Biologics Industry Overview

The cell therapy market consists of sales of cell therapy and related services. Cell therapy (CT) helps repair or replace damaged tissues and cells. A variety of cells are used for the treatment of diseases includes skeletal muscle stem cells, hematopoietic (blood-forming) stem cells (HSC), lymphocytes, mesenchymal stem cells, pancreatic islet cells, and dendritic cells. The main type in cell therapy are stem cell therapy, cell vaccine, adoptive cell transfer (act), fibroblast cell therapy and chondrocyte cell therapy. Stem cell treatment, also known as regenerative medicine, uses stem cells or their derivatives to stimulate the healing response of sick, defective, or wounded tissue. The different types of therapies include allogeneic therapies, autologous therapies and is used in various applications such as oncology, cardiovascular disease (CVD), orthopedic, wound healing, others. The global cell therapy market size is expected to grow from $7.2 billion in 2020 to $7.82 billion in 2021 at a compound annual growth rate (CAGR) of 8.6%. The growth in the market 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 global cell therapy market is expected to reach $12.06 billion in 2025 at a CAGR of 11%. The rising prevalence of chronic diseases contributed to the growth of the cell therapy market. According to the US Centers for Disease Control and Prevention (CDC), chronic disease is a condition that lasts for one year or more and requires medical attention or limits daily activities or both and includes heart disease, cancer, diabetes, and Parkinson’s disease. Stem cells can benefit the patients suffering from spinal cord injuries, type 1 diabetes, Parkinson’s disease (PD), heart disease, cancer, and osteoarthritis. For instance, according to the Center for Diseases Control and Prevention report in 2021, due to poor nutrition, and lack of physical activity, 6 in 10 adults in the USA are suffering from a chronic disease and 4 in 10 have two or more diseases. According to International Diabetes Federation, in 2019, globally 463 million people have diabetes and the number is expected to rise to 700 million by 2045. According to the Parkinson’s Foundation, every year, 60,000 Americans are diagnosed with PD, and more than 10 million people are living with PD worldwide. The growing prevalence of chronic diseases increased the demand for cell therapies and contributed to the growth of the market. The high cost of cell therapy hindered the growth of the cell therapy market. Cell therapies have become a common choice of treatment in recent years as people are looking for the newest treatment options. Although there is a huge increase in demand for cell therapies, they are still very costly to try. Basic joint injections can cost about $1,000 and, based on the condition, more specialized procedures can cost up to $ 100,000. In 2020, the average cost of stem cell therapy can range from $4000 - $8,000 in the USA. Therefore, the high cost of cell therapy restraints the growth of the cell therapy market. Key players in the market are strategically partnering and collaborating to expand the product portfolio and geographical presence of the company. For instance, in October 2021, Takeda, a Japan based pharmaceutical company acquired GammaDelta Therapeutics, a US based company that offers cell therapies, to speed up the development of allogeneic T cell therapies for solid tumours. Furthermore, in November 2020, Sanofi, a US based pharmaceutical company acquired Kiadis, a Netherlands based pharmaceutical company, to boost cell therapy which is used to develop treatments for life-threatening diseases. In August 2019, Bayer AG, a Germany-based pharmaceutical and life sciences company, acquired BlueRock Therapeutics, an engineered cell therapy company, for $1 billion. Through this transaction, Bayer AG will acquire complete BlueRock Therapeutics’ CELL+GENE platform, including a broad intellectual property portfolio and associated technology platform including proprietary iPSC technology, gene engineering, and cell differentiation capabilities. BlueRock Therapeutics is a US-based biotechnology company focused on developing engineered cell therapies in the fields of neurology, cardiology, and immunology, using a proprietary induced pluripotent stem cell (iPSC) platform. Major players in the cell therapy market are Fibrocell Science Inc., JCR Pharmaceuticals Co. Ltd., PHARMICELL Co. Ltd., Osiris Therapeutics Inc., MEDIPOST, Vericel Corporation, Anterogen Co. Ltd., Kolon TissueGene Inc., Stemedica Cell Technologies Inc. and AlloCure. The regions covered in the cell