Oral Biologics And Biosimilars Global Market Report 2023 – By Therapy (Lymphocyte Modulators, Interleukin Inhibitors, and Tumor Necrosis Factor-Alpha Inhibitors), By Disease (Asthma, Crohn's Disease, Carcinoma, Arthritis, Diabetes, Multiple Myeloma, Enterocolitis, Multiple Sclerosis, Sarcoma, Psoriasis and Other Diseases), By Molecule Type (Vaccines, Proteins and Peptides, Monoclonal Antibodies, and Other Molecule Types), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies) – Market Size, Trends, And Global Forecast 2023-2032

Analgesics are the pain killers that are used to treat mild or severe pain, including musculoskeletal pain, surgical, trauma pain, cancer pain, or another type of pain. Examples of analgesics include codeine, hydrocodone, oxycodone, and methadone. The different types of analgesics are non-opioids and opioids. Non-opioid analgesics are pain relievers available over-the-counter (OTC) and by prescription. They are rapidly being promoted as a desirable, safe, and productive first-line therapeutic alternative to opioid drugs in a range of clinical settings for mild to severe acute and chronic pain. The different types of drugs include prescription analgesics, and OTC analgesics and involve various routes of administration, such as oral, intravenous, rectal, transdermal, and topical. It is used in internal analgesics, and external analgesics and distributed through various channels, such as hospital pharmacies, retail pharmacies, and drug stores. The global analgesics market is segmented – 1) By Type: Non-opioids, Opioids 2) By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Drug Stores 3) By Route of Administration: Oral, Intravenous, Rectal, Transdermal, Topical 4) By Drug Type: Prescription Analgesics, OTC Analgesics 5) By Application: Internal Analgesics, External Analgesics The global analgesics market size will grow from $111.15 billion in 2022 to $115.13 billion in 2023 at a compound annual growth rate (CAGR) of 3.6%. The Russia-Ukraine war disrupted the chances of global economic recovery from the COVID-19 pandemic, at least in the short term. The war between these two countries has led to economic sanctions on multiple countries, a surge in commodity prices, and supply chain disruptions, causing inflation across goods and services and affecting many markets across the globe. The market size for the global analgesics size is expected to grow to $127.80 billion in 2027 at a CAGR of 2.6%. A significant rise in the prevalence of chronic diseases is driving the analgesics Market. Analgesic drugs, also known as painkillers, are used to treat and reduce chronic or severe pain in the body resulting from various medical conditions. For instance, in September 2022, according to a report shared by WHO, a Switzerland-based health organization, chronic diseases which is sometimes referred to as noncommunicable diseases (NCDs), are conditions that develop over an extended period of time as a result of a combination of genetic, physiological, environmental, and behavioural variables. Noncommunicable diseases (NCDs) account for 41 million annual fatalities, or 74% of all fatalities worldwide. Before the age of 70, 17 million individuals per year pass away from an NCD. These untimely deaths account for 86% of the deaths in low- and middle-income nations. 77% of NCD-related deaths occur in low- and middle-income nations. Therefore, significant rise in the prevalence of chronic disease is driving the growth of the analgesics market. Major players in the analgesics market are Bayer Healthcare, Pfizer, Sanofi, Johnson & Johnson, Novartis AG, GlaxoSmithKline PLC., Reckitt Benckiser (RB), Endo Pharmaceuticals, Bristol-Myers Squibb, and Eli Lilly and Company. The growth of the analgesics market is restricted by the increasing use of biologics for the treatment of inflammatory and neuropathic pain. Biologics are drugs produced from living organisms and include several components derived from humans, animals, or microorganisms. These drugs may contain protein, modified human hormones, or cells that produce substances that suppress or activate parts of the immune system. Biologics can provide greater efficacy compared to analgesics, which provide effective pain relief to only 50% of the patients, and is thus widely used nowadays. Rising demand for biologics can adversely impact the growth of the Analgesics market. For instance, Pfizer and Lilly were granted approval by the FDA for developing Tanezumab, a biologics medicine. Companies in the analgesics market are increasingly focusing on acquisition as a strategy for growth. Leading analgesic drug manufacturers are acquiring smaller companies to gain a competitive advantage and strengthen their market position. These acquisitions are helping companies to expand geographically and gain specialized expertise in the research and development of new products. For instance, Analgesic Solutions, LLC was acquired by WCG. WCG intends to make use of the superior R&D capability of Analgesic Solutions, LLC to grow and position itself as a market leader in the Analgesic Market. The US Food and Drug Administration (FDA) and the UK's Medicines and Healthcare Products Regulatory Agency are some of the regulatory bodies that regulate the Analgesic Market. For instance, the FDA has provided guidelines on the manufacturing process of analgesics, and safety measures regarding the use of both opioid and non-opioid analgesics. FDA also regulates and monitors the misuse and abuse of opioid analgesics. Opioid analgesics are prohibited from being sold without a proper medical prescription. Similarly, the Medicines and Healthcare Products Regulatory Agency in the UK safeguards the public interest through effective regulation of analgesic drugs. WCG, a US-based pharmaceuticals company, acquired Analgesic Solutions, LLC, for an undisclosed amount. WCG's newest acquisition aims to improve test sensitivity in clinical trials, through advising, novel tools, data science, technology, and specialised training. Analgesic Solutions, LLC, is a US-based pharmaceutical company that specialises in the development of new pain medications. North America was the largest region in the analgesics market in 2022. Middle East is expected to be the fastest-growing region in the global analgesics market during the forecast period. The regions covered in the