Global Induced Pluripotent Stem Cell (iPSC) Market

The cell and gene therapy market consist of sales of cell and gene therapies by entities (organizations, sole traders and partnerships) that develop cell and gene therapies. Cell therapy refers to the transfer of intact, live cells that are originated from autologous or allogenic sources and gene therapy refers to the introduction, removal, or change in the genome for treating diseases. The market consists of revenue generated by the companies developing cell and gene therapy products by the sales of these products. The cell and gene therapy market covered in this report is segmented by product into cell therapy, gene therapy and by application into oncology, dermatology, musculoskeletal, others. The global cell and gene therapy market is expected to grow from $6.69 billion in 2020 to $7.96 billion in 2021 at a compound annual growth rate (CAGR) of 19%. 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 cell and gene therapy market is expected to reach $17.32 billion in 2025 at a CAGR of 21%. Steady investment and consolidation in cell and gene therapies contributed to the growth of the cell and gene therapy (CGT) market. After recognizing the potential of the CGT market, 16 out of the 20 largest biopharma companies by revenue, added CGT products to their portfolio. For instance, Merck invested $109 million in viral vector and gene therapy manufacturing in April 2020. Moreover, 12% of industrial clinical pipeline products and at least 16% of preclinical pipeline products consist of CGT. Steady investment and consolidation in CGT production capacity led to an increase in production capacity and also contributed to the growth of the market. Limited reimbursements preventing patients from receiving treatments are expected to limit the growth of cell and gene therapy (CGT market. In 2019, Trinity Life Sciences, a life sciences solution provider, researched national and large regional commercial health insurance plans in the US. It found that the confluence of increasing price, patient volume and number of CGTs on the market is likely to change the reimbursement model for CGTs and impact payer budgets by 5-10%. Payers realize that financing needs to be generated for cost management due to the uncertainty surrounding reimbursement of ancillary costs. Limited reimbursements and uncertain insurance plans are preventing patients from receiving high-cost CGT, which is expected to limit market growth. Chimeric antigen receptor (CAR) T-cell therapy is shaping the cell and gene therapy (CGT) market. CAR T-cell therapy is a combination of cell and gene therapy in which T cells are collected from the patient’s blood and are genetically engineered to produce modified receptors at their surface, known as chimeric antigen receptors (CARs). These modified T cells with special structures (receptors) are reinfused into the patient. Then, the modified receptors of T cell help in targeting the surface antigen of the cancer cell that ultimately results in the killing of tumor cells in patients. In 2020, the US-FDA approved Bristol-Myers Squibb's two CAR-T cell therapies to treat lymphoma and multiple myeloma and is set to be launched. Currently, FDA approved CAR-T cell therapy treatments like Tisagenlecleucel for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL) in children and Axicabtagene ciloleucel for the treatment of adult patients with relapsed or refractory large B-cell lymphoma. In December 2019, Roche, a Swiss multinational healthcare company, acquired Spark Therapeutics for $4.3 billion. The acquisition supports the commitment of Roche to bring transformational therapies and innovative approaches to people with serious illnesses. Spark Therapeutics will continue to work within the Roche Group as an independent company. Spark Therapeutics, headquartered in Philadelphia, is a fully integrated commercial company involved in the discovery, production, and distribution of gene therapies for genetic disorders including blindness, hemophilia, lysosomal storage, and neurodegenerative diseases. Major players in the cell and gene therapy market are Gilead Sciences, Bristol-Myers Squibb, Novartis AG, Amgen, Merck, Organogenesis Holdings, Dendreon, Vericel, Bluebird Bio, and Fibrocell Science. The regions covered in the cell and gene therapy market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the cell and gene therapy market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The global cell and gene therapy market is segmented - 1) By Product: Cell Therapy, Gene Therapy 2) By Application: Oncology, Dermatology, Musculoskeletal, Others 3) By End User: Hospitals, Ambulatory Surgical Centers, Cancer Care Centers, Wound Care Centers, Others

Human Microbiome Therapeutics Market Definition

The human microbiome therapeutics market consists of sales of microbiome and related services used as immunotherapeutic agents in the pharmaceutical industry. Microbiomes are used as immunotherapy for a wide variety of conditions, including infectious diseases, endocrine & metabolic disorders, inflammatory conditions, cancers, irritable bowel syndrome, neurological disorders, hematological disorders and cardiovascular diseases. The microbiome consists of the genetic material within a microbiota, which is the collection of microorganisms, such as bacteria, archaea, fungi, and viruses, in a specific niche, such as the human gut. For example, the gut microbiome consists of collective genome of microbes inhabiting the gut. Microbiomes are also known as the metagenome of the microbiota.

