Global Orphan Drug Market Poised for Significant Growth Amid Rising Demand and Regulatory Support

The global orphan drug market size was USD 154.20 Billion in 2022 and is expected to register a rapid revenue CAGR of 12.3 % during the forecast period. The global orphan drug market is witnessing rapid growth, driven by the increasing prevalence of rare diseases and strong regulatory support for developing orphan medications. Orphan drugs are specifically designed to treat rare medical conditions, affecting a small percentage of the population. Governments worldwide are introducing incentives and laws to encourage the development of these drugs, ensuring better accessibility for patients in need.

In the United States, orphan drugs are developed under the Orphan Drug Act (ODA), which supports treatments for diseases affecting fewer than 200,000 people. Similarly, in Europe, orphan medicines cater to conditions affecting fewer than 5 in 10,000 individuals. The rising occurrence of rare diseases globally has prompted both developed and developing countries to establish supportive regulations, fostering research and development (R&D) in the pharmaceutical industry.

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Market Growth and Developments

According to the Genetic and Rare Diseases (GARD) Information Centre, around 30 million Americans suffer from a rare disease, while globally, rare conditions impact approximately 400 million individuals, as reported by Global Genes in September 2021. This growing patient pool is fueling investment in orphan drug research. With pharmaceutical companies increasing their R&D spending, new treatment opportunities are emerging, contributing to the expansion of the orphan drug market.

Challenges in the Market

Despite strong growth potential, high treatment costs remain a significant challenge, particularly in developing nations. Expensive medications, combined with limited reimbursement options, often result in high out-of-pocket expenses for patients. This financial burden is a concern in developed countries as well, where the affordability of orphan drugs continues to be a debated issue.

Key Market Segments

1. Drug Type:
• The biologics segment holds the largest market share, driven by the increasing number of biologic-based orphan drugs. The U.S. Food and Drug Administration (FDA) reports that over 600 orphan drugs and biologics have been developed since 1983. Biologics, including vaccines, monoclonal antibodies, and immune modulators, are widely used to treat rare diseases, further boosting demand for this segment.
2. Therapy Type:
• Oncology remains the leading therapy area in the orphan drug market. The increasing focus of pharmaceutical companies on developing cancer treatments has contributed to the dominance of this segment. Notably, the FDA granted Orphan Drug Designation (ODD) to ALX Oncology Holdings Inc. in June 2022 for its leukemia treatment, Evorpacept. With rising investments in oncology research, demand for orphan drugs is expected to grow significantly.
3. End-Use:
• Hospital pharmacies are projected to account for a significant share of the orphan drug market. Many orphan drugs require intravenous administration by healthcare professionals, making hospitals the primary point of distribution. Additionally, the aging population, which frequently requires hospital care for chronic conditions, is contributing to the demand for orphan drugs in hospital settings.

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As pharmaceutical companies continue investing in rare disease treatments, the orphan drug market is expected to witness substantial growth. However, addressing affordability challenges will be crucial to ensuring that these life-saving treatments are accessible to all patients in need.

Orphan Drug Top Companies and Competitive Landscape

The global orphan drug market is fragmented, with large and medium-sized players accounting for the majority of market revenue. Major players are deploying various strategies, entering into mergers & acquisitions, strategic agreements & contracts, developing, testing, and introducing more effective products in the market.

Some of the major companies included in the global orphan drug market 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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Orphan Drug Market Segmentation Analysis

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 Analysis of the Orphan Drug Market:

• North America (U.S., Canada)
• Europe (U.K., Italy, Germany, France, Rest of EU)
• Asia Pacific (India, Japan, China, South Korea, Australia, Rest of APAC)
• Latin America (Chile, Brazil, Argentina, Rest of Latin America)
• Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of MEA)

Key Objectives of the Report:

• Analysis and estimation of the Orphan Drug market size and share for the projected period of 2020-2027
• Extensive analysis of the key players of the market by SWOT analysis and Porter’s Five Forces analysis to impart a clear understanding of the competitive landscape
• Study of current and emerging trends, restraints, drivers, opportunities, challenges, growth prospects, and risks of the global Orphan Drug market
• Analysis of the growth prospects for the stakeholders and investors through the study of the promising segments
• Strategic recommendations to the established players and new entrants to capitalize on the emerging growth opportunities

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