Orphan Drugs Market – Global Drivers, Restraints, Opportunities, Trends, and Forecasts: 2017–2023
Orphan Drugs Market – Global Drivers, Restraints, Opportunities, Trends, and Forecasts: 2017–2023
Overview: Orphan diseases or rare diseases rarely occur among the people, which is nearly 7 out of 10,000 individuals. Around 5,000 to 8,000 rare diseases have been recognized and the origin of approximately 80% of these diseases is from the genes. Regardless of the alleged huge number of individuals being affected by rare life-threatening conditions, the disease burden estimates of the public health are unreliable. About 50% of the orphan genetic ailments are in kids’ with 30% of them cannot live for more than 5 years.
New-born screening, legislation, and construction of national strategies are the major activities being carried out in the orphan drugs market. Legislation has helped in driving the development of more orphan drugs. For instance, the US congress passed Orphan Drug Act in 1983, and it was mainly intended to encourage development of new drugs for rare diseases. Currently, numerous legislation and strategies are developed to facilitate research of orphan drugs globally in more than 35 countries.
Cancer, metabolic diseases, blood diseases, immunologic disease, and neurologic diseases are the types of diseases that are addressed with orphan drugs. Cystic fibrosis, glioma, pancreatic cancer, acute myeloid leukemia, multiple myeloma, renal cell carcinoma, ovarian cancer and Duchenne muscular dystrophy are some of the common indications among the various disease types.
Market Analysis: The “Global Orphan Drugs Market” is estimated to witness a CAGR of 11.9% during the forecast period 2017–2023. The market is analyzed based on three segments, namely types, applications, and regions.
Regional Analysis: The regions covered in the report are North America, Europe, Asia Pacific, and Rest of the World (RoW). North America is the leading region for the orphan drugs market growth followed by Europe. Asia Pacific and RoW are set to be the emerging regions. India, China, and Japan are set to be the most attractive destinations due to the large untapped market.
Types Analysis: The global orphan drugs market by products is segmented into biologics and non-biologics. Biologics orphan drugs is the largest segment in the market with a market share of more than 60% in 2016. It is expected to grow at a double-digit CAGR in the market. However, non-biologic orphan drugs are still expected to hold more than quarter of the market share by 2023. The market is also witnessing various mergers, acquisitions, and collaborations among the top players, which is defining the future of the global orphan drugs market.
Key Players: Novartis AG, F. Hoffmann-La Roche Ltd, Celgene, Bristol-Myers Squibb Company, Shire pharmaceuticals, Pfizer, Sonafi, and Bayer Healthcare are the key players in the market. These top ten players occupy nearly 50% of the orphan drugs market.
Competitive Analysis: Currently, large pharmaceutical companies are extremely active in the orphan drugs market. Merger and acquisition is the major trend in the market. For instance, around 40% of the biotechnology companies are acquired between the year 2008-2012, and they have an orphan drug in development. Novartis, GSK, Roche, and Pfizer are the largest orphan drug companies. Pfizer, Gilead, Roche, Shire, BMY, and Celgene are leading orphan drug acquirers. Around 50% of the top 20 orphan drugs were either acquired or in-licensed by large pharmaceutical companies.
Benefits: The report provides complete details about the usage and adoption rate of orphan drugs during the forecast period and among the regions. With that, key stakeholders can know about the major trends, drivers, investments, vertical player’s initiatives, government initiatives toward the orphan drugs adoption in the upcoming years along with the details of commercial drugs available in the market. Moreover, the report provides details about the major challenges that are going to impact the market growth. Additionally, the report gives complete details about the key business opportunities to key stakeholders to expand their business and capture the revenue in the specific verticals to analyze before investing or expanding the business in this market.
Key Stakeholders:
Overview: Orphan diseases or rare diseases rarely occur among the people, which is nearly 7 out of 10,000 individuals. Around 5,000 to 8,000 rare diseases have been recognized and the origin of approximately 80% of these diseases is from the genes. Regardless of the alleged huge number of individuals being affected by rare life-threatening conditions, the disease burden estimates of the public health are unreliable. About 50% of the orphan genetic ailments are in kids’ with 30% of them cannot live for more than 5 years.
