Our leading subject matter experts share their insightful analysis and points of view to help you stay abreast of industry trends
Despite the challenges of the pandemic, the pharma industry has enjoyed steady growth during the past two years, which is expected to continue in 2023. The global pharmaceutical market is forecast to expand at a CAGR of 5.7% between now and 2028. Hundreds of products are currently awaiting FDA approval, and new modalities, including cell and gene therapies, have increased to 21% of the drug development pipeline.
Of course, plenty of existing hurdles remain, along with several new challenges and opportunities.…
The FDA has created a number of pathways to bring drugs for serious conditions onto the market sooner than the traditional approval process would allow. These include priority review, accelerated approval, fast track and breakthrough therapy designations, as well as emergency use authorizations, which are used in emergency situations, such as the COVID-19 pandemic.
One of the most popular routes is accelerated approval, which allows the agency to approve drugs using surrogate endpoints that are thought to predict a clinical benefit.…
According to the National Institutes of Health (NIH), approximately 80% of research studies fail to meet their enrollment goals within the stated timeframes. Recruitment and trial design challenges can prolong the timeline for phase III studies, driving up costs and delaying market entry.
While many sponsors use aggregated data and predictive analytics to improve the trial process, one data source is often overlooked: lab data. By analyzing normalized lab data sourced from both commercial and inpatient labs, pharma companies can optimize…
With rebates now a common pharma practice, and generics and biosimilars launching in oncology, payer management of once-untouchable cancer drugs is growing. As the FDA continues to approve a large number of cancer drugs, resulting in increased competition in various tumor types, and spending on these agents continues to rise, PBM and payer formularies are now excluding some oncolytics while designating others as preferred.
Not so long ago, oncology was fairly off-limits for utilization management, but that is no longer the…
This article was originally published in BioPharma Dive.
In the competitive pharma marketplace, physician engagement plays a critical role in a drug manufacturer’s commercialization strategy. However, before manufacturers can promote a new therapy directly to providers, they must first determine which physicians treat the relevant patient population. By investing in timely lab data, manufacturers can identify specific providers to target—before a diagnosis or prescribing decision is made.
Broadly speaking, lab data refers to any type of diagnostic test that passes through a…
When it comes to biosimilars, there seem to be far more questions than answers, specifically when it comes to interchangeability. Now that the FDA has granted three biosimilar products “interchangeable” status—with more to come, surely—how will this development affect the biosimilars market? What do pharma manufacturers, payers and physicians need to know about this designation? And, crucially, how might interchangeability affect biosimilar uptake in 2023 and beyond?
To learn more, we sat down with Cathy Humphries, a Senior Consultant on MMIT’s…
As researchers continue to identify specific genetic markers within different diseases, more and more treatments targeting those markers are launching. In fact, more than 77,000 genetic tests currently are available. They can identify, for example, what type of breast cancer or non-small cell lung cancer a patient has. Some can determine a person’s risk for developing a disease, and others can predict the probability of a response to a drug. With so many tests available, it can be hard for payers…
This article was originally published in Drug Channels.
Next year’s staggered launch of adalimumab biosimilars will mark one of the largest losses of exclusivity for a pharmaceutical company in U.S. market history.
For years, Humira has been the top-selling drug worldwide, raking in more than $20 billion in revenue last year. Manufacturers of reference biologics will be monitoring the impending upheaval, while companies with biosimilars in the pipeline will be eagerly tracking utilization data. Which drugs will secure a place on payers’ formularies,…
Every consumer is familiar with the rebates one may get when purchasing a product or service. However, if the rebate was invalid or was not submitted properly, the money does not always get back to the consumer. A similar issue of ineligible rebates and incurred costs also consistently occurs in the pharmaceutical industry, but on a much larger scale. As a consumer, you would be angry if you didn’t get your money back from a rebate. Why should pharma companies let…
Could previously launched drugs that significantly missed sales expectations have met a different fate if their manufacturers had accounted for payer perspectives in their early stage development strategy?
Let’s start with some stats.
About half of the drugs launched in the last 15 years underperformed analysts' sales estimates by more than 20% Only one-fifth of new meds reached $1 billion in U.S. sales, and more than half failed to hit even $250 million The average cost to develop a drug is…
