocyte Growth Factor Receptor

HSP: Heat Shock Protein

IAP: Inhibitor of Apoptosis

IgG1: Immunoglobulin G1

IL: Interleukin

ILD: Interstitial Lung Disease

IND: Investigational New Drug

kg: kilogram

LCC: Large Cell Carcinoma

LDH: Lactate Dehydrogenase

mAb: Monoclonal Antibody

m2: square meter of body surface area

mBC: Metastatic Breast Cancer

mCRC: Metastatic Colorectal Cancer

MET: Metabolic Equivalent of Task

mg: milligram

MMP: Matrix Metalloproteinase

MPM: Malignant Pleural Mesothelioma

MRP: Multidrug Resistance Protein

MRI: Magnetic Resonance Imaging

MOA: Mechanism of Action

MUC-1: Mucin 1


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Appendix

N0: No lymph node metastasis

N1: Lymph node metastases within the lungs including hilar lymph nodes

NICE: National Institute for Health and Care Excellence

NRDL: National Reimbursement Drug List

NSCLC: Non-Small Cell Lung Cancer

NOS NSCLC: Non-Squamous Non-Small Cell Lung Cancer

ORR: Overall Response Rate

OS: Overall Survival

PARP: Poly (ADP-Ribose) Polymerases

PCR: Polymerase Chain Reaction

PD: Programmed Cell Death Protein

PDGFR: Platelet-Derived Growth Factor Receptor

PDL: Programmed Cell Death Ligand

PET: Positron Emission Tomography

PFS: Progression-Free Survival

Pt: Platinum

RT: Radiation Therapy

SATURN: Sequential Tarceva in Unresectable NSCLC

sb-P + C: solvent-based paclitaxel plus carboplatin

SBRT: Stereotactic Body Radiation Therapy

SCC: Squamous Cell Carcinoma

SCLC: Small Cell Lung Cancer

S NSCLC: Squamous Non-Small Cell Lung Cancer

SFDA: State Food and Drug Administration

TB: Tuberculosis

TBNA: Transbronchial Needle Aspiration

TGA: Therapeutic Goods Administration

TK: Tyrosine Kinase

TKI: Tyrosine-Kinase Inhibitor

TNF: Tumor Necrosis Factor

TNM: Tumor Node Metastasis

TLR: Toll-Like Receptor

TTNB: Transthoracic Needle Biopsy

VEGF: Vascular Endothelial Growth Factor

VEGFR: Vascular Endothelial Growth Factor Receptor


Page 94

Appendix

7.5 Bibliography

Abraxane [package insert]. Summit, NJ: Celegene Corporation; June 2013. Available from: http://www.abraxane.com/downloads/Abraxane_PrescribingInformation.pdf

Adams C and Brantner V (2010). Spending on New Drug Development. Health Economics; 19: 130–141.

Alimta [package insert]. Indianapolis, IN: Eli Lilly and Company; May 2013. Available from: http://pi.lilly.com/us/alimta-pi.pdf

ACS (2013). Lung Cancer (Non-Small Cell). American Cancer Society. Available from: http://www.cancer.org/acs/groups/cid/documents/webcontent/003115-pdf.pdf

Ammanagi AS, et al. (2012). Sputum cytology in suspected cases of carcinoma of lung (Sputum cytology a poor man's bronchoscopy!). Lung India; 29(1): 19–23

Asahina H, et al. (2005). Transbronchial biopsy using endobronchial ultrasonography with a guide sheath and virtual bronchoscopic navigation. Chest; 128: 1761–1765

AIHW (2011). Lung cancer in Australia: An overview. Australian Institute of Health and Welfare. Available from: http://www.aihw.gov.au/WorkArea/DownloadAsset.aspx?id=10737421095&libID=10737421094 [Accessed on January 4, 2013]

Bergethon K, et al. (2012). ROS1 rearrangements define a unique molecular class of lung cancers. Journal of Clinical Oncology; 30: 863–870

Brahmer R, J et al. (2013). Immune Checkpoint Inhibitors: Making Immunotherapy a Reality for the Treatment of Lung Cancer. Cancer Immunology; 1: 365–372

