Spotlight on the generics industry: New analysis looks at access efforts of 5 major companies

Its primary business is generic medications, but it also deals in active pharmaceutical ingredients and, to a lesser extent, patented pharmaceuticals. Teva Pharmaceuticals was the world’s second-largest generic medicine manufacturer and eighth-largest pharmaceutical firm in 2020. What sets these eminent companies apart from their industry rivals are their unique qualities. They have a deep understanding of regulatory frameworks and compliance requirements, allowing them to navigate complex approval processes smoothly. They also possess strong relationships with healthcare providers, enabling them to collaborate on drug development and distribution.

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According to the National Health Interview Survey (NHIS), approximately 51.8 % of US adults have one chronic illness, while approximately 27.2% have several chronic conditions. In addition, chronic diseases can cause almost 38 Billion deaths per year worldwide, according to the WHO. As a result, the demand for generic drugs rises in tandem with the prevalence of chronic diseases, propelling the generic drugs market to new heights. They offer a wide range of generic drugs and steroids, including Carbamazepine, Cefixime, and Betamethasone Sodium Phosphate. With their commitment to quality and the use of modern knowledge, Alborz Bulk aims to become a leading player in the pharmaceutical industry and achieve self-sufficiency in the national economy.

The Evolution Of The Indian Pharma Industry

• Lupin Limited is an Indian pharmaceutical firm, that has firmly established a prominent presence in the global generic drug market.
• Linz Pharmaceuticals is committed to quality concerns and follows the guidelines outlined in their IMS Policy.
• 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.
• As the healthcare industry continues to prioritize cost-effective solutions, the generic drugs industry is likely to experience steady growth in the coming years.
• Rivopharm is a global pharmaceutical company specializing in the development, production, and distribution of generic pharmaceutical products.
• He excels at analysing complex market trends and producing comprehensive, actionable reports that help companies foster innovation and enhance end user experience.
• With a commitment to sustainability and corporate responsibility, Viatris aims to improve global healthcare and enhance patient outcomes.
• The company currently operates as a focused innovative biopharmaceutical company engaged in the discovery, development, manufacturing, marketing, sales, and distribution of biopharmaceutical products around the world as a result of the combination.

Once a brand-name drug’s patent expires, other manufacturers can produce generic versions, increasing accessibility to affordable medications for consumers. Thecorporation offers over 1,600 commercial products spanning a wide spectrum ofillnesses and therapeutic areas. These include anti-retrovirals and treatmentsfor tuberculosis, acute and chronic generic drugs, branded medications,specialized sterile products (such as those for thrombosis, oncology, andanesthesia), emergency medications, and vaccines.

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• Anushka Bhattacharya is an editor and content writer for a market research and business consultancy company, IMARC Services Pvt.
• Generic medicine suppliers play a vital role in reducing expenses, enhancing access to essential treatments, and bridging global healthcare gaps.
• It’s a cornerstone of healthcare equity, leveling the playingfield and empowering individuals to take charge of their health without theburden of financial strain.
• Ciplais a global pharmaceutical enterprise deeply committed to enhancingaccessibility and affordability of medications for individuals in need.
• Educating stakeholders on their benefits is crucial, and the generics industry holds a central position in improving access globally.
• In2023, Teva obtained tentative approvals for generic counterparts of variousproducts including Tofacitinib Tablets, Fidaxomicin Tablets, EncorafenibCapsules, among others, while ensuring no duplication of applications.

He excels at analysing complex market trends and producing comprehensive, actionable reports that help companies foster innovation and enhance end user experience. Also, his ability to tailor research solutions to the specific needs of healthcare clients, combined with his collaborative approach with industry stakeholders, has made him an invaluable resource in navigating the intricate healthcare market. Anil’s work empowers companies to seize emerging opportunities and achieve sustainable success. 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. 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. Its API products include Acamprosate Calcium, Alendronate Sodium, Amifostine trihydrate, Budesonide, and Carvedilol.

Victoza & Saxenda Revenue, USDmn (FY2015-FY2024e)

This diverse portfolio includes significant generics alongside a widearray of consumer healthcare products and specialty pharmaceuticals. Notably,in the Generics segment, STADA introduced Sugammadex, Fampridin, and Apixabanin 2023, providing healthcare practitioners and patients with additionaltherapeutic options. In summary, generic medicines are indispensable for sustaining healthcare systems, especially in Europe where costs are rising. Generic medicine suppliers play a vital role in reducing expenses, enhancing access to essential treatments, and bridging global healthcare gaps.

Lupin Limited

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. They have a strong focus on healthcare innovation and improving access to life-saving treatments.

Novartis AG

Generics and biosimilars are crucial in providing affordable and effective treatments for various diseases. According to the World Health Organization (WHO), 90% of essential medicines are off-patent, allowing generic and biosimilar manufacturers to enter the market and develop these medicines at a lower cost, potentially introducing competition and increasing supply. This is particularly important in emerging markets, where access to affordable and effective medicines is limited, and communicable diseases remain significant public health concerns.

