Global Rituximab Biosimilars Market

Oncology Drugs Market Definition

The oncology drugs market consists of sales of oncology drugs and related services by entities (organizations, sole traders and partnerships) that produce oncology drugs to diagnose and treat all types of cancers. This industry includes establishments that produce drugs used in chemotherapy, surgery and radio therapies for treating pancreatic cancer, breast cancer, ovarian cancer, gastric cancer, kidney cancer, brain tumor, and other cancer types. The pharmaceutical industry develops drugs to diagnose, treat or prevent diseases. Pharmaceutical drugs are subjected to various laws and regulations that deal with patenting, testing, safety, efficacy and marketing. Oncology drug manufacturers produce pharmaceutical drugs made from active pharmaceutical ingredients (API) and excipients.

CAR-T Therapy Market Definition

The chimeric antigen receptor -T therapy market consists of sales of CAR-T therapy products and related services by entities (organizations, sole traders and partnerships) that develop chimeric antigen receptor (CAR) T-cell therapies to treat blood cancers. CAR-T therapy is type of immunotherapy in which T-cells taken from patient’s blood are modified in a laboratory with the addition of a special protein receptor that grants T-cells the power to recognize as well as kill cancer cells easily, along with infusing the same back into that patient. This special protein receptor, known as chimeric antigen receptor (CAR), attaches to a specific protein on a patient’s cancer cells. The infused cells multiply and prevail in the patient’s body as living drugs.

Ophthalmology Drugs Market Definition

The ophthalmology drugs market consists of sales of ophthalmology drugs and related services by entities (organizations, sole traders and partnerships) that produce ophthalmology drugs to treat eye related diseases. The ophthalmology drugs industry includes establishments that produce pharmaceutical drugs to treat glaucoma diseases, anti- inflammatory and tear stimulating drugs under dry eye medications drugs, and other drugs for treating retinal disorders and allergies. Some of the major ophthalmic drugs include Eylea, Lucentis, Restasis, Vigamox, Azopt, and Lotemax. The pharmaceutical industry develops drugs to diagnose, cure, treat or prevent diseases. Pharmaceutical drugs are subjected to various laws and regulations that deal with patenting, testing, safety, efficacy and marketing. Ophthalmologic drug manufacturers produce pharmaceutical drugs made from active pharmaceutical ingredients (API) and excipients.

Dry Eye Medication Market Definition

The dry eye medication market consists of sales of dry eye drugs and other related services by entities (organizations, sole traders and partnerships) that manufacture dry eye medication (or drugs) used to treat dry eyes. The dry eye medication market covers drugs that are used in the treatment of diseases related to dry eyes, irritation, pain, and infection.

Respiratory diseases drugs market covers drugs that are used in the treatment of a wide range of respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), chronic and acute bronchitis, emphysema and cystic fibrosis.

Respiratory Drugs Global Market Size

The global respiratory drugs market was valued at $54.80 billion in 2017. North America was the largest geographic region in the respiratory diseases drugs market in 2017, accounting for $26.2 billion or 47.8% market share. The USA was the largest country in the market in 2017, accounting for $20.4 billion or 37.1% market share.

Respiratory Drugs Global Market Trend

Many companies in the respiratory diseases drugs market are strategically partnering and collaborating with other companies to broaden their product portfolio. These collaborations help drug manufacturing companies enhance their product strength in specific therapy areas.