The nucleic acid-based gene therapy market consists of sales of nucleic acid-based gene therapy products and services. Gene therapy is used for correcting defective genes that are responsible for disease development. Moreover, nucleic acid-based therapeutics are used to treat genetic disorders and diseases for which there exists no permanent cure such as anaemia, sickle cell, cystic fibrosis, diabetes, and thalassemia. The nucleic acid-based gene therapy market covered in this report is segmented by technology into anti-sence and anti-gene, short inhibitory sequences, gene transfer therapy, nucleoside analogs, ribozymes, aptamers, others. It is also segmented by application into oncology, muscular dystrophy/ muscular disorders, rare diseases and by end user into hospitals and clinics, academic and research institutes. The global nucleic acid based gene therapy market is expected to grow from $0.56 billion in 2020 to $0.61 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 nucleic acid-based gene therapy market is expected to reach $0.85 billion in 2025 at a CAGR of 9%. Rising financial support by the government and the companies is projected to drive the demand for nucleic acid based gene therapy. Nucleic acid therapeutics are analogs of naturally occurring acids or proteins responsible for genetic expression. The traditional therapies do not have any cure for the treatment of diseases such as cystic fibrosis, hemophilia, sickle cell anaemia, thalassemia, and diabetes. Genetic profiling and molecular target identification form the backbone of these classes of drugs. Nucleic acid medication has greater potential for the treatment of these diseases, as they target the genetic basis of diseases and have a permanent cure. Rising financial support by the government and the companies dealing in the market for gene therapy is expected to contribute to increasing the demand for nucleic acid-based gene therapies. For instance in October 2019, the USA National Institutes of Health (NIH) announced plans to invest $100 million for the next four years to cure HIV and sickle cell disease with gene therapies. The government support for gene therapies will contribute to the growth of the market. Stringent regulations imposed on gene therapies raises the price of gene therapies, which in turn hinders the demand for nucleic acid-based gene therapies. The excessive regulatory oversights create an expensive and elongated route for approval increasing the expenses. According to Foundation for Economic Education (FEE), unlike other drugs approved or regulated by the Food and Drug Administration (FDA), gene therapies are not only subject to the regulatory structure of FDA, but also the Recombinant DNA Advisory Committee and Office of Biotechnology Activities. Also, as estimated by FEE, an approved gene therapy drug cost nearly $5.0 billion, which is five times higher than that of the average cost of FDA approval. The high cost of gene therapeutics drugs places them beyond the financial reach of the populace. This scenario is anticipated to restrain the market growth of the nucleic acid-based gene therapy market. In May 2018, Vectalys, a leading biotechnology company specializing in the manufacturing of high-quality solutions for gene delivery and FlashCell, a company engaged in developing non-integrated lentiviral delivered RNA Therapeutics announced the merger to create Flash Therapeutics, a privately held gene therapy company developing cell and gene therapeutics. The new company Flash Therapeutics is expected to focus on the development of RNA therapeutics based on LentiFlash, a non-integrative lentiviral delivery technology for incurable diseases. Major players in the nucleic acid-based gene therapy market are Wave Life Sciences, Imugene, Caperna, Phylogica, Protagonist Therapeutics, Benitec Biopharma, EGEN, BioMedica, Transgene and Copernicus Therapeutics. The regions covered in the nucleic acid-based gene therapy market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the nucleic acid-based gene therapy market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The global nucleic acid based gene therapy market is segmented - 1) By Technology: Anti-Sence and Anti-Gene, Short Inhibitory Sequences, Gene Transfer Therapy, Nucleoside Analogs, Ribozymes, Aptamers, Others 2) By Application: Oncology, Muscular Dystrophy/ Muscular Disorders, Rare Diseases 3) By End User: Hospitals And Clinics, Academic And Research Institutes

