Sanofi swoops for Pfizer insulin plant, scuppering MannKind's bid By Gareth Macdonald, 09-Jun-2009 Related topics: Mergers and acquisitions, Industry Drivers, Processing (automation, control, separation)
Sanofi Aventis will pay Pfizer €30m ($41m) for a former Exubera manufacturing plant in Frankfurt-Höchst, Germany that was due to be bought by inhaled insulin specialist MannKind.
The French drugmaker said the facility, one of the largest of its kind in the world, will produce its Lantus SoloStar (insulin glargine) diabetes treatment, sales of which increased nearly 28 per cent to $2.45bn (€1.75bn) last year.
Pfizer, which has been seeking to sell the plant for several years following the market failure of its inhaled insulin product Exubera, agreed a sale with California, US-based MannKind in March.
The deal hinged on MannKind gaining manufacturing approval from operator Infraserv and, crucially, approval by Pfizer's original Exubera co-developer Sanofi, which retained a "right of first refusal" option on the plant.
Evidently, gains made by Lantus in the SoloStar pen format coupled with growing worldwide demand for diabetes treatments, the World Health Organization predicts that more than 350m will develop the condition by 2030, convinced Sanofi to exercise its option.
In a press statement Martin Stewart, general manager of Sanofi in Germany, said: "The strong increase in demand for our insulins, and especially Lantus, drives us to considerably extend our production capacities.
"In combining the acquired Diabel site with our existing plants Sanofi-Aventis will operate the largest insulin capacity in the world in Frankfurt," Stewart continued.
The acquisition fits with Sanofi's ongoing efforts to "double Lantus sales by 2012." In April, the firm said it that it will invest $90m (64m) over the next three years to boost Lantus manufacturing capacity in China.
One small setback for MannKind?
According to some observers MannKind, which is yet to issue a statement on the Sanofi deal, may be less disappointed about the "loss" of the plant itself than it is about the regulatory benefits the acquisition would have provided.
When MannKind signed its original acquisition deal with Pfizer in March, Rodman & Renshaw analyst Jason Butler said that the manufacturing capacity provided by the facility was not the key motivation for the deal.
Instead, he suggested that the insulin inventory MannKind was due to gain and the license to make insulin for pulmonary delivery that it was required to obtain under the original terms would be of more benefit for MannKind.
If this reading of the situation is accurate, the fact MannKind still obtains EUR3m worth of insulin regardless of the Sanofi deal, will be seen as positive for the US firm.
Positive Ph III Afresa data boosts share price
The response to data from the latest Afresa trials reported at this year's American Diabetes Association's scientific sessions is also likely to boost MannKind's spirits and alleviate any lingering disappointment.
Results from a two-year Phase III study showed that there is no difference in forced expiratory volumes (FEV) between patients treated with Afresca compared with standard insulin.
The news saw MannKind's share price climb 15 per cent to a 52-week high of $8.12 in trading on the New York Stock Exchange late last week.
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Zydus, Teva end patent disputes
2 Jun 2009, 0144 hrs IST, Nina Mehta, ET Bureau
MUMBAI: Ahmedabad-based ZydusCadila and Israeli generic major Teva have settled their patent disputes over active pharmaceutical ingredients (APIs) used to make generic versions of GlaxoSmithKline's heart drug and Johnson & Johnson's anti-psychotic drug. Zydus will now be able to sell its generic versions of these products in the US without legal implications from Teva. Teva currently controls a majority market share in these products. When contacted about the settlement and the company's product launch in the US, a Zydus Cadila spokesperson declined to comment.
Judge Garrett E Brown Jr. of the US District Court of New Jersey signed a stipulation on May 14 of dismissal, bringing an end to the claims and counterclaims of patent infringement and federal antitrust law violations in a lawsuit over two of Teva's patents related to blood pressure and congestive heart failure treatment Coreg.
GlaxoSmithKline makes the heart drug Coreg, while Johnson & Johnson makes the antipsychotic drug Risperdal.
Teva had filed a case against Zydus over the patent that Teva had for preparing a chemical compound Carvedilol - a pharmaceutical compound used in the treatment of congestive heart failure. It is the API used in the product sold by GSK under the trade name Coreg.
According to data from IMS Health, the annual sales of Carvedilol in the US were about $1.7 billion for the year ended June 2007, making this is significant market for both companies. Annual sales of Risperdal were approximately $2.6 billion in the US for the year ended March 31, 2008.
In 2006, just before it went off-patent, Coreg grossed revenues of £195 million for GSK. Teva currently controls a majority share in this market, closely with GSK. According to data from IMS Health, the annual sales of Carvedilol in the US were about $1.7 billion for the year ended June 2007, making this is significant market for both companies. The dispute had centred on Zydus's alleged infringement of Teva's patents relating to Carvedilol, the active ingredient in Coreg. In its complaint, Teva said it attempted to obtain information on the composition and processes the company intended to use in May 2007, but Zydus declined to produce the samples, forcing it to file its lawsuit on October 12, 2007.
In the case of Risperidone, Zydus had submitted a motion to transfer the case to the US District Court for the Eastern District of Virginia, which it later withdrew. Zydus had sued Teva in the court for violating antitrust laws and deceiving the Patent and Trademark Office in the US in obtaining the patents for preparation of Risperidone. |
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New report on cardiovascular drug delivery.
