Syndromic and Monogenic Obesity Market

Key Highlights

• Obesity is a modern pandemic, with the WHO recently reporting that almost 1 in 3 children are overweight or obese. Importantly, a large percentage of obese children become obese adults with many comorbidities such as type 2 diabetes (T2D), hypertension, cardiovascular diseases (CVD), and an increased risk of early death. 
• Obesity can be classified into three categories based on genetic factors: common polygenic obesity, syndromic obesity, and monogenic obesity. Advances in genetic testing are continuously uncovering more genetic causes of obesity.
• In 2023, there were approximately 8 million prevalent cases of obesity among children aged 5 to 19 and approximately 190 million cases among adults in the 7MM. Given current lifestyle trends, this number is expected to increase at a significant rate.
• Among the 7MM, the US accounts for the highest market share of obesity.
• In patients with genetic obesity, general measures such as restriction of food consumption, psychological and behavioral support, increased physical activity, and reduced carbohydrate consumption should be initiated as soon as possible during childhood. Additionally, recent progress in pharmacological treatment should be focused on. The MC4R agonist, IMCIVREE (setmelanotide), should be administered to patients with POMC, PCSK1, or LEPR deficiency, and BBS. 
• Recently, significant advancements have been made in the treatment landscape for syndromic and monogenic obesity. In January 2024, Rhythm Pharmaceuticals announced a global licensing agreement with LG Chem for LB54640, a melanocortin-4 receptor (MC4R) agonist currently in Phase II clinical trials. This collaboration represents a crucial effort by pharmaceutical companies to advance treatments for genetic obesity.
• However, there is a critical need for a stronger pipeline of emerging therapies, for syndromic and monogenic patients, as current developments are insufficient to meet the growing demand.

DelveInsight's “Syndromic and Monogenic Obesity Market Insights, Epidemiology and Market Forecast – 2034” report delivers an in-depth understanding of syndromic and monogenic obesity, historical and forecasted epidemiology as well as the syndromic and monogenic obesity therapeutics market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The syndromic and monogenic obesity market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM syndromic and monogenic obesity market size from 2020 to 2034. The report also covers current syndromic and monogenic obesity treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Syndromic and Monogenic Obesity Treatment Market

Syndromic and Monogenic Obesity Overview, Country-Specific Treatment Guidelines and Diagnosis

Obesity is a metabolic disorder where energy balance is disrupted, leading to weight gain, often starting in childhood. Syndromic obesity includes obesity with intellectual disability, dysmorphic features, or organ abnormalities, and follows a Mendelian inheritance pattern. Monogenic obesity, also inherited in a Mendelian fashion, involves severe obesity due to single-gene mutations, often in the leptin-melanocortin pathway. In this pathway, leptin binds to hypothalamic receptors, triggering proopiomelanocortin (POMC) production. PCSK1 cleaves POMC into melanocortin ligands, activating MC4R to reduce food intake and increase energy expenditure. BDNF also regulates this pathway.

Other Types of Obesity:

1. Obesity – A chronic condition involving excessive fat accumulation, increasing the risk of metabolic disorders like diabetes and cardiovascular diseases. It results from a combination of genetic, environmental, and lifestyle factors.

2. Hypothalamic Obesity – Caused by hypothalamic damage, often due to brain tumors or injuries, leading to disrupted appetite control, reduced energy expenditure, and rapid weight gain.

3. HET Obesity/POMC Deficiency Obesity – A rare genetic condition due to POMC gene mutations, impairing appetite regulation and resulting in severe early-onset obesity.

4. Pediatric Obesity – Obesity in children and adolescents, mainly influenced by poor diet, sedentary behavior, and genetic predisposition, leading to long-term health complications.

5. Pro-Opiomelanocortin (POMC) Deficiency Obesity & Leptin Receptor (LEPR) Deficiency Obesity – Genetic disorders affecting hunger regulation, leading to excessive appetite, early-onset severe obesity, and metabolic dysfunction.

The syndromic and monogenic obesity report provides an overview of syndromic and monogenic obesity pathophysiology, diagnostic approaches, and detailed treatment algorithm along with a real-world scenario of a patient’s journey beginning from the first symptom, the time taken for diagnosis to the entire treatment process.

Further details related to country-based variations in diagnosis are provided in the report

Syndromic and Monogenic Obesity Treatment

For patients with genetic obesity, general measures should be implemented as early as possible in childhood. These measures include food restriction, psychological and behavioral support, increased physical activity, and reduced carbohydrate intake. Recent progress in pharmacological treatments also offers promising options. The MC4R agonist, setmelanotide, is recommended for patients with POMC, PCSK1, or LEPR deficiencies and Bardet-Biedl syndrome (BBS). Additionally, GLP-1 receptor agonists, semaglutide and liraglutide, have been FDA-approved for treating obesity and represent novel therapeutic agents.

Syndromic and Monogenic Obesity Epidemiology

The syndromic and monogenic obesity epidemiology chapter in the report provides historical as well as forecasted in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2024 to 2034. Syndromic And Monogenic obesity epidemiology is segmented with detailed insights into Total Prevalent Cases of Obesity, Total Prevalent Cases of Syndromic and Monogenic Obesity, Total Syndromic, and Monogenic Obesity patients seeking help, and Total Treated Cases of Syndromic and Monogenic Obesity

• According to findings, the prevalence of overweight (including obesity) among children and adolescents aged 5–19 has risen dramatically from just 8% in 1990 to 20% in 2022. The rise has occurred similarly among both boys and girls: in 2022 19% of girls and 21% of boys were overweight.
• Among EU4 and the UK, Germany accounted for the highest number of prevalent cases of obesity.

