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.

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.

The coronavirus (COVID-19) current therapy market consists of sales of drugs currently used for the treatment of COVID-19 infection. The market report includes single-drug therapeutics and combination drug therapeutics used in treating COVID-19 patients. The market consists of revenue generated by the companies that manufacture coronavirus current therapeutics by the sales of these products. The global COVID-19 current therapy market is expected to grow from $10.83 billion in 2019 to $16.51 billion in 2020 at a compound annual growth rate (CAGR) of 52.5%. The growth is mainly attributed to the COVID-19 outbreak and the urgent need to treat the growing number of cases. With no effective therapeutics discovered so far, existing drugs such as Remdesivir, Hydroxychloroquine, Ritonavir, Lopinavir, Interferon Beta, among others are repurposed for the COVID-19 treatment. The market is then expected to stabilize and reach $27.27 billion in 2023 at a CAGR of 18.2%. North America is anticipated to be the largest region in the COVID-19 current therapy market by the end of 2020. The coronavirus (COVID-19) current therapy market covered in this report is segmented by drug type into antiviral (remdesivir, ritonavir, lopinavir), antimalarial (hydroxychloroquine), interferons (interferon beta), corticosteroid (dexamethasone), others, and by end-use into hospitals, clinics, research institutes, others. The outbreak of the pandemic COVID-19 contributed to the growth of coronavirus (COVID-19) current therapy market. On March 11, 2020, the World Health Organization (WHO) declared the outbreak as a global pandemic. According to the World Health Organization (WHO), there were 10,719,946 cases of COVID19 including 517,337 deaths reported to WHO as on 3rd July 2020, and this number is expected to grow soon. As there is no officially approved drug for COVID-19, the demand has risen significantly for repurposed drugs that are used for corona therapy. Countries across the world are facing shortages of drugs and the drug manufacturers are ramping up production to meet the global demand. Coronavirus Treatment Acceleration Program (CTAP) is a special emergency program initiated by the FDA for the development of potential COVID-19 therapies to be made available to the patients as quickly as possible. High costs involved in research and development of therapeutic drugs and vaccines and long waiting time required for each phase of clinical trials are expected to limit the growth of coronavirus (COVID-19) current therapy market. According to a recent study published in the Journal of Health Economics by Tufts Center for the Study of Drug Development, it is estimated to cost $2.6 billion in developing a new prescription medicine and gain marketing approval, and seven out of eight pipeline drugs will fail in the development process. Moreover, the time required for each phase of the clinical trial and drug approval process takes an average of 12 years for an experimental drug to reach the market. High costs and long waiting times for drug development are expected to hamper the coronavirus (COVID-19) current therapy market. Convalescent Plasma Therapy is used as an experimental therapy to treat COVID-19 patients. The blood plasma of patients who have recovered from a disease is called convalescent plasma (CP). Convalescent Plasma (CP) therapy is a type of passive antibody therapy in which blood plasma is isolated from patients who have recovered from the disease of interest and administered to the patient with severe disease to suppress the virulence and improve clinical symptoms. The blood plasma of recovered COVID-19 patients has antibodies to fight COVID-19 infection. According to guidance issued by the FDA, Convalescent Plasma Therapy is recommended as an investigational product during the public health emergency. By 30th April, 2020, around 2,004 participating sites adhering to a single expanded access protocol by the US FDA had been registered, around 7,774 patients have enrolled, and 3,809 of them have undergone convalescent plasma transfusion. The experimental convalescent plasma therapy is likely to gain attention if enough data is supporting the results. In March 2020, Sanofi and Regeneron Pharmaceuticals planned to initiate clinical trials of rheumatoid arthritis drug Kevzara (sarilumab) for the treatment of COVID-19 symptoms. The US Food and Drug Administration (FDA) approved Kevzara in 2017 to treat rheumatoid arthritis. The drug is part of an ongoing antibody partnership between Sanofi and Regeneron. Kevzara is a fully-human monoclonal antibody that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor. IL-6 may play a role in driving the overactive inflammatory response in the lungs of patients who are severely or critically ill with COVID-19. Following a review by the Independent Data Monitoring Committee (IDMC) of all available Phase 2 and Phase 3 data, the trial will be immediately amended so that only critical patients continue to be enrolled to receive Kevzara 400 mg.

