Opportunities and Challenges for Bioequivalent Generic Drugs in Brazil

Date: April 22, 2007
Pages: 190
Price:
US$ 1,390.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: O0DFF1C8D59EN
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Opportunities and Challenges for Bioequivalent Generic Drugs in Brazil
THE BRAZILIAN GENERIC MARKET IN CONTEXT

Strong generic pipeline.

A number of products are due to lose their patent protection between 2007 and 2012, bringing market opportunities worth US$307.2 million to the generics sector. Key products affected include Plavix in 2007, Mercilon in 2009 and Viagra and Lipitor, both in 2011. At manufacturers’ prices, their respective sales stood at US$41.1 million, US$58.3 million, US$73.1 million and US$53.4 million in 2005.

Furthermore, in March 2007, ANVISA authorised the registration of generic alternatives to oral contraceptives and endogenous hormones. This sector was valued at US$481 million in 2006 and generic producers are expected to account for 60% by 2012. The leading producers, including Medley, EMS-Sigma Pharma and Eurofarma, have indicated that they will enter this market.

Meeting the challenge of AIDS

Since 1996, antiretrovirals have been provided free of charge to HIV/AIDS patients. The cost per patient fell from R$8,500 (US$4,574) in 1999 to R$3,400 (US$1,162) in 2004, but rose to US$2,500 in 2005. Costs remain high as imported antiretrovirals represent between 80% and 85% of the national AIDS programme’s expenditure. According to the Ministry of Health, public domestic manufacturers produce eight of the 17 antiretrovirals used.

Brazil can issue compulsory licences and allow local generic production of imported antiretrovirals. So far, it has negotiated drug price reductions and encouraged local production under licence. However, the rising number of patients, increasing levels of drug resistance, rising costs, the lack of systematic surveillance of HIV prevalence and high-risk behaviour might still be a threat.

Domestic producers dominate…for now?

There were 66 producers with registrations of generic medicines in 2006, but the four leading producers, which are indigenous, controlled over 80% of the sector. Medley and EMS were the leaders, with a combined 65% market share, followed by Eurofarma and Aché. Mergers & acquisitions will continue to consolidate the Brazilian generics market.

Local producers dominate with low prices and increasing production capabilities. They also have the local know-how to deal with bureaucracy and the government favours them. With the global generics markets consolidating into ever bigger groups, markets such as Brazil are increasingly under scrutiny from large generic corporates. All – with the exception of Teva – have some presence or alliance in Brazil, but it is probably only a question of time before the domination of the market by local companies changes.

The prescribing challenge.

If the generics market is to reach its full potential then it will have to tackle the prescribing habits of a great number of doctors who continue to prescribe branded products. Prescription of generic medicines is still low, representing 15.8% of the total in 2006, compared to 15.2% in 2005 or 11.8% in 2002. For some specific substances, however, generic medicines have achieved high prescription levels, for instance omeprazole (88%), cephalexin (77%) and fluconazole (65%). Using generics, consumers saved about US$2.2 billion in 2006.

Domestic producers of generic pharmaceuticals evaluated in the report:

Aché-Biosintética
Americano (FARMASA)
Arrow (Erowlabs)
Brainfarma
Cimed
Cristália
EMS-Sigma Pharma
Eurofarma
Hipolabor
LAFEPE
Medley
Neo Química
Prati, Donaduzzi
Teuto
União Química

Foreign producers of generic pharmaceuticals evaluated in the report:

Abbott
Apotex
Mepha-ratiopharm
Merck
Ranbaxy
Sandoz

The report answers key questions such as:
  • What is the estimated value of the bioequivalent generic market now and in 2012?
  • What is the current regulatory situation for bioequivalent generics and how might it change?
  • What are the opportunities for international players looking to expand operations in Brazil?
  • How many products have just a single producer of a bioequivalent generic? What are they and which company is currently producing?
  • What key educational challenges must the industry overcome if it is to see the wider adoption of generics throughout the country.

