Orphan Drugs CDMO Market Size, Share & Trends Analysis Report 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, And By Segment Forecasts, 2025-2034

Global Orphan Drugs CDMO Market Size is valued at USD 13.5 Bn in 2024 and is predicted to reach USD 27.6 Bn by the year 2034 at a 7.5% CAGR during the forecast period for 2025-2034.

Orphan drugs, also known as orphan medicines or orphan therapies, are pharmaceuticals designed to treat rare medical illnesses known as orphan diseases. These disorders often impact a small proportion of the population, making them commercially undesirable for drug companies to research and market in the absence of additional incentives. Several important drivers have influenced the Orphan Drugs CDMO (Contract Development and Manufacturing Organization) market, contributing to its growth and relevance in the pharmaceutical sector.

Orphan medications are in high demand due to increased awareness and diagnosis of rare diseases. As more uncommon diseases are discovered and characterized, the demand for specialized CDMOs to support their development and manufacture grows.However, the COVID-19 pandemic substantially impacted numerous sectors of the pharmaceutical business, particularly the CDMO (Contract Development and Manufacturing Organization) market for orphan drugs. The COVID-19 pandemic had a greater impact on specific pharmaceutical markets due to the deferral of non-life-threatening disease diagnosis and treatment. This was especially true for people suffering from uncommon diseases since various governments concentrated more financial and healthcare resources towards combating the pandemic.

Competitive Landscape

Some Major Key Players In The Orphan Drugs CDMO Market:

• Novartis AG
• Hoffmann-La Roche Ltd
• Celgene,
• Bristol-Myers Squibb Company
• Sanofi
• Bayer Healthcare
• Doppel
• Lubrizol Life Science (LLS) Health
• Others

Market Segmentation:

The Orphan Drugs CDMO Market segmentation consists of drug type, therapy type, and end-user. As per the drug type, the market is segmented as Biologics and Non-biologics. The therapy type segment includes Oncology, Neuromuscular, Respiratory, Hematology, and Others. The end-user segment includes Pharmaceutical companies, Biotechnology companies, CROs, and Other End-users.

Based On Drug Type, The Biologics Segment Is A Major Contributor In The Orphan Drugs CDMO Market. 

The Biologics category is expected to hold a major share of the global Orphan Drugs CDMO Market in 2022 due to the overwhelming prevalence of product offers classed as biologics. According to the U.S. FDA, the organization's Office of Orphan Products Development (OOPD) has developed and marketed approximately 600 medicines and biologic products to treat uncommon illnesses since 1983. 

The Personal Care Segment Witnessed Growth At A Rapid Rate.

The personal care catagory is projected to grow at a rapid rate in the global Orphan Drugs CDMO Market. The Orphan Drugs Contract Development and Manufacture Organisation (CDMO) market assists pharmaceutical companies with orphan medication development and manufacture. The fundamental reason for the segment's dominance is that a considerable number of medications must be administered intravenously in hospitals by qualified healthcare workers.

In The Region, The North America Orphan Drugs CDMO Market Holds A Significant Revenue Share.

The North America Orphan Drugs CDMO Market is projected to record the highest market share in terms of revenue in the near future. The substantial amount spent on orphan pharmaceuticals, the large patient population, and the existence of major market players all contributed to North America's dominance in the creation of sophisticated and cutting-edge technologies. For instance, the Genetic and Rare Diseases (GARD) Information Centre estimates that there are more than 10,000 rare diseases that afflict 30 million Americans, or about 1 in 10 persons, in the U.S. This contributes to North America's dominance in the worldwide market, together with the favourable reimbursement practices in the U.S. Due to a growing patient population in the region and a large uptake of cutting-edge treatments for rare diseases, the European market is expected to grow at a significant CAGR.

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).

Orphan Drugs CDMO Market Report Scope: