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.
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.
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 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.
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.
| Report Attribute | Specifications |
| Market Size Value In 2024 | USD 13.5 Bn |
| Revenue Forecast In 2034 | USD 27.6 Bn |
| Growth Rate CAGR | CAGR of 7.5% from 2025 to 2034 |
| Quantitative Units | Representation of revenue in US$ Bn,and CAGR from 2025 to 2034 |
| Historic Year | 2021 to 2024 |
| Forecast Year | 2025-2034 |
| Report Coverage | The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends |
| Segments Covered | By Drug Type, Therapy Type, End-User |
| Regional Scope | North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
| Country Scope | U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico; The UK; France; Italy; Spain; China; Japan; India; South Korea; South East Asia; South Korea; South East Asia |
| Competitive Landscape | Novartis AG, F. Hoffmann-La Roche Ltd, Celgene, Bristol-Myers Squibb Company, Sanofi, Bayer Healthcare, Doppel, Lubrizol Life Science(LLS) Health, and Others |
| Customization Scope | Free customization report with the procurement of the report and modifications to the regional and segment scope. Particular Geographic competitive landscape. |
| Pricing And Available Payment Methods | Explore pricing alternatives that are customized to your particular study requirements. |
Orphan Drugs CDMO Market By Drug Type-
Orphan Drugs CDMO Market By Therapy Type-
Orphan Drugs CDMO Market By End-User-
Orphan Drugs CDMO Market By Region-
North America-
Europe-
Asia-Pacific-
Latin America-
Middle East & Africa-
This study employed a multi-step, mixed-method research approach that integrates:
This approach ensures a balanced and validated understanding of both macro- and micro-level market factors influencing the market.
Secondary research for this study involved the collection, review, and analysis of publicly available and paid data sources to build the initial fact base, understand historical market behaviour, identify data gaps, and refine the hypotheses for primary research.
Secondary data for the market study was gathered from multiple credible sources, including:
These sources were used to compile historical data, market volumes/prices, industry trends, technological developments, and competitive insights.
Primary research was conducted to validate secondary data, understand real-time market dynamics, capture price points and adoption trends, and verify the assumptions used in the market modelling.
Primary interviews for this study involved:
Interviews were conducted via:
Primary insights were incorporated into demand modelling, pricing analysis, technology evaluation, and market share estimation.
All collected data were processed and normalized to ensure consistency and comparability across regions and time frames.
The data validation process included:
This ensured that the dataset used for modelling was clean, robust, and reliable.
The bottom-up approach involved aggregating segment-level data, such as:
This method was primarily used when detailed micro-level market data were available.
The top-down approach used macro-level indicators:
This approach was used for segments where granular data were limited or inconsistent.
To ensure accuracy, a triangulated hybrid model was used. This included:
This multi-angle validation yielded the final market size.
Market forecasts were developed using a combination of time-series modelling, adoption curve analysis, and driver-based forecasting tools.
Given inherent uncertainties, three scenarios were constructed:
Sensitivity testing was conducted on key variables, including pricing, demand elasticity, and regional adoption.