therapy market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the cell therapy market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA The global cell therapy market is segmented - 1) By Type: Stem Cell Therapy, Cellular Immunotherapy 2) By Therapy Type: Allogeneic Therapies, Autologous Therapies 3) By Application: Oncology, Cardiovascular Disease (CVD), Orthopedic, Wound Healing, 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 main types of vectors in gene therapy are viral vector, non-viral vector, others. Viral vectors are methods that molecular biologists often utilise to convey genetic material into cells.It is used in oncological disorders, rare diseases, cardiovascular diseases, neurological disorders, infectious diseases, others and implemented in various sectors such as hospitals, homecare, specialty clinics, others. The global gene therapy market size 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 in the market 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 global gene therapy 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. Major players in the 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. and Sangamo Therapeutics. The regions covered in the gene therapy market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the gene therapy market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The global gene therapy market is segmented - 1) By Vector: Viral Vector, Non-Viral Vector, Others 2) By Application: Oncological Disorders, Rare Diseases, Cardiovascular Diseases, Neurological Disorders, Infectious Diseases, Others 3) By End-User: Hospitals, Homecare, Specialty Clinics, Others Sub Segments: 1) By Viral Vector: Adenovector, Retro Vector, Lentivector, Others 2) By Non-Viral Vector: Nucleic Acid Based Gene Therapy, Electroporation, Lipofection 3) Other Vector: Bacterial Vectors, Yeasy Vectors, Others

The microbiome market consists of sales of microbiomes drugs and related services. Microbiome therapy aims at restoring balanced gut microbiota and is expected to decrease the risk of infection recurrence and greatly increase the quality of life of patients. The main types of microbiomes are bacteria and other microbiome. Bacteria are ubiquitous, generally free-living creatures that typically consist of a single biological cell. The different technologies include genomics, proteomics, metabolomics and is used in inflammatory bowel disease, diabetes, multiple sclerosis, rheumatoid arthritis, others. The global microbiome market size is expected to grow from $0.27 billion in 2020 to $0.37 billion in 2021 at a compound annual growth rate (CAGR) of 37%. The growth in the market 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 global microbiome therapy market is expected to reach $0.94 billion in 2025 at a CAGR of 26%. The increasing prevalence of inflammatory bowel disease (IBD) is a key factor driving the growth of the microbiome market. Inflammatory bowel disease (IBD) is a multifactorial and autoimmune infection group consisting of two major entities such as ulcerative colitis (UC) and Crohn's disease (CD). Fecal microbiota transplantation (FMT) and probiotics were discovered as potential applications in many immune-mediated disorders, such as IBD, to restore microbial balance. These microbial therapies have shown the potential to reduce both the dysbiotic condition and the development of inflammatory mediators, thereby enabling remission, particularly in UC. In 2019, approximately 1.6 million people in the United States suffered from untreatable inflammatory bowel disease (IBD), including Crohn's or ulcerative colitis. Therefore, the increasing prevalence of inflammatory bowel disease (IBD) is expected to drive the growth of the microbiome market. The high cost of microbial therapy is a key factor hampering the growth of the microbiome market. The price of fecal transplantation, a microbial therapy, may vary considerably depending on the delivery method used by users and where users receive it. Fecal microbiota transplant processes can charge around $600-$1,000 based on the method of treatment, area, insurance coverage and other variables. Therefore, the high cost of microbial therapy is expected to hinder the growth of the microbiome market. The growing technological improvement is a major trend gaining popularity in the microbiome market. Major companies in the microbiome sector are focusing on developing advanced technology solutions for microbiomes. For instance, Seed, a new microbiome company, has introduced Probiotic and Prebiotic Daily Synbiotica for both females and males. The Daily Synbiotic Seed is the