New-born screening, legislation, and construction of national strategies are the major activities being carried out in the orphan drugs market. Legislation has helped in driving the development of more orphan drugs. For instance, the US congress passed Orphan Drug Act in 1983, and it was mainly intended to encourage development of new drugs for rare diseases. Currently, numerous legislation and strategies are developed to facilitate research of orphan drugs globally in more than 35 countries.
Cancer, metabolic diseases, blood diseases, immunologic disease, and neurologic diseases are the types of diseases that are addressed with orphan drugs. Cystic fibrosis, glioma, pancreatic cancer, acute myeloid leukemia, multiple myeloma, renal cell carcinoma, ovarian cancer and Duchenne muscular dystrophy are some of the common indications among the various disease types.
Market Analysis: The “Global Orphan Drugs Market” is estimated to witness a CAGR of 11.9% during the forecast period 2017–2023. The market is analyzed based on three segments, namely types, applications, and regions.
Regional Analysis: The regions covered in the report are North America, Europe, Asia Pacific, and Rest of the World (RoW). North America is the leading region for the orphan drugs market growth followed by Europe. Asia Pacific and RoW are set to be the emerging regions. India, China, and Japan are set to be the most attractive destinations due to the large untapped market.
Types Analysis: The global orphan drugs market by products is segmented into biologics and non-biologics. Biologics orphan drugs is the largest segment in the market with a market share of more than 60% in 2016. It is expected to grow at a double-digit CAGR in the market. However, non-biologic orphan drugs are still expected to hold more than quarter of the market share by 2023. The market is also witnessing various mergers, acquisitions, and collaborations among the top players, which is defining the future of the global orphan drugs market.
Key Players: Novartis AG, F. Hoffmann-La Roche Ltd, Celgene, Bristol-Myers Squibb Company, Shire pharmaceuticals, Pfizer, Sonafi, and Bayer Healthcare are the key players in the market. These top ten players occupy nearly 50% of the orphan drugs market.
Competitive Analysis: Currently, large pharmaceutical companies are extremely active in the orphan drugs market. Merger and acquisition is the major trend in the market. For instance, around 40% of the biotechnology companies are acquired between the year 2008-2012, and they have an orphan drug in development. Novartis, GSK, Roche, and Pfizer are the largest orphan drug companies. Pfizer, Gilead, Roche, Shire, BMY, and Celgene are leading orphan drug acquirers. Around 50% of the top 20 orphan drugs were either acquired or in-licensed by large pharmaceutical companies.
Benefits: The report provides complete details about the usage and adoption rate of orphan drugs during the forecast period and among the regions. With that, key stakeholders can know about the major trends, drivers, investments, vertical player’s initiatives, government initiatives toward the orphan drugs adoption in the upcoming years along with the details of commercial drugs available in the market. Moreover, the report provides details about the major challenges that are going to impact the market growth. Additionally, the report gives complete details about the key business opportunities to key stakeholders to expand their business and capture the revenue in the specific verticals to analyze before investing or expanding the business in this market.
