Vulvovaginal Candidiasis

Vulvovaginal Candidiasis (VVC) is an infectious disease, also known as ‘Vaginal thrush’, ‘monilia’, and vulvovaginal candidosis. VVC is usually caused by the yeast species Candida albicans, an infection of vagina associated with itchy rash of the vulva. Common symptoms include itching, soreness or burning discomfort in the vagina and vulva, heavy white curd-like vaginal discharge and bright red rash affecting inner and outer parts of the vulva, sometimes spreading widely in the groin to include pubic areas, inguinal areas and thighs.

As reported in many epidemiology based studies, the prevalence of VVC is highest among women in their reproductive years: 55 percent of female university students report having had at least one healthcare provider-diagnosed episode by age 25 years, 29 to 49 percent of premenopausal women report having had at least one lifetime episode, and 9 percent of women report having had four or more infections in a 12-month period (i.e., recurrent vulvovaginal candidiasis [RVVC]). In women with an initial infection, the probability of RVVC was 10 percent by age 25 years, and 25 percent by age 50 years.

Generic drugs are dominating the current therapeutic market for vaginal disease. Diflucan (fluconazole), a highly selective small molecule inhibitor of fungal cytochrome P450 C-14 alpha demethylase (CYP51) from Pfizer is the top-selling medication in the market. The major companies focused on the research and development of therapies for Vulvovaginal Candidiasis are Pfizer, Medinova, Bayer, Ferrer, Cidara Therapeutics, Scynexis, Viamet Pharmaceuticals and Matinas BioPharma. The pipeline drugs such as Arasertaconazole, CD101 Topical, SCY-078, and VT-1161 are few mid stage emerging therapies being evaluated for the treatment of VVC.

In a most recent event in January 2017, Cidara Therapeutics completed enrollment in phase 2 RADIANT trial evaluating novel antifungal CD101 topical in vulvovaginal candidiasis. Ferrer Internacional S.A. is also ready for the Phase III clinical trial development for the treatment of vulvovaginal candidiasis. There are many aspects that remain to be elucidated regarding the disease pathogenesis and clinical outcomes. The management of the disease is still a clinical challenge for scientific community due to unexplained aspects of the disease. There is a significant unmet medical need in the field of effective treatments with positive safety profile for better clinical outcomes.

 

Insight by:
Yuktie
Associate Analyst

DelveInsight is a leading Business Consulting and Market Research Firm. We help our clients to find answers relevant to their business, facilitating their decision-making. DelveInsight also serves as a knowledge partner for business strategy and market research. We provide comprehensive analytical reports across various therapeutic indications. DelveInsight has a database of 3000+ high-quality analytical reports.

Colony Stimulating Factor 1 Receptor (CSF1R): A key regulator of myeloid lineage cells

Colony Stimulating Factor 1 Receptor (CSF1R) is a cell-surface protein encoded, in humans, by the CSF1R gene. CSF1R is also known as macrophage colony-stimulating factor receptor (M-CSFR), and CD115 (Cluster of Differentiation 115), and is encoded by CSF1R gene which controls the production, differentiation, and function of macrophages. This receptor mediates most- if not all- of the biological effects of this cytokine. Clinically, mutations in CSF1R are associated with various types of leukemia such as chronic myelomonocytic leukemia and type M4 acute myeloblastic leukemia. Also, increased levels of CSF1R1 are found in microglia in Alzheimer’s disease and after brain injuries. It is also believed to have a role in the process of mammary gland carcinogenesis. Mutations in the tyrosine kinase domain have been associated with hereditary diffuse leukoencephalopathy with spheroids.

A study conducted by Jian Luo et al. demonstrates that the systemic administration of human recombinant CSF1 ameliorates memory deficits in a transgenic mouse model of Alzheimer’s disease. Colony Stimulating Factors (CSF) has also role in inflammatory responses. It helps in synergizing the attracting capabilities of chemokines and of inducing the accumulation and/or activation key components of inflammatory responses. Researchers are developing various therapeutic candidates in the form of small molecule as well as monoclonal antibodies mainly for the treatment of cancers and inflammatory diseases. These drugs are being evaluated as monotherapy and/or combination therapy.

