US Generic Drug Market Outlook 2018
The US is the largest pharmaceutical market in the world. Driven by the factors such as large healthcare spending, high per-capita income, and strong research & development investments, the pharmaceutical market in the US has witnessed an upward surge over the past few years. Additionally, the share of Generics has increased steadily in the pharmaceutical market, in terms of both revenue and prescriptions.
The US generic drugs market accounts for a share of around 45% in the global Generics market. This share has been growing at a fast pace on the back of factors, such as demand for cost-effective medications, rising healthcare expenditure, increasing ageing population, patent expiration of blockbuster drugs, and enhanced government support. Besides, factors such as surging drug prices, lack of FDA support, long product approval process, and legal controversies related to drug approvals are holding back growth in the Generics industry.
According to RNCOS “US Generic Drug Market Outlook 2018”, the US Generics market, which was US$ 43.5 Billion in 2013, is anticipated to grow at a CAGR of around 11% during 2013-2018. Currently, the market is witnessing significant developments in terms of new product categories that are attracting huge investments from both public and private players. The Generics market in the US will showcase a healthy growth potential in various therapy segments, such as oncology, respiratory, thyroid, ulcers as well as cholesterol disorders in the coming years. Growth in the aforementioned segments will be the result of patent expirations of a number of the major drugs in the next few years. The support from the US government in the form of approvals and incentives, will also act as a catalyst for future growth in the generic domain.
The report covers all the important aspects of the US Generics market and provides an in-depth analysis on the current status of the market, emerging trends, competitive landscape and future outlook, among other pointers. It also provides valuable information to pharmaceutical and generic drug companies and investors looking to enter this market. Facts and figures regarding market size, growth, share, regulatory environment and trends in technology development have been thoroughly analyzed in the report to provide clients a comprehensive overview of the market.
The US generic drugs market accounts for a share of around 45% in the global Generics market. This share has been growing at a fast pace on the back of factors, such as demand for cost-effective medications, rising healthcare expenditure, increasing ageing population, patent expiration of blockbuster drugs, and enhanced government support. Besides, factors such as surging drug prices, lack of FDA support, long product approval process, and legal controversies related to drug approvals are holding back growth in the Generics industry.
According to RNCOS “US Generic Drug Market Outlook 2018”, the US Generics market, which was US$ 43.5 Billion in 2013, is anticipated to grow at a CAGR of around 11% during 2013-2018. Currently, the market is witnessing significant developments in terms of new product categories that are attracting huge investments from both public and private players. The Generics market in the US will showcase a healthy growth potential in various therapy segments, such as oncology, respiratory, thyroid, ulcers as well as cholesterol disorders in the coming years. Growth in the aforementioned segments will be the result of patent expirations of a number of the major drugs in the next few years. The support from the US government in the form of approvals and incentives, will also act as a catalyst for future growth in the generic domain.
The report covers all the important aspects of the US Generics market and provides an in-depth analysis on the current status of the market, emerging trends, competitive landscape and future outlook, among other pointers. It also provides valuable information to pharmaceutical and generic drug companies and investors looking to enter this market. Facts and figures regarding market size, growth, share, regulatory environment and trends in technology development have been thoroughly analyzed in the report to provide clients a comprehensive overview of the market.
