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Home Pharmaceutical CINV Existing & Pipeline Drugs (Aloxi, Emend, Netupitant-Palonosetron Fdc, Apf530 & Rolapitant) - Global Market Opportunity Assessment Study, 2012 - 2018

CINV Existing & Pipeline Drugs (Aloxi, Emend, Netupitant-Palonosetron Fdc, Apf530 & Rolapitant) - Global Market Opportunity Assessment Study, 2012 - 2018

78pages
Published Date: 2012-11-28
 

Description




Description

This report is an effort to identify factors, which will be the driving force behind the market penetration and corresponding sales of the pipeline chemotherapy-induced nausea and vomiting (CINV) drugs, namely the combination drug netupitant–palonosetron FDC (fixed-dose combination), APF530 and rolapitant, in the next seven years. The report provides extensive analysis of APF530, rolapitant and netupitant–palonosetron (netu-palo) FDC, current market trends, unmet needs and challenges faced by the CINV market and opportunities for these drugs. The report has segregated the pipeline drugs in terms of estimated sales, patient pool and geography. The study presents a comprehensive assessment of the current clinical trials status and estimated future market penetration of each of these drugs in the CINV market and covers the following content as well:
  • Trends and forecast analysis for two prominent geographic markets, namely North America and Europe. Pipeline drug analysis of Asia and RoW (rest of the world) regions are not included in this study as it is assumed that the CINV pipeline drugs would be launched in these regions by 2018 and in the years ahead and so does not come under the scope of the forecast period of this report
  • Recent developments of major players and strategies followed by them for gaining competitive advantage
  • Profiles of major market participants for better understanding of their contributions

Table of Contents




TABLE OF CONTENTS

CHAPTER 1 PREFACE
1.1 REPORT DESCRIPTION
1.2 METHODOLOGY
1.3 LIST OF ACRONYMS
1.4 SALES ASSUMPTIONS

CHAPTER 2 EXECUTIVE SUMMARY AND MARKET OVERVIEW
2.1 GLOBAL CINV DRUGS MARKET, BY PRODUCT, 2011 – 2018 (USD MILLION) 
2.2 GLOBAL CINV DRUGS ESTIMATED PATIENT POOL, BY DRUGS, 2009 - 2018

CHAPTER 3 CINV MARKET ANALYSIS
3.1 OVERVIEW
      3.1.1 AETIOLOGY/CAUSES FOR CINV
      3.1.2 MULTIPLE SYSTEMS INVOLVED IN THE PATHOGENESIS OF CINV
3.2 CINV - CURRENT DRUG TREATMENTS AVAILABLE
      3.2.1 ANTICIPATORY N/V
      3.2.2 ACUTE-ONSET CINV
              3.2.2.1 Highly Emetogenic Chemotherapy
              3.2.2.2 Moderately Emetogenic Chemotherapy
              3.2.2.3 Low Emetogenic Chemotherapy
              3.2.2.4 Minimally Emetogenic Chemotherapy
      3.2.3 DELAYED-ONSET CINV
              3.2.3.1 Highly Emetogenic Chemotherapy
              3.2.3.2 Moderately Emetogenic Chemotherapy
3.3 CINV - PIPELINE PRODUCTS
      3.3.1 APF530 (LONG-ACTING GRANISETRON - 5-HT3RA) 
              3.3.1.1 Efficacy Results of APF530 MEC Phase III Study
              3.3.1.2 Efficacy Results of APF530 HEC Phase III Study
      3.3.2 ROLAPITANT (NK-1-RA) 
Chemical structure of rolapitant
      3.3.3 NETUPITANT-PALONOSETRON FDC
              3.3.3.1 Introduction
              3.3.3.2 Mechanism of Action
Chemical structure of netupitant
3.4 UNMET NEEDS IN THE CINV MARKET
3.5 CLINICAL TRIAL DETAILS FOR CINV PIPELINE DRUGS
      3.5.1 APF530
              3.5.1.1 Clinical Trial: ID- NCT00343460
      3.5.2 ROLAPITANT
              3.5.2.1 Clinical Trial: ID – NCT01500226
              3.5.2.2 Clinical Trial: ID – NCT01500213
              3.5.2.3 Clinical Trial: ID – NCT01499849
      3.5.3 NETUPITANT-PALONOSETRON FDC
              3.5.3.1 Clinical Trial: ID – NCT01376297
              3.5.3.2 Clinical Trial: ID – NCT01339260