Drug delivery to the cardiovascular system is different from delivery to other systems because of the anatomy and physiology of the vascular system; it supplies blood and nutrients to all organs of the body. Drugs can be introduced into the vascular system for systemic effects or targeted to an organ via the regional blood supply. In addition to the usual formulations of drugs such as controlled release, devices are used as well. This report starts with an introduction to molecular cardiology and discusses its relationship to biotechnology and drug delivery systems.
Drug delivery to the cardiovascular system is approached at three levels: (1) routes of drug delivery; (2) formulations; and finally (3) applications to various diseases. Formulations for drug delivery to the cardiovascular system range from controlled release preparations to delivery of proteins and peptides. Cell and gene therapies, including antisense and RNA interference, are described in full chapters as they are the most innovative methods of delivery of therapeutics. Various methods of improving systemic administration of drugs for cardiovascular disorders are described including use of nanotechnology.
Cell-selective targeted drug delivery has emerged as one of the most significant areas of biomedical engineering research, to optimize the therapeutic efficacy of a drug by strictly localizing its pharmacological activity to a pathophysiologically relevant tissue system. These concepts have been applied to targeted drug delivery to the cardiovascular system. Devices for drug delivery to the cardiovascular system are also described.
Role of drug delivery in various cardiovascular disorders such as myocardial ischemia, hypertension and hypercholesterolemia is discussed. Cardioprotection is also discussed. Some of the preparations and technologies are also applicable to peripheral arterial diseases. Controlled release systems are based on chronopharmacology, which deals with the effects of circadian biological rhythms on drug actions.A full chapter is devoted to drug-eluting stents as treatment for restenosis following stenting of coronary arteries.Fifteen companies are involved in drug-eluting stents.
New cell-based therapeutic strategies are being developed in response to the shortcomings of available treatments for heart disease. Potential repair by cell grafting or mobilizing endogenous cells holds particular attraction in heart disease, where the meager capacity for cardiomyocyte proliferation likely contributes to the irreversibility of heart failure. Cell therapy approaches include attempts to reinitiate cardiomyocyte proliferation in the adult, conversion of fibroblasts to contractile myocytes, conversion of bone marrow stem cells into cardiomyocytes, and transplantation of myocytes or other cells into injured myocardium.
Advances in molecular pathophysiology of cardiovascular diseases have brought gene therapy within the realm of possibility as a novel approach to treatment of these diseases. It is hoped that gene therapy will be less expensive and affordable because the techniques involved are simpler than those involved in cardiac bypass surgery, heart transplantation and stent implantation. Gene therapy would be a more physiologic approach to deliver vasoprotective molecules to the site of vascular lesion. Gene therapy is not only a sophisticated method of drug delivery; it may at time need drug delivery devices such as catheters for transfer of genes to various parts of the cardiovascular system.
The cardiovascular drug delivery markets are estimated for the years 2008 to 2018 on the basis of epidemiology and total markets for cardiovascular therapeutics. The estimates take into consideration the anticipated advances and availability of various technologies, particularly drug delivery devices in the future. Markets for drug-eluting stents are calculated separately. Role of drug delivery in developing cardiovascular markets is defined and unmet needs in cardiovascular drug delivery technologies are identified. |
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Anti-Obesity Treatments Report - Analysis & Forecasts 2009-2024
Obesity has been described as a ‘public health time-bomb'. In 2005, the World Health Organization estimated that approximately 400 million individuals are obese. Prevalence of obesity is rising worryingly in many countries, despite campaigns emphasising the link between being overweight and contracting diabetes. This new report - Anti-Obesity Treatments 2009-2024 - explains those trends in commercial terms. In two of the largest national markets for anti-obesity treatments - the US and UK - over 20% of the population are seriously overweight. Obesity is a major risk factor in a number of other serious disorders, particularly diabetes and heart disease. Importantly, the financial burden of obesity and its associated conditions - both direct and indirect costs - are vast. Obesity is a serious, chronic condition with an emerging market for therapeutic products, as we show in this study. High socioeconomic costs and increasing prevalence are inspiring government initiatives to deal with the problem, with obesity becoming one of the most prominent global health concerns worldwide. Visiongain recognizes the contribution of drugs in this important emerging market, as diet and exercise are frequently not successful alone. We predict that new classes of drugs will invigorate the market - driving total sales in the next decade. In this report you will find out about those treatments, especially their sales potential.
Drug sales in the global anti-obesity market approached $2bn in 2008, with the market to grow substantially over the forecast period 2009-2024. This growth will be associated with a complex environment of label changes, reformulations, patent expiry, OTC switching and new product launches. Those opportunities are highlighted by the extensive R&D pipeline, crowded with novel therapies to improve treatment of obesity. Which new treatments have blockbuster potential? Our report will cover this and other important matters. Importantly, too, prevalence of obesity is rising in Latin America, India and China in particular - important pharmaceutical markets covered here.
Anti-Obesity Treatments 2009-2024 provides detailed analysis of the global anti-obesity market, with comprehensive sales forecasting. With a rigorous study of sources, including commercial databases, company reports, industry news and first-hand interviews with experts in the obesity sector, this report is a unique opportunity to discover how your company can develop over the next 5 years. The result is a comprehensive market- and industry-based report with detailed analyses and informed opinion that you will not find anywhere else.
