Generic Drugs: World Market 2013-2023

  • November 2012
  • -
  • Visiongain
  • -
  • 149 pages

Report Details

Your guide to trends and sales potential for generics

Where's the generic drugs market heading? Visiongain's updated report gives you revenue predictions to 2023. There you find data, trends, opportunities and commercial prospects.

That new study lets you assess forecasted sales at overall world market and national level. You discover the potential of the generics market, seeing how, why and where it can grow. As pharma patents expire, much opportunity remains.

Forecasts and other analyses to help you find growth potentials

In our report you find revenue forecasting to 2023, historical data, growth rates and market shares. Also, you see qualitative analysis (inc. SWOT), progress, competition, developments and business outlooks. You receive 48 tables, 36 charts and six research interviews.

Our work lets you investigate the most lucrative areas of the generics industry. See the outlook for that large, expanding pharmaceutical segment. Spending restraints will benefit it.

You can stay ahead in knowledge, benefiting your research and analyses. The following sections show what you discover in our study.

Leading national markets - where will high growth occur?

In addition to analyses of the overall world market, you discover individual revenue forecasts for seven developed national markets, with sales data from 2011 to 2023.
• US
• Japan
• Germany, France, UK, Italy and Spain (EU5).

Also our work shows you individual forecasts to 2023 for seven developing countries:
• Brazil, Russian Federation, India and China (BRIC nations)
• Turkey, South Korea and Mexico.

There will be growth in established pharma markets and in developing countries. Our analyses show that Japan, India, Mexico and Brazil, in particular, will achieve high revenue growth to 2016. You see what's likely to happen. Events will influence that market.

What issues will affect the generics industry?

Our study discusses matters affecting that sector from 2012 onwards:
• US, European and Japanese regulations
• Authorised, branded and other generics, including modified products
• Patent expiries and business strategies, including patenting challenges
• Generic drug prescribing linked to budgetary constraints
• Growing consumer acceptance of generic medicines
• M&A activities, including entry of big pharma companies.

Also you find coverage of these aspects:
• European pricing systems and generic penetration
• Price changes, trends, prescribers and pharmacies
• Patient co-payment
• ANDAs and approvals
• Pathways to the market for biosimilars
• Product differentiation.

See what the future holds. You find discussions of commercial, technological, regulatory and economic issues, with emphasis on the competitive landscape and sales predictions.

Leading companies and market value in 2013

Overall world revenue for generic medicines will reach $127.8bn in 2013, our report forecasts. Rising demand for prescription drugs, expanding healthcare coverage, payers favouring generics and changes to prescribing will increase sales to 2023.

Also, our investigation discusses these specialty companies and others:
• Teva Pharmaceutical Industries
• Sandoz (Novartis)
• Mylan
• Apotex
• Hospira
• Watson Pharmaceuticals.

From this decade onwards, many opportunities will arise for generics specialists and other pharma companies producing those medicines. You see how revenues can increase.

Nine ways Generic Drugs: World Market 2013-2023 benefits you

To sum up, our report gives you the following knowledge on the topic:
• Predicted revenues to 2023 for the overall world generics market - find the industry's prospects
• Forecasting to 2023 for 14 countries in North America, Europe, Asia andLatin America - see national sales prospects
• Profiles of 6 leading companies - hear about products, results and strategies
• Opinions on the sector - discover our interviews with leaders in industry
• IP policy and other regulations - see what affects market access and entry
• Patent expiry - find prominent drug brands facing generic competition
• Trends of prescribers and healthcare payers - assess developments
• Competition and opportunities influencing sales - see what affects the future
• Discussions of what stimulates and restrains the industry and market - find trends, drivers and restraints.

Benefit from our analyses, gaining information found nowhere else

That work gives independent analysis from our primary and secondary research. You receive business intelligence found only in our study, seeing where prospects are lucrative and growth is likely.

With our report you are less likely to fall behind in knowledge or miss opportunity. Discover how our work could benefit your research, analyses and decisions, saving you time and getting you recognition for commercial insight.

Ordering now lets you investigate prospects to 2023 for generic medicines

Visiongain's study is for everyone needing analysis of the pharmaceutical industry and market. You find data, trends and predictions. Please ask for our report now.

