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Shaping
the Future of Biopharma Manufacturing

From economic challenges to breakthrough innovations, the CDMO industry is evolving rapidly.The Nice Insight Review 2025 explores the changes shaping capabilities, locations, and technologies worldwide.

The CDMO Landscape in Numbers

400+

400+

CDMOs tracked globally across all modalities

1,200+

1,200+

Manufacturing sites

50

50

50 FDA Therapeutic Approvals in 2024, maintaining the 6-year average

15+

15+

Therapeutic modalities in development

10.7%

10.7%

CAGR projected for antibody-based therapeutics through 2030

44

44

CDMOs with
ADC conjugation capabilities

79

79

CDMOs offering
RNA-based manufacturing

$2B+

$2B+

in new sterile fill-finish investment during 2024

4%

4%

Forecasted growth in global R&D spend in 2025

David Alvaro, Ph.D.
David Alvaro, Ph.D.
Editor-in-Chief,
Pharma’s Almanac

The biopharma sector faces heightened uncertainty and volatility in 2025, owing to a mix of legislative, trade, and political pressures that could reshape industry dynamics, particularly for CDMOs and investors.”

The Global
Pipeline Holds
Steady

Despite funding pressures, the global therapeutic pipeline remained strong in 2024, with 50 new FDA approvals. The economic pressures facing the industry did not affect all drug modalities equally.

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Global Pipeline
Daniel Smith, Ph.D.,
Daniel Smith, Ph.D.,
Chief Scientific Officer,
That’s Nice

Annual drug approvals are an indicator for the clinical pipeline and by extension a barometer for the health of the CDMO sector... a decrease in approval numbers for a modality can indicate trouble ahead for the CDMO sector serving that modality.”

Four Foundational Platforms Support the Therapeutic Continuum

In the last 20 years, more than 15 different therapeutic modalities have been developed, each with specific manufacturing and operational challenges. CDMOs are reorganizing around four foundational technology platforms to support this continuum of new therapeutic modalities. Specialization within a foundational platform allows CDMOs to evolve into experts in the sector

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Foundational Platforms Card

Cell Engineering

Artificial Intelligence, Machine Learning and Continuous Manufacturing.

Foundational Platforms Card

Antibodies & Proteins

Viral genetic engineering, production and immunogenicity, and novel non-viral delivery systems (e.g., lipid nanoparticles).

Foundational Platforms Card

Small Molecules & Nucleic Acids

Closed-system automation

Foundational Platforms Card

Viruses & Delivery Systems

Applying existing expertise to advance new modalities

April Stanley
April Stanley
Senior Scientific
Research Director,
That’s Nice

The therapeutics pipeline reveals a trend toward more precise drug targeting, focused on smaller patient populations and more complex therapeutics than developed historically.”

The Global CDMO Landscape

Throughout 2024 and into 2025, CDMOs, innovators, and investors in the biopharma sector are navigating a landscape defined by funding constraints, capacity overages in certain modalities and scarcity in others, evolving regulatory pressures, and a continued — if staggered — shift toward advanced therapies. Overall, the CDMO landscape mirrors the trends and challenges of the wider biopharma sector.

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Global CDMO Landscape
Foundational Platforms Card

Small Molecules APIs

  • 31% of CDMOs serve this segment.
  • India hosts 58% of the APAC API sites.
  • Price erosion pressures European suppliers as modernization costs rise.
Foundational Platforms Card

Sterile Fill-Finish

  • 57 CDMOs operate 105 sites. 82% are in North America or Europe.
  • Over $2B+ invested in new capacity.
  • Prefilled syringe demand expected to grow 12% annually.
Foundational Platforms Card

Antibody–Drug Conjugates (ADCs)

  • 10 CDMOs worldwide can handle complete ADC manufacturing.
  • The market is expected to grow at a CAGR of more than 15% through 2030.
Foundational Platforms Card

RNA Therapeutics

  • 80 CDMOs are active, but only 20% have vaccine-scale capacity.
  • mRNA demand is down 70% from the 2021 peak, prompting diversification into synthetic RNA and oligonucleotide production.
Foundational Platforms Card

Cell & Gene Therapy (CGT)

  • 67 viral vector and 51 cell therapy CDMOs tracked.
  • 60% of pipeline programs are gene-modified cell therapies.
  • Industry consolidation continues as CDMOs pivot to commercial scale.
Nigel Walker
Nigel Walker
Founder,
That’s Nice

Having fewer small-scale U.S.-based API CDMOs means that this market has almost reached critical mass, limiting innovators’ choices for 2025.”