Major companies involved in the development of the CSF1R antagonists includes Eli Lilly and Company, Hoffmann-La Roche Novartis Pharmaceuticals, Pfizer, Daiichi Sankyo, Amgen and many other. Plexxikon (A member of the Daiichi Sankyo Group) has three products in its pipeline, including Pexidartinib in Phase III stage of development for the treatment of Tenosynovial Giant Cell Tumor (TGCT), Pigmented villonodular synovitis (PVNS), Giant cell tumors of the tendon sheath (GCT-TS), Glioblastoma and Melanoma. PLX7486 and PLX 73086 are currently in Phase I stage of development for the treatment of Pancreatic and Solid Tumors and Tenosynovial Giant Cell Tumor (TGCT), respectively. BCI Pharma has its two therapeutic candidates (Dual flt3-CSF1R kinase inhibitor and Selective CSF1R kinase inhibitor) in pipeline, currently in discovery stage of development.

Pexidartinib (Plexxikon), AB 1010 (AB Science SA), FPA-008 (Five Prime Therapeutics, Inc.) and SB1518 (CTI BioPharma) have been granted Orphan Drug Designation (ODD) by the US Food and Drug Administration (USFDA) and/or the European Medicines Agency (EMA) for different indications. More than 10 different types of collaboration agreement between different pharmaceutical and biotechnology companies and research institutes for the development of CSF1R antagonist makes it an interesting and promising target mainly for the Immuno-Oncology drugs, and has provided hope to meet the challenges of treating these diseases.

Insight by:
Mohammad Rizwan
Associate Analyst

DelveInsight is a leading Business Consulting and Market Research Firm. We help our clients to find answers relevant to their business, facilitating their decision-making. DelveInsight also serves as a knowledge partner for business strategy and market research. We provide comprehensive analytical reports across various therapeutic indications. DelveInsight has a database of 3000+ high-quality analytical reports.

Diminishing pipeline of Galectin Inhibitors

Galectin belongs to the family of lectins that has the ability to bind to β-galactose, and binds to glycoproteins that are present on the extracellular as well as intracellular surface. Galectins have varied roles in many cellular functions like adhesion, migration, polarity, chemotaxis, proliferation, apoptosis and differentiation, with 15 mammalian galectins being identified till now. Out of all types of galectins, Galectin-1 and Galectin-3 plays an important role in progression of cancer and its metastasis.

There are drugs being developed for the inhibition of Galectins- particularly Galectin-1 and Galectin-3- where chemically modified heparin derivatives like N-acetylated heparin derivatives act on Galectin-3 and inhibits its action in diseases like cancer and solid tumors. Currently, Galectin therapeutics is developing galectin inhibitors that are carbohydrate based drug compounds. Its drug candidate, GR-MD-02, is in its mid stage of development mainly for the treatment of fibrotic liver disease associated with fatty liver disease. Though galectins are becoming the major cause of various diseases like chronic kidney disease, hepatic fibrosis, inflammation, but there are very few companies that are in progress of developing galectin inhibitors.

The pipeline for galectin inhibitors is decreasing rapidly due to very less success in studies being conducted. Earlier there were around 16 drugs that were in progress of development for various indications, but only some of them remained active. Though there are some companies like Galectin therapeutics, Bristol Myers Squibb, Glycomantra and Cancure who are in progress of developing inhibitors of Galectin, but mostly drugs like GCS 100, OTX008 which were earlier being developed got discontinued and inactive when the respective company failed to gain any progress in mid stage development. With current scenario of Galectin inhibitors, there are only few drugs in pipeline of galectin inhibitors that has potential of being marketed and developed further, leaving a great unmet need in terms of inhibiting this target for controlling many diseases.

Insight by:
Neha Chaudhary
Associate Analyst
DelveInsight is a leading Business Consulting and Market Research Firm. We help our clients to find answers relevant to their business, facilitating their decision-making. DelveInsight also serves as a knowledge partner for business strategy and market research. We provide comprehensive analytical reports across various therapeutic indications. DelveInsight has a database of 3000+ high-quality analytical reports.

