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Global Pharmaceutical & Biotechnology Outlook 2013: Global Pharma Product Image

Global Pharmaceutical & Biotechnology Outlook 2013: Global Pharma

  • ID: 2365176
  • January 2013
  • Region: Global
  • 131 Pages
  • MP Advisors

FEATURED COMPANIES

  • AstraZeneca
  • Bristol Myers-Squibb
  • Eli-Lilly
  • GlaxoSmithKline
  • Merck
  • Novartis
  • MORE

Global Pharmaceutical & Biotechnology Outlook 2013: Global Pharma

Over the next five years, we will witness surge in approval of new drugs that would deliver a major improvement in the standard of care. Therapy areas - Oncology, Diabetes, Ophthalmology HCV, Atrial Fibrillation, Multiple Sclerosis, Dyslipidemia, Alzheimer’s and Melanoma are few select areas where newer therapies that are safer and more efficacious will reach the market. Many of these innovations promise a paradigm shift in the standard of care. The year 2012 has marked the beginning of this trend as many new blockbuster drugs were approved and we also witnessed promising proof of concept data on many of the potential path breaking innovation. There are also major outcome clinical trials that will deliver data over the next few years and if positive, we will see the change in fortunes of many existing drugs that are on the market.

In the near term as well the sector continues to remain attractive, as cost containment initiatives, restructuring/deconsolidation, share repurchase program, M&A, emerging market growth potential and dividend policy continue to be encouraging. Over the next few years, READ MORE >

FEATURED COMPANIES

  • AstraZeneca
  • Bristol Myers-Squibb
  • Eli-Lilly
  • GlaxoSmithKline
  • Merck
  • Novartis
  • MORE

Global Pharmaceutical & Biotechnology 2013: Global Pharma

I. Global Pharma: Value based pricing to gain strength - A Perspective
Strength of Innovation Vs Fiscal Pressure
a. With Austerity Measures already in place, the next wave of Investment opportunities will only be driven by Innovations and M&A
b. Can Innovation Transform the Growth Trajectory for Pharma Companies Going Forward? – The Trend seems to be encouraging
c. Pricing Pressure in the US is likely to be driven by challenge to insure more people, and yet manage the healthcare costs
d. Transformation of Large cap Pharma after patent cliff
e. Reimbursement hurdles
f. Key measures of the ObamaCare in the US that should impact Drug Expenditure going forward

II. New Innovations in Select Therapy Area’s if Successful, could Drive Growth beyond Patent Expiries
Prevalence, market size opportunities and competitive landscape analysis of following therapy class
- New generation oral anticoagulants
- Multiple Sclerosis
- Breast cancer
- Respiratory-COPD and Asthma
- Melanoma
- Hepatitis C Virus (HCV)
- Diabetes – GLP-1 agonists and DPP-4 inhibitor
- Antiobesity
- Acute Coronary Syndrome – PCSK9 antibody –Mechanism and Opportunities
- Alzheimer’s – BACE Inhibitors – Mechanism and opportunities

III. Support from Emerging market for Global large cap pharma

IV. Dividend yield and Net cash position of Global Pharma

1. Merck: News flows from mega trials on MRK’s cardiology franchise would reshape growth prospects
1.1. Fate of cholesterol lowering therapy going forward: HPS2 Thrive failed but It is not indicative for IMPROVE-IT and REVEAL
1.2. Important News-Flow analysis for MRK in 2013
1.3. Peak Sales forecast for MRK’s DPP-IV franchise
1.4. Growing evidence base on CV benefit of DPP-IV’s
1.5. Once weekly DPP-IV
1.6. Januvia would continue to dominate the DPP-IV space
1.7. Odanacatib peak sales analysis
1.8. Key milestones in 2013

2. Novartis: Back on a growth trajectory
2.1. PhIII Clinical News- flow on Biosimilars and NCE candidates will continue to be robust in 2013
2.2. The other important clinical news flow and events to watch out in 2013
2.3. Gilenya ramp up in Multiple Sclerosis and market position going forward
2.4. Tasigna penetration in 1st Line Chronic Myelogenous Leukemia
2.5. Serelaxin in Acute Heart failure – An analysis
2.6. Ilaris Opportunities in sJIA
2.7. Market positioning of Pasireotide (SOM 230) in acromegaly
2.8. AIN457 (Secukinumab) in Plaque Psoriasis – Competitive scenario analysis
2.9. Patent expiry impact and potential drivers
2.10. Sandoz growth to be driven by biosimilars and respiratory generics
2.11. Key milestones in 2013

