Generic Pharmaceuticals Global Market Report 2022

Generic Pharmaceuticals Global Market Report 2022

  • March 2022 •
  • 400 pages •
  • Report ID: 6241838 •
  • Format: PDF
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 global generic pharmaceuticals market is expected to grow from $302.39 billion in 2021 to $332.43 billion in 2022 at a compound annual growth rate (CAGR) of 9.9%. The growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $426.30 billion in 2026 at a CAGR of 6.4%.

The generic pharmaceuticals market consists of sales of generic pharmaceuticals.A generic medicine is a medication designed to be identical as branded drugs marketed by private companies in dosage form, strength, safety, route of administration, performance characteristics, quality, and intended use.

Generic drugs work in the same way as branded drugs in terms of clinical benefits.Generic drugs are manufactured after the expiration of the exclusive rights or patent of the branded drugs.

For example, some of the generic drugs in the generic pharmaceuticals market include metformin, metoprolol, acarbose, acebutolol, aztreonam and many more.

The 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, inectables, dermal/topical and inhaler that are used for various therapies such as CNS, cardiovascular, dermatology, genitourinary/harmonal, respiratory, rheumatology, diabetes and oncology. The various distribution channel involved are hospital pharmacies, retail pharmacies and online pharmacies.

North America was the largest region in the generic pharmaceuticals market in 2021.Middle East is expected to be the fargest growing region in the forecast period.

The regions covered in this report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

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 the treatment.

Branded drugs come at a premium price, while generic drugs are available at a lower cost having the same chemical composition of 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 for a longer period of time and hence, the sales of generic drugs also increase.For instance, according to the WHO (World Health Organization), over the next 10 years, the deaths due to chronic disease is projected to increase by 17%.

Also, in 2020, almost 3-quarters of all deaths in the world is due to chronic diseases.

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 substitute for expensive branded drugs.

Thus, consumers opt branded drugs despite the fact that 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 at par with branded drugs.For example, according to a research conducted by Sahana K Hebbar, on 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, lack of awareness about the availability of generic drugs hamper the generic pharmaceuticals market.

3D printing technology has the ability to transform the manufacturing of drugs in the generic pharmaceuticals market. 3D printed pharmaceuticals help in improve R&D productivity and deliver new benefits to patients. 3D printing allows the manufacturer to produce drugs with customized 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 taste. 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 advantages to manufacture pills and tablets. Also, Aprecia pharmaceutical company launched ’ZipDose’ technology which manufactures 3D printed drugs.

The 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 manufacturing, packaging, and processing of drug product.

The 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 with 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 Amerigen Pharmaceuticals, Ltd. for $52.5M in cash. This acquisition substantially increases ANI Pharmaceuticals, Inc. commercial portfolio and late stage generic pipeline. Amerigen Pharmaceuticals, a USA based company focused on development, manufacture and sale of high quality generic pharmaceutical products.

The countries covered in the generic pharmaceuticals market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA.