Global Cancer Biologics Market

The cancer vaccines market consists of sales of vaccines used for the treatment of cancers and related services by entities (organizations, sole traders and partnerships) that produce vaccines for cancer treatment. Cancer treatment vaccines, also called therapeutic vaccines are a type of immunotherapy, which stops tumor growth, destroys cancer cells and prevents the reoccurrence of cancers. The market consists of revenue generated by the company’s manufacturing cancer vaccines by the sales of these products. The cancer vaccines market covered in this report is segmented by type into preventive cancer vaccines, therapeutic cancer vaccines. The cancer vaccines market is also segmented by technology into dendritic cells (DC) cancer vaccines, recombinant cancer vaccines, antigen/adjuvant cancer vaccines, whole cell cancer vaccines, viral vector & DNA cancer vaccines, by cancer type into prostate, cervical, colorectal, throat, others and by end-user into cancer treatment centers, research institutes. The global cancer vaccines market is expected to grow from $4.9 billion in 2020 to $5.55 billion in 2021 at a compound annual growth rate (CAGR) of 13.3%. The growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The cancer vaccines market is expected to reach $9.18 billion in 2025 at a CAGR of 13%. The rise in the number of cancer cases across the globe is likely to contribute to the growth of the cancer vaccines market during the forecast period. According to the American Cancer Society, there were 1,7 million new cases and 0.6 million cancer deaths in 2019 in the USA. The four most common types of cancer worldwide are lung, prostate, bowel, and female breast cancer, accounting for 43% of all the new cancer cases. Therefore, the rise in cancer incidence rate globally is anticipated to boost the demand for the cancer vaccines market over the coming years. Alternative treatment methods and natural remedies are increasingly becoming popular globally and this is expected to have a negative impact on the revenues of cancer vaccines manufacturing companies. Treatments in the fields of homeopathy, Ayurveda, yoga, acupuncture, sujok therapy are gaining popularity and slowly replacing some traditional hospital practices. For instance, Ayurvedic medicine, an ancient Indian system of medicine uses a range of techniques and treatments for cancer. According to the World Health Organization (WHO), some nations are still responding to plant-based treatment as their main medicine source and developing nations are using the benefits of natural compounds for therapeutic purposes, which is affecting the cancer vaccine sales. Also, the global homeopathic product market is projected to reach $18.6 billion by the end of 2027. This trend is expected to continue during the forecast period and limit the demand for cancer vaccines. Companies in the cancer vaccines market are increasingly investing in preventive or prophylactic vaccines for cancer prevention. Prophylactic vaccines are designed to build immunity in a patient. A prophylactic or preventative vaccine involves introducing antigens into a person's body. According to the World Health Organization, cervical cancer was reported as the second-most common cancer in women with an estimation of 84% new cases worldwide. So far, there are 3 HPV vaccines currently present for the prophylaxis of cancers. Two among these will protect against both HPV 16 and HPV 18, which causes 70% of cervical cancer and the third vaccine prevents 3 more oncogenic HPV types, which further causes 20% of cervical cancers. These three vaccines include Gardasil and Gardasil9 by Merck and Cervarix by GSK. In April 2019, Bayer, through its investment arm Leaps by Bayer, has invested in a US-based biotechnology firm Khloris Biosciences, which is focused on developing prophylactic anti-cancer vaccines. In May 2020, Merck, a US-based pharmaceutical company, acquired Themis Bioscience for an undisclosed amount. The acquisition is expected to complement Merck's capabilities in the development, manufacturing, and distribution of vaccines. Themis Bioscience is a pharmaceutical company that manufactures vaccines and immune-modulatory therapies developed using the measles virus vector platform based on a vector originally. Major players in the cancer vaccines market are, GlaxoSmithKline, Merck, Aduro Biotech, Astrazeneca Plc, Dendreon, Astellas Pharma Inc, Sanofi Pasteur, Sanpower Group, and CSL Limited. The regions covered in the cancer vaccines market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the cancer vaccines market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The global cancer vaccines market is segmented - 1) By Type: Preventive Cancer Vaccines, Therapeutic Cancer Vaccines 2) By Technology: Dendritic Cells (DC) Cancer Vaccines, Recombinant Cancer Vaccines, Antigen/Adjuvant Cancer Vaccines, Whole Cell Cancer Vaccines, Viral Vector & DNA Cancer Vaccines 3) By Cancer Type: Prostate, Cervical, Colorectal, Throat, Others 4) By End-User: Cancer Treatment Centers, Research Institutes

