The Antiviral Drugs Market: Challenges and opportunities
Therapeutic
Sales of antiviral drugs are growing at over 20% but there remains massive scope for innovative drugs that address the unmet needs of this market. With increased drug resistance and quality of life issues, the $12.5 billion antivirals market offers pharmaceutical companies both great challenges and opportunities.
Scrip's Antiviral Drugs Market: Challenges and opportunities answers the vital questions to help you overcome "the most formidable development challenge of our time" (United Nations Secretary General Kofi Annan).
This extensive and authoritative review of innovative products in development contains profiles of companies with major interests in the antivirals sector. The opportunities are there, is your company as well prepared as it could be to take advantage of them?
Published: May 2001
Pages: 194
Ref: BS1094E
Price: £495/$1,040/¥119,000
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CONTENTS
LIST OF TABLES
LIST OF FIGURES
EXECUTIVE SUMMARY
ABBREVIATIONS
SCOPE AND METHODOLOGY
S.1 Objectives
S.2 Scope
S.3 Methodology
CHAPTER 1 AN INTRODUCTION TO VIRAL INFECTIONS
1.1 Introduction
1.2 Hepatitis
1.2.1 Hepatitis B
1.2.1.1 Classification and virology
1.2.1.2 Diagnosis
1.2.1.3 Pathogenesis
1.2.1.4 Incidence and prevalence
1.2.1.5 Treatment
1.2.2 Hepatitis C
1.2.2.1 Classification and virology
1.2.2.2 Diagnosis
1.2.2.3 Pathogenesis
1.2.2.4 Incidence and prevalence
1.2.2.5 Treatment
1.3 Herpes simplex virus
1.3.1 Classification and virology
1.3.2 Diagnosis
1.3.3 Pathogenesis
1.3.4 Incidence and prevalence
1.3.5 Treatment
1.4 Human papillomavirus
1.4.1 Classification and virology
1.4.2 Diagnosis
1.4.3 Pathogenesis
1.4.4 Incidence and prevalence
1.4.5 Treatment
1.5 Cytomegalovirus
1.5.1 Classification and virology
1.5.2 Diagnosis
1.5.3 Pathogenesis
1.5.4 Incidence and prevalence
1.5.5 Treatment
1.6 Human immunodeficiency virus
1.6.1 Classification and virology
1.6.2 Diagnosis
1.6.3 Pathogenesis
1.6.4 Incidence and prevalence
1.6.5 Treatment
1.7 Conclusion
CHAPTER 2 ANTIVIRAL DRUGs ON THE MARKET
2.1 Introduction
2.2 Drugs used to treat hepatitis B
2.2.1 Lamivudine
2.2.2 Interferon therapy
2.2.2.1 Interferon alpha-2b recombinant
2.3 Drugs used to treat chronic hepatitis C
2.3.1 Rebetron Combination Therapy
2.3.2 Peginterferon alpha-2b
2.4 Drugs used to treat herpes simplex types 1 and 2
2.4.1 Acyclovir
2.4.2 Valacyclovir
2.4.3 Penciclovir
2.4.4 Famciclovir
2.4.5 Docosonol
2.5 Drugs used to treat cytomegalovirus
2.5.1 Ganciclovir
2.5.2 Foscarnet sodium
2.5.3 Cidofovir
2.5.4 Fomivirsen sodium
2.5.5 Cytomegalovirus immunoglobulin
2.5.6 Valganciclovir
2.6 Drugs used to treat human papillomavirus
2.6.1 Podophyllotoxin
2.6.2 Imiquimod cream
2.6.3 Interferon alpha
2.7 Drugs used to treat HIV
2.7.1 Highly active antiretroviral therapy
2.7.2 Nucleoside reverse transcriptase inhibitors
2.7.2.1 Abacavir sulphate
2.7.2.2 Didanosine
2.7.2.3 Lamivudine
2.7.2.4 Stavudine
2.7.2.5 Zalcitabine
2.7.2.6 Zidovudine
2.7.2.7 Trizivir
2.7.3 Non-nucleoside reverse transcriptase inhibitors
2.7.3.1 Efavirenz
2.7.3.2 Delavirdine mesylate
2.7.3.3 Nevirapine
2.7.4 Protease inhibitors
2.7.4.1 Amprenavir
2.7.4.2 Lopinavir/ritonavir
2.7.4.3 Indinavir sulphate