global analgesics market analysis report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, the Middle East, and Africa. The countries covered in the analgesics market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The analgesics market consists of sales of codeine, hydrocodone, oxycodone, and methadone. Values in this market are factory gate values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods. The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified). The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products. The analgesics market research report is one of a series of new reports from The Business Research Company that provides analgesics market statistics, including analgesics industry global market size, regional shares, competitors with an analgesics market share, detailed analgesics market segments, market trends, and opportunities, and any further data you may need to thrive in the analgesics industry. This analgesics market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

Diuretic drugs refer to the drugs that help increase the flow of urine by reducing the concentration of sodium and chloride in the body. It helps the body eliminate salt (sodium) and water with these so-called "water tablets." Diuretic drugs include diuril, microzide, and indapamide. The main types of diuretics are osmotic diuretics, carbonic anhydrase inhibitors, loop diuretics, thiazides and thiazide-like diuretics, and aldosterone antagonists. An osmotic diuretic is a form of diuretic that prevents water and sodium from being reabsorbed. They are intravenously administered, pharmacologically inactive compounds. The different routes of administration include intravenous and oral, and they are used in hypertension, glaucoma, heart failure, and kidney stones. It is distributed through various channels, such as hospital pharmacies, independent pharmacies, retail pharmacies, drug stores, and online pharmacies. The global diuretics market is segmented - 1) By Type: Osmotic Diuretics, Carbonic Anhydrase Inhibitors, Loop Diuretics, Thiazides & Thiazide-Like Diuretics, Aldosterone Antagonists 2) By Application: Hypertension, Glaucoma, Heart Failure, Kidney Stones 3) By Distribution: Hospital Pharmacies, Independent Pharmacies, Retail Pharmacies, Drug Stores, Online Pharmacies 4) By Route of Administration: Intravenous, Oral The global diuretics market size will grow from $0.64 billion in 2022 to $0.67 billion in 2023 at a compound annual growth rate (CAGR) of 4.4%. The Russia-Ukraine war disrupted the chances of global economic recovery from the COVID-19 pandemic, at least in the short term. The war between these two countries has led to economic sanctions on multiple countries, a surge in commodity prices, and supply chain disruptions, causing inflation across goods and services and affecting many markets across the globe. The market size of the global diuretics is expected to grow to $0.75 billion in 2027 at a CAGR of 2.9%. The increase in renal and kidney disorder cases drives the diuretics market. In such cases, the kidney does not function properly increases the need for water pills (diuretic drugs) to maintain a proper flow of urine. The rise in kidney disorders can be attributed to changes in lifestyle such as the consumption of unhealthy food high in calcium and other minerals. For example, in 2021, according to the Centers For Disease Control and Prevention, a US-based government agency, more than 1 in 7 people, that is 15% of US adults,approximately 37 million people, are suffering from chronic kidney diseases. Therefore, increase in renal and kidney disorder cases drives the growth of the diuretics market. Major players in the diuretics market are Merck & Co., Meda Manufacturing GmbH, Pfizer Inc., GlaxoSmithKline, Roche, Aton Pharma Inc., Boehringer Ingelheim GmbH, Novartis AG, and Teva Pharmaceuticals Industries Ltd. The diuretics market is restricted by the stringent regulatory policies governing the market. Several requirements are laid down by the regulatory bodies to manufacture, process, and pack the drugs and the companies should abide by various compliances such as FDA's CGMP regulations, Compliance with European Medicines Agency Regulations, and WHO Guidelines. For instance, the Current Good Manufacturing Practice (CGMP) regulations of the FDA in the USA impose several regulations under 21 CFR parts 314, 210, and 211, concerning the application and licensing of new and generic drugs, regulations for manufacturing, processing, packaging or holding of drugs, and requirements for finished pharmaceuticals respectively. These regulations negatively impact the growth of the market. A new drug delivery technology called the oral nanoparticle delivery technology is developed to improve the pH and intestinal permeability of the diuretic drugs to increase the digesting capability as the majority of these drugs have low water solubility and bioavailability. Drugs such as amlodipine and isradipine having low bioavailability (less number of solvents to get diluted) and high light sensitivity were delivered using Nanoemulsion (dispersion that consists of oil, surfactants, and aqueous phase) as a drug delivery system. Pharmacokinetics (study of how an organism affects a drug) data of both the drugs revealed enhanced stability and bioavailability. For instance, Nanomerics, a pharmaceutical nanotechnology drug delivery company is carrying out R&D in this technology by working on MET (Molecule Envelop Technology) Nanoparticles Oral Delivery. Also, in 2020, a Japanese research team from Kumamoto University developed a new nanocarrier drug delivery technology to enhance the drugs, from moving from the blood into the brain. The manufacturers must comply with the European Medicines Agency’s scientific guidelines on the quality that should be maintained in the manufacturing, processing, and packaging of the drugs and help manufacturers prepare marketing authorization applications. In addition, the International Council for Harmonization (ICH) guidelines lay down the Good Manufacturing Practice (ICHQ7) guide, which states that all the utilities like steam, gases, compressed air, heating, ventilation, and air conditioning could impact the quality of the product (drug). Hence, proper monitoring should be conducted and actions should be taken if limits are exceeded. It has