Anti-Obesity Treatments 2009-2024 highlights the following essential aspects of the market:
A global forecast for the anti-obesity drugs market with comprehensive discussions Sales forecasts for the current-leading drugs Assessment of new drug releases, both therapeutically and commercially Sales forecasts for the leading national anti-obesity markets, as well as for emerging national markets Discussion of strengths, weakness, opportunities and threats (SWOT) facing major stakeholders in the anti-obesity drug sector Extensive analysis of pipeline developments, including avenues for future research Discussion of current un-met and under-met needs in the anti-obesity market, revealing both therapeutic needs and commercial opportunities.
Why you should buy this report:
To receive a comprehensive analysis of the prospects for anti-obesity therapies from 2009-2024, including predicted revenues, growth rates and other key metrics To identify key pipeline developments, the most promising therapy classes and potential methods of treatment To discover the important drivers and restraints for the global anti-obesity market, including factors affecting leading national markets To find out where the global anti-obesity market is heading - both technologically and commercially - from the present onwards.
This report is essential reading for anyone in the pharmaceutical and healthcare sector with an interest in obesity and related conditions. Purchasing this report will help you to recognise those important market opportunities and understand the possibilities there. You can order today. I look forward to receiving your order.
Table of Contents
1 Executive Summary: Anti-Obesity Treatments 2009-2024
2 An Introduction to Obesity and Its Treatment
2.1 What is Obesity?
2.1.1 Fat is a Necessary Component of the Body
2.1.2 Obesity is a Chronic Disease
2.1.3 Body Weight is Dependent upon Several Factors
2.2 How is Obesity Measured?
2.2.1 Weight-for-Height Tables
2.2.2 Waist Circumference
2.2.3 Body Mass Index (BMI)
2.3 How Serious is the Problem?
2.3.1 Prevalence
2.3.2 Risk Factors of Other Diseases (Co-Morbidities)
2.3.3 Economic Costs
2.4 Historical Causes and Lifestyle Changes
2.4.1 Urbanisation, Modernisation and Economic Development
2.4.2 Developed Countries and in Developing Nations
2.5 Factors Causing Obesity
2.5.1 Lifestyle, Environment and Diet
2.5.2 Behaviour
2.5.3 Psychological Factors
2.5.4 Genetics
2.5.5 Antecedent Illnesses and Treatments
2.5.6 Other Causes
2.6 Treatment of Obesity
2.6.1 Lifestyle and Behavioural Changes
2.6.2 Unapproved Drugs
2.6.3 Alternative Therapies
2.6.4 Pharmacotherapy
2.6.5 Surgical Options
2.6.6 Drugs have a Role in the Treatment of Obesity.
2.7 Pharmacotherapy in the Treatment of Obesity
2.7.1 Lipase Inhibitors
2.7.2 Anorectic Drugs
2.7.3 Off-Label Use of Drugs
2.8 Need for Future Development in the Treatment of Obesity
2.8.1 Unmet Needs and Market Potential
3 The World Market for Anti-Obesity Drugs, 2009-2024
3.1 The Current Anti-Obesity Market Climate - a Potential Blockbuster Market
3.2 Leading Companies in the Anti-Obesity Market
3.3 Market History and the Current Situation
3.3.1 The Effect of Pondimin, Redux and Public Opinion on the Anti-Obesity Market
3.3.2 Rimonabant and other Cannabinoid Receptor Antagonists
3.3.3 Phentermine
3.4 Total Anti-Obesity Market Forecast 2009-2024
3.4.1 Market Growth in 2009-2024
3.4.2 Drugs after 2012
3.5 Xenical Forecast 2009-2024
3.5.1 Will Generic Erosion Drive Down Xenical's Sales?
3.5.2 Competition Increases with New Releases
3.5.3 Will Xenical be Driven Out by Newer Rivals?
3.6 Reductil/Meridia Forecast 2009-2024
3.6.1 How Will Competition Affect Sales?
3.6.2 Expiry of Patents in 2013
3.7 Alli Forecast 2009-2024
3.7.1 Early Launch-Stocking
3.7.2 European Launch
3.7.3 Is Alli Failing to Distinguish Itself?
3.8 Dinintel Forecast 2009-2024
3.8.1 Will the Rapidly Evolving Anti-Obesity Market Will Leave Dinintel Behind?
3.9 Total Other Drugs Forecast 2009-2024
3.9.1 Generic Competitors
3.9.2 New Drug: Contrave (Orexigen)
3.9.3 New Drug: Lorcaserin (Arena)
3.9.4 New Drug: Qnexa (Vivus)
3.9.5 New Drug: Liraglutide (Novo Nordisk)
3.9.6 New Drug: Empatic/Excalia (Orexigen)
3.10 Market Summary
3.10.1 New Drugs and the Market
3.10.2 Lack of Innovation and the Market Opportunities?
3.10.3 The Problems with Anorectic Drugs
3.10.4 The Problems with Lipase Inhibitors
3.10.5 The Future of Anti-Obesity Treatments
4 Anti-Obesity Treatments - SWOT Analysis