first to follow a microbe-system strategy with strain-specific advantages beyond digestive health such as cardiac safety, dermatological health, immune control, reproductive health, the integrity of the gut barrier and oxidative stress. In January 2021, Novozymes, a Denmark based biotechnology company acquired Microbiome Labs for an undisclosed amount. Microbiome Labs’ acquisition is a crucial step in expanding Novozymes’ Human Health platform, giving it exposure to a wide range of patented solutions as well as access to the firm’s network of health professionals. Microbiome Labs is a US-based probiotics company. Major players in the microbiome market are MicroBiome Therapeutics LLC, Seres Therapeutics, Enterome Bioscience, Second Genome, Vedanta Biosciences Inc, AbbVie Inc., Rebiotix, Inc., Ritter Pharmaceuticals, LNC Therapeutics Inc. and ViThera Pharmaceuticals Inc. The regions covered in the microbiome therapy market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the microbiome market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The global microbiome market is segmented - 1) By Type: Bacteria, Others 2) By Application: Inflammatory Bowel Disease, Diabetes, Multiple Sclerosis, Rheumatoid Arthritis, Others 3) By Technology: Genomics, Proteomics, Metabolomics

The monoclonal antibodies (MAbs) market consists of sales of monoclonal antibodies and related services. Monoclonal antibodies are used to enhance and suppress the immune response in various medical conditions and to treat various diseases such as cancer, cardiovascular and cerebrovascular diseases. This industry includes establishments that produce anti-cancer monoclonal antibodies to prevent metastasis by reducing cell proliferation, immunological monoclonal anti-bodies, neuropharmacological monoclonal anti-bodies, anti-infective monoclonal antibodies, and other MAbs for human beings and animals. The main types of sources in monoclonal antibodies (MAbs) are murine, chimeric, humanized and human. A murine antibody has two types of chains, one of which is from a mouse and the other from a human. The pre-stem -o- in a murine antibody's INN is used to identify it. It is used in anti-cancer, immunological, anti-infective MAbs, neuropharmacological, cardiovascular and cerebrovascular, others and implemented in various sectors such as hospitals, private clinics, research institute. The global monoclonal antibodies (MAbs) market size is expected to grow from $168.70 billion in 2021 to $188.18 billion in 2022 at a compound annual growth rate (CAGR) of 11.5%. The growth in the market 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 MAbs market is expected to reach $292.22 billion in 2026 at a CAGR of 11.6%. The Increasing prevalence of cost-efficient biosimilar monoclonal antibodies are driving the monoclonal antibodies market growth. The biosimilar aim is to curb the increasing healthcare cost and handle economic pressure from the patient pod and governments to reduce the cost of medication and increase access to treatment. Biosimilar is the pharmaceuticals that are developed to have similar properties to a biologic drug that has already been approved. A biosimilar monoclonal antibody costs 20%-25% lesser than the originator biologic drug. The number of clinical trials for a biosimilar is comparatively lesser than that of the original biologic drug and this proves to be the reason for the low cost of a biosimilar drug. In India, a new biosimilar policy called the ‘Guidelines on Similar Biologics’ prepared by the Central Drugs Standard Control Organization (CSDCO) is expected to give a major boost to the Indian biosimilar drugs industry. Alternative treatment methods and natural remedies are increasingly becoming popular globally and this is expected to have a negative impact on the revenues of the monoclonal antibody drugs market. Treatments in the fields of homeopathy, Ayurveda, yoga, acupuncture, sujok therapy are gaining popularity and slowly replacing some traditional hospital practices. For instance, the revenue of US retail sales of homeopathic and herbal remedies was around $7.5 billion. These less expensive alternatives increase competitiveness for the biologics market putting downward pressure and limiting the demand for monoclonal antibody drugs. The monoclonal antibodies market has been witnessing multiple strategic initiatives in recent years. Top companies in the market are strategically acquiring start-ups and mid-sized companies to broaden products and services. Strategic collaborations or acquisitions and partnership agreements help vendors expand their existing product portfolio and