New Drug Approvals and Their Contract Manufacture – 2023 Edition

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Published: March 31, 2023 Report Code: GDPS0046MAR-BB

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Explore actionable market insights from the following data in our ‘New Drug Approvals and Their Contract Manufacture’ report. This report is required reading for –

  • CMO executives who must have a 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 who need a deeper understanding of the market to identify and value potential investment targets.

How is the ‘New Drug Approvals and Their Contract Manufacture’ report different from other reports in the market?

  • The report provides 11 tables and 34 figures to illustrate major points and trends.
  • 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.

We recommend this valuable source of information to anyone involved in:

  • ​Pharmaceutical Industry (Big Pharma, Small Biotech, Start-Ups, etc.),
  • Pharmaceutical Industry Suppliers (e.g., Consulting Companies, CMOs, CDMOs, CROs, Technology Vendors)
  • Professional Services (e.g., Investment Companies, Investment Banks, etc.)
  • Clinical Research Organisations (CROs)
  • Government/Financial Institutions (Investors in Pharma/Biotech, Pricing Consultancies)
  • Professional Services – Investment Banks, PE/VC firms
  • M&A/Investment, Management Consultants, and Consulting Firms

To get a snapshot of the new drug approvals and their contract manufacture report, download a free report sample

New Drug Approvals and their Contract Manufacture Report Overview

In 2022, the FDA approved 109 new drug applications (NDAs) and biologics license applications (BLAs). The overall number of approvals is eight lower when compared to 2021. Both small molecule and biologic new molecular entity (NME) approvals declined substantially, causing overall NDA approvals to drop, which meant fewer commercial-scale production contracts for the most innovative products compared to other recent years. Small cap companies’ (market cap $300M–2B) and private companies’ NDA approvals were relatively high in 2022, with 15 and 42 FDA approvals, respectively. In recent years, COVID-19 vaccine drives have allowed economies and societies to safely reopen during the pandemic. However, new challenges such as rising inflation will bring uncertainty to the ongoing global recovery. The pharma industry faces increasing cost pressures, shrinking consumer spending power, staff shortages, and geopolitical tensions.

The new drug approvals and their contract manufacture report is the 13th edition of a 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 Emergency Use Approvals for COVID-19 and how inflation has impacted pharma manufacturers.

For more insights on the new drug approvals and their contract manufacture forecasts, download a free sample report

New Drug Approvals and their Contract Manufacture – Key Trends

The main trends that affected FDA drug approvals and their manufacturing in 2022 are classified into three categories: approval types, increased outsourcing, and changing business environment.

Approval types: Record cell/gene therapy approvals continue 2021’s strong performance, huge drop in FDA approvals for NMEs, and biologic NME approvals outnumbered small molecules in 2022 are some of the top approval type trends in new drug approvals and their contract manufacture study.

Increased outsourcing: Domination of dose outsourcing by a few key CMOs, higher biologic NME outsourcing than for small molecule equivalents, and more reliance on nano and micro cap sponsors on CMOs are some of the increased outsourcing trends boosting new drug approvals and their contract manufacture.

Changing business environment: The impact of inflation on pharma manufacturing and shifts in market demand are likely to impact the new drug approvals and their contract manufacture. In addition, although many of the vaccines will still generate blockbuster revenues, sales will decrease, as will the volumes of production. COVID-19 vaccines and treatments will still represent lucrative contracts for CMOs, but with production volumes dwindling and manufacturing relationships becoming well-established, are less profitable than in earlier stages of the pandemic.

For more insights on the new drug approvals and their contract manufacture trends, download a free sample report

New Drug Approvals and their Contract Manufacture Industry Analysis

New Drug Approvals and Their Contract Manufacture – 2023 Edition analyzes the performance of the pharmaceutical CMO industry, using NDA and BLA approvals by the FDA and new active substance (NAS) approvals by the EMA’s central pathway as the primary indicators of performance.

The new drug approvals and their contract manufacture report also covers –

  • FDA NDA approvals overview
  • US vs. EU approval performance
  • FDA EUAs in 2022 for COVID-19
  • FDA: outsourced dose manufacture
  • Special product categories
  • Outsourcing by company market cap
  • CMO performance
  • Outsourced API approvals
  • ANDA approvals
  • What it means

For more new drug approvals and their contract manufacture industry analysis, download free sample

New Drug Approvals and their Contract Manufacture – Value Chain Insights

The contract manufacturing industry’s value chain is simplified into three main segments, beginning with API, dose form manufacturing, and packaging. API is the starting point and can have big implications on which dosage forms or packaging are used later in the process. For instance, if there were a greater number of contract service agreements being made for biologic API manufacture, this would have major implications for injectable dose form manufacturing and packaging.

