Amplification of the HER2/neu oncogene and related genetic elements on chromosome 17 increases HER2 expression and accelerates tumorigenesis. The natural disease progression meant that, historically, women with breast cancer who overexpressed HER2 were found to have significantly shorter disease-free survival and overall survival compared with women without HER2 amplification; however, the introduction of trastuzumab in 1998 drastically changed patient outcomes, to the point where HER2+ breast cancer patients now have the longest median survival of all breast cancer subtypes. HER2 is overexpressed in approximately 20% of breast cancers.
Despite Truvada’s and Descovy’s commercial success, PrEP remains underutilized due to poor awareness and lack of/limited reimbursement in some European countries, though uptake is increasing due to recent favorable reimbursement decisions in Germany, Spain, England, Wales, and Northern Ireland, as well as due to Gilead’s marketing efforts. The US has the highest rate of uptake (estimated at 22% of at-risk individuals in 2020) and generates the majority of global PrEP revenues.
The HIV treatment market in the US, Japan, and five major European markets (France, Germany, Italy, Spain, and the UK) is expected to continue to expand through to 2025, driven primarily by increases in disease prevalence and continued uptake of Gilead’s Biktarvy and ViiV Healthcare’s portfolio of two-drug regimens. However, a plethora of products undergoing patent expiry across the forecast period will tip the market into decline from 2026.
Hormone receptor-positive (HR+) is the most common breast cancer subtype, with approximately 70% of breast cancers presenting with overexpression of estrogen receptors, progesterone receptors, or both (De Placido and Pronzato, 2015). Overexpression of the hormone receptors allows estrogen and progesterone to drive tumor growth and proliferation. Therefore, endocrine therapy remains the standard treatment for advanced patients with HR+/human epidermal growth factor receptor 2-negative (HER2-) breast cancer.
HPV is a member of the papillomavirus family, which are known for causing warts. Over 200 different types have been identified so far, and while most HPV infections are not harmful, persistent infection with certain HPV strains can cause warts and anogenital lesions, which if untreated may become cancers. HPV infection is the major cause of cervical cancers, with almost all cases (99%) being caused by HPV infection. Other cancers related to HPV include cancers of the vulva, vagina, penis, or anus. Only about 14 HPV strains are considered high risk for causing cervical cancer, and of these the two most common types, HPV 16 and 18, are responsible for causing around 70% of all cervical cancers globally.
Melanoma accounts for just 1% of all skin cancer cases, but is responsible for the majority of skin cancer-related deaths. Melanoma occurs when melanocytes – pigment-producing cells of the skin that are intercalated in the basal cell layer – become malignant. Although surgical excision is a potentially curative option for many melanoma patients, the disease can disseminate rapidly. Currently, only 27.3% of patients diagnosed with distant metastatic melanoma survive for five years, compared to about 99.0% of those with localized disease. Although 83% of patients present with localized disease, approximately one quarter to one third of these patients will eventually experience disease recurrence.
Meningococcal meningitis is caused by the bacteria Neisseria meningitidis, which causes a serious infection to the lining surrounding the brain and spinal cord. In all, 12 known serogroups of Neisseria meningitidis have been identified, six of which (A, B, C, W, X, and Y) can cause epidemics. The Centers for Disease Control and Prevention (CDC) has reported around 1 in 10 people are asymptomatic carriers of the bacteria.
Migraine is a common, disabling, and recurring neurological disorder characterized by severe headache co-occurring with nausea, vomiting, and other symptoms, the duration of which can range from hours to days.
Multiple myeloma (MM) is a hematological malignancy characterized by the infiltration of malignant, antibody-producing plasma cells in the bone marrow. The disease represents approximately 1% of all cancers, and 10% of hematological cancers. The hallmarks of MM are high levels of monoclonal (M-) protein, high levels of clonal plasma cells in the bone marrow, and organ damage.
Multiple sclerosis (MS) is an inflammatory, autoimmune disease characterized by neuronal demyelination leading to physical and cognitive disability.
Follicular lymphoma (FL) is an indolent subtype of non-Hodgkin’s lymphoma (NHL) specifically originating from centrocyte and centroblast B cells and usually beginning in the lymph nodes. The disease is among the most common forms of NHL alongside diffuse large B-cell lymphoma (DLBCL), accounting for approximately 35% of all NHLs.
Non-alcoholic fatty liver disease (NAFLD) encompasses a spectrum of patients who have fatty liver in the absence of significant alcohol consumption. NAFLD patients are often segmented into non-alcoholic fatty liver (NAFL) and non-alcoholic steatohepatitis (NASH) patients. NAFLD diagnosis requires evidence of hepatic steatosis and lack of secondary causes of liver fat accumulation such as substantial alcohol consumption, long-term use of a steatogenic medicine, or monogenic hereditary disorders. NASH is defined as the presence of >5% hepatic steatosis and inflammation with hepatocyte injury, with or without fibrosis. Although the presence of fibrosis is not required for a diagnosis of NASH, fibrosis is present in over 80% of NASH patients. For this reason, NASH patients are often further segmented by their fibrosis stage.