also framed guidelines for Quality Risk Management (ICHQ9) that provide all the risk management methods and tools like FMEA (Failure Mode Effects Analysis), FMECA (Failure Mode, Effects and Criticality Analysis), FTA (Fault Tree Analysis), HACCP (Hazard Analysis and Critically Control Points) and others. In March 2020, AstraZeneca, a UK-based pharmaceutical company, acquired AtnahsPharma for $350 million. Through this acquisition, AstraZeneca gets the commercial rights to various drugs such as Tenoretic (atenolol, chlorthalidone fixed-dose combination), and Tenormin (atenolol), Zestoretic (lisinopril, hydrochlorothiazide fixed-dose combination), Inderal (propranolol), and Zestril (lisinopril). AtnahsPharma is a UK-based company that develops diuretic drugs. North America was the largest region in the diuretics market in 2022. The Middle East is expected to be the fastest-growing region in the global diuretics market share during the forecast period. The regions covered in the global diuretics market analysis report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, the Middle East, and Africa. The countries covered in the diuretics market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The diuretics market consists of sales of diuril, microzide, and indapamide. Values in this market are factory gate values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods. The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified). The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products. The diuretics market research report is one of a series of new reports from The Business Research Company that provides diuretics market statistics, including diuretics industry global market size, regional shares, competitors with a diuretics market share, detailed diuretics market segments, market trends and opportunities, and any further data you may need to thrive in the diuretics industry. This diuretics market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

Anemia and Other Blood Disorder Drugs refer to the medications or drugs that are used to treat anemia and other blood disorder diseases. It refers to a blood condition that develops when a medication prompts the body's immune system to begin attacking its own red blood cells. Hemolysis, a process that causes red blood cells to degrade earlier than usual, is brought on by this. The main types of anemia and other blood disorder drugs are iron deficiency anemia, chronic kidney disease anemia, sickle cell anemia, and aplastic anemia. Iron deficiency anemia is a common kind of anemia in which the blood does not contain enough healthy red blood cells. The oxygen-carrying red blood cells transport oxygen to the body's cells. The different types of anemia include microcytic (Low MCV), normocytic (Normal MCV), and macrocytic (High MCV) and involve various routes of administration such as oral, and injectable. It is distributed through hospitals pharmacies, online pharmacies, and pharmacy. The global anemia and other blood disorder drugs market is segmented – 1) By Type: Iron Deficiency Anemia, Chronic Kidney Disease Anemia, Sickle Cell Anemia, Aplastic Anemia 2) By Distribution Channel: Hospitals Pharmacy, Online Pharmacy, Pharmacy 3) By Route of Administration: Oral, Injectable 4) By Anemia Type: Microcytic (Low MCV), Normocytic (Normal MCV), Macrocytic (High MCV) The global anemia and other blood disorder drugs market size will grow from $11.14 billion in 2022 to $11.87 billion in 2023 at a compound annual growth rate (CAGR) of 6.6%. The Russia-Ukraine war disrupted the chances of global economic recovery from the COVID-19 pandemic, at least in the short term. The war between these two countries has led to economic sanctions on multiple countries, a surge in commodity prices, and supply chain disruptions, causing inflation across goods and services and affecting many markets across the globe. The market size of the global anemia and other blood disorder drugs is expected to grow to $14.80 billion in 2027 at a CAGR of 5.7%. The increasing prevalence of anemia among the global population acts as a strong driving factor for the market. Unhealthy lifestyles, changing dietary habits and increased stress levels increased the cases of anemia worldwide. For instance, anemia was found to be the most frequent disease in the elderly population (> 65 years of age), reaching a prevalence rate of around 17%. the World Bank reported that anemia is the 8th leading cause of disease among women and the young population. Growth in the prevalence rate of anemia drives the anemia and other blood disorder drugs market. Major players in the anemia and other blood disorder drugs market are Amgen Inc., GlaxoSmithKline PLC., Akebia Therapeutics, Bayer AG, Pfizer Inc., Regenbiopharma, Hoffmann-La Roche Ltd., Merck Sharp &Dohme Corp., Novartis AG and Janssen Pharmaceutical. There has been an increase in the use of biologics for treating anemia and other blood disorders. Biologics are composed of protein, sugar, nucleic acids, or a combination of these substances or might be derived from living organisms like humans, animals, or microorganisms or that may contain components of living organisms. The growth in the use of biologics over the drugs restricts the market resulting in the decline of the number of drugs being used for the treatment of anemia& other blood disorders. For example, Hospira, a medical device and pharmaceutical company, submitted its first biologics license application to FDA for the approval of a drug that treats anemia. Moreover, the FDA approved the first Epoetin Alfa biosimilar for the treatment of anemia caused by chronic kidney disease, chemotherapy, or the use of zidovudine in patients with HIV infection. The increase in the use of biologics will hamper the growth of the anemia and other blood disorder drugs market. Companies in the anemia and other blood disorder drugs market are collaborating with other companies to develop and commercialize a specific kind of drug by sharing the knowledge, technology, and cost. Such collaborations are also helpful to the companies in case of expiring licenses and a stringent regulatory environment. For example, in 2020, Akebia Therapeutics announced collaboration with Tobacco Inc. to treat adult patients with iron deficiency anemia. Another such example is, Akebia Therapeutics Inc. and