3. Roche: Breast cancer franchise and Actemra to drive near term growth, and multiple blockbusters in pipeline to take care of long term growth
3.1. Perjeta ramp up in first line breast cancer
3.2. Penetration of Actemra in first line Methotrexate failure RA
3.3. Avastin use in ovarian cancer and as treatment through multiple lines in colorectal cancer
3.4. Approval and ramp up of T-DM1 in Herceptin failure breast cancer patients
3.5. T-DM1: MARIANNE, EMILIA and APHINITY trial will lend Sustainable growth to Roche’s breast cancer franchise
3.6. T-DM1 as third line treatment option
3.7. T-DM1 PhII trial – Adjuvant and Neo-adjuvant setting
3.8. Herceptin sales beyond Patent Expiry in US and EU and Roche strategy in protecting Rituxan and Herceptin Franchise
3.9. Lucentis and Avastin Outlook beyond 2013
3.10. Bitopertin (RG1678, PhIII, Schizophrenia-negative symptoms)
3.11. Obinutuzumab (GA101) in frontline CLL
3.12. Onartuzumab (MetMab) in NSCLC
3.13. Strong late stage pipeline will offer potential sustainability and growth
3.14. Future of Zelboraf in competition
3.15. Key milestones in 2013

4. AstraZeneca: 2013 Will Be a Transition Year and AZN May Have To Take Some Bold Initiatives
4.1. Launch of Forxiga in Europe
4.2. Crestor outlook beyond 2013
4.3. PhIII data on Lesirunad (PhIII, URAT1 inhibitor/Hyperuricemia in Gout)
4.4. Head to head study (IDEAL-PCI Registry) comparing Brilinta or Effient against Plavix
4.5. Impact of competition on Faslodex
4.6. Bydureon prefilled pen
4.7. SGLT-2 emerging competition
4.8. PhIII data on Fostamatinib in DMARD refractory (OSKIRA-1 and OSKIRA-2) and TNF refractory RA patients
4.9. Naloxegol/NKTR-118 (PhIII) in Opioid induced Constipation
4.10. Impact of therapeutic substitution on Crestor
4.11. Impact of Outcome data from IMPROVE-IT Study on Crestor
4.12. Key milestones in 2013

5. Bristol-Myers Squibb: Pressures to Dominate In the Near Term, Pipeline Will Take Longer To Deliver
5.1. Eliquis ramp up amidst competition
5.2. Daiichi’s Edoxaban is an underestimated Threat
5.3. Three reasons on why Edoxaban could show solid data early next year
5.4. Upcoming News flow on Competition in Anticoagulant Space
5.5. Yervoy’s Potential and status in other indications
5.6. Anti-PD1 antibody (BMS-936558)
5.7. Forxiga (dapagliflozin) –likely to loose its first mover advantage in the US
5.8. SGLT-2 competition is intensive from a clinical perspective
5.9. Analysis on Daclatasvir, Elotuzumab and antiviral franchise
5.10. Key milestones in 2013

6. Eli Lilly: Late Stage Pipeline Fickle and Risky
6.1. Solanezumab – Risky, and Years to go before it reaches the market
6.2. Edivoxetine (NERI, PhIII, MDD)-Clinical data analysis
6.3. Dulaglutide
6.4. Empagliflozin –Competitive analysis
6.5. LY2963016- like Insulin Glargine and LY2605541 (Basal Insulin) - Novo’s Insulin degludec is much ahead in the clinical development
6.6. Ramucirumab (IMC-1121B)
6.7. Analysis on Baritinib, Tabalumab (BAFF antibody) and Ixekizumab (anti-IL17)
6.8. Key milestones in 2013

7. GlaxoSmithKline: Next Generation Bronchodilators, Melanoma, HIV And Emerging Market To Lead The Way While Regulatory Overhang In Respiratory and EU Pricing Pressure Persist
7.1. Analysis of expected NME approvals in 2013
7.2. Major Clinical News flow in 2013
7.3. PhIII data on Melanoma pipeline (BRAF and MEK inhibitor, MAGE-A3)
7.4. Umeclidinium/Vilanterol (LABA/LAMA FDC-Ellipta device) market positioning
7.5. Market positioning of Albiglutide
7.6. Relvar (Vilanterol/Fluticasone FDC) - Crosses the safety hurdle, while needs more data on the efficacy front
7.7. PhIII study exploring Tykerb in Adjuvant High risk Head and Neck cancer
7.8. Darapladib (PhIII, atherosclerosis)-high risk and potential
7.9. Key milestones in 2013

8. Novo Nordisk: Hemophilia Franchise and Thrice Weekly Degludec – The Future Drivers
8.1. Competitive pressures would weigh on Insulin Degludec
8.2. Victoza Sales may succumb to Competition, while approval in Obesity is likely to be more difficult and time consuming
8.3. Haemostasis Franchise (Turictocog, Novo Thirteen, N8-GP)
8.4. Hemophilia market size and competition
8.5. Key milestones in 2013

