New Drug Approvals and Their Contract Manufacture – 2024 Edition

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Published: April 16, 2024 Report Code: GDPS0049MAR-ST

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This report is the 14th edition of our long-running analysis of the CMO industry, using the FDA’s NDA approvals as the primary indicator of performance. New Drug Approvals and Their Contract Manufacture (formerly called “CMO Scorecard”) is critical for benchmarking the performance of the contract manufacturing organization (CMO) industry and the relative performance of major CMOs. This year’s edition includes a discussion of how inflation and increasing global conflict has impacted pharma manufacturers.

Scope

This 87-page report gives important, expert insight you won’t find in any other source. 18 tables and 25 figures throughout the report illustrate major points and trends. This report is required reading for –

• CMO executives who must have deep understanding of drug approvals and outsourcing to make strategic planning and investment decisions.

• Sourcing and procurement executives who must understand crucial components of the supply base in order to make decisions about supplier selection and management.

• Private equity investors that need a deeper understanding of the market to identify and value potential investment targets.

Reasons to Buy

Overview of NDA drug and vaccine approvals and the levels of outsourcing associated with NDA sub segments

Detailed view of CDMO performance by number of drug and vaccine approvals

An assessment of pharmaceutical companies’ propensity to outsource manufacture, by their market caps, based on GlobalData’s Contract Service Providers database

Outsourcing propensity for New Molecular Entities (NMEs), different dosage forms, and other drug attributes.

Analysis of NME special product approvals such as those with Accelerated Approval, Orphan, Breakthrough or Fast Track designations and assessment of outsourcing

AbbVie Inc
ACS Dobfar SpA
AdhexPharma
Aenova Holding GmbH
Afton Scientific Corp
AGC Biologics Inc
Ajinomoto Bio-Pharma Services
Akorn Operating Company LLC
Alcami Corp
Alfasigma SpA
Allergopharma GmbH & Co KG
Almac Group Ltd
Alpex Pharma SA
Altasciences Co Inc
AqVida GmbH
Arx LLC
ASM Aerosol-Service AG
AstraZeneca Plc
AtomVie Global Radiopharma Inc
Aurobindo Pharma Ltd
AustarPharma LLC
Avara Pharmaceutical Services Inc
Baccinex SA
Basic Pharma
Bausch & Lomb Pharmaceuticals Inc
Bayer AG
Berkshire Sterile Manufacturing LLC
Biogen Inc
BioRamo LLC
BioReliance Corp
Boehringer Ingelheim Biopharmaceuticals GmbH
Boehringer Ingelheim RCV GmbH & Co KG
Bora Pharmaceuticals Co Ltd
Bristol-Myers Squibb Co
BSP Pharmaceuticals SpA
Bushu Pharmaceuticals Ltd
Cambrex Corp
Catalent Inc
Cenexi SAS
Cerovene Inc
Chia Tai Tianqing Pharmaceutical Group Co Ltd
Contract Pharmaceuticals Ltd
Corden Pharma International GmbH
CoreRx Inc
Corium Innovations Inc
Curia Global Inc
Delpharm SAS
Dexcel PT Israel Ltd
DPT Laboratories Ltd
Eisai Co Ltd
EMD Serono Inc
Emergent BioSolutions Inc
EuroAPI SAS
Eurofins Scientific SE
Excella GmbH & Co KG
Exela Pharma Sciences LLC
Exelead Inc
Fareva SA
Ferndale Pharma Group Inc
Fidia farmaceutici SpA
FinVector Oy
Fresenius Kabi AG
Fritz Keller Holding AG
Fuji Yakuhin Co Ltd
FUJIFILM Diosynth Biotechnologies USA Inc
Gensenta Ilac Sanayi ve Ticaret AS
Gland Pharma Ltd
Glatt GmbH
Grifols SA
Groupe Parima Inc
Grunenthal GmbH
Hanford Pharmaceuticals
Hetero Drugs Ltd
Hikma Pharmaceuticals Plc
Holopack Verpackungstechnik GmbH
Hovione FarmaCiencia SA
IDT Biologika GmbH
Importfab Inc
Ipsen SA
Iwaki Seiyaku Sakura Factory Co Ltd
James Alexander Corp
Jubilant HollisterStier LLC
Juzen Chemical Corp
Kyowa Hakko Bio Co Ltd
Laboratorios Farmaceuticos Rovi SA
Lek Pharmaceuticals dd
LGM Pharma LLC
Lichtenheldt GmbH
Lifecore Biomedical LLC
Lonza Group Ltd
LTS Lohmann Therapie-Systeme AG
Lupin Ltd
Mawdsley-Brooks & Co Ltd
MIAS Pharma Ltd
Mibe GmbH Arzneimittel
Mikart LLC
Minaris Regenerative Medicine LLC
Mipharm SpA
Mission Pharmacal Co
Molteni Farmaceutici
National Resilience Inc
Neolpharma SA De CV
NerPharma Srl
NextPharma Technologies Holding Ltd
Nova Laboratories Ltd
Novartis AG
Novast Holdings Ltd
NUVISAN Pharma Holding GmbH
OishiKoseido Corp
Oncotec Pharma Produktion GmbH
Organon & Co
PARI Pharma GmbH
PCI Pharma Services
Pfizer Inc
Pharmaceutics International Inc
Pharmasol Corp
Pharmathen Global BV
Pharmstandard
Pierrel SpA
Piramal Pharma Solutions Inc
Polymun Scientific Immunbiologische Forschung GmbH
Procaps SAS
PYRAMID Laboratories Inc
Qilu Pharmaceutical Co Ltd
QPS Holdings LLC
Quotient Sciences Ltd
Rechon Life Science AB
Recipharm AB
Renaissance Lakewood LLC
Rentschler Biopharma SE
Rivopharm SA
Rottendorf Pharma GmbH
R-Pharm
Samsung Biologics Co Ltd
Sandoz International GmbH
Sanico NV
Sanofi
Sawai Pharmaceutical Co Ltd
Sever Pharma Solutions AB
SGS Quay Pharmaceuticals Ltd
Sharp Packaging Services
Sichuan Huiyu Pharmaceutical Co Ltd
Siegfried Holding AG
Simtra BioPharma Solutions
Sintetica SA
Sirton Pharmaceuticals SpA
Skyepharma Production SAS
SM Farmaceutici Srl
Stada Arzneimittel AG
Steri-Pharma LLC
Takeda Pharmaceutical Co Ltd
Tapemark Co
Teikoku Seiyaku Co Ltd
Teligent Inc
The Biovac Institute
The Ritedose Corp
Thermo Fisher Scientific Inc
TOYO Pharmaceutical Co Ltd
Toyobo Co Ltd
Tulex Pharmaceuticals Inc
Unither Pharmaceuticals SAS
UPM Pharmaceuticals Inc
Vetter Pharma-Fertigung GmbH & Co KG
Vianex SA
Woodstock Sterile Solutions
WuXi Biologics Cayman Inc
WuXi XDC Cayman Inc
Xellia Pharmaceuticals ApS
Zydus Lifesciences Ltd

