New Drug Approvals and Their Contract Manufacture: 2026 Edition

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Published: June 12, 2026 Report Code: GDPS0053MAR-ST

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New Drug Approvals and Contract Manufacturing Industry Analysis. Benchmark leading CDMOs and CMOs, analyze FDA drug approval outsourcing trends, identify manufacturing partners, and evaluate growth opportunities with GlobalData’s expert market intelligence.

Understand FDA Drug Approval Outsourcing Trends and the Future of Contract Manufacturing

The pharmaceutical contract manufacturing industry continues to evolve as drug developers seek greater flexibility, specialized manufacturing capabilities, and faster routes to commercialization. At the same time, FDA approvals, biologics, cell and gene therapies, and complex dosage forms are reshaping outsourcing strategies across the global pharmaceutical industry.

GlobalData’s New Drug Approvals and Their Contract Manufacture is the 16th edition of our flagship analysis of the contract development and manufacturing organization (CDMO) industry. Widely recognised as the industry’s benchmark report, it provides unique insight into how newly approved drugs are manufactured, which companies are winning outsourcing contracts, and how outsourcing strategies are changing over time.

Rather than simply reporting FDA approval data, this report helps you understand what those approvals mean for CDMO performance, pharmaceutical manufacturing strategy, supplier selection, and investment opportunities.

Whether you are evaluating manufacturing partners, benchmarking competitors, planning capacity expansion, or assessing acquisition targets, this report provides the intelligence needed to support informed strategic decisions.

Report Value Proposition – Why This CDMO Market Report Matters

Choosing the right manufacturing strategy requires more than understanding approval numbers.

This report helps you connect FDA approval activity with outsourcing behaviour, manufacturing trends, and competitive performance.

You can use it to:

  • Benchmark leading CDMOs and CMOs using FDA approval performance
  • Identify outsourcing trends across new drug approvals and biologics
  • Evaluate which manufacturers are gaining market share
  • Understand pharmaceutical companies’ outsourcing strategies by market capitalization
  • Support supplier selection and procurement decisions
  • Identify acquisition, partnership, and investment opportunities
  • Monitor manufacturing trends in high-growth therapeutic areas
  • Assess how policy changes, reshoring initiatives, and technology innovation may influence future outsourcing

As a result, you can strengthen commercial strategy with evidence-based market intelligence rather than relying on isolated approval data.

FDA Drug Approval Trends, CDMO Performance and Pharmaceutical Manufacturing Insights

The report delivers comprehensive analysis of the relationship between FDA drug approvals and pharmaceutical contract manufacturing.

Coverage includes:

  • FDA New Drug Application (NDA) and Biologics License Application (BLA) approvals
  • Contract manufacturing outsourcing trends
  • CDMO market share analysis
  • Outsourced API manufacturing
  • Dosage form outsourcing
  • Biologic manufacturing
  • Vaccine manufacturing
  • Biosimilar manufacturing
  • Cell and gene therapy manufacturing
  • Antibody-drug conjugate (ADC) manufacturing
  • Generic drug approvals (ANDA)
  • Manufacturing value chain analysis

In addition, the report evaluates outsourcing trends across:

  • New Molecular Entities (NMEs)
  • Accelerated Approval products
  • Orphan Drugs
  • Breakthrough Therapies
  • Fast Track products
  • Special handling products

This enables you to understand where outsourcing demand is growing and which manufacturing capabilities may become increasingly valuable.

Scope

What You Will Learn

The report provides detailed insight into:

  • FDA drug approval trends

  • NDA and BLA approval analysis

  • CDMO market performance

  • Contract manufacturing market shares

  • API outsourcing trends

  • Dose manufacturing outsourcing

  • Manufacturing by dosage form

  • Outsourcing by sponsor size

  • Biosimilar manufacturing trends

  • Cell and gene therapy manufacturing

  • Antibody-drug conjugate manufacturing investment

  • US pharmaceutical manufacturing reshoring

  • Manufacturing value chain analysis

  • Company benchmarking

  • Industry outlook and strategic implications

Moreover, expert commentary explains what these developments may mean for pharmaceutical manufacturers, outsourcing providers, investors, and procurement teams.

Target Buyers

This report is designed for decision-makers across the pharmaceutical manufacturing ecosystem, including:

  • Chief Executive Officers

  • Chief Operating Officers

  • Chief Manufacturing Officers

  • Heads of Technical Operations

  • CDMO Executive Leadership

  • CMO Executive Leadership

  • Business Development Directors

  • Procurement and Strategic Sourcing Leaders

  • Manufacturing Strategy Teams

  • Supply Chain Executives

  • Corporate Development Teams

  • Competitive Intelligence Professionals

  • Market Intelligence Teams

  • Pharmaceutical Manufacturing Directors

  • Biotech Executives

  • Investment Analysts

  • Private Equity Investors

  • Healthcare Investment Banks

  • Pharmaceutical Consultants

How Companies Use This Report

Organisations throughout the pharmaceutical manufacturing ecosystem use this report in different ways.

