Global Generic Pharmaceuticals Market

The pharmaceutical active pharmaceutical ingredients (API) manufacturing market consists of sales of pharmaceutical active pharmaceutical ingredients and related services. Active pharmaceutical ingredients are used to produce drugs which treat various diseases such as cardiovascular diseases, rare genetic disorders, infections, metabolic disorders, cancers, respiratory diseases and others. Active pharmaceutical ingredient is a chemical which is responsible for the pharmacological activity in the living body and are used as a major base for preparation of drugs. The pharmaceutical API manufacturing market covered in this report is segmented by therapy area into cardiovascular disorders, metabolic disorders, neurological disorders, oncology, musculoskeletal disorders, NSAIDs, other therapeutics uses. The pharmaceutical active pharmaceutical ingredients (API) manufacturing market is also segmented by API type into chemical API, biological API and by drug type into innovative drugs, generic prescription, over-the-counter (OTC) drugs. The global pharmaceutical API manufacturing market is expected to grow from $170.06 billion in 2020 to $177.32 billion in 2021 at a compound annual growth rate (CAGR) of 4.3%. The growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The pharmaceutical active pharmaceutical ingredients (API) manufacturing market is expected to reach $215.9 billion in 2025 at a CAGR of 5%. The rise in aging population is one of the major drivers of the pharmaceutical API manufacturing market. As the aging population increases, the demand for pharmaceutical drugs also increases. API acts as a specialty drug in these medicines to cure a particular disease. For instance, in 2019, number of people over the age of 65 were 703 million, in 2050, the number of elderly people is expected to double to 1.5 billion. This led to increase demand for pharmaceutical drugs, significantly impacting the pharmaceutical API manufacturing market growth. Stringent regulations for approval of pharmaceutical drugs acts as a restraint on the pharmaceutical API manufacturing market. Various regions have their own set of rules, guidelines, and regulations set by their respective drugs regulatory bodies. For example, in Japan, the manufacturers have to register an API with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) through the country’s Drug Master File (DMF) system. Products like APIs and new excipients i.e. inactive substances used in a drug should be registered compulsorily. The API manufacturer is also responsible for DMF registration, even if they don't have their office in Japan. They should appoint an in-country caretaker (ICC) to apply on their behalf. Also, if there are any changes to be made to DMF products, either an application for change in registration or a minor change notification should be submitted by the ICC to the PMDA. This whole process delays the drugs approvals, thereby negatively affecting the pharmaceuticals API manufacturing market. Many companies use modern technologies such as process control, and powder handling to optimize API manufacturing. These technologies include advances in Lyophilization i.e. freeze-drying process. It is a low-temperature dehydration process which involves freezing the product, lowering pressure and then removing the ice formed. For instance, Telstar, a company that manufactures efficient integrated systems for pharmaceutical and manufacturing processes, developed LyoGistics Zero, an automatic loading and unloading system for freeze dryers to manufacture hazardous products. The system uses a linear magnetic driving mechanism which functions without racks and belts to reduce particle generation and this improves the hygiene in API manufacturing. Also, ILC Dover, a pharmaceutical company, developed JetBreaker system, a semi-automatic powder handling system that separates powdered media and buffers powders so that they can be mixed better in a solution. In January 2019, Bristol-Myers Squibb, a US-based company that discovers and manufactures biopharmaceutical products and drugs for cancer and other diseases acquired Celgene Corporation for $74 billion. With this acquisition, Bristol-Myers Squibb led to develop more innovative medicines and also result in a wider portfolio. Celgene Corporation, a US-based company that discovers, develops and commercializes medicines for cancer and inflammatory disorders. Major players in the pharmaceutical active pharmaceutical ingredients (API) manufacturing market are Teva Pharmaceutical Industries Ltd., Sun Pharmaceutical Industries Ltd., Boehringer Ingelheim), Pfizer, Inc. and Aurobindo Pharma. The regions covered in the pharmaceutical active pharmaceutical ingredients manufacturing market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the pharmaceutical API manufacturing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The global pharmaceutical API manufacturing market is segmented - 1) By Therapy Area: Cardiovascular Disorders, Metabolic Disorders, Neurological Disorders, Oncology, Musculoskeletal Disorders, NSAIDs, Other Therapeutics Uses 2) By API Type: Chemical API, Biological API 3) By Drug Type: Innovative Drugs, Generic Prescription, Over-The-Counter (OTC) Drugs