New Drug Approvals and their Contract Manufacture Value Chain Insights

New Drug Approvals and their Contract Manufacture Value Chain Insights

For additional value chain insights in the new drug approvals and contract manufacture report, download a free sample

New Drug Approvals and their Contract Manufacture Outlook

Page Count 94
Key Trends Approval Types, Increased Outsourcing, and Changing Business Environment
Key Value Chain Components API, Dose formation, and Packaging

Key Players

AbbVie Inc
ACS Dobfar SpA
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
Alvogen Inc
AOP Health
ARx LLC
ASM Aerosol-Service AG
AstraZeneca Plc
Astrea SA
AtomVie Global Radiopharma Inc
Aurobindo Pharma Ltd
AustarPharma LLC
Avara Pharmaceutical Services Inc
Baccinex SA
Basic Pharma
Bausch & Lomb Pharmaceuticals Inc
Baxter Biopharma Solutions
Bayer AG
Berkshire Sterile Manufacturing LLC
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 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
Gilead Sciences Inc
Gland Pharma Ltd
Glatt GmbH
Grifols SA
Groupe Parima Inc
Grunenthal GmbH
Hanford Pharmaceuticals
Hikma Pharmaceuticals Plc
Holopack Verpackungstechnik GmbH
Hovione FarmaCiencia SA
IDT Biologika GmbH
Importfab Inc
Institutt for Energiteknikk
Ipsen SA
Italfarmaco SpA
Iwaki Seiyaku Sakura Factory Co Ltd
James Alexander Corp
Janssen-Cilag SpA
Jubilant HollisterStier LLC
Juzen Chemical Corp
KP Pharmaceutical Technology Inc
Kyowa Hakko Bio Co Ltd
Laboratorios Farmaceuticos Rovi SA
Lek dd
LGM Pharma LLC
Lifecore Biomedical LLC
Lonza Group Ltd
LTS Lohmann Therapie-Systeme AG
Lupin Ltd
Lyne Laboratories Inc
Lyophilization Services of New England Inc
Mawdsley-Brooks & Co Ltd
MIAS Pharma Ltd
Mibe GmbH Arzneimittel
Mikart LLC
Minaris Regenerative Medicine LLC
Mipharm SpA
Molteni Farmaceutici
National Resilience Inc
Neolpharma SA De CV
Nephron Pharmaceuticals Corp
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
Padagis LLC
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 Pharma Solutions Inc
Polymun Scientific Immunbiologische Forschung GmbH
Procaps SAS
PYRAMID Laboratories Inc
Qilu Pharmaceutical Co Ltd
QPS Holdings LLC
Quay Pharmaceuticals Ltd
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
Sharp Packaging Services
Sichuan Huiyu Pharmaceutical Co Ltd
Siegfried Holding AG
Sintetica SA
Sirton Pharmaceuticals SpA
Societal CDMO Inc
Stada Arzneimittel AG
Sterigenics LLC
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
UI Pharmaceuticals
Unither Pharmaceuticals SAS
UPM Pharmaceuticals Inc
Vetter Pharma-Fertigung GmbH & Co KG
Vianex SA
Woodstock Sterile Solutions
WuXi Biologics Cayman Inc
Xellia Pharmaceuticals ApS
Zydus Lifesciences Ltd

