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Global Orphan Drugs Market 2017-2021

  • ID: 4199057
  • Report
  • April 2017
  • 70 pages
  • TechNavio
OFF
until 30th Apr 2017
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FEATURED COMPANIES

  • AbbVie
  • Alexion Pharmaceuticals
  • Bayer
  • Bristol-Myers Squibb
  • Eli Lilly
  • Johnson & Johnson
  • MORE
 
One Hour Free Analyst Time

Speak directly to the analyst to clarify any post sales queries you may have.

According to Orphan Drug Designation program of the US Food and Drug Administration (FDA), orphan diseases are defined as rare diseases that affects less than 2,00,000 Americans. The global orphan drugs market is expected to benefit from patent extensions like Orphan Drug Exclusivity (ODE), increasing focus of vendors on orphan drug products, and financial incentives provided by government in form of tax credits and waived FDA fees.

For instance, the FDA grants a seven-year patent exclusivity to orphan drugs to treat a rare disease. Therefore, any other drug with the same indication cannot be approved by the FDA during these seven-years period. In addition, they also provide tax credits up to 50% of the total R&D cost after the drug receives the orphan drug designation. This credit can be used by the sponsor during the R&D phase of any drug irrespective of the drug designation. The orphan designated drugs are also exempted from paying the FDA fees. Thus, these financial incentives and grants for orphan drug attract many vendors to invest in developing drugs for rare diseases and make huge profits.

The analysts forecast the global orphan drugs market to grow at a CAGR of 10.20% during the period 2017-2021.

Covered in this report

The report covers the present scenario and the growth prospects of the global orphan drugs market for 2017-2021. To calculate the market size, the report presents a detailed picture of the market by way of study, synthesis, and summation of data from multiple sources.

The market is divided into the following segments based on geography:

- Americas
- APAC
- EMEA

The report, Global Orphan Drugs Market 2017-2021, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years. The report also includes a discussion of the key vendors operating in this market.

Key vendors
- AbbVie
- Celgene
- F. Hoffmann La Roche
- Novartis

Other prominent vendors
- Amgen
- Actelion
- Alexion Pharmaceuticals
- Bayer
- Biogen
- Bristol-Myers Squibb
- Eli Lilly
- Johnson & Johnson
- Novo Nordisk
- Pfizer
- Sanofi
- Shire
- Teva pharmaceutical

Market drivers
- Large growth opportunities through orphan drug designation.
- For a full, detailed list, view the full report

Market challenges
- Costly treatment regimen results in financial burden on patients.
- For a full, detailed list, view the full report

Market trends
- Emerging application for orphan drug development.
- For a full, detailed list, view the full report

Key questions answered in this report
- What will the market size be in 2021 and what will the growth rate be?
- What are the key market trends?
- What is driving this market?
- What are the challenges to market growth?
- Who are the key vendors in this market space?
- What are the market opportunities and threats faced by the key vendors?
- What are the strengths and weaknesses of the key vendors?

You can request one free hour of the analyst’s time when you purchase this market report. Details are provided within the report.
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FEATURED COMPANIES

  • AbbVie
  • Alexion Pharmaceuticals
  • Bayer
  • Bristol-Myers Squibb
  • Eli Lilly
  • Johnson & Johnson
  • MORE
 
One Hour Free Analyst Time

Speak directly to the analyst to clarify any post sales queries you may have.

