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Healthcare Contract Manufacturing Market to Reach USD 610.9 Billion by 2035, Driven by Biologics Expansion, Emerging Market Outsourcing, and Advanced Manufacturing Technologies

09-30-2025 01:40 PM CET | Health & Medicine

Press release from: MarketGenics India Pvt. Ltd.

Healthcare Contract Manufacturing Market to Reach USD 610.9 Billion by 2035, Driven by Biologics Expansion, Emerging Market

Healthcare Contract Manufacturing Market to Reach USD 610.9 Billion by 2035, Driven by Biologics Expansion, Emerging Market

The global Healthcare Contract Manufacturing Market is projected to grow from USD 193.2 billion in 2025 to USD 610.9 billion by 2035, expanding at a CAGR of 12.2% during the forecast period.

Growth is powered by rising pharmaceutical outsourcing, the surge in biologics and personalized medicine, and manufacturers' increasing reliance on CMOs (Contract Manufacturing Organizations) to cut costs and streamline operations.

MarketGenics identifies healthcare contract manufacturing as a strategic enabler for pharmaceutical, biologics, and medical device companies, allowing them to focus on innovation and R&D while leveraging specialized partners for large-scale, compliant production.

Get the Detailed Industry Analysis (including the Table of Contents, List of Figures, and List of Tables) - from the Healthcare Contract Manufacturing Market Research Report: https://marketgenics.co/press-releases/healthcare-contract-manufacturing-market-31805

Recent Developments Shaping the Market

Johnson & Johnson Expands U.S. Manufacturing Footprint

In August 2025, Johnson & Johnson announced a USD 2 billion investment in a new facility in Holly Springs, North Carolina, in partnership with Fujifilm Diosynth. The facility strengthens domestic production capabilities in response to proposed U.S. pharmaceutical import tariffs.

MSD Reshapes Global Production Strategy

Also in August 2025, MSD (Merck & Co.) revealed plans to shift part of its Keytruda production from Dublin, Ireland, to Wilmington, Delaware. The restructuring aims to save USD 3 billion while reinforcing U.S.-based production capacity amid tariff and policy shifts.

Novo Nordisk Pursues Reshoring Strategy

Novo Nordisk announced the relocation of parts of its diabetes and obesity drug production to the U.S. in 2025, a move designed to de-risk supply chains and ensure domestic drug availability.

Lonza Expands in Asia

In June 2025, Lonza opened a new API (Active Pharmaceutical Ingredient) plant in Hyderabad, India, supporting rising demand in Asian markets and strengthening its role as a global supply chain partner.

Market Forecast 2035

The market is expected to generate an incremental opportunity of USD 418 billion between 2025 and 2035.

Asia Pacific will remain the largest and most attractive region, accounting for 40.3% of global revenue in 2025 (USD 77.9 billion), led by India and China as contract manufacturing hubs.

North America will benefit from reshoring initiatives, tariffs, and large-scale biologics investments.

Europe will see steady demand but will face regulatory complexity and cost pressures.

To know more about the Healthcare Contract Manufacturing Market - Download our Sample Report: https://marketgenics.co/download-report-sample/healthcare-contract-manufacturing-market-31805

Key Drivers, Challenges, and Opportunities

Driver - Rising Demand for Biologics and Personalized Medicine

Biologics, cell therapies, and personalized drugs require advanced, specialized production capabilities. In August 2025, Catalent expanded its Bloomington, Indiana facility with new bioreactors to meet growing biologics demand. Such investments fuel the CMO sector as pharma companies increasingly outsource high-tech manufacturing.

Restraint - Regulatory Compliance Challenges Across Regions

Divergent regulatory frameworks between agencies such as the FDA (U.S.) and EMA (Europe) create costly delays and resource burdens. In July 2025, a leading CMO faced setbacks in device approvals due to documentation inconsistencies, highlighting the risks of fragmented compliance environments.

