Category: Articles

Urinary Tract Infections (UTIs)– How is it affecting the Globe?

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Urinary tract infections (UTIs) are caused by microbes, such as bacteria, by overcoming the body’s immune defenses in the urinary tract. They can affect different parts of the urinary tract which includes the kidneys, bladder, tubes that run between them and the tube from the bladder out of the body. The predominant group of organisms responsible for UTI is mostly the Enterobacteriaceae, especially E. coli, which cause around 80–85% of urinary tract infections and accounts for 80-85% of the total isolate. The infection affects both genders; women are the most vulnerable due to their anatomy and reproductive physiology. Most of the UTIs are not serious but if the infection reaches the kidneys, serious illness and even death can occur. Ten percent of women >18 years of age report at least one suspected UTI every 12 months, but the majority of cases occur in women with a history of 2 or more previous UTIs. Approximately 20% to 40% of women with an initial UTI develop recurrent UTI. UTIs are among the most common conditions encountered in primary care, hospitals, and extended care facilities.

Ten percent of women >18 years of age report at least one suspected UTI every 12 months, but the majority of cases occur in women with a history of 2 or more previous UTIs. Approximately 20% to 40% of women with an initial UTI develop recurrent UTI. UTIs are among the most common conditions encountered in primary care, hospitals, and extended care facilities. According to global estimates, UTIs results in as many as 8.3 million visits to outpatient clinics, 1 million visits to emergency departments, and 100,000 hospitalizations annually. The prevalence increases with age, catheterization, sexual activity, menopause and prostate problems. The estimate shows that one-third of adult women are diagnosed with UTI before 24 years. They occur most frequently between the ages of 16 and 35 years, with 10% of women getting an infection yearly and 60% having an infection at some point in their lives. Recurrences are common, with nearly half of the previously affected people getting a second infection within a year.

Therapeutic research and development activities are encouraging, seeing the involvement of various companies and research institutes in this field. A majority of the pipeline drugs are in early stage (pre-clinical and discovery) of development. Companies like Achaogen, Tetraphase Pharmaceuticals and Merck are developing emerging Phase III therapies for UTIs. Various companies have also received Fast Track designations along with Qualified Infectious Disease Product (QIDP) for their pipeline drugs from regulatory authorities. This impressive spread of clinical development for UTI promises good treatment options in the near future.

Insight by:
Sadaf Javed
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.

Vitiligo – High Unmet Need Indeed!

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Vitiligo is a common acquired, idiopathic depigmentation disorder which affects at least 1% to 2% of the population irrespective of sex, race, or age. The onset of this disease occurs between the ages of 10 and 30.  In this condition, patients progressively lose their skin color, mostly in patches. The patches are more visible in people with darker skin. Vitiligo often causes social awkwardness and disturbs the social life of a person.

Instead of worldwide occurrence of this disease, Vitiligo remains one of the most untouched areas in the medical history. There is huge unmet need for this indication as only few treatment options are available for patients with limited efficacy. Vitiligo serves as a gateway for other pigemetary disorders.  Exploring this indication not only opens more treatment options for Vitiligo, but also leads to better understanding of pigmentary disorders.  The exact cause of the disease is still under debate. There are over 30 genes identified to date which might be related to disease onset and development.

In last few years, Researchers and Pharma Players have started focusing on this indication which gives some hope to millions of patients who have been remained unrecognized for years. The driving force behind the increased research activity is the correlation of immune response during melanoma with Vitiligo. Melanoma is the extreme reverse case of the same autoimmune response. The pipeline for Vitilgo is not so strong, with less than 10 products under development. But in coming years, Vitiligo treatment paradigm may take drastic shift due to products which have advanced to clinical studies. Clinuvel Pharmaceuticals and Aclaris Therapeutics are the leaders for this indication with two pipeline products each. Apart from them, many other Pharma companies, researchers from renowned Universities and Institutions such as University of Massachusetts, University of Medicine and Dentistry of New Jersey, University Hospital, Bordeaux etc. are actively exploring this area for potential therapeutic candidates.

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.

