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Adenomyosis

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Published Date : Nov 2023
Category : Chronic Diseases
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An Impact of Adenomyosis on Women's Fertility and its Management

Adenomyosis is a thickening of the uterine walls. It happens when endometrial tissue expands into the uterus's outer, muscular walls. The lining of the uterus is made of endometrial tissue. The German pathologist Carl von Rokitansky initially reported the histopathologic discovery in 1860, termed "cystosarcoma adenoids uterinum." Exact demographics and disease prevalence are unclear due to previous underreporting and under-diagnosis. According to NCBI in June 2023, estimates range from 5% to 70% with more recent data suggesting a prevalence of 20% to 35%. Classically, adenomyosis is labelled as a disease of pre-menopausal, multiparous women between the ages of 30 to 40. However, this replicates the inherent bias towards women undergoing a hysterectomy.

Discovery in the diagnostic and treatment fields has been identified as an important element of expanding the marketplace on a global scale for industry players. Consequently, it plays a role in the globalization of product development. Adenomyosis causes painful and heavy periods. Adenomyosis most often occurs in women ages 35 to 50 who have had at least one pregnancy. It happens in response to the hormone estrogen. Adenomyosis after menopause usually goes away when estrogen levels drop. This condition affects 20% to 35% of females.

Through different mechanisms, inappropriate endometrial tissue proliferation within the adenomyosis of myometrium leads to various symptoms. Menstrual contractions are caused by prostaglandin, produced by healthy endometrial tissue. Ectopic adenomyosis foci raise prostaglandin levels, which cause dysmenorrhea, the disease's defining feature. Additionally, endometrial proliferation is driven by estrogen and is a focus of medical therapies. Several variables, including increased endometrial surface area, increased vascularization, aberrant uterine contractions, and increased levels of cell signalling molecules like prostaglandins, eicosanoids, and estrogen, are thought to be responsible for heavy menstrual bleeding.

Adenomyosis is a gynecologic condition considered by ectopic endometrial tissue within the uterine myometrium. Adenomyosis occurs when the cells that usually line the inside of the uterus also grow in the layer of muscle in the wall of the adenomyotic uterus. It is not definite how or why the uterus-lining cells enter the muscle wall. Signs and symptoms differ, but most commonly are painful menses and heavy menstrual bleeding. Other symptoms included are pain during sex, chronic pain in the pelvis, bleeding between periods, and infertility. Risk factors for adenomyosis consist of conditions leading to increased estrogen exposure which is increased due to various reasons like increased parity, early menarche, short menstrual cycles, elevated body mass index, oral contraceptive pill use, and tamoxifen use. Along with these prior uterine surgeries like dilation and curettage, caesarean section, and myomectomy.

DiseaseLandscape Insights helps the stakeholders by offering information about the Adenomyosis market, as well as informed decisions about medical equipment, treatments, and diagnostic methods. Many new technologies and innovations are also having an impact on the disease market and propelling its growth.

Adenomyosis is spreading throughout the world creating a drastic shift in an individual’s standard of life. The present condition of Adenomyosis disease would propel the industries in the appropriate direction and provide emerging opportunities for a variety of market leaders in the domain of landscape insights.

Adenomyosis Diagnostic Analysis:

Adenomyosis diagnosis often takes time. The doctor diagnoses it by symptoms and examines the person. During the examination, a doctor noticed adenomyosis in the uterus was tender and enlarged. A doctor recommends various tests like laboratory tests and radiologic evaluation which includes an adenomyosis ultrasound scan and magnetic resonance imaging (MRI scan).

Laboratory Evaluation

Laboratory testing helps to identify certain complicating features, such as anemia from heavy menstruation, and rule out other disease entities included in the differential diagnosis. Although there are some biomarkers, none of them are unique to adenomyosis.

Radiologic Evaluation

The primary method of diagnosis is imaging. Previously the ideal modality was MRI, however recently transvaginal ultrasound has been found to match the sensitivity and specificity of MRI which is 89% sensitivity, and 86% specificity. Due to the availability of ultrasound and the higher cost of MRI, ultrasound is now the preferred modality for the initial evaluation, with MRI being saved for unclear cases.

Ultrasound

For adenomyosis, transvaginal ultrasonography is the recommended diagnostic imaging modality. Three categories are used to classify the characteristic findings, which represent the histopathologic alterations of the disease process:

  • Endometrial infiltration - Myometrial cysts, "lollipop" diverticula (cystic striations), and echogenic striations and nodules are examples of endometrial infiltration.
  • Smooth muscle proliferation - Characterized by focal or diffuse myometrial thickening, often involving the posterior fundus, with indistinct borders and heterogeneous echotexture that appears as thin, linear shadows that are "Venetian blind."
  • Vascularity - Compared to leiomyomas, which displace vessels, Colour Doppler shows a greater number of tortuous vessels throughout the affected myometrium.

