Investigational New Drug CDMO

Global Investigational New Drug CDMO Market to Reach US$15.8 Billion by 2030

The global market for Investigational New Drug CDMO estimated at US$11.3 Billion in the year 2024, is expected to reach US$15.8 Billion by 2030, growing at a CAGR of 5.8% over the analysis period 2024-2030. Small Molecule, one of the segments analyzed in the report, is expected to record a 4.7% CAGR and reach US$9.7 Billion by the end of the analysis period. Growth in the Large Molecule segment is estimated at 7.6% CAGR over the analysis period.

The U.S. Market is Estimated at US$3.0 Billion While China is Forecast to Grow at 5.7% CAGR

The Investigational New Drug CDMO market in the U.S. is estimated at US$3.0 Billion in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$2.5 Billion by the year 2030 trailing a CAGR of 5.7% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 5.2% and 5.0% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 4.8% CAGR.

Investigational New Drug CDMO Market – Key Trends & Growth Drivers Summarized

The Contract Development and Manufacturing Organization (CDMO) market for Investigational New Drugs (INDs) has become a critical component in the pharmaceutical and biotechnology industries. As pharmaceutical companies continue to focus on innovation while outsourcing drug development and manufacturing, CDMOs play a vital role in accelerating the path from preclinical research to clinical trials. IND CDMOs specialize in offering end-to-end solutions, including formulation development, clinical trial material manufacturing, regulatory support, and analytical services, enabling pharmaceutical firms to navigate the complex drug approval process efficiently. Given the increasing complexity of drug molecules, stringent regulatory requirements, and growing demand for specialized expertise, the role of CDMOs in the IND market is expanding rapidly, shaping the future of drug development worldwide.

How Are Technological Advancements Transforming IND CDMO Services?

The IND CDMO market is undergoing a significant transformation driven by technological innovations that enhance efficiency, compliance, and speed in drug development. One of the most important advancements is the integration of continuous manufacturing techniques, which streamline production processes, minimize waste, and improve product consistency. Unlike traditional batch manufacturing, continuous manufacturing allows for real-time quality monitoring, reducing the risk of variability and improving scalability for early-phase drug production.

Another breakthrough in the industry is the use of artificial intelligence (AI) and machine learning (ML) in drug formulation and process optimization. AI-driven predictive modeling helps CDMOs identify the most effective drug formulations, optimize stability conditions, and enhance process efficiencies. Additionally, automation and robotics in laboratory and manufacturing environments have improved precision in compound handling, minimizing human errors and ensuring reproducibility in IND production. The adoption of single-use bioprocessing technologies is another trend gaining momentum, particularly in biologics and cell and gene therapy manufacturing. These disposable systems reduce contamination risks, lower operational costs, and enhance flexibility, making them ideal for early-stage clinical production.

What Market Trends Are Reshaping the IND CDMO Landscape?

The IND CDMO market is witnessing several key trends that are reshaping its growth trajectory. One of the most prominent trends is the increasing demand for specialized CDMO services in biologics and advanced therapies. With the rapid expansion of monoclonal antibodies, cell and gene therapies, and RNA-based drugs, pharmaceutical companies are seeking CDMOs with expertise in handling complex biologic formulations, requiring specialized infrastructure and regulatory knowledge. This shift is prompting many CDMOs to invest heavily in biopharmaceutical production capabilities, including high-containment facilities for viral vector and mRNA-based therapeutics.

Another significant trend is the globalization of IND CDMO services, with companies expanding their operations across North America, Europe, and Asia-Pacific. Emerging markets, particularly in China and India, are witnessing rapid growth in CDMO capabilities due to cost advantages, skilled workforce availability, and favorable government policies promoting pharmaceutical outsourcing. Additionally, the rising focus on regulatory compliance and quality assurance is influencing CDMOs to adopt Good Manufacturing Practice (GMP) guidelines and implement stringent quality control measures to meet the requirements of the FDA, EMA, and other global regulatory agencies.

