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.

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

PART 15: Explore Technavio