CHAPTER 4 CINV PIPELINE DRUGS MARKET ANALYSIS
4.1 CINV MARKET SIZE & OPPORTUNITY SCENARIO
      4.1.1 GLOBAL CINV PATIENT POOL, 2011 – 2018 (MILLION) 
      4.1.2 GLOBAL CINV PATIENT POOL, BY DRUG TYPE, 2011 – 2018
      4.1.3 GLOBAL CINV PATIENT POOL, BY GEOGRAPHY, 2011 – 2018
      4.1.4 GLOBAL CINV MARKET, 2011 – 2018 (USD MILLION) 
      4.1.5 GLOBAL CINV MARKET, BY GEOGRAPHY, 2011 – 2018 (USD MILLION) 
4.2 FACTORS INFLUENTIAL TO THE SALES OF PIPELINE CINV DRUGS
4.3 SALES PROJECTION OF CINV PIPELINE DRUGS
       4.3.1 CINV PATIENT POOL ESTIMATE
               4.3.1.1 Global CINV Drugs - Target Patient Pool, 2009 – 2018
               4.3.1.2 Global CINV Drugs Market, 2011 – 2018 (USD million) 
       4.3.2 NETUPITANT-PALONOSETRON FDC – SALES FORECAST
               4.3.2.1 Global Netupitant-Palonosetron FDC – Sales Projection (USD Million) 
       4.3.3 ROLAPITANT – SALES FORECAST
               4.3.3.1 Global Rolapitant – Sales Projection (USD Million) 
       4.3.4 APF530 – SALES FORECAST
               4.3.4.1 Global APF530 – Sales Projection (USD Million) 
4.4 SWOT ANALYSIS FOR CINV PIPELINE DRUGS
       4.4.1 NETUPITANT-PALONOSETRON FDC
               4.4.1.1 Netupitant – palonosetron FDC - Strength
               4.4.1.2 Netupitant – palonosetron FDC - Weakness
               4.4.1.3 Netupitant – palonosetron FDC - Opportunity
               4.4.1.4 Netupitant – palonosetron FDC - Threat
      4.4.2 ROLAPITANT
               4.4.2.1 Rolapitant – Strength
               4.4.2.2 Rolapitant – Weakness
               4.4.2.3 Rolapitant – Opportunity
               4.4.2.4 Rolapitant – Threat
      4.4.3 APF530
               4.4.3.1 APF530 – Strength
               4.4.3.2 APF530 – Weakness
               4.4.3.3 APF530 – Opportunity
               4.4.3.4 APF530 – Threat
4.5 OVERALL LICENSE AGREEMENT FOR PIPELINE DRUGS
      4.5.1 NETUPITANT–PALONOSETRON FDC
               4.5.1.1 Global
               4.5.1.2 United States
               4.5.1.3 UK & Ireland
               4.5.1.4 Japan
               4.5.1.5 Australia
               4.5.1.6 Europe
               4.5.1.7 South Korea
       4.5.2 ROLAPITANT
       4.5.3 APF530

CHAPTER 5 CINV PIPELINE DRUGS MARKET, BY GEOGRAPHY
5.1 NORTH AMERICA CINV PIPELINE DRUGS MARKET, 2011 – 2018
      5.1.1 NORTH AMERICA CINV ESTIMATED PATIENT POOL, 2013 – 2018 (THOUSANDS) 
      5.1.2 NORTH AMERICA CINV PIPELINE DRUGS MARKET, 2013 – 2018 (USD MILLION) 
5.2 EUROPE CINV PIPELINE DRUGS MARKET, 2011 – 2018
      5.2.1 EUROPE CINV ESTIMATED PATIENT POOL, 2014 – 2018 (THOUSANDS) 
      5.2.2 EUROPE CINV PIPELINE DRUGS MARKET, 2014 – 2018 (USD MILLION) 

