Global Orphan Drugs Market: Overview
Orphan drug products are medicines for the therapy of life-threating or extremely severe illnesses or disorders which are uncommon for diagnosis, prevention or therapy. The pharmaceutical industry is little interested in the development and marketing of products designed for a tiny amount of patients under ordinary market circumstances. These medicines are called orphans. In 1983, the Orphan Drug Act was enacted to encourage drug companies to create rare disease therapy. The FDA Office for the Development of Orphan Products determines whether a drug is an orphan.
The incredibly high costs of placing a medicinal product on the market in drug companies would not be recovered from anticipated product revenues. This also leads to a small market potential for fresh drug use and an economic loss for the drug companies sector.
The worldwide orphan medicinal products market is expected to swell during the forecast period to give increasing significance to research and development operations. Over the forecast period 2017 to 2025 the international market for orphan drugs is expected to improve by 12.10 percent at CAGR. By the end of 2025, the worldwide market for orphan drugs should reach a net estimate of 318,5 billion US dollars.
The global orphan drugs market is segmented by the disease type, by indicator, and by technology for study. Further, the market is considered in terms of different geographical regions in the report.
Rising Prevalence of Rare Diseases to Strengthen Orphan Drugs Market
Recurring, chronic and rare illnesses and the elevated demand for significant amounts of orphan drug production are currently forecast to affect around 300 million people worldwide. Rare disease medicines, such as Yellow Fever, von Willebrand Disease, Waardenburg Syndrome, Diabetes Macular Edema, Abetalypoproteinemia, ASD, Yellow Nail Syndrome or Von Hippel Lindau Syndrome and others, are increasing in demand for medicinal products that help increase the market. In addition, FDA free exemptions, public R&D grants, favourable reimbursement policies and premium pricing for business development.
In 2019, it is likely that the U.S. will see around 1,762,450 new cancer cases, according to the National Center for Health Statistics. The demand for orphan medicines is likely to rise in the coming years as these figures are motivated. As a result, there have been a total of 4,171 drugs in the US as orphan drugs. Such Government initiatives encourage drug manufacturers to invest more in the said industry.
Although the market for orphan medicines is developing at a decent rate, certain variables can impede its development. The elevated price of orphan medicines, inadequate data on rare illnesses and the absence of competent health experts are factors that reduce development in the worldwide market for orphan medicines. Furthermore, increasing competition from generic sectors can seriously threaten market growth.
Global Orphan Drugs Market: Regional Outlook
The global orphan drugs market is segmented for study into North America, Europe, and Rest of the World. Among these, North America is expected to register for high growth in the global market.
There are several factors contributing to the development of the industry, including promoting laws that enable rapid approval of such drugs, drug status exclusivity for such drugs and a solid medical infrastructure.
Global Orphan Drugs Market: Companies Mentioned
Key vendors profiled in our report on the global orphan drugs market include Novartis AG, F. Hoffmann-La Roche Ltd., Bristol-Myers Squibb Company, GlaxoSmithKline plc., Daiichi Sankyo Company Limited, Novo Nordisk A/S, Bayer AG, AstraZeneca plc., and Amgen Inc., among several others.
Orphan Drugs Market will Gain Significant Revenues from Growing Prevalence of Rare Diseases
Orphan drug items are medications for the treatment of life-threating or amazingly extreme ailments or problems which are phenomenal for conclusion, counteraction or treatment. The drug business is minimal keen on the turn of events and showcasing of items intended for a small measure of patients under conventional market conditions. These medications are called orphan drugs. The staggeringly significant expenses of setting a restorative item available in drug organizations would not be recuperated from expected item incomes. This additionally prompts a little market potential for new medication use and a financial misfortune for the medication organizations area.
Orphan medication can be characterized as a drug specialist explicitly intended to treat uncommon (orphaned) illnesses. These sicknesses contrast from regular illnesses as their predominance rate is low and consequently appeal to a little tolerant populace. Subsequently, when contrasted with non-orphan drugs, these drugs don't ensure achievable profits from speculation. Nonetheless, different government specialists urge to create and market such drugs. Cost related with the advancement of these drugs is higher when contrasted and non-orphan drugs. The various signs for which orphan drugs are utilized incorporate lymphoma, leukemia, cystic fibrosis, and others.
The rising mindfulness activities are projected to push the interest for orphan drugs. Moreover, expanding instances of metabolic problem and cardiovascular illnesses to support the worldwide orphan drug market towards an amazing development in the impending years. The oncology division of drugs runs over rising number of malignancy patients with different sorts of disease, every year. The number is by all accounts just expanding measurably, to battle the circumstance, there is developing need and interest for the powerful drugs in the medication advancement region. Consequently, the worldwide orphan drug market is projected to see development openings in the approaching years.
