Biotechnology CMO and CDMO Market on Track for USD 199.67 Billion by 2034 with a Strong 11.54% CAGR

The global biotechnology CMO and CDMO market size is calculated at USD 74.01 billion in 2025 and is expected to reach around USD 199.67 billion by 2034, growing at a CAGR of 11.54% for the forecasted period.

Ottawa, Nov. 21, 2025 (GLOBE NEWSWIRE) -- The global biotechnology CMO and CDMO market size was valued at USD 67.25 billion in 2024 and is predicted to hit around USD 199.67 billion by 2034, rising at a 11.54% CAGR, a study published by Towards Healthcare a sister firm of Precedence Research. The market is experiencing rapid growth, driven by the increasing demand for biologics, biosimilars, and gene therapies.

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Key Takeaways

By region, North America was dominant in the Biotechnology CMO and CDMO Market in 2024, with approximately 42% share.
By region, Asia Pacific is expected to grow at the fastest CAGR from 2025 to 2034.
By service type, the commercial manufacturing segment was dominant in 2024, with approximately 46% share.
By service type, the fill–finish and packaging segment is expected to be the fastest-growing over the forecast period, 2025 to 2034.
By product type, the monoclonal antibodies (mAbs) segment was dominant in the market in 2024, with approximately 41% share.
By product type, the cell & gene therapies segment is expected to register the fastest growth over the forecast period, 2025 to 2034.
By scale of operation, the commercial scale segment was dominant in the biotechnology CMO and CDMO market in 2024, with approximately 53% share.
By scale of operation, the flexible/hybrid manufacturing segment is expected to register the fastest growth over the forecast period, 2025 to 2034.
By technology platform, the mammalian cell culture segment was dominant in the market in 2024, with approximately 48% share.
By technology platform, the cell & gene therapy platforms segment is expected to register the fastest growth over the forecast period, 2025 to 2034.
By end user, the large pharmaceutical companies segment was dominant in the biotechnology CMO and CDMO market in 2024, with approximately 47% share.
By end user, the biotechnology companies segment is expected to register the fastest growth over the forecast period, 2025 to 2034

Market Overview & Potential

The biotechnology contract manufacturing organisation (CMO) and contract development and manufacturing organisation (CDMO) market provides outsourced services for the development and production of biotechnology-based therapies. These include monoclonal antibodies, recombinant proteins, vaccines, RNA therapies, cell & gene therapies, and biosimilars. CMOs primarily focus on manufacturing services, while CDMOs offer end-to-end support covering development, process optimisation, clinical manufacturing, regulatory support, and large-scale commercial production.

Key Indicators and Highlights

Table	Scope
Market Size in 2025	USD 74.01 Billion
Projected Market Size in 2034	USD 199.67 Billion
CAGR (2025 - 2034)	11.54	%
Leading Region	North America by 42%
Market Segmentation	By Service Type, By Product Type, By Scale of Operation, By Technology Platform, By End User, By Region
Top Key Players	Thermo Fisher Scientific (Patheon), Boehringer Ingelheim BioXcellence, Rentschler Biopharma SE, AGC Biologics, AbbVie Contract Manufacturing, KBI Biopharma, Emergent BioSolutions, Minaris Regenerative Medicine, Vibalogics (Recipharm), Charles River Laboratories (Biologics CDMO unit), Ajinomoto Bio-Pharma Services, Binex Co., Ltd., Evotec SE (Biologics CDMO division), Thermo Fisher Viral Vector Services, Cognate BioServices

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What is the Growth Potential Responsible for The Growth of The Biotechnology CMO and CDMO Market?

The main drivers of the biotechnology CMO and CDMO market are the increasing complexity and volume of biologic drugs, the growing need for cost-effective and flexible outsourcing, and the pressure to accelerate time-to-market for new therapies. This growth is further fueled by the expanding pipeline of advanced therapies like cell and gene therapies, which require specialised manufacturing expertise and facilities that many companies outsource.

What are the Growing Trends Associated with the Biotechnology CMO and CDMO Market?

Digitalisation and automation: CDMOs are adopting digital technologies like AI, real-time analytics, and automation to improve process efficiency, enhance quality control, and minimise batch failures.

Strategic partnerships and M&A: The industry is seeing a rise in both long-term strategic partnerships between pharma companies and CDMOs, as well as mergers and acquisitions, which help consolidate capabilities and expand geographic presence.

Shift toward integrated services: There is a growing demand for integrated services that cover the entire process from development through to commercial manufacturing.