Camidge R, et al. (2012). Final results of a phase 2, open-label study of ramucirumab (IMC-1121B; RAM), an IGG1 MAB targeting VGFR-2, with paclitaxel and carboplatin as first-line therapy in patients (PTS) with stage IIIB/IV NSCLC (NCT00735696). European Society of Medical Oncology; Abstract #1287

Cappuzzo F, et al. (2010). Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomized, placebo-controlled phase 3 study. Lancet Oncology; 11: 521–529

CDC (2012). Lung Cancer: Basic Information about Lung Cancer. Centers for Disease Control and Prevention. Available from: http://www.cdc.gov/cancer/lung/basic_info/index.htm [Accessed on January 16, 2013]

CFDA (2013). Provisions for Drug Registration. China Food and Drug Administration. Available from http://eng.sfda.gov.cn/WS03/CL0768/61645.html.

Ciuleanu, et al. (2009). Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomized, double-blind, phase 3 study. The Lancet; 374(9699): 1432–1440

Colagiuri B, et al. (2012). Does Assessing Patients' Expectancies About Chemotherapy Side Effects Influence Their Occurrence? Journal of Pain and Symptom Management; [E-pub ahead of print]

Connor S, et al. (2000). Image-guided automated needle biopsy of 106 thoracic lesions: a retrospective review of diagnostic accuracy and complication rates. European Radiology; 10(3): 490–494

Cullen M (2003). Chemotherapy for non-small cell lung cancer: the end of the beginning. Thorax; 58: 352–356

Doebele R, et al. (2012). A phase 2 randomized open-label study of ramucirumab (IMC 1121B;RAM) in combination with platinum-based chemotherapy in patients (PTS) with recurrent or advanced non-small cell lung cancer (NSCLC): Results from non-squamous (NSQ) pts (NCT01160744). European Society of Medical Oncology; Abstract #1245

Engelman, et al. (2007). PF00299804, an Irreversible Pan-ERBB Inhibitor, Is Effective in Lung Cancer Models with EGFR and ERBB2 Mutations that Are Resistant to Gefitinib. Cancer Research; 67: 11924-32


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Socinski MA, et al. (2013). A multicenter Phase II study of ganetespib monotherapy in patients with genotypically defined advanced non-small cell lung cancer. Clinical Cancer Research; 19: 3068–3077

Spigel DR, et al. (2011). Final efficacy results from OAM4558g, a randomized phase II study evaluating MetMAb or placebo in combination with erlotinib in advanced NSCLC. American Society of Clinical Oncology; Abstract #7505

Tammemagi CM, et al. (2003). Impact of comorbidity on lung cancer survival. International Journal of Cancer; 103: 792–802

Tanizaki J, et al. (2011). MET tyrosine kinase inhibitor crizotinib (PF-02341066) shows differential antitumor effects in non-small cell lung cancer according to MET alterations. Journal of Thoracic Oncology; 6: 1624–1631

Thatcher N, et al. (2005). Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomized, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer). Lancet; 366: 1527–1537

Vineis P, et al. (2005). Environmental tobacco smoke and risk of respiratory cancer and chronic obstructive pulmonary disease in former smokers and never smokers in the EPIC prospective study. British Medical Journal; 330(7486): 277

World Health Organization (2010). Visual Impairment and Blindness 2010. World Health Organization. Available from: http://www.who.int/blindness/data_maps/VIFACTSHEETGLODAT2010full.pdf

Yao X, et al. (2012). Fine-needle aspiration biopsy versus core-needle biopsy in diagnosing lung cancer: a systematic review. Current Oncology; 19(1): e16–27

Yoshmini I, et al. (2003). A Comparison of Trends in the Incidence Rate of Lung Cancer by Histological Type in the Osaka Cancer Registry, Japan and in the Surveillance, Epidemiology and End Results Program, USA. Japanese Journal of Clinical Oncology; 33(2): 98–104

7.6 Research Methodology

GBI Research’s dedicated research and analysis teams consist of experienced professionals with marketing, market research and consulting backgrounds in the pharmaceutical industry as well as advanced statistical expertise.