The cancer monoclonal antibodies market consists of sales of monoclonal antibodies used for the treatment of cancer and related services by entities (organizations, sole traders and partnerships) that produce monoclonal antibodies for cancer treatment. Monoclonal antibodies are highly specific molecules for cancer cells as they bind to the proteins on their surface and it activates an immune response. The market consists of revenue generated by cancer monoclonal antibodies companies manufacturing cancer monoclonal antibodies drugs. The cancer monoclonal antibodies market covered in this report is segmented by monoclonal antibody therapies into bevacizumab (avastin), rituximab (rituxan), trastuzumab (herceptin), cetuximab (erbitux), panitumumab (vectibix), others and by application into breast cancer, blood cancer, liver cancer, brain cancer, colorectal cancer, others. The global cancer monoclonal antibodies market is expected to grow from $45.51 billion in 2020 to $49.77 billion in 2021 at a compound annual growth rate (CAGR) of 9.4%. The growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The cancer monoclonal antibodies market is expected to reach $69.96 billion in 2025 at a CAGR of 9%. The rise in the number of cancer cases across the globe is likely to contribute to the growth of the cancer monoclonal antibodies market. According to the American Cancer Society, there were 1.7 million new cases and 0.6 million cancer deaths in 2019 in the USA. The four most common types of cancer worldwide are lung, prostate, bowel, and female breast cancer, accounting for 43% of all new cancer cases. Therefore, the rise in cancer incidence rate globally is anticipated to boost the demand for the cancer monoclonal antibodies market. The high costs involved in the development of monoclonal antibodies with advanced techniques act as a major restrain for the market due to the complex production process, expensive biological and chemical materials, and clinical trials, as well as required safety, efficacy, and quality tests. Advanced equipment is required for the large-scale production of monoclonal antibodies that encompass multiple disulfide bonds and post-translational modifications, and this equipment is expensive. Clinical efficacy is usually achieved by injecting large amounts of monoclonal antibodies into the system, which means that large quantities are required to be produced for each treatment, thus increasing the cost. According to The American Journal of Managed Care, the annual price of monoclonal antibody therapies used in oncology and hematology is about $100,000 higher than those used in other disease states. Thus, the high development costs in using these advanced techniques will restrain market growth. Companies in the cancer monoclonal antibodies market are increasing their product innovation through strategic collaborations. To sustain in the increasingly competitive market, companies are developing innovative products as well as sharing skills and expertise with other companies. While companies have long collaborated with each other as well as academic and research institutions in this market by way of partnerships and in- or out-licensing deals, this trend has been increasing over recent years. For instance, in September 2020, AbbVie and I-Mab entered into a strategic partnership for the development and commercialization of lemzoparlimab (also known as TJC4), which is a monoclonal antibody drug used to treat multiple cancers. In September 2019, IRBM announced the signing of a service and development agreement with The University of Texas MD Anderson Cancer Center. The agreement will focus on the development of therapeutic monoclonal antibodies for cancer. In March 2020, Gilead Sciences, a US-based biopharmaceutical company, announced its decision to acquire Forty Seven for $4.9 billion. This acquisition is expected to strengthen Gilead’s immuno-oncology R&D portfolio with the addition of Forty Seven’s investigational lead product candidate, magrolimab. Magrolimab is a monoclonal antibody in clinical development for the treatment of several cancers. Forty Seven Inc. is a clinical-stage immuno-oncology company that develops therapies targeting cancer immune evasion pathways and specific cell targeting approaches based on technology licensed from Stanford University. Major players in the cancer monoclonal antibodies market are Amgen, Bristol Myers Squibb Company, Eli Lilly and Company, F. Hoffmann-La Roche Ltd, Genmab AS, GlaxoSmithKline, Johnson & Johnson, Novartis AG, Merck & Co., and Spectrum Pharmaceuticals. The regions covered in the cancer monoclonal antibodies market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the cancer monoclonal antibodies market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The global cancer monoclonal antibodies market is segmented - 1) By Monoclonal Antibody Therapies: Bevacizumab (Avastin), Rituximab (Rituxan), Trastuzumab (Herceptin), Cetuximab (Erbitux), Panitumumab (Vectibix), Others 2) By Application: Breast Cancer, Blood Cancer, Liver Cancer, Brain Cancer, Colorectal Cancer, Others 3) By End User: Hospitals And Clinics, Research Laboratories, Pharmacies, Others

