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New Drug Approvals and Their Contract Manufacture – 2022 Edition

Pages: 82 Published: March 30, 2022 Report Code: GDPS0041MAR

In 2021, the FDA approved 122 New Drug Applications (NDAs) and Biologics License Applications (BLAs), including new molecular entities (NMEs), biologics approved as BLAs through the Center for Biologics Evaluation and Research (CBER), and new formulations of older drugs. The overall number of approvals is like 2020; however, the total number of innovative NME cell/gene therapy and non-NME NDAs has risen since 2020. There were four NME cell/gene therapy approvals in 2021, the highest over the last decade. These include two cell therapies and two gene-modified cell therapies.

NDA approvals were high in 2021 for small-cap and mega-cap companies compared to historic standards. This trend is potentially advantageous to CMOs, given that historically their clients are more likely to be smaller companies that are unable to invest in their facilities or enhance their capabilities. For small-cap company sponsors, the number of NDAs is the second-highest recorded over the last decade, with the highest occurring in 2018.

New drug approvals and their contract manufacture 2022 edition analyze the performance of the pharmaceutical CMO industry, using NDA and BLA approvals by the FDA and new active substance (NAS) approvals by the European Medicines Agency’s (EMA’s) central pathway as the primary indicators of performance. FDA NDA and BLA approvals include NMEs, as well as reformulations of previously approved APIs. The EMA approvals include all NAS. NAS are chemical substances not previously approved in the EU, or derivatives of previously approved APIs that differ significantly from the previously approved product in safety or efficacy.

What are the FDA NDA and BLA approval overviews in the new drug approvals and contract manufacture report?

The key FDA NDA and BLA approvals are NME small molecule, NME cell/gene therapy, NME biologic, and non-NME NDA approvals.

New drug approvals and contract manufacture, by FDA NDA and BLA approvals

New drug approvals and contract manufacture, by FDA NDA and BLA approvals

For more insights on FDA NDA and BLA approvals, download a free report sample

What are the key sponsor types in the new drug approvals and contract manufacture report?

The key sponsor types for NDA approvals are small-cap companies, mega-cap companies, mid-cap companies, large-cap companies, and private companies.

NDA approvals were relatively high in 2021 for small-cap companies and mega-cap companies. However, the number of approved products sponsored by large and private companies decreased since 2020, varying markedly in the case of large cap, which had its lowest number of associated approvals recorded in the last decade. Mid-cap companies’ count of drugs increased very slightly from 2021 but they still tend to account for the fewest approvals as a group.

New drug approvals and contract manufacture, by sponsor types

New drug approvals and contract manufacture, by sponsor types

To know more about key sponsor types, download a free report sample

Which are the key CMOs and pharma companies that are making a mark in dose manufacturing?

Some of the key CMOs and pharma companies that are making a mark in dose manufacturing are Celgene Corp, Enzyvant Therapeutics Inc, Juno Therapeutics Inc, Mallinckrodt LLC, Merck Sharp & Dohme Corp, Pfizer Inc, ProMetic BioTherapeutics Inc, VBI Vaccines Inc, Almac, Catalent, PCI Pharma Services, Thermo Fisher Scientific (owner of Patheon), and Vetter.

Market report scope

Key FDA NDA and BLA approvals NME Small Molecule, NME Cell/Gene Therapy, NME Biologic, and Non-NME NDA
Key sponsor types Small Cap Companies, Mega Cap Companies, Mid Cap Companies, Large Cap Companies, and Private Companies
Key CMOs and pharma companies Celgene Corp, Enzyvant Therapeutics Inc, Juno Therapeutics Inc, Mallinckrodt LLC, Merck Sharp & Dohme Corp, Pfizer Inc, ProMetic BioTherapeutics Inc, VBI Vaccines Inc, Almac, Catalent, PCI Pharma Services, Thermo Fisher Scientific (owner of Patheon), and Vetter

Scope

This 82-page report gives important, expert insight you won’t find in any other source. 11 tables and 30 figures throughout the report illustrate major points and trends. This report is required reading for:

  • CMO executives must have a deep understanding of the injectables marketplace to make strategic planning and investment decisions.
  • Sourcing and procurement executives must understand crucial components of the supply base to make decisions about supplier selection and management.
  • Private equity investors need a deeper understanding of the market to identify and value potential investment targets.

Reasons to Buy

  • Overview of NDA drug approvals and the levels of outsourcing associated with NDA sub-segments.
  • Detailed view of CDMO performance by the number of approvals and an assessment of their sponsors market caps from GlobalData’s Contract Service Providers database.
  • Outsourcing propensity for NMEs, different dosage forms and sponsor company cap have all been assessed.
  • Analysis of NME special products approvals such as those with Orphan, Breakthrough, or Fast Track designations and assessment of outsourcing.

