Krka is an international pharmaceutical company and one of the leading generic manufacturers worldwide. Macleods Pharma is a pharmaceutical company that offers a wide range of high-quality generic and branded drugs. With a focus on research and development, they provide innovative and affordable healthcare solutions to improve the well-being of individuals globally. The high cost of branded medicines has been a significant barrier to healthcare access, especially in developing nations.

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Almatica’s Gralise (gabapentin) is a medication primarily used to treat epilepsy and neuropathic pain, with patent set to expire in early 2024. 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.

• Despite the dominance of a few major players, smaller companies are also making their mark in the generic drugs market.
• The success of these top companies can be attributed to several shared elements and approaches.
• Intas is a leading multinational pharmaceutical formulation development, manufacturing, and marketing company.
• Companies in this industry prioritize efficiency to create affordable and readily accessible alternatives to innovator drugs without compromising quality.
• It focuses on the research, development, manufacturing, and marketing of active pharmaceutical ingredients (APIs) and finished formulations.

Hetero Drugs Ltd

In 2020, Mylan merged with Upjohn to form Viatris Inc., marking the end of its independent existence. Aspen Pharmacare Holdings Ltd (Aspen) is a prominent supplier of specialty and generic pharmaceuticals for the treatment of various acute and chronic ailments. Aspen Pharmacare has a robust quality management system and adheres to strict regulatory compliance standards and is approved by multiple regulatory agencies on a global level. Aspen’s generic drugs provide a cost-effective option for patients, thereby enhancing accessibility to its products for a broader population, particularly in emerging markets. The company operates across various regions, including Sub-Saharan Africa, South East Asia, Latin America, Eastern Europe, Western Europe, and the Commonwealth of Independent States. Lupin Limited is an Indian pharmaceutical firm, that has firmly established a prominent presence in the global generic drug market.

Expanding Global Footprint

The company has entered into strategic partnerships with other pharmaceutical companies to develop generic drugs and expand its patient base. A world leader in generic drug manufacturing with operations in North America, Europe, Asia, and Latin America, Teva has a strong distribution network with a presence in over 60 countries. One of the primary contributions of Indian pharmaceutical companies to global healthcare is the production of high-quality generic drugs. Generic medicines, which are bioequivalent to their branded counterparts, provide a cost-effective alternative without compromising efficacy. Indian pharmaceutical firms have become pioneers in producing generic versions of essential drugs, making treatments more affordable and accessible globally.

Key Companies in the Generic Drug Market

• Normon is a pharmaceutical company that has been manufacturing high-quality prescription and non-prescription drugs for 80 years.
• Furthermore, itholds a prominent position among the top ten generic players in the UnitedStates.
• 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.
• Generic drugs sales are facing increasing challenges in the US, mainly due to pricing pressures.
• Pfizer Inc. refers to an American multinational pharmaceutical and biotechnology corporation that is considered as one of the major market players in the generic drugs market.

They offer a wide range of products such as Mycophenolate Mofetil, Propofol Injectable Emulsion, and Octreotide Acetate. Avet Pharma aims to provide high-quality medications to patients, ensuring their safety and well-being. They specialize in pharmaceutical trading, contract development and manufacturing, and pharmacovigilance.

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• Tabuk Pharmaceuticals is a company that develops, manufactures, markets, and distributes branded and generic pharmaceutical products with a strong focus on the Middle East and North Africa.
• These companies, driven by innovation, efficiency, and a commitment to public health, are instrumental in making healthcare accessible worldwide.
• Sandozboasts a diverse global portfolio comprising approximately 1,500 high-qualitybiosimilar and generic medications.
• As part of its research and development efforts, Fresenius Kabi develops new generic drugs and pipeline products.
• The market in the Middle East and Africa is expected to hold a moderate share of the worldwide market during the forecast period.
• This diverse portfolio includes significant generics alongside a widearray of consumer healthcare products and specialty pharmaceuticals.
• Teva Pharmaceuticals Industries Ltd. is a well-known brand in the pharmaceutical industry and is recognized for its quality generic drugs that are affordable, making them accessible to a larger patient population, especially in developing countries.

Genpharma is a pharmaceutical laboratory specializing in the development, production, and commercialization of generic drugs. With a capacity of 120 million boxes, Genpharma aims to increase its strategic position as a leader in the Moroccan generic market. 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.

AbbVie Inc. [Annual Revenue: USD 14.301 Billion]

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With their online distribution system and distribution portal, they provide 24/7 access to their products. Linz Pharmaceuticals is committed to quality concerns and follows the guidelines outlined in their IMS Policy. Intas is a leading multinational pharmaceutical formulation development, manufacturing, and marketing company.

Companies have potential to register more of their essential products in LMICs

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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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. Many patients in conflict zones and low-income countries have limited pharmaceutical manufacturing and are heavily reliant upon imports to access generics. Weak regulatory systems in many sub-Saharan African countries, lack of financing, and insufficient healthcare infrastructure impede access to quality generic medicines.

