A keynote session at AMCP 2024 outlined notable pharmaceutical industry trends from 2023 and predictions shaping pharmacy benefits management in the coming months.

“There is so much going on in this business right now,” said keynote speaker Douglas M. Long, BA, MBA, Vice President, Industry Relations, IQVIA. “Probably more than I’ve ever seen before.” 

Some of the numerous challenges facing the shifting pharmacy landscape today are drug shortages and quality concerns, staffing challenges, and changing consumer preferences. Major industry disruptors are the Inflation Reduction Act (IRA), the Drug Supply Chain Security Act (DSCSA), direct and indirect remuneration (DIR) fee changes, and pharmacy benefit manager (PBM) reform and transparency. 

“If you talk to most pharmaceutical companies, they don't call it the Inflation Reduction Act,” said Mr Long. “They call it the Innovation Reduction Act. And there is a real danger that it's going to affect innovation, particularly in disincentivizing putting first indications out.” 

Other major influences highlighted is the massive 340B program, the popularity of GLP-1s, discount card use trends, and the rise of biologics.

The keynote addressed the state of infectious diseases in the past year, sharing that after a decrease during lockdown during the COVID-19 pandemic the most recent cough, cold, and flu season reached average case levels. However, prescriptions for these illnesses are surpassing last season's numbers. Vaccines for COVID-19 and influenza are lower this season than prior seasons and the speaker noted many people are not returning to receive ongoing COVID-19 booster vaccinations. 

The number of COVID-19 and flu vaccines administered at retail locations has decreased compared to the previous year and 60.8% of flu vaccinations were administered in a pharmacy setting season to date. 

Varicella (chickenpox) vaccination retail rates are improving but have not yet reached pre-pandemic levels, unlike other vaccinations which have shown better recovery. RSV vaccines introduced this season seem to have a strong uptake but vaccine hesitancy in general was noted as alarming. 

“Measles is making an appearance, which I thought was long gone 10 years ago,” said Mr Long. “Polio is back. We’ve created confusion and [vaccine] hesitancy and we’re going to be paying the price going forward.” 

For market trends, the Health Services Utilization Index indicates the US is operating at pre-COVID-19 levels with shifts in utilization. Office visits, telehealth visits, institutional visits, and new prescriptions are all trending upwards but elective procedures are remaining low and screenings are lower. 

“These screening numbers are abysmal and that's going to lead to more extensive cancer care for some people because they were diagnosed late,” said Mr Long. 

The use of antibiotics is rising. The speaker noted that 2.4Bn antibiotic days of therapy in 2022 are down 7% from pre-pandemic and that antibiotic use in children and older adults is up 8% in Q4 2022 from historic seasonal levels. ADHD medicine use grew 11% over the last 5 years to over 3Bn days of therapy in 2022 and women aged 20 to 64 are a growing demographic of patients taking ADHD medications. Mental health prescriptions reached 567Mn in 2022, up 9% since 2019. 

“The most disturbing [change] for me is the mental health in young people,” said Mr Long. “Mental health prescriptions for girls under age 19 are up 33 % since pre-pandemic.” 

Other changes were noted related to the opioid epidemic as per capita prescription opioid use is down 64% since the peak in 2011 and opioid overdose deaths are up 253% since then. The rising use of novelty obesity drugs came as no surprise and in February 2023 there were over 500,000 new prescriptions for GLP-1 agonists across diabetes and obesity, up 152% compared to the prior year. On the front of women’s health, contraception use was down 6% in 2022 with 100Mn fewer days of therapy. Lower use includes long-acting birth control, such as IUDs and injectables. Specialty medicines also now account for 51% of spending. 

The most recent data suggests that now, the total market is experiencing double-digit growth. Total market (retail, non-retail, and mail) percent of sales has grown 7.4% from 2019 to 2023. Retail and mail alone have grown 9.7% since 2019 and non-retail sales have grown 4.2% since 2022. The 13.2% total US pharmaceutical market growth in 2023 can be partially attributed to volume and line extensions. While the proportion of sales revenue from mail had been increasing, it has stabilized over the past two years. 

Sales growth is robust in clinics and long-term care and has been less vigorous in hospitals and home health care. 

“There is far more demand for home health care than practitioners to do home health care with,” Mr Long said. 

Other observations included that within retail, grocery stores show the strongest growth percentage. For the overall market, the growth in specialty sectors was not as strong as the growth in traditional sectors for the year ending December 2023 and based on sales dollars, specialty is increasing in non-retail spaces. Immunology and antithrombotics led in terms of long-term growth and vaccines led in short-term growth. On just a units basis, antibacterials led short-term growth and antidiabetics led long-term growth.

“Another big change started this year is now the diabetes category,” said Mr Long. “Diabetes is now bigger than immunology and oncology. It is a 130 billion dollar class and it drew 27 billion dollars last year.” 

The top 10 therapy areas have grown at 15.7% and account for 72.8% market share and the top 20 therapy areas are growing at 15.5% and account for 85.2% market share. The list is led by the big hitters of antidiabetes, immunology, and oncologics. Immunology and oncologics contributed the most absolute value growth for specialty therapy areas and antidiabetics and antithrombotics led absolute value growth for traditional therapy areas.

For specific products, the top 10 products are growing at 30.1% and account for 25.4% market share. While the top 3 products were Humira, Ozempic, and Eliquis, the product with the most overall growth was Mounjaro at 368.8% growth. Humira ranks as the leading product in the mail sector, whereas Ozempic dominates in retail and Keytruda holds the top position in non-retail. Whereas Ozempic and Mounjaro have the greatest absolute sales gains in the last 12 months, Latuda has the greatest absolute sales loss within last 12 months.