A further notable trend is the growing emphasis on accelerated clinical development timelines. With the pharmaceutical industry prioritizing fast-track approvals for breakthrough therapies, CDMOs are enhancing their capabilities to support expedited IND submissions. This includes offering integrated drug development solutions that combine formulation, analytical testing, and clinical trial supply management under a single contract, reducing timelines and improving project efficiency. The increasing adoption of decentralized clinical trials (DCTs) is also influencing CDMOs to adapt their clinical supply chains to meet the demands of remote and hybrid trial models.

What Is Driving the Growth of the IND CDMO Market?

The growth in the Investigational New Drug CDMO market is driven by several factors, including rising pharmaceutical R&D investments, increasing complexity of drug molecules, and the growing need for outsourcing among biopharmaceutical companies. A key driver is the expanding pipeline of novel therapeutics, particularly in oncology, neurology, and rare diseases. With many pharmaceutical firms focusing on precision medicine and targeted therapies, CDMOs are witnessing heightened demand for specialized formulation and analytical services tailored to complex drug candidates.

Another crucial factor propelling market growth is the rising adoption of biologics and cell and gene therapies. The surge in demand for advanced therapeutic modalities has created a need for CDMOs equipped with high-containment manufacturing facilities and expertise in viral vector production, mRNA technology, and regenerative medicine. Furthermore, the increase in orphan drug designations and expedited regulatory pathways, such as the FDA’s Fast Track and Breakthrough Therapy designations, are pushing pharmaceutical firms to seek agile and highly capable CDMO partners to speed up clinical development and regulatory approval processes.

The strategic shift toward virtual biotech models is also fueling demand for IND CDMO services. Many small and mid-sized biotech companies lack in-house manufacturing and regulatory capabilities, making outsourcing an essential strategy for advancing their drug candidates. Additionally, stringent regulatory requirements in early-phase clinical development are compelling pharmaceutical companies to collaborate with experienced CDMOs that offer regulatory consulting, risk mitigation strategies, and GMP-compliant production. Lastly, the growing trend of CDMO partnerships with big pharma to co-develop and manufacture investigational drugs is further driving market expansion, ensuring that innovative therapies reach clinical trials faster while maintaining high-quality standards.

SCOPE OF STUDY:

The report analyzes the Investigational New Drug CDMO market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:
Product (Small Molecule, Large Molecule); Service (Contract Development, Contract Manufacturing); End-Use (Pharmaceutical Companies, Biotech Companies, Others)

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; and Rest of Europe); Asia-Pacific; Rest of World.

Select Competitors (Total 34 Featured) -

• AGC Biologics
• Aurigene Discovery
• Bachem Holding AG
• BioCina
• Biocon
• Cambrex Corporation
• Catalent
• Emergent BioSolutions
• Fujifilm Diosynth
• Hovione
• Jubilant Pharmova
• Laurus Labs
• Lonza Group
• Recipharm AB
• Samsung Biologics
• Siegfried Holding AG
• Syngene International Ltd.
• Thermo Fisher Scientific
• WuXi AppTec
• WuXi Biologics

TARIFF IMPACT FACTOR

Our new release incorporates impact of tariffs on geographical markets as we predict a shift in competitiveness of companies based on HQ country, manufacturing base, exports and imports (finished goods and OEM). This intricate and multifaceted market reality will impact competitors by artificially increasing the COGS, reducing profitability, reconfiguring supply chains, amongst other micro and macro market dynamics.

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We expect this chaos to play out over the next 2-3 months and a new world order is established with more clarity. We are tracking these developments on a real time basis.

As we release this report, U.S. Trade Representatives are pushing their counterparts in 183 countries for an early closure to bilateral tariff negotiations. Most of the major trading partners also have initiated trade agreements with other key trading nations, outside of those in the works with the United States. We are tracking such secondary fallouts as supply chains shift.

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APRIL 2025: NEGOTIATION PHASE

Our April release addresses the impact of tariffs on the overall global market and presents market adjustments by geography. Our trajectories are based on historic data and evolving market impacting factors.

JULY 2025 FINAL TARIFF RESET

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