With a production base that allows the manufacture of 13 different pharmaceutical forms, SOTHEMA represents 35 client laboratories ranking among the global R&D leaders. Drawingfrom over 50 years of experience in manufacturing active pharmaceuticalingredients (APIs), Cipla has developed over 200 generics and complex APIs. Thecompany is eager to collaborate with leading generic firms to introduce newproducts, thus expanding its presence in markets such as Japan, Korea, andBrazil. Moreover, Cipla is actively pursuing strategies to deepen itspenetration in the generic distribution channel through digital platforms,engaging directly with retailers. By March 2023, it had onboarded over 135,000retailers, facilitating enhanced market outreach and accessibility. Asthe 10th largest generics company in the United States, Sun Pharma possesses aformidable research and development infrastructure, equipped to developtechnologically advanced products in both generics and specialty segments.

Cost-Effective Solutions

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.

These are long-term illnesses caused by genetic, environmental, behavioral, and psychological factors. Non-communicable diseases (NCDs) such as cardiovascular disorders, chronic respiratory diseases such as COPD and asthma, malignancies, and diabetes are the most common. Rapid unplanned urbanization, globalization of unhealthy lifestyles, and an aging population drive these diseases.

Amriya for Pharmaceutical Industries S.A.E

Low-income countries across various regions, including parts of Asia and Latin America, struggle with access to generics due to high out-of-pocket costs for patients, tariffs on imported medicines, and limited availability of essential drugs. We anticipate that new regional and national initiatives will be developed, targeting improving regulatory capacities, establishing better procurement practices, negotiating price reductions, and encouraging local production of generic medicines. GSK plc, or GlaxoSmithKline, a prominent global pharmaceutical company, has been a leader in innovation since its formation in 2000 through the merger of Glaxo Wellcome and SmithKline Beecham. Specializing in prescription medicines, vaccines, and consumer healthcare products, GSK offers a diverse portfolio spanning respiratory, HIV, oncology, and vaccines.

Encouragingly, the report found strong examples of how companies are engaging in adaptive R&D to tailoring products to the needs of people in LMICs, with nine adaptive R&D projects identified among the companies in scope. These include products specifically adapted for children; products adapted so that they do not require refrigeration; and formulations that simplify dosing regimens. BCC Research provides objective, unbiased measurement and assessment of market opportunities with detailed market research reports. Our experienced industry analysts assess growth opportunities, market sizing, technologies, applications, supply chains and companies with the singular goal of helping you make informed business decisions, free of noise and hype. Beyond his professional achievements, Anil is deeply passionate about the intersection of technology and healthcare. He is committed to staying at the forefront of industry innovations, ensuring that his work consistently exceeds client expectations.

Industry

• The concept of digital health is having a big impact on healthcare, especially when it comes to improving …
• As a key player in generic medicine supply, India consistently upholds high standards in pharmaceutical production.
• Many patients in conflict zones and low-income countries have limited pharmaceutical manufacturing and are heavily reliant upon imports to access generics.
• Oxialfarm is a pharmaceutical company based in Ecuador that specializes in the production of retroviral medications.
• This commitment to quality ensures that patients worldwide can access affordable medicines without compromising safety or efficacy.

Consequently, low-cost generics from India and China will remain in high demand from the US until sufficient subsidies or alternative support for domestic generic drugs production expansion are offered. Throughout 2023, India -based pharmaceutical companies have been the frontrunners of US ANDA approvals, which are generic approvals by the FDA that can be sold and distributed in the US. According to the FDA, India is the second-largest provider of finished dose pharmaceuticals to the US, and accounts for nearly 20% of the global exports of generics. India supplies approximately 40% of generic and OTC drugs consumed in the US, meaning that in the near-to-medium term, the US will remain highly reliant upon India for access to many generic drugs. The company is dedicated to providing affordable and high-quality medicines while promoting sustainability.

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. By establishing a presence in diverse markets, they contribute to healthcare access and the overall economic development of their regions.

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). While generics share the same active pharmaceutical ingredient (API) as brand-name drugs, variations in characteristics such as formulation and packaging exist. Government regulations, including FDA evaluations, ensure their safety and efficacy, marking them as reliable alternatives to brand-name counterparts.

• Sandoz was the world’s leading generics manufacturer in 2020, with 9.5 Billion US dollars in revenue.
• By addressing the challenges and seizing the opportunities, generic medicine manufacturers can ensure that high-quality, safe, and effective medications are available to those who need them most.
• They have emerged as the key players in the pharmaceutical industry, contributing to the availability and affordability of generic drugs worldwide.
• Future growth and expansion of the industry are projected due to factors such as growing drug patent expiracies and an increasing emphasis on cost-effective healthcare solutions.
• Psychiatry, anti-infectives, neurology, cardiology, orthopedics, diabetology, gastroenterology, ophthalmology, nephrology, urology, dermatology, gynecology, respiratory, oncology, dental, and nutrition are among the therapeutic categories covered by the goods.
• Sun Pharmaceutical Industries Limited is a Mumbai-based Indian multinational pharmaceutical firm that develops and sells pharmaceutical formulations and active pharmaceutical ingredients (APIs) primarily in India and the United States.
• This growth is anticipated to be particularly strong in the Asia-Pacific (APAC) region (10% in 2024 to USD246bn), led by Mainland China and supported by wider demographic shifts and economic growth.

