Global CDMO Market Forecast to Hit USD 588B by 2035

What is driving the growth of the global CDMO market, and how is it expected to evolve by 2035?

The global contract development and manufacturing organization (CDMO) market is experiencing significant growth, driven by rising demand for novel drugs, biologics, and therapies to address chronic diseases worldwide. The market was valued at USD 246.11 Billion in 2025 and is projected to grow at a CAGR of 9.10% between 2026 and 2035, reaching USD 588.00 Billion by 2035.

CDMOs play a crucial role in the pharmaceutical and biotechnology industries by offering end-to-end drug development, manufacturing, and packaging services, allowing pharmaceutical companies to accelerate time-to-market, reduce operational costs, and focus on core research activities.

Market Overview and Current Landscape

CDMOs offer a broad range of services, including:

Active Pharmaceutical Ingredient (API) manufacturing

Finished dosage formulation development and manufacturing

Secondary packaging

Clinical research and development (CRO services)

Increasing outsourcing by pharmaceutical and biotechnology companies is a key trend, enabling businesses to streamline production and improve flexibility. Additionally, the growing focus on biologics, high-potency APIs, and complex formulations has strengthened the demand for specialized CDMO services.

Market Highlights

Market Value (2025): USD 246.11 Billion

Forecast Value (2035): USD 588.00 Billion

CAGR (2026-2035): 9.10%

Primary Drivers:

Rising prevalence of chronic diseases

Growth in biologics and specialty therapies

Increasing outsourcing of drug manufacturing and R&D

Strong global pipeline of novel therapeutics

Get a Free Sample Report with Table of Contents - https://www.expertmarketresearch.com/reports/contract-development-and-manufacturing-organization-cdmo-market/requestsample.

Factors Driving Market Growth

Rising Demand for Novel Drugs and Biologics

Increase in oncology, cardiovascular, and infectious disease therapies

Growing focus on personalized medicine and high-value biologics

Outsourcing to CDMOs allows pharmaceutical companies to manage complex biologics manufacturing efficiently

Cost-Efficiency and Operational Flexibility

CDMOs provide scalable production without the need for significant capital investment

Enable pharmaceutical companies to focus on R&D and commercialization

Reduce risks associated with regulatory compliance and manufacturing setup

Technological Advancements in Drug Manufacturing

Adoption of continuous manufacturing and single-use systems

Advanced formulations for injectables, oral solids, and liquid dosages

Expertise in HPAPI (high-potency API) production and biologics

Expanding Clinical Development Outsourcing

Contract research organization (CRO) services include pre-clinical to Phase IV trials

CDMOs with integrated CRO capabilities provide end-to-end drug development solutions

Accelerates clinical timelines and ensures regulatory compliance

Growing Pharmaceutical Pipeline

Pharmaceutical companies increasingly rely on CDMOs for new drug candidates

High-value pipeline products in oncology, cardiovascular, and infectious diseases increase CDMO service demand

Challenges Limiting Market Growth

Despite the strong growth potential, several challenges exist:

Regulatory Complexity

Stringent regulatory requirements for APIs, biologics, and drug formulations

Compliance with FDA, EMA, PMDA, and other regional regulations is essential

High Capital Investment for Advanced Facilities

Specialized biologics, HPAPI, and sterile manufacturing require significant investment

Smaller CDMOs may face challenges in scaling operations

Intellectual Property and Confidentiality Risks

Outsourcing drug development involves sharing sensitive IP

Maintaining confidentiality and compliance is critical

Competition Among CDMOs

Highly competitive market with large multinational CDMOs and regional players

Price competition and service differentiation are key challenges

Market Segmentation by Service Type - CMO

CDMOs provide contract manufacturing services (CMO) across multiple product types and dosage forms.

Active Pharmaceutical Ingredient (API) Manufacturing

Small Molecule APIs: Commonly used for oral and injectable drugs

Large Molecule APIs: Biologics, monoclonal antibodies, and protein therapeutics

High Potency APIs (HPAPI): Oncology drugs, targeted therapies

Finished Dosage Formulation (FDF) Development and Manufacturing

Solid Dose Formulations: Tablets, capsules, and powders

Liquid Dose Formulations: Syrups, suspensions, and solutions

Injectable Dose Formulations: Biologics, vaccines, and specialty injectables

Secondary Packaging Services

Labeling, blister packs, bottles, vials

Serialization and track-and-trace solutions for regulatory compliance

Read the Full Report with the Table of Contents - https://www.expertmarketresearch.com/reports/contract-development-and-manufacturing-organization-cdmo-market.

Market Segmentation by Research Phase - CRO

CDMOs also provide contract research services (CRO) for clinical trials:

Pre-clinical: Animal studies, toxicology testing, and pharmacokinetics

Phase I: Safety, tolerability, and dose-escalation studies in healthy volunteers

Phase II: Efficacy and side-effect profiling in small patient populations

Phase III: Large-scale clinical trials to demonstrate therapeutic benefit

Phase IV: Post-marketing surveillance and real-world effectiveness studies

Integrated CDMOs with CRO capabilities provide end-to-end drug development solutions, reducing timelines and operational complexity.

