New Drug Approvals and Their Contract Manufacture: 2023 Report - Detailed view of CDMO Performance by Number of Drug and Vaccine Approvals - ResearchAndMarkets.com

2023-05-19

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DUBLIN--(BUSINESS WIRE)--The "New Drug Approvals and Their Contract Manufacture - 2023 Edition" report has been added to ResearchAndMarkets.com's offering.

'New Drug Approvals and Their Contract Manufacture - 2023 Edition'

In 2022, the FDA approved c100+ new drug applications (NDAs) and biologics license applications (BLAs). This figure represents a decrease over the 2017-21 period. 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 comparative to other recent years.

In June 2021, the FDA granted accelerated approval of Biogen's Aduhelm for Alzheimer's disease, despite there being little to no evidence of clinical benefit and the majority of an FDA advisory panel voting against the drug's approval. This event caused controversy and added to pre-existing claims that the FDA approval process may not be as rigorous as it was in the past, the long-standing push for speed in the FDA approval process having meant a reduced level of certainty and evidence related to a drug. As a result of these issues, there may have been an increased reluctance to authorize innovative drugs for use.

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. Contract Manufacturing Organization's (CMO's) will need to find ways to remain competitive in these difficult conditions while maintaining quality and compliance. High inflation will also impact supply chains and R&D activities, and challenge their feasibility.

New Drug Approvals and Their Contract Manufacture - 2023 Edition; is the 13th edition in the series of 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.

Scope

This report gives important, expert insight you won't find in any other source. 11 tables and 34 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 the publisher'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

Key Topics Covered:

Executive Summary

Players

Technology Briefing

Innovative drug approvals

Dose outsourcing of drug approvals

Trends

Industry Analysis

Introduction

FDA NDA approvals overview

More biologic NME approvals than small molecule equivalents

Cell and gene therapies

First-in-class

First-time approvals

Rejected drugs

Predicted approvals for 2023

Sponsor trends

US vs. EU approval performance

FDA EUAs in 2022 for COVID-19

FDA: outsourced dose manufacture

Dosage form outsourcing

Special product categories

Accelerated approvals

Orphan drug designation

Fast track designation

Breakthrough therapy designation

Containment

Solubility enhancement

Outsourcing by company market cap

CMO performance

Dosage form

Outsourced API approvals

ANDA approvals

What it means

FDA approvals decline with a large decrease of NMEs approved

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

A few large CMOs gain majority of dose contracts

High inflation and other business conditions

Record high number of ATMP approvals in 2022

Value Chain

Companies

Appendix

Methodology

Bibliography

Primary research - key opinion leaders