Off label is the unwarranted or non-approved use of the drug. Under three conditions a drug is off-label. The conditions are
• The measures needed to extend the consent were not made albeit implication of adequacy is applicable
• The drug is ineffectual or ineffective
• It falls in 'grey zone' information-based medicine in which top-level evidence of is tough to find even for the treatments which are fairly effective.
For some reasons, these are more accurate in oncology when compared to other medical areas. Multiple across the board drugs are yet to receive the label for all the indications under which they can be effectively employed. The off-label usage of FDA-approved drugs is not regulated however; in many countries including the United State, it is legal. The usage of off-label drug use is more frequent in cancer treatment because multiple drugs are efficient in fighting against more than one cancer. A large study conducted by Kocs D, Fendrick AM in the US revealed that 33.2% of chemotherapy, including hormonal therapy, administered by oncologists was being used off-label. It is most common among cancer therapies due to limited availability of approved drugs for treatment. They are proven effective for many indications and in combination therapies when compared to monotherapy. Further, rising cancer prevalence among general population fuelled the growth of the market. Along with this, changing regulatory conditions to support manufacturers in the rapid advancement of technologies led to robust growth. Persistent demand for anti-neoplastic drugs in better management of cancer fuelled the demand for off-label drugs. It is legal in the US for off-label drug use and offers reimbursements for cancer treatment. Additionally, growing research activities to expand the disease indication fuelled the investments. All these factors led to the robust growth of the market during the forecast period. However, It's authorized for doctors to use off label drug but it's not legitimate for drug companies to promote off label drugs.
Usage of off label drug can perplex reimbursement and coverage of health insurance which acts as a restraint for the growth of the market. Since the drug is not formally indicated for the treatment of the specific disease, the prescriber can end up paying its full price. Also, there's a slight chance that producing company might withdraw the drug from the market when it's no longer required which may hinder the prospects of the market.
The global market is dominated by North America due to supportive regulatory policies and high adoption among physicians. North America is dominated by the US and it is expected to remain dominant same throughout the forecast period. It is followed by the European region and it is dominated by the UK, Germany, and France. European regulatory bodies restrict the off-label drug use but there is high adoption among the general physicians. It is followed by the Asia Pacific and Latin America regions are fast growing regions due to increasing adoption. They are expected accounts for 25% share of the global market. Rest of World accounts the small fraction of the global market and expected to remain the same throughout the forecast period.
Off Label Anticancer Drugs market players include Pfizer Inc, Roche Holding, Merck Co & Inc, Novartis AG, Sanofi S.A., Gilead, J&J and others.
Off-Label Anticancer Drugs Restraints:
• Perplexes reimbursement and coverage of health insurance.
• Manufacturing company might withdraw the drug from the market when it's no longer required
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Off-Label Anticancer Drugs Segmentation
By Indications
• Lung Cancer
• Breast Cancer
• Prostate Cancer
• Skin Cancer
• Bladder Cancer
• Others
By End Users
• Hospitals
• Pharmacies
By Region:
• North America
• Latin America
• Europe
• Asia Pacific
• Rest of the World
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Competitive Landscape:
• Tier 1 players- established companies in the market with a major market share
• Tier 2 players
• Emerging players which are growing rapidly
• New Entrants
FutureWise Key Takeaways
• Growth prospects
• SWOT analysis
• Key trends
• Key data-points affecting market growth
Objectives of the Study:
• To provide with an exhaustive analysis on the Global Off-Label Anticancer Drugs Market by Indications, by End-User, and by Region
• To cater comprehensive information on factors impacting market growth (drivers, restraints, opportunities, and industry-specific restraints)
• To evaluate and forecast micro-markets and the overall market
• To predict the market size, in key regions (along with countries)—North America, Europe, Asia Pacific, Latin America, and the Middle East
• To record evaluate and competitive landscape mapping- product launches, technological advancements, mergers and expansions
• Profiling of companies to evaluate their market shares, strategies, financials and core competencies