MRI – Magnetic Resonance Imaging

Similar characteristics observed on ultrasound line up with characteristic findings on MRI:

  • On T2 - Uterine enlargement on T2-weighted imaging that exhibits low-signal-intensity, ill-defined regions within the junctional zone is indicative of smooth muscle hyperplasia, a thicker junctional zone than 12 mm is considered diagnostic.
  • T2 hyperintense myometrial cysts, which also exhibit elevated intrinsic T1 signal or greater susceptibility to hemorrhagic foci, are indicative of ectopic endometrial tissue.
  • When assessing vascularity, contrast enhancement is typically less accurate than color Doppler ultrasound.

Like ultrasound, there are many mimics, from physiologic variations to co-existing gynecologic pathologies. MR spectroscopy, cine MR imaging, susceptibility-weighted imaging, diffusion-weighted imaging, and enhanced 3T field strength are all methods for addressing issues.

Due to the reduced signal of normal myometrium during the early proliferative phase (days 1 to 6), it is crucial to get an MRI during the late proliferative or secretory phase (days 7 to 28).

The global Adenomyosis diagnostic market is highly competitive and continuously growing. Market players have scope in the development of various diagnostic kits by using new technologies. Along with that launching of cost-efficient and quick diagnostic tests is important in the diagnostic field of Adenomyosis.

DiseaseLandscape Insights assists the industry players in the development of various diagnostic kits, the use of new technologies for improving the existing diagnostic method, and providing data on current market players and their products for more knowledge about market dynamics. By using the data from DLI, stakeholders choose the path of their business and implement strategies for the growth of the market.

Adenomyosis Diagnostic Market Players:

Key Players

Products

Ultrasound

MRI

Ultrasound

MRI

Wipro GE Healthcare

GE Healthcare

LOGIQ

SIGNA™ MRI

Prystyn Med X

Philips

HD15 Ultrasound

3 T (Tesla) MRI

 

Lynor Health Care

Simens

Aloka Prosound F37

Visart 1.5T

Modern Surgical House

Toshiba

BISTOS

Discovery™ MI

 

Adenomyosis Treatment Analysis:

The choice of Adenomyosis treatment depends on symptoms and stage of life. This includes thinking about whether a female is planning a pregnancy or wants to have a baby in the future. Various treatment techniques are listed below:

Self-care Measures - Warm baths and heat packs help relieve the pain allied with adenomyosis. Exercise, meditation, or acupuncture also be tried. However, there is little to no research evidence showing that they improve the symptoms of adenomyosis.

Medical Therapies - Primary medical therapy includes Nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs target the cyclooxygenase enzyme which produces the hormone prostaglandins accountable for painful cramping during menstruation.

Various hormonal therapies are available which consist of oral contraceptive pills (OCPs), levonorgestrel intrauterine device (IUD), danazol, and aromatase inhibitors. These therapies goal to reduce the estrogenic effects which lead to endometrial proliferation. However, levonorgestrel IUDs are usually considered to be the primary therapy due to decreased side effect profile and overall success rates.

Surgical Therapies - Various interventional radiologic procedures exist which is an option for the patient who fails medical therapy but wants future fertility. MRI-guided and ultrasound-guided high-intensity ultrasound thermal ablation is done to target focal disease. Uterine artery embolization decreases blood flow to the adenomyosis uterus as a whole, thereby inducing necrosis and leading to an overall reduction in uterine size. These therapies' goal is to preserve fertility, infertility is an understood risk. Endometrial ablation is considered in patients who do not desire future fertility but prefer a less invasive alternative to hysterectomy.

To maintain fertility, more invasive options like partial hysterectomy and myomectomy are available. These options make it possible to target deeper foci, but because they disrupt the endometrial-myometrial interface, which is a risk factor for adenomyosis, the resulting scarring causes the disease to recur. The possibility of future pregnancy complications resulting from altered uterine anatomy, such as an elevated risk of uterine rupture, premature rupture of the membranes, premature labor, and spontaneous abortion, is another factor to consider.

The only effective treatment for adenomyosis is still hysterectomy.

Treatment Market Players:

                                                                              Treatment Market Players

Nonsteroidal Anti-Inflammatory drugs (NSAIDs)

Oral Contraceptive Pills (OCPs)

Intrauterine Device (IUD),

Dr. Reddy's

wellona Pharma

Pregna

Pfizer

Piramal

Aetos pharma

Sanofi

mankind

Global Healthcare

GSk

Wyeth Laboratories Inc.

SMB Corporation

Bayer Healthcare LLC

Syntex Incorporated

Laboratoire CCD

Horizon Therapeutics

ORGANON USA INC

Egemen International

 

                                                                             Treatment Products

Nonsteroidal Anti-Inflammatory drugs (NSAIDs)

Oral Contraceptive Pills (OCPs)

Intrauterine Device (IUD),

NAPROSYN

Evicer 72

Copper T 380

CELEBREX

i-Pill

Copper T 380A

Buscogast ®

Unwanted 72

FREEDOM 5

Advil

Alesse-28

SMB Cu 380A

Duexis

Brevicon

Etherena® T Cu 380A

Aleve

Desogen

Gynelle® 375

 

Regulatory Framework for Adenomyosis:

The updated regulatory guidelines from DiseaseLandscape Insights (DLI) are very helpful for growing companies. These updates ensure that companies maintain their adherence to evolving industry standards, avoid potential legal snags, and enhance their marketing and development procedures.