geographical reach. For instance, In February 2019, AbCellera and Novartis enter into a multi-target partnership to create an antibody-drug discovery platform and technology for treating clinically-relevant and neurodegenerative diseases. Furthermore, AbCellera collaborated with GlaxoSmithKline (GSK), a pharmaceutical company, for the discovery of monoclonal antibodies against an undisclosed membrane protein target. Merck completed the acquisition of Sigma-Aldrich Corp., a leading life science company. Post this acquisition, Merck has more than 50,000 employees, 72 manufacturing sites, and a presence in 67 countries worldwide. Companies in the industry are increasingly realigning their portfolios and pursue profitable inorganic growth opportunities. Additionally, M&A interest is also being fueled by stronger corporate balance sheets, liquid debt markets, and continued favorable interest rates globally. The Food and Drug Administration (FDA) is a federal agency of the United States Department of Health and Human Services, in the USA regulating the monoclonal antibodies and pharmaceutical drugs market. Increasing product launches and regulatory support for the treatment of rare diseases by USFDA is expected to support the monoclonal antibody therapeutics market growth. For instance, the U.S. FDA granted accelerated approval to avelumab (BAVENCIO, EMD Serono, Inc.), a human monoclonal antibody, for the treatment of a rare disease, metastatic Merkel cell carcinoma (MCC). Similarly, the U.S FDA granted accelerated approval to immunotherapy product- TECENTRIQ (atezolizumab), a humanized, engineered monoclonal antibody, for the treatment of people with locally-advanced or metastatic urothelial carcinoma (mUC). Major players in the monoclonal antibodies (MAbs) market are Johnson & Johnson, Merck, AbbVie, Amgen, GlaxoSmithKline plc., Norvatis AG, Pfizer Inc, Thermofischer Scientific, Elililly and Company and Bristol-Myers Squibb. The regions covered in the monoclonal antibodies market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the MAbs market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The global monoclonal antibodies (MAbs) market is segmented - 1) By Source: Murine, Chimeric, Humanized, Human 2) By Application: Anti-Cancer, Immunological, Anti-Infective Monoclonal Antibodies (MAbs), Neuropharmacological, Cardiovascular and Cerebrovascular, Others 3) By End-User: Hospitals, Private Clinics, Research Institutes

The therapeutic proteins market consists of sales of therapeutic proteins. Therapeutic proteins provide important therapies for diseases such as diabetes, cancer, infectious diseases, hemophilia, and anemia. The main types of products in therapeutic proteins are insulin, fusion protein, erythropoietin, interferon, human growth hormone and follicle stimulating hormone. Insulin is a peptide hormone produced by beta cells in the pancreatic cells that serves as the individual 's primary anabolic hormone. It affects fat, carbohydrate and protein metabolism by boosting glucose uptake from the blood into the fat, liver and skeletal muscle cells. The different functions include enzymatic and regulatory activity, special targeting activity, vaccines, protein diagnostics and is used in various applications such as metabolic disorders, immunologic disorders, hematological disorders, cancer, hormonal disorders, genetic disorders, others. The global therapeutic proteins market size is expected to grow from $100.06 billion in 2021 to $112.17 billion in 2022 at a compound annual growth rate (CAGR) of 12.1%. The growth in the market 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 therapeutic protein market is expected to reach $177.30 billion in 2026 at a CAGR of 12.1%. Advance technologies for protein-based drug development drives the therapeutic proteins market. Therapeutic proteins cannot be synthesized chemically, they need to be produced by genetic engineering and recombinant DNA technology in living cells or organisms. Protein-engineering platform technologies such as glycoengineering, pegylation, Fc-fusion, albumin fusion, albumin drug conjugation help to increase the production yield, product purity, circulating half-life, targeting, and functionality of therapeutic protein drugs. Belimumab, ipilimumab, taliglucerase alfa, albiglutide, coagulation factor IX recombinant human are some therapeutic protein drugs developed using protein engineering technologies approved by FDA in the past five years. Increasing biosimilar drugs in global market decline the growth of the therapeutic proteins market. Patent expiry of therapeutic proteins such as monoclonal antibodies