Table of Contents
Introduction
Scope and Objective
Assumptions and Acronyms
Forecast Factors
Research Methodology
Executive Summary
Industry Cluster Analysis
Competition Matrix
Strategies Recommendations
Market Definition
Report Scope (Inclusions & Exclusions)
Market Segmentation
Global Off-Label Anticancer Drugs Market Overview
Global Off-Label Anticancer Drugs Market Revenue (USD Mn)
Key Inclusions
Porter’s Five Force analysis
Market Dynamics
Industry Trends
Regulatory Guidelines
Opportunities in Off-Label Anticancer Drugs
Competition Dynamics
Company Share Analysis (2019)
Top 10 Product Pricing by Region
Global Off-Label Anticancer Drugs Market Revenue (USD Mn), 2019-2026 by Indication
Key Market Findings
Long Term ROI Segments
Revenue Opportunity Influencing Factors
Market Revenue (USD Mn) Assessment and Forecast by Indication, 2019-2026
Lung Cancer
Breast Cancer
Prostate Cancer
Skin Cancer
Bladder Cancer
Others
Global Off-Label Anticancer Drugs Market Revenue (USD Mn), 2019-2026 by End User
Key Market Findings
Long Term ROI Segments
Revenue Opportunity Influencing Factors
Market Revenue (USD Mn) Assessment and Forecast by End User, 2019-2026
Hospitals
Pharmacies
Global Off-Label Anticancer Drugs Market Revenue (USD Mn), 2019-2026 by Region
Key Market Findings
Long Term ROI Segments
Revenue Opportunity Influencing Factors
Market Revenue (USD Mn) Assessment and Forecast by Region,2026
North America
Latin America
Europe
Asia Pacific
Rest of world
North America Off-Label Anticancer Drugs Market Revenue (US$ Mn), 2019-2026
Key Market Findings
Long Term ROI Segments
Revenue Opportunity Influencing Factors
Market Revenue (USD Mn) Assessment and Forecast by Country, 2019-2026
US
Canada
Market Revenue (USD Mn) Assessment and Forecast by Indication, 2019-2026
Lung Cancer
Breast Cancer
Prostate Cancer
Skin Cancer
Bladder Cancer
Others
Market Revenue (USD Mn) Assessment and Forecast by End User, 2019-2026
Hospitals
Pharmacies
Latin America Off-Label Anticancer Drugs Market Revenue (US$ Mn), 2019-2026
Key Market Findings
Long Term ROI Segments
Revenue Opportunity Influencing Factors
Market Revenue (USD Mn) Assessment and Forecast by Country, 2019-2026
Brazil
Mexico
Argentina
Rest of Latin America
Market Revenue (USD Mn) Assessment and Forecast by Indication, 2019-2026
Lung Cancer
Breast Cancer
Prostate Cancer
Skin Cancer
Bladder Cancer
Others
Market Revenue (USD Mn) Assessment and Forecast by End User, 2019-2026
Hospitals
Pharmacies
Europe America Off-Label Anticancer Drugs Market Revenue (US$ Mn), 2019-2026
Key Market Findings
Long Term ROI Segments
Revenue Opportunity Influencing Factors
Market Revenue (USD Mn) Assessment and Forecast by Country, 2019-2026
Germany
France
Spain
UK
Russia
Poland
Rest of Europe
Market Revenue (USD Mn) Assessment and Forecast by Indication, 2019-2026
Lung Cancer
Breast Cancer
Prostate Cancer
Skin Cancer
Bladder Cancer
Others
Market Revenue (USD Mn) Assessment and Forecast by End User, 2019-2026
Hospitals
Pharmacies
Asia Pacific America Off-Label Anticancer Drugs Market Revenue (US$ Mn), 2019-2026
Key Market Findings
Long Term ROI Segments
Revenue Opportunity Influencing Factors
Market Revenue (USD Mn) Assessment and Forecast by Country, 2019-2026
Emerging Asia
China
India
ASEAN-5
Rest of Emerging Asia
Japan
Market Revenue (USD Mn) Assessment and Forecast by Indication, 2019-2026
Lung Cancer
Breast Cancer
Prostate Cancer
Skin Cancer
Bladder Cancer
Others
Market Revenue (USD Mn) Assessment and Forecast by End User, 2019-2026
Hospitals
Pharmacies
Rest of World America Off-Label Anticancer Drugs Market Revenue (US$ Mn), 2019-2026
Key Market Findings
Long Term ROI Segments
Revenue Opportunity Influencing Factors
Market Revenue (USD Mn) Assessment and Forecast by Country, 2019-2026
Middle East
South Africa
North Africa
Rest of World
Market Revenue (USD Mn) Assessment and Forecast by Indication, 2019-2026
Lung Cancer
Breast Cancer
Prostate Cancer
Skin Cancer
Bladder Cancer
Others
Market Revenue (USD Mn) Assessment and Forecast by End User, 2019-2026
Hospitals
Pharmacies
Company Profiles
Competition Landscape
Global Company Share (USD Mn) Overview, 2019
Company Profiles
Pfizer Inc
Corporate Overview
Financial Performance
Peer Comparison & 3C marketing equation
Company Strategy & Channel Management
Roche Holding
Corporate Overview
Financial Performance
Peer Comparison & 3C marketing equation
Company Strategy & Channel Management
Merck Co & Inc
Corporate Overview
Financial Performance
Peer Comparison & 3C marketing equation
Company Strategy & Channel Management
Novartis AG
Corporate Overview
Financial Performance
Peer Comparison & 3C marketing equation
Company Strategy & Channel Management
Sanofi S.A.
Corporate Overview
Financial Performance
Peer Comparison & 3C marketing equation
Company Strategy & Channel Management
Research Sources & Primary Verbatim
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