Otsuka Pharmaceutical Co. Ltd. agreed to manufacture and commercialize vadadustat, an oral HIF stabilizer, used for the treatment of anemia. The anemia and other blood disorder drugs market is governed by several regulatory bodies that regulate their functioning by carrying out quality checks for that drug before it can be launched in the market. For instance, the U.S. Food & Drug Administration (FDA) requires every pharmaceutical company to get its drugs examined by the concerned authority. FDA sorts to a Risk Evaluation and Mitigation Strategy (REMS) for determining the safety and quality standards of the drug and grants approvals only if the standards are up to the mark. In October 2022, Pfizer, a US-based pharmaceutical company acquired Global Blood Therapeutics Inc. for an undisclosed amount. Through this acquisition, Pfizer expanded its portfolio in the development of drugs and brought various potential best-in-class treatments to people living with sickle cell disease. Global Blood Therapeutics Inc. is a US-based biotech company operating in anemia and other blood disorder drugs. North America was the largest region in the anemia and other blood disorder drugs market in 2022. Middle East is expected to be the fastest-growing region in the global anemia and other blood disorder drugs market during the forecast period. The regions covered in the global anemia and other blood disorder drugs market analysis report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, the Middle East, and Africa. The countries covered in the anemia and other blood disorder drugs market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The anemia and other blood disorder drugs market consists of sales of folate analogues, multivitamin and mineral supplements, iron supplements, and erythropoiesis-stimulating agents. Values in this market are factory gate values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods. The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified). The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products. The anemia and other blood disorder drugs market research report are one of a series of new reports from The Business Research Company that provides anemia and other blood disorder drugs market statistics, including anemia and other blood disorder drugs industry global market size, regional shares, competitors with anemia and other blood disorder drugs market share, detailed anemia and other blood disorder drugs market segments, market trends and opportunities, and any further data you may need to thrive in the anemia and other blood disorder drugs industry. This anemia and other blood disorder drugs market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

Generic pharmaceuticals refer to a drug that was developed to have the same dosage form, safety, strength, mode of administration, quality, performance attributes, and intended use as an already marketed brand-name drug. The action and clinical benefits of a generic drug are identical to those of a brand-name drug. The three main types of generic pharmaceuticals are biosimilar; simple generic, and super generic. A biosimilar is a biological product that is very similar to a reference biologic and has no clinically significant differences in terms of safety, purity, or potency. The drugs are delivered through oral, injectable, dermal/topical, and inhalers that are used for various therapies such as CNS, cardiovascular, dermatology, genitourinary/hormonal, respiratory, rheumatology, diabetes, and oncology. The various distribution channels involved is hospital pharmacies, retail pharmacies, and online pharmacies. The global generic pharmaceuticals market is segmented - 1) By Therapy: CNS, Cardiovascular, Dermatology, Genitourinary/Harmonal, Respiratory, Rheumatology, Diabetes, Oncology 2) By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Online Pharmacies 3) By Type: Biosimilar, Simple Generic, Super Generic 4) By Drug Delivery: Oral, Inectables, Dermal/Topical, Inhaler The global generic pharmaceuticals market size grew from $332.43 billion in 2022 to $358.5 billion in 2023 at a compound annual growth rate (CAGR) of 7.8%. The Russia-Ukraine war disrupted the chances of global economic recovery from the COVID-19 pandemic, at least in the short term. The war between these two countries has led to economic sanctions on multiple countries, a surge in commodity prices, and supply chain disruptions, causing inflation across goods and services and affecting many markets across the globe. The market size of global generic pharmaceuticals is expected to grow from $453.19 billion in 2027 at a CAGR of 6.0%. The rising incidence of chronic diseases is one of the major drivers of the generic pharmaceuticals market. As more individuals are diagnosed with chronic diseases, they look for more medicines for treatment. Branded drugs come at a premium price, while generic drugs are available at a lower cost and have the same chemical composition as branded drugs. The low cost and same chemical composition and strength of generic drugs make a patient buy generic drugs instead of branded drugs. If it is a chronic disease, the treatment goes on for a longer period, and hence, the sales of generic drugs also increase. For instance, according to the WHO (World Health Organization), over the next 10 years, the number of deaths due to chronic disease is projected to increase by 17%. Also, in 2020, almost 3-quarters of all deaths in the world are due to chronic diseases. Major players in the generic pharmaceuticals market are Teva Pharmaceuticals, Mylan NV, Sandoz International GmbH, Hospira (Pfizer Inc.), Sun Pharmaceutical, Lupin Limited, Endo International PLC., Dr Reddy's Laboratories, Apotex Holdings, Fresenius Kabi Ag, Aurbindo Pharma, Aspen Pharmacare, Sanofi, Cipla, Hikma Pharmaceuticals, Stada Arzneimittel, Krka Group, Nichi-Iko Pharmaceutical, Valeant, Zydus Cadila, Merck & Co., Mitsubishi Tanabe Pharma, Momenta Pharmaceuticals, Nexus Pharmaceuticals, Novo Nordisk, Ranbaxy Laboratories Ltd., Sawai Pharmaceuticals, Novartis AG, Pfizer and Johnson & Johnson Services. The lack of awareness about generic drugs is one of the restraints on the generic pharmaceuticals market. The high marketing and advertisement of branded drugs overshadow the availability of generic drugs, which are a substitute for expensive branded drugs. Thus, consumers opt for branded drugs even though the generic drugs carry the same chemical formulation as their counter-branded drugs. According to an article published on CVS HEALTH, many doctors and pharmacists preferred to offer branded drugs to their patients over generic drugs. This prevents the patients to go for generic drugs as they develop a preconceived notion of generic drugs not being on par with branded drugs. For example, according to research conducted by Sahana K Hebbar, in the International Journal of Basic & Clinical Pharmacology, out of 100 patients and 50 non-medical staff, 95% of the patients and 60% of the non-medical staff didn't know about generic drugs. Thus, a lack of awareness about the availability of generic drugs hampers the generic pharmaceuticals market. 