give space for entry of biosimilar. In EU, AbbVie evidenced patent expiration of Humira (adalimumab) in 2018, five biosimilar of Humira from Mylan, Amgen, Sandoz, Samsung Bioepis received drug approvals from European commission to enter the EU market. These cost-effective treatments similar to original biologics decline the revenue and sales of therapeutic proteins. Monoclonal antibody drug approvals are increasing in the protein therapeutic segment. Chronic diseases such as cancer, immunological disorders are well treated with monoclonal antibodies. Monoclonal antibodies are dominant and well-established product class in the protein therapeutic segment with more safety and immunogenicity than antibodies. Cell-based expression systems such as Chinese hamster ovary (CHO) mammalian cell expression system with latest technologies increased the productivity of monoclonal antibodies by overcoming the problems associated with earlier antibody drugs. In last five years, FDA approved 213 drugs, among them 44 are monoclonal antibodies. For instance, twelve monoclonal antibodies were approved by FDA for the treatment of cancer and immunological disorders. In the United States, therapeutic protein drug manufacturers file therapeutic biologics application (BLA) to FDA for the product approvals. The drug approved through BLA should be proved as safe, pure and potent. FDA consolidated review of most therapeutic proteins in Center for Drug Evaluation and Research (CDER). In European Union, biologics are regulated by Committee for Medicinal Products for Human Use (CHMP) for marketing authorization. In July 2021, Eli Lilly and Company, a US-based pharmaceutical company acquired Protomer Technologies Inc. for $ 1 billion. Lilly is delighted to add protomer’s breakthrough technology to its diabetes pipeline through this acquisition, since the company’s glucose-sensing insulin programme, which is based on its proprietary molecular engineering of protein sensors (MEPS) platform, is exhibiting great potential. Protomer Technologies Inc. is a US-based company that specializes in next-generation protein therapies which can detect molecular activators in the body that are being developed. Major players in the therapeutic proteins market are Abbott Laboratories, Amgen Inc., Baxter International Inc., Eli Lilly and Company, F. Hoffmann-La Roche Ltd, Pfizer Inc, Johnson & Johnson, Merck & Co. Inc, Novo Nordisk A/S and Sanofi. The regions covered in the therapeutic proteins market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the therapeutic proteins market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The global therapeutic proteins market is segmented - 1) By Product Type: Insulin, Fusion Protein, Erythropoietin, Interferon, Human Growth Hormone, Follicle Stimulating Hormone 2) By Application: Metabolic Disorders, Immunologic Disorders, Hematological Disorders, Cancer, Hormonal Disorders, Genetic Disorders, Others 3) By Function: Enzymatic and Regulatory Activity, Special Targeting Activity, Vaccines, Protein Diagnostics

The biosimilars market consists of sales of biosimilars and related services that are used to treat chronic diseases such as diabetes, arthritis, and cancer. Biosimilars are pharmaceuticals that are manufactured using cell lines and offer no clinical difference as compared to biologics. Biosimilars are made once the patent of biologics is expired. The main types of biosimilars are human growth hormone, erythropoietin, monoclonal antibodies, insulin, interferon, granulocyte-colony stimulating factor and others. Erythropoietin is a hormone produced by the kidneys to stimulate the production and maintenance of vital red blood cells. The various products include recombinant non-glycosylated proteins and recombinant glycosylated proteins that are used for the treatment of oncology, chronic and autoimmune diseases, growth hormone deficiency, infectious diseases and others. The global biosimilars market size is expected to grow from $15.67 billion in 2021 to $19.10 billion in 2022 at a compound annual growth rate (CAGR) of 21.8%. The growth in the market 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 biosimilar market is expected to reach $42.30 billion in 2026 at a CAGR of 22%. The rising prevalence of chronic diseases such as arthritis, asthma, and cancer is expected to be a major driver of the biosimilars market. Long working hours, limited physical activity, unhealthy eating and drinking habits contribute to the prevalence of chronic diseases and biosimilars are increasingly used to treat these chronic diseases. Biosimilars activate the immune system response