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

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.

• For instance, in May 2022, Sandoz will expand its respiratory portfolio by launching the first generic pirfenidone in the United States for patients with idiopathic pulmonary fibrosis.
• Cardiology, psychiatry, neurology, gastroenterology, ophthalmology, and psychiatry are some of the therapeutic areas where the company is a significant player.
• Projected to reach $65 billion by 2024 and $130 billion by 2030, India’s pharmaceutical sector demonstrates significant growth potential from its current $50 billion valuation.
• The role of Indian pharmaceutical companies in improving healthcare access worldwide through high-quality generic drugs is commendable and pivotal.
• They have over 1,000 molecules covering a wide range of therapeutic areas and are a renowned pioneer in antimicrobials with over 150 product and technology combinations.
• Furthermore, itholds a prominent position among the top ten generic players in the UnitedStates.

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

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. 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”. The Indian pharmaceutical industry has invested significantly in research and development (R&D) activities, creating innovative generic drugs.

Sectors & research

With a commitment to sustainability and corporate responsibility, Viatris aims to improve global healthcare and enhance patient outcomes. 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. Publicly funded health systems are under amplified pressure to reduce the ever-rising drug budgets. The government is finding ways to restore the fiscal balance by transferring more funds to patients and private health insurance.

Keypoints

They possess a well-diversified portfolio of over 200 generic medicines and a strong presence in both developed and emerging markets. Based on type, the pure generic drugs segment dominated the market in 2023 and held more than half of the global market share, 51%. Therefore, the upper hand of the pure generic drugs segment is predicted to continue during the forecast period. The cost-effectiveness of these drugs and the growing adoption of pure generic drugs in developing countries primarily drive the segment’s growth.

Novartis AG

The Emerging Markets sector includes the Company’s ARV franchise as well as activities in countries with developing markets and emerging economies, including Asia, the Middle East, South, and Central America, Africa, and Eastern Europe. Avet Pharmaceuticals Inc. is a pharmaceutical company that specializes in the production and distribution of various medications, including tablets, capsules, and injectables. 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. Esseti Farmaceutici is a pharmaceutical company that offers a range of products and services. They specialize in pharmaceutical trading, contract development and manufacturing, and pharmacovigilance.

Sandoz Group AG [Annual Revenue: USD 15 Billion]

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. With the rising demand for affordable medications, the generic drugs industry has experienced significant growth in recent years. According to market research, the global generic drugs market is projected to reach a value of $380 billion by 2025, reflecting its upward trajectory and economic magnitude. Eli Lilly and Company, founded in 1876, is a global pharmaceutical leader headquartered in Indianapolis, USA.

Sandoz

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. Geolab is committed to providing affordable and high-quality medications to improve people’s health and well-being.

Global Generic Drugs Market Size

Alvogen is a global pharmaceutical company that develops, manufactures, and sells generic, brand, over-the-counter, and biosimilar products. The cost-effectiveness of generic medications has increased demand for the generic drugs market. Generic drugs increase competition in the industry, leading to a drop in prices and more people being prescribed generic drugs by healthcare providers. Generic drugs are 85 % less expensive than conventional drugs, so in the United States, 9 out of 10 prescriptions are filled with generic drugs, saving almost $2.2 trillion over the past decade. The company is dedicated to providing affordable and high-quality medicines while promoting sustainability.

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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. Novartis AG is a Swiss multinational pharmaceutical corporation based in Basel, Switzerland that focuses on the discovery, development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products. The company develops and manufactures medications to treat cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, hematologic diseases, solid tumors, immune disorders, and infections.

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This concerted effort has enabled the company to extend its reachto over 15,000 pin codes, ensuring access to quality medications for patientsin tier 2 cities and beyond. With a portfolio comprising over 200 brands across26 therapeutic categories, the generics segment has achieved remarkable 9%growth, driven by the robust performance of flagship brands and successfullaunches of new products. 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). With a strategicemphasis on crafting intricate pharmaceutical products for global markets,Aurobindo specializes in tackling complex and challenging manufacturingprocesses. Auro Peptides, a subsidiary of Aurobindo Pharma Limited,concentrates on the development of peptide-based generic APIs, with aparticular focus on the oncology and diabetology segments. Teva Argentina is a leading pharmaceutical laboratory that develops and produces high-quality medications to improve the lives of patients and their communities.

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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. We’re able to make these medicines affordable because we manage the entire value chain – from producing the active ingredients to developing formulations to distributing them through our streamlined supply chain. We leverage our inherent strength—one of the largest manufacturing bases in India—to provide a distinct cost advantage for our customers. 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. 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. Ratiopharm is a pharmaceutical company that offers a wide range of prescription and over-the-counter medications, as well as generic versions of existing drugs.