  • CDMOs and CMOs, including Thermo Fisher Scientific (Patheon), Catalent, Recipharm, Piramal Pharma Solutions, and WuXi Biologics, may use the report to benchmark market position, identify growth opportunities, and understand competitive performance across FDA-approved products.

  • Pharmaceutical companies, including Pfizer, AbbVie, GSK, Novo Nordisk, Johnson & Johnson, and Biogen, can evaluate outsourcing strategies, identify manufacturing partners, and compare supplier capabilities.

  • Biotechnology companies may use the report to identify experienced manufacturing partners for innovative therapies, biologics, cell therapies, and gene therapies.

  • Procurement and sourcing teams can evaluate supplier capabilities, benchmark outsourcing trends, and strengthen supplier selection strategies.

  • Private equity firms and institutional investors may assess acquisition opportunities, identify high-performing CDMOs, and evaluate market consolidation trends.

  • Corporate development teams can use the report to identify partnership opportunities, evaluate acquisition targets, and support strategic expansion.

  • Consultants and market intelligence teams may use the analysis to advise clients on outsourcing strategy, manufacturing capacity, and competitive positioning.

Reasons to Buy

Benchmark Against Leading Global CDMOs and Pharmaceutical Manufacturers

Competitive benchmarking is a core strength of this report.

You can compare the performance of leading contract manufacturers and pharmaceutical companies involved in FDA-approved products.

Company analysis includes organisations such as:

  • Thermo Fisher Scientific (Patheon)

  • Catalent

  • WuXi Biologics

  • PCI Pharma Services

  • Piramal Pharma Solutions

  • Recipharm

  • Vetter Pharma

  • Siegfried

  • Almac

  • Bora Pharmaceuticals

  • Hovione

  • Corden Pharma

The report also evaluates outsourcing behaviour among pharmaceutical companies including:

  • Pfizer

  • Novo Nordisk

  • AbbVie

  • GSK

  • Biogen

These insights may help you benchmark your organisation against global industry leaders while identifying emerging competitors and strategic partners.

Built on Trusted Research and Industry Expertise

This report combines GlobalData’s proprietary pharmaceutical databases with extensive primary research, secondary research, and expert industry analysis.

Customers rely on GlobalData because our insights are:

  • Trusted by Fortune 500 companies and leading governments

  • Backed by experienced healthcare and life sciences analysts

  • Supported by proprietary industry databases and rigorous research methodologies

  • Designed to provide objective, evidence-based market intelligence

Why Act Now?

The pharmaceutical outsourcing landscape is changing rapidly. FDA approvals continue to evolve, biologics and advanced therapies are becoming more prominent, and manufacturers are investing heavily in new production capacity.

At the same time, reshoring initiatives, supply chain resilience, and strategic manufacturing partnerships are reshaping competitive dynamics.

Therefore, timely market intelligence can help you identify opportunities, benchmark leading organisations, and support more informed investment and outsourcing decisions.

If your organisation is evaluating CDMO partners, expanding manufacturing capacity, assessing competitors, or planning future investments, this report provides authoritative insight into one of the pharmaceutical industry’s most important strategic markets.

AbbVie Inc
Adare Pharmaceuticals Inc
Adimmune Corp
AGC Biologics Inc
Almac Group Ltd
Altergon Italia SRL
Alvotech SA
Astrea Pharma
Bilthoven Biologicals BV
Biogen Inc
BioReliance Corp
Bora Pharmaceuticals Co Ltd
BSP Pharmaceuticals SpA
Caplin Point Laboratories Ltd
Catalent Inc
Cenexi SAS
Contract Pharmaceuticals Ltd
Corden Pharma International GmbH
Delorbis Pharmaceuticals Ltd
DPT Laboratories Ltd
GSK plc
Halo Pharma Inc
Hovione FarmaCiencia SA
Industria Farmaceutica Galenica Senese
Ingenus Pharmaceuticals LLC
Janssen-Cilag SpA
Kymos Pharma Services SL
Mabxience Holding SL
MIAS Pharma Ltd
Midas Pharma GmbH
Nanjing King-friend Biochemical Pharmaceutical Co Ltd
NextPharma Technologies Holding Ltd
Novo Nordisk AS
NUVISAN Pharma Holdings GmbH
Par Sterile Products LLC
PCI Pharma Services
Pfizer Inc
Pharmaloop SL
Piramal Pharma Solutions Inc
Rechon Life Science AB
Recipharm AB
Rottendorf Pharma GmbH
ROVI Pharma Industrial Services SA
Sharp Sterile Manufacturing LLC
Siegfried Holding AG
Simtra US LLC
Skyepharma Production SAS
Thermo Fisher Scientific Inc
Tjoapack BV
Tulex Pharmaceuticals Inc
Unither Pharmaceuticals SAS
UPM Pharmaceuticals Inc
Vetter Pharma-Fertigung GmbH & Co KG
Woodstock Sterile Solutions
WuXi Biologics Co Ltd