PART 01: Executive summary

PART 02: Scope of the report

PART 03: Research Methodology

PART 04: Introduction
- Key market highlights
- Pipeline analysis

PART 05: Market landscape
- Market overview
- Market size and forecast
- Five forces analysis

PART 06: Regulatory approval
- Orphan drug legislation

PART 07: Market segmentation by product type
- Biologics
- Non-biologics

PART 08: Geographical segmentation
- Orphan drugs market in Americas
- Orphan drugs market in EMEA
- Orphan Drugs Market in APAC

PART 09: Decision framework

PART 10: Drivers and challenges
- Market Drivers
- Impact of drivers on key customer segments
- Market Challenges
- Impact of challenges on key customer segments

PART 11: Market trends
- Emerging applications for orphan drug development
- Increasing focus on development of biologics
- Repurposing of non-orphan drugs to orphan drugs

PART 12: Competitive Scenario
- Vendor landscape

PART 13: Key vendor analysis
- AbbVie
- Celgene
- F. Hoffmann La Roche
- Novartis
- Other prominent vendors

PART 14: Appendix
- List of Abbreviations

List of Exhibits

Exhibit 01: Overview of phase III molecules for few vendors
Exhibit 02: Pipeline overview based on different therapies
Exhibit 03: Pipeline analysis
Exhibit 04: Global orphan drugs market snapshot
Exhibit 05: Orphan drug requests' year-over-year growth 2014-2016
Exhibit 06: Few breakthroughs in global orphan drugs market 2014-2016
Exhibit 07: Global orphan drugs market 2016-2021 ($ billions)
Exhibit 08: Opportunity analysis in global orphan drugs market
Exhibit 09: Five forces analysis
Exhibit 10: Global orphan drugs market segmentation based on product type
Exhibit 11: Increasing trend of approval of biologics
Exhibit 12: Global orphan drugs market for biologics 2016-2021 ($ billions)
Exhibit 13: Few significant non-biologics approved as orphan drugs
Exhibit 14: Global orphan drugs market for non-biologics 2016-2021 ($ billions)
Exhibit 15: Global orphan drugs market by geography 2016 and 2021
Exhibit 16: Global orphan drugs market by geography 2016-2021 ($ billions)
Exhibit 17: Global orphan drugs market share by geography 2016-2021
Exhibit 18: Market Scenario in Americas
Exhibit 19: Orphan drugs market in Americas 2016-2021 ($ billions)
Exhibit 20: Market scenario in EMEA
Exhibit 21: Orphan drugs market in EMEA 2016-2021 ($ billions)
Exhibit 22: Market scenario in APAC
Exhibit 23: Orphan drugs market in APAC 2016-2021 ($ billions)
Exhibit 24: Increase in FDA approval of orphan drugs 2012-2015
Exhibit 25: List of few benefits through orphan drug designation
Exhibit 26: Impact of drivers
Exhibit 27: Current pricing scenario of orphan drugs
Exhibit 28: Impact of challenges
Exhibit 29: Successful examples of repurposed blockbuster orphan drugs
Exhibit 30: Competitive structure analysis of global orphan drugs market 2016
Exhibit 31: Competitive analysis of global orphan drugs market
Exhibit 32: AbbVie: Key highlights
Exhibit 33: AbbVie: Key orphan drugs
Exhibit 34: AbbVie: Strength assessment
Exhibit 35: AbbVie: Strategy assessment
Exhibit 36: AbbVie: Opportunity assessment
Exhibit 37: Celgene: Key highlights
Exhibit 38: Celgene: Key orphan drugs
Exhibit 39: Celgene: Strength assessment
Exhibit 40: Celgene: Strategy assessment
Exhibit 41: Celgene: Opportunity assessment
Exhibit 42: Roche: Key highlights
Exhibit 43: Roche: Key orphan drugs
Exhibit 44: Roche: Strength assessment
Exhibit 45: Roche: Strategy assessment
Exhibit 46: Roche: Opportunity assessment
Exhibit 47: Novartis: Key highlights
Exhibit 48: Novartis: Key orphan drugs
Exhibit 49: Novartis: Strength assessment
Exhibit 50: Novartis: Strategy assessment
Exhibit 51: Novartis: Opportunity assessment
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FEATURED COMPANIES

  • AbbVie
  • Alexion Pharmaceuticals
  • Bayer
  • Bristol-Myers Squibb
  • Eli Lilly
  • Johnson & Johnson
  • MORE
 
One Hour Free Analyst Time

Speak directly to the analyst to clarify any post sales queries you may have.