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. Also, it enables them to hold an attractive position to fulfill the increasing essential need for these medicines. Also, as generic-friendly policies are expected to be enacted, the market share of patented drugs is expected to erode further in the next decade, thereby resulting in the growth of the generic drugs market worldwide. With a focus on affordability and accessibility, Mylan expanded its reach worldwide, particularly in emerging markets.

Aspen Pharmacare Holdings Limited

• With subsidiaries and offices in over 80 countries across the Americas, Europe, the Middle East, Africa, and Asia-Pacific, Novartis products reach about 800 million customers globally.
• In addition to its global reach, Fresenius Kabi has subsidiaries and sales offices in over 100 countries, giving the company an opportunity to serve a broad range of customers.
• This commentary is published by BMI, a Fitch Solutions company, and is not a comment on Fitch Ratings Credit Ratings.
• With a focus on innovation and customer satisfaction, Aurobindo Pharma offers a wide range of healthcare products globally.
• With over 3,000 pharmaceutical companies and 10,500 manufacturing facilities, India boasts a robust industry.
• Similarly, in May 2022, the company received final FDAapproval for its ANDA for generic Mesalamine Extended Release Capsules, 500 mg,based on Pentasa® Extended-Release Capsules, 500mg as the reference product.
• Pfizer’s generic drug portfolio includes a diverse range of products across various therapeutic areas, including cardiovascular disease, pain management, and central nervous system disorders.
• 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.
• Unlike their brand-namecounterparts, generic drug manufacturers focus not on inventing new moleculesbut on replicating existing ones once patents expire.

The analysis reveals areas where companies can focus their attention as they step up efforts to expand access to their essential medicines. Anil Kumar P is the lead author of this report and the manager of the team responsible for authoring healthcare reports at Market Data Forecast. He holds a Bachelor’s degree in Pharmacy (Hons.) from BITS Pilani, one of India’s premier institutions. The Diagnostic Products segment contains a diverse range of diagnostic systems and tests that are produced, marketed, and sold around the world.

Novartis AG [Annual Revenue: USD 46.66 Billion]

Established Pharmaceutical Products, Diagnostic Products, Nutritional Products, and Medical Devices are the four reportable segments for Abbott. They started with the production of solid dosage forms and later expanded to other types of dosages. Their goal is to provide reliable and affordable pharmaceutical facilities to all types of customers.

• In Europe, Freseniusswiftly introduced Sugammadex, a neuromuscular block reversal agent, to themarket upon patent expiry.
• The generic pharmaceuticals industry is centered around creating and distributing cost-effective alternatives to brand-name prescription medicines.
• In addition, the growing patient count suffering from chronic diseases such as cardiovascular diseases, cancer, diabetes, and others is expected to propel the segment’s growth rate as these drugs are used in the treatment procedures of chronic diseases.
• The launch of generic Gralise, especially in Q124, as anticipated, could offer patients more options for their treatment plans.
• Unlock industry potential through cutting-edge research, data-driven insights, and strategic guidance.
• With a strong commitment to research and development, Beximco Pharmaceuticals aims to improve the health and well-being of people globally.
• Notable drugs that are open to generic competition in 2024 include Novo Nordisk’s Victoza (liraglutide), an anti-diabetic medication used to treat type 2 diabetes (T2D) and chronic obesity.

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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.

Amriya for Pharmaceutical Industries S.A.E

Leveraging strategic partnerships and investments in R&D, the company continues to expand its offerings and enhance its manufacturing capabilities to meet the evolving needs of healthcare providers and patients worldwide. The global pharmaceutical industry faces a significant challenge in ensuring access to essential medicines, particularly in emerging markets where affordability and availability are major concerns. The generics industry plays a critical role in addressing this issue, offering cost-effective alternatives to branded medications. This article explores the role of generics in expanding access to medicines in emerging markets, highlighting the challenges and opportunities that exist. The role of Indian pharmaceutical companies in improving healthcare access worldwide through high-quality generic drugs is commendable and pivotal.

• 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.
• 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.
• Teva Pharmaceutical Industries Ltd. is a global leader in generics and biopharmaceuticals, dedicated to improving the lives of patients worldwide.
• Linz Pharmaceuticals is committed to quality concerns and follows the guidelines outlined in their IMS Policy.
• These companies have achieved remarkable accomplishments in terms of revenue, market share, and innovation.
• Itsdiverse product portfolio encompasses complex generics and medicationstargeting respiratory, anti-retroviral, urology, cardiology, anti-infective,CNS, and various other critical therapeutic segments.
• The Diagnostic Products segment contains a diverse range of diagnostic systems and tests that are produced, marketed, and sold around the world.
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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.

In the event of negative reactions or patient side effects resulting in the report, the FDA investigates and makes required changes in the usage and manufacturing of these medicines. These medicines cost less than branded medicines as they do not involve repeated animal and clinical studies required for branded medicines. However, the issue of these medicines abiraterone price in uae 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.

Mohammed