Global Orphan Drug Market to Reach New Heights, Driven by Rising Rare Disease Cases and Government Incentives

The global orphan drug market was valued at USD 154.20 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 12.3% over the forecast period, according to the latest analysis. This strong growth is being fueled by the increasing number of rare diseases and supportive government policies that encourage the development of treatments for such conditions.

The latest report, titled 'Global Orphan Drug Market,' comprises a profound analysis of the fundamental parameters contributing to the global Orphan Drug market scenario. The research report provides the reader with an in-depth interpretation of the Orphan Drug market dynamics, including the crucial drivers, opportunities, threats, and challenges. The report also describes the key business strategies, demand and supply ratios, leading regions, and the renowned market players, in a nutshell, offering a futuristic outlook of the overall Orphan Drug industry. The market intelligence report is a prototype of the 360° overview of the global Orphan Drug industry, shedding light on the estimated market value, share, growth trends, gross revenue, competitive overview, prominent manufacturers and buyers, available product types, and end-use applications.

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Orphan drugs are specifically developed to treat rare diseases that affect a small portion of the population. In the U.S., a rare disease impacts fewer than 200,000 people, as defined by the Orphan Drug Act (ODA), while in Europe, it is fewer than 5 in 10,000 individuals.

Key Drivers of Growth

The rise in rare diseases across both developed and developing countries is creating greater demand for effective treatment options. In response, many governments have introduced policies and incentives-such as tax credits, market exclusivity, and regulatory support-to encourage pharmaceutical companies to develop these specialized treatments. These initiatives are significantly boosting the orphan drug market.

Additionally, the rapid expansion of the pharmaceutical industry and advancements in biotechnology are contributing to the development and availability of innovative therapies.

Challenges Facing the Market

Despite the promising growth, high treatment costs remain a major hurdle, especially in low- and middle-income countries. Limited insurance coverage and high out-of-pocket expenses may restrict access to these drugs for many patients, potentially slowing down market growth.

Market Segments Overview

By Drug Type:
The market is divided into biologics and non-biologics.
Biologics dominated the market in 2022, driven by an increase in biologically derived products such as vaccines, monoclonal antibodies, and immune therapies. According to the U.S. FDA, over 600 drugs and biological products have been developed under its Orphan Products Development Program since 1983.

By Therapy Area:
The oncology segment is expected to show strong growth in the coming years due to a rising number of cancer cases and increased focus by pharmaceutical companies on developing cancer-specific orphan drugs. Notably, in June 2022, the FDA granted orphan drug designation to ALX Oncology Holdings Inc. for its drug Evorpacept for treating acute myeloid leukemia. Cancer therapies currently account for approximately 20% of global pharmaceutical sales.

By End-Use:
The hospital pharmacies segment is anticipated to hold the largest share of the market. Many orphan drugs require intravenous administration and are monitored closely by healthcare professionals in hospital settings. The growing elderly population, who are more likely to be hospitalized for chronic conditions, is also driving demand in this segment.

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Outlook

With rare diseases gaining increased recognition and pharmaceutical innovation accelerating, the orphan drug market is set to continue its upward trajectory. While affordability remains a challenge, the growing support from regulatory bodies worldwide is creating new opportunities for drug developers and offering hope to millions of patients living with rare conditions.

Competitive Terrain:

The global Orphan Drug industry is highly consolidated owing to the presence of renowned companies operating across several international and local segments of the market. These players dominate the industry in terms of their strong geographical reach and a large number of production facilities. The companies are intensely competitive against one another and excel in their individual technological capabilities, as well as product development, innovation, and product pricing strategies.

The Leading Market Contenders Listed In The Report Are:

Pfizer Inc.

AbbVie Inc.

Novartis AG

Amryt Pharma plc

Amgen Inc.

GSK plc.

JOHNSON & JOHNSON

Sanofi

Hoffmann-La Roche Ltd

Takeda Pharmaceutical Company Limited.

Teva Pharmaceutical Industries Ltd.

Bristol-Myers Squibb Company

Biogen

Merck & Co., Inc.

Jazz Pharmaceuticals, Inc,

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Segmentation

For the purpose of this report, Emergen Research has segmented the global orphan drug market on the basis, drug type, therapy end-use, and region:

Drug Type Outlook (Revenue, USD Billion; 2019-2032)

Biologics

Non-Biologics

Therapy Outlook (Revenue, USD Billion; 2019-2032)

Oncology

Hematology

Neurology

Infectious Diseases

Metabolic Disorders

Endocrinology

Immunology

Others

End-use Outlook (Revenue, USD Billion; 2019-2032)

Hospital Pharmacies

Retail Pharmacies

Online Pharmacies

Others

Regional Segmentation:

North America

Latin America

Europe

Middle East & Africa

Asia Pacific

Report Highlights:

Besides offering a vivid depiction of the global Orphan Drug business sphere and its fundamental operations, the latest report provides the industrial chain analysis and list down the current and future market trends and growth opportunities.

The report includes information on the present and historical market scenarios, which helps forecast the market conditions over the next eight years (2020-2027).

The report scrutinizes the salient factors influencing the growth of the market in the near future.

The strategic marketing recommendations, crucial information related to the new market entrants, and expansion plans of various businesses are poised to provide the reader with a competitive edge in the market.

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Key Benefits of the Report:

Comprehensive analysis of the competitive scenario and its changing dynamics

Analytical data with detailed SWOT analysis and Porter's Five Forces analysis

In-depth 8 year analysis of the Global Orphan Drug Market

Critical assessment of the key market segments

Comprehensive analysis of the drivers, restraints, trends, and opportunities

Detailed regional analysis and extensive company profiling

Extensive assessment of current and emerging trends of the market

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