TRAIL Receptor Agonists: Emerging target therapies against Cancer

 

Tumor necrosis factor (TNF)-related apoptosis-inducing ligand (TRAIL), also known as Apo-2 ligand (Apo2L) is a type II trans membrane protein belonging to the Tumor Necrosis Factor (TNF) superfamily that are widely expressed on the surface of Natural Killer (NK) and T cells, macrophages and dendrite cells.

These proteins bind to the Death receptor 4 (DR4) and 5 (DR5), and trigger apoptosis in tumor cells. Discovery of TRAIL proteins and its receptors came as a promising therapeutic approach in anti-cancer target therapies because of its unique quality of binding to variety of tumor cells while sparing the normal vital cells of the body. Unfortunately, first generation of TRAIL agonist didn’t match the expected clinical efficacy as most tumors were resistant to the apoptosis induced by TRAIL proteins. Later, it was identified that poor clinical efficacy of these agents was due to their insufficient agonist activity.

Since then, vigorous research is going on for developing novel TRAIL-Receptor targeting agents with increased agonistic activity. Currently, many second generation therapies targeting TRAIL receptor are in development. For instance, hvTRA, a novel second generation TRAIL agonist has demonstrated an efficient and sustained reduction in melanoma cell growth in cell lines and xenograft models. Recently, a research demonstrated that TRAIL-coated lipid-nanoparticles improves TRAIL cytotoxic ability. Combination of TRAIL agonist along with other anti-cancer drugs has the potential to overcome resistance and can provide greater anti-tumor activity. For example, Choline kinase inhibitors in combination with TRAIL enhances the TRAIL-induced apoptosis and can overcome the resistance.

Although, the combination approach and second generation TRAIL agonist are mostly in early clinical developmental stage, but evidences based on various research work indicates the emergence of promising TRAIL agonist in near future. Companies like Apogenix, Genmab, MedImmune etc., are developing drug candidates which are likely to enter into clinical studies in next few years.

Insight by:
Jyoti Kumari
Associate Analyst

DelveInsight is a leading Business Consulting and Market Research Firm. We help our clients to find answers relevant to their business, facilitating their decision-making. DelveInsight also serves as a knowledge partner for business strategy and market research. We provide comprehensive analytical reports across various therapeutic indications. DelveInsight has a database of 3000+ high-quality analytical reports.

Familial Adenomatous Polyposis (FAP): A cataclysmic genetic mutation

Familial Adenomatous Polyposis (FAP) results from a germ line mutation in the Adenomatous Polyposis Coli (APC) gene. FAP is an autosomal dominantly inherited disorder, which is characterized by the formation of numerous colorectal adenomatous polyps and leads to the cancer of the large intestine (colon) and rectum. The mutation in the APC affects the ability of the cell to maintain normal growth and function. Cell overgrowth resulting from mutations causes complications in the form of colon and rectum cancer.

The incidence of FAP, as reported in many epidemiology based reports varies from 1 in 7,000 to 1 in 22,000 individuals. About 30% of people with FAP do not have any family history of the condition; they have a de novo (new) mutation in the APC gene. Males and Females are equally affected (1:1) by FAP and reported in all races. The average age of onset of polyposis in FAP is 16 (range 7-36 years) years, whereas by age 35 years, 95% of individuals with FAP have polyps; without colectomy, colon cancer is unavoidable.

In January 2017, Marina Biotech was granted European claims covering Bacteria Mediated Gene Silencing (EP 08768475.9, European Patent 2173875), which claims the company’s tkRNAi technology being utilized in its CEQ508 program that is being developed to treat FAP. Previously in 2015, the U.S. Food and Drug Administration (FDA) have granted Fast Track designation to CEQ508, for the treatment of FAP. There are around 7 drugs in pipeline being investigated in different stage of development for FAP. A few projects for FAP, such as development of Ursodeoxycholic by Aptalis have been put on hold (dormant) due to some undisclosed reasons. Whereas, the development of Exisulind by OSI Pharmaceuticals and Valproic acid by Onxeo SA has now been discontinued.

Despite rigorous investigation by researchers to develop a reliable therapeutic to treat patients with FAP, there remains significant unmet medical needs. The long-term and frequent assessment and interventions even after radical colectomy, represent one of the major unmet medical needs. Modest Efficacy measured by reduction in the number (and size) of polyps demonstrated with current therapies is also a matter of concern for the researchers that needs to be addressed soon.

