PUBLISHER: DelveInsight | PRODUCT CODE: 2019012
PUBLISHER: DelveInsight | PRODUCT CODE: 2019012
Several factors augment disease propensity at greater risk of developing endometriosis, such as never giving birth, early menarche, late menopause, short menstrual cycles, genetic (mother, aunt or sister) with endometriosis, disorders of the reproductive tract etc.
Endometriosis market growth is expected to be mainly driven by the entry of novel Endometriosis therapies with better clinical profiles, an upsurge in research and development, and an enriched understanding of the disease.
Endometriosis Treatment Market Report Summary
The table given below further depicts the key segments provided in the report:
Key Factors Driving the Growth of the Endometriosis Market
Endometriosis Market
Various key Endometriosis companies are leading the Endometriosis treatment landscape, such as Abbvie, Myovant, Pfizer, ASKA Pharmaceutical, Enteris BioPharma, and others. The details of the country-wise and therapy-wise Endometriosis market size have been provided below.
Endometriosis Recent Developments
The section dedicated to Endometriosis drugs in the Endometriosis treatment market report provides an in-depth evaluation of late-stage Endometriosis pipeline drugs (Phase III and Phase II) related to Endometriosis.
The drug chapters section provides valuable information on various aspects related to Endometriosis clinical trials, such as the pharmacological mechanisms of the drugs involved, designations, approval status, patent information, and a comprehensive analysis of the pros and cons associated with each Endometriosis drugs. Furthermore, it presents the most recent news updates and press releases on drugs targeting Endometriosis.
Marketed Endometriosis Therapies
ORILISSA (elagolix): AbbVie
ORILISSA (elagolix) is a gonadotropin-releasing hormone (GnRH) receptor antagonist and is available in two oral dosages 150 mg once daily and 200 mg twice daily. ORILISSA inhibits endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. Administration of ORILISSA results in dose-dependent suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to decreased blood concentrations of the ovarian sex hormones estradiol and progesterone. ORILISSA was the first FDA-approved oral treatment for managing moderate-to-severe pain associated with endometriosis.
MYFEMBREE (relugolix, estradiol, and norethindrone acetate): Myovant/Pfizer
MYFEMBREE (relugolix, estradiol, and norethindrone acetate) is an oral once-daily tablet. MYFEMBREE contains relugolix, which reduces the amount of estrogen (and other hormones) produced by ovaries; estradiol (an estrogen) which may reduce the risk of bone loss; and norethindrone acetate (a progestin), which is necessary when women with a uterus (womb) take estrogen. MYFEMBREE was approved as a one-pill, once-a-day therapy for managing moderate-to-severe pain associated with endometriosis in premenopausal women, with the treatment of up to 24 months.
Emerging Endometriosis Therapies
HMI-115: Bayer/Hope Medicine
HMI-115 is a first-in-class monoclonal antibody that targets the prolactin receptor, a key mediator involved in the development and persistence of endometriosis. Prolactin signaling contributes to lesion growth, inflammation, and pain associated with the disease. By blocking the prolactin receptor, HMI-115 aims to alleviate endometriosis-related pain and suppress lesion progression through a non-hormonal mechanism.
Merigolix/TU2670: Tiumbio
TU2670 is an oral, small-molecule GnRH receptor antagonist designed to suppress estradiol production by directly binding to pituitary GnRH receptors. Unlike injectable GnRH agonists, which induce profound hormone suppression to menopausal levels and are associated with reduced patient comfort and adverse effects such as bone loss, TU2670 enables dose-dependent hormonal control limited to therapeutic levels. This targeted suppression is intended to maintain efficacy while reducing hypoestrogenic side effects and improving convenience through oral administration. Currently, a Phase IIa clinical trial is underway in five European countries to evaluate the efficacy and safety of TU2670 in patients with endometriosis-associated pain.
Without a cure, endometriosis treatments aim to manage symptoms, especially pain and infertility, including drug therapies (analgesic and hormone) and surgery. While drug therapies reduce pain, surgery is currently the only treatment option shown to improve fertility rates. Current treatment guidelines for endometriosis emphasize the management of pain and infertility. Most treatment guidelines recommend using nonsteroidal anti-inflammatory drugs, combined hormonal contraceptives, progestogens (or antiprogestogens), gonadotropin-releasing hormone agonists and antagonists, surgical fulguration or excision of endometrial lesions, or hysterectomy with and without bilateral salpingo-oophorectomy.
Many new molecules with novel mechanisms, like LHRH receptor antagonists, Gonadotropin-releasing hormone stimulants, Prolactin receptor antagonists, among others, are being developed for the treatment of Endometriosis by key Endometriosis companies like ObsEva SA, Myovant Sciences, Hope Medicine, and Organon among others.
In conclusion, despite the lack of appropriate treatment in the current treatment landscape, many potential therapies with novel mechanisms are expected to enter the market, resolving a dire unmet need and leading to significant improvement in the treatment outcome of Endometriosis patients. Hence, with the upcoming availability of new Endometriosis treatment options and increasing healthcare spending across the 7MM, the treatment scenario is expected to experience significant growth during the forecast period (2024-2034).