3D printing technology can transform the manufacturing of drugs in the generic pharmaceuticals market. 3D printed pharmaceuticals help improve R&D productivity and deliver new benefits to patients. 3D printing allows the manufacturer to produce drugs with customised size, shape, and texture, which is not possible in traditional manufacturing of generic drugs. 3D printing can help the manufacturer to make generic drugs that have different release dates, appearances, and tastes. For example, GlaxoSmithKline (GSK) completed a study where ultraviolet (UV) and 3D printing were used to manufacture tablets to treat Parkinson's disease. Martin Wallace, director of GSK Technology, said that GSK is investing in 3D printing to manufacture pills and tablets. Also, Aprecia pharmaceutical company launched 'ZipDose' technology, which manufactures 3D printed drugs. Drug manufacturers must comply with the CGMP (Current Good Manufacturing Practice) regulations that come under the US Food and Drug Administration (FDA) which includes generic pharmaceuticals. The CGMP regulations require manufacturers to maintain a minimum quality standard for the methods, controls, and facilities used in the manufacturing, packaging, and processing of drug products. Part- 99 of chapter 1 under title 21-Food And Drugs of CFR (Code of Federal Regulations) contains subparts from A to H. The whole part-99 describes the guidelines that need to be followed by drug manufacturers regarding the dissemination of information on human drugs, including biologics, and devices. The guidelines concern the safety, effectiveness, or benefit of use that is not included in the approved labelling for a drug or device approved by the Food and Drug Administration for marketing. The guidelines regulate the information regarding the drugs that should be delivered to the health care practitioner, pharmacy benefit manager, health insurance issuer, group health plan, or federal or state government agency. In January 2020, ANI Pharmaceuticals, Inc., a USA-based integrated specialty pharmaceutical company focused on developing, manufacturing, and marketing high-quality branded and generic prescription pharmaceuticals, acquired Commercial and Pipeline Generic Products from American Pharmaceuticals, Ltd. for $52.5M in cash. This acquisition substantially increases ANI Pharmaceuticals, Inc.’s commercial portfolio and late-stage generic pipeline. American Pharmaceuticals is a USA-based company focused on the development, manufacture, and sale of high-quality generic pharmaceutical products. North America was the largest region in the generic pharmaceuticals market in 2022. Middle East is expected to be the fastest-growing region in the generic pharmaceuticals market report during the forecast period. The regions covered in the generic pharmaceuticals analysis report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, the Middle East, and Africa. The countries covered in the generic pharmaceuticals market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, the UK, and the USA. The generic pharmaceuticals market consists of sales of paracetamol, cefixime, amoxicillin, and ofloxacin. Values in this market are factory gate values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods. The generic pharmaceuticals market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified). The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the chain or as part of other products. The generic pharmaceuticals market research report is one of a series of new reports from The Business Research Company that provides generic pharmaceuticals market statistics, including generic pharmaceuticals industry global market size, regional shares, competitors with a generic pharmaceuticals market share, detailed generic pharmaceuticals market segments, market trends and opportunities, and any further data you may need to thrive in the generic pharmaceuticals industry. The generic pharmaceuticals market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

The vaccines market consists of sales of vaccines and related services. This industry includes establishments that produce anti-infective vaccines, autoimmunity vaccines and vaccines for cancer and other diseases. Vaccines create antibody-antigen reaction that helps in attaining resistance to the disease causing organism. Vaccines include recombinant vaccines, conjugate vaccines, live attenuated vaccines, inactivated vaccines, toxoid vaccines and others. The main types of vaccines market are anti-infective vaccines, autoimmunity, others (cancer and others). Anti-infective vaccines are used to prevent infectious diseases. The various technologies of vaccines include conjugate vaccines, inactivated and subunit vaccines, live attenuated vaccines, recombinant vaccines, and toxoid vaccines that are administered through intramuscular (IM), subcutaneous (SC), oral, and others. The different valance of vaccines market are monovalent and multivalent which are distributed by institutional sale, hospital pharmacies, and retail pharmacies. The global vaccines market size is expected to decline from $92.70 billion in 2021 to $105.20 billion in 2022 at a compound annual growth rate (CAGR) of 13.5%. The slow decline is mainly due to the outbreak of COVID-19 that has led to deferment of immunocompromised treatments. The vaccines market is expected to reach $290.67 billion in 2026 at a CAGR of 28.9%. Rising awareness on immunization and vaccination benefits in emerging markets is consistently driving the global vaccines market