Progressive Supranuclear Palsy– A neurodegenerative disorder

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Steele-Richardson-Olszewski syndrome, commonly known as Progressive Supranuclear Palsy, is an uncommon brain disorder that causes serious problems for patients in terms of walking, balance and eye movements. The disorder arises as a result of deterioration of cells in areas of the brain that control body movement and thinking. PSP worsens over time and can lead to life-threatening complications, such as pneumonia and difficulty in swallowing. The disease also damages certain parts of the brain above nerve cell clusters called nuclei (supranuclear), which control eye movements. Thus, individuals diagnosed with PSP experience a classic symptom i.e. blurring of the vision. The US epidemiological review says that only about three to six in every 100,000 people worldwide, or approximately 20,000 Americans, have PSP—making it less common than Parkinson’s disease. Symptoms of PSP occur on an average after the age of 60, but may occur earlier in some cases. The male population is more affected as compared to the female population.

Recent research work conducted demonstrated that deteriorating brain cells of people with Progressive Supranuclear Palsy have abnormal amounts of a protein called Tau. A positron emission tomography (PET) scan is recommended that can help in diagnosing early signs of brain abnormalities that may not appear on Magnetic Resonance Imaging (MRI). Although there is no cure for Progressive Supranuclear Palsy, but treatments are available to help ease symptoms of the disorder including Parkinson’s disease medications, eyeglasses with bifocal or prism lenses, speech and swallowing evaluations, and physical therapy and occupational therapy.

Progressive Supranuclear Palsy does not have a robust pipeline as only a few active products are under development but have the potential to boost the future market since majority of the products are in mid-stage (Phase II) and early stage (Phase I) of development. AB Science is developing a drug in the Phase III stage which is an emerging therapy for this indication. Another pipeline product being developed by Biogen utilizes induced Pluripotent Stem Cell (iPSC) technology acquired from iPierian. Some companies are also working in collaboration with other institutional and non-institutional organizations. Most of the drugs have been granted Orphan drug and Fast-track drug designations by different regulatory bodies, providing companies added incentive to introduce a product into the market.

Insight by:
Ayushi Sinha
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.

Notizia

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AstraZeneca’s new benralizumab helps severe asthma patients cut back on steroids

AstraZeneca’s respiratory candidate benralizumab can help some severe asthma patients cut down on—or even stop—the unsavory steroid pills they use daily to stave off attacks, a new study showed. Dubbed Zonda, the phase 3 trial found that patients taking benralizumab were more than four times more likely to reduce oral steroid use than those who received a placebo. And 52% of eligible patients were able to completely discontinue the pills, investigators reported, while still seeing reductions in asthma exacerbations. In addition to cutting back on steroids, patients on benralizumab saw a 70% reduction in the rate of exacerbations compared to those on placebo. The respiratory biologic was associated with a 93% reduction in exacerbations that required emergency room visits. AZ unveiled the new data at the American Thoracic Society conference in Washington, D.C. The findings were simultaneously published in the New England Journal of Medicine. Benralizumab has an FDA action date during the fourth quarter of 2017. Until then, AZ is preparing to be ready in the beginning of next year to launch this product.

Sanofi, Regeneron set Kevzara up for tough RA turf battle with $39K list price

Sanofi and Regeneron just added another building block to a nascent immunology franchise expected to bring in $5 billion or more by 2022. But to get there, their new Kevzara will have to go up against a host of other rheumatoid arthritis meds already on the market—and a few still on their way. One way Kevzara can do that? A lower price, according to doctors surveyed by GlobalData analysts. And Kevzara will have a list price of $39,000 per year, the companies say, 30% lower than the two most widely used TNF-alpha drugs, which will be among its chief competitors. Kevzara’s nod comes more than six months after the FDA turned back the drug on manufacturing problems at a Sanofi plant where drugs are filled and finished. The two companies worked with the agency to fix them, and after a successful inspection earlier this year, the Kevzara approval was widely expected. Kevzara (sarilumab) is Sanofi and Regeneron’s second entry into the immunology field, after the approval of Dupixent, a treatment for severe eczema, in March.

Novo Nordisk preps Saxenda sales drive in Latin America after its ‘phenomenal’ Q1

Novo Nordisk, facing more pressure than ever in the U.S., is revving up for a push into Latin America with its obesity drug Saxenda, hoping to put already-promising sales into a higher gear. The drug maker plans to expand its capacity in Latin America and step up its efforts in the obesity market there. The Danish drugmaker sees a particular opportunity in Mexico. Saxenda generated sales of $81 million for the first quarter, including $10.5 million in Latin America. Novo first launched Saxenda in 2015 in an effort to diversify beyond diabetes, a business that has had trouble growing lately due to competitive pressures in the U.S. The Danish drugmaker rolled its obesity shot out at $1,000 per month and said it has “blockbuster potential.” In Latin America, Doustdar said he believes Novo can expand the entire obesity market as well as capture a share of it with Saxenda.