The cell culture market consists of sales of cell culture equipment and consumables for drug development and related services. Cell culture is the process by which cells are grown in suitable sterile environments under controlled conditions. Cell culture is one of the major tools used in molecular & cellular biology, manufacturing of medicines, and large-scale manufacture of biological compounds. The cell culture market covered in this report is segmented by type into primary cell culture, secondary cell culture, cell line. The cell culture market is also segmented by media into natural, artificial, and by applications into stem cell technologies, cancer research, biopharmaceutical, tissue engineering & regenerative medicine, others. The global cell culture market is expected to grow from $15.13 billion in 2020 to $16.45 billion in 2021 at a compound annual growth rate (CAGR) of 8.7%. 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 cell culture market is expected to reach $27.22 billion in 2025 at a CAGR of 13%. The rise in the demand for cell therapy is expected to drive the cell culture market. In cell therapy, viable cells are injected or implanted into a patient's body to cure a medicinal disease. Cell culture is a vital step in any cell-based therapy. According to the Cancer Research Institute (CRI), there are about 1,483 active cell therapies in development in 2020 compared to 1,011 in 2019. Cell culture is used in the development, manufacture, and commercialization of cell therapies and holds the potential to revolutionize the healthcare industry for the treatment of various diseases. Hence, a surge in the demand for cell therapy aids in the growth of the cell culture market. The lack of skilled professionals is expected to hinder the cell culture market’s growth. The consequence of having unskilled workers can also be detrimental to the bottom line of a company, as even a small batch error can cost an organization millions of dollars. The regulatory agency that issues the facility's license requires an annual report that includes all failed batches, and if the failure rate is more than 5%, the plant may be at risk of losing the ability to sell its drug. Furthermore, according to a skills survey by the Cell and Gene Therapy Catapult (CGTC) in 2019, UK cell and gene therapy firms are worried about the shortage of skilled manufacturing staff for the expansion of their business. The lack of talent is expected to adversely impact the growth of the cell and gene therapy industry, thereby restraining the growth of the cell culture market. The development of products for 3D cell culture by the companies operating in the cell culture market is gaining significant popularity. A 3D cell culture is an artificially created environment in which biological cells are permitted to grow or interact with their surroundings in all three dimensions, similar to how they would in a living organism. For instance, in July 2020, Rigenerand, an Italian company engaged in the production of innovative cell-based technology products for regenerative medicine and oncology, has launched a 3D bioreactor called VITVO handheld bioreactor to offer increased usability, sizing, closed system, and flexibility for 3D cell culture technologies. Similarly, Jellagen, a UK-based marine biotechnology company, launched JellaGel, a jellyfish collagen hydrogel, suitable for 3D cell culture and tissue engineering. In March 2020, Danaher, a US-based Fortune 500 science and technology company, has acquired the biopharma business of General Electric Life Sciences for an amount of $21.4 billion. As a part of Danaher, the company is to be called Cytiva and will be a standalone operating company within Danaher's Life Sciences segment. GE Biopharma’s offerings included cell culture media, single-use technologies, process chromatography hardware & consumables, development instrumentation and consumables, and service. Major players in the cell culture market are Thermo Fisher Scientific Inc., Corning, Inc., Becton, Dickinson and Company, Eppendorf AG, Merck KGAA, Lonza Group AG, Sartorius AG, Promocell GmbH, Danaher, Sartorius. The regions covered in the cell culture market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the cell culture market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The global cell culture market is segmented - 1) By Type: Primary Cell Culture, Secondary Cell Culture, Cell Line 2) By Media: Natural, Artificial 3) By Applications: Stem Cell Technologies, Cancer Research, Biopharmaceutical, Tissue Engineering & Regenerative Medicine, Others