The COVID19 drug-associated APIs market consists of sales of active pharmaceutical ingredients used in the manufacturing of COVID19 drugs. The active pharmaceutical ingredients are chemicals which are responsible for pharmacological activity in the human body and are used as a base in pharmaceutical drug or medicine. The APIs used for the preparation of COVID19 drugs and include Azithromycin, Fentanyl, Albuterol, Cisatracurium and others. The global COVID-19 associated API market is expected to grow from $4.07 billion in 2019 to $5.11 billion by the end of 2020 at a compound annual growth rate (CAGR) of 25.6%. The growth is mainly attributed to the COVID-19 outbreak and the urgent need to treat the growing number of cases. However, with the COVID-19 cases continuously increasing, restrictive containment measures involving social distancing are enforcing the closure of industries and other commercial activities. This has an impact on all stages from production to international trade attributing to transportation and supply chain disruptions. The market is expected to reach $6.02 billion in 2023 at a CAGR of 5.6%. Asia Pacific is anticipated to be the largest region in the COVID-19 associated API market by the end of 2020. The COVID19 drug-associated APIs market covered in this report is segmented by drug class into antimalarials, bronchodilators, antibiotics, antivirals, others. High demand for some antiretrovirals, antimalarials, sedatives, bronchodilators, and other respiratory drugs drives the demand for the active pharmaceutical ingredients (APIs) used in the production of COVID19 drugs. Active pharmaceutical ingredients (APIs) are the biologically active component used in manufacturing pharmaceutical drugs. Remdesivir and Favipiravir are two common antiviral medications used currently for the treatment of COVID19 patients. Remdesivir is a medication approved for emergency use in the USA and Japan for the treatment of COVID19 patients. Remdesivir gained emergency use authorization (EUA) from the FDA on May 1, 2020, based on its preliminary data showing a faster time to recovery in hospitalized patients with several diseases. Favipiravir, which used to treat influenza in Japan, has also shown a positive effect on COVID patients. As COVID-19 is a respiratory ailment, the demand for bronchodilators spiked significantly. Therefore, the increasing demand for antivirals, antimalarials, and bronchodilators is projected to boost the demand for COVID19 associated drug APIs market over the forecast period. The disruptions caused by the COVID19 outbreak in the supply chain of medical products limited the growth of the COVID-19 drug-associated APIs market in the past few months. The source for APIs plays a crucial part in the strategic plan to combat the COVID19 pandemic. The majority of APIs for generic drug manufacturing across the globe are sourced from India, with nearly 30% generic APIs used in the USA. The restrictions imposed on the export of pharma products owing to COVID19 supply chain disruptions restricted the market growth. For instance, India imposed an export ban on 26 pharma products and medical devices in March 2020. The ban was imposed attributing to the supply chain disruptions on API and other bulk drugs due to restrictive measures such as lockdown and closure of factories in many countries across the globe to ensure that the disease spread is contained. Thus, shortages caused by the disruptions in supply chains and restrictions imposed on the export of pharma products impacted the growth of the COVID19 drug-associated APIs market over the last few months. Key players operating in the pharmaceutical industry that manufactures COVID19 drug associated APIs are focusing on strategies such as plant capacity or production capacity expansion to meet the increasing demand due to the rising number of coronavirus cases across the globe. For instance, in March 2020, Alembic Pharmaceuticals Ltd announced that the company is ramping up the production for the company’s production for azithromycin to 20 tons per month. Likewise, In April 2020, FUJIFILM Corporation announced the expansion of its manufacturing capacity and increase in the production of influenza antiviral Avigan Tablet (Favipiravir) by nearly 2.5 times by the end of July. Avigan is currently undergoing clinical trials testing its safety and efficacy for the treatment of COVID19 patients. In February 2020, Dr. Reddy Labs announced the acquisition of the branded generics business of Wockhardt for an amount of $242 million (INR 1,850 crore). The acquisition is expected to scale-up the former company’s presence in home markets including India, Nepal, Sri Lanka, Bhutan, and the Maldives. The Wockhardt business consists of a product portfolio of 62 brands and in multiple therapy fields such as dermatology, neurology, respiratory, VMS, pain, gastroenterology, and vaccine. Wockhardt Ltd. was founded in 1999 and is a global biotechnology and pharmaceutical company based in Mumbai, India.