About the Author:

This report has been written by Espicom staff writer Ricardo Vicente. Ricardo has over 5 years market analysis experience in pharmaceuticals. He is the editor of Espicom's leading Latin American market analysis service in World Pharmaceutical Markets (WPM). Among his recent studies are:

The Latin American Market for Generic Drugs

The Outlook for Pharmaceuticals in Latin America to 2011

HIGHLY DETAILED REPORT CONTENTS

REGULATORY ENVIRONMENT

Regulation of generic medicines vs similar & biosimilar medicines;
Registration of generic medicines ;
Authorised centres to perform bioequivalence studies;
Marketing authorisations of generic medicines;
Labelling & packaging requirements for generic medicines;
Patent protection vs extension;
Pricing policies affecting generic medicines

MARKET ANALYSIS

Market overview of generic pharmaceuticals in Latin America, 2006;
Overview of the pharmaceutical market in Brazil, 1997-2006;
Pharmacy sales of generic pharmaceuticals in Brazil, 2000-2006;
Market projections of generic pharmaceuticals in Brazil, 2007-2012;
Espicom SWOT analysis of generic pharmaceuticals in Brazil, 2007;
Domestic production of generic pharmaceuticals

MARKET OUTLOOK

Generic production of oral contraceptives & endogenous hormones;
More uniform market penetration across all the regions;
Unsustainable reliance on research-based HIV/AIDS medicines;
Foreign producers of generic medicines, squashed by local competition;
Sales strategies devised by producers of generic medicines;
Potential government production of bioequivalent generic medicines;
Research-based medicines with patents expiring between 2006 & 2013;
Challenges in the public sector;
Teva’s acquisition possibilities in Brazil;
High cost savings vs low prescription levels

COMPANY REPORTS

Product portfolio, financial indicators & manufacturing capabilities for over 20 producers.
FOREWORD

EXECUTIVE SUMMARY

WHAT IS OBESITY?

Defining obesity
What causes obesity?
What effects does obesity have?
  Figure 1: Effects of obesity on health
  Table 1. Relative risks of health problems associated with obesity
The scale of the problem
  Prevalence of obesity
  Figure 2. Estimated global prevalence of obesity
  Highest prevalence of obesity
  Prevalence in the US
  Prevalence in the UK
  Prevalence in Europe
  Prevalence in Asia
  Prevalence in developing countries
  Figure 3. Percentage of households having both underweight and overweight members in seven countries
  Figure 4. Country comparison - percentage of adults with normal BMI
Childhood and future obesity
  Figure 5. Percentage of population that is overweight
  Figure 6. Predicted prevalence of obesity by 2025
The economic burden
  US
  UK
  Europe
  Developing Countries

THE OBESITY THERAPY MARKET

Competitor Ratio Analysis
  Table 2. Competitor Ratio Analysis summary

OBESITY MANAGEMENT

Controlling energy balance
Achieving weight loss
  Table 3. The benefits of a 10kg weight loss
  Lifestyle modifications
  Behaviour therapy
  Pharmacotherapy
  Surgery
Approved drugs for obesity management
  Table 4. History of drug treatments for obesity
  Table 5. Anti-obesity drugs approved for short-term use
  Table 6. Anti-obesity drugs approved for long-term use
Acomplia
  Approval History
  Key Markets
  Key Agreements
  Clinical Trial Data
  Safety Issues
  Further Development
  Sales
  Sales Forecast
  Figure 7. Acomplia reported and projected sales, 2006A-2012E (EUR million)
Competitor Ratio Analysis
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the marketplace
  Risks associated with drug development in therapeutic class
Meridia/Reductil
  Approval History
  Key Markets
  Key Agreements
  Clinical Trial Data
  Table 7. Percentage change in subject's body weight at varying doses of sibutramine
  Table 8. Health profile of subjects losing at least 5 per cent of body weight
  Safety Issues
  Further Development
Xenical/alli
  Approval History
  Key Markets
  Key Agreements
  Patent History
  Clinical Trial Data
  Safety Issues
  Further Development
  Sales
  Sales Forecast
  Figure 8. Reported and projected Sales of Xenical 2001A-2011E
Regulatory authority guidelines for drug approval
  Approval for additional indications
Potential new drugs
  Table 9. Novel drugs in development by Phase
  Table 10. Novel drugs in development by company