Visiongain is a trading partner with the US Federal Government
CCR Ref number: KD4R6

Table Of Contents

Table of Contents

1. Executive Summary
1.1 Generic Drugs: Industry and Market Review
1.2 Aims, Scope and Format of the Report
1.3 Research and Analysis Methods

2. Introduction to the World Generics Market
2.1 Generic Drugs (Generics)
2.1.1 Authorised, Branded and True Generics
2.2 The 'Evergreening' of Pharmaceuticals
2.3 Restraints Facing the World Pharmaceutical Market
2.4 Branded Pharmaceuticals: End of a Business Model?
2.5 US Regulations
2.5.1 Obtaining FDA Approval: NDAs and ANDAs
2.5.2 The Hatch-Waxman Act Title 1: Promotion of Generic Drugs
2.5.3 The Hatch-Waxman Act Title 2: Incentives for the Branded Industry
2.5.4 Consequences of the Hatch-Waxman Act
2.5.5 Me First: Timing as a Crucial Factor
2.6 European Regulations
2.6.1 Generics' Entry into the European Markets
2.6.2 Further Protection of Branded Products in the European Market
2.6.3 Variations among European Countries
2.6.4 Moving Towards Standardisation
2.6.5 The 8+2+1 Rule
2.7 Japanese Regulations
2.8 Compulsory Licensing
2.9 Generic Drugs: Overview

3. The World Generic Drugs Market, 2013-2023
3.1 The World Generic Pharmaceuticals Market in 2011
3.2 Generic Products to Benefit from Patent Expiries
3.2.1 Sales Forecast for the World Generic Drugs Market, 2012-2016
3.2.2 Sales Forecast for the World Generic Drugs Market, 2017-2023
3.3 Global Market Breakdown, 2013-2023

4. Leading Companies in the World Generics Market
4.1 Teva Pharmaceutical Industries - Prospects from 2013
4.1.1 ANDAs and Approvals
4.1.2 MandA Activity
4.2 Sandoz (Novartis) - Prospects from 2013
4.3 Mylan - Prospects from 2013
4.3.1 Mylan's Acquisition of Bioniche Pharma Holdings
4.3.2 Mylan's Acquires Exclusive Worldwide Rights to GSK's Advair, Diskus and Seretide
4.4 Apotex - Prospects from 2013
4.5 Hospira - Prospects from 2013
4.5.1 Acquisition of Orchid's Generic Injectable Pharmaceutical Business
4.5.2 Hospira's Acquisition of Javelin Pharma
4.6 Watson Pharmaceuticals - Prospects from 2013
4.6.1 ANDAs and Approvals
4.6.2 MandA Activity
4.6.3 Eden Becomes Wholly-Owned Subsidiary of Watson
4.6.4 Watson Acquires Specifar Pharmaceuticals
4.6.5 Purchase of Ascent Pharmahealth Gives Watson Strong Footprint inSoutheast Asia

5. The US Generics Market, 2013-2023
5.1 Analysis of the Current Market
5.2 The US Generics Market: Revenue Forecast 2013-2023
5.3 Regulatory Reform Can Keep the Market Growing
5.3.1 A New Pathway to the US Market for Biosimilars?
5.3.2 Reverse Payments
5.3.3 The ANDA Backlog
5.4 Growing Consumer Acceptance of Generic Medicines
5.5 Leading Companies in the US Generics Market
5.6 Concluding Remarks

