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A draft joint EU network strategy to 2028 has been published by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA). The overarching theme of our updated strategy to 2028 is that of change – rapid, somewhat unpredictable but nonetheless full of promise.
A great example of pharma’s profiteering is biosimilar drugs which cost a lot and add billions of dollars to healthcare costs. Pharma has gone to court again and again to delay generic competition of biologic drugs. One company AbbVie has used the courts to stop competition of its top drug Humira.
Without sufficient support systems and experienced reviewers, the implementation timelines were extended, with final compliance dates now pushed to December 2028 (from May 2024 originally). This situation raises concerns that similar delays could impact the EU AI Act, creating uncertainty for companies relying on clear, consistent timelines.
Globalization and health equity: Healthcare is global, and patients are diverse. Globalization: Healthcare for All Healthcare systems worldwide face challenges including rising chronic diseases, aging populations, workforce shortages, and sustainability concerns. But the extent to which brands still have U.S.-insured-only
What really matters are the orthopedic medical device trends that are already shaping the healthcare industry. Advancements in medical technology will always be a favorite topic of discussion when analyzing the healthcare sector. million by 2028. Healthcare executives are also looking into AR spinal surgical systems.
These are forecast to generate $264 billion in sales between 2021 and 2028. Comirnaty, which was first approved in the UK by an Emergency Use Approval (EUA) from the Medicines and Healthcare products Regulatory Agency (MHRA) on December 2, 2020, is currently the leading prophylactic vaccine with 2021 sales of $41.5
As many in the industry now know, the Inflation Reduction Act (IRA) is the most significant reform of Medicare prescription drug coverage since the creation of Part D and has wide-ranging implications for the healthcare industry. They do not have biosimilar or generic competition available in the market.
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.
Biosimilars: The Future of Affordable Biologic Therapies Biologics are some of the most expensive forms of therapy in modern healthcare. The existence of biosimilars is meant to address both the cost and access of biologics in the healthcare industry. [1]
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 ).
What really matters are the orthopedic medical device trends that are already shaping the healthcare industry. Advancements in medical technology will always be a favorite topic of discussion when analyzing the healthcare sector. million by 2028. Healthcare executives are also looking into AR spinal surgical systems.
Cons: Highly competitive with new options continually emerging. That being said, the clinical laboratory market is expected to see growth of nearly 40% by 2028. Pros: A growing market means a good chance for long-term success with each client. Mostly cash-pay, which means dependable, fast commissions. Opportunities: Liquid Amnion.
According to figures from the Healthcare Research & Data Analytics team at Clarivate, the top three best-selling products for Pfizer, AbbVie, Merck/MSD and Bristol Myers Squibb contributed more than half their revenue in 2022, ranging from 53.3% of AbbVie’s $51.8 billion in revenue to a whopping 67.2% for Bristol Myers Squibb’s $44.7
In our September 2023 report on the electrophysiology market, Clarivate projected that by 2028, PFA would represent 50% of the U.S. FDA approval in the fourth quarter, with Johnson & Johnson’s Varipulse system close behind, so competition will pick up. ablation market and would have a total global market value of $3 billion.
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. Edward Turtle is a products lawyer, regulatory advisor and litigator with particular experience in the healthcare, technology and consumer product sectors.
healthcare system with major implications for the Medicare Advantage and Medicare Part D programs. Although the dynamics within each therapeutic area may vary, certain archetypes could influence competitive dynamics. In this type of class, selecting one product could materially disrupt competitive dynamics.
In 2026, CMS will select up to 15 additional Part B or Part D drugs for negotiations that take effect in 2028, and up to 20 additional drugs every year thereafter (Part B covers physician-administered drugs, including infusions of complex biologics). In highly competitive categories like diabetes, net price could be half of the list price.
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