New Report Released: - Global Orphan Drugs Market 2017-2021

The author of the report recognizes the following companies as the key players in the global orphan drugs market: AbbVie, Celgene, F. Hoffmann La Roche, and Novartis.

Other Prominent Vendors in the market are: Amgen, Actelion, Alexion Pharmaceuticals, Bayer, Biogen, Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson, Novo Nordisk, Pfizer, Sanofi, Shire, and Teva pharmaceutical.

Commenting on the report, an analyst from the research team said: “One trend in market is repurposing of non-orphan drugs to orphan drugs. The orphan drugs market has witnessed many successful repositioning of drugs from non-orphan label to orphan label. Since the implementation of the orphan drug legislation in the United States, more than 69 drugs which were first approved by US FDA for the treatment of rare diseases were not entirely new and had been repurposed from the non-orphan label to the orphan label. Today, most of the pharmaceutical and biotechnological companies has adopted the strategy of drug repurposing in order to save time and money.

Repurposing of an already approved drug for a different indication helps to mitigate the risk of drug failure as the drug has undergone the pharmacovigilance regulatory requirement and post-marketing survey. This reduces the risk of heavy financial loss to the manufacturer. In addition, the drug repurposing strategy also helps manufacturers to extend their product life cycle by getting orphan drug status, and also prevents their product from generic competition. Moreover, the external forces such as availability of huge amount of data, computational tools which helps in effective analysis of data and the advent of precession medicines for development of drugs that target a specific diseased population, has led to increase the adoption of this strategy.”

According to the report, one driver in market is high unmet need drives growth. The global orphan drugs market is growing at a rapid pace. Yet, it represents a high unmet need for the development of more efficacious drugs with fewer side-effects. Though the market is relatively small pertaining to the small patient pool, the return on investment is very high owing to the expensive orphan drugs. It has encouraged many big as well as small emerging pharmaceutical and biotechnological companies to invest in this market.

The growing prevalence of rare diseases combined with the rising awareness among population and higher life expectancy rates are helping the global orphan drugs market to grow at a rapid rate. Additionally, government initiatives worldwide have positively influenced R&D on orphan drugs. Further, the number of marketing approvals of these drugs has shown a dramatic increase over the past few years.

Further, the report states that one challenge in market is costly treatment regimen results in financial burden on patients. The orphan drugs market is currently witnessing a growing concern due to increasing cost of orphan drugs and the need for a cost-effective therapy to treat rare disease in developing countries. The reason behind the rise in cost of these drugs is due to lack of competition and low density of drugs marketed for the treatment of same indication.

The low availability of alternatives is because of the enforcement of patent exclusivity rule under the US ODA, which restricts the approval of an alternative drug until it represents evidence of being superior to the first-approved drug in terms of safety and efficacy. For instance, the average cost of a rare disease therapy for a year is more than the cost of a car. This limits the access to orphan drug for patients living in developing countries such as India and China. As the reimbursement rates for these drugs are low, healthcare professionals hesitate to prescribe these drugs considering the financial status of a patient.

The study was conducted using an objective combination of primary and secondary information including inputs from key participants in the industry. The report contains a comprehensive market and vendor landscape in addition to a SWOT analysis of the key vendors.
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One Hour Free Analyst Time

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  • AbbVie
  • Celgene
  • F. Hoffmann La Roche
  • Novartis
  • Amgen
  • Actelion
  • Alexion Pharmaceuticals
  • Bayer
  • Biogen
  • Bristol-Myers Squibb
  • Eli Lilly
  • Johnson & Johnson
  • Novo Nordisk
  • Pfizer
  • Sanofi
  • Shire
  • Teva pharmaceutical
Note: Product cover images may vary from those shown
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