1. ANALYST VIEW
2. RESEARCH METHODOLOGY
3. MARKET DRIVERS
3.1 Inclining Healthcare Expenditure
3.2 Rising Disposable Incomes
3.3 Increasing Ageing Population
3.4 Patent Expiry of Blockbuster Drugs
3.5 Mergers & Acquisitions
4. MARKET CHALLENGES
4.1 Surging Generic Drug Prices
4.2 Long Product Approval Process
4.3 Legal Controversies
5. OVERVIEW OF GENERICS SECTOR
5.1 US Pharmaceutical Market
5.2 Share of Branded vs. Generics
5.3 Generics Drugs Market
6. MARKET POTENTIAL FOR GENERIC DRUGS IN KEY THERAPIES SEGMENTS
6.1 Oncology
6.2 Obesity & Cholesterol
6.3 Mental Health (Antipsychotics & Anti-Depressants)
6.4 Hypertension (Angiotensin II Receptor)
6.5 Diabetes
6.6 Anti-Ulcerants (Proton Pump Inhibitors)
6.7 Thyroid
6.8 Respiratory
7. MARKET TRENDS & DEVELOPMENTS
7.1 New Product Launch
7.2 Launch of Biosimilars (BioGenerics)
7.3 Progress in User Fees for Generic Manufacturers (GDUFA)
7.4 Revision of Pay-for-delay Agreement Policies
8. REGULATORY ENVIRONMENT
8.1 Drug Efficacy Study Implementation (DESI) Program
8.2 Hatch-Waxman Act
8.3 Patent Infringement Litigations
8.4 Para IV & the 180-day Marketing Exclusivity
8.5 FDA Requirements
8.6 Generic Initiative for Value & Efficiency (GIVE)
8.7 Healthcare Bill 2013
8.8 Ban on “Pay for delay” Settlements
8.9 Patient Protection and Affordable Care Act
9. COMPETITIVE LANDSCAPE
9.1 Market Share of Leading Players
9.2 Market Share of Leading Generic Drugs
9.3 Profiles
9.3.1 Teva Pharmaceuticals USA
9.3.2 Actavis Plc
9.3.3 Mylan Inc.
9.3.4 Pfizer Inc.
9.3.5 Sandoz Inc. (Novartis)
9.3.6 Endo International Plc.
9.3.7 Lupin Limited
9.3.8 Dr. Reddy’s Laboratories Ltd.
9.3.9 Zydus Pharmaceuticals Inc.
9.3.10 Amneal Pharmaceuticals
2. RESEARCH METHODOLOGY
3. MARKET DRIVERS
3.1 Inclining Healthcare Expenditure
3.2 Rising Disposable Incomes
3.3 Increasing Ageing Population
3.4 Patent Expiry of Blockbuster Drugs
3.5 Mergers & Acquisitions
4. MARKET CHALLENGES
4.1 Surging Generic Drug Prices
4.2 Long Product Approval Process
4.3 Legal Controversies
5. OVERVIEW OF GENERICS SECTOR
5.1 US Pharmaceutical Market
5.2 Share of Branded vs. Generics
5.3 Generics Drugs Market
6. MARKET POTENTIAL FOR GENERIC DRUGS IN KEY THERAPIES SEGMENTS
6.1 Oncology
6.2 Obesity & Cholesterol
6.3 Mental Health (Antipsychotics & Anti-Depressants)
6.4 Hypertension (Angiotensin II Receptor)
6.5 Diabetes
6.6 Anti-Ulcerants (Proton Pump Inhibitors)
6.7 Thyroid
6.8 Respiratory
7. MARKET TRENDS & DEVELOPMENTS
7.1 New Product Launch
7.2 Launch of Biosimilars (BioGenerics)
7.3 Progress in User Fees for Generic Manufacturers (GDUFA)
7.4 Revision of Pay-for-delay Agreement Policies
8. REGULATORY ENVIRONMENT
8.1 Drug Efficacy Study Implementation (DESI) Program
8.2 Hatch-Waxman Act
8.3 Patent Infringement Litigations
8.4 Para IV & the 180-day Marketing Exclusivity
8.5 FDA Requirements
8.6 Generic Initiative for Value & Efficiency (GIVE)
8.7 Healthcare Bill 2013
8.8 Ban on “Pay for delay” Settlements
8.9 Patient Protection and Affordable Care Act
9. COMPETITIVE LANDSCAPE
9.1 Market Share of Leading Players
9.2 Market Share of Leading Generic Drugs
9.3 Profiles
9.3.1 Teva Pharmaceuticals USA
9.3.2 Actavis Plc
9.3.3 Mylan Inc.
9.3.4 Pfizer Inc.
9.3.5 Sandoz Inc. (Novartis)
9.3.6 Endo International Plc.
9.3.7 Lupin Limited
9.3.8 Dr. Reddy’s Laboratories Ltd.
9.3.9 Zydus Pharmaceuticals Inc.