The gene therapy market consists of sales of gene therapy related services by entities (organizations, sole traders and partnerships) that manufacture gene therapy drugs. Gene therapy is used to replace faulty genes or add new genes to cure disease or improve the body's ability to fight disease. Only goods and services traded between entities or sold to end consumers are included. The global gene therapy market is expected to grow from $3.18 billion in 2020 to $3.97 billion in 2021 at a compound annual growth rate (CAGR) of 24.8%. 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 market is expected to reach $12.16 billion in 2025 at a CAGR of 32%. Incidences of cancer and other target diseases have been increasing significantly, which is calling for effective treatments, driving the growth of the gene therapy market. The rise in the number of cancer cases across the globe is likely to contribute to the growth of the gene therapy 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 the cancer incidence rate globally is anticipated to boost the demand for the gene therapy market over the forthcoming years. Gene therapy is one of the most effective treatments in oncology. In this treatment, new genes are introduced into a cancerous cell or the surrounding tissue to cause cell death or slow the growth of cancer. For instance, in September 2019, RMIT University, Australia has found that non-viral gene therapy can be used to speed up cancer research, which can bring patient-friendly cancer treatment in the market. The high prices of gene therapy medicines are expected to limit the growth of the gene therapy market. The pressure to contain costs and demonstrate value is widespread. Political uncertainty and persistent economic stress in numerous countries are calling into question the sustainability of public health care funding. In less wealthy countries, the lack of cost-effective therapies for cancer and other diseases has influenced the health conditions of the population and has led to a low average life expectancy. Luxturna, a one-time treatment for acquired retinal eye disease, costs $850,000 in the US and £613,410 in the UK, despite a markdown that is applied through Britain's National Health Service. Zolgensma, for spinal muscular atrophy, is valued at $2.1 million in the US and Zynteglo, which focuses on a rare genetic blood disorder, costs $1.78 million, thus restraining the growth of the market. The use of machine learning and artificial intelligence is gradually gaining popularity in the gene therapy market. Artificial intelligence (AI) is the simulation of human intelligence in machines, which are programmed to display their natural intelligence. Machine learning is a part of AI. Machine learning and AI help companies in the gene therapy market to conduct a detailed analysis of all relevant data, provide insights between tumor and immune cell interactions, and offer a more accurate evaluation of tissue samples often conflicted between different evaluators. For instance, since January 2020, GlaxoSmithKline, a pharmaceutical company, has been investing in AI to optimize gene therapy and develop off-the-shelf solutions for patients. It is also expected to reduce turnaround time and also the cost of gene therapies. In December 2019, Roche, a Switzerland-based company, completed its acquisition of Spark Therapeutics for $4.3 billion. With this deal, Roche is expected to strengthen its presence in the gene therapy segment, support transformational therapies and increase its product portfolio. Spark Therapeutics is a US-based company involved in gene therapy. The major players covered in the global gene therapy market are Novartis AG, Bluebird Bio, Inc., Spark Therapeutics, Inc., Audentes Therapeutics, Voyager Therapeutics, Applied Genetic Technologies Corporation, UniQure N.V., Celgene Corporation, Cellectis S.A., Sangamo Therapeutics, Gilead Lifesciences, Inc., Orchard Therapeutics, Sibiono GeneTech Co., Ltd., Gensight Biologics S.A., Shanghai Sunway Biotech Co., Ltd., Biogen, Sarepta Therapeutics, Inc., Sangamo Therapeutics, Audentes Therapeutics, Regenxbio, Inc., Gegenxbio, Inc, Oxford BioMedica plc., Dimension Therapeutics, Inc., Bristol-Myers Suibb Company, Sanofi, Taxus Cardium Pharmaceuticals Group, Inc. (Gene Biotherapeutics), Shrine Plc, Benitech Biopharma, Transgene, Epeius Biotechnologies Corp., Calimmune, Inc. The countries covered in the global gene therapy market are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The regions covered in the global gene therapy market are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The global gene therapy market is segmented - 1) By Gene Type: Antigen, Cytokine, Suicide Gene, Others 2) By Vector: Viral Vector, Non-Viral Vector, Others 3) By Application: Oncological Disorders, Rare Diseases, Cardiovascular Diseases, Neurological Disorders, Infectious Diseases, Others 4) By End Users: Hospitals, Homecare, Specialty Clinics, Others