against cancer cells thus helping the immune system to eliminate the cancer cells from the body. According to a United Nations article, by 2030 the proportion of global deaths due to chronic diseases is expected to increase to 70% of total deaths. The global burden of chronic disease is expected to reach about 60%. Therefore, the rise in the prevalence of chronic diseases is projected to propel the demand for biosimilars, thus driving the biosimilars market. The lack of awareness about biosimilars among primary care physicians (PCPs) and specialists limits the growth of the biosimilars market. Biosimilars are manufactured from cell lines and offer the same effectiveness as biologics. However, lack of familiarity with biosimilars reduces the likelihood of prescribing the drugs to patients which affects the demand for new biosimilars in the market. For instance, according to the PwC’s Health Research Institute, out of 442 clinicians surveyed 55% of clinicians were unfamiliar with biosimilars and 35% were reluctant to prescribe them due to concerns included safety of the follow-on biologic. Thus, the lack of awareness about biosimilars among primary care physicians and specialists restricts the growth of the biosimilars market. Production of new insulin biosimilars is trending in the biosimilars market. The key players operating in the biosimilars market are investing in creating a biosimilar of insulin. This is also promoting competition among various biosimilar manufacturers. For instance, in 2019, Mylan, a U.S-based pharmaceutical company, in partnership with Biocon, an Indian based biopharmaceutical company launched biosimilar insulin glargine named Semglee. Also, in 2019, Oramed Pharmaceuticals, a Jerusalem based pharmaceutical company developed an oral insulin drug named ORMD-0801 to treat type 2 diabetes. Thus, companies in the biosimilars market are investing in the development of insulin biosimilar to gain profits. Major players in the biosimilars market are Pfizer, Amgen, Biocon, Celltrion, Dr. Reddy's Laboratories, Boehringer Ingelheim, Elli Lilly and Company, Mylan N.V., Sanofi, STADA Arzneimittel, Sandoz International, Samsung Bioepis, Teva Pharmaceuticals, Apotex, AMEGA Biotech S.A., Bioton S.A., Innovent Biologics International, Allergan plc, BioXpress Therapeutics, 3SBio, Intas Biopharmaceuticals, Lupin Merck, Novartis, Ratiopharm, Wockhardt, Zydus Cadila, Allergan Plc., Hospira International., Actavis International., Johnson & Johnson and Roche. North America was the largest region in the biosimilars market in 2021. The Middle East is expected to be the fargest growing region in the forecast period. The regions covered in the biosimilars market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the biosimilars market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The global biosimilars market is segmented - 1) By Product: Recombinant Non-Glycosylated Proteins, Recombinant Glycosylated Proteins 2) By Type: Human Growth Hormone, Erythropoietin, Monoclonal Antibodies, Insulin, Interferon, Granulocyte-Colony Stimulating Factor, Others 3) By Application: Oncology, Chronic and Autoimmune Diseases, Growth Hormone Deficiency, Infectious Diseases, Others

The digestive enzymes market consists of sale of digestive enzymes and related services used to ease up the digestion of food in stomach. Digestive enzymes are enzymes in the digestive system that break large molecules into smaller digestible molecules to be absorbed by the body. The digestive enzymes market commercially provides these enzymes as dietary supplements or drugs to be taken orally when the body fails to produce enough enzymes naturally for the digestion of fats, proteins and carbohydrates. The main types of digestive enzymes are carbohydrates, protease, lipase and other enzyme types. Lipase is a protein produced by the pancreas; a small organ located near the stomach that aids in fat digestion. The enzymes are originated from animal, fungi, microbial, and plant that are used for indigestion, chronic pancreatitis, irritable bowel syndrome and other applications. The various distribution channel include retail stores and online stores. The global digestive enzymes market size is expected to grow from $0.75 billion in 2021 to $0.82 billion in 2022 at a compound annual growth rate (CAGR) of 9.2%. The growth in the market 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 digestive enzymes market is expected to reach $1.17 billion in 2026 at a CAGR of 9.3%. The rising prevalence of gastrointestinal disorder among different age groups drives the growth of the digestive enzymes market. Gastrointestinal