Focus on specialised therapies: CMOs and CDMOs are increasingly developing expertise in manufacturing high-value, small-batch drugs like orphan drugs and precision medicine.

Navigating complexity: The growing complexity of global supply chains and regulatory requirements is creating opportunities for CDMOs that can provide reliable, high-quality manufacturing services across different markets.

What is the Challenge in the Biotechnology CMO and CDMO Market?

Key challenges facing the biotechnology CMO and CDMO market include navigating complex and evolving global regulations, high capital investment for specialised facilities and technology, supply chain disruptions, a shortage of skilled personnel, and the need to protect intellectual property. Additionally, intense market competition, especially from smaller and emerging companies, and balancing cost with high-value services are significant challenges.

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Major Government Initiative

Initiative	Description
BioE3 Policy	The "Biotechnology for Economy, Environment and Employment" policy was established to foster high-performance biomanufacturing.
Biotechnology Research, Innovation, and Entrepreneurship Development	The government continued this umbrella scheme with new components focused on biomanufacturing and biofoundries. It offers capital grants, seed funding, and other incentives to startups and small to medium-sized enterprises (SMEs).
Production Linked Incentive (PLI) Scheme	This program offers financial incentives to pharmaceutical companies that achieve production targets for critical raw materials, biologics, and complex generics.
National Biopharma Mission	Co-funded by the World Bank, this mission strengthens India's capabilities in biopharmaceuticals, including vaccines, biosimilars, and diagnostics.
BioSecure Act (Pending)	The proposed legislation banning federal funding for U.S. companies working with certain Chinese biotech firms has influenced planning within the CDMO sector throughout 2025.

Regional Analysis

How Did North America Dominate the Biotechnology CMO and CDMO Market in 2024?

North America was dominant in the Biotechnology CMO and CDMO Market in 2024, with approximately a 42% share. Its dominance is driven by the region's strong base of pharmaceutical and biotech companies, which outsource drug development and manufacturing due to demand for complex products like biologics and cell/gene therapies. Key market drivers include the growing demand for biologics and biosimilars and the trend of outsourcing complex manufacturing processes to specialised contract organisations.

What Made the Asia Pacific Significantly Grow in The Biotechnology CMO and CDMO Market In 2024?

Asia Pacific is expected to grow at the fastest CAGR from 2025 to 2034. The Asia Pacific biotechnology CMO and CDMO market is experiencing rapid growth, driven by a large population, a high prevalence of chronic diseases, and increasing investments in healthcare. This expansion is fueled by strong demand for biologics and biosimilars, with countries like China and India leading the way. Key factors contributing to this growth include cost-effective manufacturing, rising government support and incentives for foreign investment, and a growing number of smaller biotech firms needing specialised manufacturing services.

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Segmental Insights

By Service Type,

The commercial manufacturing segment was dominant in 2024, with approximately 46% share. Commercial manufacturing services account for the largest share of the biotechnology CMO and CDMO market, focusing on large-scale production of biologics, biosimilars, and advanced therapies. These services ensure GMP compliance, cost-efficiency, and scalability. Demand is driven by biopharma firms outsourcing production to meet growing therapeutic needs and accelerate product commercialisation.

The fill–finish and packaging segment is expected to be the fastest-growing over the forecast period, 2025 to 2034. Fill-finish and packaging are critical stages ensuring product sterility, stability, and dosage accuracy for biologics and vaccines. CDMOs offer advanced aseptic filling lines and specialised containment solutions tailored for sensitive molecules like mAbs and gene therapies. Automation and single-use technologies enhance efficiency, minimise contamination risk, and support rapid scale-up capabilities.

By Product Type,

The monoclonal antibodies (mAbs) segment was dominant in the market in 2024, with approximately 41% share. Monoclonal antibodies dominate biotechnology outsourcing, owing to their therapeutic relevance in oncology, autoimmune, and infectious diseases. CMOs and CDMOs specialise in high-yield mammalian cell expression systems, purification processes, and analytical testing. The increasing approval of biosimilars and next-generation antibody formats further fuels this segment’s growth.

The cell & gene therapies segment is expected to register the fastest growth over the forecast period, 2025 to 2034. Cell and gene therapies represent one of the fastest-growing product categories, requiring specialised manufacturing facilities and regulatory expertise. CDMOs provide end-to-end support, from viral vector production to final fill-finish of autologous and allogeneic products. Strategic partnerships and capacity expansion are increasing to meet the rising demand for personalised medicine.