The cancer clinical decision tools market consists of sales of cancer decision support tools and related services. Cancer decision tools are designed to support the general practitioner's assessment of patients with potential cancer symptoms. The tools do not change the clinical judgment but give more information that is used to inform patient management decisions. The risk is measured based on reading coded information from the patient record including demographic data, medical history, and symptoms. The cancer clinical decision tools market covered in this report is segmented by type into risk assessment tool (RAT), Qcancer and by end-user into hospitals, clinics. The global cancer clinical decision tools market is expected to grow from $0.36 billion in 2020 to $0.39 billion in 2021 at a compound annual growth rate (CAGR) of 8.3%. The growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The cancer clinical decision tools market is expected to reach $0.55 billion in 2025 at a CAGR of 9%. The rise in the number of cancer cases across the globe is likely to contribute to the growth of the cancer clinical decision tools market. According to the American Cancer Society, there were 1.7 million new cases and 0.6 cancer deaths in 2019 in the USA. The four most common types of cancers worldwide are lung, prostate, bowel, and female breast cancer, accounting for 43% of all new cancer cases. Therefore, the rise in cancer incidence rates across the globe will increase the demand for cancer clinical decision tools to make treatment decisions faster, thereby contributing to the market growth. The breach of data and privacy of patients is a major challenge in the cancer clinical decision tools market. Hackers can get access to data centers through healthcare employee’s emails leading to a breach of patients' information privacy. For instance, in 2019, the Regional Cancer Care Association (RCCA) reported a data breach through phishing email attempts. Email phishing is a primary attack because it is not detectable by email security tools, out of 15 million patient records breached, 11.4 million records were caused by phishing attacks. The risk of the loss of data and privacy of patients harms the growth of the cancer clinical decision tools market. In January 2019, Qiagen, a Germany based provider of sample and assay technologies for molecular diagnostics, applied testing, academic and pharmaceutical research acquired N-of-One for an undisclosed amount. The acquisition of N-of-One will enable QIAGEN to significantly expand its decision-support solutions while offering a broader range of software, content and service-based solutions. It will also enable QIAGEN to expand its clinical bioinformatics capabilities in molecular oncology decision support. N-of-One, a privately-held U.S. molecular decision support company and pioneer in clinical interpretation services for complex genomic data. Major players in the cancer clinical decision tools market are McKesson Corporation, Medical Information Technology Inc., Philips Healthcare, Siemens Healthineers, Elsevier B.V., Macmillan, and National Decision Support Company. The regions covered in the cancer clinical decision tools market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the cancer clinical decision tools market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The global cancer clinical decision tools market is segmented - 1) By Type: Risk Assessment Tool (RAT), Qcancer 2) By End-User: Hospital, Clinics

The cancer diagnostics market consists of sales of cancer diagnostic devices and equipment. Cancer diagnostic equipment is used to identify biomarkers, proteins and symptoms in order to detect a cancerous tumor in the patient. Cancer diagnostics market is segmented into companion diagnostics and molecular diagnostics. The cancer diagnostics market covered in this report is segmented by products into companion diagnostics, molecular diagnostics. The cancer diagnostics market is also segmented by end-user into cancer research institutes, diagnostic laboratories, hospitals, others; by method into biopsy, endoscopy, tumor biomarker tests, imaging; by application into cervical cancer, breast cancer, liver cancer, blood cancer, kidney cancer, colorectal cancer, pancreatic cancer, ovarian cancer, melanoma, others. The global cancer diagnostics market is expected to grow from $156.27 billion in 2020 to $170.21 billion in 2021 at a compound annual growth rate (CAGR) of 8.9%. The growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The