6. Leading European Generics Markets, 2013-2023
6.1 Analysis of the Current Generics Market in Europe
6.2 Revenue Prospects for European Generics Markets 2013-2023
6.2.1 The Two Categories of European Market
6.2.2 European Pricing Systems and their Effect on Generic Penetration
6.2.3 Patient Co-Payment
6.2.4 Challenges with the European Regulatory Environment
6.3 The German Generics Market
6.3.1 German Generics Market: Sales Forecast 2013-2023
6.3.2 The Future of the German Generics Market
6.4 The French Generics Market
6.4.1 French Generics Market: Sales Forecast 2013-2023
6.4.2 The Future of the French Generics Market
6.5 The UK Generics Market
6.5.1 UK Generics Market: Sales Forecast 2013-2023
6.5.2 Generics Prescribing Linked to Increasing Budgetary Constraints
6.5.3 Reducing Generic Drug Prices: the Drug Tariff System
6.5.4 The Increasing Role of Pharmacists
6.5.5 Easy Entry, Strong Price Competition
6.5.6 The Future of the UK Generics Market
6.6 The Italian Generics Market
6.6.1 Italian Generics Market: Sales Forecast 2013-2023
6.6.2 Promoting Generic Penetration
6.6.3 Prospects for the Italian Generics Market
6.7 The Spanish Generics Market
6.7.1 Spanish Generics Market: Sales Forecast 2013-2023
6.7.2 Challenges for the Spanish Market
6.7.3 Prospects for the Spanish Generics Market
6.8 Concluding Remarks

7. The Japanese Generics Market, 2013-2023
7.1 Analysis of the Current Market
7.2 Japanese Generics Market: Sales Forecast 2013-2023
7.3 Government Initiatives Have Driven Market Growth
7.3.1 Mergers and Acquisitions
7.4 Concluding Remarks

8. Emerging Generics Markets, 2013-2023
8.1 The EM-7: Pharma's Best Hope
8.2 MandA as a Tactic for Entering the Generic Drugs Sector
8.3 Turkish Generics Market: Sales Forecast 2013-2023
8.4 Brazilian Generics Market: Sales Forecast 2013-2023
8.5 Mexican Generics Market: Sales Forecast 2013-2023
8.6 South Korean Generics Market: Sales Forecast 2013-2023
8.7 Russian Federation Generics Market: Sales Forecast 2013-2023
8.7.1 Russian Federation Generics Market, 2013-2023
8.7.2 Analysis of the Russian Federation Market
8.8 India - Market Prospects from 2013
8.8.1 Indian Generics Market: Sales Forecast 2013-2023
8.8.2 International Success of India's Pharmaceutical Industry
8.9 China - Market Prospects from 2013
8.9.1 Chinese Generics Market: Sales Forecast 2013-2023
8.9.2 Chinese Generics Market: Discussion of Sector

9. World Generics Market: Strengths, Weaknesses, Opportunities and Threats
9.1 The Generics Sector Will Remain a High-Growth Area
9.2 Generics Offer Limited Profitability
9.3 Emerging Markets and Generics: The Pharma Industry's BiggestOpportunity?
9.4 The Generic Drug Market's Growth is Assured, but Some Threats Remain

10. Opinions from Our Survey - Research Interviews
10.1 James Harris, CEO, Healthcare Economics LLC, Florida, USA
10.1.1 Main Challenges for the US Generics Market
10.1.2 Pricing Trends in Generic Products
10.1.3 On Authorised Generic Products
10.1.4 Current State of Biogeneric (Biosimilar) Legislation in the US
10.1.5 On Para 4 Challenges and Patent Cliff
10.1.6 On Generics Market in the Next Decade
10.2 Charlie Mayr, Generic Pharmaceutical Association (GPhA)
10.2.1 The Value of the Generics Market
10.2.2 Main Challenges for the US Generics Market
10.2.3 On Growth Trend in Generic Products
10.2.4 On US Pricing Trends in Generic Products
10.2.5 On Authorised Generic Products
10.2.6 On Biogeneric (Biosimilar) Products
10.3 Anjan Selz, CEO, Finox
10.3.1 Finox
10.3.2 Challenges in Biosimilar Development
10.3.3 Differences Between Europe and the US
10.3.4 Product Differentiation
10.3.5 Opportunities Existing in the Biosimilars Market
10.4 Dr Robin Thorpe, Head, Biotherapeutics Group, National Institute for Biological Standards and Control (NIBSC) [UK]
10.4.1 Immunogenicity in Biosimilars
10.4.2 Biosimilar Uptake in Europe
10.4.3 Biosimilar Monoclonal Antibodies
10.5 Cecil Nick, VP (Biotechnology), Parexel Consulting
10.5.1 Challenges in Biosimilar Development
10.5.2 Asian Biosimilar Development
10.5.3 Biosimilar Interferons
10.6 Dr Jason Kantor, Managing Director, RBC Capital Markets
10.6.1 Challenges in Developing Biosimilars
10.6.2 Biosimilar Pricing
10.6.3 Next-Generation Antibody Therapies

