Our Generic Formulations business addresses this urgent need by offering more than 200 high-quality generic versions of expensive innovator medicines—at a fraction of the cost—in over 20  countries around the world. Despite this, an analysis of ten essential medicines per company reveals that companies have registered these products – identified as priorities for access – in 77 countries in scope, out of the 90 in which they have existing regulatory reach. Some of these products have been registered in very few LMICs, and analysis of the companies’ product registration practices in LMICs shows significant variation between companies. Through generics and biosimilars, people around the world gain access to the medicines they require – including lifesaving treatments. Of the medicines classed as “essential” by the World Health Organization (WHO), 90% are off patent, including treatments for cancers, heart disease, epilepsy, diabetes, maternal haemorrhage, bacterial infection, tuberculosis, malaria and HIV. When patents expire, generic and biosimilar manufacturers can enter the market and develop these medicines at a lower cost, potentially introducing competition and increasing supply.

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Many blockbuster drugs have met their expiry in the European region in recent years, which has given the manufacturers of generic drugs a significant opportunity to grow. The increasing number of initiatives by the European governments favoring generic drugs is fuelling the European market growth. In addition, the growing aging population in the European region supports regional market growth.

• Anushka Bhattacharya is an editor and content writer for a market research and business consultancy company, IMARC Services Pvt.
• Access to high-quality generic medications continues to be a pivotal issue across the globe in 2024, with various regions deploying targeted strategies to overcome barriers to affordability and quality.
• The company is firmly committed to adhering to regulatory compliance requirements in different markets, which has facilitated its expansion into new markets and bolstered its business growth.
• Initiatives, such as the Access to Medicine Foundation’s work, aim to mobilize generic medicine manufacturers, ensuring greater access to generic medicines.
• Our in-depth knowledge of regulation and intellectual property also helps us to bring high-quality, regulatory-compliant medicines within reach of millions throughout the world.
• AurobindoPharma Limited, headquartered in Hyderabad, India, stands as a leading globalpharmaceutical entity renowned for its expertise in manufacturing both genericformulations and active pharmaceutical ingredients (API).

Companies are engaging in adaptive R&D, tailoring products to the needs of people in LMICs

Gabapentin is already available in other generic forms, but the specific release characteristics and dosing regimen of Gralise are protected by patents. Once these patents expire and if any market exclusivity periods have lapsed, other companies can produce generic versions of this particular formulation, potentially leading to price reductions and increased accessibility for patients. The launch of generic Gralise, especially in Q124, as anticipated, could offer patients more options for their treatment plans. We expect a positive impact for both patients and healthcare providers, as the lower cost could facilitate treatment adherence and reduce the financial burden on individuals and insurance systems. China will retain the largest proportion of generic drug sales through to 2030, at around 70% of the APAC region. Growth within the generic drug sub-sector will be mainly supported by increased volume consumption, driven by rising medicine demand and cost-containment measures, such as centralised drug procurement programmes encouraged by regulatory authorities.

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They are committed to providing affordable and high-quality healthcare solutions to improve the lives of people worldwide. Teva Pharmaceutical Industries Ltd. is a global leader in generics and biopharmaceuticals, dedicated to improving the lives of patients worldwide. With a focus on quality medicines and ethical business practices, Teva strives to deliver innovative healthcare solutions and increase access to essential medications.

Top 16 Generic Pharmaceuticals Companies

Ritedose is a leader in aseptic production of sterile, single-dose medication for the contract development manufacturing, generics, and 503B outsourcing markets. With over 27 years of experience, Ritedose has delivered more than 10 billion doses since 2012 without any interruptions, demonstrating a commitment to precision and reliability. Generic medicine manufacturers can develop business models prioritizing long-term sustainability, and balancing commercial viability with approaches that increase access to medicines. Discover the top 20 fine chemicals companies offering tailored solutions for pharmaceuticals, crop protection, and specialty polymers.

