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United States Off–Label Drugs Market Analysis
Off–label prescribing of medicines is prevalent worldwide because it gives freedom to
physicians to apply new therapeutic options based on the latest evidence. Although physicians
may lawfully prescribe approved Drugs for any use consistent with available scientific data and
proper medical practice, but unfortunately, this is done without adequate scientific data.
Often, when the best available therapeutic option fails, patients demand new approach or new
treatment which ultimately leads to off–label uses.
Off–label use is very common in United States. United States Off–label Drugs demand has grown
at a fast pace in the past decade and likely to grow in the forecasting period. It is likely that
United States off–label market will cross the figure of 60 Billion by the year 2020. Central
Nervous System (CNS) and Cancer off–label Drugs controls the largest market share of the total
US off–label Drugs market. Anti–Infectives Off–Label Drugs Market and Anti–Ashmatics Off–Label
Drugs together are expected to control close to 35% market share by 2020.
Renub Research study titled “United States Off–Label Drugs Market & Forecast” report
provides a comprehensive analysis of the emerging Off–Label Drugs market. The report also
entails commonly prescribed Off–Label Drugs, Perspective of Physicians, Patients,
Pharmaceutical Companies and Regulatory Authorities, Off–label Promotion Settlements under
the False Claims Act. The report also studies Drivers and Challenges of United States Off–Label
Drugs market. This 67 page report with 16 Figures and 1 Table studies 6 Off–Label Drugs
Segment.
The 6 Off–Label Drugs Segment Covered in the Report are as Follows:
1. Cancer Off–Label Drugs
2. Central Nervous System (CNS) Off–Label Drugs
3. Anti–Ashmatics Off–Label Drugs
4. Anti–Allergies Off–Label Drugs
5. Anti–Hypertensives Off–Label Drugs
6. Anti–Infectives Off–Label Drugs
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Data Sources
This report is built using data and information sourced from proprietary databases, primary and
secondary research and in–house analysis by Renub Research team of industry experts.
Primary sources include industry surveys and telephonic interviews with industry experts.
Secondary sources information and data has been collected from various printable and non–
printable sources like search engines, News websites, Government Websites, Trade Journals,
White papers, Government Agencies, Magazines, Newspapers, Trade associations, Books,
Industry Portals, Industry Associations and access to more than 500 paid databases.
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© United States Off–Label Drugs Market & Forecast
Renub Research, 2015
Edition 1.0
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Table of Contents
1. Executive Summary
2. United States Off–Label Drugs Market & Forecast
3. United States Off–Label Drugs Market Share & Forecast
4. United States Off–Label Drugs Market – Segment wise
4.1 United States – Cancer Off–Label Drugs Market & Forecast
4.2 United States – Central Nervous System (CNS) Off–Label Drugs Market & Forecast
4.3 United States – Anti–Ashmatics Off–Label Drugs Market & Forecast
4.4 United States – Anti–Allergies Off–Label Drugs Market & Forecast
4.5 United States – Anti–Hypertensives Off–Label Drugs Market & Forecast
4.6 United States – Anti–Infectives Off–Label Drugs Market & Forecast
5. Drugs Commonly Prescribed Off–Label
6. Off–Label Use of Medicine & Different Perspectives
6.1 Physicians Perspective
6.1.1 Physicians’ Liability for Off–Label Prescriptions
6.2 Patients Perspective
6.3 Perspective of the Pharmaceutical Companies
6.4 Perspective of Regulatory Agencies
7. Off–Label Promotion Settlements Under The False Claims Act
7.1 Year 2004
7.2 Year 2005
7.3 Year 2006
7.4 Year 2007
7.5 Year 2008
7.6 Year 2009
7.7 Year 2010
7.8 Year 2011
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7.9 Year 2012
7.10 Year 2013
7.11 Year 2014
8. United States Off–Label Drugs Market – Growth Drivers
8.1 Clinical Practices and Application in the Off–Label Drugs
8.2 Vulnerable Patient Populations: Information and Access
8.3 Off–Label Promotion Reform
9. United States Off–Label Drugs Market – Challenges
9.1 Lack of Regulation & Information of the United States Off–Label Drugs Market
9.2 Reimbursement
9.3 Safety and Efficacy of Unapproved and Under Evaluated Use
9.4 Point of View on Bioethical Off–Label Drugs Use
9.5 Inaccuracy of Off–Label Clinical Publications
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List of Figures
Figure 2–1: United States – Off–Label Drugs Market (Billion US$), 2011 – 2014
Figure 2–2: United States – Forecast for Off–Label Drugs Market (Billion US$), 2015 – 2020
Figure 3–1: United States – Off–Label Drugs Market Share (Percent), 2011 – 2014
Figure 3–2: United States – Forecast for Off–Label Drugs Market Share (Percent), 2015 – 2020
Figure 4–1: United States – Cancer Off–Label Drugs Market (Billion US$), 2008 – 2014
Figure 4–2: United States – Forecast for Cancer Off–Label Drugs Market (Billion US$), 2015 – 2020
Figure 4–3: United States – Central Nervous System (CNS) Off–Label Drugs Market (Billion US$), 2009 –
2014
Figure 4–4: United States – Forecast for Central Nervous System (CNS) Off–Label Drugs Market (Billion
US$), 2015 – 2020
Figure 4–5: United States – Anti–Ashmatics Off–Label Drugs Market (Billion US$), 2010 – 2014
Figure 4–6: United States – Forecast for Anti–Ashmatics Off–Label Drugs Market (Billion US$), 2015 –
2020
Figure 4–7: United States – Anti–Allergies Off–Label Drugs Market (Billion US$), 2011 – 2014
Figure 4–8: United States – Forecast for Anti–Allergies Off–Label Drugs Market (Billion US$), 2015 – 2020
Figure 4–9: United States – Anti–Hypertensives Off–Label Drugs Market (Billion US$), 2009 – 2014
Figure 4–10: United States – Forecast for Anti–Hypertensives Off–Label Drugs Market (Billion US$), 2015
– 2020
Figure 4–11: United States – Anti–Infectives Off–Label Drugs Market (Billion US$), 2008 – 2014
Figure 4–12: United States – Forecast for Anti–Infectives Off–Label Drugs Market (Billion US$), 2015 –
2020
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List of Tables
Table 5–1: Commonly Prescribed Off–Label Drugs
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