On 28 February 2023, TGA approved Khapregesic manufactured by Bioactive Laboratories Pty Ltd, medicine continues to be permitted for supply. Based on the sponsor's certification, the use of this medicine poses a safety risk for some people. Follow the recommended actions given below –

Note that the TGA does not allow this medication to be used to treat, prevent, or relieve symptoms related to adenomyosis endometriosis, polycystic ovary syndrome, anxiety, or arthritis.

Overall, regulatory regulations have a considerable influence on the Adenomyosis disease sector, and DLI offers an in-depth evaluation of several regional standards that are now in place, as well as prospective future changes in the Adenomyosis disease market.

Market Trend Analysis:

The market is rising because of the development of numerous adenomyosis medications for the treatment of Adenomyosis, which cannot cure the condition entirely. To develop a fully curative treatment for cystic fibrosis Adenomyosis, a lot of research is necessary. Market participants have several prospects in both the diagnostic and therapy domains.

According to a recent study published in the American Journal of Obstetrics & Gynecology, adenomyosis relates to negative obstetrical and neonatal outcomes. Where Adenomyosis increases risks of adverse obstetrical outcomes, due to difficulties in diagnosing adenomyosis arising from nearly one-third of women not exhibiting any symptoms and a lack of standardized diagnostic criteria. This makes it challenging to come to a consensus regarding adenomyosis-related obstetrical complications.

Clinical Trial Assessment:

The crucial role of clinical trials in the practice of evidence-based medicine and reproductive health care reform is highlighted by the government's increasing concentration on comparing the effectiveness of studies. One of the main goals of reforming healthcare is achieved by the market participants accurately examining medical therapy with the use of clinical data.

The table below includes the study names of the ongoing clinical trials as well as the stages at which they are taking place.

 

Phase 1

Phase 2

Phase 3

Phase 4

Vaginal Bromocriptine for the Treatment of Adenomyosis

Mifepristone Versus Placebo to Treat Adenomyosis: a Double-blind, Multicentre, Randomized Clinical Trial

Mifepristone Versus Placebo to Treat Adenomyosis: a Double-blind, Multicentre, Randomized Clinical Trial

Assisted Reproductive Technology (ART) and Pregnancy Outcomes in Women with Adenomyosis (Internal Endometriosis) According to Stimulation Protocol about Immunological and Endometrial Features: A Prospective, Randomized Study

 

A Phase II, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Proof of Concept Study with an Interim Futility Analysis of Epelsiban in Patients with Adenomyosis

Phase III Trial to Assess Impact of Ultra-long Versus Long Down-regulation Protocol on IVF/ICSI Outcomes in Infertile Women Presenting with Adenomyosis.

Modified Downregulation for Women with Adenomyosis of the Uterus Before Frozen-thawed Embryo Transfer.

 

Pilot Phase II, Randomized, and Control in Double Blind Placebo Effectiveness a 3 Months on Bleeding Fibroids Treatment with ULIPRISTAL ACETATE 10 mg/Day in Patients Suffering from Symptomatic Endometriosis

Multi-institution, Randomized Trial for Efficacy and Safety of Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy for the Treatment of Uterine Myoma or Adenomyosis

Role of Dienogest in the Treatment of Patients with Symptomatic Adenomyosis

 

Levonorgestrel-releasing Intrauterine System Compared to Low Dose Combined Oral Contraceptive Pills for Treatment of Adenomyosis: A Randomized Controlled Trial

Randomized Controlled Study of Different Pain Scores in Single-Port Access (SPA) Laparoscopic Hysterectomy Versus Conventional Laparoscopic Hysterectomy

Use of Oxytocin in MRI-HIFU Treatment

 

Conclusion:

DiseaseLandscape Insights (DLI) helps industry participants create and carry out workable diagnosis and treatment programs to stop and manage Adenomyosis. Furthermore, due to increased awareness and anticipated epidemics, there is a growing need for diagnostic instruments, clinical assessments, and adenomyosis surgery. DiseaseLandscape Insights (DLI) gives important players in the treatment product manufacturing process the information they need. Market participants find it simple to plan and execute clinical trials for novel medications and pharmaceuticals, patient recruitment strategies, and regulatory compliance with the help of DiseaseLandscape Insights. This helps companies find sources for raw materials, learn about contract manufacturing groups, carry out focused R&D, and maintain compliance with the law.  Overall, DLI helps all important parties establish a more solid base of operations in Adenomyosis.

SUMMARY
VishalSawant
Vishal SawantBusiness Development
vishal@diseaselandscape.com

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