Christine Blank

Treatments for the human immunodeficiency virus (HIV) are expected to reach $28 billion in sales in 2029, driven by injectable medications, a recent report says.

The total HIV therapeutics market was worth an estimated $22.9 billion across 7 major markets globally in 2019, according to GlobalData’s ‘

Therapeutics: Global Drug Forecast and Market Analysis to 2029

The 7 markets include the U.S., France, Germany, Italy, Spain, the United Kingdom, and Japan,

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Sales of injectable therapies are expected to exceed $1.8 billion in 2029. Injectables provide a viable alternative to oral medications since patients may not remember to take their medications, said Magdalene Crabbe, MA, senior ophthalmology and infectious diseases analyst at GlobalData, in a 

“The launch of STRs [single-tablet regimens of combination antiretroviral drugs] revolutionized the treatment landscape of HIV and met major unmet needs by increasing patient compliance and improving the safety and tolerability profiles of antiretroviral drugs,” Crabbe said.

However, there are challenges with STRs, according to Crabbe. “A key component of multiple drugs is tenofovir disoproxil fumarate (TDF), which has been linked to osteoporosis and kidney disease. There are also people who don’t remember to take their medication, and people who feel embarrassed about living with HIV, which lowers compliance,” she said.

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Roche’s Fuzeon (enfuvirtide) was the first subcutaneously-administrable drug to be approved for the treatment of HIV-infected patients. “However, the fact that the drug is administered multiple times daily has led to difficulties with adherence and the emergence of injection-site related adverse events such as lipohypertrophy, erythema and pruritus,” GlobalData said.

By 2029, other injectable therapies such as CytoDyn’s leronlimab and Gilead Sciences’ Lenacapavir will be available in the market, according to Crabbe.

In addition, TaiMed’s Trogarzo (ibalizumab), which is an intravenously administered monoclonal antibody, launched in the U.S. in 2018 and in Europe in 2020.

There is also an increased market for HIV treatments due to the increase in cases of the disease. GlobalData projects that the diagnosed prevalent HIV cases in the seven major markets will increase from 1.87 million in 2019 to 2.1 million in 2029.

The U.S. will have the highest number of diagnosed prevalent cases of HIV in 2029 with more than 1.4 million, according to GlobalData’s report, 

Human Immunodeficiency Virus (HIV): Epidemiology Forecast to 2029

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Injectables are driving the growth because they can be taken less frequently and adherence is a problem with oral medications.


 HIV therapeutics market to reach $28 billion in 2029

FDA’s approval of a broader indication  for sacubitril/valsartan (Entresto, Novartis) is expected to generate signficant additional sales of the drug that netted $1.7 billion in sales last year.

FDA approved the expanded indication to reduce the risk of cardiovascular death and hospitalization in a specific type of heart failure. The benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal, Novartis said in a 

Blockbuster diabetes drug snags new heart indication

Entresto is already approved to treat heart failure with reduced ejection fraction (HFrEF).

“For the first time, there is a treatment with benefit for patients diagnosed with guideline-defined heart failure that includes both those with heart failure with reduced ejection fraction (HFrEF) and many with heart failure with preserved ejection fraction (HFpEF)1-3,” Novartis said.

Many heart failure patients were not previously eligible for treatment before because “their ejection fraction was above the region we normally considered reduced,” said Scott Solomon, MD, professor of medicine at Harvard Medical School and Brigham and Women's Hospital, and PARAGON-HF Executive Committee Co-Chair. “We can now offer a treatment to a wider range of patients who have an LVEF below normal.”

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The label expansion is based on efficacy and safety results from the PARAGON-HF, which Novartis says is the largest and only Phase 3 active-controlled study to date in patients with guideline-defined HFpEF2,5,6.

In the trial, the greatest benefit was shown in patients with LVEF below normal, Novartis said.

Around 6 million Americans are living with chronic heart failure (CHF). Approximately 3 million have HFrEF, and of the remaining 3 million, about 2 million have HFpEF with LVEF below normal, according to Novartis.

The expanded indication is important because CHF patients often face worsening symptoms that result in frequent heart failure hospitalizations and approximately 1 in 4 patients are re-admitted for heart failure. In addition, 10% may die within 30 days of discharge, Novartis said.

Drug’s indication expanded to reduce heart attack, stroke risk

The FDA approved the use of Entresto in a broader group of heart failure patients that includes a large percentage of those with preserved ejection fraction. 

Blockbuster heart drug Entresto gets expanded indication

Novo Nordisk has asked the FDA to expand the indication for its type 2 diabetes drug semaglutide (Ozempic) after a study sponsored by the company showed significant weight loss in patients without diabetes.

