kinase inhibitors for treating cancer market forecast 2014-2024

Kinase Inhibitors for Treating Cancer: Industry Analysis, R&D Trends and World Market Forecasts 2014-2024

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Contents

1.1 Overview of the World Market for Those Medicines

1.2 Why You Should Read This Report

1.3 How This Report Delivers

1.4 Main Questions Answered by This Analysis

1.5 Who is This Study For?

1.6 Methods of Research and Analysis

1.7 Frequently Asked Questions (FAQ)

1.8 Some Associated Reports

1.9 About Visiongain

2.1 What are Protein Kinases?

2.2 Protein Kinases in Oncology

2.3 Mechanisms for Kinase Inhibition

2.4 Glossary of Terms

3.1 The Global Market for Anti-Cancer Kinase Inhibitors in 2013

3.1.1 Leading Anti-Cancer Kinase Inhibitors by Sales, 2013

3.1.2 Leading Companies in the Protein Kinase Inhibitor Market

3.2 World Protein Kinase Inhibitors for Oncology Market: Sales Forecast by Class, 2014-2024

3.2.1 Changing Market Shares by Segment 2014-2024

3.2.2 Leading Anti-Cancer Kinase Inhibitors Manufacturers, 2014-2024

3. Anti-Cancer Kinase Inhibitors: World Market 2014-2024

2. Introduction to Anti-Cancer Kinase Inhibitors

1. Report Overview

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Contents 3.3 Bcr-Abl Inhibitors Lead the Protein Kinase Inhibitors for Oncology Market in 2013

3.3.1 Bcr-Abl Kinase Inhibitors: Drivers and Restraints 2014-2024

3.4 Imbruvica and Other Novel Kinase Inhibitors Will Eventually Dominate the Market

3.4.1 Other Kinase Inhibitors: Drivers and Restraints, 2014-2024

4.1 Regional Breakdown of the World Protein Kinase Inhibitors for Drugs Treating Cancer

4.2 World Protein Kinase Inhibitors for Oncology Market: Regional Forecast 2014-2024

4.2.1 How Will Regional Market Shares Change Through to 2024?

4.3 The US Anti-Cancer Kinase Inhibitor Market Forecast, 2014-2024

4.4 The US Market: Drivers and Restraints, 2014-2024

4.5 The EU Union Anti-Cancer Kinase Inhibitors Market Forecast, 2014-2024

4.5.1 EU Market: Drivers and Restraints

4.5.2 German Market Forecast, 2014-2024

4.5.3 French Market Forecast, 2014-2024

4.5.4 Italian Market Forecast, 2014-2024

4.5.5 UK Market Forecast, 2014-2024

4.5.6 Spanish Market Forecast, 2014-2024

4.6 The Japanese Anti-Cancer Kinase Inhibitor Market Forecast, 2014-2024

4.7 Forecasting Anti-Cancer Kinase Inhibitor Markets in Developing Countries, 2014-2024

4.7.1 Chinese Market Forecast, 2014-2024

4.7.2 Brazilian Market Forecast, 2014-2024

4.7.3 Russian Market Forecast, 2014-2024

4.7.4 Indian Market Forecast, 2014-2024

4. Leading National and Regional Markets, 2014-2024

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Contents

5.1 Brc-Abl Inhibitors – Managed Care for Chronic Myeloid Leukaemia

5.1.1 Gleevec (imatinib) - Novartis

5.1.1.1 Historic Sales Performance

5.1.1.2 Lifecycle Management, Generic Challenges and Tasigna

5.1.1.3 Gleevec Forecast, 2014-2024

5.1.2 Sprycel (dasatanib) – Bristol-Myers Squibb

5.1.2.1 Patents and Market Exclusivity


5.1.2.3 Sprycel Forecast, 2014-2024

5.1.3 Tasigna (nilotinib) - Novartis

5.1.3.1 Indications and Market Exclusivity


5.1.3.3 Tasigna Forecast, 2014-2024

5.1.4 Bosulif (bosutinib) - Pfizer

5.1.4.1 Bosulif Forecast, 2014-2024

5.1.5 Iclusig (ponatinib) – ARIAD Pharmaceuticals

5.1.5.1 Iclusig Forecast, 2014-2024

5.2 EGFR Inhibitors

5.2.1 Tarceva (erlotinib) – Roche/Astellas

5.2.1.1 Patent Litigation and Market Exclusivity

5.2.1.2 Historic Sales Performance, 2004-2012

5.2.1.3 Tarceva Forecast, 2014-2024

5. Leading Anti-Cancer Kinase Inhibitors Products, 2014-2024

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Contents 5.2.2 Iressa (gefitinib) - AstraZeneca


