Generics Series: Key trends and events in the 7 major markets

Published by: Datamonitor

Published: Dec. 19, 2007 - 91 Pages

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the report

Key findings

CHAPTER 2 OVERVIEW OF THE GENERICS MARKET IN 2007

Patent expiries drive generic use

The global generics divide

Intellectual property environment

Awareness and trust of generic drugs

Availability of generic drugs

Price differential between branded and generic drugs

Competitive pressures drive consolidation of the generics industry

Industry strategy in mature and immature generics markets

Generics market outlook

CHAPTER 3 THE US

Conditions in the US market push drive towards globalization

Mylan's acquisition of Merck Generics put it into the top three global generics companies

Barr gained a leading position in Eastern Europe through Pliva acquisition

Despite market pressures, the US remains a prize for which international generic companies continue to fight, and Indian generics companies are making inroads into by acquisition.

FDA implements legislation to deal with generic application backlog

FDA suggests introduction of user fees to speed ANDA approvals

New legislation allowing ANDA approval to continue in parallel with Citizen Petition processing will reduce delays

Wal-Mart's revolutionary $4 prescription scheme expanded to attract a wider demographic

Generic companies conspire with pharmacies to increase Medicaid reimbursements

Inclusion of authorized generics in calculation of average manufacturer and best price

Exclusion payment settlements delay generic entry

Changing relations between innovators and generic manufacturers

Authorized generic agreements as a form of reverse payment

Zocor (simvastatin)

Zoloft (sertraline)

The US Supreme Court has yet to make a ruling regarding reverse payments

CHAPTER 4 FRANCE

Generic drug use is being promoted by the government

Pharmacist-driven awareness campaigns and dispensing targets

French physicians resist generic use

Pharmaceutical price cuts reduce industry profits

International generic companies seek to gain a further foothold in France

Indian manufacturer Zydus gains increased distribution rights in France

Wockhardt acquired Negma Laboratories

Innovators acting to limit generic incursion

France incorporates biosimilar approval legislation into law

CHAPTER 5 GERMANY

The German generics market is the largest in Europe and one of the most mature

The Healthcare Modernization Act had a significant impact on promoting generic use

The AVWG Act was introduced to curb the continued increase in healthcare spending

Krankenkassen have become increasingly important in the German generic market

CHAPTER 6 ITALY

Although pharmaceutical expenditure in Italy has been rising, generic use remains minimal - but this is set to change

The regulatory environment of the Italian healthcare system is not pro-generic

Italy's patent laws mean that generic entry is delayed relative to other countries

Branded 'copies' are common in Italy, and act as a deterrent to generic penetration

Italy's reference pricing system deters entry of multiple generics

Incentives to increase generic use are lacking in the Italian healthcare system

It is more profitable for pharmacists to dispense branded drugs

Patients have little awareness of or motivation to use generics

The bioequivalence of generic drugs to their branded counterparts is mistrusted

Italy has used compulsory licensing to promote competition in the industry

Cost-cutting of branded drug prices has had a knock-on effect on generic sales

CHAPTER 7 SPAIN

Spain's intellectual property laws provide a favorable environment for the generics industry

Spain's generics market is small, but offers long-term growth prospects

Indian generic companies invest in Spanish market

Apotex enters market by acquisition of Lareq Pharma

Barr divests Spanish subsidiary

Government initiatives to promote generic use have had mixed results

Lack of clarity regarding pharmacist substitution policy

CHAPTER 8 THE UK

The UK is one of the largest and most mature generics markets of the 5 major EU pharmaceutical markets

Drug spending is an area which presents cost saving opportunities

The proportion of prescribed and dispensed generic drugs has been steadily rising in the UK

Improved efficiency in generic pricing across PCTs could significantly cut drug costs

Savings achievable through increased generic statin use have made them a target for cost cutting initiatives

Large price differential between branded and generic drugs

CHAPTER 9 JAPAN

Key players in the Japanese generic market

Increasing generic awareness is key to promoting use

Physicians encouraged to allow substitution

Generic manufacturers are looking to forge stronger links with wholesalers

There is great unevenness among pharmacies regarding propensity to dispense generics.

Generics supply is a major stumbling block to pharmacist substitution

Generics to be listed for reimbursement twice yearly

Information regarding generic bioequivalence to be included with drugs to promote their use

CHAPTER 10 BIBLIOGRAPHY

Publications and online articles

Conference literature

Datamonitor resources

APPENDIX

Abbreviations

List of Tables

Table 1: Generic penetration in the 5 major markets of Europe, 2006

Table 2: Major international acquisitions by a US company, 2005-07

Table 3: Major international acquisitions of a US company, 2005-07

Table 4: Product expiries in Italy and Germany

List of Figures

Figure 1: Issues influencing the generics use in the 7 major markets

Figure 2: Cost of patent expiries by top 50 pharma companies ($m), 2006-12

Figure 3: Drug patent expires in the US, 2008-12

Figure 4: Generic use in the 7 major markets, 2006

Figure 5: Change in generics company ranking, 2001-06

Figure 6: Acquisition history of top 12 global generics companies, 2004-07

Figure 7: Recent issues influencing the US generics market

Figure 8: Settlements filed with Federal Trade Commission, FY2006

Figure 9: Compensation in exchange for restriction of generic entry

Figure 10: Impact of authorized generic launch during 180-day exclusivity for Zocor (simvastatin), US

Figure 11: Impact of authorized generic launch during 180-day exclusivity for Zoloft (sertraline), US

Figure 12: Major issues shaping the French generic industry

Figure 13: Change in market share for proton pump inhibitors in France, 2002-06

Figure 14: Germany's position within the European generics market, 2006

Figure 15: Major healthcare reforms in Germany influencing generic drug use, 2002-06

Figure 16: Generic market growth in Italy, 2001-06

Figure 17: Drivers and resistors influencing generic use in Italy

Figure 18: Issues motivating generic use in Spain

Figure 19: Proportion of generic sales in the 5EU during 2001-05

Figure 20: Key factors influencing the UK generic industry

Figure 21: Change in generic prescribing during 1995-2005, UK

Figure 22: Brand and generic prices in the 5EU, 2002-05

Figure 23: Factors driving generic drug use in Japan

Figure 24: Key players in the Japanese generic market

Abstract

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