Our leading subject matter experts share their insightful analysis and points of view to help you stay abreast of industry trends
As medicine evolves, even smaller therapeutic areas are impacted by scientific breakthroughs and novel technologies, leading to an eruption of new therapies. Hereditary angioedema (HAE), a rare genetic disorder affecting 1 in 50,000 people worldwide, is the latest indication to reap the benefits of several new market entrants.
Due to a deficiency of the C1 inhibitor protein, HAE patients experience recurrent episodes of severe swelling in various parts of the body, most commonly the face, throat, limbs, and intestinal tract. Individuals…
For pharma manufacturers, securing expedited approval for a drug in development is typically seen as a win, which will result in faster patient access as well as faster revenue recognition. However, the realities of market access mean that drugs approved by expedited pathways—most notably, the accelerated approval pathway—may face a much more difficult path to coverage and provider uptake.
The use of FDA expedited approval pathways has grown significantly in the past two decades, and expedited approval of one sort or…
Pharma companies have made significant strides in omnichannel marketing, building programs that engage healthcare professionals (HCPs) across email, digital, social, and peer-to-peer platforms. However, many of these campaigns are often based on static HCP lists and pre-scheduled sequencing, leaving brand teams unable to adapt to clinical events as they occur.
Real-world data (RWD) changes that dynamic. By integrating insights from lab results, claims, EMR systems, and patient journeys, pharma companies can not only broaden their pool of target HCPs, but also…
Generative AI (GenAI) has become one of the most talked-about innovations in healthcare analytics, but for life sciences organizations, simply deploying an AI-powered solution is not enough. To truly unlock the power of real-world data (RWD), GenAI must go beyond checking a box or riding the latest buzzword wave. It should provide a guided, intuitive experience that aligns with regulatory standards and commercial and clinical teams’ needs.
GenAI has the potential to paint a more complete picture of the patient journey,…
Manufacturers should be prepared for a period of uncertainty and potential disruption in vaccine policy. The recent overhaul of the CDC’s Advisory Committee on Immunization Practices (ACIP) signals a shift that could affect vaccine recommendations, public trust, and payer coverage decisions.
After Robert F. Kennedy Jr. was sworn in as the new secretary of the U.S. Department of Health and Human Services in February, the agency has taken several steps that could undermine confidence in vaccines. Manufacturers must remain transparent and proactive…
As biosimilars continue to redefine the specialty drug landscape, payers and their associated pharmacy benefit managers (PBMs) are executing new strategies to capture a larger share of revenue. PBMs are partnering with manufacturers to co-develop and commercialize their own private-labeled biosimilar products. This coordinated approach provides value to both parties, as it enables them to siphon off market share from originator therapies and their competitors.
In this article, we explore how the fragmented rollout of Humira biosimilars exposed the drawbacks of…
Over the next five years, 88 biologics—including several blockbuster agents like Eliquis, Keytruda, Opdivo, and Darzalex—are facing a loss of exclusivity, representing an estimated market of more than $100 billion. After the fierce competition between Humira (adalimumab) biosimilars, manufacturers are keeping a close eye on adoption dynamics for biosimilars of Johnson & Johnson’s autoimmune drug, Stelara (ustekinumab).
While Stelara is used in fewer indications than Humira, it commands a large market share in its therapeutic areas, most notably in plaque psoriasis,…
As high-cost specialty treatments become more common, manufacturers are turning to innovative contracting to boost coverage for their products. Many cell and gene therapies, orphan drugs, and oncology therapies are prohibitively expensive, with costs ranging from several hundred thousand to millions of dollars.
Warranty-based agreements help mitigate the risk of paying for these therapies, as they offer payers financial protection if a patient must stop treatment for clinical reasons. If a therapy fails to work as intended, manufacturers agree to reimburse…
In 2024, biotechs were behind almost two-thirds of the FDA’s new drug approvals. Many biotechs are choosing to commercialize their products themselves, rather than partnering with Big Pharma players. Many fail, but some market factors are now in biotech’s favor.
A recent Evaluate report, Going Solo: Commercializing Biotech, analyzes the dynamics that are enabling biotech companies to bring their own therapies to market. The report explains the advantages small players can have over larger companies, and shares tips on how to…
For pharma companies, securing favorable coverage for a new asset is far more complicated than it used to be. Indications are more competitive, and the market is full of specialized niche therapies for smaller patient populations. While market access data has never been easy to parse, we’ve seen an evolution in the amount and type of information that’s needed to understand a product’s positioning.
A decade ago, our pharma clients were interested primarily in coverage binaries: is a product covered, or…