“Why are GLP-1s a topic of conversation?” said Mr Long. “Because in 2018, it was a 10 billion dollar category. In 2023, it was a 63 billion dollar category. In 2024, it will be a 100 billion dollar category.” 

GLP-1s have grown around 58% over the last 12 months and about 84% of the sales are in retail. Ozempic and Mounjaro drove most of the volume growth among GLP-1s and recent adoption of GLP-1s has skewed to females and slowed, primarily due to shortages.

Self-reported prevalence of obesity has increased significantly in the last decade and Mr Long referred to the recent development of weight loss agents as “the obesity gold rush” with now over 120 weight loss agents being developed by over 60 companies. 

“It's not all smooth sailing because there's no one size fits at all and there are several products that deliver weight loss,” said Mr Long. “The clinical data suggests outcomes vary between patients but one of the most interesting things to me was that these weight loss drugs are more efficacious or just as efficacious as gastric bypass surgery. And patient support programs needed because short-term aid is no guarantee for long-term success. A major concern is suicide risk and that seems to be in the background now but there's several other adverse reactions that have been observed.” 

Within the obesity space, 2 main strategies are playing out: monotherapy and portfolio play. Monotherapy has opportunities for differentiation through aspects such as improved safety, improved quality of weight loss, oral medicines for chronic management, and more. Portfolio play may have advantages for latecomers due to obesity comorbidities, obesity therapies becoming backbone agents across the cardiovascular and metabolic treatments (CV-met) continuum, and development flexibility. The medical-led and reimbursed obesity market co-exists alongside the consumer-led, out-of-pocket market. 

When it comes to trends around generics and biosimilars, unbranded generic sales and prescriptions are positive. About 87.9% of prescriptions in the US are dispensed as generics and in the US, the price of generics has fallen by around 20% since 2019. Generic price deflation is slowing down and growth in sales for generics stems from new products and volume. 

While in 2018, it may have taken 7 brand drugs to equal total generic business, in 2023 it only takes 2 brand drugs. The traditional generics business is very fragmented and continues to fragment further, said Mr Long. Unlaunched Abbreviated New Drug Applications (ANDAs) account for 39% of approvals since 2013, including 42% of injectables and 33% of other forms. 

According to the FDA, there are currently 46 biosimilars approved since 2015 and with a couple of exceptions, most of those products have launched. The biological and biosimilar market represents almost 41% of the total sales in 2023 and biosimilars launched to date account for 24% of competitive molecule volume. Biosimilar sales are slowly starting to rise but significant numbers of biologics currently do not have a pipeline. Expected launches and uptake are likely to increase overall spending on biosimilars significantly to between $20 and $49 billion in 2027. Savings over the next 5 years because of biosimilars are projected to exceed $180 billion, though uncertainties remain.

Drug shortages have been a widely-recognized issue in the US recently and few seem to be resolved. Key drugs in shortage include cancer medications cisplatin and carboplatin, amoxicillin, Ozempic, Mounjaro, Trulicity, Adderall, and more. Some of the impact of injectable shortages is driven by demand and some  purchasers have increased orders to buffer expected disruptions. There are more shortages in generics and injectables and shortages of orals and brands are attributed to demand. More reported shortages continue to not be resolved and 58% of current shortages may go on for more than two years. Many supply issues can be traced back to concerns over quality following less inspections during the pandemic. 

“It's time that we need to have these plants inspected because there's a concern, particularly in India, that a number of small manufacturers have not been inspected and have taken shortcuts,” said Mr Long. 

Declining numbers of retail pharmacies also raised concerns. There are over 2,200 fewer retail pharmacies today than 4 years ago. Despite store closings, average prescriptions per store continue to rise. It is crucial to address these issues strategically to improve profitability, highlighted the speaker.

About 80 new products were launched by the end of 2023, surpassing 2022 and 2021. This was largely attributed to a Q3 influx of Humira biosimilars and RSV vaccines. Arexvy and Abrysvo were the most profitable new products in 2023. 

The launch landscape as of February 2024 is promising with 8 new product launches. Immunology is the top therapy area in 2024, accounting for 38% of new product launches. With only 2 diabetes launches in 2022, transformative therapies like Mounjaro helped the class to drive 67% of 2022 sales. The 2023 sales have been dominated by GSK and Pfizer RSV vaccines and the pipeline has grown across therapy areas in the last decade with significant growth in oncology in the past 5 years.
Per capita prescription opioid use continues to decline to levels seen in 2000, with varying decreases across specialties. Fentanyls still is the leading cause of overdose deaths and accounts for close to 70% of all overdose deaths. Prescription opioid overdose deaths have begun to decline and 39% of individuals who use pain relievers got them from one doctor in a 2021 survey by SAMHSA. 

“Over the next year, the market is going to grow on a dollar basis. But on net basis, it's going to grow more slowly,” said Mr Long. 

The US market net price basis is forecasted to grow 1%–2% compound annual growth rate (CAGR) over the next 5 years, down from 4% CAGR for the past 5 years. Immunology, oncology, and neurology will drive growth through 2026 along with COVID-19 vaccines.

In conclusion, the retail pharmacy sector is experiencing a decrease in numbers, with growth being driven by Medicaid D prescriptions. The mild cough, cold, and flu season resulted in minimal use of RSV vaccines. Specialty medications represent a significant portion of total market sales, while non-specialty GLP-1s are experiencing remarkable growth. Challenges remain in drug shortages, opioid usage, and the impact of COVID-19 on non-retail settings such as hospitals and long-term care facilities. Additionally, the pharmaceutical benefit Biosimilar wave is affecting competition in the market, with opportunities for growth in both small molecules and biologics.

Reference 
Long, D. 2023-2024 health care and pharmaceutical marketplace trends. Presented at: AMCP 2024; April 18, 2024; New Orleans, LA