Table of Contents

  • 1 Executive Summary

  • 2 Players

  • 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 NDA approvals overview

      • 5.2.1 More biologic NME approvals than small molecule equivalents

      • 5.2.2 Cell and gene therapies

      • 5.2.3 First-in-class

      • 5.2.4 First-time approvals

      • 5.2.5 Rejected drugs

      • 5.2.6 Predicted approvals for 2023

      • 5.2.7 Sponsor trends

    • 5.3 US vs. EU approval performance

    • 5.4 FDA EUAs in 2022 for COVID-19

    • 5.5 FDA: outsourced dose manufacture

      • 5.5.1 Dosage form outsourcing

    • 5.6 Special product categories

      • 5.6.1 Accelerated approvals

      • 5.6.2 Orphan drug designation

      • 5.6.3 Fast track designation

      • 5.6.4 Breakthrough therapy designation

      • 5.6.5 Containment

      • 5.6.6 Solubility enhancement

    • 5.7 Outsourcing by company market cap

    • 5.8 CMO performance

      • 5.8.1 Dosage form

    • 5.9 Outsourced API approvals

    • 5.10 ANDA approvals

    • 5.11 What it means

      • 5.11.1 FDA approvals decline with a large decrease of NMEs approved

      • 5.11.2 COVID-19 vaccine demand waning but there are still lucrative contracts

      • 5.11.3 A few large CMOs gain majority of dose contracts

      • 5.11.4 High inflation and other business conditions

      • 5.11.5 Record high number of ATMP approvals in 2022

  • 6 Value Chain

  • 7 Companies

  • 8 Appendix

    • 8.1 Methodology

    • 8.2 Bibliography

    • 8.3 Primary research – key opinion leaders

    • 8.4 Further reading

  • 9 About the Authors

Table

Table 1: Drug approval trends, 2022

Table 2: FDA and EMA drug filings rejected or withdrawn in 2022

Table 3: Predicted drug events in 2023

Table 4: Dose outsourcing of therapies and vaccines granted FDA emergency use approval for COVID-19 in 2020–22

Table 5: Outsourced NDA approvals by dosage form

Table 6: Dose outsourcing relationships by sponsor market cap and FDA approval type, 2017–22

Table 7: CMOs with API contracts for NMEs approved in 2022

Table 8: Companies with 2022 Center for Biologics Evaluation and Research (CBER) approvals

Table 9: 2022 outsourced dose approvals

Table 10: CMOs receiving dose contracts for FDA approvals in 2013–22

Table 11: 2022 outsourced API approvals

Table 12: CMOs receiving dose contracts for FDA approvals in 2022

Table 13: Further reading

Figures

Figure 1: Leading players for US new drug approvals and their manufacturing, 2022

Figure 2: Top drug approval trends, 2022

Figure 3: FDA NDA and BLA approvals, 2013–22

Figure 4: FDA biologic NME approvals, 2013–22

Figure 5: FDA NDA approvals by sponsor type, 2013–22

Figure 6: EMA approvals, 2013–22

Figure 7: FDA EUAs for COVID-19 products, 2020–22

Figure 8: Share of FDA NDA approvals outsourced, 2013–22

Figure 9: NDA approvals outsourced, 2013–22

Figure 10: Dose outsourcing of small molecule and biologic NMEs, 2013–22

Figure 11: Dose outsourcing of FDA NME approvals by sponsor market cap

Figure 12: Dose outsourcing of non-NME NDA approvals by sponsor market cap

Figure 13: Dose outsourcing of accelerated approval NMEs, 2013–22

Figure 14: Dose outsourcing of FDA orphan NMEs, 2013–22

Figure 15: Dose outsourcing of FDA fast track NMEs, 2013–22

Figure 16: Dose outsourcing of breakthrough therapy designation NMEs, 2013–22

Figure 17: NME approvals requiring special handling, 2013–22

Figure 18: FDA approvals and outsourcing of NMEs utilizing solubility enhancement, 2013–22

Figure 19: Small, micro, and nano cap sponsors’ dose outsourcing propensity for NMEs, 2013–22

Figure 20: Small, micro, and nano cap sponsors’ dose outsourcing propensity for non-NMEs, 2013–22

Figure 21: Mid cap sponsors’ dose outsourcing propensity, 2013–22

Figure 22: Large cap dose outsourcing propensity, 2013–22

Figure 23: Mega cap dose outsourcing propensity, 2013–22

Figure 24: Private company dose outsourcing propensity, 2013–22

Figure 25: Breakdown in composition of dose-outsourced NMEs, by sponsor market cap, 2013–22

Figure 26: Dose-outsourced non-NME NDAs, by sponsor market cap, 2013–22

Figure 27: CMO market share of parenteral NME approvals, 2013–22

Figure 28: CMO market share of parenteral non-NME NDA and biosimilar approvals, 2013–22

Figure 29: CMO market share of solid dose NME approvals, 2013–22

Figure 30: CMO market share of solid dose non-NME NDA approvals, 2013–22

Figure 31: API outsourcing of small molecule and biologic NMEs, 2013–22

Figure 32: ANDA approvals by dosage form, 2013–22

Figure 33: ANDA approvals by route of administration, 2013–22

Figure 34: The contract manufacturing value chain

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