Features

As we begin to look back at 2024, what were the top developments from the bio/pharma industry this year? DCAT Value Chain Insights gives its take on the most significant news in the industry spanning manufacturing, product innovation, and deal-making.

The US government is rolling out a new initiative, the Cell and Gene Therapy Access Model, which uses a health outcomes payment model, with Vertex Pharmaceuticals and bluebird bio as the first manufacturers in the program. What’s the market impact?

Although a niche area, market interest in radiopharmaceuticals is on the rise as certain bio/pharma majors and smaller companies strike drug-development deals and CDMOs/CMOs specializing in this area expand production capacity. 

This week marks the second anniversary of the launch of the EU’s “Rare Disease Moonshot,” a commitment by nine European associations to break down barriers to advance development of therapeutics…

Which bio/pharma companies and CEOs may be under the industry’s radar but are executing better-than expected performance and winning strategies for their companies? What products—development and commercial—are delivering? DCAT Value Chain Insights takes an inside look.

FDA conducted 621 foreign and 444 domestic inspections in fiscal year 2023, which was up from pandemic levels when in-person inspections were paused, but 36% fewer than pre-pandemic levels. A shortage of inspectors is a major factor. What’s the impact on Pharma?

Following the US Presidential election this week, two industry groups, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO), issued statements broadly highlighting key policy issues of interest. What’s on the agenda?

Driven by strong demand in the oncology drug market, high-potency manufacturing continues to be an active area of investment for CDMOs/CMOs for both drug substances and drug products. Growth in the contract market for antibody drug conjugates, one component, is projected in the double-digits.

How is product innovation faring in the bio/pharma industry thus far in 2024? Through the end of October, FDA’s Center for Drug Evaluation and Research has approved 38 new drugs. Which companies  and products have made the cut, and which may be best poised for market success?

Continual monitoring and evaluation of risk once working with suppliers is critical. An upcoming DCAT webinar will provide a customer–supplier view of the key performance indicators. key risk indicators, challenges, and scenarios to take into consideration to mitigate risk.