Biologics Market Definition

The biologics market consists of sales of biologics and related services by entities (organizations, sole traders and partnerships) that produce biologics or biosimilars to treat and prevent various microbial diseases and cancers. The biologics market comprises companies manufacturing biological products that are derived from genetically modified proteins and human genes. Biologics products include a wide range of recombinant therapeutic proteins, gene therapy tissues, somatic cells, vaccines, and allergenics. Biologics products are subjected to various laws and regulations that deal with patenting, testing, safety, efficacy and marketing. Biologics products are isolated from natural sources such as human, animal, and microorganisms by biotechnological methods and other cutting-edge technologies. Biosimilars should have similar safety and efficacy compared to the reference biologic product. The biologics market comprises of biologics and biosimilar drugs through oral, IV and other delivery routes for the treatment of chronic diseases.

The antifungals market consists of sales of antifungal drugs which are used to detect and eliminate fungal pathogens. The fungal pathogens thrive in the body under unhygienic and unclean environments. These drugs are also known as an antimycotic medication, used to treat and prevent mycosis such as athlete's foot, ringworm, candidiasis (thrush), serious systemic infections such as cryptococcal meningitis, and others. The global antifungals market is expected to grow from $9.98 billion in 2020 to $10.29 billion in 2021 at a compound annual growth rate (CAGR) of 3.1%. The growth 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 market is expected to reach $13.71 billion in 2025 at a CAGR of 7.4%. A point prevalence survey was conducted in Turkey. According to the survey, antifungal drugs were mostly prescribed in pediatric hematology and oncology (PHO) units (35.2%), followed by neonatal ICUs (NICUs) (19.6%). The other units prescribing antifungal drugs included pediatric services (18.3%), pediatric ICUs (PICUs) (14.6%) and hematopoietic (HSCT) units (7.3%). According to the same survey, the antifungals were used for prophylaxis in 48.8% of patients and about 50% of patients were treated with antifungal drugs based on observation. Among 50% of patients, who were treated post observation, around 18.8% of patients were prescribed an antifungal therapy and 31.2% of patients were targeted for the treatments. Antifungal drugs manufacturers are offering skimming price for branded drugs. The discovery, development and manufacturing processes of branded drugs generally require high investments. As a result, companies in the market offer the branded drugs at the highest initial prices, and implement other pricing strategies to ensure the product stays competitive at a high price. Price skimming is a pricing strategy in which a company charges a high initial price and then gradually lowers the price to attract more price-sensitive customers. It is used to maximize profits when a new product is introduced in the market. Manufacturers and marketers of branded drugs should consider adopting the price skimming strategy for branded drugs. They should price these branded drugs high to recover the high costs incurred during drug development and manufacturing. Drug developers and manufacturers are scaling up the various departments such as research and development, marketing, and manufacturing through collaborations and strategic partnerships with other companies and research institutes, to expand the product portfolios. So, companies in the anti-infective drugs market should consider strategic collaborations to broaden their scope and product portfolios to increase the revenues and stay competitive in the market. Major players in the market are Pfizer, Novartis, Merck & Co., Bayer Healthcare and Abbott Laboratories. The countries covered in the global antifungals market are Brazil, China, France, Germany, India, Indonesia, Japan, South Korea, Russia, UK, USA, Australia. The regions covered in the global antifungals market are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The global antifungals market is segmented - 1) By Drug Type: Echinocandins, Azoles, Polyenes, Allylamines 2) End users: Hospitals & Clinics, Dermatology Clinics, Other Users 3) By Route of Administration: Oral, Parenteral, Topical 4) By Therapeutic Indications: Aspergillosis, Dermatophytosis, Candidiasis, Others

Biologics Market Definition

The biologics market consists of sales of biologics and related services by entities (organizations, sole traders and partnerships) that produce biologics or biosimilars to treat and prevent various microbial diseases and cancers. The biologics market comprises companies manufacturing biological products that are derived from genetically modified proteins and human genes. Biologics products include a wide range of recombinant therapeutic proteins, gene therapy tissues, somatic cells, vaccines, and allergenics. Biologics products are subjected to various laws and regulations that deal with patenting, testing, safety, efficacy and marketing. Biologics products are isolated from natural sources such as human, animal, and microorganisms by biotechnological methods and other cutting-edge technologies. Biosimilars should have similar safety and efficacy compared to the reference biologic product. The biologics market comprises of biologics and biosimilar drugs through oral, IV and other delivery routes for the treatment of chronic diseases.