Endometriosis Understanding and Treatment
Endometriosis is a disease distinguished by endometrial tissue outside the uterine cavity with recurrent intralesional bleeding because of the hormonal responsiveness of ectopic endometrial tissue, resulting in fibrosis. It is a disease of adolescents and reproductive-aged women commonly associated with chronic pelvic pain and infertility. The most common locations for endometriosis are the ovaries, pelvic peritoneum, uterosacral ligaments, and torus uterinus. Atypical pelvic endometriosis localizations can occur in the cervix, vagina, round ligaments, ureter, and nerves. Moreover, rare extrapelvic endometriosis implants can be localized in the upper abdomen, subphrenic fold, or abdominal wall.
Endometriosis Diagnosis
Clinically diagnosing endometriosis can be challenging because the signs and symptoms are nonspecific. A thorough history and a comprehensive assessment of a patient's pain experience are recommended. A stepwise pelvic exam may reveal anatomic features of endometriotic implants, and imaging, predominantly transvaginal ultrasound, can be a useful adjunct.
Laparoscopy- At laparoscopy, endometriosis may be visualized as peritoneal implants, peritoneal windows, endometriomas, and deep infiltrating nodules of endometriosis which may each be associated with adhesions.
Imaging- Imaging has limited utility in diagnosing endometriosis, as it lacks adequate resolution to identify adhesions or superficial peritoneal implants. Ultrasound is cheap and easy to perform but user-dependent; MRI is more accurate but considerably more expensive. As CT of the pelvis does not visualize pelvic organs well, it is not useful in diagnosing endometriosis.
Serum markers- Serum markers for endometriosis have been eagerly sought for their use in diagnosing, measuring disease activity, and monitoring improvement. Serum cytokines, matrix metalloproteinases, adhesion molecules, and markers of angiogenesis or inflammation have been investigated.
Endometrial nerve fibers- Endometrial biopsy is being explored for the diagnosis of endometriosis. Recent studies have shown an increased number of nerve fibers in the endometrium of women with endometriosis compared to women without endometriosis.
Endometriosis Treatment
Current strategies for treating endometriosis include surgical removal of endometriotic lesions by laparoscopy, which reduces pain and improves pregnancy rates, and/or therapeutics that suppress pain, ovarian function, and estrogen action. The recurrence rate of endometriosis is high; estimates show that 21.5% of patients experience recurrence within 2 years after surgery, and 40-50% of patients experience recurrence within 5 years of surgery. Patients with endometriosis thus often undergo several surgeries and/or are treated pharmacologically for decades during their reproductive years.
The available Endometriosis therapies include oral contraceptives (off-label), progestins as the first-line pharmacological treatment, and GnRH agonists/antagonists as the second-line treatment. The latter option leads to hypoestrogenism and is associated with serious side effects, including drug-induced menopause and osteoporosis. Importantly, all these therapies preclude fertility. Persistent pain, a typical and debilitating symptom of endometriosis, is most commonly alleviated with NSAIDs which show variable efficacy and have serious side effects when used for a prolonged time. There is an unmet clinical need for new non-hormonal treatments for endometriosis.
The Endometriosis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Prevalent cases, Diagnosed prevalent cases, Age-specific diagnosed prevalent cases, Diagnosed prevalent cases by pain severity, Total treated cases of endometriosis in the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2022 to 2036.
KOL Views
To stay abreast of the latest trends in the Endometriosis market, we conduct primary research by seeking the opinions of Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) who work in the relevant field. This helps us fill any gaps in data and validate our secondary research.
We have reached out to industry experts to gather insights on various aspects of Endometriosis, including the evolving treatment landscape, patients' reliance on conventional therapies, their acceptance of therapy switching, drug uptake, and challenges related to accessibility. The experts we contacted included gynaecologists, medical/scientific writers, professors, and researchers from prestigious universities in the US, Europe, the UK, and Japan.
Our team of analysts at Delveinsight connected with more than 15 KOLs across the 7MM. We contacted institutions such as the Michigan State University College of Human Medicine, Women's Healthcare of Princeton etc., among others. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the Endometriosis market, which will assist our clients in analyzing the overall epidemiology and market scenario.
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 disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.
Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, 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 trials for Endometriosis, important primary endpoints are verbal rating scale (VRS), numeric rating scale (NRS), endometriosis health profile-30 (EHP-30), endometriosis-associated pelvic pain (EAPP), endometriosis impact questionnaire (EIQ), etc. Based on these parameters, the overall efficacy is evaluated.
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 route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, a final weightage score is decided, based on which the emerging therapies are ranked.
Market Access and Reimbursement
Because newly authorized drugs are often expensive, some patients escape receiving proper treatment or use off-label, less expensive prescriptions. Reimbursement plays a critical role in how innovative treatments can enter the market. The cost of the medicine, compared to the benefit it provides to patients who are being treated, sometimes determines whether or not it will be reimbursed. Regulatory status, target population size, the setting of treatment, unmet needs, the number of incremental benefit claims, and prices can all affect market access and reimbursement possibilities.
The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved 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.