The growing geriatric rate of elderly population with constant conditions calls for viable drugs to treat the condition or keep them in charge. Along these lines, the interest for orphan drug builds, inferable from considerable development in the worldwide orphan drug market during the conjecture time frame.
For the purpose of this study, the market has been segmented as follows:
by Disease Type |
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by Indicator |
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by Technology |
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by Geography |
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List of Tables
Table 01: Comparative Analysis of orphan drug policies
Table 02: Top selling orphan drugs of 2016
Table 03: Orphan Drugs- Drug Exclusivity Details (of Few Orphan Drugs)
Table 04: Pipeline Analysis
Table 05: Global Orphan Drugs Market Size (US$ Bn) Forecast, by Disease Type, 2015–2025
Table 06: Global Orphan Drugs Market Size (US$ Bn) Forecast, by Product Type, 2015–2025
Table 07: Global Orphan Drugs Market Size (US$ Bn) Forecast, by Distribution Channel, 2015–2025
Table 08: Global Orphan Drugs Market Size (US$ Bn) Forecast, by Region, 2015–2025
Table 09: North America Orphan Drugs Market Size (US$ Bn) Forecast, by Country, 2015–2025
Table 10: North America Orphan Drugs Market Size (US$ Bn) Forecast, by Product Type, 2015–2025
Table 11: North America Orphan Drugs Market Size (US$ Bn) Forecast, by Disease Type, 2015–2025
Table 12: North America Orphan Drugs Market Size (US$ Bn) Forecast, by Distribution Channel, 2015–2025
Table 13: Europe Orphan Drug Market Size (US$ Bn) Forecast, by Country, 2015–2025
Table 14: Europe Orphan Drug Market Size (US$ Bn) Forecast, by Product Type, 2015–2025
Table 15: Europe Orphan Drugs Market Size (US$ Bn) Forecast, by Disease Type, 2015–2025
Table 16: Europe Orphan Drugs Market Size (US$ Bn) Forecast, by Distribution Channel, 2015–2025
Table 17: Rest of the World Orphan Drugs Market Size (US$ Bn) Forecast, by Country, 2015–2025
Table 18: Rest of the World Orphan Drugs Market Size (US$ Bn) Forecast, by Product Type, 2015–2025
Table 19: Rest of the World Orphan Drugs Market Size (US$ Bn) Forecast, by Disease Type, 2015–2025
Table 20: Rest of the World Orphan Drugs Market Size (US$ Bn) Forecast, by Distribution Channel, 2015–2025
List of Figures
Figure 01: Global Orphan Drugs Market Size (US$ Mn) and Y-o-Y Growth (%), and Forecast, 2017–2025
Figure 02: Market Value Share By Disease Type (2017)
Figure 03: Market Value Share By Product Type (2017)
Figure 04: Market Value Share By Distribution Channel (2017)
Figure 05: Market Value Share By Region (2017)
Figure 06: Porter’s Five Force Analysis
Figure 07: Orphan Drugs Market- SWOT Analysis
Figure 08: Regulatory Approval Process- The U.S.
Figure 09: Regulatory Approval Process- Europe
Figure 10: Regulatory Approval Process- Japan
Figure 11: Prevalence of Orphan (rare) diseases
Figure 12: Factors contributing to the orphan drugs pricing decision
Figure 13: Pricing of certain orphan drugs (US$ per patient per year)
Figure 14: Factors for high prices of orphan drugs
Figure 15: Orphan Drugs- Price Volume Analysis
Figure 16: Conferences held on Orphan Diseases
Figure 17: Global Orphan Drugs Market Value Share Analysis, by Disease Type, 2016 and 2025
Figure 18: Global Orphan Drugs Market Revenue (US$ Bn) and Y-o-Y Growth (%) Forecast, by Oncology, 2015–2025
Figure 19: Global Orphan Drugs Market Revenue (US$ Bn) and Y-o-Y Growth (%) Forecast, by Gastrointestinal, 2015–2025
Figure 20: Global Orphan Drugs Market Revenue (US$ Bn) and Y-o-Y Growth (%) Forecast, by Pulmonary, 2015–2025
Figure 21: Global Orphan Drugs Market Revenue (US$ Bn) and Y-o-Y Growth (%) Forecast, by Neurology, 2015–2025