4.1 Strengths
4.1.1 Long-Term Therapy with Anti-Obesity Drugs
4.1.2 Prospects of Multiple Indications for Anti-Obesity Drugs
4.1.3 Off-Label Potential and Competition
4.1.4 The Anti-Obesity Market is Ready to be Revolutionised
4.1.5 Failure of Rimonabant Leaves Vacuum in the Market
4.1.6 New Drugs May Not Fill the Entirety of Customer Needs
4.2 Weaknesses
4.2.1 Limited Efficacy
4.2.2 Undesirable Side-Effects Limit Market Potential of Anti-Obesity Medications
4.2.3 Increased Competition by both Impending New Releases and Generic Competitors
4.2.4 Regulatory Hurdles have Become Stricter - Companies Pay the Price
4.2.5 Pharmacotherapy Will Never be the First Line of Treatment?
4.3 Opportunities
4.3.1 Rising Prevalence Drives Market Potential
4.3.2 Unmet Market Needs - Can Drugs Solve this Problem?
4.3.3 A Safe and Effective Anti-Obesity Treatment has Applications in Both the Clinical and Cosmetic Sectors
4.3.4 How the Changing Government Agenda and the High Economic Costs of Obesity Will Drive Growth in the Anti-Obesity Market
4.3.5 Diet and Exercise May be the Mainstay Treatment, but this Approach is not Always Effective
4.4 Threats
4.4.1 Reimbursement May Continue to be a Limiting Factor
4.4.2 Long-Term Safety Issues Continue to Stunt Growth
4.4.3 Opinion of Both the Public and Prescribing Bodies is Heavily Dependent upon Individual Drug Successes and Success of the Market as a Whole
4.4.4 Will Healthier Lifestyles Limit the Current Need for Anti-Obesity Drugs?
5 Pipeline Developments in Anti-Obesity Treatments
5.1 Treatments in Phase III
5.1.1 Lorcaserin
5.1.2 Qnexa
5.1.3 Contrave
5.1.4 Cetilistat
5.2 Treatments in Phase II
5.2.1 Empatic/Excalia
5.2.2 Liraglutide
5.2.3 Obinepitide
5.2.4 Solabegron
5.2.5 Tesofensine
5.2.6 Velneperit
5.2.7 Histalean
5.2.8 Sodium Tungstate
5.2.9 Serglifozin Etabonate
5.2.10 Pramlintide & Metreleptin
5.2.11 Hoodia gordonii Extract
5.2.12 MTP Inhibitor
5.2.13 TM 30339
5.2.14 SLx 4090
5.2.15 MK 0493
5.2.16 KRP 204
5.2.17 FM VP4
5.2.18 AZD 2207
5.2.19 CE 326597
5.3 Treatments in Phase I
5.3.1 Trodusquemine
5.3.2 THCV
5.3.3 Oral PYY3-36
5.3.4 ATHX 105
5.3.5 AZD 1175
5.3.6 AZD 1656
5.3.7 BVT 74316
5.3.8 CP 404
5.3.9 KD 3010
5.3.10 PRX 07034
5.3.11 PSN 602
5.3.12 TKS 1225
5.3.13 V 24343
5.3.14 TTP 435
5.4 Other Promising Pipeline Developments
5.4.1 Melanotan
5.4.2 Increasing Mitochondrial Activity to Increase Energy Expenditure
5.4.3 Inhibiting the Creation of Fat Stores after Gut Absorption
7 Experts' Views on the Main Issues in the Treatment of Obesity
7.1 An Interview with Dr. Tyrberg from The Burnham Institute Diabetes and Obesity Research Centre
7.1.1 The Effect of Anti-Obesity Drugs on the Obese Population
7.1.2 The Cause-Effect Relationship between Diet, Obesity and Type 2 Diabetes
7.1.3 Off-Label Indications and Diabetes Treatments Used to Treat Obesity
7.1.4 Obesity as a Lifestyle Disease?
7.1.5 The Future of Anti-Obesity Treatments and the Role Diet and Exercise Will Play
7.1.6 The Role of Pharmaceutical Companies, Ethics and the Cosmetic Use of Anti-Obesity Treatments
7.1.7 Unmet Medical Needs in the Treatment of Obesity
7.1.8 The Future of the Anti-Obesity Market
7.2 Commentaries and Views from Other Experts in the Field
7.2.1 The Most Important Unmet Medical Needs in the Treatment of Obesity
7.2.2 The Future of Anti-Obesity Treatment
7.2.3 Funding of Anti-Obesity Treatments
7.2.4 The Anti-Obesity Market in Developing Nations
7.2.5 Concluding Thoughts
8 Conclusions
8.1 Obesity is a Chronic Disease with Serious Health Implications
8.2 The Prevalence and Economic Costs of Obesity
8.3 The Modern Lifestyle has Contributed Significantly to Obesity
8.4 Obesity is Caused by a Complex Interplay of Factors
8.5 Obesity Treatments and the Role of Pharmaceuticals
8.6 The Unmet Needs and Market Potential for Anti-Obesity Treatments
8.7 The Anti-Obesity Market Will Expand from 2009-2024
8.8 The Main Drivers and Restraints of the Anti-Obesity Market
Some Organisations Mentioned in this Report
7TM Pharma
Abbott
Ache Laboratories
Actavis
Alizyme
American Home Products
Amylin
Arena
AstraZeneca
Athersys
Barcelona University
Bayer
Biovitrum
Bristol-Myers Squibb
Clinuvel
Compellis
Council for Scientific and Industrial Research
Duke University
Eli Lilly
EMEA
Emisphere
EMS
Epix
FDA
Forbes Medi-Tech
Gate Pharmaceuticals
Genaera
GlaxoSmithKline
Graceway Pharma
GW Pharmaceuticals
Han Wha
Hanmi
Inova Pharma
Johnson & Johnson
Kalypsys
Kissei
Kyorin
Louisiana State University
Medley
Merck & Co.