Key Stakeholders:
1 INDUSTRY OUTLOOK
1.1 Industry Overview
1.2 Industry Trends
2 REPORT OUTLINE
2.1 Report Scope
2.2 Report Summary
2.3 Research Methodology
2.4 Report Assumptions
3 MARKET SNAPSHOT
3.1 Market Definition – Infoholic Research
3.2 Segmented Addressable Market (SAM)
3.2.1 Advantages of Development of Orphan Drug
3.2.2 Trends of orphan drug market
3.3 Related Addressable Markets (RAM)
3.3.1 Oncology (Cancer) Drugs
3.3.2 Active pharmaceutical ingredients (APIs)
3.3.3 Over the counter drugs (OTC)
4 MARKET OUTLOOK
4.1 Overview
4.2 Regulatory Framework for orphan drugs
4.3 Funding Scenario for orphan drugs
4.4 Market Segmentation
4.5 Porter 5(Five) Forces
4.6 PEST Analysis
5 MARKET CHARACTERISTICS
5.1 Market Dynamics
5.1.1 Drivers
5.1.1.1 Conducive government legislation
5.1.1.2 Marketing exclusivity for orphan drugs
5.1.1.3 Growing unmet need for treatment of orphan diseases
5.1.2 Opportunities
5.1.2.1 Growing Novel indications for known orphan drugs
5.1.2.2 Untapped emerging market
5.1.3 Restraints
5.1.3.1 High cost of treatment
5.1.3.2 Lack of Adequate patients for clinical trials
5.1.4 DRO – Impact Analysis
5.1.5 Key Stakeholders
6 DRUG DETAILS: MARKET SIZE AND ANALYSIS
6.1 Overview
7 TYPES: MARKET SIZE AND ANALYSIS
7.1 Overview
7.1.1 Biologics
7.1.2 Non-Biologics
8 APPLICATION: MARKET SIZE AND ANALYSIS
8.1 Overview
8.1.1 Oncology
8.1.2 Metabolic Diseases
8.1.3 Hematology
8.1.4 Infectious Diseases
8.1.5 Neurology
8.1.6 Others
9 PIPELINE MOLECULES: MARKET SIZE AND ANALYSIS
9.1 Overview
10 REGIONS: MARKET SIZE AND ANALYSIS
10.1 Overview
10.2 North America
10.2.1 Overview
10.2.2 US
10.2.3 Canada
10.3 Europe
10.3.1 Overview
10.3.1.1 UK
10.3.1.2 Germany
10.3.1.3 France
10.4 APAC
10.4.1 Overview
10.4.1.1 India
10.4.1.2 Japan
10.4.1.3 China
10.5 Rest of the World
10.5.1 Overview
10.5.1.1 Brazil
10.5.1.2 Mexico
10.5.1.3 Africa
10.5.1.4 Middle East
11 COMPETITIVE LANDSCAPE
12 VENDOR PROFILES
12.1 Novartis AG
12.1.1 Overview
12.1.2 Business Unit
12.1.3 Geographic Presence
12.1.4 Business Focus
12.1.5 SWOT Analysis
12.1.6 Business Strategy
12.2 F.Hoffmann-La Roche Ltd
12.2.1 Overview
12.2.2 Business Unit
12.2.3 Geographic Presence
12.2.4 Business Focus
12.2.5 SWOT Analysis
12.2.6 Business Strategy
12.3 Celgene Corporation
12.3.1 Overview
12.3.2 Geographic Presence
12.3.3 Business Focus
12.3.4 SWOT Analysis
12.3.5 Business Strategy
12.4 Bristol-Myers Squibb
12.4.1 Overview
12.4.2 Geographic Presence
12.4.3 Business Focus
12.4.4 SWOT Analysis
12.4.5 Business Strategy
12.5 Shire PLC
12.5.1 Overview
12.5.2 Business Unit
12.5.3 Geographic Presence
12.5.4 Business Focus
12.5.5 SWOT Analysis
12.5.6 Business Strategy
13 COMPANIES TO WATCH FOR
13.1 Pfizer Inc.,
13.1.1 Overview
13.1.2 Highlights
13.2 Sanofi
13.2.1 Overview
13.3 Bayer AG
13.3.1 Overview
13.4 Alexion Pharmaceutical Inc.
13.4.1 Overview
13.5 Biogen Pharmaceuticals.
13.5.1 Overview
13.6 Eli Lilly and Company.
13.6.1 Overview
13.7 Amgen Inc.
13.7.1 Overview