Market Segmentation by Therapeutic Area

CDMOs cater to diverse therapeutic areas, reflecting global disease burdens:

Oncological Diseases

High demand for small molecules, biologics, and HPAPIs

Increasing prevalence of cancer globally drives specialized CDMO services

Cardiovascular Diseases

Development of antihypertensives, statins, and biologic cardiovascular therapies

Growing incidence of heart disease in aging populations

Infectious Diseases

Vaccines, antivirals, and antibiotics require robust CDMO capabilities

Recent focus on pandemic preparedness and rapid vaccine production

Others

Neurology, autoimmune, and rare disease therapies

Expansion of orphan drug development and specialty formulations

Market Segmentation by Region

North America

Largest market due to high pharmaceutical R&D expenditure

Strong presence of leading CDMOs and CROs

Regulatory support from FDA and advanced clinical infrastructure

Europe

Established CDMO hubs in Germany, Switzerland, and the UK

Strong biologics and oncology pipeline driving demand

EMA regulations support high-quality manufacturing standards

Asia Pacific

Fastest-growing region with investments in India, China, and Singapore

Cost-effective manufacturing and growing biologics capability

Increasing outsourcing from Western pharmaceutical companies

Latin America

Moderate growth due to emerging pharmaceutical infrastructure

Focus on infectious diseases and vaccines

Middle East and Africa

Rising healthcare investment and pharmaceutical expansion

Growing demand for generic APIs and contract manufacturing

Competitive Landscape

The global CDMO market is highly competitive, with major multinational players and regional service providers competing on quality, capability, and technological expertise.

Key Companies

Catalant Inc.

Baxter Biopharma Solutions (Baxter International Inc.)

Vetter Pharma-Fertigung GmbH & Co. KG

Recipharma AB

Albany Molecular Research Inc. (AMRI)

Thermo Fisher Scientific

Boehringer Ingelheim Group

Pfizer Inc.

NextPharma Technologies

Jubilant Pharmova Ltd

Famar SA

Lonza Group

TapeMark

Novotech Pty Ltd

ARX LLC

Aenova Holding GmbH

Tesa Labtec GmbH (TESA SE)

CMIC Holdings Company Ltd

Syneos Health Inc.

LabCorp Drug Development

Strategies Adopted by Market Players

Expansion of API and biologics manufacturing capabilities

Mergers, acquisitions, and strategic partnerships

Adoption of advanced technologies, single-use systems, and continuous manufacturing

Development of integrated CDMO-CRO solutions for end-to-end services

Technological Trends in the CDMO Market

Single-Use Systems and Modular Facilities

Reduce cross-contamination risk and cleaning requirements

Increase flexibility in scaling biologics manufacturing

Continuous Manufacturing

Improves efficiency, quality, and cost-effectiveness

Enables faster batch-to-batch consistency

Advanced Formulation Development

Specialty injectables, nanoparticles, and liposomal formulations

Tailored delivery systems for high-potency and complex therapies

Digitalization and Data Integration

Real-time process monitoring and analytics

Digital twin models for optimized manufacturing and predictive maintenance

Future Outlook

The CDMO market is expected to experience robust growth driven by:

Rising demand for biologics, specialty therapies, and orphan drugs

Expansion of integrated CDMO-CRO services for faster drug development

Adoption of advanced manufacturing technologies

Growth in Asia Pacific as a cost-effective outsourcing hub

Strategic collaborations between pharmaceutical companies and CDMOs

By 2035, the market is expected to reach USD 588.00 Billion, reflecting a CAGR of 9.10%, highlighting the increasing reliance of the pharmaceutical and biotechnology industries on outsourced development and manufacturing services.

Discover More Reports

Dental Laboratories Market - https://bit.ly/3XDJUiI.

Energy Recovery Ventilator Market - https://bit.ly/4o1VcYY.

Emergency Escape Breathing Device Market - https://bit.ly/3X6PmdR.

Nootropics Market - https://bit.ly/4oNrHvd.

Media Contact

Company Name: Claight Corporation
Contact Person: Roshan Kumar, Business Consultant
Email: sales@expertmarketresearch.com
Toll-Free Number: US +1-415-325-5166 | UK +44-702-402-5790
Address: 30 North Gould Street, Sheridan, WY 82801, USA
Website: www.expertmarketresearch.com

About Us

Acquire unparalleled access to critical industry insights with our comprehensive market research reports, meticulously prepared by a team of seasoned experts. These reports are designed to equip decision-makers with an in-depth understanding of prevailing market trends, competitive landscapes, and growth opportunities.

Our high-quality, data-driven analysis provides the essential framework for organizations seeking to make informed and strategic decisions in an increasingly complex and rapidly evolving business environment. By investing in our market research reports, you can ensure your organization remains agile, proactive, and poised for success in today's competitive market.

Don't miss the opportunity to elevate your business intelligence and strengthen your strategic planning. Secure your organization's future success by acquiring one of our Expert Market Research reports today.

This release was published on openPR.