NeuroSearch
Novartis
Novo Nordisk
Nycomed Pharma
OBEcure
Orexigen
OSI Pharmaceuticals
Pfizer
Phytopharm
Roche
Sanofi-Aventis
Shionogi
Sirtris Pharmaceuticals
Solvay
Surface Logix
Takeda
Teva
The Burnham Institute
Transition
TransTech
URL Pharma
Vernalis
Vivus
Wyeth Pharmaceuticals
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How is the OTC pharmaceuticals market defined?
The OTC pharmaceuticals market values the total sales of traditional medicines, cough and cold preparations (tablets, mixtures, lozenges, topical remedies, inhalers), vitamins and minerals (multi-vitamins, single minerals, single vitamins, tonics), indigestion preparations (tablets, powders, mixtures), analgesics (Paracetamol, Ibuprofen, Aspirin, other analgesics), and other OTC healthcare products including; medicated skin products (anti-bacterials, acne treatments, antifungals, other medicated skin products, disinfectants), topical OTC medicines (anesthetic products, anti-itch products, antibiotic creams/gels), plasters & bandages (adhesive bandages/plasters, first aid tape, gauze pads/rolled gauze, other tape or bandage, liquid bandages), first aid kits and other OTC healthcare products (anti-smoking aids, rectal medications, eye/ear drops, sleeping aids, motion sickness).
The market values are at retail selling price (RSP) and include any applicable taxes. Any currency conversions used in the creation of this report have been calculated using constant 2007 annual average exchange rates. For the purpose of this report the Americas comprise Brazil, Canada, Mexico and the US. Europe comprises Belgium, the Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Russia, Spain, Sweden and the UK.
Asia-Pacific comprises Australia, China, Japan, India, Singapore, South Korea and Taiwan.
The global figure comprises the Americas, Asia-Pacific and Europe. Some key findings in this report...
Market Value
The global OTC pharmaceuticals market grew by 3.9% in 2008 to reach a value of $104.2 billion. The compound annual growth rate of the market in the period 2004-2008 was 4%.
Product Market Segmentation
Sales of traditional medicines account for 20.3% of the global OTC pharmaceutical market's overall value. In comparison, sales of cough and cold preparations account for 15.5% of the market's value.
Geographical Market Segmentation
The Asia-Pacific accounts for 38.2% of the global OTC pharmaceutical market's value. Europe accounts for a 29.9% of the global market's value, while the US market holds a further 24.5%.
Distribution
Pharmacies and drug stores distribute 57.8% of the value within the global OTC pharmaceutical market.
In comparison, supermarkets and hypermarkets distribute 14.3% of the market's value. OTC Pharmaceuticals Global Industry Guide
Global OTC Pharmaceuticals Market
Share: % Share, by Value, 2008(e)
"Pfizer is a leading company in global OTC pharmaceuticals market with 7.2% of the market's value. GlaxoSmithkline Plc holds further 5.2% of the global OTC pharmaceuticals market's share..."
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Global Antivirals Market Analysis & Forecasts by Visiongain
Investors are turning their attention to antiviral drug discovery because there is a renewed recognition of the promising opportunities in this $20bn market. Twenty years from the inception of focused antiviral drug research, there are 8 blockbuster drugs currently on the market. Its double-digit growth makes it a standout segment within the general anti-infective therapeutic class. You should be maximizing your opportunities in this market. The opportunities for success are there now, you should capitalize on them immediately.
The key driver of the market is the rapid development of resistance to existing therapies by the evolving viruses. The constant need to update the pipeline fuels your investigative and commercial interest in this market - so you must act on this today. This report - Global Antivirals Market, 2008-2023 - analyses the global antiviral market comprehensively, outlining where you should aim your future developments to guarantee success. The analyses tackle different aspects of the market, including the leading therapeutic classes, leading antiviral products, key industrial players as partners and financial prospects and opportunities. The report also delivers in-depth predictions concerning how the market will develop from present until 2023.
Global Antivirals Market, 2008-2023 examines the market for antivirals critically, through comprehensive primary and secondary research. In addition to consultation with experts in the industry, this research involved a detailed study of policy documents, industrial reports and relevant news. Essentially, visiongain also applied unique in-house techniques such as our developed financial forecasting, SWOT analyses and qualitative projections which are unavailable elsewhere. The result is a comprehensive market-focused study with detailed financial analyses and uniquely informed opinion on the future of the antivirals market.