11. Conclusions
11.1 The World Generics Market Will Continue to Expand
11.2 The Emerging National Markets Hold Much Promise
11.3 Biosimilars Have Promise, but Difficulties and Uncertainties Remain
11.4 Concluding Remarks

Appendices
Appendix A: Supplementary Information: Patent Expiries
Appendix B: About Visiongain
Appendix C: Visiongain Report Evaluation Form



List of Tables

Table 3.1 Generic Drugs Market: World Sales Forecast, 2011-2016
Table 3.2 Generic Drugs Market: World Sales Forecast, 2017-2023
Table 3.3 Generic Drugs Market: Developed Countries - Sales Forecasts, 2011-2023
Table 3.4 Generic Drugs Market: Emerging Countries - Sales Forecasts, 2011-2023
Table 4.1 Leading Companies in the World Generics Market: Sales and Market Shares, 2011
Table 4.2 The Top 10 Generics Market: MandA Deals, 2004-2010
Table 4.3 Sandoz Overview: Key Figures, 2009-2011
Table 5.1 US Generic Drug Market Penetration (%) by Volume, 2000-2010
Table 5.2 US Generic Drug Market Penetration (%) by Revenue, 2000-2010
Table 5.3 US Generics Market: Sales Forecast, 2011-2016
Table 5.4 US Generics Market: Sales Forecast, 2017-2023
Table 6.1 German Generics Market: Sales Forecast, 2011-2016
Table 6.2 German Generics Market: Sales Forecast, 2017-2023
Table 6.3 French Generics Market: Sales Forecast, 2011-2016
Table 6.4 French Generics Market: Sales Forecast, 2017-2023
Table 6.5 UK Generics Market: Sales Forecast, 2011-2016
Table 6.6 UK Generics Market: Sales Forecast, 2017-2023
Table 6.7 Italian Generics Market: Sales Forecast, 2011-2016
Table 6.8 Italian Generics Market: Sales Forecast, 2017-2023
Table 6.9 Spanish Generics Market: Sales Forecast, 2011-2016
Table 6.10 Spanish Generics Market: Sales Forecast, 2017-2023
Table 7.1 Japanese Generics Market: Sales Forecast, 2011-2016
Table 7.2 Japanese Generics Market: Sales Forecast, 2017-2023
Table 8.1 Turkish Generics Market: Sales Forecast, 2011-2016
Table 8.2 Turkish Generics Market: Sales Forecast, 2017-2023
Table 8.3 Brazilian Generics Market: Sales Forecast, 2011-2016
Table 8.4 Brazilian Generics Market: Sales Forecast, 2017-2023
Table 8.5 Mexican Generics Market: Sales Forecast, 2011-2016
Table 8.6 Mexican Generics Market: Sales Forecast, 2017-2023
Table 8.7 South Korean Generics Market: Sales Forecast, 2011-2016
Table 8.8 South Korean Generics Market: Sales Forecast, 2017-2023
Table 8.9 Russian Federation Generics Market: Sales Forecast, 2011-2016
Table 8.10 Russian Federation Generics Market: Sales Forecast, 2017-2023
Table 8.11 Indian Generics Market: Sales Forecast, 2011-2016
Table 8.12 Indian Generics Market: Sales Forecast, 2017-2023
Table 8.13 Chinese Generics Market: Sales Forecast, 2011-2016
Table 8.14 Chinese Generics Market: Sales Forecast, 2017-2023
Table 9.1 SWOT Analysis of World Generic Drugs Market: Strengths and Weaknesses, 2013-2023
Table 9.2 SWOT Analysis of World Generic Drugs Market: Opportunities and Threats, 2013-2023
Table 11.1 Generic Drugs National Markets: Leading Developed Countries - Sales Forecasts, 2011, 2013, 2016, 2018, 2020 and 2023
Table 11.2 Generic Drugs National Markets: Leading Emerging Countries - Sales Forecasts, 2011, 2013, 2016, 2018, 2020 and 2023
Table A.1 Main Patent Expiries, 2011-2014
Table A.2 Main Patent Expiries by Number, 2011-2014
Table A.3 Main Patent Expiries, 2010
Table A.4 Main Patent Expiries, 2011
Table A.5 Main Patent Expiries, 2012
Table A.6 Main Patent Expiries, 2013
Table A.7 Main Patent Expiries, 2014