CHAPTER 6 COMPETITIVE LANDSCAPE

CHAPTER 7 COMPANY PROFILES
7.1 HELSINN HOLDING S.A. 
      7.1.1 COMPANY OVERVIEW
      7.1.2 FINANCIAL OVERVIEW
               7.1.2.1 Helsinn Group’s total assets, 2007 - 2011 (USD Million) 
                          7.1.2.1.1 Helsinn group total assets, 2007 - 2011 (USD million) (conversion rate: 1 Euro = 1.2744 USD) 
               7.1.2.2 Helsinn’s net turnover from netupitant – palonosetron FDC, 2010 – 2011 (USD Million) 
                          7.1.2.2.1 Helsinn’s net turnover from netupitant–palonosetron fdc, 2010 – 2011 (USD million) (conversion rate: 1 Euro = 1.2744 USD) 
              7.1.2.3 Helsinn Group’s net turnover by products, 2011 (%)
                          7.1.2.3.1 Helsinn Group’s net turnover by products, 2011 (%)
              7.1.2.4 Helsinn Group’s net turnover by business divisions, 2011 (USD Million) 
              7.1.2.5 Comparative analysis of Helsinn Group’s net turnover by geography, 2011 & 2012 (%)
     7.1.3 BUSINESS STRATEGIES
              7.1.3.1 Research and Development Initiatives
              7.1.3.2 Five year Vision
              7.1.3.3 Investing in new and emerging markets
              7.1.3.4 Strategic Alliances
              7.1.3.5 4Ps and working towards developing a Quality of Life Company
              7.1.3.6 Efficient Business Model
     7.1.4 RECENT DEVELOPMENTS
7.2 MERCK INC. 
     7.2.1 COMPANY OVERVIEW
              7.2.1.1 Merck’s total revenue by business segment, 2007 – 2011 (USD MILLION) 
     7.2.2 BUSINESS STRATEGIES
              7.2.2.1 Corporate Social Responsibility
              7.2.2.2 R&D Initiatives
              7.2.2.3 Strategic alliances and out licensing
     7.2.3 PRODUCT PORTFOLIO
     7.2.4 RECENT DEVELOPMENTS
7.3 TESARO INC. 
     7.3.1 COMPANY OVERVIEW
     7.3.2 STRATEGIC OVERVIEW
     7.3.3 FINANCIAL OVERVIEW
     7.3.4 SWOT ANALYSIS
     7.3.5 RECENT DEVELOPMENT
7.4 AP PHARMA INC. 
     7.4.1 COMPANY OVERVIEW
     7.4.2 FINANCIAL OVERVIEW
     7.4.3 BUSINESS STRATEGY
     7.4.4 RECENT DEVELOPMENTS

LIST OF FIGURES

FIG. 1 GLOBAL CINV ESTIMATED PATIENT POOL, BY DRUGS, 2009-2018
FIG. 2 PATHOGENESIS OF CINV
FIG. 3 PATIENTS RECEIVING MEC
FIG. 4 PATIENTS RECEIVING HEC
FIG. 5 CHEMICAL SRUCTURE OF ROLAPITANT
FIG. 6 CHEMICAL SRUCTURE OF NETUPITANT
FIG. 7 GLOBAL CINV PATIENT POOL, 2011 – 2018 (MILLION) 
FIG. 8 GLOBAL CINV MARKET 2011 – 2018 (USD MILLION) 
FIG. 9 GLOBAL CINV ESTIMATED PATIENT POOL, BY DRUGS, 2009-2018
FIG. 10 GLOBAL NETUPITANT-PALONOSETRON FDC SALES PROJECTION, 2014 – 2018 (USD MILLION) 
FIG. 11 GLOBAL ROLAPITANT SALES PROJECTION, 2014 – 2018 (USD MILLION) 
FIG. 12 GLOBAL APF530 SALES PROJECTION, 2013 – 2018 (USD MILLION) 
FIG. 13 HELSINN GROUP TOTAL ASSETS, 2007 - 2011 (USD MILLION) (CONVERSION RATE: 1 EURO = 1.2744 USD) 
FIG. 14 HELSINN’S NET TURNOVER FROM NETUPITANT–PALONOSETRON FDC, 2010 – 2011 (USD MILLION) (CONVERSION RATE: 1 EURO = 1.2744 USD) 
FIG. 15 HELSINN GROUP’S NET TURNOVER BY PRODUCTS, 2011 (%)
FIG. 16 HELSINN GROUP’S NET TURNOVER BY BUSINESS DIVISIONS, 2011 (USD MILLION) 
FIG. 17 COMPARATIVE ANALYSIS OF HELSINN GROUP’S NET TURNOVER BY GEOGRAPHY, 2010 & 2011 (%)
FIG. 18 MERCK’S TOTAL REVENUE BY BUSINESS SEGMENT, 2007 – 2011 (USD MILLION)