Overweight and obese people taking Ozempic had a “sustained, clinical relevant reduction in body weight,” according to the doule-blind, placebo-controlled

 published in the Feb. 10, 2021, issue of the 

The results from that study are the basis for the company’s application for the expanded indication for Ozempic.

Semaglutide is an glucagon-like peptide-1 (GLP-1) agonist. Other drugs in that class include dulaglutide (Trulicity), liraglutide (Victoza) and exenatide (Byettta).

, the injection of 2.4 mg of semaglutide once weekly plus lifestyle intervention resulted in a mean loss in body weight of 14.9% from baseline in the study volunteers who were treated with semaglutide group compared with a 2.4% loss of body weight among those who were treated with a placebo.

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The study included nearly 2,000 adults who had tried to lose weight by changing their diets and either had a BMI of 30 or greater (the standard definition of obesity or a BMI of 27 or greater with one or more treated or untreated weight-related conditions, such as high blood pressure, high LDL cholesterol level or obstructive sleep apnea

“Obesity is associated with a wide range of serious complications, yet many healthcare providers still do not have sufficient medical options available to help people with this chronic disease ,” said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk, in a 

. "We are excited about the regulatory filing of semaglutide 2.4 mg in the U.S. and we believe once-weekly semaglutide 2.4 mg has the potential to transform the medical management of obesity."

More participants in the semaglutide group than in the placebo group achieved weight reductions of 5% or more (86.4% vs. 31.5%), 10% or more (69.1% vs. 12%), and 15% or more (50.5% vs. 4.9%) at week 68 (P<0.001 for all three comparisons of odds).

Participants who received semaglutide had a greater improvement in cardiometabolic risk factors and a greater increase in participant-reported physical functioning from baseline than those who received placebo.

Nausea and diarrhea were the most common adverse events associated with semaglutide, but they were typically transient and mild-to-moderate in severity, according to the authors.

More participants in the semaglutide group than in the placebo group discontinued treatment due to gastrointestinal events (4.5% vs. 0.8%).

Application to the FDA is based on results from a placebo-controlled trial showing a 15% decrease in body weight among those who are obese or overweight.





Novo Nordisk seeks weight-loss indication for Ozempic

The FDA granted emergency authorization to a new monoclonal antibody COVID-19 treatment and millions of additional doses of COVID-19 vaccines will be available this year.

President Joe Biden said last week that his administration had finalized deals for an additional 100 million doses of the Pfizer-BioNTech and the Moderna’s vaccines — 200 million doses in total—  “giving the country enough vaccine by the end of July to cover every American adult,” 

Today's Bloomberg says that the latest vaccination rate is 1,699,303 doses per day. At that rate, it will take eight months to cover 75% of the population with a two-dose vaccine, according to Bloomberg's calculations. 

However, Johnson & Johnson has applied for an emergency use authorization (EUA_ of its single-dose vaccine. if the single-dose vaccine gets an FDA OK (as it is expected to do) then the proportion of vaccinated Americans could increase faster.

The doses that Biden spoke of last week won’t be immediately available, but they will serve to prevent a shortfall later in the year by increasing supply by 50%, the 

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Meanwhile, FDA an issued an EUA on Feb. 9 for Eli Lilly's monoclonal antibody combination, bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016).

The agency's go-ahead is  for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization.

Bamlanivimab alone under emergency use authorization has already provided many people with an early treatment option that could prevent hospitalizations, said Daniel Skovronsky, MD, PhD, Lilly's chief scientific officer and president of Lilly Research Laboratories, in a 

. “We are excited to now add an additional therapeutic option with a similar demonstrated clinical benefit.”

With the risk of resistance emerging as various strains of the virus arise, bamlanivimab and etesevimab together could potentially allow efficacy against a broader range of naturally occurring SARS-CoV-2 variants as the new strains spread around the world, Skovronsky added.

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The EUA is based on Phase 3 data from the BLAZE-1 trial, which demonstrated bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70%.

Bamlanivimab and etesevimab are administered together via a single intravenous infusion as soon as possible after a positive COVID-19 test and within 10 days of symptom onset, according to Lilly.

In addition, the FDA has authorized infusion times for bamlanivimab alone and bamlanivimab and etesevimab together to be as short as 16 or 21 minutes, respectively – a significant reduction from the previously authorized time of 60 minutes, according to the pharma maker.

“This decision has been made in response to feedback received from front-line nurses and doctors administering these infusions and are aimed at reducing the burden on the healthcare system,” Lilly said.

FDA grants emergency use for COVID-19 treatmen

Christine Blank

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HIV therapeutics market to reach $28 billion in 2029

Blockbuster heart drug Entresto gets expanded indication

Novo Nordisk seeks weight-loss indication for Ozempic

FDA authorizes new COVID-19 treatment; more vaccine doses on the way