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Orphan Drugs CDMO Market Key Players Analysis - Novartis AG, F. Hoffmann-La Roche Ltd, Celgene, Bristol-Myers Squibb Company.

07-24-2025 01:58 PM CET | Health & Medicine

Press release from: Insightace Analytic Pvt Ltd.

Orphan Drugs CDMO Market

Orphan Drugs CDMO Market

InsightAce Analytic Pvt. Ltd. announces the release of a market assessment report on the "Global Orphan Drugs CDMO Market- (By Drug Type (Biologics, Non-biologics), By Therapy Type (Oncology, Neuromuscular, Respiratory, Hematology, Others), By End-User (Pharmaceutical companies, Biotechnology companies, CROs, Other End Users)), Trends, Industry Competition Analysis, Revenue and Forecast To 2034."

According to the latest research by InsightAce Analytic, the Global Orphan Drugs CDMO Market is to show a CAGR of 7.5% during a forecast period of 2025-2034.

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Contract Development and Manufacturing Organizations (CDMOs) specializing in orphan drugs play a critical role in supporting the development and production of treatments for rare diseases, commonly referred to as orphan drugs. These therapies are designed to address serious and often life-threatening conditions that affect a limited number of patients and typically lack effective treatment alternatives. In recent years, the oncology segment has emerged as a significant driver within the orphan drug market, propelled by the rising incidence of cancer-related diseases.

Looking ahead, the commercial landscape for orphan drugs-particularly in oncology-is expected to expand, supported by a growing number of FDA approvals for targeted cancer therapies. Furthermore, increasing demand for immunomodulatory agents, which help regulate or enhance immune function, is projected to further stimulate market growth. This trend is largely influenced by the rising prevalence of infectious diseases across both mature and emerging markets, alongside escalating pharmaceutical costs. Together, these factors are anticipated to contribute to sustained growth in the global orphan drug market over the forecast period.

List of Prominent Players in the Orphan Drugs CDMO Market:
• Novartis AG
• F. Hoffmann-La Roche Ltd
• Celgene,
• Bristol-Myers Squibb Company
• Sanofi
• Bayer Healthcare
• Doppel
• Lubrizol Life Science(LLS) Health
• Others

Market Dynamics:
Drivers-
A key factor propelling the growth of the global market is the intensified research and development (R&D) initiatives undertaken by leading pharmaceutical and biotechnology companies to develop novel therapeutics. Numerous established firms and clinical-stage biopharmaceutical organizations are actively progressing promising orphan drug candidates through various phases of clinical evaluation, spurred by heightened awareness and improved understanding of rare diseases. The strategic focus on rare conditions is largely attributed to the substantial potential they offer for groundbreaking advancements in treatment, which can lead to the development of high-impact, commercially successful therapies.

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Challenges:
Although global efforts to discover and commercialize treatments for rare diseases are gaining momentum, several challenges continue to impede market growth. One of the most significant barriers is the high cost associated with orphan drug therapies. Their elevated pricing has restricted adoption, particularly in developing economies. Even in high-income countries, the affordability of these treatments remains a concern, as limited reimbursement options often result in substantial out-of-pocket expenses for patients.

Regional Trends:
The North American orphan drug contract development and manufacturing organization (CDMO) market is expected to secure a significant share of global revenue and is projected to experience robust compound annual growth in the foreseeable future. This regional expansion is underpinned by several key factors, including North America's position-specifically the United States and Canada-as a leading center for pharmaceutical research and innovation. Increasing diagnostic capabilities and heightened public awareness of rare diseases have contributed to the rising demand for orphan drugs, thereby driving the need for specialized CDMO services to support their development and production.

Recent Developments:
• In Aug 2021, Novartis disclosed that Sabatolimab (MBG453) has been awarded as orphan drug by the EC (European Commission) for the management of myelodysplastic syndromes (MDS). The decision was based on clinical evidence demonstrating a significant response rate in patients with high-risk MDS who received concurrent treatment with sabatolimab and hypomethylating agents (HMAs).

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Segmentation of Orphan Drugs CDMO Market-
By Drug Type-
• Biologics
• Non-biologics
By Therapy Type-
• Oncology
• Neuromuscular
• Respiratory
• Hematology
• Others
By End-User-
• Pharmaceutical companies
• Biotechnology companies
• CROs
• Other End Users
By Region-
North America-
• The US
• Canada
• Mexico
Europe-
• Germany
• The UK
• France
• Italy
• Spain
• Rest of Europe
Asia-Pacific-
• China
• Japan
• India
• South Korea
• Southeast Asia
• Rest of Asia Pacific
Latin America-
• Brazil
• Argentina
• Rest of Latin America
Middle East & Africa-
• GCC Countries
• South Africa
• Rest of Middle East and Africa

Read Overview Report- https://www.insightaceanalytic.com/report/orphan-drugs-cdmo-market/2150

About Us:
InsightAce Analytic is a market research and consulting firm that enables clients to make strategic decisions. Our qualitative and quantitative market intelligence solutions inform the need for market and competitive intelligence to expand businesses. We help clients gain competitive advantage by identifying untapped markets, exploring new and competing technologies, segmenting potential markets and repositioning products. Our expertise is in providing syndicated and custom market intelligence reports with an in-depth analysis with key market insights in a timely and cost-effective manner.

Contact us:
InsightAce Analytic Pvt. Ltd.
Visit: www.insightaceanalytic.com
Tel : +1 607 400-7072
Asia: +91 79 72967118
info@insightaceanalytic.com

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