2.7.4.4 Nelfinavir
2.7.4.5 Saquinavir
2.8 Conclusion
CHAPTER 3 ANTIVIRAL DRUGS IN DEVELOPMENT
3.1 Introduction
3.2 Drugs in development to treat hepatitis B
3.2.1 Adefovir dipivoxil
3.2.2 AM365
3.2.3 Entecavir
3.2.4 Emtricitabine
3.2.5 L-FMAU
3.2.6 XTL-001
3.2.7 EHT-899
3.2.8 Ampligen
3.3 Drugs in development to treat hepatitis C
3.3.1 LY-466700
3.3.2 ISIS 14803
3.3.3 Interferon, Biomedicines
3.3.4 Lactoferrin
3.3.5 Histamine dihydrochloride
3.3.6 Peginterferon alpha-2a
3.3.7 VML-600
3.3.8 VX-497
3.3.9 VP50406
3.3.10 Anti-hepatitis antibodies (Hyperimmune)
3.4 Drugs in development to treat herpes simplex virus
3.4.1 Aciclovir, ES-Gel
3.4.2 MIV-606
3.4.3 ME-609
3.4.4 VML-600
3.4.5 Viraplex
3.5 Drugs in development to treat cytomegalovirus
3.5.1 Bay-38-4766
3.5.2 ISIS-13312
3.5.3 GEM-132
3.5.4 T611
3.6 Drugs in development to treat human papillomavirus
3.6.1 Polyphenon E
3.6.2 Pen-203
3.6.3 Reticulose
3.6.4 Zyc-101a
3.6.5 Interferon, Biphasix
3.6.6 MPI-5003
3.6.7 HspE7
3.7 Drugs in development to treat HIV
3.7.1 HIV entry inhibitors
3.7.1.1 PRO-542
3.7.1.2 PRO-367
3.7.1.3 PRO-2000
3.7.1.4 AMD 3100
3.7.1.5 PRO-140
3.7.1.6 T-20
3.7.1.7 T-1249
3.7.2 Immune-based therapies
3.7.2.1 HE2000
3.7.2.2 Interleukin-2
3.7.2.3 HIV-1 immunogen
3.7.2.4 Ampligen
3.7.3 Established mechanisms
3.7.3.1 Emtricitabine
3.7.3.2 Emivirine
3.7.3.3 DAPD
3.7.3.4 Tenofovir disoproxil fumarate
3.7.3.5 Capravirine
3.7.3.6 VX-175
3.7.3.7 Tipranavir
3.7.3.8 BMS-232632
3.7.4 Conclusion
CHAPTER 4 THE ANTIVIRAL DRUGS MARKET
4.1 Introduction
4.2 World pharmaceutical sales
4.3 The antiviral drugs market
4.3.1 Antiviral market excluding anti-HIV drugs
4.4 The market for hepatitis B drugs
4.4.1 Incidence in the major markets
4.4.2 Market potential
4.4.3 Market drivers
4.5 The market for hepatitis C drugs
4.5.1 Incidence in the major markets
4.5.2 Market potential
4.5.3 Market drivers
4.6 The market for human papillomovirus therapeutics
4.6.1 Incidence in the major markets
4.6.2 Market potential
4.6.3 Market drivers
4.7 The market for herpes simplex therapeutics
4.7.1 Incidence in the major markets
4.7.2 Market potential
4.7.3 Market drivers
4.8 The market for anti-cytomegalovirus drugs
4.8.1 Incidence in the major markets
4.8.2 Market potential
4.8.3 Market drivers
4.9 The market for anti-HIV drugs
4.9.1 Incidence
4.9.2 Market potential
4.9.3 Market drivers
4.10 Conclusion
CHAPTER 5 PROFILES OF SELECTED COMPANIES WITH ANTIVIRAL INTERESTS
5.1 Abbott
5.1.1 Agreements relating to antiviral therapy
5.1.2 Financial highlights
5.1.3 Antiviral portfolio/pipeline
5.2 BioChem Pharma
5.2.1 Agreements relating to antiviral therapy
5.2.2 Financial highlights
5.2.3 Antiviral portfolio/pipeline
5.3 Boehringer Ingelheim
5.3.1 Agreements relating to antiviral therapy
5.3.2 Financial highlights
5.3.3 Antiviral drug portfolio/pipeline
5.4 Bristol-Myers Squibb
5.4.1 Agreements relating to antiviral therapy
5.4.2 Financial highlights
5.4.3 Antiviral portfolio/pipeline
5.5 DuPont Pharmaceuticals
5.5.1 Agreements relating to antiviral therapy
5.5.2 Financial highlights
5.5.3 Antiviral drug portfolio/pipeline
5.6 Gilead Sciences
5.6.1 Agreements relating to antiviral therapy
5.6.2 Financial highlights
5.6.3 Antiviral drug portfolio/pipeline
5.7 GlaxoSmithKline
