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

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