DRUGS IN CLINICAL DEVELOPMENT

  Figure 9. Estimated launch dates for profiled drugs
Beta3 adrenergic receptor modulators
  Table 11. Beta3 adrenergic receptor modulators in development
KR P-204 (N-5984)
  Safety Issues
  Competitors
  Launch Prediction
Cannabinoid receptor modulators
  Table 12. Cannabinoid receptor modulators in development:
CP-945,598
  Safety Issues
  Competitors
  Launch Prediction
taranabant
  Safety Issues
Competitors
Launch Prediction
AVE 1625
  Safety Issues
  Competitors
  Launch Prediction
SLV 319
  Key Agreements
  Safety Issues
  Competitors
  Launch Prediction
Digestive inhibitors/lipid metabolism modulators
  Table 13. Digestive inhibitors/lipid metabolism modulators in development
cetilistat
  Key Agreements
  Clinical Trial Data
  Safety Issues
  Further Developments
  Launch Prediction
  Competitor Ratio Analysis
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the marketplace
  Risks associated with drug development in therapeutic class
869682
  Safety Issues
  Competitors
  Launch Prediction
Histaminergic system modulators
  Table 14. Histaminergic system modulators in development
OBE 101
  Table 15. Properties of OBE101 and histamine compared
  Key Agreements
  Clinical Trial Data
  Safety Issues
  Table 16. Adverse effects of OBE101 when compared to anti-obesity medications currently in use
  Patent History
  Further Development
  Competitors
  Launch Prediction
Hormone analogues
  Table 17. Hormone analogues in development
pramlintide
  Clinical Trial Data
  Further Development
  Safety Issues
Launch Prediction
  Competitor Ratio Analysis
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the marketplace
  Risks associated with drug development in therapeutic class
liraglutide
  Clinical Trial Data
  Safety Issues
  Launch Prediction
  Competitor Ratio Analysis
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the marketplace
  Risks associated with drug development in therapeutic class
obinepitide
  Patent History
  Clinical Trial Data
  Further Development
  Safety Issues
  Competitors
  Launch Prediction
PYY 3-36
  Key Agreements
  Patent History
  Clinical Trial Data
  Further Development
  Safety Issues
  Competitors
  Launch Prediction
Monoamine reuptake inhibitors/5-HT receptor modulators
  Table 18. Monoamine reuptake inhibitors/5-HT receptor modulators in development
lorcaserin
  Patent History
  Clinical Trial Data
  Table 19. Incidence of FDA-defined valvulopathy
  Further Development
  Safety Issues
Launch Prediction
  Competitor Ratio Analysis
  Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
tesofensine
  Clinical Trial Data
  Further Development
  Safety Issues
Launch Prediction
  Competitor Ratio Analysis
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the marketplace
  Risks associated with drug development in therapeutic class
Neuropeptide receptor modulators
  Table 20. Neuropeptide receptor modulators in development
S-2367
  Clinical Trial Data
  Safety Issues
  Launch Prediction
  Competitor Ratio Analysis
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the marketplace
  Risks associated with drug development in therapeutic class
Combination drugs
  Table 21. Combination drugs in development
Contrave
  Patent History
  Clinical Trial Data
  Further Developments
  Safety Issues
  Launch Prediction
  Competitor Ratio Analysis
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the marketplace
  Risks associated with drug development in therapeutic class
Qnexa
  Clinical Trial Data
  Further Development
  Safety Issues
  Launch Prediction
  Competitor Ratio Analysis
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the marketplace
  Risks associated with drug development in therapeutic class
pramlintide+phentermine/sibutramine
  Safety Issues
Competitors
Launch Prediction
Empatic
  Patent History
  Clinical Trial Data
  Table 22. Percentage change in body weight at week 24
  Safety Issues
  Launch Prediction
  Competitor Ratio Analysis
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the marketplace
  Risks associated with drug development in therapeutic class

RECENTLY-TERMINATED PROGRAMMES

AMG 076
AOD 9604
  Clinical Trial Data
CP-741952
CYT 009-GhrQb
  Clinical Trial Data
oleoyl-estrone
  Patent History
  Clinical Trial Data
  Further Development
PF-431499

THE FUTURE OF OBESITY TREATMENT

Towards an all-encompassing cure; targeting the metabolic syndrome?
Recent advances and future developments
CD 36
Targeting ghrelin
Vaccines
Gene therapy
RNA interference

CONCLUSIONS

SOURCES

Espicom sources
Others
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