growth. World Health Organization (WHO) is taking initiatives to increase awareness of immunization through global vaccine action plan (GVAP) and global Immunization vision and strategy (GIVS). They aim to strengthen routine immunization, control morbidity and mortality from vaccine preventable diseases and help countries to immunize more people with a greater range of vaccines. The Organization accomplishes this work through its biological programme, the WHO Collaborating Centers, and the WHO Expert Committee on Biological Standardization (ECBS). In 2019, according to the WHO, approximately 85% of infants globally (116 million infants) received 3 doses of diphtheria-tetanus-pertussis (DTP3) vaccine, protecting them against infectious diseases that can cause serious illness and disability or be fatal. Furthermore, 125 countries reached at least 90% coverage of the DTP3 vaccine in 2019. The vaccines market growth is limited due to severe shortage of skilled healthcare professionals for developing biologics drugs which requires specialized skillsets. These skillsets are limited to some research organizations and medical equipment companies in the USA and Europe, this is expected to be a major restraint on the market. According to a study conducted by the consulting firm Mercer, the United States will face significant healthcare worker shortages in the coming decade. The firm predicts a shortage of more than 400,000 home health aides and 29,400 nurse practitioners by 2025. This shortage also led to rise in competition and salaries for the limited talent pool available for biologics talent, thereby further limiting growth of the market. The vaccines market has been witnessing multiple strategic initiatives and mergers and acquisitions in the recent years. Top companies in the market are strategically acquiring start-ups and mid-sized companies to broaden products and services. For instance, in February 2019, Bharat Biotech acquired Chiron Behring Vaccines, a clinical biotechnology company, one of the leading manufacturers of rabies vaccines across the globe. Similarly, in September 2021, Sanofi, a France based healthcare company, acquired Translate Bio, an mRNA therapeutics company developing potentially transformative medicines to treat diseases caused by protein or gene dysfunction, for a deal amount of $3.2 billion to develop mRNA vaccines. Companies in the industry are increasingly realigning their portfolios and pursuing profitable inorganic growth opportunities. Additionally, M&A interest is also being fueled by stronger corporate balance sheets, liquid debt markets, and continued favourable interest rates globally. The Food and Drug Administration (FDA) is the National Regulatory Authority (NRA) in the United States responsible for assuring quality, safety, and effectiveness of all vaccines for human use. Center for Biologics Evaluation and Research (CBER) within the US FDA is responsible for regulating vaccines market. Governments across the world are encouraging the research and development of biologics in order to develop more targeted therapies and vaccines for various diseases. In May 2014, the US FDA announced a fast-track initiative to review its drugs and biologics policy to speed the availability of therapies to patients with serious conditions, orphan drugs for rare disease, while preserving the safety and efficacy standards. In 2016, FDA also removed a rule (Section 610.21 of the FDA code) which specified minimal potency limits for certain antibodies and antigens. In addition, FDA is also updating regulations (Section 610.53 of FDA code) regarding storage periods and storage conditions for biologics. In May 2020, Novavax, a US-based late-stage biotechnology company specialising in next-generation vaccines, announced the acquisition of Praha Vaccines, a subsidiary of the Cyrus Poonawalla Group, for a deal amount of $167 million. With this acquisition, Novavax increased its annual capacity of more than one billion doses of antigen for NVX-CoV2373, Novavax's COVID-19 vaccine candidate. Praha Vaccines was a subsidiary of the Cyrus Poonawalla Group, which is the parent company of Serum Institute of India and specialises in the production of immuno-biologicals. Major players in the vaccines market are AstraZeneca, Emergent Biosolutions, Glaxosmithkline, Merck, Pfizer, Sanofi Pasteur, Abbott, Astellas Pharma, Bavarian Nordic, CSL Limited, Daiichi Sankyo Company, Johnson & Johnson, Mitsubishi Tanabe Pharma Corporation, Serum Institute of India, Takeda Pharmaceutical Co. Ltd., Biological E Limited, BiondVax Pharmaceuticals Ltd, Bristol-Myers Squibb, Inovio Pharmaceuticals Inc., Madison Vaccines Incorporated, NOVARTIS AG, Novavax Inc., Panacea Biotec, Sinovac Biotech Ltd., Valneva SE, and VBI Vaccine Inc. North America was the largest region in the vaccines market in 2021. The Middle East is expected to be the fastest growing region in the forecast period. The regions covered in the vaccine market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the vaccines market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK and USA. The global vaccines market is segmented - 1) By Type: Anti-Infective Vaccines, Autoimmunity, Others (Cancer and Others) 2) By Technology: Conjugate Vaccines, Inactivated and Subunit Vaccines, Live Attenuated Vaccines, Recombinant Vaccines, Toxoid Vaccines 3) By Route of Administration: Intramuscular (IM), Subcutaneous (SC), Oral, Others 4) By Valence: Monovalent, Multivalent 5) By Distribution Channel: Institutional Sale, Hospital Pharmacies, Retail Pharmacies