cancer diagnostics market is expected to reach $239.23 billion in 2025 at a CAGR of 8.9%. A high prevalence rate of various types of cancers is a major driver of the cancer diagnostics market. This is because the increasing incidences of various types of cancers is leading to a greater number of people opting for diagnosis and treatment. In addition, according to the World Health Organization (WHO), cancer was the second-leading cause of death worldwide. The National Cancer Institute (NCI) has estimated the number of new cancer cases per year to reach 23.6 million by 2030. Product recall is one of the major restraints for the cancer diagnostics market. Product recall is a process of retrieving all faulty and defective products that have been sold or are available in the market. When a company recalls a product from the market, it takes up the cost of fixing the defective product and replacing it. This cost of replacement of cancer diagnostics devices can be very high for manufacturers, which ultimately restricts the growth of the market. For example, Siemens Healthcare Diagnostics had to recall its IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay as it was not meeting the required high-dose hook effect expectation. An IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay can be used as an aid in the detection of prostate cancer along with digital rectal examination (DRE) in men aged 50 years or older. AI-based cancer detection system is an emerging trend in the cancer diagnostics market. AI helps in improving the accuracy of image detection in diagnostic processes such as breast cancer and lung cancer diagnostics, by detecting the cancers in early stages. AI also reduces the instances of false positives in lung cancer screening, thus, improving the lung cancer detection accuracy. For instance, researchers at the Naval Medical Center San Diego and Google's AI research division Google AI, developed a reliable solution comprised of cancer-detecting algorithms used for autonomous evaluation of lymph node biopsies. This AI solution improved the accuracy of metastatic breast cancer detection to 99%. The cancer diagnostics market is regulated by the FDA which imposes restrictions on cancer diagnostic devices such as magnetic resonance imaging (MRI) and nuclear magnetic resonance spectroscopy (NMR). The FDA categorizes these devices into class II category, as they have a moderate risk associated with usage. Class II devices are bounded by device specific regulations which include performance standards, premarket data requirements, post market surveillance and labelling requirements associated with their usage. For instance, the labelling of such devices is required to have a list of contraindications, adverse reactions, precautions, warnings and other instructions before being released in the market. Hence, regulations such as these would keep a check on manufacturers of cancer diagnostics devices. Major players in the cancer diagnostics market are Abbott, Becton Dickinson and Company, Hoffmann-La Roche Ltd, GE Healthcare Ltd., and Thermo Fisher Scientific. The regions covered in the cancer diagnostics market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the cancer diagnostics market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The global cancer diagnostics market is segmented - 1) By Products: Companion Diagnostics, Molecular Diagnostics 2) By End-User: Cancer Research Institutes, Diagnostic Laboratories, Hospitals, Others 3) By Method: Biopsy, Endoscopy, Tumor Biomarker Tests, Imaging 4) By Application: Cervical Cancer, Breast Cancer, Liver Cancer, Blood Cancer, Kidney Cancer, Colorectal Cancer, Pancreatic Cancer, Ovarian Cancer, Melanoma, Others

The antibody-drug conjugates (ADCs) market consists of sales of antibody-drug conjugates. ADCs are complex engineered therapeutics consisting of monoclonal antibodies, directed toward tumor-associated antigens, to which highly potent cytotoxic agents are attached using chemical linkers. The antibody drug conjugates market covered in this report is segmented by type into monoclonal antibodies, linker, drug/toxin, others. The antibody-drug conjugates (ADCs) market is also segmented by application into blood cancer, breast cancer, ovarian cancer, lung cancer, brain tumor, others; by product into adcertis, kadcyla, others; by technology into immunogen technology, seattle genetics technology, immunomedics technology, others; by end user into hospital, clinics, others. The global antibody drug conjugates market is expected to grow from $2.34 billion in 2020 to $2.6 billion in 2021 at a compound annual growth rate (CAGR) of 11.1%. The growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The antibody-drug conjugates (ADCs) market is expected to reach $6.12 billion in 2025 at a CAGR of 23.9%. The antibody drug conjugates market is being driven by rising incidences of cancer