Trade Policy
Reshapes
Manufacturing
Strategy

The April 2025 U.S. tariff announcements on imports from China, India, and the EU sent shockwaves through global sourcing.

Trade Policy
Trade Policy Card

10% baseline tariffs

and selective retaliations threaten API and consumable pricing.

Trade Policy Card

Up to 70%

of critical manufacturing materials cross multiple borders before final assembly.

Trade Policy Card

Latin America & India

are emerging as alternate sourcing hubs.

Trade Policy Card

Winners

Diversified, multi-region CDMOs with digital supply-chain visibility

Trade Policy Card

Losers

Single-region CDMOs heavily reliant on China or the EU

Trade Policy

Strategic Recommendations

  • Conduct tariff scenario planning across various possible outcomes to spot vulnerabilities before they affect operations.
  • Prioritize supply chain redundancy by qualifying multiple suppliers across regions, building strategic stockpiles, and diversifying trade corridors.
  • Leverage digital infrastructure to track inventory, supplier performance, and logistics risks in real-time, allowing for quick pivots if disruptions occur.
April Stanley
April Stanley
Senior Scientific
Research Director,
That’s Nice

Simple product origin labels belie a complicated supply chain. The confusion around how tariffs are applied will complicate costing forecasts for consumables.”

The Rise and Fall
of Advanced
Therapies

After explosive pandemic-era growth, the RNA therapeutics market has cooled dramatically. While RNA technologies are expanding into oncology and rare diseases, commercial traction remains limited, and 2025 is a year of survival for many CDMOs in this space.

Trade Policy
Trade Policy Card

RNA approvals dropped from 10 in 2023 to 3 in 2024, leaving many facilities underutilized.

Trade Policy Card

Synthetic RNA CDMOs are faring better, thanks to a steadier ASO/RNAi pipeline and more automated, cost-efficient manufacturing.

Slide 1
Slide 2
Slide 3

A rapid 10% decline in the cell and gene therapy (CGT) preclinical pipeline in 2023 led to challenging conditions for CGT CDMOs in 2024.

By the end of 2024, nearly 60% of CGT products in development were ex vivo gene-modified cell therapies. CDMOs offering cell therapy–based services should fare better than those offering gene therapy services during 2025. However, deeper analysis of the CGT CDMO sector reveals a more nuanced position, as many CGT CDMOs aim to build resilience by establishing integrated services across the supply chain.

  • Viral vector CDMOs offer an integrated pDNA and viral vector service
  • Cell therapy CDMOs provide comprehensive pDNA, lentiviral vector and cell therapy manufacturing services.
Sophie Lutter
Sophie Lutter
Ph.D., Scientific
Strategy Director,
That’s Nice

Viral vector CDMOs face a double challenge in 2025: a declining preclinical pipeline coupled with over-capacity issues. Market consolidation could help by concentrating scientific expertise into a smaller number of specialist CDMOs.”

Outlook:
Cautious Optimism

  • 4% increase in global R&D spend projected for 2025
  • Biologics demand continues to expand in the U.S.
  • Synthetic and enzymatic DNA manufacturing is entering mainstream adoption
  • Multi-modality CDMOs and those supporting commercial products are best positioned to lead recovery
Outlook
Daniel Smith, Ph.D.,
Daniel Smith, Ph.D.,
Chief Scientific
Officer, That’s Nice

Despite headwinds predicted for 2025, the CDMO sector will continue to play an essential role in enabling new drugs to reach patients. However, CDMOs need to remain resilient in the short- to medium-term. Inevitably, the sector will see attrition in the CDMO base in 2025, and more downsizing in skilled talent and human resources.”

Explore the Complete Report

Dive deeper into market data, modality forecasts, and strategic insights that reveal how CDMOs are navigating the next evolution in global biomanufacturing.

Explore the Complete Report

Access CDMO pricing, market trends, provider profiles and capacity overviews across 10 therapeutic modalities.

Access CDMO pricing, market trends, provider profiles and capacity overviews across 10 therapeutic modalities.
Nice Insight

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