Global orphan drugs (Global orphan drugs) are drugs used for the treatment of rare diseases and disorders that affects a small percentage of the population.

There are approximately 7,000 different types of rare diseases and disorders and an estimated 30 million people in the United States, 30 million in Europe and 350 million people worldwide suffer from rare disease. Four fifth of rare diseases are genetic in origin, with 50% of the people affected being children. The distribution of rare diseases is skewed with four fifth cases accounted by some 350 rare diseases. Only 5% of rare diseases have approved drug treatment with only 326 new drugs being approved by the FDA and brought to market.

In 2015, orphan drug sales were of the order of 93 billion. Orphan drugs, represented 35% of the industry’s new drug approvals. The $93 billion (2015) global orphan drug market, is projected to reach $200 billion in 2022, reflecting a compound annual growth rate (CAGR) of 11.56%. The revenues of biological orphan drug market and non-biological drug market will be 142.85 billion and 57.14 billion respectively in 2022.

The major driving factor for the growth are unmet needs for rare diseases and the growing investment in research and development, legislative, economic and tax benefits provided by governments, high return on investment, development of new technologies such as DNA recombinant, hybridoma and gene mapping, faster uptake and low marketing cost and extensive exclusivity.

However constraints such as high cost of development followed by costly clinical trials and extensive post market surveillance, monopolized and unitary market, competition from generics and biosimilars, and concern over the safety are threats which have to be managed. Active commercialization and distribution can be hindered by the differential availability of developed and developing countries due to social and economic factors.

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Key players in the Orphan Drugs market:

Hoffmann-La Roche AG (Germany), Celgene Corporation (U.S.), Alexion Pharmaceuticals, Inc. (U.S.), Novartis AG (Germany), Takeda Pharmaceuticals Company Limited (Japan), Biogen Idec Limited (U.K), Eli Lilly (U.S.), Bristol-Myers Squibb (U.K), Vertex pharmaceuticals, Inc. (U.S.), Bayer AG (Germany), Sanofi (France), and Johnson & Johnson (U.S.).

Key developments:

Strategic approaches adopted help the major players in the market to sustain their growth and develop their business in various geographical areas across the globe. Agreements and collaborations, mergers and acquisitions, and new product launches are various strategies followed by the key players. This help the companies to reach untapped markets in developing nations of the worlds, thus reducing the supply demand gap.

Johnson & Johnson:

Headquartered at New Brunswick, New Jersey, Johnson & Johnson Services Inc. is an American medical devices, pharmaceutical and consumer goods manufacturing company. Consumer care of Johnson & Johnson Services Inc. includes OTC, Beauty, Baby Care, Oral Care, Women’s Health, Wound Care and other products.

Novartis AG:

Novartis AG operates through three operating divisions, namely; Pharmaceuticals, Alcon (eye care) and Sandoz (generics).

GlaxoSmithKline:

November 2016: GlaxoSmithKline and Innoviva, Inc. announced a new drug application for FF/UMEC/VI in the US of once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol for patient’s chronic obstructive pulmonary disease (COPD).

December 2015: GlaxoSmithKline announced that it has been granted selling authorisation for Nucala (mepolizumab) by the European Commission. Nucala (mepolizumab) is used as an add-on treatment for refractory eosinophilic asthma in adult patients. The drug is approved for use in 31 countries in Europe covered by the European Medicines Agency (EMA).

October, 2015: GlaxoSmithKline completed the acquisition of Novartis Healthcare's vaccines business. It will enhance the company’s growth in vaccine portfolio.

October, 2015: GlaxoSmithKline sold its oncology portfolio to Novartis India. By selling oncology division, the company will be more focused on other segments such as vaccine business.
Segments:

Global Orphan Drugs Market has been segmented on the basis of pharmacological class, applications, technology, source and region.
Regional Analysis of Global orphan drugs Market:

Globally North America is the largest market for Global orphan drugs. Europe is the second-largest market for Global orphan drugs. The near future market for orphan drugs will be dominated by the developed regions with developing regions providing a supporting role only. However the developing regions market particularly Asia Pacific will be the fastest growing and is likely to be the key to the future.

Global Orphan Drugs Market Table of Contents

1 Introduction

1.1 Definition

1.2 Scope of Study

1.3 Research Objective

1.4 Assumptions & Limitations

1.5 Market Structure

2 Research Methodology

2.1 Research Process

2.2 Primary Research

2.3 Secondary Research

3 Market Dynamics

3.1 Drivers

3.2 Restraints

3.3 Opportunities

3.4 Challenges

3.5 Macroeconomic Indicators

4 Market Factor Analysis

4.1 Porter’s Five Forces Model

4.1.1 Bargaining Power of Suppliers

4.1.2 Bargaining Power of Customer

4.1.3 Intensity Of Competitor’s

4.1.4 Threat of New Entrants

List of Tables

Table 1 Global Orphan Drugs Market, 2013-2022 (Usd Million)

Table 2 global orphan drugs market, by application, 2013-2022 (usd million)

Table 3 global orphan drugs market, by pharmacological class, 2013-2022 (usd million)

Table 4 global orphan drugs market, by technology, 2013-2022 (usd million)

Table 5 global orphan drugs market, by source, 2013-2022 (usd million)

Table 6 global orphan drugs market, by region, 2013-2022 (usd million)

List of Figures

Figure 1 research process

Figure 2 porters five forces model

Figure 3 global orphan drugs market, by application

Figure 4 global orphan drugs market, by pharmacological class

Figure 5 global orphan drugs market, by tehcnology

Figure 6 global orphan drugs market, by source

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