9. Pfizer: M&A Only Can Drive Further Upside in The Near Term
9.1. Xeljanz (Tofacitinib) – RA broader label but limited potential
9.2. Prevnar 13 US growth will be driven by outcome of the CAPITA study
9.3. Eliquis Superiority claim in Stroke will give an edge over competitor
9.4. Affordability and Penetration of Patient Self Testing Device might restrict switching to Eliquis
9.5. Daiichi’s Edoxaban is an underestimated Threat - Three reasons on why Edoxaban could show solid data early next year
9.6. Prescription trend: Warfarin remains sticky, while it seems once daily Dosing has a meaningful advantage
9.7. Eliquis - Additional opportunity from DVT treatment –AMPLIFY-EXT
9.8. PD0332991 (CDK inhibitor)
9.9. Dacomitinib (secondline NSCLC)
9.10. Key milestones in 2013

10. Sanofi: Solid Base Business, But Upside From Pipeline Will Take Longer To Come About
10.1. Anti-PCSK9 antibody
10.2. Dengue vaccine –Launch timelines and peak sales potential
10.3. Long term guidance??
10.4. Market positioning of Lemtrada and Aubagio
10.5. Emerging competition in RRMS market
10.6. Key milestones in multiple sclerosis
10.7. Lixisenatide –Superior Post Prandial Glucose reduction will allow differentiation
10.8. Kynamro (Mipomersen in familial hypercholesterolemia)
10.9. New Lantus formulation (PhIII) and Lantus/Lixisenatide combination
10.10. Growth from recently launched products and generic impact
10.11. Patent Expiry Impact to continue in 2013
10.12. Orphan diseases (Eliglustat and Mipomersen)
10.13. Key milestones in 2013

List of Charts

1. Januvia-Market share of DPP-IV inhibitors across major Geographies- first mover advantage is the key
2. Januvia dominates on efficacy
3. NRx market share of DPP-IV in the US (as on Nov 12)
4. TRx market share of DPP-IV in the US (as on Nov 12)

List of Tables

1. Drugs approved by FDA in 2012 with Indications
2. Ongoing Cardiovascular Outcome studies in Diabetes therapy area
3. Ongoing clinical trials in adjuvant breast cancer
4. Consolidated Patent expiry pressure (% loss of revenue) on large cap Innovator through 2017
5. List of Drug products patent to be expired through 2017
6. Emerging market sales growth by Global Pharma
7. Expected drug approvals in 2013
8. Global Pharma: Dividend yield (2012-2017) and Net cash position in 2017
9. Competitive landscape in acromegaly wrt SOM 230
10. PASSPORT-efficacy and safety comparison: Signifor vs.Sandostatin LAR
11. Select late- & Mid-Stage pipeline: Plaque Psoriasis
12. PHIII clinical data on plaque psoriasis of marketed products
13. Novartis-Patent expiry impact through 2017 and growth drivers
14. Roche- major pipeline molecules with expected filing
15. Roche- Efficacy and safety comparison of TDM1 vs. Trastuzumab+docetaxel in first-line BC
16. Roche- Ongoing important clinical studies of T-DM1 in late stage her 2 positive breast cancer
17. Ongoing clinical trials on Biosimilar Rituxan
18. Efficacy target profile of GA101 in clinical studies
19. Clinical data of BRAF inhibitor in metastatic melanoma
20. AZN-PhIIb combo data of lesinurad in gout pts -allopurinol-inadequate responders
21. AZN-Generic exposure through 2017
22. Pipeline of anti-PD1 mAB
23. SGLT2 inhibitors- clinical data comparison
24. BMY-Key growth drivers
25. BMY-Commercial Potential of future blockbuster
26. BMY-Generic exposures thru 2017
27. Ongoing pivotal clinical studies: Ipilimumab
28. LLY-Patent expiry pressure thru 2017
29. LLY-On going clinical studies – Edivoxetine
30. Ongoing PhIII clinical studies of Ramucirumab
31. LLY-Key growth drivers and pressures
32. On-going LABA/LAMA late stage clinical trials
33. DURATION 6 vs. HARMONY 6, 7 clinical data comparison
34. Select oral RA drugs in development
35. Sanofi- 2012 Sales from recently patent expired products
36. Dengue vaccine pipeline development

Annexures

1. Global Pharma -Drugs Losing Patent Protection By 2017
2. Impact of patent expiry in w.r.t. 2012 total revenue thru 2017
3. Global Pharma Research Pipeline (PhII And PhIII)- 2013
4. Global Pharma Milestones 2013

- AstraZeneca
- Bristol Myers-Squibb
- Pfizer
- Merck
- Novartis
- Novo Nordisk
- GlaxoSmithKline
- Roche
- Sanofi
- Eli-Lilly

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