9.3.10 Amneal Pharmaceuticals
LIST OF FIGURES:
Figure 3-1: Personal Disposable Income (Billion US$), 2008-2013
Figure 3-2: Total Health Expenditure (Billion US$), 2008-2013
Figure 3-3: Share of Public & Private Health Expenditure (2008-2013)
Figure 3-4: Population above 65 Years (Million), 2008-2013
Figure 5-1: US Pharmaceutical Market (Billion US$), 2013-2018
Figure 5-2: US Pharmaceutical Supply Chain
Figure 5-3: Share of Branded and Generics Drugs by Revenue (2013)
Figure 5-4: Market Share by Total Prescriptions (2011-2013)
Figure 5-5: Generic Drugs Market (Billion US$), 2013-2018
Figure 6-1: Estimated Cancer Deaths (2012 & 2013)
Figure 6-2: Adult Obesity Rate (%), 2013 & 2030
Figure 6-3: Diabetic Patients in Age Group 20-79 Years ('000), 2013 & 2030
Figure 8-1: Generic Drugs Approval Process
Figure 9-1: Share of Key Players in Generics Market (2013)
Figure 9-2: Teva Pharmaceuticals - Generics Revenue Share by Geographic Regions (2014)
Figure 9-3: Actavis Plc - Revenue Share by Geographic Regions (2013)
Figure 9-4: Mylan Inc - Revenue Share by Geographic Regions (2013)
Figure 9-5: Mylan Inc - Generics Revenue Share by Geographic Region (2014)
Figure 9-6: Pfizer - Revenue Share by Business Segments (2013)
Figure 9-7: Pfizer - Revenue Share by Geographical Regions (2013)
Figure 9-8: Sandoz - Revenue Share by Business Segments (2014)
Figure 9-9: Novartis - Revenue Share by Geographic Regions (2014)
Figure 9-10: Endo International Plc - Revenue Share by Business Segments (2013)
Figure 9-11: Lupin Ltd - Revenue Share by Business Segments (2013)
Figure 9-12: Lupin Ltd - Generics Share in the US by Value (2012 & 2013)
Figure 9-13: Lupin Ltd - Revenue Share by Geographic Regions (2013)
Figure 9-14: Dr. Reddy’s Laboratory - Revenue Share by Business Segments (2013)
Figure 9-15: Dr. Reddy’s Laboratory - Revenue Share by Geographical Regions (2013)
Figure 9-16: Amneal Pharmaceuticals - Revenue (Million US$), 2007 & 2014
Figure 3-1: Personal Disposable Income (Billion US$), 2008-2013
Figure 3-2: Total Health Expenditure (Billion US$), 2008-2013
Figure 3-3: Share of Public & Private Health Expenditure (2008-2013)
Figure 3-4: Population above 65 Years (Million), 2008-2013
Figure 5-1: US Pharmaceutical Market (Billion US$), 2013-2018
Figure 5-2: US Pharmaceutical Supply Chain
Figure 5-3: Share of Branded and Generics Drugs by Revenue (2013)
Figure 5-4: Market Share by Total Prescriptions (2011-2013)
Figure 5-5: Generic Drugs Market (Billion US$), 2013-2018
Figure 6-1: Estimated Cancer Deaths (2012 & 2013)
Figure 6-2: Adult Obesity Rate (%), 2013 & 2030
Figure 6-3: Diabetic Patients in Age Group 20-79 Years ('000), 2013 & 2030
Figure 8-1: Generic Drugs Approval Process
Figure 9-1: Share of Key Players in Generics Market (2013)
Figure 9-2: Teva Pharmaceuticals - Generics Revenue Share by Geographic Regions (2014)
Figure 9-3: Actavis Plc - Revenue Share by Geographic Regions (2013)
Figure 9-4: Mylan Inc - Revenue Share by Geographic Regions (2013)
Figure 9-5: Mylan Inc - Generics Revenue Share by Geographic Region (2014)
Figure 9-6: Pfizer - Revenue Share by Business Segments (2013)
Figure 9-7: Pfizer - Revenue Share by Geographical Regions (2013)
Figure 9-8: Sandoz - Revenue Share by Business Segments (2014)
Figure 9-9: Novartis - Revenue Share by Geographic Regions (2014)