globally. The major causes for most cancers include obesity, smoking, alcohol, improper eating habits. The Cancer Research UK predicts that there will be 27.5 million new cases of cancer each year by 2040. The rising incidences of cancer are expected to increase the demand for antibody drug conjugates driving market growth. The challenges involved in the manufacturing of ADC's is acting as a restraint on the antibody drug conjugates market. ADC manufacturing facilities require high capital investment and extensive specialized training for operators. ADC process development is complicated as it requires optimization of additional process steps that are not present in conventional monoclonal antibodies manufacturing such as the antibody-drug conjugation reaction and subsequent drug substance purification. Also, antibody drug conjugates must be manufactured in aseptic environments and operating personnel should be protected from the highly toxic drug compounds, thereby presenting operational difficulties. Manufacturers of antibody drug conjugates are increasingly collaborating or partnering with other companies to share technology, resources, product knowledge and expand business. For instance, in March 2019, Astrazeneca entered into a global development and commercialization collaboration agreement with Daiichi Sankyo Company for the proprietary antibody drug conjugate trastuzumab deruxtecan (DS-8201). In April 2019, Shanghai Miracogen entered into an agreement with Netherlands based Synaffix to use its tools for building antibody drug conjugates. According to the deal, Miracogen is licensing two platforms from Synaffix which is expected to boost its product pipeline. Manufacturers of antibody drug conjugates are monitored by various regulatory bodies such as the Food and Drug Administration in the USA. In the USA, there is no specific regulatory guidance to industry on ADC development and the FDA follows existing guidelines for small drugs and monoclonal antibodies to regulate ADC. The product quality offices at FDA such as the Office of Biotechnology Products (OBP)/Office of Pharmaceutical Quality primarily focus on the manufacturing of the antibody component of the ADC and the control strategy for the antibody intermediate, as well as for the drug substance (DS) and drug product (DP). Small molecule review groups in the Office of Pharmaceutical Quality bear primary responsibility for review of the adequacy of the payload and linker, conjugation reaction and aspects of the control strategy. Major players in the antibody-drug conjugates (ADCs) market are Bayer AG, Concortis Biotherapeutics, F. Hoffman-La Roche Ltd., Immunomedics Inc., and Oxford BioTherapeutics. The regions covered in the antibody-drug conjugates (ADCs) market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the antibody-drug conjugates (ADCs) market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The global antibody drug conjugates market is segmented - 1) By Type: Monoclonal Antibodies, Linker, Drug/Toxin, Others 2) By Application: Blood Cancer, Breast Cancer, Ovarian Cancer, Lung Cancer, Brain Tumor, Others 3) By Product: Adcertis, Kadcyla, Others 4) By Technology: Immunogen Technology, Seattle Genetics Technology, Immunomedics Technology, Others 5) By End User: Hospital, Clinics, Others

The drugs for hormonal replacement therapy market consists of sales of drugs for hormonal replacement therapy and related services. The drugs for hormonal replacement therapy are used to treat patients with growth hormone deficiency caused due to conditions such as dwarfism or menopause (a condition which describes changes a woman goes through when her menstruating cycle stops). The drugs for hormonal replacement therapy help to replace low level hormones from the body, maintain growth hormone deficiency and prevent women from vaginal dryness, mood swings, weakening of bones and others. The market covered in the drugs for hormonal replacement therapy market report is segmented by therapy type into estrogen replacement therapy, human growth hormone (HGH) replacement therapy, thyroid replacement therapy, testosterone replacement therapy; by distribution channel into hospital pharmacies, retail pharmacies, online pharmacies; by application into hypothyroidism, male hypogonadism, growth hormone deficiency, menopause, others; by route of administration into oral, parental, others. The global drugs for hormonal replacement therapy market is expected to grow from $14.76 billion in 2020 to $14.88 billion in 2021 at a compound annual growth rate (CAGR) of 0.8%. The slow growth is mainly due to defering treatments that led to fall in the demand for drugs. The drugs for hormonal replacement therapy market is expected to reach $16.77 billion in 2025 at a CAGR of 3%. Increasing population of aging and postmenopausal women is driving the drugs for hormonal replacement therapy market growth. Hormonal replacement therapy