The pediatric vaccines market consists of sales of pediatric vaccines and its related services used to provide immunity to infants and children for specific diseases. The pediatric vaccine is a preparation of killed microorganisms, living attenuated organisms, or living fully virulent organisms that are administered to stimulate the production of antibodies and provide immunity against one or several diseases among children. Pediatric vaccines are used in childhood immunization schedules to enhance a child’s immunity or prevent diseases such as diphtheria, tetanus, pertussis, influenza, Hepatitis B, polio, and many other infectious and non-infectious diseases. The global pediatric vaccine market is expected to grow from $28.97 billion in 2020 to $32.44 billion in 2021 at a compound annual growth rate (CAGR) of 12%. 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 market is expected to reach $49.9 billion in 2025 at a CAGR of 11.4%. The rising prevalence of chronic diseases such as tuberculosis, diphtheria, and pneumonia in the age group of 15 years and below will contribute to the growth of the pediatric vaccines market. The risk of severe disease outcomes and complications of infectious diseases are increasing in children and adolescents with chronic conditions. According to the World Health Organization, chronic disease prevalence is expected to rise by 57% by the year 2020. The increased prevalence of chronic diseases among children rises the demand for immunization from chronic diseases, hence, driving the pediatric vaccines market’s growth. Vaccine refusal by parents for their children is a prevailing tradition in many countries. Among the reasons for withholding children for vaccination are lack of knowledge, religious and philosophical objections, exaggerated concerns regarding vaccine safety, and others. According to a nationwide survey found that over half (51%) of pediatric services in the United States have the policy to dismiss families that refuse childhood vaccines. Thirty-seven percent of pediatricians themselves said they often dismissed families for refusing vaccines, and 6% said they would dismiss a family for choosing to reach out to crucial early vaccines. Governments are imposing laws and organizing awareness programs to overcome parent’s and family’s resistance to the child’s vaccine, but are unable to impose any strict rules against parents’ refusal for children’s immunization, which is hindering the pediatric vaccines market’s growth. The demand for novel vaccines is steadily growing to deliver improved immunization against challenging infectious diseases (e.g. tuberculosis, HIV/ AIDS) and non-communicable chronic diseases such as cancer and neurodegenerative diseases. Novel approaches to vaccine development include structural immunogenic design, gene-based vaccine platforms, and effective adjuvant recombinant antigen formulations. To meet the increasing demand for novel vaccines, there is a continuous quest for pediatric vaccine manufacturers and developers for innovation of vaccine design and manufacturing technologies. For instance, in January 2020, Hilleman laboratories, global research, and development organization, has announced their plans to develop a novel vaccine against Group B Streptococcus, a major cause for neonatal infections in women, in the area of maternal and child health. The major players covered in the global pediatric vaccine market are GlaxoSmithKline plc, Pfizer Inc., Sanofi S.A., Merck & Co., Inc., Indian Immunologicals Limited, AstraZeneca plc, CSL Limited, Mitsubishi Tanabe Pharma Corporation, Serum Institute of India Pvt. Ltd., Panacea Biotec Ltd., Zydus Cadila, BIO-MED, Squibb, Novartis, Abbott Laboratries, Eli Lillyand Company, F. Hoffmann- La Roche Ltd., Novo Nordisk A/S, VF Corporation, Sinovac Biotech Ltd., Bristol- Myers, Sun Pharmaceutical Industries Ltd, Sellas and Takeda Pharmaceutical Company Limited, Daiichi Sankyo, Bristol- Myers, Sinovac Biotec Ltd. The countries covered in the global pediatric vaccine market are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The regions covered in the global pediatric vaccine market are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The global pediatric vaccine market is segmented - 1) By Vaccine Type: Monovalent, Multivalent 2) By Technology: Live Attenuated, Inactivated, Toxoid, Conjugate, Other Technologies 3) By Application: Infectious Disease, Allergy, Cancer