5.7.1 Agreements relating to antiviral therapy
5.7.2 Financial highlights
5.7.3 Antiviral drug portfolio/pipeline
5.8 Merck & Co
5.8.1 Agreements relating to antiviral therapy
5.8.2 Financial highlights
5.8.3 Antiviral drugs portfolio/pipeline
5.9 MediGene
5.9.1 Agreements relating to antiviral therapy
5.9.2 Financial highlights
5.9.3 Antiviral drug portfolio/pipeline
5.10 Medivir
5.10.1 Agreements relating to antiviral therapy
5.10.2 Financial highlights
5.10.3 Antiviral portfolio/pipeline
5.11 Hoffmann-La Roche
5.11.1 Agreements relating to antiviral therapy
5.11.2 Financial highlights
5.11.3 Antiviral drugs portfolio/pipeline
5.12 Schering-Plough
5.12.1 Agreements relating to antiviral therapy
5.12.2 Financial highlights
5.12.3 Antiviral drug portfolio/pipeline
5.13 Triangle Pharmaceuticals
5.13.1 Agreements relating to antiviral therapy
5.13.2 Financial highlights
5.13.3 Antiviral drug portfolio/pipeline
5.14 Trimeris
5.14.1 Agreements relating to antiviral therapy
5.14.2 Financial highlights
5.14.3 Antiviral drug portfolio/pipeline
5.15 Vernalis
5.15.1 Agreements relating to antiviral therapy
5.15.2 Financial highlights
5.15.3 Antiviral drugs portfolio/pipeline
5.16 Vertex Pharmaceuticals
5.16.1 Agreements relating to antiviral therapy
5.16.2 Financial highlights
5.16.3 Antiviral drug portfolio/pipeline
CHAPTER 6 DIRECTORY
REFERENCES
List of Tables
Table 2.1 Drugs on the market to treat herpes simplex
Table 2.2 Drugs on the market to treat cytomegalovirus
Table 2.3 Drugs on the market to treat human papillomavirus
Table 2.4 Marketed nucleoside reverse transcriptase inhibitors
Table 2.5 Marketed non-nucleoside reverse transcriptase inhibitors
Table 2.6 HIV protease inhibitors on the market
Table 3.1 Drugs in clinical development to treat hepatitis B
Table 3.2 Hepatitis B prophylaxis in clinical development
Table 3.3 Candidate drugs in preclinical development to treat hepatitis B
Table 3.4 Drugs in clinical development to treat hepatitis C
Table 3.5 Hepatitis C prophylaxis in clinical development
Table 3.6 Candidate drugs in preclinical development to treat hepatitis C
Table 3.7 Drugs in development to treat herpes simplex virus
Table 3.8 Herpes simplex virus prophylaxis in development
Table 3.9 Candidate drugs in preclinical development to treat herpes simplex virus
Table 3.10 Drugs in development to treat cytomegalovirus
Table 3.11 Cytomegalovirus prophylaxis in development
Table 3.12 Candidate drugs in preclinical development to treat cytomegalovirus
Table 3.13 Drugs in development to treat human papillomavirus
Table 3.14 Human papillomavirus prophylaxis in development
Table 3.15 Candidate drugs in preclinical development to treat human papillomavirus infection
Table 3.16 Drugs in clinical development to treat HIV
Table 3.17 HIV prophylaxis in development
Table 3.18 Candidate drugs in preclinical development to treat HIV
Table 4.1 Pharmaceutical sales by therapeutic category, 2000
Table 4.2 WHO regional HIV/AIDS statistics, year end 2000
Table 4.3 AIDS figures and statistics in the US, year end 1999
Table 4.4 AIDS figures and statistics in Europe, year end 1999
Table 4.5 AIDS figures and statistics in Japan, year end 1999
Table 4.6 Percentage prescription market share, nucleoside reverse transcriptase inhibitors and non-nucleoside reverse transcriptase inhibitors, 1999