Lung cancer is generally categorized as either small cell lung cancer (SCLC) or non-small cell lung cancer (NSCLC). Of these, NSCLC is the most common type of lung cancer, accounting for roughly 85% of all cases. NSCLC can be further divided into non-squamous and squamous NSCLC histologies. Squamous NSCLC refers to patients with squamous cell carcinoma, whereas non-squamous NSCLC includes patients with adenocarcinoma, large cell carcinoma, and other less common subtypes. Incidence of adenocarcinoma and squamous cell carcinoma varies greatly by both geographic region and gender. In general, adenocarcinoma comprises approximately 30–50% of all lung cancer cases, while squamous cell carcinoma accounts for roughly 25–35%.
Osteoporosis is the most common metabolic bone disease, and is characterized by compromised bone strength which predisposes individuals to an increased risk of fracture. Bone strength itself is not directly measurable, but can be inferred from bone mass and quality, with bone mass being most commonly approximated by assessing bone mineral density (BMD). A person with a BMD measurement that falls within one standard deviation (SD) of the healthy reference (30-year-old male or female) is considered to have healthy bone mass and structure (T-score >-1).
Ovarian cancer is defined as a group of tumors that originate in the ovaries. Most ovarian cancers are epithelial carcinomas which begin in the tissue surrounding the ovary. Other less common types of ovarian tumors include primary peritoneal, fallopian tube, and malignant germ cell tumors. Ovarian cancer is the fourth most common cancer among women, and is the leading cause of gynecological cancer-related death in women.
Parkinson’s disease (PD) is a chronic disorder characterized by movement abnormalities and other non-motor symptoms, such as dementia, depression, visual hallucinations, and autonomic dysfunction. Although not fatal, there is currently no cure for the disease, and its chronicity is associated with significant morbidity and disability.
Streptococcus pneumoniae (S. pneumoniae) is a bacterium that can cause multiple types of pneumococcal disease, including bloodstream infections (sepsis), pneumonia, meningitis, and other milder diseases such as sinusitis and otitis media. The severity of pneumococcal disease is characterized as invasive or non-invasive, with invasive pneumococcal disease being more severe as the bacterium can be isolated from ordinarily sterile sites (eg blood or cerebrospinal fluid), and requires hospital treatment.
Prostate cancer occurs when malignant cells originate in the prostate gland. The vast majority of prostate cancers are adenocarcinomas, but other less common types include sarcomas, small cell carcinomas, neuroendocrine tumors, and transitional cell carcinomas. Some prostate cancers can grow and spread quickly, but many are relatively indolent. Because of this, depending on patient age and other co-morbidities, some prostate cancer patients may not receive active treatment for the disease during their lifetime.
First-line treatment of milder forms of psoriasis will continue to be with cheaper, topical medications. Use of more expensive, systemic therapies will continue to be relegated to more severe psoriasis.
Psoriatic arthritis is grouped with spondyloarthritis and is characterized by inflammation in the spine (spondylitis) and/or joints (arthritis). It is often preceded by a diagnosis of psoriasis by about 10 years. The disease may be characterized by joint pain, swelling, or morning stiffness, and about 80–90% of psoriatic arthritis patients experience nail lesions, which include pitting (dents) and onycholysis (detachment). Around 30% of individuals with psoriasis develop psoriatic arthritis.
Pulmonary arterial hypertension is one of a group of rare and life-threatening diseases collectively known as pulmonary hypertension (PH). Each PH subgroup shares similar pathophysiology, clinical presentation, and therapeutic approaches.
Sutent is set to lose ground due to both newer, more effective treatments and imminent biosimilar erosion. Previously the SOC across many treatment settings, the pivotal trials of several newer therapies, which include checkpoint inhibitors Keytruda, Opdivo, and Bavencio, and the RTK inhibitor Cabometyx, have demonstrated significant clinical benefit over Sutent in the first-line setting. Keytruda and Cabometyx have also demonstrated benefit over Sutent in subsequent-line settings.
Respiratory syncytial virus (RSV), a member of the Paramyxoviridae family, is an enveloped, non-segmented, single-stranded, negativesense RNA virus. It is a common respiratory virus that is the leading cause of bronchiolitis in infants, and is estimated to be responsible for 22% of all episodes of acute lower respiratory tract infections in young children.
The rheumatoid arthritis (RA) market is set to experience increasing attrition due to biosimilar competition. The EU market has taken the brunt of biosimilar erosion, with earlier launches and more acceptance of biosimilars compared to other countries. Over time, biosimilar penetration is anticipated to gain more momentum as international real-world evidence builds, with long-term data supporting biosimilar efficacy and safety. This should allow physicians and patients to grow their confidence and familiarity with biosimilars, and encourage uptake.
The current dynamics of the antipsychotic market show domination by atypical antipsychotics, mainly oral agents, but there is also increasing uptake of long-acting injectable (LAI) neuroleptics, which will continue. Oral atypical antipsychotics that were historical blockbusters are now facing intense generic erosion. The highest-selling oral antipsychotic is Latuda, one of the newer atypical drugs, but its market exclusivity is only set to last until 2023.