Intas Pharmaceuticals

Nonetheless, the FDA’s stringent approval and distribution process restrict the expansion of the generic drug industry. For instance, Sun Pharma recalled 747 bottles of generic diabetes medication in October 2020 because they could contain cancer-causing nitroso dimethylamine above the limit. Emerging markets like India and China are supposed to generate more opportunities for the generic drugs market. Viatris Inc. is a global healthcare firm founded in November 2020 by the merger of Mylan and Upjohn.

Top 16 Generic Pharmaceuticals Companies

North America held the largest share of the global generic drugs market in 2023 and is predicted to maintain the same dominating position throughout the forecast period. The United States had the largest market share of 92% for generic drugs in North America in 2022, followed by Canada, which had a market share of 8%. They specialize in the research, development, manufacturing, and marketing of complex injectables. Operating primarily under a business-to-business model, they have a track record of delivering long-term value to employees, shareholders, and investors. With state-of-the-art facilities and a professional management team, Gland Pharma is one of the largest and fastest-growing generic injectables manufacturers.

Keypoints

However, the issue of these medicines in certain countries is about something other than being expensive but about dubious quality. 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.

• The administration said concerns over the quality of bulk-buy generic drugs have largely stemmed from secondhand information or subjective impressions.
• We anticipate growth for generics in all global regions in 2024, with growth outside of China being led by the US, India, Italy and Germany in absolute value terms.
• The company is primarily involved in the manufacturing,development, and marketing of a broad spectrum of branded and genericformulations, as well as Active Pharmaceutical Ingredients (APIs).
• Gabapentin is already available in other generic forms, but the specific release characteristics and dosing regimen of Gralise are protected by patents.
• As Jayasree K. Iyer, CEO of the Access to Medicine Foundation, emphasized, “It is vitally important that all healthcare sectors address inequality and improve access, which we have articulated in our new Strategic Direction”.
• Victoza is not approved for weight management, the aspect of GLP-1 that is recently of interest, nor will Victoza likely gain approval for such an indication based on its existing clinical trial results.

These companies have demonstrated exceptional growth, strategicforesight, and operational excellence, enabling them to navigate complexregulatory environments and fierce competition within the pharmaceuticalindustry. Amneal Pharmaceuticals is a pharmaceutical company that specializes in the development and production of essential medicines. They have a broad portfolio of approximately 270 generic and specialty pharmaceuticals, and they are committed to improving the lives of patients and care for the communities they serve. It focuses on the research, development, manufacturing, and marketing of active pharmaceutical ingredients (APIs) and finished formulations. Dedicated to affordability and improving well-being, Qilu has a robust pipeline of over 200 generic, 30 biosimilar, and 80 innovative products.

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. The widespread availability of generic medicines plays a pivotal role in controlling and eradicating infectious diseases, notably demonstrated in the cases of HIV/AIDS, malaria, and tuberculosis. Generic antiretrovirals and antimalarials have been instrumental in globally expanding treatment options for these conditions.

World’s Prominent Companies Offering Generic Drug; Top 10 by Revenue

The government’s involvement is essential in facilitating the export of generic medicines through policies and laws that promote competition and ensure affordability. Compulsory licensing is a significant measure allowing the production and export of low-cost generic drugs by bypassing patent monopolies, especially crucial during public health crises like pandemics. Additionally, governmental policies aim to streamline access to generic medicines, promote their use, reduce healthcare costs, and ensure affordability for all. Generic medicines play a crucial role in bridging healthcare gaps on a global scale by providing affordable and accessible healthcare solutions.

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. The global market for generic drugs is expected to grow from $435.3 billion in 2023 and projected to reach $655.8 billion by the end of 2028, at a compound annual growth rate (CAGR) of 8.5% from 2023 to 2028.

Additionally, collaborative effortswith partners focus on novel and intricate products like the BOTOX®(onabotulinumtoxinA) biosimilar and Glatiramer Acetate Depot, a long-actinginjectable form of the approved glatiramer acetate. Contributing significantly to India’s economy, the pharmaceutical industry is ranked 3rd worldwide in production volume and 14th by value. Projections harvoni price in malaysia indicate a soaring industry value of USD 130 billion by 2030, underlining its economic significance. Prioritizing long-term sustainability in business models ensures the widespread availability of essential treatments. Generics stand as pillars of global health, addressing challenges and fostering innovation for a more inclusive and sustainable healthcare future worldwide.

About the Generic & Biosimilar Medicines Programme

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. 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.

Additionally, anesthesiologists and hospital officials from various hospitals in Shanghai said the generic versions of the anesthetics they use produce the desired clinical outcomes. Interviews with them, along with a retrospective study at Ruijin Hospital, showed no significant dosage changes before and after the bulk procurement program. This commentary is published by BMI, a Fitch Solutions company, and is not a comment on Fitch Ratings Credit Ratings. Any comments or data included in the report are solely derived from BMI and independent sources.

Generic drugs sales are facing increasing challenges in the US, mainly due to pricing pressures. Politicians are beginning to target the high costs of medicine through the inflation reduction act and other ongoing legislation, with undifferentiated generic drugs being targeted for such cost controls. This has led many US and foreign generic drug companies to lower their expectations for growth in the US. 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.