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 remdesivir market consists of sales of remdesivir drugs currently found effective in treating the COVID-19 disease. Remdesivir (RDV) is one of the promising drugs used currently for the treatment of the COVID19 disease. Gilead, the US drug manufacturer is expanding its Remdesivir production due to the high demand for this drug. RDV is a synthetic compound throughout the class of antiviral drugs that target RNA synthesis. Gilead`s antiviral remdesivir is being tested in multiple phase 3 clinical trials as a treatment for moderately and severely ill COVID-19 patients. Until January, the company wasn’t manufacturing more than a few doses of its experimental antiviral remdesivir, but currently, Gilead began advancing remdesivir and is rapidly expanding its production as the research showed that remdesivir might be effective against COVID-19. Gilead spent $50 million on research and development of the drug during the first quarter. The company expects to produce more than 140,000 rounds of its 10-day treatment regimen by the end of May. Gilead released preliminary results from its clinical trial on remdesivir, showing at least 50% of the patients treated with a five-day dosage of the drug have improved. The clinical trial involved 397 patients with severe cases of COVID-19. Gilead will focus on making remdesivir both accessible and affordable to governments and patients around the world. Taking into consideration the R&D investment, and the affordable price range, the drug is expected to generate an estimated $2 billion in sales in 2020. It is expected to grow at 29.02% and reach $4.2 billion in 2023. The revenue will then drop off in subsequent years. North America was the dominant region in the Remdesivir market in 2019. The remdesivir market covered in this report is segmented by route of administration into oral, intravenous. It is also segmented by dosage form into tablets, frozen solution, lyophilized solution and by distribution channel into hospitals, clinics, drug stores/pharmacies, online, others. Increasing prevalence of COVID-19 disease globally is a key factor driving the growth of the remdesivir market. According to the World Health Organization (WHO), there were 10,719,946 cases of COVID19 including 5,17,337 deaths reported to WHO as on 24th May 2020, and this number is expected to grow in the near future. American authorities have approved the immediate use of experimental remdesivir, which seemed to help several patients with coronavirus recover more quickly, and this was the first drug that helped to overcome COVID-19, which killed more than 300,000 individuals around the globe. Gilead Sciences, which is working to develop the drug, has seen its share of New York trading increase by more than 5.5% in the first quarter of 2020. The United States and Asia shares have increased expectation that an experimental drug will further support in the control of COVID-19 symptoms. Therefore, the increasing prevalence of COVID-19 disease across different parts of the globe is expected to drive the growth of the remdesivir market. The high cost associated with the drug is a key factor hampering the growth of the market. Gilead Sciences that produces remdesivir donates its initial supply of 1.5 million doses, but the company has demonstrated that it would have to begin charging the drug for sustainable production. There are various speculations on the pricing of the drug. According to the Institute for Clinical and Economic Review (ICER), the estimated price of Remdesivir would be between $4,580 to $5,080. The higher-end pricing of remdesivir is expected to hinder the growth of the market. Also, Gilead licensed remdesivir for COVID-19 to companies manufacturing generic drugs for sale in 127 countries. Five generic companies Cipla, Ferozsons Labs, Hetero Labs, Jubilant Lifesciences and Mylan will have the right to manufacture and sell generic versions of the drug in mostly lower-income countries, as well as higher-income countries that face significant obstacles to healthcare access. The licensees won’t pay royalties to Gilead until the pandemic is called off or until a second drug is approved. This is likely to challenge the growth of the market. In March 2020, Gilead Sciences, Inc., an America-based biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines, acquired Forty Seven Inc. for $4.9 billion. This acquisition will strengthen Gilead’s immuno-oncology research and development portfolio. Forty Seven Inc., an America-based clinical-stage immuno-oncology company focused on developing novel checkpoint therapies.