The interferons market consists of sales of interferons, the biopharmaceuticals that are produced using living organisms, such as microorganisms and animal cells, and have a high-therapeutic value. The market consists of revenues generated by the establishments by the sales of various types of interferons such as alpha interferons, beta interferons and gamma interferons. The global interferons market is expected to grow from $7.46 billion in 2020 to $7.61 billion in 2021 at a compound annual growth rate (CAGR) of 2%. 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 $8.74 billion in 2025 at a CAGR of 3.5%. The pandemic outbreak of coronavirus is expected to drive the growth of interferons market. This is because of the ongoing trials on various drug candidates including interferons as potential therapeutic options for COVID-19 treatment. Interferon-beta (IFN-beta) is a naturally occurring protein that controls the body’s antiviral responses. The drug regulators including the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) have approved the initiation of trials evaluating interferons. For example, SNG001 which is an inhalation formulation of interferon-beta-1a that is delivered to the lungs directly via nebulization. The global interferon drugs market is projected to grow at a rapid pace in the next few years due to the increasing incidence of chronic diseases such as hepatitis-B, hepatitis-C, cancer and multiple sclerosis, the use of interferons in combinational therapies, and advent of novel drug delivery systems. Various types of interferon (IFN) have been used to treat these diseases and an important development in treating some of these diseases was the recognition that the clinical effects of IFN drug could be greatly enhanced by combining it with other drugs. For instance, IFN-a (interferon-alpha) in combination with ribavirin and polyethylene glycol molecule has shown significant improvements in virologic response and without any adverse effects. However, due to the poor stability of interferon-alpha in the gastrointestinal tract, only parenteral administration ensures bioavailability, which is associated with severe side effects. Studies showed that nanoencapsulation of IFN-a within nanoparticles would improve the oral bioavailability of this drug. The use of interferons in combinational therapies, and advent of novel drug delivery systems is therefore expected to drive the market for interferons. Interferons are also being tested for their use in the treatment of COVID-19. The development of interferons involves high R&D costs. The development of interferons is costlier than developing small molecules which are chemically synthesized, involves high operating costs, and requires a greater capital investment. This is because biologic drugs are more complex than small molecules and involve complex manufacturing processes. Additionally, manufacturers have to submit more data to demonstrate the efficacy and safety of these biologics in pre-clinical and clinical studies for successful registration. This makes the registration of biologics a costly and time-consuming process which is restraining the market growth. Due to the high R&D costs, and lengthy testing and manufacturing process, the marketed drugs would be priced much higher than the actual manufacturing costs, and this factor is likely to challenge the market growth. Biologics therapy is expensive and it places a substantial financial burden on the healthcare system. Increasing prevalence of diseases such as hepatitis, MS, and cancers in the world presented an opportunity to evaluate the clinical applications of biosimilars and have stimulated some of the local pharmaceutical companies to produce interferon biosimilar medications to compete (or replace) the original expensive brands. IFNs were initially investigated for their potential as antivirals, however, they are now commonly used in anti-HBV (hepatitis B virus) and anti-HCV (hepatitis C virus) therapy. The therapeutic potential of interferon biosimilars for hepatitis and cancer, coupled with the ongoing studies on interferon biosimilars to have prophylactic or therapeutic effectiveness in SARS (severe acute respiratory syndrome), influenza or another virus pandemic, is contributing to the increasing adoption of interferon biosimilars over expensive biologics. Bayer and Curadev Pvt. Ltd., a drug discovery company based in India, have announced a research collaboration and license agreement for Curadev’s Stimulator of Interferon Genes (STING) antagonist program. The objective of this collaboration between Bayer and Curadev is to discover new drug candidates for the treatment of lung diseases, cardiovascular diseases and other inflammatory diseases. STING antagonists have huge potential for new treatments as STING is known to help in activating the innate immune system in auto-inflammatory diseases. The major players covered in the global interferons market are Roche, Merck, Bristol-Myers Squibb, Biogen Inc, Bayer AG, Zydus Cadila, Novartis AG, Pfizer Inc, Biosidus, Nanogen, Amega Biotech, Rhein Minapharm Biogenetics, PROBIOMED, Schering-Plough Corporation, 3Sbio. The countries covered in the global interferons market are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The regions covered in the global interferons market are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The global interferons market is segmented - 1) By Type: Inteferon Alpha, Inteferon Beta, Inteferon Gamma 2) By Application: Hepatitis B, Hepatitis C, Melanoma, Leukemia, Multiple Sclerosis, Renal Cell Carcinoma 3) By Distribution Channel: Hospital Pharmacies, Online Pharmacies, Retail Pharmacies, Others

The antisense & RNAi therapeutics market consists of sales of antisense & RNAi therapeutics products and related services by entities (organizations, sole traders and partnerships) that develop antisense & RNAi therapeutics to treat various diseases. RNA interference (RNAi)-based and RNA-based antisense oligonucleotide therapies are advanced methods used for the treatment of various respiratory diseases including chronic obstructive pulmonary disease (COPD) and asthma. In addition to this, antisense & RNAi therapeutics finds its application in curing cancer, infectious diseases, cardiovascular diseases, and genetic disorders.

The global antisense & rnai therapeutics market is expected to grow from $1.11 billion in 2020 to $1.2 billion in 2021 at a compound annual growth rate (CAGR) of 8.1%. 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 market is expected to reach $1.79 billion in 2025 at a CAGR of 11%.