The COVID19 vaccine and therapeutics clinical trial analysis report consists of drugs and vaccines which are under clinical trials for the treatment of COVID 19. The various drugs and vaccines trials are categorized under 4 phases i.e. Phase I (drug or vaccine safety is tested on a small group of humans), Phase II (efficacy and safety are tested on a large group of humans), Phase III (efficacy and safety are tested on thousands of humans), and Phase IV (obtaining government approval and market launch, many vaccines undergo more monitoring). The urgent need to develop vaccines or therapeutics in response to the outbreak of the 2019 Novel Coronavirus (COVID-19) has resulted in a significant increase in clinical trials worldwide. Many research institutes, healthcare organizations and biopharmaceutical companies worldwide are conducting clinical trials for COVID-19 vaccines and therapeutics. According to the ClinicalTrials.gov database, there are more than 1,300 clinical trials registered (195 in phase I, 817 in phase II, 442 in phase III, 188 in phase IV). For instance, Solidarity is an international clinical trial to help find an effective treatment for COVID-19 launched by the World Health Organization and its partners. By region, Europe registered the highest number of trials (616 trials), followed by the Americas (418). Asia-pacific registered around 158 trials, and the Middle-East and Africa registered about 137 trials. The COVID19 vaccine and therapeutics clinical trial analysis covered in this report is segmented by product type into small molecules, biologics, blood & plasma derivatives, monoclonal antibodies, vaccines, others. It is also segmented by the phase of development into clinical phase I (active trial & discontinued trials), clinical phase II (active trial & discontinued trials), clinical phase III (active trial & discontinued trials), clinical phase IV (active trial & discontinued trials), by route of administration into oral, intravenous, subcutaneous, other routes of administration, and by type of sponsor into pharma/biotech company, academic research/institution, others (such as Government Organizations and CROs). The growing number of coronavirus cases across the globe together with an urgent requirement for vaccine or drug to curb the disease is a major driver for the growth of COVID19 vaccine & therapeutics clinical trials. According to the World Health Organization (WHO), there were 10,719,946 cases of COVID19 including 517,337 deaths globally reported to WHO as on 3rd July 2020, and this number is expected to grow in the near future. In many countries, dozens of vaccines or drugs are at various development phases of clinical trials. For instance, on 25th May 2020, the Union Health Ministry of India announced that four out of 14 COVID19 vaccine candidates from India may enter the clinical trial stage in the next three to five months. Therefore, the rising number of coronavirus cases along with an urgent need to treat COVID19 patients are projected to boost COVID19 vaccine & therapeutics clinical trials in the coming months. The long and costly drug development process is anticipated to limit the growth of the COVID19 vaccine & therapeutics clinical trials in the coming days. The safety and efficacy of drugs and vaccines are tested in various stages of the clinical trials. A vaccine takes an average of two to five years to develop. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), the average cost of research and development of a new drug is approximately $2.6 billion. Moreover, the stringent regulations imposed by the various regulatory authorities such as European Medicines Agency and the US Food and Drug Administration (FDA) in regards with clinical trials during COVID19 outbreak attributing to the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity is a major challenge faced in COVID19 vaccine & therapeutics clinical trials. New programs launched by companies and organizations to develop vaccines for protection against COVID19 are expected to be a major trend shaping the growth of the COVID19 vaccine and therapeutics clinical trials. For instance, in March 2020, Heat Biologics Inc., a clinical-stage biopharmaceutical company specializing in the development of therapeutic vaccines, announced the launch of a program within its subsidiary Zolovax, Inc. to develop a vaccine using its immune-activating gp96 vaccine platform for prevention and treatment against SARS-CoV-2 that causes coronavirus. Various programs being launched by the companies are likely to act as a key factor driving the COVID19 vaccines & therapeutics clinical trials in the coming days. In June 2020, Moderna Inc. collaborated with Catalent to fill-finish manufacturing of Moderna’s COVID19 vaccine candidate. The collaboration is expected to utilize Catalent filling and packaging capacity and staffing for manufacturing operations for producing an initial 100 million doses of the vaccine. Moderna Inc is a clinical-stage biotechnology organization that spent significant time in messenger RNA (mRNA) therapeutics and immunizations to make another age of transformative drugs. Catalent is the main supplier of cutting-edge conveyance advances, improvement, manufacturing drugs, biologics, cell, and quality treatments.