Pharmaceuticals Market Definition

The pharmaceuticals market consists of sales of pharmaceuticals and related services by entities (organizations, sole traders and partnerships) that produce pharmaceuticals used in treating diseases. This industry includes establishments that produce biologics and pharmaceutical drugs. The pharmaceutical industry develops drugs to diagnose, cure, treat or prevent diseases, infections, and injuries. Pharmaceuticals are subjected to various laws and regulations that deal with patenting, testing, safety, efficacy and marketing. Pharmaceutical drug manufacturers produce pharmaceutical drugs made from active pharmaceutical ingredients (API) and excipients.

The anemia and other blood disorder drugs market consists of sales of anemia and other blood disorder drugs and related services. Anemia and other blood disorder drugs that are used to stimulate red blood cell production or hemoglobin in the human body include Erythropoietin (Epoetin alpha), Ferrous Sulfate, Iron Dextran, Deferoxamine, Immunosuppressant, Bone marrow stimulants, Corticosteroids, Aminoxin, Hespan, Hextend, and Pyridoxine. The market also comprises of sales of drugs that are responsible for curing other blood disorders, including inherited orphan blood disorder. The global anemia and other blood disorder drugs market is expected to grow from $52.24 billion in 2020 to $53.43 billion in 2021 at a compound annual growth rate (CAGR) of 2.3%. The growth 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 market is expected to reach $84.59 billion in 2025 at a CAGR of 12.2%. 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 market. 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 use of zidovudine in patients with HIV infection. The increase in the use of biologics will hamper the growth of the 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 stringent regulatory environment. For example, in 2020, Akebia Therapeutics announced a collaboration with Tobacco Inc to treat adult patients with iron deficiency anemia. Another such example is, Akebia Therapeutics Inc. and Otsuka Pharmaceutical Co. Ltd. entered into an agreement 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 their 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 2019, AMAG Pharmaceutical, an American pharmaceutical company agreed to acquire Perosphere for $415 million. The acquisition would result in expanding AMAG's pipeline and enhance its presence in the Hematology drugs market with the help of Perosphere's next-generation Anticoagulant reversal agent called Ciraparantag. Perosphere is a specialty pharmaceutical company focusing on rescue drug medications. The Company was established in 2011 and is headquartered in Danbury, Connecticut, USA. Major players in the market are Amgen Inc., GlaxoSmithKline plc, Akebia Therapeutics, Bayer AG and Pfizer, Inc. The countries covered in the global anemia and other blood disorder drugs market are Brazil, China, France, Germany, India, Indonesia, Japan, South Korea, Russia, UK, USA, Australia. The regions covered in the global anemia and other blood disorder drugs market are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. 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)

Pharmaceutical Drugs And Biologics Logistics Market Definition

The pharmaceutical drugs and biologics market consists of sales of pharmaceutical drugs and biologics logistics services by entities (organizations, sole traders and partnerships) that provide pharmaceutical drugs and biologics logistics services. Pharmaceutical drugs and biologics logistics is the logistics of pharmaceutical and biologic drugs from the manufacturer to the end-user. It includes transportation, warehousing, inventory management and other logistics functions.

Oral Biologics & Biosimilars Market Definition

The oral biologics and biosimilars market consist of sales of oral biologics and biosimilar products and related services used to treat chronic diseases such as diabetes, arthritis, and cancer. Biologics are drugs made from living cells using highly complex technology, while biosimilars are biological products which are being produced to be identical to a biologic already approved, known as reference drugs. Biosimilars should have similar safety and efficacy compared to the reference biologic product. The oral biologics and biosimilar market comprise of biologics and biosimilar drugs through oral delivery route, for the treatment of chronic diseases.