Syndromic and Monogenic Obesity Drug Chapters

The drug chapter segment of the syndromic and monogenic obesity report encloses a detailed analysis of syndromic and monogenic obesity marketed drugs and pipeline drugs. It also deep dives into the syndromic and monogenic obesity pivotal clinical trial details; recent and expected market approvals, patent details, the latest news, and recent deals and collaborations. 

Syndromic and Monogenic Obesity Marketed Drugs

IMCIVREE (setmelanotide): Rhythm Pharmaceuticals

IMCIVREE is a melanocortin 4 (MC4) receptor agonist indicated for chronic weight management in adult and pediatric patients aged 6 years and older with monogenic or syndromic obesity. It is used specifically for those with obesity due to Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency, as determined by an FDA-approved test showing pathogenic, likely pathogenic, or uncertain significance (VUS) variants in the POMC, PCSK1, or LEPR genes. IMCIVREE is also indicated for patients with Bardet-Biedl syndrome (BBS).

Note: Detailed current therapies assessment will be provided in the full report on syndromic and monogenic obesity

Emerging Syndromic and Monogenic Obesity Drugs

LB54640 (LR19021): LG Chem/ Rhythm Pharmaceuticals

LB54640 is the first orally available, small-molecule MC4R agonist. LB54640 is safe and well-tolerated in GLP toxicity studies. The efficacy and safety profiles of LB54640 observed in preclinical studies suggest that LB54640 can be a safe and effective drug for patients with genetic obesity. The US FDA has granted an Orphan Drug Designation for LB54640 for the treatment of leptin receptor deficiency obesity. Currently, LB54640 is being evaluated in a first-in-human study in healthy, non-diabetic, obese volunteers with body mass index ≥ 27 kg/m2 in the US.

DCCR: Soleno Therapeutics

Diazoxide choline controlled-release tablet (DCCR) is a novel, proprietary extended-release, crystalline salt formulation of diazoxide, which is administered once daily. Soleno is investigating, DCCR development program in several clinical trials, one of which was in PWS patients. In the PWS Phase II study, DCCR showed promise in addressing hyperphagia, the hallmark symptom of PWS, as well as several other symptoms such as aggressive/destructive behaviors, fat mass, and abnormal lipid profiles. 

• • In April 2024, Soleno Therapeutics announced that the US FDA has granted Breakthrough Therapy Designation (BTD) to diazoxide choline for the treatment of adults and children ages 4 years and older with genetically confirmed Prader-Willi syndrome (PWS) who have hyperphagia.

Note: Detailed emerging therapies assessment will be provided in the final report.

Syndromic and Monogenic Obesity Market Outlook

Key players, such as LG Chem/ Rhythm Pharmaceuticals, Soleno Therapeutics, and Company, and others are evaluating their candidates in different stages of clinical development. They aim to investigate their products for the treatment of syndromic and monogenic obesity.

• The United States accounts for the largest market size of obesity, in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.
• Among EU4 and the UK, Germany had the highest market size.

Syndromic and Monogenic Obesity Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2024–2034, which depends on the competitive landscape, safety, and efficacy data along with order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake. 

Further detailed analysis of emerging therapies drug uptake in the report…

Syndromic and Monogenic Obesity Activities

The report provides insights into Syndromic and Monogenic Obesity clinical trials within Phase I, Phase II, and Phase III stages. It also analyzes key players involved in developing targeted therapeutics. 

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for syndromic and monogenic obesity emerging therapies. 

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility.

DelveInsight’s analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging treatment patterns of obesity. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. 

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival. 

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided. 

Market Access and Reimbursement

The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Syndromic and Monogenic Obesity Market Report

• The report covers a segment of key events, an executive summary, descriptive overview of syndromic and monogenic obesity, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, and disease progression along with country specific treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the syndromic and monogenic obesity market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM syndromic and monogenic obesity market.

Syndromic and Monogenic Obesity Report Insights

• Syndromic and Monogenic obesity Patient Population
• Syndromic and Monogenic obesity Therapeutic Approaches
• Syndromic and Monogenic obesity Pipeline Analysis
• Syndromic and Monogenic obesity Market Size and Trends
• Existing and future Market Opportunity 

Syndromic and Monogenic Obesity Report Key Strengths

• Eleven Years Forecast
• 7MM Coverage 
• Syndromic and Monogenic obesity Epidemiology Segmentation
• Inclusion of Country specific treatment guidelines
• KOL’s feedback on approved and emerging therapies 
• Key Cross Competition 
• Conjoint analysis
• Syndromic and Monogenic obesity Drugs Uptake
• Key Syndromic and Monogenic obesity Market Forecast Assumptions

Syndromic and Monogenic Obesity Report Assessment

• Current Syndromic and Monogenic obesity Treatment Practices
• Syndromic and Monogenic obesity Unmet Needs
• Syndromic and Monogenic obesity Pipeline Product Profiles
• Syndromic and Monogenic obesity Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)
• Syndromic and Monogenic obesity Market Drivers
• Syndromic and Monogenic obesity Market Barriers

FAQs

• What is the growth rate of the 7MM syndromic and monogenic obesity treatment market?
• What was the syndromic and monogenic obesity total market size, the market size by therapies, market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors/key catalysts for this growth?
• Is there any unexplored patient setting that can open the window for growth in the future?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends? 
• What are the current and emerging options for the treatment of syndromic and monogenic obesity? 
• How many companies are developing therapies for the treatment of syndromic and monogenic obesity?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies? 
• Patient/physician acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies? 

Reasons to buy Syndromic and Monogenic Obesity Market Forecast Report

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the syndromic and monogenic obesity market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.