Generic Drugs: World Market 2013-2023

November 2012 | 149 pages | ID: W73F5173DDDEN
Visiongain

Abstracts

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 and Latin 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.

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 M&A 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 M&A 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 in Southeast 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 M&A 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 Biggest Opportunity?
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

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: M&A 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 & 2023
Table 11.2 GeneriC Drugs National Markets: Leading Emerging Countries - Sales ForeCasts, 2011, 2013, 2016, 2018, 2020 & 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

About

Prospects for the Italian Generics Market

Visiongain concludes that without more far-reaching reforms and an emphasis on transforming the market environment that restricts generic growth, the Italian generics market will not be able to achieve the growth rates seen in other European countries. As a result, the Italian generic marketwill remain the smallest of the five EU markets covered in this report, with its market share in the European generic sector declining from 12.3% in 2011 to 10.1% in 2023. 

The Spanish Generics Market

The Spanish generic market is historically an underdeveloped market. In 2011, the market share of generics in Spain was estimated to be approximately 14% by volume and only 6.5% by value. The low price difference between generic drugs and originator drugs is responsible for the failure of generics to make a significant impact in Spain. However, the government has announced its intent to double generic market share by 2013. The national generic industry group, the AESEG,reportedly believes that this government target is insufficiently radical, and generic penetration of 50% of the market by 2013 should be the target.

Spanish Generics Market: Sales Forecast 2013-2023 

Revenues for the Spanish generic market were $3.94bn in 2011. This represents an impressive level of growth for the Spanish generics market, which, in effect, has been in existence for only a decade. During that time more than 5,000 generic products have gained approval, with total cost savings to the Spanish national health system of $13.9bn. Governmental efforts to stimulate generic penetration should ensure that the market continues to grow throughout the forecast period, although regulatory bodies are simultaneously working to cut prices, reports suggest. This may mean that increased penetration by volume does not translate into correspondingly increased revenues in Spain. 

An additional challenge for the Spanish market is that many leading branded products are already available in generic form in Spain. This means that the market will not receive the same economic boost from blockbusters molecules entering the generic market that will be experienced in other national markets from 2011 onwards, visiongain believes.

Nevertheless, visiongain predicts that there will be significant growth in the Spanish market, with revenues reaching $5.12bn by 2016, with a CAGR of 5.4%. Sales for 2019 and 2023 will be $5.98bn and $7.35bn, respectively. This represents a CAGR of 5.2 % from 2017 through to 2023.