GBI Research adheres to the codes of practice of the Market Research Society (www.mrs.org.uk) and Strategic and Competitive Intelligence Professionals (www.scip.org).

All GBI Research databases are continuously updated and revised.

7.6.1 Coverage

The objective of updating GBI Research 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: market capitalization, revenues and media attention/innovation/market potential.

An exhaustive search of 56 member exchanges is conducted and companies are prioritized on the basis of their market capitalization.

The estimated revenues of all major companies, including private and governmental, are gathered and used to prioritize coverage.

Companies that are making the news, or that are of particular interest due to their innovative approach, are prioritized.

GBI Research aims to cover all major news events and deals in the pharmaceutical industry, updated on a daily basis.


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Appendix

The coverage is further streamlined and strengthened with additional input from GBI Research’s expert panel (see below).

7.6.2 Secondary Research

The research process begins with exhaustive secondary research on internal and external sources in order 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

News articles, press releases and web-casts specific to the companies operating in the market

7.6.3 Primary Research

GBI Research 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 and future outlook.

It helps in validating and strengthening the secondary research findings.

It further develops the analysis team’s expertise and market understanding.

Primary research involves e-mail and telephone interviews as well as face-to-face interviews for each market, category, segment and sub-segment across geographies.

The participants that 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 medical equipment markets

Key opinion leaders: Physicians and surgeons specializing in different therapeutic areas corresponding to different kinds of medical equipment.

7.6.4 Therapeutic Landscape

Revenues for each indication, geography-wise, are arrived at by utilizing the GBI Research market forecasting model. The global revenue for each indication is the sum value of revenues of all seven regions.

The annual cost of therapy for each indication is arrived at by considering the cost of the drugs, dosage of the drugs and the duration of the therapy.

The generic share of the market for each indication is obtained by calculating the prescription share for generic drugs and the respective cost of treatment.

The treatment usage pattern, which includes quantitative data on the diseased population, treatment-seeking population, diagnosed population and treated population for an indication, is arrived at by referring to various sources as mentioned below.


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Appendix

GBI Research uses the epidemiology-based treatment flow model to forecast market size for therapeutic indications.

7.6.4.1 Epidemiology-Based Forecasting

The forecasting model used at GBI Research 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, duration of treatment and number of patients who are prescribed drug treatment (prescription population). Prescription population is calculated as the percentage of population diagnosed with a disease (diagnosis population). Diagnosis population is the population diagnosed with a disease expressed as a percentage of the population that is seeking treatment (treatment-seeking population). Prevalence of a disease (diseased population) is the percentage of the total population who suffer from a disease/condition.

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 patient affordability of 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.

Annual cost of treatment is calculated using product purchase frequency and the average price of the therapy. Product purchase frequency is calculated from the dosage data available for the therapies, and drug prices are gathered from public sources. The sources for the price of drugs are MIMS India, MIMS China and ZenRx.

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 that is 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

Analogous forecasting methodology is used to account for the introduction of new products, patent expiries of branded products and the subsequent introduction of generics. Historical data for new product launches and generics penetration are used to arrive at robust forecasts. The increase or decrease of prevalence rates, the treatment seeking rate, the diagnosis rate and the prescription rate are fitted into the forecasting model to estimate market growth rate.

The proprietary model enables GBI 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. The prevalence population for this report is taken from articles published in various journals, including the Annals of Oncology, Journal of Clinical Epidemiology, and New England Journal of Medicine.

Prescription Population

NSCLC has multiple treatment options depending upon the stage of the disease and previous effectiveness of other similar treatments. Options for treatment of NSCLC include surgical intervention, radiation therapy, chemotherapy, targeted therapy and immunotherapy. The prescription population is defined as the number of patients who are prescribed biologic drug therapy. This is calculated as a percentage of the diagnosis population. Prescription population proportion is taken from articles published in various journals, including the Annals of Oncology, British Medical Journal, Current Oncology and Lancet Oncology.


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Appendix

7.6.4.2 Market Size by Geography

The treatment usage pattern and annual cost of therapy in each country has been factored in while deriving the individual country market size.