The rising prevalence of coronary artery diseases, neurodegenerative disorders, and infectious diseases is projected to contribute to the demand for the antisense & RNAi therapeutics market. Gene suppression approaches including RNA interference and antisense oligonucleotides are used for the treatment of various neurodegenerative conditions by repairing mutant genes. According to the National Institute of Environmental Health Sciences, Alzheimer’s disease and Parkinson’s disease is the most common neurodegenerative diseases affecting millions of people globally. In the USA, an estimated 930,000 people are expected to have Parkinson’s disease by the end of 2020. Furthermore, according to the World Health Organization (WHO), infectious diseases are a major concern and dominated the WHO’s list of 2019 health threats ranging from various climate change issues to inadequate healthcare facilities. Hence, the growing prevalence of several neurodegenerative diseases and infectious diseases is expected to drive the growth of the antisense & RNAi therapeutics market.

The high cost of RNA interference-based drugs is expected to act as a major restraint for the growth of the antisense & RNAi therapeutics market in the future. For instance, according to Future Medicine, the price of Onpattro is approximately $450,000 per year. Onpattro (patisaran) is the RNA interference-based drug used for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. Stringent regulations, long product approval process, high development cost, and a comparably small number of patients are few factors leading to the high cost of RNA interference drugs, which is expected to hinder the antisense & RNAi therapeutics’ market growth in upcoming years.

Major companies operating in the antisense & RNAi therapeutics market are undertaking strategic initiatives such as collaborations and partnerships for product innovation 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 with 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 August 2020, Blackstone Life Sciences, a global investment company, and Alnylam Pharmaceuticals, Inc., an RNAi therapeutics company, announced the closing of a $2 billion strategic financing collaboration to accelerate the advancement and development of RNAi therapeutics. Under the agreement, Alnylam Pharmaceuticals, Inc. will receive $150 million from Blackstone Life Sciences for the development of vutrisiran and ALN-AGT, Alnylam’s cardiometabolic disease programs. In 2018, Biogen and Ionis announced a collaboration to develop antisense drug candidates for neurological diseases. This collaboration utilizes Biogen’s expertise in neuroscience research and drug development and Ionis’ knowledge in RNA targeted therapies with the goal of developing a broad pipeline of investigational therapies. The two companies signed an agreement for 10 years.

In November 2019, Novartis International AG, a Switzerland-based pharmaceutical company acquired The Medicines Company, a US-based biopharmaceutical company, for $9.7 million. With the acquisition of The Medicines Company, Novartis International AG plans to enter RNA therapeutics by acquiring its last stage RNA interference drug designed for protection against cardiovascular diseases in twice-yearly shorts. The drug has met the primary endpoint in the three phases of clinical trials and is approved for the treatment of cardiovascular diseases in the USA in 2019 and the EU in early 2020. The Medicines Company is a US-based company focused on the development of RNA drug inclisiran that is used in the treatment of renal impairment and cardiovascular diseases.

The major players covered in the global antisense & RNAi therapeutics market are Alnylam Pharmaceuticals, Benitec Biopharma Ltd., Gene Signal, GlaxoSmithKline Plc, Ionis Pharmaceuticals, Marina Biosciences, Quark Pharmaceuticals, Sanofi S.A, Acuitas Therapeutics, Antisense Therapeutics Ltd., Arbutus Biopharma (formerly known as Tekmira Pharmaceuticals), Bio-Path Holdings Inc., Calando Pharmaceuticals, Dicerna Pharmaceuticals, Enzon Pharmaceuticals Inc, Gradalis, iCo Therapeutics, miRagen Therapeutics, Olix Pharmaceuticals, OncoGeneX Pharmaceuticals, Lorus Therapeutics (Aptose Biosciences), Regulus Therapeutics, Rexahn Pharmaceuticals, Rxi Pharmaceuticals, Santaris Pharma A/S (Roche), Sarepta Therapeutics, Silence Therapeutics Plc, Sirnaomics Inc., Tekmira Pharmaceuticals, Cenix BioScience, Sirnaomics.

The countries covered in the global antisense & RNAi therapeutics market are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA.

The regions covered in the global antisense & RNAi therapeutics market are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

The global antisense & RNAi therapeutics market is segmented - 1) By Technology: RNA Interference, Antisense RNA 2) By Route of Administration: Pulmonary Delivery, Intravenous Injections, Intra-dermal Injections, Intraperitoneal Injections, Topical Delivery, Other Delivery Methods 3) By Indication: Oncology, Cardiovascular Diseases (CVDs), Respiratory Disorders, Neurological Disorders, Infectious Diseases, Other