Sectors & research

Known for pioneering breakthrough medications like Viagra and Lipitor, Pfizer also offers a diverse portfolio of high-quality generic drugs across therapeutic areas such as cardiovascular, central nervous system, and respiratory diseases. With a strong commitment to research, quality, and affordability, Pfizer continues to innovate and expand its generic drug offerings, ensuring patients worldwide have access to essential medications at competitive prices. They offer a wide range of medications, including generic and branded drugs, as well as contract manufacturing services for other pharmaceutical companies. With a strong focus on quality and innovation, Hikma.com aims to improve global healthcare through their reliable and affordable solutions. The expiration of patents on many brand-name drugs has led to a surge in demand for generic alternatives due to their lower cost, particularly in addressing chronic diseases that account for a significant portion of global mortality.

Top 10 Globally Leading Companies in The Generic Drug Market

Specializing in prescription medicines, vaccines, and consumer healthcare products, GSK offers a diverse portfolio spanning respiratory, HIV, oncology, and vaccines. A key factor contributing to the expansion of the worldwidegeneric drugs market is the expiration of patents protecting brandedmedications. When patents expire, generic drug manufacturers gain theopportunity to produce and market their versions of these medications. Thisleads to increased competition in the market, driving down prices and expandingaccess to affordable healthcare options for consumers. Besides, generic drugsare typically more affordable than their branded counterparts, making them anattractive option for both consumers and healthcare providers.

Expanding Access to Medicines: The Role of Generics in Emerging Markets

The National Health Mission (NHM) operates a free drug initiative aimed at supporting the provision of essential generic medications at no cost in public health facilities. In many emerging markets, our products are available under a brand name, such as Omez (Omeprazole), Nise (Nimesulide),Ketorol (Ketorolac Thromethamine), Stamlo (Amlodipine Besylate), Razo (Rabeprazole), among many others. Over the years, these brands have established themselves as leaders in their respective categories. Across the five companies, the report identifies wider findings related to affordability, product registration, supply, local availability, and adaptive R&D.

Biodeal Laboratories Limited

These are companies producing drugs that have exactly the same active ingredients as brand-name drugs, but are accessible at a fraction of the cost. Their responsibilities include compliance with health, safety, and regulatory standards, and ensuring the efficacy and quality of the products. The industry plays a crucial role in enhancing global healthcare systems, offering affordable alternatives to more expensive branded drugs.

Pharma International Company

They focus on providing high-quality, cost-effective solutions in various therapeutic areas, including antibiotics, antidepressants, anti-inflammatories, epilepsy, and angina. With a commitment to research and development, Rivopharm continuously reinvests its financial performance to expand laboratory and production facilities. The company is firmly committed to adhering to regulatory compliance requirements in different markets, which has facilitated its expansion into new markets and bolstered its business growth. Latin America is anticipated to hold a considerable share of the worldwide market during the forecast period. Healthcare costs are growing significantly, making it difficult for people to afford quality healthcare. Due to this, the demand for affordable healthcare is growing in the Latin American region, driving the generic drugs market in Latin America as these drugs are an effective alternative to branded drugs.

• A generic drug is a medication containing the same active ingredient as a brand-name drug, but typically sold under its chemical name at a lower cost.
• These drugs undergo stringent testing to ensure they are bioequivalent to their branded counterparts, offering the same safety and efficacy.
• Beximco Pharmaceuticals Ltd. is a company that specializes in the manufacturing and marketing of generic pharmaceutical products.
• They started with the production of solid dosage forms and later expanded to other types of dosages.

• Oxialfarm aims to contribute to the social and economic stability of its workforce and achieve significant growth in the local market.
• The presence of notable generic drug manufacturers in Europe, such as Teva Pharmaceutical Industries Ltd., Mylan NV, and Novartis International AG, favors the growth of the generic drugs market.
• The continued rise in the expenditure on prescribed drugs and the healthcare expenditure accounting for a substantial percentage of a nation’s GDP is attributed to the generic drug manufacturers producing effective products at an advantageous price.

As Indian companies continue to invest in R&D, they are poised to play an even more substantial role in shaping the future of the global pharmaceutical landscape. Indian pharmaceutical companies are not merely suppliers of generic drugs but have also become significant players in the global pharmaceutical market. These firms are expanding their global footprint through strategic partnerships, acquisitions, and collaborations.