European countries offer goodies in bid to win EMA after Brexit

Even before European officials present the groundwork for relocating the bloc’s drug regulator, a fight has emerged between countries vying for the economic lift and status that come with hosting the authority, using perks like child care as ammo. Some 20 countries in Europe hope to host the European Medicines Agency after the U.K.’s vote to leave the union last summer. And even though the EU hasn’t announced its official criteria for the move, the countries aren’t hesitating to make their case by showcasing local lifestyle perks and more. Countries in Europe are offering language lessons, local scenery and child care as they push to win the EMA, according to the news service. They’re seeking to attract an agency that could bring an economic lift worth an estimated €1 billion and employs about 900 experts.

Cutaneous Squamous Cell Carcinoma – A promising pipeline

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Non-melanoma skin cancer is a group of cancers of the skin and is broadly classified into Basal Cell Carcinoma (BCC) and Squamous Cell Carcinoma (SCC). It has the greatest prevalence in the United States, which can be seen through statistics which show that basal cell carcinoma accounts for 80% while Squamous cell carcinoma accounts for 20% of the non-melanoma cancers. Cutaneous Squamous Cell Carcinoma, also known as cSCC, arises from malignant proliferation of the keratinocytes of the epidermis and are associated with a substantial risk of metastasis. The incidence of cSCC has increased over the past 20 years globally and is associated with higher levels of sun exposure or the use of tanning beds. Different sub-types of cSCC occur rarely but are linked with more aggressive behavior.

The occurrence of shallow ulcer with elevated margins covered by a plaque, crusting, surface changes such as deep ulceration and pink cutaneous nodule are some of the signs and symptoms of Cutaneous Squamous Cell Carcinoma, which can also be predicted in unaffected people by marking the presence of actinic keratoses (AKs) on the sun-damaged skin. The disease mostly affects the male population and increases dramatically with age. The risk of Cutaneous Squamous Cell Carcinoma pathogenesis is increased due to immunosuppression, human papillomavirus infection, exposure to ultraviolet radiations, ionizing radiation, and chemical carcinogens. Patients who have undergone organ transplantation are 100 times more likely to develop cutaneous squamous cell carcinoma. If diagnosed early, it provides the best opportunity to cure cSCC.

The treatment is indicated since the progression of the tumor that may lead to local tissue destruction or metastasis in significant morbidity or death. Regular use of sunscreen reduces the risk of developing squamous cell carcinoma by about 40 percent. There are currently no products in the late-stage i.e. Phase III and a majority of the products are in the mid-stage (Phase II trials). Genentech is involved in the development of a drug which is in Phase II and is a combination product. Regeneron Pharmaceuticals is developing another Phase II product in collaboration with Sanofi using its proprietary technology. Other technologies being used for the therapeutic development of Cutaneous Squamous Cell Carcinoma include VDAC/HK2 Modulators technology and Immune-chemotherapy technology. With proper monitoring of the signs and symptoms, it will become easier to anticipate the diagnosis that will help in designing a proper treatment strategy.

Insight by:
Ayushi Sinha
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.

Insight on Interstitial Cystitis- The Bladder Pain Syndrome

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Interstitial cystitis (IC) is a medical condition that leads to painful bladder syndrome as it is a chronic disease that results in recurring discomfort or pain in the bladder and pelvic region. This condition can be of two types: Non-Ulcerative (90% of IC cases) and Ulcerative (5%-10% of IC cases). The exact cause of interstitial cystitis is unknown, but researchers believe that many factors are at play which may contribute to the development of the condition like Bladder trauma, Bladder overdistention, Pelvic floor muscle dysfunction, Bacterial infection (cystitis), etc. Damage to the bladder wall allows particles in the urine, such as potassium, to leak into the bladder lining. The diagnosis of interstitial cystitis can be challenging as the patient poses a variety of symptoms that may be difficult to diagnose and may also lead to misdiagnosis, underdiagnosis and delayed diagnosis.

In terms of prevalence of this condition, DelveInsight has analyzed that United States is the one to have the highest incident of probable IC Cases, and that out of the total, 90% of IC cases occur in women and only 10% occur in men; however, this can also be attributed to misdiagnosis. Coming to the treatment scenario, the market for Interstitial Cystitis is mainly driven by Elmiron which is the only approved Oral drug by FDA specifically for IC. Other treatment options include bladder instillations like Cystistat, Hyacyst, Uracyst, etc which are not approved by FDA. NSAIDs, Anti-depressants, anti-histamines, etc are used for controlling symptoms like pain.