LIST OF TABLES

TABLE 1 GLOBAL CINV DRUGS MARKET, BY PRODUCT, 2011-2018, (USD MILLION) 
TABLE 2 CHEMOTHERAPY INDUCED NAUSEA AND VOMITING: CONDITIONS AND SYMPTOMS
TABLE 3 TREATMENT RECOMMENDATIONS FOR CINV
TABLE 4 OVERVIEW OF APF530 PHASE III EFFICACY WITH DIFFICULT CHEMO REGIMENS STUDY
TABLE 5 EVALUATION OF NETUPITANT-PALONOSETRON FDC
TABLE 6 CINV UNMET NEEDS
TABLE 7 DETAILS OF TRIAL ID - NCT00343460
TABLE 8 DETAILS OF TRIAL ID - NCT01500226
TABLE 9 DETAILS OF TRIAL ID - NCT01500213
TABLE 10 DETAILS OF TRIAL ID - NCT01499849
TABLE 11 DETAILS OF TRIAL ID - NCT01376297
TABLE 12 DETAILS OF TRIAL ID - NCT01339260
TABLE 13 GLOBAL CINV PATIENT POOL, BY DRUG TYPE, 2011 – 2018 (THOUSANDS) 
TABLE 14 GLOBAL CINV PATIENT POOL, BY GEOGRAPHY, 2011 – 2018 (THOUSANDS) 
TABLE 15 GLOBAL CINV MARKET, BY GEOGRAPHY, 2011 – 2018 (USD MILLION) 
TABLE 16 GLOBAL CINV DRUGS MARKET, 2011 - 2018 (USD MILLION) 
TABLE 17 NORTH AMERICA CINV ESTIMATED PATIENT POOL, 2013 – 2018 (THOUSANDS) 
TABLE 18 NORTH AMERICA CINV PIPELINE DRUGS MARKET, 2013 – 2018 (USD MILLION) 
TABLE 19 EUROPE CINV ESTIMATED PATIENT POOL, 2014 – 2018 (THOUSANDS) 
TABLE 20 EUROPE CINV PIPELINE DRUGS MARKET, 2014 – 2018 (USD MILLION) 
TABLE 21 PATENT STATUS OF ANTI-EMETIC DRUGS
TABLE 22 QUARTER THREE FINANCIAL RESULTS 

Enquiry Before Buying




Free Market Analysis




Nausea and vomiting represent the most frequent side-effects experienced by chemotherapy patients, referred to as chemotherapy-induced nausea and vomiting (CINV), which is debilitating to cancer patients. Delayed-onset CINV affects more patients than acute-onset CINV, affecting as many as 50–70% of patients, for which, with the exception of palonosetron, there is no other treatment approved in patients receiving highly emetogenic chemotherapy. 

Major impacts of CINV on the patient include physiological impairment, loss of functional ability and a decline in performance status as well as a deleterious effect on quality of life, leading to withdrawal from therapy. 

The struggle with CINV has been continuous for cancer patients, although anti-emetics such as Aloxi and other 5-HT3 antagonists have been shown to help prevent the nausea and vomiting caused by chemotherapy, but it has helped only to some extent. The principal reason for this deficiency in treatment has been the inefficiency of healthcare providers to understand the complex physiology of CINV as well as to effectively predict its incidence, and adhere to recommended guidelines. 

The pipeline drugs in the CINV market offer huge opportunities for patients in terms of better treatment and efficient clinical outcomes as well as for physicians to opt for alternative treatment options. One of the most promising pipeline drugs, netupitant is a potent and selective Neurokinin -1 (NK-1) receptor antagonist being developed in combination with palonosetron to treat chemotherapy-induced-nausea and vomiting (CINV), referred to as netupitant-palonosetron FDC. 

Other prominent pipeline drugs include APF530 (long acting granisetron) and rolapitant (NK-1 receptor antagonist). Experts view rolapitant as a direct competitor to Merck’s Emend (aprepitant) owing to its better efficacy in clinical trials, once it is launched in 2014. With the help of its own Biochronomer™ polymer-based drug delivery technology, A.P.Pharma has increased the effectiveness for APF530 from one day to five days, resulting in significant therapeutic advantage. For patients showing little relief from palonosetron, physicians would prefer alternative treatment options, such as APF530 which is expecting its market launch in 2013.

GLOBAL CINV MARKET 2011 - 2018
 

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