Seasonal influenza is an acute viral infection that is spread by person-to-person transmission. Influenza, commonly referred to as the flu, circulates worldwide and can affect anyone in any age group, although annual epidemics peak during winter in temperate climates.
Triple-negative breast cancer (TNBC) is a relatively rare breast cancer subtype. It is characterized by the absence of estrogen and progesterone receptors and does not involve the overexpression of HER2. TNBC is associated with poor prognosis, a high risk of local recurrence, and poor disease-free and cancer-specific survival. It accounts for roughly 14% of breast cancers.
Diabetes mellitus is a group of chronic endocrine disorders characterized by hyperglycemia due to insufficient levels or action of insulin, a hormone responsible for regulating blood sugar. Symptoms include excessive excretion of urine (polyuria), thirst (polydipsia), constant hunger, weight loss, vision changes, and fatigue. In the long term, the disease can also cause disabling and lifethreatening complications such as cardiovascular disease (CVD), nerve damage (neuropathy, which along with peripheral vascular disease can lead to amputations), kidney damage (nephropathy), and eye disease (leading to retinopathy, loss of vision, and potentially blindness). If untreated, life-threatening conditions can develop, including diabetic ketoacidosis (DKA), particularly in type 1 diabetes, and the hyperosmolar hyperglycemic state in type 2 diabetes
Diabetes mellitus is a group of metabolic disorders which are characterized by hyperglycemia (elevated blood glucose levels) due to insufficient insulin secretion, which in type 2 diabetes occurs in the setting of insulin insensitivity.
Ulcerative colitis (UC) is a form of chronic inflammatory bowel disease (IBD), which causes mucosal inflammation affecting the colon. The idiopathic inflammation is commonly associated with the rectum (proctitis) and may extend proximally, evolving into left-sided colitis or extensive colitis. UC typically presents with bloody diarrhea, which may manifest alongside mucus, rectal urgency, tenesmus, and abdominal pain. The disease course is relapsing and remitting with intermittent periods of acute exacerbation, which may be serious enough to warrant therapy escalation, hospitalization, or even colectomy.
Age-related macular degeneration (AMD) is the progressive degradation of the part of the eye responsible for visual acuity, causing a loss of central vision. AMD is the leading cause of blindness in individuals who are over 65 years old. As the chances of experiencing any form of AMD increase with age, treatment of this disease is becoming even more important as life expectancies continue to rise in most regions.
This comprehensive market and medical technology report provides an overview of the inhalation-based devices used in the management of asthma and chronic obstructive pulmonary disease (COPD), and includes an in-depth, product-specific market analysis. Countries covered by this report comprise the US, the five major EU markets (France, Germany, Italy, Spain, and the UK), and Japan.
A US key opinion leader (KOL) discusses the epilepsy treatment landscape, including new market entrant Epidiolex, and provides their perspective on late-phase pipeline anti-epileptic drugs such as Fintepla.
The human immunodeficiency virus, or HIV, is a retrovirus that infects the cells of the immune system such as T lymphocytes, specifically cluster of differentiation-4+ T cells, dendritic cells, and macrophages.
Stroke is the second most common cause of death and a major cause of disability worldwide. A stroke occurs when there is a blockage or bleed in the cerebrovascular system that leads to either a neurological deficit persisting beyond 24 hours or death.
This Market Spotlight report covers the Acne market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, regulatory events, probability of success, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
Approved drugs in the ADHF – preserved ejection fraction (acute HFpEF) space target natriuretic peptide receptors. These drugs are administered via the intravenous route.
This Market Spotlight report covers the Acute Lymphoblastic Leukemia (ALL) market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming and regulatory events, probability of success, a 10-year disease incidence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
This Market Spotlight report covers the Amyloidosis market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming and regulatory events, probability of success, licensing and acquisition deals, and a 10-year disease incidence forecast, as well as presenting drug-specific revenue forecasts.
This Market Spotlight report covers the Amyotrophic Lateral Sclerosis (ALS) market, comprising key marketed and pipeline drugs, clinical trials, upcoming and regulatory events, recent events and analyst opinion, a 10-year disease incidence forecast, probability of success, and licensing and acquisition deals.
This Market Spotlight report covers the Atopic Dermatitis market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, epidemiology information, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
This Market Spotlight report covers the Atrial Fibrillation market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, regulatory events, probability of success, and a 10-year disease prevalence forecast, as well as presenting drug-specific revenue forecasts.
This Market Spotlight report covers the Attention Deficit Hyperactivity Disorder (ADHD) market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming and regulatory events, probability of success, a 10-year disease prevalence forecast, as well as presenting drug-specific revenue forecasts.
This Market Spotlight report covers the Axial Spondyloarthritis (axSpA) market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, and a 10-year disease prevalence forecast, as well as presenting drug-specific revenue forecasts.
This Market Spotlight report covers the Basal Cell Carcinoma market, comprising key marketed and pipeline drugs, epidemiology, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
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