Table 4.7 Percentage prescription market share, protease inhibitors, 1999
Table 5.1 Abbott's financial results, 1998�2000
Table 5.2 Abbott's sales by region, 1998�2000
Table 5.3 Abbott's healthcare sales by business area, 1998�2000
Table 5.4 BioChem Pharma's financial results, 1998�2000
Table 5.5 BioChem Pharma's operating revenue by business area, 1998�2000
Table 5.6 Boehringer Ingelheim's financial results, 1998�2000
Table 5.7 Boehringer Ingelheim's financial results by business segments, 1998�2000
Table 5.8 Sales of Boehringer Ingelheim's top ten products, 1998�1999
Table 5.9 Bristol-Myers Squibb's financial results, 1998�2000
Table 5.10 DuPont Pharmaceuticals' financial results, 1998�2000
Table 5.11 Gilead's financial results, 1998�2000
Table 5.12 GlaxoSmithKline's financial results, 1998�2000
Table 5.13 GlaxoSmithKline's sales by business segments, 1998�2000
Table 5.14 GlaxoSmithKline's pharmaceutical sales by geographical region, 2000
Table 5.15 Sales of GlaxoSmithKline's top products, 1998�2000
Table 5.16 Merck & Co's financial results, 1998�2000
Table 5.17 Merck & Co's sales by product, 1998�2000
Table 5.18 MediGene's financial results, 1998�2000
Table 5.19 Medivir's financial results, 1998�2000
Table 5.20 Roche's financial results, 1998�2000
Table 5.21 Schering-Plough's financial results, 1998�2000
Table 5.22 Schering-Plough's sales by therapeutic category, 1998�2000
Table 5.23 Triangle's financial results, 1998�2000
Table 5.24 Trimeris' financial results, 1998�2000
Table 5.25 Vernalis' financial results, 1998�2000
Table 5.26 Vertex's financial results, 1998�2000
List of Figures
Figure 4.1 Regional pharmaceutical sales breakdown, 2000 ($ billion)
Figure 4.2 Past and projected growth of antiviral drug sales (including anti-HIV drugs), 1997�2010
Figure 4.3 Actual and projected growth of antiviral sales, 1997�2010
Figure 4.4 Market share by antiviral drug class, 1999
Figure 4.5 Actual and projected growth of anti-hepatitis B drug sales, 1997�2010
Figure 4.6 Actual and projected growth of sales for anti-hepatitis C drugs, 1997�2010
Figure 4.7 Actual and projected sales of anti-herpes simplex virus drugs, 1997�2010
Figure 4.8 Relative market share of leading cytomegalovirus antiviral drugs, 1999
Figure 4.9 Actual and projected sales of antivirals used to treat cytomegalovirus 1997�2010
Figure 4.10 AIDS cases and deaths by year in the US, 1981�1999
Figure 4.11 Reported AIDS cases in Europe by year of reporting, 1982�1999
Figure 4.12 Reported AIDS cases in Japan by year of reporting, 1982�1999
Figure 4.13 HIV market share by drug class, 1999
Figure 4.14 Actual and predicted growth of antiretroviral sales by drug class, 1997�2010
EXECUTIVE SUMMARY
Over the past few decades, the pharmaceutical industry has achieved many triumphs in the ongoing battle against viral infection. Numerous potent antiviral drugs have reached the marketplace and there is now a large portfolio of agents available to combat infectious disease. We cannot, however, afford to become complacent. There remains significant scope for more efficacious products and the optimisation of current treatment regimes. Furthermore, new challenges are facing this sector.