With a strong commitment to research and development, Beximco Pharmaceuticals aims to improve the health and well-being of people globally. The global healthcare landscape has witnessed a paradigm shift, with Indian pharmaceutical companies emerging as critical players in improving healthcare access worldwide. In Africa, the African Medicines Agency (AMA) aims to enhance the continent’s pharmaceutical regulatory environment to ensure that the generic drugs supplied meet international quality standards. The AMA seeks to harmonise the disparate regulatory policies and to streamline the approval processes for generic medicines across member states. In South East Asia, Thailand has implemented the ‘National List of Essential Medicines’, which prioritises generics in government procurement and healthcare delivery, ensuring that the public healthcare system provides cost-effective treatment options.

Is a pharmaceutical company established in 2015 specializing in drug production and food supplementation. With a focus on quality and innovation, the company produces its own generic drugs and food supplements, as well as offers manufacturing services for other companies. DOC PHARMA exports its products to various European countries and has the potential for global expansion. Abbott, founded in 1888, is a global healthcare company renowned for its generic drug division offering a broad range of pharmaceuticals across therapeutic areas like cardiovascular, CNS, and women’s health. With a focus on quality, affordability, and innovation, Abbott continues to expand its portfolio through strategic acquisitions and R&D investments, ensuring the delivery of high-quality, accessible healthcare solutions worldwide.

They operate in more than 85 countries and have a strong presence in highly regulated markets like the EU and US. With a focus on good health and happiness, Intas offers a wide range of high-quality pharmaceutical products globally. The Indian pharmaceutical industry has evolved significantly over the past few decades, transforming from primarily domestic to global. Today, it is the third-largest pharmaceutical market in terms of volume and ranks among the top 10 in terms of value. This growth has been fueled by a commitment to research, development, and a focus on producing cost-effective generic drugs. The industry’s expansion goes beyond generic drug manufacturing, with Indian pharmaceutical companies increasingly emphasizing innovation, novel drug development, and substantial investments in biopharmaceuticals and biosimilar research.

Founded in 1983, Sun Pharmaceutical Industries Ltd. (Sun Pharma) is one of the world’s largest specialty generic pharmaceutical companies with over 40 manufacturing facilities. In addition to providing high-quality, affordable medicines, the company also offers a wide range of therapeutic categories, including basic and complex medicines, branded as well as generics, committed to patient-centricity and offering value-added services. Cardiology, psychiatry, neurology, gastroenterology, ophthalmology, and psychiatry are some of the therapeutic areas where the company is a significant player. With operations in over 100 countries, Sun Pharma is a global company, with a well-positioned presence in markets, such as the United States, Europe, Japan, and India. Apotex is a global pharmaceutical company that offers a wide range of generic and over-the-counter medications. They are committed to providing affordable and high-quality healthcare solutions to improve the lives of people worldwide.

The issue of cheaper generics is grounded on measurable and enforceable assurance about quality through tests and other internationally mandated parameters. In addition, the absence of a standard drug regulatory body in certain countries leads to quality issues. Aurobindo is a global pharmaceutical company focused on the development and production of high-quality generic medicines. With over 24,000 employees and presence in 155 countries, we strive to make affordable and accessible medicines available to everyone. Qilu Pharma Spain is the European subsidiary of Qilu Pharmaceutical, one of the leading pharmaceutical companies in China. They specialize in research, development, manufacturing, and marketing of generic and biosimilar medications in various therapeutic areas.

This strategy enables Pfizer to maintain a strong foothold in the generic drug market while also protecting its revenue streams from branded drugs that come off-patent. The company operates in more than 175 countries worldwide and some of the key markets include the United States, Canada, the United Kingdom, Germany, Japan, China, Brazil, and Australia. Teva Pharmaceuticals Industries Ltd. is a well-known brand in the pharmaceutical industry and is recognized for its quality generic drugs that are affordable, making them accessible to a larger patient population, especially in developing countries. As a manufacturer of generic drugs, Teva has an extensive product portfolio covering a variety of therapeutic areas, such as central nervous system disorders, respiratory diseases, cardiovascular diseases, and oncology.

The cardiovascular segment is estimated to showcase a healthy CAGR during the forecast period. CVDs are one of the leading causes of death worldwide, including heart failure, circulatory disorders, high blood pressure, cholesterol, dyslipidemia, angina, arrhythmias, and stroke. Moreover, the cardiovascular segment covers more than 6% of the global generic drug market due to a series of cardiovascular drug patent expiration. In addition, global population growth and aging benefit the healthcare sector and the manufacturers of generic drugs. Hetero.com is a pharmaceutical company that specializes in the research, development, and production of high-quality and affordable medicines.

Torrent.com.br is a pharmaceutical company that specializes in the production and distribution of high-quality medications in areas such as cardiovascular and diabetes, central nervous system, and generics. SOTHEMA is a 100% Moroccan pharmaceutical company specializing in the manufacturing and sale of medicines since 1976. They offer custom manufacturing of pharmaceutical forms for several national and international pharmaceutical companies.