disorders include disorders in the gastrointestinal tract starting from mouth, oesophagus, stomach, small intestine, large intestine, and anus caused due to lack of digestive enzymes. The gastrointestinal disorders require the digestive enzymes to be taken orally as a dietary supplement or as a drug. The increased rates of gastrointestinal disorders are linked to smoking, diet and genetics, sanitation, increased use of antibiotics and the changing environmental factors due to industrialization and urbanization. According to the American Gastroenterological Association’s survey published in April 2020 on worldwide prevalence and burden of functional gastrointestinal disorder, among 73,076 adult respondents, about 40.3% people met diagnostic criteria for at least 1 functional gastrointestinal disorders (FGIDs). FGID were more prevalent among women than men. A large-scale multinational study found that more than 40% of population is having FGIDs across the globe. Therefore, the increase in the prevalence of digestive diseases contributes to the growth of the market. The potential side effects of digestive enzyme supplements and drugs restrain the growth of digestive enzymes market. Continuous intake of digestive enzyme increases dependency on the digestive enzymes resulting in weaker digestive system over time. The weakened digestive system leads to digestive distress, gas, nausea, bloating, decreased stomach acid and allergic reactions accompanied with diarrhoea, and vomiting. For instance, digestive enzyme bromelain causes thinning of the blood and increases the risk of excess bleeding. The thinning of the blood is the result of the anti-platelet activity caused by the drug. Thus, the side effects caused by the excess and continuous intake of digestive enzymes negatively impacts the growth of the digestive enzyme market. The companies in digestive enzymes market are investing towards developing customized digestive enzymes. These customized digestive enzymes are condition-specific enzymes to support digestion for digestive sensitive patients and may contain multiple enzymes in the same product. The companies involved in manufacturing digestive enzymes are developing customized digestive enzymes to ease the digestion of different types of food. For instance, Sabinsa, a USA based provider of herbal extracts, cosmeceuticals, minerals, dietary supplements, formulated DigeZyme. DigeZyme is a multi-enzyme complex comprising of five different enzymes, namely, cellulase, lactase, amylase, lipase, and protease. It is widely used by the people who have difficulty in digesting carbohydrates, fats, and proteins, respectively. The companies are increasingly investing towards developing customized digestive enzymes. In January 2020, Nestlé, a Switzerland based food and drink processing corporation, entered into an asset purchase agreement with Allergan, an Ireland based pharmaceutical company that acquires, develops, and markets brand name drugs, to acquire Zenpep for an amount undisclosed. Through the acquisition Nestle aims to expand its medical nutrition portfolio by including Zenpep product to support food ingestion, digestion and absorption. Zenpep is a medication for people who cannot digest food properly due to the lack of digestive enzymes. Major players in the digestive enzymes market are Garden of Life, Biotics Research Corporation, Klaire Laboratories, Abbott Nutrition, AbbVie Inc., Allergan PLC, Johnson & Johnson Inc. Amway Corporation, Food State Inc., Matsun Nutrition, Metagenics Inc., Twinlab Corporation, Food State Inc., AST Enzymes, VEMO 99 OOD, Advanced Vital Enzymes Pvt. Ltd., Zeus Biotech Limited, Vox Nutrition Inc., Enzyme Bioscience Pvt. Ltd., Metagenics, XYMOGEN Inc., Douglas Laboratories, Thorne Research, Integrative Therapeutics LLC, Pure Encapsulations, Ortho Molecular Products Inc., Designs for Health Inc., Master Supplements Inc., and Proteozymes. North America was the largest region in the digestive enzymes market in 2021. The Middle East is expected to be the fargest growing region in the forecast period. The regions covered in the digestive enzymes market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the digestive enzymes market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The global digestive enzymes market is segmented - 1) By Enzyme Type: Carbohydrates, Protease, Lipase, Other Enzyme Types 2) By Origin: Animal, Fungi, Microbial, Plant 3) By Application: Indigestion, Chronic Pancreatitis, Irritable Bowel Syndrome, Other Applications 4) By Distribution Channel: Retail Stores, Online Stores

