New Drug Approvals & Contract Manufacturing Market to Reach USD 87.3 Billion by 2030

Sub-Headline: The global market for newly approved drugs and their contract manufacturing services is projected to grow from USD 54.6 billion in 2023 to USD 87.3 billion by 2030, reflecting a strong CAGR of 7.0%, driven by rapid approvals of biologics, antibody-drug conjugates (ADCs), mRNA vaccines, cell & gene therapies, and the rising outsourcing needs of pharmaceutical innovators.

Introduction
The New Drug Approvals and Their Contract Manufacture Market is entering a high-growth phase as pharmaceutical and biotech innovators increasingly rely on contract development and manufacturing organizations (CDMOs) to accelerate commercialization, scale global production, and reduce operational risk.

In 2024-2025, the FDA, EMA, and PMDA collectively approved a rising number of biologics, biosimilars, mRNA vaccines, cell & gene therapies, ADCs, peptide drugs, and precision oncology therapies, creating strong manufacturing demand across the CDMO landscape.

Supply chain modernization, regulatory harmonization, global API shortages, and increased investment in high-potency biologics manufacturing (HPAPI + fill-finish) are shaping the evolving CDMO ecosystem.

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Key Takeaways
• Market Size (2023): USD 54.6 Billion
• Expected Market Size (2030): USD 87.3 Billion
• CAGR (2024-2030): 7.0%
• Biologics manufacturing accounted for 38% of all outsourcing value in 2024.
• Leading CDMOs include Lonza, Catalent, Samsung Biologics, Thermo Fisher Scientific, WuXi AppTec, Fujifilm Diosynth, Boehringer Ingelheim BioXcellence, AbbVie Contract Manufacturing, and AGC Biologics.
• Increased outsourcing driven by complex modality approvals-ADCs, mRNA, cell therapies, viral vectors, and HPAPIs.

Market Story
The contract manufacturing landscape is evolving due to several powerful factors:

1. Surge in Biologics & ADC Approvals
Biologics represented more than half of all new drug approvals in major markets during 2024-2025.
High-growth areas include:
• ADCs (Antibody-Drug Conjugates)
• Monoclonal antibodies (mAbs)
• Bispecific antibodies
• Recombinant proteins
• Next-generation immunotherapies
These require advanced CDMO capabilities such as HPAPI containment, sterile fill-finish, and biologics fermentation.

2. Explosive Growth of mRNA & RNA-Based Manufacturing
The mRNA platform-validated by COVID-19-continues expanding across:
• Cancer vaccines
• Infectious disease vaccines
• Rare-disease therapeutics
• Self-amplifying RNA (saRNA)
CDMOs are investing in LNP formulation, in-vitro transcription (IVT) processes, and end-to-end cold-chain logistics.

3. Cell & Gene Therapy Manufacturing Scaling Rapidly
Demand for viral vectors and cell therapy manufacturing surged, driven by approvals and late-stage trials.
Key bottlenecks CDMOs are addressing:
• AAV, LV & RV vector production
• CAR-T and T-cell engineering
• Plasmid DNA manufacturing
• Cryogenic logistics
This category recorded >15% annual growth in outsourcing.

4. API & HPAPI Shortages Accelerate Outsourcing
Rising complexity of small-molecule APIs, supply disruptions, and regulatory pressure have led innovators to outsource:
• High-potency APIs
• Controlled substances manufacturing
• Complex peptides & oligonucleotides
• Continuous manufacturing solutions
Asia-Pacific CDMOs are gaining strong traction in API outsourcing.

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Market Segments
By Drug Type Approved
• Biologics (largest segment)
• Small Molecules
• RNA & mRNA Therapies
• Cell Therapies
• Gene Therapy Products (AAV, LV)
• Peptides & Oligonucleotides
• ADCs & HPAPIs

By Manufacturing Type
• API Manufacturing
• Biologics Manufacturing
• Fill-Finish Operations
• Formulation Development
• Packaging & Serialization
• Analytical Testing & QC
• Viral Vector & Cell Processing

By End User
• Biotech Companies (fastest growing)
• Pharma Innovators
• Research Institutes
• Vaccines Manufacturers

By Region
• North America - highest value per project
• Europe - strong in biologics & high-potency drugs
• Asia-Pacific - fastest growing due to cost differentiation
• Latin America
• Middle East & Africa

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Recent Developments
• Samsung Biologics expanded large-scale biologics capacity with a new multi-plant complex.
• Lonza added high-capacity viral vector suites to support gene therapy programs.
• Thermo Fisher strengthened injectable-fill operations for oncology biologics.
• Catalent invested in next-gen mRNA + LNP manufacturing capabilities.
• WuXi AppTec/WuXi Biologics expanded global GMP sites in Europe & Asia.
• Fujifilm Diosynth scaled up cell-culture manufacturing for biosimilars and antibody formats.
• AGC Biologics increased viral vector capacity to support personalized gene therapy projects.

Expert Quote
"New drug approvals are becoming increasingly complex, and CDMOs are now essential partners for biologics, ADCs, gene therapies, and next-generation RNA platforms. The contract manufacturing market is entering a long-term growth cycle driven by scientific innovation and global supply chain realignment."
-Irfan Tamboli, Business Development Executive, Exactitude Consultancy

Market Drivers
• Increasing approvals of complex modalities (ADCs, mRNA, CGT)
• Rising cost pressure on pharma companies
• Supply chain de-risking & diversification
• Regulatory support for outsourced GMP capabilities
• Strong biotech pipeline with limited in-house capacity
• Expansion of personalized & precision therapeutics
• Investments in high-potency and sterile manufacturing infrastructure

Forecast Outlook
The market will reach USD 87.3 billion by 2030, driven by:
• Higher biologics adoption
• Expansion of CGT (cell & gene therapy) manufacturing
• AI-enabled manufacturing optimization
• Growing demand for flexible, multi-modal CDMO platforms
• Increased global GMP harmonization
Regional Trends
• U.S. & Europe lead in high-value biologics & CGT manufacturing.
• Asia-Pacific expanding in small-molecule APIs and biosimilars.
• Middle East emerging as a new pharma manufacturing hub.

Government & Regulatory Initiatives
• FDA & EMA streamlined review pathways for advanced modalities
• Global GMP compliance modernization for biologics & vectors
• Government incentives for expanding local manufacturing
• Public-private partnerships for mRNA capacity build-out
• Funding programs for pandemic preparedness & biomanufacturing resilience

Conclusion
The New Drug Approvals & Contract Manufacturing Market is entering a transformative growth era driven by biologics, mRNA, ADCs, and CGT platforms. CDMOs investing in flexible, scalable, multi-technology facilities will dominate the next decade of outsourced pharma manufacturing.

This report is also available in the following languages : Japanese (新薬承認と受託製造市場), Korean (신약 승인 및 계약 제조 시장), Chinese (新药审批及其合同生产市场), French (Marché des nouvelles autorisations de mise sur le marché des médicaments et de leur fabrication sous contrat), German (Markt für neue Arzneimittelzulassungen und deren Auftragsfertigung), and Italian (Approvazioni di nuovi farmaci e il loro mercato di produzione a contratto), etc.

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Exactitude Consultancy is a market research & consulting services firm which helps its client to address their most pressing strategic and business challenges. Our market research helps clients to address critical business challenges and also helps make optimized business decisions with our fact-based research insights, market intelligence, and accurate data.

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