Guidelines for new obesity drugs must be established

[Bio Research] 79 pipelines & 148 products have been developed by pharmaceutical companies worldwide.

Wegovy is expected to enter the Korean market…discussion on how to offer reimbursement for treating patients with extreme obesity is necessary

Obesity is projected to impact around 2 billion individuals by 2035.

 

Including overweight, about 4 billion individuals will be affected by obesity, making it a significant global healthcare issue.

 

Following this trend, pharmaceutical and biotech industry is focusing on developing next-generation treatments for obesity.

 

Glucagon-like peptide 1 (GLP-1) drugs, including Saxenda, Wegovy, and Zepbound, showed outstanding weight loss effects in clinical trials.

 

As a result, companies are developing GLP-1-based therapeutics.

 

The number of companies developing obesity drugs by country; big pharmas developing obesity drugs; small businesses and new companies developing obesity drugs.

Recently, these drugs have been found to provide cardiovascular benefits and aid weight loss effects.

 

As a result, their expanded use has been gathering attention in clinical settings.

 

The analysis suggests that it's time to consider using these drugs in clinical settings in South Korea.

 

According to drug market research company IQVIA on July 20th, there are 79 obesity drug pipelines worldwide, from preclinical to launched products.

 

Pharmaceutical and biotech companies have developed over 148 products.

 

GLP-1 drugs account for 39% of the pipelines.

 

This suggests that pharmaceutical and biotech companies have begun developing drugs in this class as latecomers after witnessing the success of Saxenda, Wegovy, and Zepbound.

 

79 obesity drug pipelines worldwide, from preclinical to launched products, and 148 products from pharmaceutical and biotech companies have been developed.

 

The analysis indicates that major companies that have begun developing obesity drugs employ two major development strategies.

 

They either develop a drug as 'monotherapy' based on their differentiation strategy, or consider potential expansion for treating obesity, type 2 diabetes, cardiovascular diseases, and metabolic dysfunction-associated steatohepatitis (MASH) as part of their portfolio strategy.

 

As part of differentiation therapy, monotherapy is being developed to achieve the ▲Highest weight loss rate, ▲Improved safety, and ▲Chronic disease management with oral formulation.

 

For instance, Pfizer and Viking Therapeutics are developing candidate products.

 

Under the portfolio strategy, the market leaders, such as Novo Nordisk (Wegovy) and Lily (Zepbound), and latecomers, aim to expand indications.

 

Lately, the development of 'oral formulation drugs' has gained attention.

 

These drugs are expected to shift the paradigm of a market dominated by injectables.

 

Global companies, Pfizer and Viking Therapeutics, and domestic companies, including Ildong Pharmaceutical and D&D Pharmatech, have started to develop them.

 

Novo Nordisk and Lily, the market-leading companies that already have injectables, have proprietary pipelines.

 

However, Wegovy and Zepbound, which dominate the global market for obesity, have unresolved issue of weight loss rebound.

 

IQVIA Korea's Marketing & Sales Director Kang-Bok Lee said, "Most obesity pipelines at the clinical stage are being developed as oral formulations." Lee added, "However, there are still discussions about oral obesity drugs.

 

Along with the convenience, we must consider whether these drugs are suitable for chronic and maintenance management, and whether their cost and supply network outweigh any remaining issue." Lee added that "There are questions about whether it can have similar efficacy compared to injectables, as well as concerns about tolerability." Lee expressed optimism about oral drug development, saying, "Recently, Viking's oral drug, VK2735, had no clinically significant gastrointestinal side effects compared to placebo, with most being mild." Reflecting on the global trend for obesity drug development, new GLP-1 drugs, such as Wegovy and Zepbound, will likely be introduced to South Korea.

 

According to IQVIA, the market for obesity drugs is rapidly growing after the launch of Wegovy.

 

The worldwide market size in 2023 totaled US$11 billion (about KRW 15.3 trillion), driven by Wegovy.

 

Wegovy contributed 72% of the total US$11 billion-worth market in 2023.

 

In contrast, in South Korea, the release of Wegovy has been delayed due to an issue with 'securing stock' after obtaining marketing approval.

 

As a result, Saxenda (Novo Nordisk) and Qsymia (Alvogen Korea) have taken 60% of the market share, dominating the market.

 

Sources said that the release of Wegovy is set to be released in the Korean market, making it the ninth country globally.

 

A professor from the Department of Endocrinology at an unnamed University Hospital, who is also an executive member of the Korean Society for the Study of Obesity, said, "Following Japan, China has also approved Wegovy.

 

Since an official launch date has not yet been set, it is difficult to guarantee the timing of the release." He analyzed, "This appears to reflect the position of the domestic market within the global market." "Even if it is released, it seems that obesity drugs will be used entirely as non-reimbursable in the domestic market," He added.

 

"While there has been some progress in recognizing obesity as a disease, reimbursement coverage, especially concerning domestic insurance finances, will not be easy." As a result, the pharmaceutical and biotech industries have proposed that, considering the potential of the drug market due to the rising prevalence of obesity, there is a need to accelerate discussions on disease recognition, enhancements in social awareness, and the establishment of clinical practice guidelines and insurance.

 

At the same time, domestic pharmaceutical and biotech companies developing treatments may need to focus on differentiation strategies from competing products, improving efficacy such as preventing weight regain after discontinuation and establishing a stable supply chain to meet global demand.

 

IQVIA Korea's Director Kang-Bok Lee said, "In the past two years, global spending on obesity has increased rapidly with new drugs, and by 2030, more than 15 new items are expected to enter the market, making the next-generation obesity treatment market much more competitive." Lee also said, "Improving educational programs for healthcare professionals to raise awareness of obesity treatment and integrating it into chronic disease management would be an ideal approach." Lee also added, "Currently, even though obesity treatments are approved by the Ministry of Food and Drug Safety (MFDS), there are no cases where these drugs are covered by reimbursement.

 

In the U.S., Medicare (Part D) will now cover Wegovy for some patients with a history of heart disease, as announced by the Centers for Medicare & Medicaid Services (CMS)." Lee added, "In the future, obesity drugs will be divided into reimbursed and out-of-pocket markets, so it is necessary to consider establishing reimbursement criteria for patients with severe obesity or accompanying diseases.

 

We must develop and distribute comprehensive obesity treatment guidelines through collaboration with the medical community and organizations."