drugs such as Estrogen, Progestin and others are used to treat medical conditions caused due to menopausal conditions. According to a report by The Indian Menopause Society, New Delhi, in India there are 65 million women over the menopausal age affected with menopausal symptoms. According to European Menopause and Andropause Society (EMAS) report, women aged over 60 are expected to reach over 1 billion by 2050. In South Korea, the female population is expected to exceed male population by 2060, out of which 59.6% of female population is expected to suffer from postmenopausal symptoms. Thus, growing women population suffering from menopausal symptoms and aging population drives the market for hormonal replacement therapy drugs market. Increasing occurrence of side effects due to the intake of drugs for hormonal deficiency may hinder growth of drugs for hormonal replacement therapy market. The side effects include vagina dryness, irregular heartbeat, breast swelling, osteoporosis (weakening of bones) and other effects when women undergo hormonal replacement therapy. High dosage of drugs for hormonal replacement therapy may cause rapid heartbeat, bloating (a build-up of gas in the stomach and intestines), nausea, indigestion, vaginal bleeding, blood clots, heart attack, breast cancer and others. According to an online study, decrease in the intake of drugs for combined hormone therapy showed a decrease in breast cancer cases by 126,000 and cardiovascular disease cases by 76,000. Thus, the increasing side effects of drugs hinders the growth of drugs for hormonal replacement therapy. Companies in the industry are increasingly developing of drugs for hormonal replacement therapy with better safety profiles and novel drug delivery mechanisms. The drug delivery mechanisms include transdermal estrogen, varginal estrogen and others. Transdermal estrogen drug delivery is in the form of estradiol transdermal gel, patch, and spray that are used to treat symptoms of menopause, vaginal dryness, itching, burning and others occur due to low estrogen levels. Varginal estrogen in the form of cream, vaginal ring, vaginal tablets are used to get the hormone estrogen into the system. For instance, Novo Nordisk, a multinational pharmaceutical company provides novel drug delivery mechanisms and low dose drugs for hormonal replacement therapy (HRT) to cater to the rising demand of patient needs. Some of the brands offering of novel drugs include Climara, Divigel, Elestrin, Esclim, Estraderm, Estrasorb, EstroGel, Evamist, Oesclim, Rhoxal-Estradiol Derm 50, Vivelle 100 Mcg, Estradot Transdermal Therapeutic System and others. Department Of Health And Human Services of Food And Drug Administration (FDA), a federal agency, is a regulatory body monitoring, controlling and regulating the drugs for hormonal replacement therapy market. In April 2018, FDA's Department Of Health And Human Services has revised the requirements of specific hormone-containing drug products for human use. These hormones include estrogens, progestins, androgens, anabolic steroids, adrenal corticosteroids, and synthetic analogs. The purpose of the revisal of existing regulations by FDA is to establish effectiveness and ensure safety for any over-the-counter drug use of these ingredients. Major players in the drugs for hormonal replacement therapy market are Novartis AG, Bayer AG, Pfizer Inc., Novo Nordisk A/S, and Eli Lilly and Company. The regions covered in the drugs for hormonal replacement therapy market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the drugs for hormonal replacement therapy market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The global drugs for hormonal replacement therapy market is segmented - 1) By Therapy Type: Estrogen Replacement Therapy, Human Growth Hormone (HGH) Replacement Therapy, Thyroid Replacement Therapy, Testosterone Replacement Therapy 2) By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Online Pharmacies 3) By Application: Hypothyroidism, Male Hypogonadism, Growth Hormone Deficiency, Menopause, Others 4) By Route of Administration: Oral, Parental, Others

The molecular diagnostics devices (or) equipment market consists of sales of molecular diagnostics devices and related services. Molecular diagnostics devices are used to diagnose infectious diseases and perform screening by detecting specific sequences in DNA or RNA at molecular level. It helps doctors to prescribe more accurate therapeutic interventions in the early stages of a disease. This market is segmented into instruments, reagents and consumables. The global molecular diagnostics devices and equipment market is expected to decline from $18.07 billion in 2020 to $13.57 billion in 2021 at a compound annual growth rate (CAGR) of -24.9%. The change in growth trend is mainly due to the companies stabilizing their output after catering to the demand that grew exponentially during the COVID-19 pandemic in 2020. The