The overall market of IC in 7 major markets for Elmiron and bladder instillations was around USD 261.3 Millions of which major share is of U.S. Apart from the marketed drugs, the ones in pipeline for IC are also a source of hope for increasing efficacy in treatment for IC, and as a source of expectation to see the market grow at a steady rate. Till yet, there is no cure for interstitial cystitis, and treatment options only help relieve the symptoms of bladder pain, urgency, and frequency. Thus, there is a need for better treatment option and combination therapies to emerge for better and sustained approach towards managing this condition across the globe.

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

Hemophilia: A Lifelong Genetic Disorder

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Hemophilia is a rare congenital disorder which impairs the ability of the blood to clot properly. This disorder is characterized by the bleeding into the joints which leads to swelling and pain or tightness in the joints. It also causes bleeding into the skin which results in building up of blood in hematoma. Studies have reflected that hemophilia is found to be more common in males in contrast to females. Hemophilia is caused due to the genetic mutation in the DNA sequence of the genes responsible for major role in the blood clotting process. Based on the deficiency of coagulating factor hemophilia is classified into three different types viz. Hemophilia A, Hemophilia B and Hemophilia C. Coming to its occurrence, high incidence rate is observed in EU 5 Market (United Kingdom, France, Germany, Spain and Italy) as compared to United States and Japan. If we talk about the types then; Hemophilia A is more prevalent as compared to Hemophilia B.

It is forecasted that Hemophilia therapeutics market in seven major markets is expected to increase to USD 13,751.6 million by the end of 2023. United States has the largest market share whereas Spain contributes the lowest market share in 2016. Hemophilia A contributes the major share of the market as compared to Hemophilia B. Several factors such as the development of novel coagulating factors, technological advancement, and advancement in diagnosis techniques are stimulating the growth of the market.

If we see the Market Scenario then the market is dominated with several recombinant proteins developed by the major players such as Baxter, Bayer, and Pfizer. BeneFIX developed by Pfizer is leading the race for Hemophilia B whereas Advate developed by Baxalta (Now Shire) is leading the race for Hemophilia A.

Approval of Idelvion developed by CSLBehring for Hemophilia B and Kovaltry developed by Bayer for Hemophilia A in March 2016 by USFDA will play a major role in stimulating the growth of the market.  Also, the lost of patents of Kogenate and Novoseven in 2014 and 2010 respectively will impact the market growth.

The pipeline of Hemophilia is robust with the involvement of novel therapies being developed by major players such as Hoffmann-La Roche, Novo Nordisk, Pfizer and Shire plc. Companies such as Biogen and Baxalta have entered into collaborations for bringing the gene therapy for Hemophilia in future. The launch of emerging therapies such as Refixia for Hemophilia B, Turoctocog alfa pegol for Hemophilia A , LR769 for Hemophilia A and Hemophilia B , Emicizumab and Damoctocog alfa pegol for Hemophilia A will further fuel the market growth. Launch of the Adynovate in Europe in 2018 for Hemophilia A which is already approved in United States and Japan as an on-demand treatment for Hemophilia will have the major impact in market.

Insight by:
Anuj Thakur
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

Urinary Incontinence: Epidemiology Insight on Leaking Bladder

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Urinary Incontinence is a multifactorial syndrome which occurs due to the failure of the storage function of the lower urinary tract and loss of bladder control resulting in leakage of urine.  Embarrassment, isolation, and depression are observed among patients with urinary incontinence. Millions of individuals worldwide are suffering from this problem, and it is most common among the old people.  It increases the chances of developing several medical conditions such as local skin irritation, rashes, and urinary infections. There are around eight types of urinary incontinence, namely, Stress Incontinence; Urge Incontinence; Overflow Incontinence; Functional Incontinence; Mixed Incontinence; Transient Incontinence; Total Incontinence; and Reflex Incontinence.

High prevalence rate is observed in EU 5 Market (United Kingdom, France, Germany, Spain and Italy) as compared to the United States and Japan. An increase in aging and obese population are major factors contributing the increase in prevalence cases of Urinary Incontinence.