Figure 9-10: Endo International Plc - Revenue Share by Business Segments (2013)
Figure 9-11: Lupin Ltd - Revenue Share by Business Segments (2013)
Figure 9-12: Lupin Ltd - Generics Share in the US by Value (2012 & 2013)
Figure 9-13: Lupin Ltd - Revenue Share by Geographic Regions (2013)
Figure 9-14: Dr. Reddy’s Laboratory - Revenue Share by Business Segments (2013)
Figure 9-15: Dr. Reddy’s Laboratory - Revenue Share by Geographical Regions (2013)
Figure 9-16: Amneal Pharmaceuticals - Revenue (Million US$), 2007 & 2014
LIST OF TABLES:
Table 3-1: Total Health Expenditure (% of GDP), 2008-2013
Table 3-2: Blockbuster Drugs Going Off Patent (2014-2016)
Table 3-3: Premium Deals in the US Generics Industry (2013- 2015)
Table 6-1: Patent Expiration of Key Oncology Drugs
Table 6-2: Patent Expiration of Key Antipsychotic Drugs
Table 6-3: Patent Expiration of Key Antidepressant Drugs
Table 6-4: Patent Expiration of Key Human Insulin Drugs
Table 6-5: Patent Expiry of Key Thyroid Drugs
Table 6-6: Patent Expiry of Key Respiratory Drugs
Table 7-1: Generic Drugs Launched in the US Market (2013 & 2014)
Table 7-2: List of Biosimilars under Development in the US
Table 9-1: Top Generic Drugs by Sales (Million US$), 2013
Table 9-2: Top Generic Drugs by Prescription (2013)
Table 9-3: Teva Pharmaceuticals - Revenue by Business Segments (Million US$), 2013 & 2014
Table 9-4: Teva Pharmaceuticals - Generics Revenue by Geographic Regions (Million US$), 2013 & 2014
Table 9-5: Actavis Plc - Revenue by Business Segments (Million US$), 2012 & 2013
Table 9-6: Mylan Inc - Revenue by Business Segments (Million US$), 2013 & 2014
Table 9-7: Pfizer - Revenue by Business Segments (Million US$), 2011-2013
Table 9-8: Endo International Inc - Revenue by Companies (Million US$), 2011-2013
Table 9-9: Lupin Ltd - Revenue by Business Segments (Million US$), 2011-2013
Table 9-10: Dr. Reddy’s Laboratory - Revenue by Business Segments (Million US$), 2011-2013
Table 3-1: Total Health Expenditure (% of GDP), 2008-2013
Table 3-2: Blockbuster Drugs Going Off Patent (2014-2016)
Table 3-3: Premium Deals in the US Generics Industry (2013- 2015)
Table 6-1: Patent Expiration of Key Oncology Drugs
Table 6-2: Patent Expiration of Key Antipsychotic Drugs
Table 6-3: Patent Expiration of Key Antidepressant Drugs
Table 6-4: Patent Expiration of Key Human Insulin Drugs
Table 6-5: Patent Expiry of Key Thyroid Drugs
Table 6-6: Patent Expiry of Key Respiratory Drugs
Table 7-1: Generic Drugs Launched in the US Market (2013 & 2014)
Table 7-2: List of Biosimilars under Development in the US
Table 9-1: Top Generic Drugs by Sales (Million US$), 2013
Table 9-2: Top Generic Drugs by Prescription (2013)
Table 9-3: Teva Pharmaceuticals - Revenue by Business Segments (Million US$), 2013 & 2014
Table 9-4: Teva Pharmaceuticals - Generics Revenue by Geographic Regions (Million US$), 2013 & 2014
Table 9-5: Actavis Plc - Revenue by Business Segments (Million US$), 2012 & 2013
Table 9-6: Mylan Inc - Revenue by Business Segments (Million US$), 2013 & 2014
Table 9-7: Pfizer - Revenue by Business Segments (Million US$), 2011-2013
Table 9-8: Endo International Inc - Revenue by Companies (Million US$), 2011-2013
Table 9-9: Lupin Ltd - Revenue by Business Segments (Million US$), 2011-2013
Table 9-10: Dr. Reddy’s Laboratory - Revenue by Business Segments (Million US$), 2011-2013