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By Scale of Operation,

The commercial scale segment was dominant in the biotechnology CMO and CDMO market in 2024, with approximately 53% share. Commercial-scale manufacturing supports large-volume production for approved biologics and biosimilars. CDMOs focus on maintaining consistency, quality assurance, and global regulatory compliance. Integration of digital biomanufacturing and process intensification technologies enhances yields and reduces timelines, catering to established pharmaceutical companies seeking cost-effective global supply chains.

The flexible/hybrid manufacturing segment is expected to register the fastest growth over the forecast period, 2025 to 2034. Flexible or hybrid manufacturing combines small- and large-scale capacity for multiproduct operations. This approach allows rapid adaptation to variable demand, especially for emerging biotechs and mid-sized pharma companies. CDMOs use modular facilities, single-use systems, and adaptive bioreactor platforms to enhance efficiency and shorten time-to-market for new therapeutics.

By Technology Platform,

The mammalian cell culture segment was dominant in the market in 2024, with approximately 48% share. Mammalian cell culture remains the backbone of biologics manufacturing, particularly for antibodies, fusion proteins, and recombinant therapeutics. CMOs and CDMOs invest in high-density perfusion systems and advanced upstream technologies to boost productivity. Regulatory compliance and process scalability are key factors driving sustained adoption across commercial-scale production.

The cell & gene therapy platforms segment is expected to register the fastest growth over the forecast period, 2025 to 2034. The cell and gene therapy platform includes viral vector production, cell processing, and genome editing workflows. Specialised CDMOs provide capabilities for GMP manufacturing, plasmid production, and cryogenic logistics. The segment is growing rapidly due to expanding clinical pipelines, FDA approvals, and investment in next-generation therapeutic modalities.

By End User,

The large pharmaceutical companies segment was dominant in the biotechnology CMO and CDMO market in 2024, with approximately 47% share. Large pharmaceutical companies rely heavily on CDMOs for scaling biologics and gene therapy production. Outsourcing reduces operational complexity and capital expenditure while ensuring regulatory compliance and consistent supply. Strategic partnerships and long-term contracts are common, enabling faster global market access for innovative biopharmaceuticals.

The biotechnology companies segment is expected to register the fastest growth over the forecast period, 2025 to 2034. Biotechnology companies, often focused on R&D and early-stage innovation, use CDMOs for end-to-end manufacturing solutions. They benefit from flexible capacity, technical expertise, and regulatory support without the need for in-house infrastructure. Growing investment in novel biologics and gene-based therapies continues to expand outsourcing opportunities in this segment.

Browse More Insights of Towards Healthcare:

The global biotechnology and pharmaceutical services market was valued at USD 76.51 billion in 2024, rising to USD 80.7 billion in 2025, and is projected to reach USD 130.56 billion by 2034, reflecting a CAGR of 5.48% from 2025 to 2034.

The biotechnology reagents and kits market stood at USD 733.17 billion in 2024, increased to USD 813.38 billion in 2025, and is expected to reach USD 2,070.55 billion by 2034, advancing at a CAGR of 10.94% between 2024 and 2034.

The biotechnology instruments market is forecasted to grow from USD 97.33 billion in 2025 to USD 138.06 billion by 2034, registering a CAGR of 3.96% during 2025–2034.

The marine biotechnology market reached USD 6.72 billion in 2024, increased to USD 7.21 billion in 2025, and is anticipated to rise to USD 13.25 billion by 2034, expanding at a CAGR of 7.24% from 2025 to 2034.

The APAC biotechnology market was valued at USD 372.23 billion in 2024, grew to USD 432.72 billion in 2025, and is projected to achieve USD 1,611.67 billion by 2034, driven by a strong CAGR of 14.80% between 2025 and 2034.

The AI in biotechnology market reached USD 3.27 billion in 2024, is expected to grow to USD 3.89 billion in 2025, and is projected to reach USD 18.76 billion by 2034 at a CAGR of 19.04%.

The agricultural biotechnology market was valued at USD 126.3 billion in 2024, expanded to USD 137.46 billion in 2025, and is forecasted to reach USD 294.63 billion by 2034, growing at a CAGR of 8.84% between 2025 and 2034.

The global animal biotechnology market stood at USD 28.17 billion in 2024, rose to USD 30.97 billion in 2025, and is expected to reach USD 72.6 billion by 2034, advancing at a CAGR of 9.93% during 2025–2034.