Table of Contents

Table of Contents

1 Executive Summary

2 Players

2.1 Pharma leaders

2.1.1 Johnson & Johnson

2.2 Pharma disruptors

2.2.1 Soleno Therapeutics

2.3 Contract manufacturing organization leaders

2.3.1 Patheon

2.4 Contract manufacturing organization disruptors

2.4.1 Halo Pharma

3 Technology Briefing

3.1 Innovative drug approvals

3.2 Dose outsourcing of drug approvals

4 Trends

5 Industry Analysis

5.1 Introduction

5.2 FDA New Drug Application approvals overview

5.2.1 Cell and gene therapies

5.2.2 First-in-class drugs

5.2.3 First-time approvals

5.3 Sponsor trends

5.3.1 FDA outsourced dose manufacture

5.3.2 Dosage form outsourcing

5.4 Special product categories

5.4.1 Accelerated approval

5.4.2 Orphan drug designation

5.4.3 Fast track designation

5.4.4 Breakthrough therapy designation

5.4.5 Containment

5.5 Contract manufacturing organization performance

5.5.1 Dosage form

5.6 Outsourced active pharmaceutical ingredient approvals

5.7 Abbreviated new drug application approvals

5.8 What it means

5.8.1 US onshoring push creates billion-dollar manufacturing investments

5.8.2 Biosimilars continue their long-term growth trajectory

5.8.3 US domestic needs filled by European manufacturers

5.8.4 The glucagon-like peptide-1 era approaches its pill phase

5.8.5 Volatility overshadows success in cell and gene therapy

5.8.6 Pharma and contract manufacturing organizations invest for future antibody-drug conjugate manufacturing

5.8.7 Most Favored Nation and investment negotiations interlock

6 Value Chain

7 Companies

8 Appendix

8.1 Methodology

8.2 Bibliography

8.3 Further reading

8.4 About the Authors

Table

Table 1: Drug approval trends, 2025

Table 2: FDA biologic NME approvals, 2016–25

Table 3: Outsourced NDA approvals by dosage form

Table 4: Dose outsourcing relationships by sponsor market cap and FDA approval type, 2020–25

Table 5: CMOs with API contracts for NMEs approved in 2025

Table 6: Companies with 2025 CBER approvals

Table 7: FDA and EMA drug filings rejected or withdrawn in 2025

Table 8: Outsourced dose approvals, 2025

Table 9: CMOs receiving dose contracts for FDA approvals in 2016–25

Table 10: 2025 outsourced API approvals

Table 11: CMOs receiving dose contracts for FDA approvals in 2025

Table 12: Small, micro-, and nano-cap sponsors’ dose outsourcing propensity for NMEs, 2016–25

Table 13: Small, micro-, and nano-cap sponsors’ dose outsourcing propensity for non-NMEs, 2016–25

Table 14: Mid-cap sponsors’ dose outsourcing propensity, 2016–25

Table 15: Large cap sponsors’ dose outsourcing propensity, 2016–25

Table 16: Mega cap sponsors’ dose outsourcing propensity, 2016–25

Table 17: Private companies’ dose outsourcing propensity, 2016–25

Table 18: Further reading

Figures

Figure 1: Leading players for US new drug approvals and their manufacturing, 2025

Figure 2: Top drug approval trends, 2025

Figure 3: FDA NDA and BLA approvals, 2016–25

Figure 4: FDA NDA approvals by sponsor type, 2016–25

Figure 5: Share of outsourced FDA NDA approvals, 2016–25

Figure 6: Outsourced FDA NDA approvals, 2016–25

Figure 7: Dose outsourcing of small molecule and biologic NMEs, 2016–25

Figure 8: Dose outsourcing of FDA NME approvals by sponsor market cap

Figure 9: Dose outsourcing of FDA non-NME approvals by sponsor market cap

Figure 10: Dose outsourcing of accelerated approval NMEs, 2016–25

Figure 11: Dose outsourcing of FDA orphan NMEs, 2016–25

Figure 12: Dose outsourcing of FDA fast track NMEs, 2016–25

Figure 13: Dose outsourcing of FDA breakthrough therapy designation NMEs, 2016–25

Figure 14: NME approvals requiring special handling, 2016–25

Figure 15: Breakdown in composition of dose-outsourced NMEs, by sponsor market cap, 2016–25

Figure 16: Breakdown in composition of dose-outsourced non-NMEs, by sponsor market cap, 2016–25

Figure 17: CMO market share of parenteral NME approvals, 2016–25

Figure 18: CMO market share of parenteral non-NME approvals, 2016–25

Figure 19: CMO market share of solid-dose NME approvals, 2016–25

Figure 20: CMO market share of solid dose non-NME approvals, 2016–25

Figure 21: API outsourcing of small molecule and biologic NMEs, 2016–25

Figure 22: ANDA approvals by dosage form, 2016–25

Figure 23: ANDA approvals by route of administration, 2016–25

Figure 24: The contract manufacturing value chain

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