5.2.2.2 Iressa Forecast, 2014-2024

5.2.3 Gilotrif (afatinib) - Boehringer Ingelheim

5.2.3.1 Gilotrif Forecast, 2014-2024

5.3 Angiogenesis Inhibitors

5.3.1 Nexavar (sorafenib) – Bayer/Onyx


5.3.1.2 Nexavar Forecast, 2014-2024

5.3.2 Sutent (sunitinib) – Pfizer


5.3.2.2 Sutent Forecast, 2014-2024

5.3.3 Votrient (pazopanib) - GSK


5.3.3.2 Votrient Forecast, 2014-2024

5.3.4 Inlyta (axitinib) - Pfizer

5.3.4.1 Inlyta Forecast, 2014-2024

5.4 BRAF and MEK Inhibitors

5.4.1 Zelboraf (vemurafenib) – Roche/Daiichi Sankyo

5.4.1.1 Zelboraf Forecast, 2014-2024

5.4.2 Mekinist (trametinib) and Tafinlar (dabrafenib) - GSK

5.4.2.1 Mekinist Forecast, 2014-2024

5.4.2.2 Tafinlar Forecast, 2014-2024

5.5 mTOR Inhibitors

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Contents 5.5.1 Afinitor (everolimus) - Novartis

5.5.1.1 Patents and Market Exclusivity


5.5.1.3 Afinitor Forecast, 2014-2024

5.5.2 Torisel (temsirolimus) – Pfizer

5.5.2.1 Torisel Forecast, 2014-2024

5.6 Other leading Anticancer Kinase Inhibitors

5.6.1 Imbruvica (ibrutinib) –J&J/Pharmacyclics

5.6.1.1 Imbruvica Forecast, 2014-2024

5.6.2 Jakafi (ruxolitinib) – Novartis/Incyte

5.6.2.1 Jakafi Forecast, 2014-2024

5.6.3 Xalkori (crizotinib) - Pfizer

5.6.3.1 Xalkori Forecast, 2014-2024

5.6.4 Cometriq (cabozantinib) – Exelixis

5.6.4.1 Cometriq Forecast, 2014-2024

5.6.5 Caprelsa (vandetanib) – AstraZeneca

5.6.5.1 Caprelsa Forecast, 2014-2024

5.6.6 Tykerb (lapatinib) - GSK


5.6.6.2 Tykerb Forecast, 2014-2024

5.6.7 Stivarga (regorafenib) – Bayer

5.6.7.1 Stivarga Forecast, 2014-2024

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Contents

6.1 Cyclin-Dependent Kinase 4/6 Inhibitors in Development

6.1.1 Palbociclib – Pfizer

6.1.1.1 Palbociclib Forecast, 2014-2024

6.1.2 LEE-011 – Novartis

6.1.2.1 LEE-011 Forecast, 2014-2024

6.1.3 Bemaciclib (LY2835219) – Eli Lilly

6.1.3.1 Bemaciclib Forecast, 2014-2024

6.2 Anaplastic Lymphoma Kinase (ALK) Inhibitors In Development

6.2.1 Alectinib – Roche

6.2.1.1 Alectinib Forecast, 2014-2024

6.2.2 Ceritinib (LDK378) - Novartis

6.2.2.1 Ceritinib Forecast, 2014-2024

6.2.3 AP26113 - ARIAD

6.3 Bruton’s Tyrosine Kinase and PI3K Inhibitors in Development

6.3.1 Idelalisib – Gilead

6.3.1.1 Idelalisib Forecast, 2014-2024

6.3.2 RG7601 (ABT-199) – Roche/AbbVie

6.3.2.1 ABT-199 Sales Forecast, 2014-2024

6.3.3 IPI-145 – Infinity Pharmaceuticals

6.3.3.1 IPI-145 Forecast, 2014-2024

6.3.4 Buparlisib (BKM120) – Novartis

6.3.4.1 Buparlisib Forecast, 2014-2024

6. Anti-Cancer Kinase Inhibitors: R&D Pipeline 2014-2024

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Contents 6.3.5 ONO-4059 – Ono Pharmaceuticals