Opportunity - Expansion into Emerging Markets

Emerging markets present volume-driven growth opportunities. Lonza's Hyderabad API facility and Jubilant Life Sciences' 2025 manufacturing expansion in Gujarat, India, reflect the trend of building scalable, low-cost capacity in Asia to serve global supply chains.

Key Trend - Adoption of Advanced Manufacturing Technologies

AI, automation, and continuous manufacturing are transforming CMO operations. In May 2025, Medtronic deployed AI-driven predictive maintenance, reducing downtime by 15% and boosting productivity by 10%. These technologies are becoming differentiators in securing long-term outsourcing contracts.

Segmental Insights

Pharmaceutical Products Lead with 46% Share

Pharmaceutical products dominate healthcare contract manufacturing due to expanding drug pipelines, chronic disease prevalence, and rising demand for cost-effective outsourced manufacturing. Lonza's 2025 capacity expansion in Switzerland reflects sustained demand for small-molecule and specialty drug production.

Biologics and Biosimilars Gaining Share

The rise of biologics and biosimilars, including monoclonal antibodies and cell therapies, is accelerating demand for specialized CMOs with GMP-certified biologics capacity.

Medical Devices and Diagnostics Growing Steadily

Contract manufacturing in medical devices and diagnostics is also expanding, driven by miniaturization, regulatory compliance needs, and OEMs focusing on innovation.

Buy Now: https://marketgenics.co/buy/healthcare-contract-manufacturing-market-31805

Regional Highlights

Asia Pacific: Market leader with scalable, cost-efficient, high-quality capacity. India and China are central hubs for APIs, finished dosages, and clinical trial supplies.

North America: Benefiting from reshoring, tariff-driven investments, and high biologics adoption.

Europe: Growth steady but challenged by fragmented regulations and cost pressures.

Middle East, Africa, South America: Early-stage but offering opportunities through infrastructure build-outs and government-backed localization programs.

Competitive Landscape

The market is moderately fragmented, with the top five players holding just over 30% of global share in 2025.

Tier 1 Leaders: Catalent, Lonza, FUJIFILM Diosynth, Samsung Biologics, and WuXi AppTec

Tier 2/3 Regional Players: Alcami, Jubilant Pharmova, Delpharm, Famar, and others

Buyer concentration is moderate, as pharma companies can shift between multiple CMOs. Supplier concentration remains higher due to reliance on specialized raw materials and advanced bioprocessing technology.

Future Outlook

By 2035, healthcare contract manufacturing will evolve into a technology-enabled, globally distributed ecosystem where biologics, personalized medicine, and advanced drug delivery systems drive demand. Key growth themes include:

Expansion of biologics and cell/gene therapy outsourcing

Adoption of AI, automation, and continuous manufacturing processes

Supply chain diversification and reshoring strategies in North America and Europe

Rising outsourcing demand in emerging Asia-Pacific and Latin America

The industry's ability to integrate compliance, technology, and cost efficiency will define its role as a critical partner in global healthcare innovation.

Get a preview of our Healthcare Contract Manufacturing Market Playbook - your guide to GTM strategy, competitive intelligence, supplier dynamics, and Consumer Behavior Analysis: https://marketgenics.co/playbook/healthcare-contract-manufacturing-market-31805

Prominent Companies Operating in the Global Healthcare Contract Manufacturing Market:

Catalent, Lonza Group, FUJIFILM Diosynth, Samsung Biologics, WuXi AppTec, Jubilant Pharmova, Alcami, Delpharm, Famar, and other regional players.

About Us

MarketGenics is a global market research and management consulting company empowering decision makers across healthcare, technology, and policy domains. Our mission is to deliver granular market intelligence combined with strategic foresight to accelerate sustainable growth.

We support clients across strategy development, product innovation, healthcare infrastructure, and digital transformation.

Contact:

Mr. Debashish Roy

MarketGenics India Pvt. Ltd.

800 N King Street, Suite 304 #4208, Wilmington, DE 19801, United States

USA: +1 (302) 303-2617

Email: sales@marketgenics.co

Website: https://marketgenics.co

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