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This dual-layer certification process can create significant delays, as each framework involves extensive assessments for safety and performance under separate requirements specific to medical device and AI-specific criteria.
The use of medicines worldwide grew by 14% over the past five years, and is expected to grow an additional 12% by 2028. Some countries require local studies due to different safety and efficacy results. Navigating global regulations shouldnt be seen as a hurdle; its a competitive advantage for the brands that do it well.
Attention deficit hyperactivity disorder (ADHD) drug Vyvanse (lisdexamfetamine dimesylate) , manufactured by Takeda, also is facing generic competition. In the respiratory area with inhalers, it’s tough to get drugs approved, so the competition comes slowly,” he said. Starting in 2026, the provision will affect 10 Part D drugs.
million by 2028. From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. The potential increase in industry competition could also spell trouble for some. Now, the demand for such equipment is on track to grow exponentially.
The vaccine demonstrated a similar safety profile to Pfizer’s marketed 20-serotype shot Prevnar 20 at all assessed doses, and showed non-inferior efficacy. billion and $812 million in 2028. Competition in an increasingly heated market. VAX-24 has forecasted sales of $21 million in the same year. Further plans in the making.
These high prices are the result of multiple factors: theyre derived from living organisms making them sensitive and complex for both manufacturers and patients, research requires advanced technology to test for safety and effectiveness, and theyre in high demand without much competition. billion and $13 billion in 2023, respectively.
By this same virtue, PROTACs are able to degrade previously undruggable targets, which provides a major competitive advantage for this modality if shown to be true. GlobalData’s analyst consensus forecast database estimates peak annual sales for ARV-110 of $325 million in 2028. with Calquence, 16% with Imbruvica, NCT02477696).
In addition, the devices must not present an unacceptable risk to patient and user health and safety as established in Articles 94 and 95 of the MDR. However, a delicate balance will need to be struck between the need for affordable and accessible medicinal products and the desire to foster innovation and competitiveness in the EU.
The dearth of cancer drugs (only blood cancer drug Imbruvica made this first list) stems from CMS only pursuing negotiations for Part D drugs in 2026 and 2027, then expanding to Part B drugs in 2028. exclusions exist for orphan drug designation and biosimilar competition ).
In our September 2023 report on the electrophysiology market, Clarivate projected that by 2028, PFA would represent 50% of the U.S. In addition, the improved safety profile of PFA is making the cost-benefit of ablation an easier calculation for many patients. ablation market and would have a total global market value of $3 billion.
million by 2028. From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. The potential increase in industry competition could also spell trouble for some. Now, the demand for such equipment is on track to grow exponentially.
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