Press release
Growing Demand for Orphan Drugs Driven by Rising Rare Diseases and Regulatory Support
Orphan Drug Market
Orphan drugs are specifically designed to treat rare medical conditions that affect a small percentage of the population. In the United States, a medication is classified as orphan if it targets a condition affecting fewer than 200,000 people. In Europe, the threshold is fewer than 5 in 10,000 individuals. Currently, it is estimated that 30 million Americans and approximately 400 million people worldwide suffer from rare diseases, highlighting the growing need for innovative medical solutions.
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The pharmaceutical sector has seen a surge in research and development (R&D) efforts aimed at discovering new orphan drugs. Government regulations, such as the Orphan Disease Act in the U.S. and the European Orphan Medicines Regulation, have been pivotal in encouraging the pharmaceutical industry to invest in treatments for rare diseases. Since the establishment of these regulations, over 600 orphan drugs have been developed, significantly contributing to market growth.
Despite this positive momentum, the orphan drug market faces challenges. High treatment costs, particularly in developing nations, pose a significant barrier. Many of these drugs come with hefty price tags, and inadequate reimbursement options can lead to substantial out-of-pocket expenses for patients. Addressing these cost issues will be critical to ensuring broader access to orphan drugs.
The orphan drug market is divided into two main categories based on drug type: biologics and non-biologics. The biologics segment currently dominates the market, fueled by a growing number of biologic products. Biologics encompass a range of therapies, including vaccines and monoclonal antibodies, and have become essential in treating rare diseases.
In terms of therapeutic areas, oncology is poised for rapid growth within the orphan drug market. Increased investment in cancer treatment innovations and the introduction of orphan drugs specifically for cancer patients are driving this trend. Recent approvals, such as the Orphan Drug Designation granted to ALX Oncology Holdings for a new leukemia treatment, underscore the focus on developing effective therapies for oncology.
Additionally, the market is segmented by end-use, with hospital pharmacies expected to hold a significant share. The need for skilled healthcare professionals to administer intravenous medications in hospitals supports this trend. As the elderly population continues to grow and more individuals require chronic disease management, hospital pharmacies are becoming crucial in distributing orphan drugs.
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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,
Orphan Drug Latest Industry Updates
On 24 April 24, 2023, Genentech, a member of the Roche Group announced three new partnerships focused on improving brain health outcomes. These industry-leading initiatives are designed to quantify and assess the complexity, economic impact and patient and care partner burden of brain health conditions and generate robust data around the nuanced dynamics of neurologic care.
On January 16, 2023, CARsgen Therapeutics Holdings Limited collaborated with Huadong Medicine (Hangzhou) Co., Ltd. for the commercialization of CARsgen's BCMA CAR-T product CT053 in mainland China. Under the terms of the agreement, CARsgen will receive an upfront payment of around USD 28 million and is eligible to receive regulatory and commercial milestone payments up to USD 140 million.
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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 Outlook (Revenue, USD Billion; 2019-2032)
North America
U.S.
Canada
Mexico
Europe
Germany
France
UK
Italy
Spain
Benelux
Rest of Europe
Asia Pacific
China
India
Japan
South Korea
Rest of APAC
Latin America
Brazil
Rest of LATAM
Middle East & Africa
Saudi Arabia
UAE
South Africa
Turkey
Rest of Middle East & Africa
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Look Over transcripts provided by Emergen Research
Orphan Drug Market Size@ https://www.emergenresearch.com/industry-report/orphan-drug-market/market-size
Orphan Drug Market Share@ https://www.emergenresearch.com/industry-report/orphan-drug-market/market-share
Orphan Drug Market Trends@ https://www.emergenresearch.com/industry-report/orphan-drug-market/market-trends
Orphan Drug Regional Market Demand@ https://www.emergenresearch.com/industry-report/orphan-drug-market/regional-market-demand
Orphan Drug Market Analysis@ https://www.emergenresearch.com/industry-report/orphan-drug-market/market-analysis
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