The dermatology drugs market consists of sales of dermatology drugs by entities (organizations, sole traders and partnerships) that produce dermatology drugs to treat skin diseases. This industry includes establishments that produce drugs to treat diseases such as rosacea, dermatitis, hyperhidrosis, androgenic alopecia, acne drugs, microbial infections and other skin disorders. The main types of dermatology drugs are acne drugs, dermatitis, psoriasis, and other drugs for dermatology diseases. Psoriasis is a skin condition that causes red, itchy scaly patches on the knees, elbows, trunk, and scalp. Hypolipidemic drugs are a diverse class of medications used to treat high levels of fats (lipids) in the blood, such as cholesterol (hyperlipidemia). The drugs are administered through oral, parenteral, and others that are classified into branded and generic drugs. The various mode of purchase includes prescription-based drugs and over-the-counter drugs which are distributed by hospital pharmacies, retail pharmacies/ drug stores, and others. The global dermatology drugs market size is expected to grow from $49.55 billion in 2021 to $54.54 billion in 2022 at a compound annual growth rate (CAGR) of 10.1%. 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 dermatology drugs market is expected to reach $117.82 billion in 2026 at a CAGR of 21.2%. The dermatology drugs market was mainly driven by rapid growth in emerging markets in the historic period. Emerging markets growth was aided by rising disposable income, stable political environment and increasing foreign investments in these countries. For instance, according to the IMF, China’s GDP growth rate was 2.3% in 2020. Additionally, according to the World Economic Outlook Reports by the IMF, the global growth is 6% in 2021 and expected to be 4.4% in 2022. Thus, strong economic growth boosted the demand for dermatology drugs and this drove the market during the historic period. High costs associated with drugs is a major issue faced by citizens of many countries. 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, lack of cost-effective drugs has influenced the health conditions of the population and has led to a low average life expectancy. As a result, in countries such as Chad, Macedonia, Serbia, the pharmaceutical companies are faced with the pressure of reducing the price of drugs. The high costs associated with drugs are putting pressure on the revenues of dermatology drugs manufacturers. Drug manufacturing companies are using genome testing (genetic diagnosis) to reduce the time and costs spent in clinical trials. A clinical trial is a complex process and it often takes months for a drug to be available in the market. This deprives patients of cost-effective treatment. Researchers in the Rockefeller University used genomic testing and data analytics to predict the response of psoriasis patients for a given treatment. Genomic testing algorithms collect gene-expression data from skin biopsies and detect activity in 50,000 different genes. This technique can predict the response of a patient with an accuracy of 95% and within 12 weeks, thus saving significant time for clinical trials and the launch of new drugs. Major companies in the dermatology drugs market include Amgen, Reckitt Benckiser Group plc, AbbVie, Galderma S.A., LEO Pharma A/S, Bayer AG, GlaxosmithKline, Eli Lilly And Company, Novartis AG and Perrigo Company Plc. North America was the largest region in the dermatology drugs market in 2021. The Middle East is expected to be the fastest growing region in the forecast period. The regions covered in the dermatology drugs market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the dermatology drugs market report are Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, UK, USA, Venezuela and Vietnam. The global dermatology drugs market is segmented - 1) By Type: Acne Drugs, Dermatitis, Psoriasis, Other Drugs for Dermatology Diseases 2) By Distribution Channel: Hospital Pharmacies, Retail Pharmacies/ Drug Stores, Others 3) By Route of Administration: Oral, Parenteral, Others 4) By Drug Classification: Branded Drugs, Generic Drugs 5) By Mode of Purchase: Prescription-Based Drugs, Over-The-Counter Drugs

The hematology drugs market consists of sales of hematology drugs and related services by entities (organizations, sole traders and partnerships) that produce hematology drugs to treat diseases such as genetic disorders, anemia, and other related diseases. This industry includes establishments that produce blood products such as red blood cells, white blood cells, platelets, and fresh frozen plasma. It also consists of establishments which produce of anemia and other blood disorder drugs to treat anemia, hemophilia and blood clots. The main types of hermatology drugs are blood products, anemia and other blood disorder drugs. Any therapeutic substance derived from human blood is referred to as a blood product, which includes whole blood and other blood components for transfusion as well as plasma-derived medicinal products. The drugs are administered through oral, parenteral, and others that are classified into branded and generic drugs. The various mode of purchase includes prescription-based drugs and over-the-counter drugs which are distributed by hospital pharmacies, retail pharmacies/ drug stores, and others. The global hematology drugs market size is expected to grow from $33.06 billion in 2021 to $36.13 billion in 2022 at a compound annual growth rate (CAGR) of 9.3%. 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 hematology drugs market is expected to reach $73.67 billion in 2026 at a CAGR of 19.5%. The hematology drugs market growth is aided by stable economic growth forecasted in many developed and developing countries. The International Monetary Fund (IMF) stated that the global GDP growth rate was 3.3% in 2020 and 3.4% in 2021. Recovering commodity prices, after a significant decline in the historic period is further expected to aid the market growth. Developed economies are also expected to register stable growth during the forecast period. Additionally, emerging markets are expected to continue to grow slightly faster than the developed markets in the forecast period. This is expected to increase spending on healthcare services, thereby driving the demand for hematology drugs. Regulatory agencies and federal governments adopted stringent regulations and took a tough stance on drug pricing by pharmaceutical companies during the historic period. Pharmaceutical companies faced criticism from politicians, patients and physicians over high pricing of some medicines and drugs. Moreover, companies had to sell drugs and medicines at subsidized rates to government hospitals, doctors and clinics, further effecting companies’ revenues. This led to drug manufacturing companies operating on a reduced profit margin, which negatively impacted the attractiveness of the hematology drugs industry in the historic period. Tranexamic acid is increasingly being used to prevent postpartum hemorrhage (blood loss of over 500 ml or 1,000 ml within 24 hours of childbirth) due to its low price and