Table of Contents
1 Executive Summary 1.1 Aims of This Report 1.2 A Brief Overview of the Chapters
2 Introduction 2.1 What is a Virus? 2.2 History of Virology 2.2.1 Origin of Viruses 2.2.2 Historical Developments in Virology 2.3 Classification of Viruses 2.3.1 DNA Viruses 2.3.2 RNA Viruses 2.3.3 Reverse Transcribing Viruses 2.4 Introduction to Viral Infections 2.4.1 Viral Life Cycle 2.4.2 Intrinsic Human Defences against Virus 2.5 How Do Antivirals Work? 2.5.1 Approach to Life Cycle Management 2.5.1.1 Before Cell Entry 2.5.1.2 During Viral Synthesis 2.5.1.3 Release Phase 2.5.2 Immune System Modulating 2.6 Antivirals Battle Highly Mutational Viral Genomes 2.7 The World Anti-Infective Market 2.7.1 Market Shares
3 The Global Market for Anti-Viral Drugs, 2008-2023 3.1 The Global Anti-Viral Market Generated High Revenues in 2007 3.1.1 Leading Segments in the Global Anti-Viral Market 3.1.2 Reverse Transcriptase Inhibitors, Immunoglobulin, Protease Inhibitors and Vaccine Segments 3.2 Global Anti-Viral Market Forecast, 2008-2023 3.3 Global Anti-Viral Market by Disease Area, 2008-2023 3.4 The Rise of the Hepatitis Segment from 2008 to 2013 3.5 The HIV Market Impeded by Patent Issues 3.5.1 Anti-HIV Agents Facing Looming Patent Expiries 3.5.2 Controversy Surrounding Patent Rights 3.6 The Influenza Segment Growth is Hampered by Conflicts 3.7 The Global Anti-Viral Market Will Undergo Shift 3.8 Leading Anti-Viral Brands and Forecast, 2008-2023 3.8.1 Will Tamiflu Retain its Leadership Position? 3.8.2 Combination Therapy Deemed Most Effective 3.8.3 Pegasys-Ribavirin Combination Therapy 3.8.4 Atripla - the Way Forward? 3.9 The Anti-Viral Market and Investment Activities
4 Factors Affecting the World Anti-Viral Market, 2008-2023 4.1 SWOT Analysis of the Anti-Viral Market 4.2 There is Much Reason for Optimism in the Anti-Viral Market 4.2.1 Drug Resistance is a Major Concern, but Stimulates Research Activity 4.2.2 Chronic Indications Ensure Long-Term Demand for Antivirals 4.2.3 Outbreaks of Viral Infections Give Rise to Major Global Public Health Crises 4.2.4 Low Diagnostic Rate Means that the Majority of Patients Are Unaware of Their Infections 4.3 Current Antiviral Treatments Marred by High Toxicity and Low Patient Compliance 4.4 The Threat of Bio-generic Penetration 4.4.1 Looming Patent Expiry Threatens Some Leading Brands 4.4.2 Does the Pipeline Have Enough Potential to Replace the Aging Brands? 4.5 Variability of Novel Targets and Mechanisms 4.6 Investment and Commercial Obstacles 4.6.1 Low Prevalence of Treatable Viral Diseases 4.6.2 Low Profitability from the Developing Countries 4.7 The Market Needs to Overcome Economic and Political Obstacles to Gain Access to Patients in Need 4.7.1 Will the Expanding Patient Population Drive Market Growth? A Case Study of the HIV Market 4.7.2 Expensiveness of Antiviral Treatments Forces Market Exclusivity and Limits Market Growth 4.7.3 Conjoint Effort from the Public and Private Domains to Achieve Greater Accessibility is a Positive Step Forward 4.8 How Will the Manufacturers Answer to Public Demands for Enhancing Treatment Availability? 4.8.1 Production Rate Unable to Meet Demands 4.8.2 The Controversy Towards Overriding Patent Rights 4.9 Are Vaccines Friends or Foes to the Antiviral Market?
5 Leading Companies in the Antiviral Market, 2008-2023 5.1 GSK, Roche, Merck, Gilead Sciences and Bristol-Myers Squibb 5.2 Is GSK's Market Dominance in Jeopardy? 5.3 Roche's Pipeline 5.4 What is Merck's Competitive Edge in the Antiviral Market? 5.5 Gilead Sciences and Bristol-Myers Squibb Carve into the HIV Market
6 Leading Antiviral Brands, Forecasts and Analyses, 2008-2023 6.1 Top 15 Marketed Antivirals of 2007 6.2 Tamiflu 6.3 Gardasil 6.4 Valtrex 6.5 Pegasys 6.6 Truvada 6.7 Varivax 6.8 Synagis 6.9 Reyataz 6.10 Kaletra 6.11 Sustiva 6.12 Atripla 6.13 Combivir 6.14 Peg-Intron 6.15 Epzicom 6.16 Viread
7 Antivirals in the Leading Pharmaceutical Markets, Forecasts and Analysis, 2008-2023 7.1 Sales of Antivirals in the Leading Pharmaceutical Markets in 2007 7.2 Market Performance of Antivirals in the Leading Pharmaceutical Nations, 2008-2023 7.3 Will the US Retain Dominance? 7.4 Other Industrialised Countries to Undergo Steady Growth 7.5 How Will the Leading Developing Countries Fare in the Global Antivirals Market?