market is expected to reach $19.01 billion in 2025 at a CAGR of 8.8%. The growth in molecular diagnostic devices and equipment market is attributed to factors such as rapid rise in various bacterial and viral epidemics. The increase in the spread of diseases increases the demand for early and improved diagnostic methods. In order to improve the technology to enable early diagnosis of such diseases, Government and different organization’s extend their financial support towards the major key players of the industry. For example, according to the reports from Centres for Disease Control and Prevention (CDC) US, as on March 2019, 72 Zika virus disease cases were reported in U.S state and 148 Zika virus disease cases reported in US Territories. Thus, the rise of such chronic diseases serves as a prime driver for the players in the industry to develop more accurate and sophisticated diagnostic devices and equipment’s. Following the increase in demand of early diagnosis of Zika virus, Co-Diagnostics, Inc. in February 2019 launched its first multi-disease molecular diagnostic test for dengue, chikungunya and Zika. The regulatory process involving approval of molecular diagnostic tests is often slow. The lack of clear definition coupled with constant changes in the regulations is a challenge for companies developing these kits. In the developing nations such as India and China lack of well-defined regulatory framework negatively impacts the market, irrespective of the presence of a large population. In the US market, because of the changes in the rules and regulations, the products already in the market may also be required to go through Food and Drug Administration (FDA)’s pre-marketing approval process. For example, CLIA (Clinical Laboratory Improvement Amendments Act) in the US certifies the validity of a laboratory based tests but it does not regulate the clinical validity of molecular diagnostic tests. This means that it does not control whether these results are clinically correct. This argument puts a restraint to the industry and opens an argument that FDA should play a greater role in overseeing laboratories. The major players in the molecular diagnostic industry are focusing on developing automated solutions for devices and equipment’s used for molecular diagnostic processes. Automation of the process will help to enhance productivity and consistency of the whole diagnostic process. Computerisation of the diagnostic process gives reliable and efficient test results that manual testing by various experts does not. The major players of the industry are using nanotechnology based Oral Fluid Nano Sensor Test (OFNASET). The test uses a microfluidic-based nano sensor for the detection of oral cancer biomarkers in saliva. In order to keep up with the trend of automation and accuracy, Roche, created cobas connection modules (CCM) to improve scalability and sample-flow efficiency by allowing samples to automatically move between different systems and instruments. Thus, creating a fully automated work flow. The molecular diagnostic devices in the US are approved by Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH). These diagnostics devices are generally approved with an accompanying assay, in order to evaluate their safety and effectiveness or substantial equivalence with reference to the assays they run and the assay's defined performance parameters. However, the same instruments do not require FDA approval or clearance when used for basic scientific research-purposes. The European regulatory landscape has become more stringent and technically challenging for medical device companies. The introduction of four different risk classes of diagnostic device, i.e. classes A-D. Class A refers to lowest risk tests and class D refers to highest risk test such as HIV testing, blood grouping, and prenatal testing. Most of the genetic testing is classed into class C. The products bearing a CE mark, European approved tests, are safe to use and are in full compliance. In March 2019, Abbott received a CE mark for its Alinity m molecular diagnostic testing machine. This would allow it to sell the product across Europe. Major players in the market are Roche Ltd, Hologic, QIAGEN, Abbott, Danaher Corporation. The countries covered in the global molecular diagnostics devices and equipment market are Brazil, China, France, Germany, India, Indonesia, Japan, South Korea, Russia, UK, USA, Australia. The regions covered in the global molecular diagnostics devices and equipment market are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The global molecular diagnostics devices and equipment market is segmented - 1) By Product: Instruments, Reagents, Consumables 2) By End User: Diagnostic Laboratories, Hospitals, Others (Nursing Home, Blood Banks, Point of Care) 3) By Technology: DNA (Deoxyribonucleic acid) Sequencing, Polymerase Chain Reaction, Isothermal Nucleic Acid Amplification Technology, Transcription Mediated Amplification (TMA), In situ Hybridization, Microarrays, Mass spectrometry, Others (Southern Blotting, Northern Blotting, Electrophoresis) 4) By Application: Cancer, Pharmacogenomics, Genetic Testing, Infectious Disease, Prenatal, Neurological Disease, Cardiovascular Disease