Insight by:
Mohammad Rizwan
Associate Analyst

DelveInsight is a leading Business Consulting and Market Research Firm. We help our clients to find answers relevant to their business, facilitating their decision-making. DelveInsight also serves as a knowledge partner for business strategy and market research. We provide comprehensive analytical reports across various therapeutic indications. DelveInsight has a database of 3000+ high-quality analytical reports.

Chronic Kidney Disease (CKD): Complex Debilitating Condition

Chronic Kidney Disease (CKD) is a major global public health problem which progresses slowly and get worse over time. It is the 8th leading cause of death in United States, and is characterized by kidney damage and reduced kidney function. According to National Kidney Foundation, approximately 26 millions of adults are living with Chronic Kidney Disease and millions of others are at increased risk of developing Chronic Kidney Disease. More than 20 million patients suffer from moderate (stages 3 or 4) or severe (stage 5) forms of CKD. This condition is very common among people aged 70 years or older.

Prevalence of CKD is increasing with an increase in prevalence of diabetes, hypertension, and cardiovascular disease in aging population. Several conditions such as diabetes, high blood pressure, Polycystic Kidney Disease, Polynephrities, Glomerulonephritis, Malformation, and Vasicourorectal conditions leads to development of Chronic Kidney Disease. Recently, researchers found that patients with Chronic Kidney Disease are at high risk of developing urinary tract, viral-related, digestive and breast cancers. Patients experience cognitive impairment, dementia, sleep disturbance, pain, emotional and physical dysfunction. It also increases the chances of developing cardiovascular disease and bone-metabolism disorders.

Treatment of Chronic kidney disease mainly focuses on controlling pathologic manifestations of Chronic Kidney Disease such as Hyperphosphatemia, Hypocalcemia, cardiovascular complications and Anemia. Ravaldee was approved in 2016 by USFDA for the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease. Auryxia was approved for the treatment of hyperphosphatemia in patients with chronic kidney disease. Major players such as Celgene Corporation, Novartis Pharmaceuticals, Hoffmann-La Roche, Astellas Pharma and Boehringer Ingelheim are developing drugs which are expected to be launch in upcoming years.

Several factors such as increasing prevalence of Chronic Kidney Disease worldwide, increasing aging population, increasing number of patients with diabetes, rising demand for advanced diagnostics and therapeutics improvement in healthcare infrastructure, might help in launch of emerging therapies in coming years. This provides hope of stimulating market growth of Chronic Kidney Disease in the coming years.

Insight by:
Diksha Wadhwa
Associate Analyst

 DelveInsight is a leading Business Consulting and Market Research Firm. We help our clients to find answers relevant to their business, facilitating their decision-making. DelveInsight also serves as a knowledge partner for business strategy and market research. We provide comprehensive analytical reports across various therapeutic indications. DelveInsight has a database of 3000+ high-quality analytical reports

Cushing’s Syndrome: Cortisol Plethora

Cushing’s syndrome, also known as hypercortisolism, is an endocrine disorder that occurs due to abnormally high levels of the hormone cortisol production in the body. Cushing’s syndrome is broadly classified as endogenous and exogenous Cushing’s syndrome. Exogenous Cushing’s syndrome occurs due to excessive use of medications like glucocorticosteroids while endogenous cushing syndrome may be due to ACTH dependent causes or ACTH independent causes.

The incidence is around 1.2-1.7 per million per year for Cushing’s disease (CD), 0.6 per million per year for adrenal adenomas and 0.2 per million per year for adrenal carcinomas. All the other types of CS are very rare. Endogenous CS is more common in women. The most common types are ACTH-dependent CS (80-85%), of which CD constitutes 80% of cases and the ACTH-secreting pituitary adenomas and ectopic ACTH constitutes the rest 20% cases, whereas corticotropin-releasing hormone is diagnosed as a cause in around less than<1 cases.

Cushing syndrome is a rare disease with a prevalence of around 39 people per million. A total of 40,398 cases of Cushing’s Syndrome were diagnosed in 2015 and the total number of Cushing’s syndrome cases is expected to reach 41,683 in 2023 in the 7 major markets-United States, EU5 (France, Germany, Italy, Spain and United Kingdom) and Japan.