8 Promising Anti-Viral Technologies and Pipeline Developments 8.1 HIV Pipeline Development 8.1.1 Research Direction 8.1.2 Viral Enzymes as Targets 8.1.3 NNRTI 8.1.3.1 Intelence 8.1.3.2 Rilpivirine 8.1.4 NRTI 8.1.4.1 Apricitabine 8.1.5 Host Proteins as Targets 8.1.6 Viral-Entry Inhibitors: Attachment, Entry and Fusion Inhibitors 8.1.6.1 Selzentry/Celsentri 8.1.6.2 Vicriviroc 8.1.7 Integrase Inhibitors 8.1.7.1 Isentress 8.1.7.2 Elvitegravir 8.1.8 Maturation Inhibitors 8.1.8.1 Bevirimat 8.2 Hepatitis Pipeline Development 8.2.1 Research Direction 8.2.2 Interferons 8.2.2.1 Albuferon 8.2.3 NS3 Protease Inhibitors 8.2.3.1 Telaprevir 8.2.3.2 Boceprevir 8.2.4 Polymerase Inhibitors 8.2.4.1 R7128 8.3 Novel Technologies Head the Next Wave of Anti-Viral Drug Exploration 8.3.1 Could Monoclonal Antibodies Surpass the Dominant Small-Molecules? 8.3.2 RNA Interference Technology Raises Investment Interest
9 Interviews with Relevant Experts - Discussion of Current and Future Trends 9.1 Interview 1: Professor Erik De Clercq, Emeritus Professor, Rega Institute for Medical Research, K.U. Leuven, Belgium. 9.1.1 Promising Sub-Markets 9.1.2 Market Drivers and Restraints 9.1.3 Promising R&D Programmes 9.1.4 Market Direction 9.2 Interview 2: Dr. Michael Kinch, VP, Research and Development, Functional Genetics, Maryland, USA 9.2.1 Promising Sub-Markets 9.2.2 Market Drivers and Restraints 9.2.3 Arguments for Host-Oriented Therapeutic Approach 9.2.4 Biologicals Versus Small Molecules
10 Conclusions 10.1 Excitement Surrounds the Antivirals Market 10.2 The Next Market Leader 10.3 Hepatitis Segment Drives Innovative Antiviral Research 10.4 Pipeline Development 10.5 The Future of Antivirals
List of Tables Table 2.1, Historical Developments in Virology Table 2.2, Categorisation of Clinically Significant Viruses Table 2.3, The World Anti-Infective Market, Sales ($bn), 12 months to Q1 2008 Table 3.1, Antiviral Therapies Blockbusters, Sales ($m) and Market Share (%), 2007 Table 3.2, Global Anti-Viral Market, Sales ($bn) and Growth (%), 2006-2013, 2018, 2023 Table 3.3, Global Antiviral Market Breakdown by Disease Area, 2006 and 2007 Table 3.4, Global Anti-Viral Market by Disease Area, Sales ($bn) and Annual Growth (%), 2006-2013 Table 3.5, Market Performance of the Hepatitis Segment, Sales ($bn), Annual Growth (%), CAGR (%) and Market Share (%), 2008-2013, 2018 and 2023 Table 3.6, Marketed Antiviral Therapies for HIV/AIDS, Sales ($m), 2007 Table 3.7, Market Performance of the HIV Segment, Sales ($bn), Annual Growth (%), CAGR (%) and Market Share (%), 2008-2013, 2018 and 2023 Table 3.8, Market Performance of the Influenza Segment, Sales ($bn), Annual Growth (%), CAGR (%) and Market Share (%), 2008-2013, 2018 and 2023 Table 3.9, Global Anti-Viral Market by Disease Area, CAGR (%) and Market Share (%), 2007, 2013, 2018 and 2023 Table 3.10, Top 15 Anti-Viral Brands, Sales ($m) and Growth (%), 2007 Table 3.11, Top 15 Anti-Viral Brands, Sales ($m) and Growth (%), 2006-2013 Table 4.1, SWOT Analysis of the Antiviral Market, 2008 Table 4.2, Antivirals with Recent or Imminent Patent Expiration Table 4.3, Antiviral Patents Approved in the United States Table 5.1, Leading Companies in the Antiviral Market, Sales ($bn), 2007 Table 6.1, Sales of Tamiflu ($m), 2006-2013 Table 6.2, Sales of Gardasil ($m), 2006-2013 Table 6.3, Sales of Valtrex ($m), 2006-2013 Table 6.4, Sales of Pegasys ($m), 2006-2013 Table 6.5, Sales of Truvada ($m), 2006-2013 Table 6.6, Sales of Varivax ($m), 2006-2013 Table 6.7, Sales of Synagis ($m), 2006-2013 Table 6.8, Sales of Reyataz ($m), 2006-2013 Table 6.9, Sales of Kaletra ($m), 2006-2013 Table 6.10, Sales of Sustiva ($m), 2006-2013 Table 6.11, Sales of Atripla ($m), 2006-2013 Table 6.12, Sales of Combivir ($m), 2006-2013 Table 6.13, Sales of Peg-Intron ($m), 2006-2013 Table 6.14, Sales of Epzicom ($m), 2006-2013 Table 6.15, Sales of Viread ($m), 2006-2013 Table 7.1, Antivirals in the Leading Pharmaceutical Markets, Sales ($), Market Share (%) and Annual Growth (%), 2007 Table 7.2, Antivirals in the Leading Pharmaceutical Markets, Sales ($m), 