Advancements in generic drug manufacturing, both in terms of technology and regulations, are showcasing positive implications on generic drugs industry across the globe.
Generic medicines are replications which contain some amount of similarities in active ingredients, dosage form and route of administration to its brand-name counterpart. These drugs are based on the off-patent brand-name medicines which do not have restraining intellectual property (IP) rights. Government entities had relaxed drug related IP rights in past years to facilitate production of generic drugs. The World Trade Organization's Trade-Related Aspects of Intellectual Property Rights (TRIPS) was a stepping stone which had the greatest impact on pharmaceutical sector. This waiver on drug IP rights enabled developing countries to override patents and manufacture less expensive generic drugs. Following the regulations, the generic drug manufacturers are required to only prove that their product is identical to a certain brand-name drug, so as to obtain a status of bioequivalent, thus, enabling swift introduction of generic medicines into the market and eliminating registration data-related costs. The regulations are exhibiting its prevalence across government entities and market players, who are extensively promoting the development of generic drugs. For instance, in 2016, GlaxoSmithKline plc relaxed its intellectual property rights across low income countries to facilitate generic drug manufacturing. Government bodies of various countries, with India at forefront, are also promoting the generic drugs industry through various initiatives. For instance, under the Pradhan Mantri Bhartiya Janaushadhi Pariyojana scheme a total of 5,760 centers were established till 2019 across 33 states and Union Territories of India, for dispensing a range of more than 800 generic medicines. Japan government is encouraging the local pharmaceutical manufacturers to establish generic drug manufacturing facilities in low-cost Asian countries, so as to garner benefits associated with economies of scale. Similarly, in November 2017 the Food and Drug Administration agency of U.S announced a new health care provider education campaign intended to raise awareness about the value of generic drugs by encouraging medical professionals and patients to discuss generic alternatives for brand-name medications. These advancements in the IP laws and promotional activities are driving the growth of generic drugs market across the globe.
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The recent coronavirus crisis is anticipated to have positive implications on the generic drugs market with major pharmaceutical players undertaking initiatives to relax IP rights. For instance, Gilead Sciences, Inc. signed royalty-free license agreements allowing five generic drug firms to manufacture generic version of its ‘Remdesivir’ drug which is used in treatment of active COVID-19 patients.
Along with the regulations, technologies in manufacturing generic drugs are also witnessing transformation owing to the need to comply with the stringent quality standards. Pharmaceutical companies are striving to strengthen their manufacturing processes through automation in operating procedures and quality management systems. For instance, Actiza Pharmaceutical Private Limited, a generic drug manufacturer in India, deployed automated systems including non-fill devices, collators, multi-station tablet presses, Brevetti visual inspection machines, FFS machines and high-speed vial/ampoule filler/sealer at its plant in Surat to manufacture high-quality cost-efficient products. Hence, rapid adoption of advanced technologies in the manufacturing of generic drugs is anticipated to propel the growth of global generic drugs market in the forecast years.
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In terms of revenue, global generic drugs market was valued at US$ 284.56 Bn in 2018 and is anticipated to reach 472.32 Bn by 2027, growing at a CAGR of 5.8% over the forecast period. The study analyses the market in terms of revenue across all the major regions, which have been bifurcated into countries.
The detailed research study provides qualitative and quantitative analysis of generic drugs market. The market has been analyzed from demand as well as supply side. The demand side analysis covers market revenue across regions and further across all the major countries. The supply side analysis covers the major market players and their regional and global presence and strategies. The geographical analysis done emphasizes on each of the major countries across North America, Europe, Asia Pacific, Middle East & Africa and Latin America.
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Key Findings of the Report:
- The global generic drugs market was valued at US$ 284.56 Bn in 2018 and is anticipated to witness a compound annual growth rate of 5.8% over the forecast period owing to the high cost associated with brand-name drugs.
- Chronic illnesses such as diabetes, heart disorders and others held a significant share in global generic drugs market in 2018 due to the rise in number of patients suffering from these disease indications coupled with high treatment costs.
- The solid oral drugs such as tablets and capsules dominated the global generic drugs market in 2018 owing to the ease in replication and high number of off-patent drugs.
- North America held the highest market share in global generic drugs market in 2018 owing to the high rate of generic drugs prescribed by doctors. Asia Pacific is anticipated to witness highest growth rate over the period of next eight years owing to substantial initiatives being undertaken by manufacturers and government bodies.
- Some of the players operating in the generic drugs market are Abbott Laboratories, Allergan, Inc., Alvion Pharmaceuticals P.C., Amneal Pharmaceuticals, Inc., Aspen Pharmacare Holdings Limited., AstraZeneca plc., Cipla Inc., Dr. Reddy’s Laboratories Ltd., Egis Group, Eli Lilly and Company, Endo International plc, Fresenius Kabi (Kabi SwissBioSim GmbH), Gedeon Richter Ltd, Gilead Sciences, Inc., GlaxoSmithKline Plc., Lupin Pharmaceuticals, Inc., Mylan N.V., Novartis International AG, Pfizer Inc., STADA Arzneimittel AG, Sun Pharmaceutical Industries, Teva Pharmaceutical Industries Ltd. amongst others.
Global Generic Drugs Market:
- By Type
- Prescription Products
- Over the Counter (OTC) Products
- By Application
- Respiratory
- Dermatology
- Oncology
- Diabetes
- Infectious diseases
- Ophthalmology
- Women’s Health
- Central Nervous System (CNS)
- Cardiovascular
- Urology
- Others (Pain Management, etc.)
- By Form
- Tablets
- Capsules
- Injectables
- Topical Creams
- Others
- By Distribution Channel
- Retail Pharmacy
- Hospital Pharmacy
- By Region
- North America
- U.S
- Canada
- Mexico
- Rest of North America
- Europe
- France
- The UK
- Spain
- Germany
- Italy
- Nordic Countries
- Denmark
- Finland
- Iceland
- Sweden
- Norway
- Benelux Union
- Belgium
- The Netherlands
- Luxembourg
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- New Zealand
- Australia
- South Korea
- Southeast Asia
- Indonesia
- Thailand
- Malaysia
- Singapore
- Rest of Southeast Asia
- Rest of Asia Pacific
- Middle East and Africa
- Saudi Arabia
- UAE
- Egypt
- Kuwait
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Argentina
- Rest of Latin America
- North America
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