Treatment of Cushing’s syndrome depends on whether it is exogenous or endogenous, and the treatment can be broadly given as line of treatments.  In first line of treatment, trans-sphenoidal surgery is considered in cases where Cushing’s syndrome onset was seen due to underlying tumor or pituitary stimulation- which causes ACTH production leading to Cushing’s syndrome. Glucocorticoid replacement and discontinuation is also considered as possible treatment options in case of exogenous Cushing’s syndrome. In second line of treatment, radiotherapy, adrenalectomy and drug therapies are considered. The medical therapy for Cushing’s syndrome includes drug therapies- which are broadly classified into Steroidogenesis inhibitors, Pituitary-directed drugs and combination therapies.

Insight By:
Tejaswini Reddy
Associate Analyst

DelveInsight is a leading Business Consulting and Market Research Firm. We help our clients to find answers relevant to their business, facilitating their decision-making. DelveInsight also serves as a knowledge partner for business strategy and market research. We provide comprehensive analytical reports across various therapeutic indications. DelveInsight has a database of 3000+ high-quality analytical reports.

Statistical Insight on Some Common Cancers

Cancer is the leading cause of morbidity and mortality worldwide and one in every seven deaths is due to cancer. It has the worst incidence and mortality statistics. According to the International Agency for Research on Cancer (IARC), an estimated 14.1 million new cases of cancer occur with mortality of 8.2 million worldwide. There are more than 100 types of cancer. Here, in this article, statistical insight is shed on few of the major cancers viz.  lung cancer, breast cancer, colorectal cancer and prostate cancer.

  • Lung cancer is one of the wide spread cancer, World Health Organization (WHO) has reported that there were an estimated 1.8 million new cases for lung cancer in 2012 and 1.59 million estimated deaths globally. As reported by the American Cancer Society, the estimated new cases for lung cancer in 2017 would be around 222,500 and the estimated mortality would be around 155,870 in US alone. There are approximately 52 drugs approved for the treatment of Non-Small Cell Lung Cancer, showing an increased effort towards treating lung cancer.
  • Breast Cancer is also one of the most common cancers, and WHO has reported that there were estimated 1.67 million new cases in 2012 and 522,000 million estimated deaths globally. As reported by the American Cancer Society, the estimated new cases for invasive breast cancer and in situ breast cancer in 2017 would be around 252,710 and 63,410 respectively and the estimated mortality would be around 40,610 in US alone. There are approximately 63 drugs approved for the treatment of breast cancer, and a vast pipeline aiming to decrease the mortality associated with this type.
  • The statistics of WHO in terms of colorectal cancer show that globally there were around 1.36 million new cases for colorectal cancer in 2012 and 694,000 estimated deaths. As reported by the American Cancer Society, the estimated new cases in 2014 were around 136,830 and the estimated mortality was around 50,310 in US alone.
  • Prostate Cancer has also become a concern in terms of mortality and morbidity, with WHO reporting that globally there would be estimated 1.09 million new cases for prostate cancer in 2012 and 307,000 estimated deaths. The American Cancer Society also estimates new cases for colorectal cancer in 2017 to be around 161,360 and the estimated mortality to be around 26,730 in US alone. There are approximately 28 drugs approved for the treatment of prostate cancer, showing immense R&D interest.

Insight by:
Yuktie
Associate Analyst

DelveInsight is a leading Business Consulting and Market Research Firm. We help our clients to find answers relevant to their business and facilitating their decision-making. DelveInsight also serves as a knowledge partner for business strategy and market research. We provide comprehensive analytical reports across various therapeutical indications. Delveinsight has a database of 3000+ high-quality analytical reports

Follicle Stimulating Hormone in Endometriosis

Follicle Stimulating Hormone (FSH) is a glycoprotein secreted by the anterior pituitary, necessary for mammalian reproduction. FSH helps in development and maturation of gonads at puberty, and the hormone acts by binding to FSH receptor. Endometriosis is an extra growth of endometrial tissues in the abdominal cavity. As Follicle-stimulating hormone receptor (FSHR) is present on endothelial cells of blood vessels and endometrial glands of the proliferative and secretory endometrium, FSH therapy can be very helpful in curing endometriosis.

