Features

The FDA has issued much-awaited draft guidance that details how it plans to implement its new platform technology designation program. What does it mean for manufacturing overall and in specific sectors—biologics and advanced therapies?

Global bio/pharma sales growth was strong on a value basis at ex-manufacturers’ prices in 2023 although volume growth was relatively flat. What are the growth prospects in leading geographic markets, therapeutic sectors, and in the mix between small molecules and biologics? 

The success of mRNA vaccines in the COVID-19 pandemic has accelerated interest in mRNA technology in vaccine and drug development. Can continuous mRNA manufacturing be a potential solution to address production bottlenecks and ​facilitate​ capacity ramp-up? 

What are key trends shaping the market for bio/pharmaceutical outsourcing? DCAT Value Chain Insights takes an inside look into the market drivers, trends, and key activity shaping the CDMO/CMO sector in small-molecules, biologics, and drug products.

The US bio/pharma market showed positive signs in 2023, despite a decline in spending on COVID-19 vaccines and products. Overall, the US market grew by 2.3% last year, and by 9.9%, excluding COVID-19 products. What’s projected in the near term?

Demand for fill–finish capacity and sterile manufacturing is high, led by bio/pharma companies’ product portfolios and development pipelines in biologics and other key products, such as GLP-1 drugs. A roundup of the latest expansions by CDMOs/CMOs.

What are the blockbusters of the future? A recent industry analysis points to the leading contenders from late-stage or newly approved drugs that are slated to launch in 2024 and that are poised for potential blockbuster status over the next five years. Which drugs are the leading contenders?

The European Commission launched late last month, the Critical Medicines Alliance, a consultative mechanism for policymakers to address drug shortages and assure the supply of critical medicines in the EU. Does it portend potential legislation incentivizing manufacturing & supply-chain resilience?

GLP-1 agonist drugs, in the form of Novo Nordisk’s Wegvoy/Ozempic, and Lilly’s Mounjaro for weight management and treating Type II diabetes, were blockbuster winners in 2023, putting this therapeutic sector into high focus. What has been the impact on manufacturing and what are other contenders in this high-growth sector?

Small-molecule drugs still dominate new drug approvals, as measured by the number of new molecular entities approved by the FDA’s Center for Drug Evaluation and Research, but are they translating into market success? DCAT Value Chain Insights takes a look on the market for drugs with small-molecule active pharmaceutical ingredients and related supply–demand fundamentals.