Key Players

3SBio Inc
AbbVie Inc
ACS Dobfar SpA
Adare Pharma Solutions
Aenova Holding GmbH
Afton Scientific Corp
Ajinomoto Co Inc
Akorn Inc
Alcami Corp
Alfasigma SpA
Allergopharma GmbH & Co KG
Almac Group Ltd
Alpex Pharma SA
Altasciences Co Inc
Alvogen Inc
ARx LLC
ASM Aerosol-Service AG
Aspen Pharmacare Holdings Ltd
AstraZeneca Plc
Astrea SA
AustarPharma LLC
Avara Pharmaceutical Services Inc
Baccinex SA
Basic Pharma
Bausch Health Companies Inc
Baxter International Inc
Bayer AG
BioRamo LLC
BioReliance Corp
Boehringer Ingelheim International GmbH
Bora Pharmaceuticals Co Ltd
Bristol-Myers Squibb Co
BSP Pharmaceuticals SpA
Bushu Pharmaceuticals Ltd
Cadila Healthcare Ltd
Cambrex Corp
Catalent Inc
Cenexi SAS
Centre for Probe Development and Commercialization
Cerovene Inc
Cipla Ltd
Confab Laboratories Inc
Contract Pharmaceuticals Ltd
Corden Pharma International GmbH
CoreRx Inc
Corium Inc
Curia Inc
DAU Laboratory
Delpharm SAS
Dexcel PT Israel Ltd
Eisai Co Ltd
Emergent BioSolutions Inc
EuroAPI
Eurofins Scientific SE
Evonik Industries AG
Exela Pharma Sciences LLC
Exelead Inc
Fareva SA
Ferndale Pharma Group Inc
Fresenius Kabi AG
Fritz Keller Holding AG
Fuji Yakuhin Co Ltd
FUJIFILM Corp
Galephar Pharmaceutical Research Inc
GBA Gesellschaft fur Bioanalytik mbh
Gensenta Ilac Sanayi ve Ticaret AS
Gilead Sciences Inc
Gland Pharma Ltd
Glatt GmbH
Glenmark Pharmaceuticals Ltd
Grifols SA
Groupe Parima Inc
Grunenthal GmbH
Hikma Pharmaceuticals Plc
Holopack Verpackungstechnik GmbH
Hovione FarmaCiencia SA
Importfab Inc
Institutt for Energiteknikk
Intas Pharmaceuticals Ltd
Ipsen SA
Iwaki Seiyaku Sakura Factory Co Ltd
James Alexander Corp
Johnson & Johnson
Jubilant Pharma Ltd
Juzen Chemical Corp
Kindeva Drug Delivery LP
Kirin Holdings Co Ltd
Klocke Pharma-Service GmbH
KP Pharmaceutical Technology Inc
Laboratorios Farmaceuticos Rovi SA
LGM Pharma LLC
Lifecore Biomedical LLC
Lonza Group Ltd
LTS Lohmann Therapie-Systeme AG
Lupin Ltd
Lyne Laboratories Inc
Mawdsley-Brooks & Co Ltd
Merck & Co Inc
Metrics Contract Services
MIAS Pharma Ltd
Mibe GmbH Arzneimittel
Mikart LLC
Mipharm SpA
Molteni Farmaceutici
National Resilience Inc
Neolpharma SA De CV
Nephron Pharmaceuticals Corp
NerPharma Srl
Nova Laboratories Ltd
Novartis AG
Novast Holdings Ltd
OishiKoseido Corp
Organon & Co
Padagis LLC
Panpharma SA
PARI Pharma GmbH
PCI Pharma Services
Pfizer Inc
Pharmaceutical Manufacturing Research Services Inc
Pharmaceutics International Inc
Pharmascience Inc
Pharmasol Corp
Pharmathen Global BV
Pharmstandard
Pierrel SpA
Piramal Enterprises Ltd
Polymun Scientific Immunbiologische Forschung GmbH
Propak Health Ltd (Inactive)
PYRAMID Laboratories Inc
QPharma AB
QPS Holdings LLC
Quotient Sciences Ltd
Rechon Life Science AB
Recipharm AB
Recro Pharma Inc
Renaissance Lakewood LLC
Rentschler Biopharma SE
Rivopharm SA
Rottendorf Pharma GmbH
R-Pharm
Sanico NV
Sanofi
Sawai Pharmaceutical Co Ltd
Sharp Packaging Services
Siegfried Holding AG
Sintetica SA
Stada Arzneimittel AG
Sterigenics LLC
Steri-Pharma LLC
Takeda Pharmaceutical Co Ltd
Tapemark Co
Teligent Inc
The Biovac Institute
The Ritedose Corp
Thermo Fisher Scientific Inc
Toyobo Co Ltd
Tulex Pharmaceuticals Inc
UI Pharmaceuticals
Unither Pharmaceuticals SAS
UPM Pharmaceuticals Inc
USV Pvt Ltd
Vectura Group Plc
Vetter Pharma-Fertigung GmbH & Co KG
Vianex SA
Viatris Inc
Vifor Pharma Ltd
Woodstock Sterile Solutions
WuXi Biologics Cayman Inc
Xellia Pharmaceuticals ApS

