The global investigational new drug CDMO market size was estimated at USD 5.21 billion in 2024 and is projected to reach USD 10.40 billion by 2033, growing at a CAGR of 8.66% from 2025 to 2033. The market growth is primarily driven by the rising outsourcing demand from pharmaceutical and biotechnology companies, the increasing complexity of drug development pipelines, and a growing need for cost-efficient solutions among companies.

In addition, there is a heightened emphasis on accelerating time-to-market, with early-phase development risks being effectively managed through partnerships with specialized CDMOs. The market has also benefited from a growing therapeutic focus on oncology, rare diseases, and advanced biologics, which has further fueled the demand for IND CDMO services.

Technological advancements have played a pivotal role in strengthening CDMO service offerings across the IND space. Tools such as artificial intelligence (AI), advanced analytical platforms, organoid-based preclinical models, and digital regulatory systems have been integrated into operations to enable faster, data-driven development. Furthermore, single-use bioprocessing systems and continuous manufacturing techniques have provided flexibility in early-stage production, ensuring both scalability and operational efficiency.

Investments have also been directed toward expanding laboratory infrastructure, developing specialized bioassay capabilities, and implementing digital quality systems, all aimed at capturing higher-value IND projects. Strategic allocation of capital toward mergers, acquisitions, and alliances is enabling CDMOs to broaden their service portfolios and expand their global footprints.

Key Market Trends & Insights:

• In 2024, the North America investigational new drug (IND) CDMO industry held the largest share of 41.2% of the global market, reflecting the region’s strong presence in pharmaceutical and biotechnology research and development, advanced healthcare infrastructure, and robust outsourcing capabilities.

• The U.S. IND CDMO market is expected to experience significant growth over the forecast period, driven by increasing demand for specialized early-phase drug development services, a growing focus on biologics and advanced therapies, and the need for faster time-to-market solutions through outsourcing partnerships with experienced CDMOs.

• When analyzed by service type, the contract development segment held the highest market share in 2024. This indicates that pharmaceutical and biotechnology companies increasingly rely on CDMOs to manage the development stages of investigational drugs, benefiting from specialized expertise, operational efficiency, and resource optimization.

• Based on end-use, the pharmaceutical companies segment accounted for the largest market share in 2024. This reflects the continued reliance of pharmaceutical firms on CDMO services to support drug development pipelines, reduce costs, and accelerate clinical trial readiness, particularly for complex molecules and biologics.

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Market Size & Forecast:

• 2024 Market Size: USD 5.21 Billion

• 2033 Projected Market Size: USD 10.40 Billion

• CAGR (2025-2033): 8.66%

• North America: Largest market in 2024

• Asia Pacific: Fastest growing market

Key Companies & Market Share Insights:

The key players in the investigational new drug (IND) CDMO market are actively adopting a range of strategic initiatives—including new service launches, mergers and acquisitions, partnerships and agreements, and market expansions—to strengthen their competitive position and capture a larger market share.

A notable example of such strategic innovation occurred in June 2025, when Samsung Biologics announced the launch of “Samsung Organoids”, an advanced drug screening platform designed to enhance the efficiency of drug discovery and development. This platform offers precision screening capabilities, enabling researchers to forecast patient-specific responses, optimize preclinical workflows, and accelerate the path to IND submissions through data-driven evaluation of candidate molecules.

By leveraging such innovative platforms, market players aim to improve the accuracy, speed, and efficiency of early-stage drug development, thereby offering significant value to pharmaceutical and biotechnology companies seeking to bring investigational therapies to clinical trials more effectively.

Key Players

• Catalent, Inc.

• Lonza

• Recipharm AB

• Siegfried Holding AG

• Patheon Inc.

• Covance

• IQVIA Holdings Inc.

• Cambrex Corporation

• Charles River Laboratories International, Inc.

• Syneos Health

• Syngene International

• Jubilant Pharmova

• Piramal Pharma Solutions

• Dr. Reddy’s CPS

• Dishman Carbogen Amcis Ltd.

• Biocon Biologics

• Laurus Labs

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Conclusion:

The Investigational New Drug CDMO market is experiencing significant growth, driven by increased outsourcing from pharmaceutical and biotechnology companies, the rising complexity of drug development pipelines, and a growing need for cost-effective solutions. Technological advancements, such as artificial intelligence, advanced analytical platforms, and digital regulatory systems, are enhancing the efficiency of early-stage drug development. Additionally, the focus on oncology, rare diseases, and advanced biologics is fueling demand for specialized CDMO services.