wide availability. Tranexamic acid is an antifibrinolytic drug that helps in reducing bleeding in surgical and trauma patients, including women with postpartum hemorrhage. According to the World Maternal Antifibrinolytic (WOMAN) trial, using tranexamic acid within three hours of childbirth lowered death from bleeding by 31% and reduced the need for laparotomy (emergency bleeding control surgery) by 36%. The trial included over 20,000 women from 193 hospitals in 21 countries. Major companies in the hematology market include Amgen, Alexion Pharmaceuticals, Bayer AG, F. Hoffmann-La Roche Ltd., CSL, Takeda Pharmaceuticals, Novo Nordisk, Sanofi S.A, Daiichi Sankyo Company and Pfizer Inc. North America was the largest region in the hematology drugs market in 2021. The Middle East is expected to be the fastest growing region in the forecast period. The regions covered in the hematology drugs market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the hematology drugs market report are Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, UK, USA, Venezuela and Vietnam. The global hematology drugs market is segmented - 1) By Type: Blood Products, Anemia and Other Blood Disorder Drugs 2) By Distribution Channel: Hospital Pharmacies, Retail Pharmacies/ Drug Stores, Others 3) By Route of Administration: Oral, Parenteral, Others 4) By Drug Classification: Branded Drugs, Generic Drugs 5) By Mode of Purchase: Prescription-Based Drugs, Over-The-Counter Drugs

The central nervous system (CNS) drugs market consists of sales of central nervous system drugs and related services by entities (organizations, sole traders and partnerships) that manufacture central nervous system drugs that are used in the treatment of diseases affecting the brain or spinal cord. The central nervous system integrates sensory information and instructs the body to respond accordingly. The spinal cord is a channel for signals between the brain and the rest of the body. CNS disorder is a condition in which the brain and spinal cord’s ability to function is affected, hence affecting the body. The market for CNS disorder drugs comprises of drugs that work in different ways depending on the type of disease by suppressing or boosting the brain activities The main types of central nervous system (CNS) drugs are analgesics, anti-parkinson drugs, anesthetics, anti-epileptics and other CNS drugs. Analgesics, also known as painkillers, are medications that alleviate various types of pain, ranging from headaches to injuries to arthritis. The drugs are administered through oral, parenteral, and others that are classified into branded and generic drugs. The various mode of purchase includes prescription-based drugs and over-the-counter drugs which are distributed by hospital pharmacies, retail pharmacies/ drug stores and others. The global central nervous system drugs market size is expected to grow from $169.11 billion in 2021 to $178.70 billion in 2022 at a compound annual growth rate (CAGR) of 5.7%. The growth in the CNS drugs 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 central nervous system drugs market is expected to reach $264.97 billion in 2026 at a CAGR of 10.3%. The central nervous system drugs market will be driven by rapid growth in emerging markets in the forecast period. Emerging markets growth is aided by rising disposable income, stable political environment and increasing foreign investments in these countries. For instance, according to the IMF, China’s GDP growth rate was 2.3% in 2020., according to the World Economic Outlook Reports by the IMF, the global growth is 6% in 2021 and expected to be 4.4% in 2022. Thus, strong economic growth will boost the demand for central nervous system drugs and this will drive the market during the forecast period. During the forecast period, the growth of the central nervous system drugs market will be restrained by patent expiration of branded central nervous system drugs. In general, pharmaceutical companies invest a large sum of money in the drug development process and patents. During the patency period, the company holding the patent holds exclusivity for the manufacturing and distribution of drugs. Post expiration of patency, generic versions of the drugs are manufactured by other companies with prices much lower than the original branded drugs. Overall, this will negatively impact the growth of the market in terms of value. Many central nervous system drug manufacturers are collaborating with other manufacturers in the industry to share technical knowledge and improve product quality. These agreements are helping anti-epileptics drugs manufacturers broaden their products and services. For instance, in March 2021, SEQENS and Rondol Group had announced a collaboration in formulation research and continuous flow manufacturing for existing, repurposed, or new drugs for oncology, infectious diseases, and central nervous system disorders. In June 2021, DSM and Brains Bioceutical have established a global exclusive partnership to unlock the therapeutic potential of cannabinoids in early-stage drug development. The cannabinoid API market is rapidly expanding, fueled by strong scientific evidence demonstrating cannabinoid's potential in a variety of therapeutic areas, including Central Nervous System (CNS) diseases. Major companies in the central nervous system drugs market include Biogen Inc, Johnson & Johnson, Novartis AG, UCB S.A., Takeda Pharmaceuticals, AbbVie, Teva Pharmaceuticals, GlaxosmithKline, Daiichi Sankyo Company and H Lundbeck. North America was the largest region in the central nervous system drugs market in 2021. The Middle East is expected to be the fastest growing region in the forecast period. The regions covered in the CNS drugs market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the central nervous system drugs market report are Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, UK, USA, Venezuela and Vietnam. The global central nervous system drugs market is segmented - 1) By Type: Analgesics, Anti-Parkinson Drugs, Anesthetics, Anti-Epileptics, Other CNS Drugs 2) By Distribution Channel: Hospital Pharmacies, Retail Pharmacies/ Drug Stores, Others 3) By Route of Administration: Oral, Parenteral, Others 4) By Drug Classification: Branded Drugs, Generic Drugs 5) By Mode of Purchase: Prescription-Based Drugs, Over-The-Counter Drugs