Table of Contents

Executive Summary

Players

Technology Briefing

Innovative Drug Approvals

Dose Outsourcing of Drug Approvals

Trends

Industry Analysis

Introduction

FDA NDA Approvals Overview

Small Molecule Approvals Are Higher than Biologics

Cell and Gene Therapies

First-in-Class

Inspections Delayed Approvals

First Time Approvals

Sponsor trends

US vs. EU Approval Performance

FDA EUAs in 2021 for COVID-19

FDA: Outsourced Dose Manufacture

Dosage Form Outsourcing

Special Product Categories

FDA Expedited Programs

Containment

Solubility Enhancement

Outsourcing by Company Market Cap

CMO Performance

Dosage Form

Outsourced API Approvals

ANDA Approvals

What It Means

FDA Approvals Static but Strong

COVID Demand Boosts Outsourcing

Bio/Pharma Sponsors Diversify Supply Chains

Large CMOs Grab Dose Contracts

Injectables and Containment Drive Outsourcing

High ATMP Approvals in 2021

Bear Markets: A Gift and a Curse for CMOs

Value Chain

Companies

Appendix

Methodology

Bibliography

Primary Research – Key Opinion Leaders

Further Reading

About the Authors

List of Tables

Table 1: Drug Approval Trends, 2021

Table 2: Therapies and Vaccines Granted FDA Emergency Use Approval in 2021

Table 3: Outsourced NDA Approvals by Dosage Form

Table 4: Dose Outsourcing Relationships by Sponsor Market Cap and FDA Approval Type, 2016–2021

Table 5: CMOs with API Contracts for NMEs Approved in 2021

Table 6: Companies with 2021 Center for Biologics Evaluation and Research (CBER) Approvals

Table 7: 2021 Outsourced Dose Approvals by Company

Table 8: CMOs Receiving Dose Contracts for FDA Approvals in 2012–2021

Table 9: CMOs Receiving API Contracts for Drug Approvals in 2021

Table 10: CMOs Receiving Dose Contracts for FDA Approvals in 2021

Table 11: Further Reading

List of Figures

Figure 1: Leading Players for US New Drug Approvals and Their Manufacturing, 2021

Figure 2: Top Drug Approval Trends, 2021

Figure 3: FDA NDA and BLA Approvals, 2012–2021

Figure 4: FDA NDA Approvals by Sponsor Type, 2012–2021

Figure 5: EMA Approvals, 2012–2021

Figure 6: First FDA EUAs for COVID-19 Products and Contract Service Agreements, 20202021

Figure 7: Share of FDA NDA Approvals Outsourced, 2012–2021

Figure 8: NDA Approvals Outsourced, 2012–2021

Figure 9: Dose Outsourcing of Small Molecule and Biologic NMEs, 2012–2021

Figure 10: Dose Outsourcing of FDA NME Approvals by Sponsor Market Cap

Figure 11: Dose Outsourcing of Non-NME NDA Approvals by Sponsor Market Cap

Figure 12: Dose Outsourcing of FDA Orphan NMEs, 2012–2021

Figure 13: Dose Outsourcing of FDA Fast Track NMEs, 2012–2021

Figure 14: Dose Outsourcing of Breakthrough Therapy Designation NMEs, 2013–2021

Figure 15: NME Approvals Requiring Special Handling, 2012–2021

Figure 16: FDA Approvals and Outsourcing of NMEs Utilizing Solubility Enhancement, 2012–2021

Figure 17: Small Cap Sponsors’ Dose Outsourcing Propensity, 2012–2021

Figure 18: Mid Cap Sponsors’ Dose Outsourcing Propensity, 2012–2021

Figure 19: Large Cap Dose Outsourcing Propensity, 2012–2021

Figure 20: Mega Cap Dose Outsourcing Propensity, 2012–2021

Figure 21: Private Company Dose Outsourcing Propensity, 2012–2021

Figure 22: Breakdown in Composition of Dose-Outsourced NMEs, by Sponsor Market Cap, 2012–2021

Figure 23: Dose-Outsourced Non-NME NDAs, by Sponsor Market Cap, 2012–2021

Figure 24: CMO Market Share of Parenteral NME Approvals, 2012–2021

Figure 25: CMO Market Share of Parenteral Non-NME NDA Approvals, 2012–2021

Figure 26: CMO Market Share of Solid Dose NME Approvals, 2012–2021

Figure 27: CMO Market Share of Solid Dose Non-NME NDA Approvals, 2012–2021

Figure 28: API Outsourcing of Small Molecule and Biologic NMEs, 2012–2021

Figure 29: ANDA Approvals, 2012–2021

Figure 30: The Contract Manufacturing Value Chain

Frequently Asked Questions

The key FDA NDA and BLA approvals are NME small molecule, NME cell/gene therapy, NME biologic, and non-NME NDA approvals.

 

 

 

 

The key sponsor types for NDA approvals are small-cap companies, mega-cap companies, mid-cap companies, large-cap companies, and private companies.

Some of the key CMOs and pharma companies that are making a mark in dose manufacturing are Celgene Corp, Enzyvant Therapeutics Inc, Juno Therapeutics Inc, Mallinckrodt LLC, Merck Sharp & Dohme Corp, Pfizer Inc, ProMetic BioTherapeutics Inc, VBI Vaccines Inc, Almac, Catalent, PCI Pharma Services, Thermo Fisher Scientific (owner of Patheon), and Vetter.

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