6.3.6 Copanlisib (BAY 80-6946) - Bayer

6.3.7 Pictilisib (GDC-0941) – Roche

6.3.8 BEZ235 - Novartis

6.4 MEK and BRAF Inhibitors in Development

6.4.1 Cobimetinib (GDC-0973) – Roche

6.4.1.1 Cobimetinib Forecast, 2014-2024

6.4.2 Encorafenib (LGX818) – Novartis

6.4.3 Binimetinib (MEK162) – Novartis

6.4.4 Selumetinib (AZD 6244) – AstraZeneca

6.5 Other Kinase Inhibitors in Development

6.5.1 Volasertib – Boehringer Ingelheim

6.5.1.1 Volasertib Forecast, 2014-2024

6.5.2 Neratinib (PB272) – Puma Biotechnology

6.5.3 Tivantinib (ARQ197) – Daiichi Sankyo

6.5.4 Dovotinib (TKI258) – Novartis

6.5.5 Dacomitinib – Pfizer

6.5.6 CO-1686 – Clovis Oncology

7.1 SWOT Analysis of the Protein Kinase Inhibitors for Oncology Market

7.2 Strengths

7.2.1 Oral Dosage Preferred Over Injection

7. Qualitative Analysis of the Anti-Cancer Kinase Inhibitor Market, 2014-2024

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Contents 7.2.2 Stratifying Patients Offers Clinical and Commercial Benefits

7.2.3 Targeted Kinase Inhibitor are Generally Well Tolerated

7.2.4 A Strong Pipeline of Novel Inhibitors Will Drive Market Growth

7.3 Weaknesses

7.3.1 Small Molecule Kinase Inhibitors Will Experience Generic Competition

7.3.2 Competitor Biologics Offer Differentiated Mechanisms of Action

7.3.3 Monoclonal Antibodies are More Specific than Small Molecules

7.4 Opportunities

7.4.1 Novel Targets Identified Through Cancer Genomics

7.4.2 Combination Therapies Bring Additive Benefits

7.4.3 Commercial Success Leveraged by Clinical Benefit

7.5 Threats

7.5.1 Small Molecules Generics Are Easy to Produce

7.5.2 Individual Kinase Targets are Rapidly Becoming Crowded

7.6 STEP Analysis of the Protein Kinase Inhibitors for Oncology Market

7.7 Porter’s Five Forces Analysis of the Anti-Cancer Kinase Inhibitor Market, 2014-2024

7.7.1 Rivalry Among Competitors

7.7.2 Threat of New Entrants

7.7.3 Power of Suppliers

7.7.4 Power of Buyers

7.7.5 Threat of Substitutes

8.1 Interview with Dr Lawrence Bloch, Chief Finance and Business Officer, Infinity

Pharmaceuticals, United States

8. Research Interview

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Contents 8.1.1 Positioning a Novel Therapeutic in Blood Cancer Indications

8.1.2 Combining Therapies Offers Significant Benefit to Patients

8.1.3 Potential in Rheumatoid Arthritis and Blood Cancers

9.1 The Global Anti-Cancer Kinase Inhibitors Market to 2024

9.1.1 A Robust Pipeline of Innovative Drugs Driving Market Growth

9.2 Leading National Markets for Anti-Cancer Kinase Inhibitors to 2024

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Appendices

9. Conclusions

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release of novel kinase inhibitor classes such as the CDK4/6 and PI3K inhibitors, along with

stratified treatments in existing inhibitor classes. However, significant downward pressure on the

market will exist from the flood of generic inhibitors set to reach the market during that time.

Table 4.10 Forecast Italian Anti-Cancer Kinase Inhibitor Market: Market Size ($bn), Annual Growth (%), CAGR (%), 2013-2024

2013 2014 2015 2016 2017 2018 Italy ($bn) 0.82 0.93 1.00 1.05 1.11 1.24

Annual Growth (%) 14.3 7.3 4.9 5.5 12.0 CAGR (%) 8.7

2019 2020 2021 2022 2023 2024

Italy ($bn) 1.30 1.30 1.25 1.34 1.36 1.37 Annual Growth (%) 5.0 -0.1 -3.7 7.4 1.1 1.1

CAGR (%) 1.7

Figure 4.12 Forecast Italian Anti-Cancer Kinase Inhibitor Market: Market Size ($bn), 2013-2024

4.4.5 UK Market Forecast, 2014-2024

The UK forms one of the most important national markets for pharmaceuticals, despite its relatively

small population. Approval for medicinal use in the UK is assessed by NICE using cost-

effectiveness measurement. Decisions handed down by NICE are often used as a benchmark in

0.00

0.20

0.40

0.60

0.80

1.00

1.20

1.40

1.60

2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024

Mar

ket

size

($b

n)

Year

Source: visiongain 2014

CAGRs for periods 2013-2018 and 2018-2024. Source: visiongain 2014



benefit in patients with NSCLC, leading to an initial rejection of early use by the FDA. The drug is

far more effective in patients with mutated, over-active forms of EGFR. In these patients Tarceva is

highly effective and in 2013 the FDA approved its use as a first line therapy for NSCLC patients

who have EGFR mutation status confirmed by DNA tumour testing. Resistant to first-generation