Annexure
Abbreviations
1.1 Industry Overview
1.2 Industry Trends
2 REPORT OUTLINE
2.1 Report Scope
2.2 Report Summary
2.3 Research Methodology
2.4 Report Assumptions
3 MARKET SNAPSHOT
3.1 Market Definition – Infoholic Research
3.2 Segmented Addressable Market (SAM)
3.2.1 Advantages of Development of Orphan Drug
3.2.2 Trends of orphan drug market
3.3 Related Addressable Markets (RAM)
3.3.1 Oncology (Cancer) Drugs
3.3.2 Active pharmaceutical ingredients (APIs)
3.3.3 Over the counter drugs (OTC)
4 MARKET OUTLOOK
4.1 Overview
4.2 Regulatory Framework for orphan drugs
4.3 Funding Scenario for orphan drugs
4.4 Market Segmentation
4.5 Porter 5(Five) Forces
4.6 PEST Analysis
5 MARKET CHARACTERISTICS
5.1 Market Dynamics
5.1.1 Drivers
5.1.1.1 Conducive government legislation
5.1.1.2 Marketing exclusivity for orphan drugs
5.1.1.3 Growing unmet need for treatment of orphan diseases
5.1.2 Opportunities
5.1.2.1 Growing Novel indications for known orphan drugs
5.1.2.2 Untapped emerging market
5.1.3 Restraints
5.1.3.1 High cost of treatment
5.1.3.2 Lack of Adequate patients for clinical trials
5.1.4 DRO – Impact Analysis
5.1.5 Key Stakeholders
6 DRUG DETAILS: MARKET SIZE AND ANALYSIS
6.1 Overview
7 TYPES: MARKET SIZE AND ANALYSIS
7.1 Overview
7.1.1 Biologics
7.1.2 Non-Biologics
8 APPLICATION: MARKET SIZE AND ANALYSIS
8.1 Overview
8.1.1 Oncology
8.1.2 Metabolic Diseases
8.1.3 Hematology
8.1.4 Infectious Diseases
8.1.5 Neurology
8.1.6 Others
9 PIPELINE MOLECULES: MARKET SIZE AND ANALYSIS
9.1 Overview
10 REGIONS: MARKET SIZE AND ANALYSIS
10.1 Overview
10.2 North America
10.2.1 Overview
10.2.2 US
10.2.3 Canada
10.3 Europe
10.3.1 Overview
10.3.1.1 UK
10.3.1.2 Germany
10.3.1.3 France
10.4 APAC
10.4.1 Overview
10.4.1.1 India
10.4.1.2 Japan
10.4.1.3 China
10.5 Rest of the World
10.5.1 Overview
10.5.1.1 Brazil
10.5.1.2 Mexico
10.5.1.3 Africa
10.5.1.4 Middle East
11 COMPETITIVE LANDSCAPE
12 VENDOR PROFILES
12.1 Novartis AG
12.1.1 Overview
12.1.2 Business Unit
12.1.3 Geographic Presence
12.1.4 Business Focus
12.1.5 SWOT Analysis
12.1.6 Business Strategy
12.2 F.Hoffmann-La Roche Ltd
12.2.1 Overview
12.2.2 Business Unit
12.2.3 Geographic Presence
12.2.4 Business Focus
12.2.5 SWOT Analysis
12.2.6 Business Strategy
12.3 Celgene Corporation
12.3.1 Overview
12.3.2 Geographic Presence
12.3.3 Business Focus
12.3.4 SWOT Analysis
12.3.5 Business Strategy
12.4 Bristol-Myers Squibb
12.4.1 Overview
12.4.2 Geographic Presence
12.4.3 Business Focus
12.4.4 SWOT Analysis
12.4.5 Business Strategy
12.5 Shire PLC
12.5.1 Overview
12.5.2 Business Unit
12.5.3 Geographic Presence
12.5.4 Business Focus
12.5.5 SWOT Analysis
12.5.6 Business Strategy
13 COMPANIES TO WATCH FOR
13.1 Pfizer Inc.,
13.1.1 Overview
13.1.2 Highlights
13.2 Sanofi
13.2.1 Overview
13.3 Bayer AG
13.3.1 Overview
13.4 Alexion Pharmaceutical Inc.
13.4.1 Overview
13.5 Biogen Pharmaceuticals.
13.5.1 Overview
13.6 Eli Lilly and Company.
13.6.1 Overview
13.7 Amgen Inc.
13.7.1 Overview
Annexure
Abbreviations