Figure 22: Global Orphan Drugs Market Revenue (US$ Bn) and Y-o-Y Growth (%) Forecast, by Hematology, 2015–2025
Figure 23: Global Orphan Drugs Market Revenue (US$ Bn) and Y-o-Y Growth (%) Forecast, by Cardiovascular,
Figure 24: Global Orphan Drugs Market Revenue (US$ Bn) and Y-o-Y Growth (%) Forecast, by Metabolic Disorders, 2015–2025
Figure 25: Global Orphan Drugs Market Revenue (US$ Bn) and Y-o-Y Growth (%) Forecast, by Endocrinology,
Figure 26: Global Orphan Drugs Market Revenue (US$ Bn) and Y-o-Y Growth (%) Forecast, by Infectious Diseases, 2015–2025
Figure 27: Global Orphan Drugs Market Revenue (US$ Bn) and Y-o-Y Growth (%) Forecast, by Others, 2015–2025
Figure 28: Global Orphan Drugs Market Attractiveness, by Disease Type, 2017-2025
Figure 29: Global Orphan Drugs Market Value Share Analysis, by Product Type, 2016 and 2025
Figure 30: Global Orphan Drugs Market Revenue (US$ Bn), and Y-o-Y Growth (%), by Biologic, 2015–2025
Figure 31: Global Orphan Drugs Market Revenue (US$ Bn), and Y-o-Y Growth (%), by Non-biologic, 2015–2025
Figure 32: Global Orphan Drugs Market Attractiveness, by Product Type 2017-2025
Figure 33: Global Orphan Drugs Market Value Share Analysis, by Distribution Channel, 2016 and 2025
Figure 34: Global Orphan Drugs Market Revenue (US$ Bn), and Y-o-Y Growth (%) Forecast, by Hospital Pharmacies, 2015–2025
Figure 35: Global Orphan Drugs Market Revenue (US$ Bn), and Y-o-Y Growth (%) Forecast, by Specialty Pharmacies, 2015–2025
Figure 36: Global Orphan Drugs Market Revenue (US$ Bn), and Y-o-Y Growth (%) Forecast, by Retail Pharmacies,
Figure 37: Global Orphan Drugs Market Revenue (US$ Bn), and Y-o-Y Growth (%) Forecast, by Others, 2015–2025
Figure 38: Global Orphan Drugs Market Attractiveness, by Distribution Channel, 2017-2025
Figure 39: Global Orphan Drugs Market Revenue (US$ Bn) Forecast, 2015–2025
Figure 40: Global Orphan Drugs Market Value Share Analysis, by Region, 2016 and 2025
Figure 41: Global Orphan Drugs Market Attractiveness, by Region, 2017-2025
Figure 42: North America Orphan Drugs Market Size (US$ Bn) and Y-o-Y Growth (%) Forecast, 2015–2025
Figure 43: North America Orphan Drugs Market Attractiveness Analysis, by Country, 2017–2025
Figure 44: North America Orphan Drugs Market Value Share Analysis, by Country, 2016 and 2025
Figure 45: North America Orphan Drugs Market Value Share Analysis, by Product Type, 2016 and 2025
Figure 46: North America Orphan Drugs Market Value Share Analysis, by Disease Type, 2016 and 2025
Figure 47: North America Orphan Drugs Market Value Share Analysis, by Distribution Channel, 2016 and 2025
Figure 48: North America Orphan Drugs Market Attractiveness Analysis, by Product Type, 2017–2025
Figure 49: North America Orphan Drugs Market Attractiveness Analysis, by Distribution Channel, 2017–2025
Figure 50: North America Orphan Drugs Market Attractiveness Analysis, by Disease Type, 2017–2025
Figure 51: Europe Orphan Drug Market Size (US$ Bn) Forecast, 2015–2025
Figure 52: Europe Market Attractiveness Analysis, by Country, 2017–2025
Figure 53: Europe Orphan Drug Market Value Share Analysis, by Country, 2016 and 2025
Figure 54: Europe Orphan Drug Market Value Share Analysis, by Product Type, 2016 and 2025
Figure 55: Europe Orphan Drug Market Value Share Analysis, by Disease Type, 2016 and 2025
Figure 56: Europe Orphan Drug Market Value Share Analysis, by Distribution Channel, 2016 and 2025
Figure 57: Europe Orphan Drug Market Attractiveness Analysis, by Product type, 2017–2025
Figure 58: Europe Orphan Drug Market Attractiveness Analysis, by Distribution Channel, 2017–2025
Figure 59: Europe Orphan Drug Market Attractiveness Analysis, by Disease Type, 2017–2025
Figure 60: Rest of the World Orphan Drugs Market Size (US$ Bn) and Y-o-Y Growth (%) Forecast, 2015–2025