The oncology biosimilars market consists of sales of medicine and drug related products for cancer treatment. Biosimilars are pharmaceuticals which are manufactured using cell lines and are exclusive to the manufacturer. The manufacturing of these cell line processes is a complex and time-consuming process. The main drug types of oncology biosimilars are monoclonal antibody, immunomodulators, hematopoietic agents and granulocyte colony-stimulating factor (G-CSF). Immunomodulators are a class of drugs that primarily target pathways involved in the treatment of multiple myeloma and a few other cancers. The types of cancer treated include breast cancer, colorectal cancer, blood cancer, neutropenia cancer, non-small cell lung cancer, others and the various distribution channel involved are hospital pharmacy, retail pharmacy and online pharmacy. The global oncology biosimilars market size is expected to grow from $3.27 billion in 2021 to $4.19 billion in 2022 at a compound annual growth rate (CAGR) of 28.3%. The growth in the market 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 oncology biosimilars market is expected to reach $11.35 billion in 2026 at a CAGR of 28.3%. The expiration of patent of biologics used for the treatment of cancer is driving the production of new oncology biosimilars. Biologics can be patented for a limited period and the expiration of patents for biologics allows the development of new biosimilars. Biologics are targeted drugs synthesized from living organisms which induces the immune system to attack cancer cells. Biosimilars are similar to biologics but are not identical and offers the same effectiveness as biologics at a reduced cost. According to the Center for Biosimilars, patents on nearly 20 oncology biologics will expire by 2023, leading to the development of new biosimilars in cancer care. The increased number of patent expiry is expected to boost the demand for the production of new oncology biosimilars, thus, driving the market growth for oncology biosimilars. The lack of awareness on biosimilars among primary care physicians (PCPs) and specialist limits the growth of the oncology biosimilars market. Biosimilars are manufactured from cell lines and offer the same effectiveness as biologics. However, lack of detailed awareness on the biosimilars amongst the prescribers reduces the prescriptions of biosimilars affecting the biosimilar market. For instance, as reported by the Health Research Institute of PricewaterhouseCoopers, out of 442 clinicians surveyed 55% of clinicians were unfamiliar with biosimilars and 35% were reluctant to prescribe them due to concerns included safety of the follow-on biologic. Thus, the lack of awareness about biosimilars among primary care physicians and specialists restricts the growth of the oncology biosimilars market. The pharmaceutical companies are increasingly investing in research and development to produce new oncology biosimilars. The companies are exploiting growth potential of rising biosimilar market by investing in their research and development (R&D) processes to support the research and production process of new biosimilars. For instance, in February 2021, Coherus and Junshi Biosciences announced a collaboration in which Coherus would in-license toripalimab, an anti-PD-1 antibody in the US and Canada. Coherus' plan is to build a leading immuno-oncology franchise using cash from its commercial biosimilar business. Also, in 2019, Biocon, India’s largest biotechnology company invested to acquire some assets of Pfizer Healthcare to set up R&D facility to boost biosimilar development. Major players in the oncology biosimilars market are Biocoin, Celltrion Inc., Dr. Reddy's Laboratories Ltd., Intas Pharmaceuticals Ltd., STADA Arzneimittel AG, Pfizer Inc., Apotex Inc., Teva Pharmaceutical Industries Ltd., Sandoz International GmbH, BIOCAD, Amgen, Hospira, F Hoffmann-La Roche, Baxter, Sanofi, Mylan and F Hoffmann-La Roche. North America was the largest region in the oncology biosimilars market in 2021. The Middle East is expected to be the fargest growing region in the forecast period. The regions covered in the oncology biosimilars market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the oncology biosimilars market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The global oncology biosimilars market is segmented - 1) By Drug Type: Monoclonal Antibody, Immunomodulators, Hematopoietic Agents, Granulocyte Colony-Stimulating Factor (G-CSF) 2) By Cancer Type: Breast Cancer, Colorectal Cancer, Blood Cancer, Neutropenia Cancer, Non-Small Cell Lung Cancer, Others 3) By Distribution Type: Hospital Pharmacy, Retail Pharmacy, Online Pharmacy