The nanobiotechnology market was valued at USD 172.81 billion in 2024, surged to USD 289 billion in 2025, and is projected to reach USD 420.2 billion by 2034, growing at a CAGR of 9.37% from 2025 to 2034.

The U.S. biotechnology market is projected to rise from USD 699.02 billion in 2025 to USD 2,004.86 billion by 2034, supported by a CAGR of 12.42% over the forecast period.

Recent Developments

In April 2025, Novartis announced plans to acquire Regulus Therapeutics Inc. in a deal that could be valued at up to $1.7 billion. The acquisition aims to strengthen Novartis’s pipeline in RNA-targeted therapies. Under the terms of the agreement, Novartis will pay an upfront cash amount of $7 per share, totalling approximately $800 million.
In February 2025, CDMO Live has emerged as the definitive industry gathering, bringing together Europe's leading pharmaceutical outsourcing decision-makers at Rotterdam's World Trade Centre this May, putting the spotlight on this critical sector.

Biotechnology CMO and CDMO Market Key Players List

Thermo Fisher Scientific (Patheon)
Boehringer Ingelheim BioXcellence
Rentschler Biopharma SE
AGC Biologics
AbbVie Contract Manufacturing
KBI Biopharma
Emergent BioSolutions
Minaris Regenerative Medicine
Vibalogics (Recipharm)
Charles River Laboratories (Biologics CDMO unit)
Ajinomoto Bio-Pharma Services
Binex Co., Ltd.
Evotec SE (Biologics CDMO division)
Thermo Fisher Viral Vector Services
Cognate BioServices

Biotechnology CMO and CDMO Market – Value Chain Analysis

R&D

Various R&D processes involved in biotechnology CMO and CDMO, such as the exploration and manipulation of biological systems and living organisms to create new solutions.

Key Players: ALTEN and Cheesecake Labs

Clinical Trials

Outsource manufacturing adheres to strict government guidelines, specifically present good manufacturing practices (cGMP), to confirm the quality, safety, and integrity of the Investigational Medicinal Product (IMP) through the clinical trial phases

Key Players: Qubit Labs and Riseup Labs

Patient Services

Biotech contract manufacturing majorly focuses on manufacturing drug substances and drug products for a client organization. Patient services are managed by the client's biotech or pharmaceutical company.

Key Players: NE and Tata Consultancy Services

Top Vendors and their Offering

Lonza Group: Access end-to-end integrated biologics development services from pre-clinical to commercialization, for drug substance and drug product.
Samsung Biologics: Samsung Biologics is a reliable partner for seamless tech transfers, clinical and commercial biologics manufacturing, aseptic fill-finish, and analytical testing.
WuXi Biologics: As a premier Contract Development and Manufacturing Organization, WuXi STA offers our worldwide partners efficient, flexible, and high-quality solutions for integrated CMC from preclinical to commercial.
Catalent Inc.: Catalent Biologics’ drug product CDMO services leverage advanced technologies and proven expertise to supply better biologics, biosimilars, vaccines, sterile injectables, and diluents to your patients.
Fujifilm Diosynth Biotechnologies: FUJIFILM Biotechnologies provides process development through to commercial supply of life-impacting medicines for patients around the world.

Segments Covered in The Report

By Service Type

Process Development
Analytical & Quality Testing
Clinical Manufacturing
Commercial Manufacturing
Fill–Finish & Packaging
Regulatory & Technical Services

By Product Type

Monoclonal Antibodies (mAbs)
Recombinant Proteins
Vaccines
Cell & Gene Therapies
RNA-based Therapies (mRNA, siRNA, saRNA)
Biosimilars
Others

By Scale of Operation

Preclinical/Small Scale
Clinical Scale
Commercial Scale
Flexible/Hybrid Manufacturing

By Technology Platform

Mammalian Cell Culture
Microbial Fermentation
Cell & Gene Therapy Platforms
RNA Manufacturing Platforms
Others

By End User

Large Pharmaceutical Companies
Biotechnology Companies
Academic & Research Institutes
Contract Research Organisations (CROs) leveraging CMOs/CDMOs

By Region

North America
- U.S.
- Canada
Asia Pacific
- China
- Japan
- India
- South Korea
- Thailand
Europe
- Germany
- UK
- France
- Italy
- Spain
- Sweden
- Denmark
- Norway
Latin America
- Brazil
- Mexico
- Argentina
Middle East and Africa (MEA)
- South Africa
- UAE
- Saudi Arabia
- Kuwait

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