Table of Contents

About GlobalData

Table of Contents

Executive Summary

Players

Technology Briefing

Innovative drug approvals

Dose outsourcing of drug approvals

Trends

Industry Analysis

Introduction

FDA NDA approvals overview

Cell and gene therapies

First-in-class

First-time approvals

Predicted drug events for 2024

Sponsor trends

FDA: outsourced dose manufacture

Dosage form outsourcing

Special product categories

Accelerated approvals

Orphan drug designation

Fast track designation

Breakthrough therapy designation

Containment

CMO performance

Dosage form

Outsourced API approvals

ANDA approvals

What it means

FDA approvals hit a record high, recovering from a slump in 2022

Opportunities for injectable manufacturers

Catalent acquisition shakes up both the pharma and CMO landscape

Record ATMP approvals and gene therapy firsts

First topical gene therapy

First CRISPR approval

Cell and gene therapy current limitations

A few large CMOs gain majority of dose contracts

Increasing global conflict

The future of manufacturing: AI, ESG, drug shortages, and personalized medicines

Value Chain

Companies

Appendix

Methodology

Bibliography

Primary research – key opinion leaders

Further reading

About the Authors

Contact Us

Table

Table 1: Drug approval trends, 2023

Table 2: Predicted drug events in 2024

Table 3: Outsourced NDA approvals by dosage form

Table 4: Dose outsourcing relationships by sponsor market cap and FDA approval type, 2018–23

Table 5: CMOs with API contracts for NMEs approved in 2023

Table 6: Companies with 2023 CBER approvals

Table 7: FDA and EMA drug filings rejected or withdrawn in 2023

Table 8: 2023 outsourced dose approvals

Table 9: CMOs receiving dose contracts for FDA approvals in 2014–23

Table 10: 2023 outsourced API approvals

Table 11: CMOs receiving dose contracts for FDA approvals in 2023

Table 12: Small, micro, and nano cap sponsors’ dose outsourcing propensity for NMEs, 2014–23

Table 13: Small, micro, and nano cap sponsors’ dose outsourcing propensity for non-NMEs, 2014–23

Table 14: Mid cap sponsors’ dose outsourcing propensity, 2014–23

Table 15: Large cap dose outsourcing propensity, 2014–23

Table 16: Mega cap dose outsourcing propensity, 2014–23

Table 17: Private company dose outsourcing propensity, 2014–23

Table 18: Further reading

Figures

Figure 1: Leading players for US new drug approvals and their manufacturing, 2023

Figure 2: Top drug approval trends, 2023

Figure 3: FDA NDA and BLA approvals, 2014–23

Figure 4: FDA biologic NME approvals, 2014–23

Figure 5: FDA NDA approvals by sponsor type, 2014–23

Figure 6: Share of FDA NDA approvals outsourced, 2014–23

Figure 7: FDA NDA approvals outsourced, 2014–23

Figure 8: Dose outsourcing of small molecule and biologic NMEs, 2014–23

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

Figure 10: Dose outsourcing of FDA non-NME approvals by sponsor market cap

Figure 11: Dose outsourcing of accelerated approval NMEs, 2014–23

Figure 12: Dose outsourcing of FDA orphan NMEs, 2014–23

Figure 13: Dose outsourcing of FDA fast track NMEs, 2014–23

Figure 14: Dose outsourcing of breakthrough therapy designation NMEs, 2014–23

Figure 15: NME approvals requiring special handling, 2014–23

Figure 16: Breakdown in composition of dose-outsourced NMEs, by sponsor market cap, 2014–23

Figure 17: Breakdown in composition of dose-outsourced non-NMEs NDAs, by sponsor market cap, 2014–23

Figure 18: CMO market share of parenteral NME approvals, 2014–23

Figure 19: CMO market share of parenteral non-NME NDA and biosimilar approvals, 2014–23

Figure 20: CMO market share of solid dose NME approvals, 2014–23

Figure 21: CMO market share of solid dose non-NME NDA approvals, 2014–23

Figure 22: API outsourcing of small molecule and biologic NMEs, 2014–23

Figure 23: ANDA approvals by dosage form, 2014–23

Figure 24: ANDA approvals by route of administration, 2014–23

Figure 25: The contract manufacturing value chain

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