List of Figures

Figure 3.1 Generic Drugs Market: World Sales Forecast, 2011-2016
Figure 3.2 Generic Drugs Market: World Sales Forecast, 2017-2023
Figure 3.3 Generic Drugs Market: US and World Sales Forecasts, 2011-2023
Figure 3.4 Generic Drugs Market: Japan and Germany Sales Forecasts, 2011-2023
Figure 3.5 Generic Drugs Market: Top Five EU Countries Sales Forecasts, 2011-2023
Figure 3.6 Generic Drugs Market: Emerging Countries Sales Forecasts, 2011-2023
Figure 3.7 Generic Drugs Market: Sales Shares in Leading National Markets, 2011
Figure 3.8 Generic Drugs Market: Sales Shares in Leading National Markets, 2016
Figure 3.9 Generic Drugs Market: Sales Shares in Leading National Markets, 2019
Figure 3.10 Generic Drugs Market: Sales Shares in Leading National Markets, 2023
Figure 4.1 Leading Companies in the World Generics Market, 2011
Figure 4.2 Teva's Sales Shares by Product Line, 2011
Figure 4.3 Novartis' Business Segments Revenue Breakdown and Sandoz Share, 2011
Figure 4.4 Mylan's Sales by Therapeutic Category, 2011
Figure 4.5 Hospira's Sales by Geographical Region, 2011
Figure 4.6 Watson's Sales by Segment, 2011
Figure 5.1 US Generic Drug Market Penetration (%) by Volume, 2000-2010
Figure 5.2 US Generic Drug Market Penetration (%) by Revenue, 2000-2010
Figure 5.3 US Generics Market: Sales Forecast, 2011-2023
Figure 5.4 ANDAs Received, Approved and Tentatively Approved, 2005-2009
Figure 5.5 US Generics Market: Leading Companies by Prescription Volume, 2011
Figure 6.1 German Generics Market: Sales Forecast, 2011-2023
Figure 6.2 French Generics Market: Sales Forecast, 2011-2023
Figure 6.3 UK Generics Market: Sales Forecast, 2011-2023
Figure 6.4 Italian Generics Market: Sales Forecast, 2011-2023
Figure 6.5 Spanish Generics Market: Sales Forecast, 2011-2023
Figure 7.1 Japanese Generics Market: Sales Forecast, 2011-2023
Figure 8.1 Turkish Generics Market: Sales Forecast, 2011-2023
Figure 8.2 Brazilian Generics Market: Sales Forecast, 2011-2023
Figure 8.3 Mexican Generics Market: Sales Forecast, 2011-2023
Figure 8.4 South Korean Generics Market: Sales Forecast, 2011-2023
Figure 8.5 Russian Federation Generics Market: Sales Forecast, 2011-2023
Figure 8.6 Indian Generics Market: Sales Forecast, 2011-2023
Figure 8.7 Chinese Generics Market: Sales Forecast, 2011-2023
Figure 11.1 Generic Drugs Market: US and World Sales Forecasts, 2011-2023
Figure 11.2 Generic Drugs Market: Leading Countries - Sales Forecasts, 2011-2023