Forecasting Model for Therapeutic Areas

Figure 29: GBI Research Market Forecasting Model (Example)

D is ease P opu la ti onGener al Po pu la tio n 743,535,048

Q ualif ying c ondition 1 (Age/S ex/O c c upa tion e tc )Q ualif ying c ondition 2 (Age/S ex/O c c upa tion e tc )

Preva l ence t issu e va lve disease 0 .2% 1,784,484 Q ualif ying c ondition (c om plic at ion , s eve rity)DIS EA SE D P OPU LA T IO N 1,784,484

T r eatm en t Flow P atte rn sT rea tm ent S eeki ng R ate (Sy m ptom s / Dis Awareness ) 89% 1,588,191 Diagn osis Rat e ( C lin ical and D iagn os tic Test s ) 75% 1,191,143

Prescr iption R ate ( Ph ysic ian P ercep t io n, Tr ea tm ent E ffec tiv e n ess)Tis s ue V alve 70% 833,800 O the r T rea tm en ts fo r Valve (Sur g /M ed/N one ) -

F ulfi llm en tA vai labi lit y NAW illingness to Us e (Pa tient Pe rc ep tions) NAReady to U se (S u rgery e lig ib ility , R eus e e tc ) NA

Affo rd abil it y at PriceHE as % of G DP s pendA verage Inc om e (per individual)P at ien t O u t-o f-poc ke t Budge t (A nnua l)

Budget alloc a tion to one-t im e s u rgeryBudget alloc a tion to o the r h ealth needs

A verage Pay or CoverageP at ien t L iabi lityTarge t Pr ic e ( @20% pa t liab )A SP for Cos t of T herapy

T O TA L P AT IEN T V OLUM E SPro du ct P urch ase Fr equ en c y 1

T OT A L UN IT VO LU M ES

Pr ic in g per Un it 18 ,000$ In f lat ionP rice D ec reas e due to c om pet it ion

M ar ket Valu e

G B I R esear ch M ar ke t Siz in g M o de l

Source: GBI Research

The above figure represents a typical forecasting model followed in GBI Research. As discussed previously, the model is built on the treatment flow patterns. The model starts with the general population, then diseased population as a percentage of the general population and then follows the treatment seeking population as a percentage of the diseased population and diagnosed population as a percentage of the treatment seeking population. Finally, the total volume of units sold is calculated by multiplying the treated population by the average dosage per year per patient.

7.6.5 Geographical Landscape

GBI Research analyzes four geographies in APAC: Australia, China, India and Japan. The total market size for each country is provided which is the sum value of the market sizes of all the indications for that particular country. The maximum and minimum estimated market sizes are then provided by adjusting all variables expected to impact upon the market during the forecast period in order to provide the best and worst-case scenarios.


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Appendix

Articles from research journals and agency publications such as The Oncologist, Journal of Clinical Oncology, Lancet Oncology, Annals of Oncology, National Institute of Health and ClinicalTrials.gov are the source of data for the estimation of market size and making forecasts.

7.6.6 Pipeline Analysis

This section provides a list of molecules at various stages in the pipeline for various indications. The list is sourced from internal database and validated for the accuracy of phase and mechanism of action at ClinicalTrials.gov and company websites. The section also includes a list of promising molecules which is narrowed down based on the results of the clinical trials at various stages and the novelty of mechanism of action. A heat map, sourced from relevant clinical trials, is provided in order to compare these products to one another in addition to currently marketed products. The latest press releases issued by the company and news reports are also the source of information for the status of the molecule in the pipeline. This list of pipeline molecules, in conjunction with a list of ongoing and completed clinical trials, is analyzed in this section, and a full breakdown of pipeline molecules and clinical trials by phase, molecule type and molecular target is provided.

7.7 Expert Panel Validation

GBI Research uses a panel of experts to cross verify its databases and forecasts.

GBI Research expert panel comprises marketing managers, product specialists, international sales managers from pharmaceutical companies, academics from research universities and key opinion leaders from hospitals.

Historical data and forecasts are relayed to GBI Research’s expert panel for feedback and are adjusted in accordance with their feedback.

7.9 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, GBI Research.

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