2007-2013, 2018, 2023 Table 7.3, Antivirals in the Leading Pharmaceutical Markets, Market Share (%) and CAGR (%), 2007 and 2013 Table 8.1, HIV Life Cycle and Potential Targets for Antiretrovirals Table 8.2, Selected Viral Enzymes Inhibitors in Late Clinical Development Table 8.3, Selected Entry Inhibitors in Late Clinical Development Table 8.4, Selected Integrase Inhibitors in Late Clinical Development Table 8.5, Selected Interferons in Late Stage Development Table 8.6, Selected NS3 Protease Inhibitors in Late Clinical Development Table 8.7, Selected Polymerase Inhibitors in Late Clinical Development Table 8.8, Commercial Development of Antiviral mAbs Table 10.1, Global Anti-Viral Market, Sales ($bn) and Growth (%), 2006-2013, 2018, 2023 Table 10.2, Antiviral Therapies Blockbusters, Sales ($m) and Market Share (%), 2007
List of Figures Figure 2.1, Basic Structures of the Influenza Virus Figure 2.2, Life Cycle of a Typical RNA Virus Figure 2.3, The World Anti-Infective Market, Sales ($bn), 12 months to Q1 2008 Figure 2.4, The World Anti-Infective Market, Market Share (%), 12 months to Q1 2008 Figure 3.1, Leading Disease Areas in the Anti-Viral Market, Sales ($bn), 2007 Figure 3.2, Leading Drug Classes in the Anti-Viral Market, Sales 2007 ($bn) Figure 3.3, Global Anti-Viral Market Sales ($m), 2006-2013 Figure 3.4, Global Antiviral Market by Disease Area, Market Share (%), 2007 Figure 3.5, Global Anti-Viral Market by Disease Area, Sales ($m), 2006-2013 Figure 3.6, Global Hepatitis Market, Sales ($bn), 2006-2023 Figure 3.7, Global HIV Market, Sales ($bn), 2006-2023 Figure 3.8, Global Influenza Market, Sales ($bn), 2006-2023 Figure 3.9, Global Antiviral Market by Disease Area, Market Share (%), 2013 Figure 3.10, Market Share of the Leading Anti-Viral Drugs (%), 2007 Figure 5.1, Leading Companies in the Antiviral Market, Market Share (%), 2007 Figure 6.1, Top 15 Marketed Antiviral Therapies, Sales ($m), 2007 Figure 6.2, Top 15 Marketed Antiviral Therapies, Annual Growth (%), 2007 Figure 6.3, Sales of Tamiflu ($m), 2006-2023 Figure 6.4, Sales of Gardasil ($m), 2006-2023 Figure 6.5, Sales of Valtrex ($m), 2006-2023 Figure 6.6, Sales of Pegasys ($m), 2006-2023 Figure 6.7, Sales of Truvada ($m), 2006-2023 Figure 6.8, Sales of Varivax ($m), 2006-2023 Figure 6.9, Sales of Synagis ($m), 2006-2023 Figure 6.10, Sales of Reyataz ($m), 2006-2023 Figure 6.11, Sales of Kaletra ($m), 2006-2023 Figure 6.12, Sales of Sustiva ($m), 2006-2023 Figure 6.13, Sales of Atripla ($m), 2006-2023 Figure 6.14, Sales of Combivir ($m), 2006-2023 Figure 6.15, Sales of Peg-Intron ($m), 2006-2023 Figure 6.16, Sales of Epzicom ($m), 2006-2023 Figure 6.17, Sales of Viread ($m), 2006-2023 Figure 7.1, Antivirals in the Leading Pharmaceutical Markets, Sales ($m), 2007 Figure 7.2, Antivirals in the Leading Pharmaceutical Markets, Market Share (%), 2007 Figure 7.3, Antivirals in the US Market, Sales ($m), 2008-2013 Figure 7.4, Antivirals in Other Leading Industrialised Countries, Sales ($m), 2008-2013 Figure 7.5, Antivirals in China and India, Sales ($m), 2008-2013
Some Organisations Mentioned in this Report
Abbott AIDS Drug Assistance Programme Alnylam Pharmaceutical AnorMed AstraZeneca Aurobindo Avexa Benitec Bill and Melinda gates Foundation Biolex Therapeutics Boehringer Ingelheim Bristol-Myers Squibb (BMS) Cipla Genentech Genzyme Gilead Sciences Glaxo Wellcome GlaxoSmithKline (GSK) Hoffmann-La Roche Human Genome Sciences Incyte Intarcia International AIDS Vaccine Initiative (NIAID) Japan Tobacco Johnson and Johnson Jointed United Nations Programme on HIV/AIDS (UNAIDS) MedImmune Medivir Merck Mitsubishi Monogram Biosciences Novartis OctoPlus Panacos Pfizer Pharmaplaz Pharmasset Inc Progenics Rega Institute for Medical Research Samaritan Schering-Plough Tacere Therapeutics Teijin Pharma Tibotec Tibotec-Virco Trimeris US Centers for Disease Control and Prevention (CDC) US President's Emergency Plan for AIDS Relief (PEPFAR) Vertex Pharmaceuticals ViroChem Pharma World Bank World Health Organization (WHO)
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