The Urinary incontinence therapeutics market in seven major markets is expected to grow at a USD 7.3 billion by 2023. Among these markets, United States has the largest market share whereas Spain contributes the lowest market share in 2016. Several factors such as socio-economic factors, emerging therapies, and investments in development and research are stimulating the market growth of Urinary Incontinence.

Several tests and techniques such as cystometry, uroflowmetry, cystoscopy, electromyography, and urinalysis are used for diagnosis of urinary incontinence. Treatment of urinary incontinence is based on the use of behavioral methods such as Pelvic floor exercises and bladder training, and pharmaceutical therapies such as Anticholinergics and Alpha-Blockers are used for improving the patients’ quality of life. Different types of surgical procedures such as sling procedure and retropubic colposuspension are also used for restoring the bladder neck and urethra to their anatomically correct positions in patients. The pipeline of Urinary Incontinence is robust with the involvement of many promising pharmaceutical therapies. The launch of Emerging therapies such as ICES13 and Autologous Muscle Derived Cell Transplantation for Stress Urinary Incontinence, Vibegron and Mirabegron+solifenacin for Overactive Bladder is expected to drive additional growth within this market.

In terms of marketed drugs for this indication, Myrbetriq, Botox, Fesoterodine, Oxybutynin, Darifenacin and Solifenacin Succinate are approved for the treatment of Overactive bladder whereas Duloxetine is approved for the treatment of Stress Incontinence in Europe. VESIcare was approved by US FDA for the treatment of Overactive Bladder in November 2004. A decrease in revenues of VESIcare from 2014 had impacted the current market of Urinary Incontinence. Also, the loss of patents of Detrol in the year 2012 and 2014 for Europe and the US respectively had also impacted the market. Further, the current market of Urinary incontinence is impacted by the Fesoterodine which was approved for the treatment of Overactive Bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Botox (onabotulinumtoxinA) from Allergan, which is approved for the treatment of Urinary Incontinence in people with neurologic conditions such as spinal cord injury and Multiple Sclerosis is playing a major role in increasing the market size of Urinary Incontinence.

Insight by:
Anuj Thakur
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.

Non-Hodgkin Lymphoma: “Malignant Growth of White Blood Cells”

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Non-Hodgkin Lymphoma (NHL) is the leading cause of mortality and morbidity worldwide. It begins in lymphocytes present in lymph nodes of body parts such as neck or chest or under the arms. It widely spreads to the other lymph nodes and to other organs such as bone marrow, lungs, or liver. NHL is classified by World Health Organization (WHO) on the basis of microscopic appearance, chromosome features of the lymphoma cells and proteins present on the surface of the lymphoma. The Non-Hodgkin Lymphomas are classified as B-Cell Lymphomas and T-Cell Lymphoma.

High incidence is observed in the United States as compared to the EU 5 (United Kingdom, France, Germany, Spain, and Italy) and Japan in 2016. In Europe, high incidence was observed in Germany whereas low incidence was observed in Spain. The market of NHL is expected to increase to USD 9,072.8 Million by the end of the year 2023. Among these markets, United States has the largest market share whereas Spain contributes the lowest market share in 2016. The increase in the number of diagnosed cases of NHL is stimulating the growth of the market.

 

Treatment mainly depends on the clinical behavior of NHL on the basis of how fast the tumor is growing in patients. Chemotherapy, radiation therapy, immunotherapy, stem cell transplantation and targeted therapy are used for treating the lymphoma.  Its pipeline is robust with the involvement of several novel small molecule inhibitors and next-generation monoclonal antibodies. Major players such as Gilead Sciences, Acerta Pharma, and Celgene Corporation are involved in the development of therapies for this indication. Also, the launch of Pixantrone and Copanlisib shall fuel the market growth for Non-Hodgkin Lymphoma.

Among the marketed drugs, Rituxan is the blockbuster drug which is approved for the treatment of Non-Hodgkin Lymphoma, CD20 positive Follicular B-cell non-Hodgkins lymphoma, Chronic Lymphocytic Leukemia, and CD20 positive diffuse large B-cell non-Hodgkin’s lymphoma. Also, the approval of Obinutuzumab for Chronic Lymphocytic Leukemia and Follicular Lymphoma; idelalisib for Relapsed Chronic lymphocytic leukemia, follicular B-cell NHL, and small lymphocytic lymphoma; and ibrutinib for chronic lymphocytic leukemia has a significant impact on the market. Expiry of patents of Zevalin in 2019 will also affect the market growth for Non-Hodgkin Lymphoma.

Insight by:
Anuj Thakur
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.