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In 2023, notable additions included the anticoagulant apixaban, thediabetes medication sitagliptin, and the analgesic tapentadol. Additionally,launches encompassed tacrolimus for immune system suppression post-organtransplantation and sugammadex for reversing the effects of muscle relaxants,reflecting STADA’s unwavering commitment to innovation and patient well-being. Inthe European market, Aurobindo Pharma Limited maintains a robust presenceacross 10 countries, boasting fully operational pharmacies, hospitalfacilities, and a comprehensive infrastructure for tender sales. It ranks amongthe top ten generic companies in eight countries, including four of the topfive EU nations. Continuouslyexpanding its generic IV drug portfolio, Fresenius Kabi also introduced ZincSulfate, with one of its stock-keeping units earning a Competitive GenericTherapy (CGT) designation. Additionally, the company launched Vasopressin, acardiovascular medication available in single-dose vials.

It’s a cornerstone of healthcare equity, leveling the playingfield and empowering individuals to take charge of their health without theburden of financial strain. Par Pharmaceutical is a pharmaceutical company dedicated to helping people by providing quality medicines. They specialize in modified-release oral solid dosage forms and alternative drug delivery platforms such as nasal sprays and patches. In low and middle-income countries (LMICs), generics make up 70-80% of the private sector market share. However, while Europe and the United States have seen a significant increase in generic medicine usage, there has been little change in Asia and the Middle East/South Asia region. In Europe, generic medicine volume rose from 42% in 2005 to 49.0% in 2009, and in the US, around 80% of prescriptions in retail pharmacies were for generics.

Joint event with World Economic Forum on the evolving role of generics – Meeting Report

They have also expanded internationally, with presence in 20 countries in Africa and the Middle East. Notable contributions include 40% of generics in the U.S., 25% in the U.K., 60% of global anti-retroviral drug supplies, and fulfilling 30% of UNICEF’s annual requirements. This initiative establishes dedicated outlets known as Janaushadhi Kendras, which provide generic medicines at economical rates, thereby enhancing accessibility to essential healthcare treatments. In November 2023, US President Joe Biden announced a strategic pivot towards reducing dependence on foreign-made drugs and Active Pharmaceutical Ingredients (APIs), highlighted by a USD35mn investment in domestic API production. While such policies have the potential to increase domestic production of essential medicines, it will not be sufficient to cover an increasing list of generics shortages.

Indian generic medicines have achieved global recognition, with pharmaceutical companies producing high-quality alternatives that are widely accepted in international markets. The success of Indian generics is attributed to competitive pricing, allowing these medicines to gain significant market share, especially in countries with cost-conscious healthcare systems or large populations lacking access to expensive brand-name drugs. Generic medicines play a vital role in enhancing healthcare accessibility, particularly in low- and middle-income countries where financial constraints hinder access to essential treatments. Their cost-effectiveness serves as a practical solution, bridging the availability gap between developed and developing nations.

Top 16 Generic Pharmaceuticals Companies

Depending on the market covered, sales are conducted directly to customers or through distributors outside of the United States. IMARC Group is a leading market research company dedicated to providing data-driven insights and expert consulting services to support businesses in achieving their strategic objectives across diverse industries. Anushka Bhattacharya is an editor and content writer for a market research and business consultancy company, IMARC Services Pvt. Anushka holds a Master’s degree in Commerce and has been writing and editing long-form content for 4 years covering diverse business areas such as healthcare, digital marketing, sports equipment, home appliances, social media promotion, and clothing.

Victoza & Saxenda Revenue, USDmn (FY2015-FY2024e)

Given their portfolios and footprints, these five companies – Cipla, Hikma, Sun Pharma, Teva and Viatris – can have a huge impact on access in LMICs. They can now work to significantly enhance their efforts by acting on the opportunities and the tailored recommendations set out in their respective company profiles. The report highlights untapped potential for companies to register more essential products in low- and middle-income countries (LMICs). Promisingly, in 90 out of 108 countries in scope, at least one company has registered a product, which indicates that the companies’ existing regulatory reach in LMICs is collectively broad. In March 1996, Ciba-Geigy and Sandoz merged, forming Novartis, a separate company with pharmaceutical and agrochemical operations.