EGFR inhibitors has been attributed to the development of a point mutation at position 790 in the

EGFR gene. This mutation substitutes a small polar threonine reside for a large non-polar

methionine residue. The second-generation of EGFR inhibitors have been designed to target this

mutation as well allowing the drug to be used before or after resistance develops. Drugs

specifically designed to target and provide clinical benefit to a subset of identifiable patients are

very commercially attractive. Manufacturers will often be able to circumvent cost-effectiveness

measurements that would otherwise limit reimbursement and ensure high treatment prices. Highly

specific therapies can also reduce off-target adverse effects, increasing their clinical potential. In

the case of EGFR inhibitors, sparing the wild-type receptor reduces the incidence of skin rash

which is caused by unwanted inhibitor of normal receptor activity. Cancer genomics will continue to

provide highly specific targets for novel stratification of patient groups. Visiongain believes this

stratification of patients will provide substantial benefit to developers, reducing the cost of clinical

development and enhancing the commercial potential of treatments.

7.2.3 Targeted Kinase Inhibitor are Generally Well Tolerated

Standard chemotherapy treatments for cancer involve the use of non-selective cytotoxic anti-

neoplastic drugs administered intravenously. These therapies act by killing all cells that divide

rapidly, targeting both cancerous and healthy and causing significant adverse treatment effects.

Novel targeted kinase inhibitors are designed to suppress cancerous cell growth without the

indiscriminate killing of healthy cells. This leads to better tolerance of targeted therapeutics in

general when compared to standard cytotoxic drugs. However, there are still adverse treatment

effects reportedly associated with kinase inhibitors both from widespread inhibition of kinase

activity and unwanted off-target effects. For example the first generation EGFR inhibitors

apparently display marked cutaneous toxicity due to inhibition of normal wild-type EGFR function in

differentiating skin cells. The ability to specifically inhibit over-active oncogenic kinases will allow

further reduction in unwanted side-effect and promote the use of targeted kinase inhibitors over

generalised cytotoxic chemotherapy.

7.2.4 A Strong Pipeline of Novel Inhibitors Will Drive Market Growth

Protein kinases are one of the leading targets in drug development with over 600 products

currently in development. Candidates which demonstrate significant clinical efficacy at early



145 could be an important treatment option for patients who stop responding, or do not respond, to

Imbruvica.

8.1.2 Combining Therapies Offers Significant Benefit to Patients

visiongain: Are there any plans for a potential combination therapeutic further down the line?

LB: Our vision is that best route to approval is as a monotherapy, but we believe that the best

benefit for patients may be through a two stage process. First combining IPI-145 with the standard

of care such as Rituxan, and we have a clinical trial planned for the second half of 2014. The next

stage is combining IPI-145 with other targeted therapies, with the aspiration to achieve minimal

residual disease (MRD) negativity.

visiongain: Which other targeted therapies do you think would work as a combination?

LB: We are doing a very robust pre-clinical evaluation to answer that question as there are some

drugs that would be intuitive combinations and others which you wouldn’t predict to be synergistic.

For example at the American Society for Hematology (ASH) meeting in December 2013, we

presented data on the synergistic benefit of IPI-145 with Imbruvica in diffuse large B-cell (DLBCL)

cell lines. We think this combination has empirical basis for synergy because the drugs have

parallel but non-overlapping mechanisms. So far the pre-clinical data indicates that the synergist

effect may be greater than expected for combining these treatments, more like one plus one

equals three.

When you think about this compared to HIV treatment as an analogy. It was standard practice to

have an HIV monotherapy in the 1980s, but now it is the standard of care to provide multiple

combinations therapies. In fact, currently it wouldn’t be advisable to prescribe an HIV monotherapy

as the virus can mutate and become resistant to treatment. This is also the case with NHL and CLL

where the cancer can become resistant to treatment or potential become an even more aggressive

from. We think hitting the cancer early with multiple therapies will prevent mutations from

developing and will provide significant benefits for patients.

visiongain: Combining novel treatments is going to become hugely expensive for payers, how is

this going to be addressed?

LB: That’s a fair question, but this is the same question that occurred with HIV triple therapies.

Ultimately, the triple therapy was so much more efficacious than monotherapy there was a

substantial benefit for patients. But also the developers of the single therapies had to come

together to make a way for it be cost-effective for third party payers.

kinase inhibitors for treating cancer market forecast 2014-2024

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