Companies Listed

Abbott Laboratories
Ache Laboratórios Farmacêuticos
Actavis
Altra Investments
Amgen
Andrx
Andrx Corporation
Apotex
APP Pharmaceuticals
Arrow Group
Ascent Pharmahealth
Asociación Española de Fabricantes de Sustancias y Especialidades Farmaceuticas Genericas (AESEG)
Aspen
Assogenerici - Associazione Nazionale Industrie Farmaci Generici
AstraZeneca
Aurobindo Pharma
Barr Pharmaceuticals
Bayer HealthCare
Bedford Laboratories
Beijing MedPharm
Bioniche Pharma Holdings
Biopartners
Biotechnology Industry Organization (BIO)
Blue Cross Blue Shield Association (BCBSA)
BMP Sunstone
Boehringer Ingelheim
Bristol-Myers Squibb
British Generics Manufacturers Association (BGMA)
Cangene Corporation
Celltrion
Centers for Medicare and Medicaid Services
Cephalon
Chon Kun Dang
Cipla
Claris Lifesciences
CoGenesys
Committee for Medicinal Products for Human Use (CHMP)
Congressional Budget Office (CBO)
Corporación Infarmasa ("Infarmasa", Peru)
Corporación Infarmasa [Peru]
Daiichi Sankyo
Dey Pharma
DOC Generici
Dr. Reddy's Laboratories
Ebewe Pharma
Eden Biodesign
Egis
Eisai Pharmaceuticals
Eli Lilly
EMS Sigma Pharma
Eon Labs
Eurofarma Laboratorios
European Commission (EC)
European Court of Justice
European Generic Medicines Association (EGA)
European Medicines Agency (EMA/EMEA)
European Union (EU)
Famy Care
Farmacia del Ahorro
Farmacias Similares
Federal Trade Commission (FTC)
Finox
Food and Drug Administration (US FDA)
Fuji Pharma
Gedeon Richter
Genentech
Generic Pharmaceutical Association (GPhA)
German Association of Pharmacists (ABDA)
GlaxoSmithKline (GSK)
Glenmark Pharmaceuticals
Greenstone (Pfizer)
H. Lundbeck
Health, Education, Labor and Pensions (HELP, US Senate Committee)
Healthcare Economics LLC
Hexal
Hospira
Hospira Healthcare India
Intas Biopharmaceuticals
IVAX
Javelin Pharmaceuticals
Johnson and Johnson
Jubilant Organosys
Kowa Pharmaceuticals
Krka
Laboratorios Best
Laboratorios Kendrick
Lareq Pharma
Lek Pharmaceuticals
Lundbeck
Lupin Pharmaceuticals
MasterLek
Matrix
Matrix Laboratories
Mayne Pharma
Medi-Mart
Medley Pharmaceuticals
Merck and Co.
Merck KGaA
Ministry of Health, Labour and Welfare [Japan]
Mundipharma International
Mylan Institutional
Mylan Laboratories
Mylan Pharmaceuticals
Mylan Seiyaku
National Health Service (UK NHS)
National Institute for Biological Standards and Control (NIBSC, UK)
Nichi-iko Pharmaceutical
Nippon Chemiphar
Novartis
NOVN.V Hexal
Office of Generic Drugs (OGD, US FDA)
Onco Therapies
Orchid Chemicals and Pharmaceuticals
Oriel Therapeutics
Parexel Consulting
Pfizer
Pharmaceutical Research and Manufacturers of America (PhRMA)
Pharmstandard
Piramal Healthcare
Pliva
Purdue Pharma
Ranbaxy Laboratories
Ratiopharm
RBC Capital Markets
Roche
Samsung
Sanborns
Sandoz
Sanofi (formerly sanofi-aventis)
Sawai Pharmaceuticals
Shire Pharmaceuticals
SICOR
Sigma Pharmaceuticals
SK Chemicals
Specifar Pharmaceuticals SA
Stada Arzneimittel AG
Strides Arcolab
Sun Pharmaceuticals
Taisho Pharmaceutical Industries
Taiyo Pharmaceuticals
Takeda Pharmaceutical Company
Tecnofarma
Teva Parenteral Medicines
Teva Pharmaceutical Industries
The Rohatyn Group
Theramex
Topgen
Towa Pharmaceutical
UCB
UDL Laboratories
UK Department of Health
Veropharm
Vinca
Wal-Mart
Warner Chilcott
Watson Laboratories
Watson Pharmaceuticals
Wockhardt
World Trade Organization (WTO)
Wyeth
Zentiva
Zydus Cadila

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