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Global Orphan Drugs Market Trends and Drivers, Restraints, and Opportunities 2017-2023

September 2017 | 125 pages | ID: G815C58F4DBEN
IHR Insights

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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:


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

Tables
Table 1 REGULATORY FRAMEWORK FOR ORPHAN DRUGS
Table 2 FUNDED PROJECTS OF 2017
Table 3 LIST OF ORPHAN DRUGS APPROVED IN THE MARKET
Table 4 MARKET REVENUE OF TOP 15 DRUGS, 2016 AND 2023 ($BILLION)
Table 5 MOLECULES IN DEVELOPMENT (2015)
Table 6 AUTOIMMUNE DISEASES MOLECULES
Table 7 BLOOD DISORDER MOLECULES
Table 8 RARE CANCER MOLECULES
Table 9 BLOOD CANCER MOLECULES
Table 10 CARDIOVASCULAR DISORDERS MOLECULES
Table 11 DIGESTIVE DISORDERS MOLECULES
Table 12 EYE DISORDERS MOLECULES
Table 13 GENETIC DISORDERS MOLECULES
Table 14 GROWTH DISORDERS MOLECULES
Table 15 INFECTIOUS DISORDERS MOLECULES
Table 16 NEUROLOGIC DISORDERS MOLECULES
Table 17 RESPIRATORY DISORDERS MOLECULES
Table 18 TRANSPLANTATION MOLECULES
Table 19 OTHER DISORDERS MOLECULES IN THE PIPELINE
Table 20 ORPHAN DRUGS MARKET REVENUE BY REGIONS, 2016–2023 ($BILLION)
Table 21 TOP 5 ORPHAN DRUGS IN THE US MARKET
Table 22 REGULATORY AUTHORITIES IN ASIA PACIFIC
Table 23 NOVARTIS AG: OFFERINGS
Table 24 NOVARTIS AG: RECENT DEVELOPMENTS
Table 25 F. HOFFMANN-LA ROCHE LTD.: OFFERINGS
Table 26 F. HOFFMANN-LA ROCHE LTD.: RECENT DEVELOPMENTS
Table 27 CELGENE CORPORATION: OFFERINGS
Table 28 CELGENE CORPORATION: RECENT DEVELOPMENTS
Table 29 BRISTOL–MYERS SQUIBB: OFFERINGS
Table 30 BRISTOL–MYERS SQUIBB: RECENT DEVELOPMENTS
Table 31 SHIRE PLC: OFFERINGS
Table 32 SHIRE PLC: RECENT DEVELOPMENTS
Table 33 PFIZER: RECENT DEVELOPMENTS
Table 34 SANOFI: RECENT DEVELOPMENTS
Table 35 BAYER AG: RECENT DEVELOPMENTS
Table 36 ALEXION PHARMACEUTICAL, INC.: RECENT DEVELOPMENTS
Table 37 BIOGEN PHARMACEUTICALS: RECENT DEVELOPMENTS
Table 38 ELI LILLY AND COMPANY: RECENT DEVELOPMENTS
Table 39 AMGEN INC.: RECENT DEVELOPMENTS

Charts
Chart 1 PEST ANALYSIS OF ORPHAN DRUGS MARKET
Chart 2 RESEARCH METHODOLOGY OF GLOBAL ORPHAN DRUGS MARKET
Chart 3 GLOBAL ORPHAN DRUGS MARKET REVENUE, 2016–2023 ($BILLION)
Chart 4 SEGMENTATION OF GLOBAL ORPHAN DRUGS MARKET
Chart 5 PORTER 5 FORCES OF ORPHAN DRUGS MARKET
Chart 6 MARKET DYNAMICS – DRO ANALYSIS
Chart 7 DRO – IMPACT ANALYSIS OF GLOBAL ORPHAN DRUGS MARKET
Chart 8 KEY STAKEHOLDERS OF GLOBAL ORPHAN DRUGS MARKET
Chart 9 ORPHAN DRUGS MARKET REVENUE BY TYPES SEGMENTATION, 2016 VS. 2023 ($BILLION)
Chart 10 BIOLOGICS ORPHAN DRUGS MARKET REVENUE BY TYPES SEGMENTATION, 2016–2023 ($BILLION)
Chart 11 NON-BIOLOGICS ORPHAN DRUGS MARKET REVENUE BY TYPES SEGMENTATION, 2016–2023 ($BILLION)
Chart 12 ORPHAN DRUGS MARKET SHARE BY APPLICATION SEGMENTATION, 2016 (%)
Chart 13 HEMATOLOGY MARKET SHARE, 2016
Chart 14 ORPHAN DRUG THERAPEUTIC AREA IN PIPELINE, 2016
Chart 15 ORPHAN DRUGS IN PIPELINE, 2016
Chart 16 ORPHAN DRUGS MARKET SHARE BY REGIONAL SEGMENTATION, 2016 VS. 2023 (%)
Chart 17 ORPHAN DRUGS MARKET REVENUE IN NORTH AMERICA, 2016–2023 ($BILLION)
Chart 18 ORPHAN DRUGS MARKET REVENUE IN EUROPE, 2016–2023 ($BILLION)
Chart 19 ORPHAN DRUGS MARKET REVENUE IN APAC, 2016–2023 ($BILLION)
Chart 20 ORPHAN DRUGS MARKET REVENUE IN REST OF THE WORLD, 2016–2023 ($BILLION)
Chart 21 ORPHAN DRUGS MARKET SHARE, 2016
Chart 22 NOVARTIS AG: OVERVIEW SNAPSHOT
Chart 23 NOVARTIS AG: BUSINESS UNITS
Chart 24 NOVARTIS AG: GEOGRAPHIC REVENUE
Chart 25 NOVARTIS AG: SWOT ANALYSIS
Chart 26 F. HOFFMANN-LA ROCHE LTD.: OVERVIEW SNAPSHOT
Chart 27 F. HOFFMANN-LA ROCHE LTD.: BUSINESS UNITS
Chart 28 F. HOFFMANN-LA ROCHE LTD.: GEOGRAPHIC REVENUE
Chart 29 F. HOFFMANN-LA ROCHE LTD.: SWOT ANALYSIS
Chart 30 CELGENE CORPORATION: OVERVIEW SNAPSHOT
Chart 31 CELGENE CORPORATION: GEOGRAPHIC REVENUE
Chart 32 CELGENE CORPORATION: SWOT ANALYSIS
Chart 33 BRISTOL–MYERS SQUIBB: OVERVIEW SNAPSHOT
Chart 34 BRISTOL–MYERS SQUIBB: BUSINESS SEGMENTS
Chart 35 BRISTOL–MYERS SQUIBB: GEOGRAPHIC REVENUE
Chart 36 BRISTOL–MYERS SQUIBB: SWOT ANALYSIS
Chart 37 SHIRE PLC: OVERVIEW SNAPSHOT
Chart 38 SHIRE PLC: BUSINESS UNITS
Chart 39 SHIRE PLC: GEOGRAPHIC REVENUE
Chart 40 SHIRE PLC: SWOT ANALYSIS


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