The most formidable of these challenges is the emergence of resistance to many of the drugs approved for clinical use. Furthermore, since existing antivirals target limited points in the viral life-cycle, cross-resistance will further restrict the diminishing treatment options. Antiviral therapeutics also rarely meet patient or prescriber expectations in terms of efficacy, tolerability, or compatibility with every day life. 'Compliance and tolerability' have become buzz words in the antiviral field; even the most potent antiviral drug is of little, if any, use if the patient will not, or cannot, take it as prescribed.
Long term antiviral therapy has also raised toxicity concerns for several existing products and classes of drugs. Recently it has become apparent, for example, that HIV protease inhibitors (PIs) may cause severe side effects including serious metabolic and cardiovascular disorders.
Since the late 1970s the human immunodeficiency virus (HIV) has been responsible for 21.8 million deaths. More than 36 million people are predicted to be living with HIV or AIDS and with 5.3 million people newly infected in the year 2000 alone, the death toll is set to rise dramatically.
The hepatitis C virus (HCV) is another major cause of morbidity and mortality. According to the National Institute of Allergy and Infectious Diseases (NIAID), nearly four million Americans have been infected with HCV. This virus is a leading cause of chronic liver disease and is estimated to be responsible for 8,000�10,000 deaths in the US each year. Hepatitis C is behind one third of all US cases of cirrhosis and liver cancer and more than half of liver transplants. Furthermore, it is predicted that without better therapies, the US death toll from this disease will triple by 2015 to exceed the current annual death rate from HIV.
Other viral infections including hepatitis B (HBV), herpes simplex virus (HSV), and human papillomavirus (HPV) are also major health concerns. In addition, viral infections pose a huge financial burden and can have a major negative impact on the economy due to direct medical expenses and loss of income. In 1994, the US spent approximately $17 billion on sexually transmitted diseases, including HIV, and their complications.
Recent developments in the understanding of viral replication and the pathogenesis of disease have revealed opportunities for innovative products with novel mechanisms of antiviral activity. With many unmet demands in this field, there is a significant market opportunity for new products that address these issues.
Chapter 1 of this report will provide the reader with an introduction to viral infections focusing on six types of virus: HBV, HCV types 1 and 2 (HSV-1 and HSV-2), cytomegalovirus (CMV), HPV and HIV. It includes an overview of each virus and its life-cycle with focus on recent discoveries and potential targets for pharmaceutical intervention. Diagnosis, pathogenesis, incidence and prevalence, and the economic impact of these viral infections is discussed. The chapter also reviews current treatment strategies and their shortfalls.
Chapter 2 looks, by therapeutic area, at the antiviral drugs that have been licensed for clinical use. Selected drugs are reviewed with focus on their advantages and weaknesses. Priority is given to drugs that have recently reached the marketplace or that have made a significant clinical and/or market impact.
There are strong R&D interests in the antiviral field. More than 120 antiviral compounds are currently in clinical development including 55 to treat HIV. In the next few years, we can expect to witness the launch of improved formulations of currently marketed products, new drugs from existing classes, and entirely new classes of antiviral drugs. Increasingly, immune-based therapies will also be utilised to complement antiviral therapy.
Chapter 3 moves on to look at candidate drugs in clinical development to treat the six viral infections focused by this report. Tables are provided of compounds in clinical and preclinical investigations. Products in late stage clinical trials or with novel mechanisms of action are selected for review.
The antiviral drug market is estimated to be worth $15 billion in 2001. In Chapter 4, this market is examined by disease category and by major market region (US, EU and Japan). Disease prevalence is discussed in more detail with focus on incidence in the major pharmaceutical markets. Recent and projected sales are presented for each indication from 1997 through 2010. In addition, this chapter highlights future market drivers and the key points new products will need to address in order to succeed in the highly competitive marketplace.
Antiviral research is being pursued by both large pharmaceutical companies and smaller, more specialised groups. Chapter 5 provides profiles on 16 companies which are currently active in the antiviral field. Included are established players such as GlaxoSmithKline and companies with innovative products and exciting R&D pipelines.
There is significant market potential for innovative antiviral products. The Antiviral Drugs Market: challenges and opportunities will help prepare your company with the information it needs to succeed in this lucrative market.
© PJB Publications Ltd. 2001
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