Some of the therapies for endometriosis treatment include non-steroidal anti-inflammatory drugs (NSAIDs), progestins (medroxyprogesterone), a combination of estrogens and progestins, synthetic androgens (danazol), and gonadotropin-releasing hormone analogues with or without hormone replacement therapy and many more. Other therapies include transcutaneous electrical nerve stimulation (TENS) may be effective for the treatment of women with deep endometriosis.

For treating endometriosis, various hormonal therapies are in the market, by different companies like Teva Pharmaceuticals, Healthcare Pharmaceuticals, and Bayer. Teva has launched a drug named as Sprintec; Dienogest is marketed by Bayer HealthCare Pharmaceuticals and is considered as long term treatment for Endometriosis when administered properly.

Bayer is also in progress of developing 4 more therapies for endometriosis, out of which one relates to FSH therapy. Other companies like Abbvie (Elagolix- Phase III) and Takeda Pharmaceuticals (TAK-385; relugolix- Phase IIb) are in progress of developing appropriate hormone therapy or drug for treating Endometriosis. The field for endometriosis medicinal therapies is progressing rapidly and with the ongoing development of drugs and therapies for its treatment, the market for endometriosis treatment is on the verge of flourishing very soon in a very positive manner.

Insight by:

Neha Chaudhary
Associate Analyst
DelveInsight

DelveInsight is a leading Business Consulting and Market Research Firm. We help our clients to find answers relevant to their business and facilitating their decision-making. DelveInsight also serves as a knowledge partner for business strategy and market research. We provide comprehensive analytical reports across various therapeutical indications. Delveinsight has a database of 3000+ high-quality analytical reports

Cytomegalovirus (CMV) infection: Market Outlook

Cytomegalovirus (CMV) infection is a major Herpes virus infection, which is the leading cause of morbidity and mortality worldwide among congenitally infected newborns, HIV/AIDS patients and transplant recipients. According to Centers for Disease Control and Prevention, approximately 80,000 cases of CMV infections are found in United States and Europe. High prevalence of Cytomegalovirus (CMV) infection is found in developing countries and in areas of lower socioeconomic conditions.

In terms of treatment scenario, several drugs such as Valganciclovir (Valcyte), Foscarnet (Foscavir), Cidofovir (Vistide) are approved and marketed. Valtrex and Cytotect are approved for Cytomegalovirus (CMV) infection, and Valganciclovir or Ganciclovir are used as first-line treatment. Additionally, Foscavir is used as second-line therapy for patients who do not respond to Ganciclovir treatment. Lastly, Cidofovir is used as an alternative therapy among those patients who do not respond to Ganciclovir and Foscarnet treatment. The current market of CMV infection is weak due to presence of several generics, such as Ganciclovir and Foscarnet, and patent expiry of marketed drugs.

Due to increasing awareness related to herpes virus infections, improvement in healthcare infrastructure, increase in number of patients undergoing transplantation, government support and increase in prevalence of CMV infection, there is a hope for the Global market size of CMV infection to increase from USD 698.3 Million in 2013 to USD 1,210.4 Million by end of year 2023. Prophylactic and therapeutic market size is expected to grow at a CAGR of 6.57% and 3.44% respectively, during 2013-2023. Major players such as Merck & Co., Chimerix Inc, Astellas Pharma and CSL Behring are developing drugs which are expected to be launched in coming years. These emerging therapies have better efficacy and safety profiles as compared to the existing therapies. Launch of emerging therapies such as Letermovir and TransVax in coming years may also stimulate growth of the CMV market. Also, companies are focusing on developing drugs with novel mechanisms of action beyond DNA polymerase inhibitors, which may provide a stiff competition to the existing therapies.

Insight by:
Diksha Wadhwa
Associate Analyst

DelveInsight is a leading Business Consulting and Market Research Firm. We help our clients to find answers relevant to their business and facilitating their decision-making. DelveInsight also serves as a knowledge partner for business strategy and market research. We provide comprehensive analytical reports across various therapeutical indications. Delveinsight has a database of 3000+ high-quality analytical reports.