Figure 61: Rest of the World Market Attractiveness Analysis, by Country, 2017–2025
Figure 62: Rest of the World Orphan Drugs Market Value Share Analysis, by Country, 2016 and 2025
Figure 63: Rest of the World Orphan Drugs Market Value Share Analysis, by Product Type, 2016 and 2025
Figure 64: Rest of the World Orphan Drugs Market Value Share Analysis, by Disease Type, 2016 and 2025
Figure 65: Rest of the World Orphan Drugs Market Value Share Analysis, by Distribution Channel, 2016 and 2025
Figure 66: Rest of the World Orphan Drugs Market Attractiveness Analysis, by Product Type, 2017–2025
Figure 67: Rest of the World Orphan Drugs Market Attractiveness Analysis, by Distribution Channel, 2017–2025
Figure 68: Rest of the World Orphan Drugs Market Attractiveness Analysis, by Disease Type, 2017–2025
Figure 69: Global Orphan Drugs Market Share Analysis, by Company (2016)
Figure 70: Novartis AG, Breakdown of Net Sales, by Region, 2016
Figure 71: Novartis AG, Revenue (US$ Mn) & Y-o-Y Growth (%), 2013–2016
Figure 72: Bristol-Myers Squibb Company, Breakdown of Net Sales, by Region, 2016
Figure 73: Bristol-Myers Squibb Company, Revenue (US$ Bn) & Y-o-Y Growth (%), 2013–2016
Figure 74: Celgene Corporation, Breakdown of Net Sales, by Region, 2016
Figure 75: Celgene Corporation, Revenue (US$ Bn) & Y-o-Y Growth (%), 2013–2016
Figure 76: F. Hoffmann-La Roche Ltd., Breakdown of Net Sales (Pharmaceutical Division), by Region, 2016
Figure 77: F. Hoffmann-La Roche Ltd., Revenue (US$ Bn) & Y-o-Y Growth (%), 2013–2016
Figure 78: Pfizer, Inc., Breakdown of Net Sales, by Region, 2016
Figure 79: Pfizer, Inc., Revenue (US$ Bn) & Y-o-Y Growth (%), 2013–2016
Figure 80: Sanofi S.A., Breakdown of Net Sales, by Region, 2016
Figure 81: Sanofi S.A., Revenue (US$ Bn) & Y-o-Y Growth (%), 2013–2016
Figure 82: Alexion pharmaceuticals, Inc., Breakdown of Net Sales, by Region, 2016
Figure 83: Alexion pharmaceuticals, Inc., Revenue (US$ Bn) and Y-o-Y Growth (%), 2013–2016
Figure 84: Eli Lilly and Company, Breakdown of Net Sales, by Region, 2016
Figure 85: Eli Lilly and Company, Revenue (US$ Bn) and Y-o-Y Growth (%), 2013–2016
Figure 86: Novo Nordisk A/S, Breakdown of Net Sales, by Region, 2016
Figure 87: Novo Nordisk A/S, Revenue (US$ Bn) and Y-o-Y Growth (%), 2013–2016
Figure 88: AstraZeneca plc, Breakdown of Net Sales, by Region, 2016
Figure 89: AstraZeneca plc, Revenue (US$ Bn) and Y-o-Y Growth (%), 2013–2016
Figure 90: Eisai Co., Ltd., Breakdown of Net Sales, by Region, 2016
Figure 91: Eisai Co., Ltd., Revenue (US$ Bn) and Y-o-Y Growth (%), 2013–2016
Figure 92: Daiichi Sankyo Company Limited, Breakdown of Net Sales, by Region, 2016
Figure 93: Daiichi Sankyo Company Limited, Revenue (US$ Bn) and Y-o-Y Growth (%), 2013–2016
Figure 94: Bayer AG, Breakdown of Net Sales, by Region
Figure 95: Bayer AG, Revenue (US$ Bn) and Y-o-Y Growth (%), 2013–2016
Figure 96: GlaxoSmithKline plc, Breakdown of Net Sales, by Region, 2016
Figure 97: GlaxoSmithKline plc, Revenue (US$ Bn) and Y-o-Y Growth (%), 2013–2016
Figure 98: Merck & Co., Inc., Breakdown of Net Sales, by Region, 2016
Figure 99: Merck & Co., Inc., Revenue (US$ Bn) and Y-o-Y Growth (%), 2013–2016
Figure 100: Johnson & Johnson, Breakdown of Net Sales, by Region, 2016
Figure 101: Revenue (US$ Bn) and Y-o-Y Growth (%), 2013–2016
Figure 102: Biogen, Inc., Breakdown of Net Sales, by Region, 2016
Figure 103: Biogen, Inc., Revenue (US$ Bn) and Y-o-Y Growth (%), 2013–2016
Figure 104: Shire plc, Breakdown of Net Sales, by Region, 2016
Figure 105: Shire plc, Revenue (US$ Bn) and Y-o-Y Growth (%), 2013–2016
Figure 106: Amgen, Inc., Breakdown of Net Sales, by Region, 2016
Figure 107: Amgen, Inc., Revenue (US$ Bn) and Y-o-Y Growth (%), 2013–2016