They specialize in research, development, manufacturing, and marketing of generic and biosimilar medications in various therapeutic areas. They offer a wide range of products including generic drugs, biosimilars, and active ingredients. They offer a wide range of generic drugs with the same active ingredient, concentration, pharmaceutical form, and therapeutic indication as the innovator drug.

• In India, for example, the ‘Pradhan Mantri Bharatiya Janaushadhi Pariyojana’ scheme is pivotal in the nation’s efforts to increase the domestic availability of low-cost generics.
• With only a fraction of prescriptions being for branded generics, the market is dominated by unbranded generic drugs, offering a cost-effective solution for patients.
• They work to promote wellness, prevention, treatments, and cures for the world’s most feared diseases in developed and emerging economies.
• Developed Markets, Greater China, JANZ, and Emerging Markets are just a few of the markets and geographies covered by Viatris.
• They specialize in modified-release oral solid dosage forms and alternative drug delivery platforms such as nasal sprays and patches.
• The nation emerges as the global leader, fulfilling over 50% of the global demand for generics.
• They focus on providing branded and generic medications, active pharmaceutical ingredients (APIs), and over-the-counter products.

The administration said concerns over the quality of bulk-buy generic drugs have largely stemmed from secondhand information or subjective impressions. Chinese drug regulators have established stringent evaluation criteria and methods to ensure the efficacy and safety of generic drugs before granting market approval, followed by continuous quality oversight after their release. In 2008, India introduced the People’s Medicine Scheme (Jan Aushadhi) to make quality generic medicines more affordable. Subsequently, in 2015, the program underwent a revamp and rebranding, now known as the Pradhan Mantri Bhartiya Jan Ausadhi Pariyojana (PMBJP).

Operating across 47 manufacturingfacilities worldwide, Cipla produces over 50 dosage forms and more than 1,500generic products, catering to a broad spectrum of 85 markets. Furthermore, itholds a prominent position among the top ten generic players in the UnitedStates. While cost-effectiveness is critical, Indian pharmaceutical companies have not compromised quality. Stringent regulatory frameworks and adherence to international quality standards have elevated the credibility of Indian generic drugs.

Lupin is a global pharmaceutical company that specializes in the development, manufacture, and sale of a wide range of generic and specialty drugs. With a focus on key therapeutic areas like cardiovascular and respiratory health, Lupin offers innovative and cost-effective solutions to patients and healthcare providers worldwide. While there is continued unrest in some regions, both economically and politically, the regional pharmaceutical market is becoming more attractive. In addition, although most of the market was held previously by the originator drugs, new guidelines favoring generic drugs are being implemented worldwide.

Normon is a pharmaceutical company that has been manufacturing high-quality prescription and non-prescription drugs for 80 years. The Indian pharmaceutical industry is a global leader, with the domestic market poised to reach US$ 65 billion by 2024 and an expected surge to US$ 130 billion by 2030. Currently ranked 3rd globally in pharmaceutical production by volume and 14th by value, India commands a 20% share in global generic medicine supply and dominates vaccine manufacturing with a 60% market share. The generics industry is positioned to enhance access to essential health products in low- and middle-income countries. Initiatives, such as the Access to Medicine Foundation’s work, aim to mobilize generic medicine manufacturers, ensuring greater access to generic medicines. Formed through the merger of Mylan and Pfizer’s Upjohn business, Viatris is a relatively new player that has quickly risen through the ranks.

The company’s overarching objective is to assume a prominent globalposition in generics, pioneering medicines, and biopharmaceuticals, therebyenhancing patient well-being. Sun Pharma is a global pharmaceutical company committed to conducting business with the highest standards of professional integrity and ethical behavior. They offer a wide range of pharmaceutical products and aim to improve the health and well-being of people around the world. Despite this potential, harvoni price in singapore generic and biosimilar medicines remain out of reach for many in LMICs, particularly vulnerable populations and those living in low-income countries. The world’s leading producers of generic and biosimilar medicines – such as the five market leaders profiled in this report – occupy a central position in the global health landscape. By stepping up and taking action, they can ensure people living in LMICs have reliable, affordable access to essential medicines.