The cervical cancer drugs market consists of sales of cervical cancer drugs used for the treatment of cervical cancer in women. The cervical cancer is the medical condition in which there is a tumor formation in the lower portion of uterus which is known as cervix. The global cervical cancer drugs market is expected to grow from $7.92 billion in 2020 to $8.09 billion in 2021 at a compound annual growth rate (CAGR) of 2.1%. The growth is mainly due to the companies rearranging their operations and recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $9.73 billion in 2025 at a CAGR of 4.7%. The increasing prevalence of HIV (Human immunodeficiency virus) in women is driving the growth of the cervical cancer drugs market. Women with HIV positive have a greater risk of cervical cancer than the general population. Nearly 18 million women have tested HIV positive globally, HIV weakens the immune system which increases the likelihood of cervical cancer. Women with HIV have an increased chance of being diagnosed with cervical cancer because the count of the protein CD4 goes down. According to a survey conducted by the National cancer institute, a person with HIV is three time as likely to be diagnosed with cervical cancer. The lack of awareness and other misconceptions about cervical cancers hinder the growth of the cervical cancer drugs market. A lot of cervical cancer-related deaths among women are due to late diagnosis of disease. The lack of awareness leads to avoidance about the disease; this ignorance causes delayed diagnosis and medication/treatment. According to, a study conducted at the Bowen University Teaching Hospital (BUTH), in Nigeria, about 318 women from the general outpatient clinic were interviewed to assess the level of awareness of cervical cancer. The level of awareness for cervical cancer was 22.6% and 17.9% for screening tests, with major sources of information being from health talks and hospital staffs. The cervical cancer drugs market is experiencing a number of significant trends that helps in efficient and targeted treatment of the disease including advances in drug delivery. One such trend is the use of drugs that can be delivered directly from the vagina such as drugs using vaginal formulations as gels, creams, pessaries, rings, films and tablets. These drugs ease the localized treatment of cervical cancer. The formulation of these drugs is in such a way that they get easily absorbed into vaginal tissue and reach the site of action. For instance, companies introduced vaginal gels such as Cidofovir gel and 851B Gel into the market to treat cervical cancer. As per the reports by International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)'s Clinical Trials Registry, 851B Gel is in trial phase. Whereas Cidofovir gel, sold under the brand name Vistide, is already a success in the market. In addition to the above mentioned gels, drugs such as ISA101, AGEN2034 and Z-100 are in pipeline and promise growth to the cervical cancer drugs market. The U.S. Food And Drug Administration (FDA) regulates the safety and effectiveness of cancer drugs in the market. The Oncologic Drugs Advisory Committee process evaluation and clinical trials of cancer drugs requested by FDA. The Division of Oncology Products 1 (DOP1) regulates investigation, application, licensing of new drug for gynecological cancers. Various clinical trials are done for approval of cervical cancer drugs. Under the title 21CFR314, subpart H regulates the approval of new drugs that are for serious illness. In January 2019, Bristol-Myers Squibb, an American biopharmaceutical company acquired Celgene for $74 billion. This acquisition will enable the Bristol-Myers Squibb to hold a strong position in oncology, immunology and inflammation and cardiovascular diseases drugs market. Celgene is an American biopharmaceutical company that discovers, develops, and commercializes therapies for the treatment of cancer and inflammatory diseases globally. Major players in the market are F. Hoffmann-La Roche Ltd, Hetero, GlaxoSmithKline, Eli Lilly and Company, Pfizer. The countries covered in the global cervical cancer drugs market are Brazil, China, France, Germany, India, Indonesia, Japan, South Korea, Russia, UK, USA, Australia. The regions covered in the global cervical cancer drugs market are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The global cervical cancer drugs market is segmented - 1) By Cancer Type: Squamous Cell Cancer, Adenocarcinoma 2) By Drug Type: Avastin, Bevacizumb, Blemocin, Blenoxane, Others 3) By Distribution Channel: Hospitals Pharmacies, Retail Pharmacies, Others