Biopharmaceutical CMO and CRO Market Size, Growth, and Key Insights

The global biopharmaceutical CMO and CRO market was valued at USD 34.84 billion in 2024 and is projected to grow from USD 37.17 billion in 2025 to USD 62.36 billion by 2033, registering a CAGR of 6.68% during the forecast period (2025–2033). North America continues to dominate the market, holding the highest revenue share, largely driven by strong outsourcing demand, a robust biologics pipeline, and the presence of advanced service providers.

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Market Overview

Biopharmaceutical Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs) play a vital role in the success of the pharmaceutical industry. CMOs provide end-to-end drug manufacturing services, while CROs support research, preclinical testing, clinical trials, and commercialization on a contract basis. The biopharmaceutical sector now accounts for over 20% of the global pharmaceutical industry, reflecting the rising demand for biologics and biosimilars.

The COVID-19 pandemic accelerated the outsourcing trend, as companies turned to CMOs and CROs to overcome supply chain challenges, meet rising vaccine demand, and maintain efficiency. As a result, North American CMOs and CROs benefitted significantly from this shift, positioning the region as the global leader.

Market Drivers

Strong Biologics Pipeline Boosting Outsourcing Demand

Pharmaceutical and biotechnology companies are increasingly outsourcing development and manufacturing services. The growing pipeline of biologics and biosimilars is expected to drive demand, with smaller CMOs often growing faster than larger ones. For instance, the U.S. FDA approved 64 novel molecular entities and biologics in 2018, highlighting the scale of opportunities for outsourced services.

New Bioprocessing Technologies and Single-Use Systems

The industry is rapidly adopting advanced bioprocessing methods, single-use systems, and alternative business models to enhance capacity and reduce costs. This shift not only improves efficiency but also creates opportunities for CMOs and CROs to scale their operations and offer flexible solutions to biopharma clients.

Regional Strength of North America

North America accounted for nearly 35% of global revenue in 2021, making it the dominant region. The presence of SMEs lacking internal manufacturing capacity has strengthened collaboration with CMOs, while the U.S. market leads in biologics approvals and outsourcing partnerships.

Market Restraints

Despite growth, the market faces challenges such as high initial investments, complex legal negotiations, and limited outsourcing by large, established biopharma companies. Intellectual property concerns, warranty agreements, and the high cost of biomanufacturing facilities are additional hurdles that slow expansion.

Market Opportunities

Strategic collaborations, R&D investments, and mergers & acquisitions are opening new growth avenues. A key example is the long-term partnership between Lonza and Moderna for commercial vaccine production, which reflects how CMOs are becoming critical to the industry’s future. With biopharma companies under pressure from rising costs and declining R&D productivity, outsourcing to CMOs and CROs is set to expand further.

Regional Insights

• North America: Leading the market with strong outsourcing activity, advanced infrastructure, and significant investment in biologics.
• Asia Pacific: Expected to grow at the highest CAGR due to cost advantages in manufacturing and labor, with India emerging as a hub for large-molecule production and biosimilars.

Segment Insights

• By Source: Mammalian cell systems dominate with over 50% share, driven by their ability to produce human-like protein therapies. Non-mammalian systems are growing, supported by advanced microbial expression technologies.
• By Service: Contract research is anticipated to grow at the highest CAGR of 7.49%, fueled by demand from new entrants and smaller biopharma firms. Contract manufacturing remains the largest segment due to high biologics production demand.
• By Product: Biologics hold over 80% market share, supported by rising demand, complex manufacturing processes, and higher success rates. Biosimilars are also gaining traction as companies compete on cost and improved efficacy.

Key Players in the Biopharmaceutical CMO and CRO Market

• Samsung Biologics
• Lonza Group AG
• WuXi Biologics
• Boehringer Ingelheim GmbH
• Fujifilm Diosynth Biotechnologies
• Patheon
• AbbVie Inc.
• Rentschler Biopharma SE
• CMC Biologics
• ProBioGen AG

These players are actively expanding through acquisitions, facility upgrades, and partnerships to strengthen their market presence.

Recent Developments

• May 2022: Boehringer Ingelheim gained CDSCO approval to market Jardiance (empagliflozin) in India for heart failure treatment across all patient types.
• January 2022: Fujifilm Corporation announced the acquisition of Atara Biotherapeutics’ cell therapy manufacturing facility for USD 100 million, boosting its capabilities in CAR-T and T-cell therapies.

Conclusion

The North America biopharmaceutical CMO and CRO market is well-positioned for sustained growth, thanks to its advanced biologics pipeline, outsourcing demand, and technological innovations. With a projected market value of USD 62.36 billion by 2033, the industry presents lucrative opportunities for both established and emerging players.

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