The COVID19 vaccine and therapeutics pipeline analysis market report provides an analysis of the coronavirus (COVID-19) therapeutics and vaccines under development. The report includes existing vaccines developed against MERS-CoV and SARS-CoV. The novel coronavirus-2019 (nCoV-19) has been named as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by the International Committee on Taxonomy of Viruses (ICTV) due to its genetic similarity with the coronavirus responsible for the 2003 SARS outbreak. Currently, government agencies, international health authorities and institutions and biopharmaceutical companies worldwide are focusing on developing vaccines/drugs to prevent or treat the COVID-19 infection. The COVID19 vaccine and therapeutics pipeline analysis market covered in this report is segmented by product type into small molecules, biologics, blood & plasma derivatives, monoclonal antibodies, vaccines, others. It is also segmented by the phase of development into preclinical therapeutics & vaccines, clinical studies, and by treatment mechanism & route of administration into mechanism of action and by route of administration , and by type of sponsor into pharma/biotech company, academic research/institution, others (such as Government Organizations and CROs). The development of potential drugs and vaccines for COVID-19 is progressing quickly. There is a massive increase in COVID-19 drugs and vaccines pipeline owing to the urgent need to contain the spread of disease. Government agencies, global health authorities and institutes, and biopharmaceutical companies are focusing on remedies to treat the patients and control the infection spread. Increasing every day, 450+ potential therapeutic candidates are under investigation. While two-thirds of the pipeline account for therapeutic drugs, the remaining one-third accounts for vaccines. Of the confirmed active vaccine candidates, nearly 70% are being developed by private/industry developers, with the remaining 30% of projects being led by the academic, public sector and other non-profit organizations. Most COVID-19 vaccine development activity is in North America, with around 36 (46%) developers of the confirmed active vaccine candidates. China constitutes 18% with 14 developers, while, Asia excluding China and Europe also constitute 18% each with 14 developers in each region, respectively. According to the European Centre for Disease Prevention and Control, worldwide, there are over 10.8 million cases of COVID-19. Globally, R&D spending has increased to find a potential drug or vaccine to combat this pandemic. Currently, there is no approved targeted therapy for patients with COVID-19. However, an array of drugs approved for other indications as well as several new investigational drugs are being studied in several hundred clinical trials. The increased R&D spending has contributed to the invention/discovery of more than 400 unique drugs to treat COVID-19 among which 298 are therapeutic drugs and 140 prophylactic vaccines that are spread across all stages of development (Discovery, Preclinical, Phase I, Phase II, and Phase III). As of June 2020, over 2,341 clinical trials are investigating potential therapies for COVID-19, of which nearly 800 are interventional trials. The long and costly drug development process is anticipated to limit the growth of the COVID19 vaccine & therapeutics. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), the average cost of research and development of a new drug is approximately $2.6 billion. Moreover, the stringent regulations imposed by the various regulatory authorities such as European Medicines Agency and the US Food and Drug Administration (FDA) in regards with clinical trials during the COVID19 outbreak attributing to the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity is a major challenge faced by the COVID19 vaccine and therapeutics market. The compounds and medications that are under investigation can be grouped into three broad categories – antivirals, immune-system based, and vaccines. The anti-virals including Darunavir, Favipiravir, Hydroxychloroquine and chloroquine, Lopinavir, and Remdesivir (GS-5734), immune system-related therapies including Tocilizumab, Tocilizumab, and Vitamin C, and other medications are currently being evaluated as therapies. Three key drugs are currently in phase III, of which are two small molecule-based drugs, Remdesivir by Gilead Sciences Inc. and Favipiravir by Fujifilm Toyama Chemical Co Ltd, and Sarilumab, a monoclonal antibody by Regeneron Pharmaceutical. With regards to the prophylactic vaccine pipeline, more than 90% are in early-stage development (discovery and preclinical), and only three in Phase II. These three COVID-19 vaccines are being developed by Sinovac Biotech Ltd, the University of Oxford, and the third vaccine, named CIGB-2020, is being developed by the Center for Genetic Engineering and Biotechnology. Ever since the coronavirus hit the world as a global pandemic, many key vaccine developers are collaborating to develop potential COVID-19 vaccine against coronavirus. Most recently, on 21st May 2020, CanSino Biologics Inc. and Precision NanoSystems announced a co-development agreement of an mRNA lipid nanoparticle (mRNA-LNP) vaccine against COVID-19. The parties will leverage Precision NanoSystems`s proprietary RNA vaccine platform, comprising of lipid nanoparticle delivery system and the NanoAssemblr® manufacturing technology, to rapidly advance a COVID-19 mRNA-LNP vaccine candidate towards human clinical testing and pursuant to regulatory approvals, and commercialization in different regions. Precision NanoSystems will be responsible for the development of the mRNA-LNP vaccine and CanSinoBIO will be responsible for pre-clinical testing, human clinical trials, regulatory approval and commercialization. Similarly, on May 19, 2020, IPharmaJet®, the maker of innovative, needle-free injection technology announced that its Needle-free Injection System technology will be used to deliver a messenger RNA (mRNA) vaccine against SARS-CoV-2. The vaccine is being developed by Abnova Corporation, the world`s largest antibody manufacturer, based in Taiwan. Other Collaborations:

• • Moderna and Lonza also announced their strategic collaboration to manufacture Moderna’s Vaccine (mRNA-1273) against novel coronavirus.
• • AstraZeneca and the University of Oxford made an agreement for the global development and distribution of the University’s potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection from SARS-CoV-2.
• • Catalent signed an agreement with Johnson & Johnson to be U.S. manufacturing partner for lead COVID-19 vaccine candidate

The pharmaceutical drug market consists of sales of goods and related services by entities (organizations, sole traders and partnerships) that produce and sell pharmaceutical drugs used to treat various diseases. This industry includes establishments that produce drugs such as cardiovascular drugs, gastrointestinal drugs, genito-urinary drugs, hematology drugs and other drugs used to treat cardiovascular diseases, rare genetic disorders, infections, metabolic disorders, cancers, respiratory diseases and others.