Navigating Global Pharma: The Rise of Generic Drugs

By offering lower-cost alternatives to expensive medications, it helps reduce healthcare costs and improves accessibility for patients. 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.

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With a focus on innovation and customer satisfaction, Aurobindo Pharma offers a wide range of healthcare products globally. Alvogen is a global pharmaceutical company that develops, manufactures, and sells generic, brand, over-the-counter, and biosimilar products. In 2024, the global market for generic drugs is projected to increase by USD3bn, a growth rate of 6.7% from 2023, bringing total sales to an estimated USD51bn. 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. The APAC region is undergoing a significant transformation due to an ageing population, especially in Japan, China and South Korea.

Mylan N.V. [Annual Revenue: USD 11.5 Billion]

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.

• 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.
• When it comes to expanding access to medicine, the power of the generics industry is often underestimated.
• Drawingfrom over 50 years of experience in manufacturing active pharmaceuticalingredients (APIs), Cipla has developed over 200 generics and complex APIs.
• They offer a wide range of high-quality and affordable medicines for various therapeutic areas.
• This initiative establishes dedicated outlets known as Janaushadhi Kendras, which provide generic medicines at economical rates, thereby enhancing accessibility to essential healthcare treatments.
• 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.
• They specialize in the production of high-quality generic medications and contract manufacturing for other pharmaceutical companies.

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In Europe, Freseniusswiftly introduced Sugammadex, a neuromuscular block reversal agent, to themarket upon patent expiry. The administration said claims suggesting the generic drug is less effective are based on personal experiences. The ongoing study centers on assessing the availability, affordability, and acceptability of essential medicines under the PMBJP initiative.

• Anushka Bhattacharya is an editor and content writer for a market research and business consultancy company, IMARC Services Pvt.
• While Indian pharmaceutical companies have made remarkable strides, they face challenges such as patent issues, regulatory complexities, and the need for continuous innovation.
• 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.
• 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.
• Thirdly, they have developed strong distribution networks, enabling them to reach diverse markets and provide affordable drugs to a wide range of customers.
• The issue of cheaper generics is grounded on measurable and enforceable assurance about quality through tests and other internationally mandated parameters.
• Secondly, they have built robust manufacturing capabilities, ensuring high-quality and cost-effective production.

Advantages of Generic Medicines:

In addition, the growing chronic disease patient population in the Latin American region and the increasing number of generic drug manufacturing activities further fuel the growth of the generic drugs market in Latin America. On the other hand, the branded generic drugs market had decent occupancy in the global market in 2023 and is predicted to showcase a CAGR of 8.8% during the forecast period. The growing demand for quality drugs with a trusted brand name is majorly boosting segmental growth. Branded generic drugs have gained recognition as being of better quality than pure ones, and notable pharmaceutical companies market these. 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 generic pharmaceuticals industry is centered around creating and distributing cost-effective alternatives to brand-name prescription medicines.

Aurobindo Pharma Limited

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.

Generic Drugs Key Themes For 2024: Drug Shortages, Patent Cliffs And National Incentives To Impact Global Market

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. 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.

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Sun Pharma, based in India, is among the largest and most influential generic drug manufacturers globally. The company has a strong presence in various therapeutic segments and operates in numerous countries. Abbott Laboratories is a worldwide medical device and healthcare corporation based in Abbott Park, Illinois, United States. Abbott’s main business is the research, development, manufacturing, and distribution of a wide range of healthcare products. Established Pharmaceutical Products, Diagnostic Products, Nutritional Products, and Medical Devices are the four reportable segments for Abbott.

About the Generic & Biosimilar Medicines Programme

Novartis products reach nearly 800 million people globally and they are finding innovative ways to expand access to their latest treatments. Natco Pharma is a pharmaceutical company that manufactures and markets affordable medicines worldwide. They focus on providing specialty medicines at accessible prices and adhere to global standards. Landsteiner is a pharmaceutical company with over 20 years of experience in the Mexican market. They specialize in the development, production, and commercialization of healthcare products, including generic and biotechnological medications. They offer a wide range of high-quality prescription and over-the-counter pharmaceutical products.

#11 Bristol-Myers Squibb Company

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.

• It focuses on the research, development, manufacturing, and marketing of active pharmaceutical ingredients (APIs) and finished formulations.
• They have a strong focus on healthcare innovation and improving access to life-saving treatments.
• The Indian Pharmacopoeia (IP) undergoes regular updates to align with global standards, reflecting the nation’s commitment to industry excellence.
• 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.
• This commentary is published by BMI, a Fitch Solutions company, and is not a comment on Fitch Ratings Credit Ratings.
• 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.

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

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. Moreover, they have a strong focus on customer-centricity, prioritizing patient needs and delivering value through their generic drug offerings. 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.

This commitment to quality ensures that patients worldwide can access affordable medicines without compromising safety or efficacy. The government must take appropriate steps to encourage global pharmaceutical firms to set up new generic facilities through joint ventures by offering tax breaks. Some amendments, such as the US Generic Drug User Fee Act, are expected to result in a much stronger focus on quality with a much shorter approval process for these generic medicines.

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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.

New Markets New Geographies Competition

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.

Top 27 Manufacturers of Quality Road Bikes

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. 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.

Amneal Pharmaceuticals

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.

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. The generic drugs industry is a sector that focuses on the production and distribution of medications that are bioequivalent to brand-name drugs but are sold under their generic names. There are several types of companies in this industry, including large multinational pharmaceutical companies, smaller local manufacturers, and distributors.

In addition to providing system-critical products and services for critical and chronically ill patients, the company has a strong distribution network, which allows it to efficiently distribute products worldwide. As part of its research and development efforts, Fresenius Kabi develops new generic drugs and pipeline products. Additionally, Fresenius Kabi implements several initiatives to reduce the impact of its operations on the environment.

This seemingly simple acthas profound implications, making life-saving medications accessible tomillions who might otherwise struggle to afford them. While Indian pharmaceutical companies have made remarkable strides, they face challenges such as patent issues, regulatory complexities, and the need for continuous innovation. By addressing these hurdles, Indian pharmaceutical firms can further enhance their contribution to global healthcare access. The Indian pharmaceutical industry has swiftly ascended to global prominence, establishing itself as a primary hub for the manufacturing and export of generic medicines. As a generic medicine supplier, this achievement has earned it the distinguished title of the “pharmacy of the world.” The industry’s remarkable growth can be attributed to various pivotal factors and compelling statistics.

Also, the FDA’s Office of Generic Drugs (OGD) gained huge success after implementing the Generic Drug User Fee Amendments Reauthorization (GDUFA II) in the first year. The main purpose of the FDA was to promote international trade and harmonization of generic medicine development, thereby creating opportunities to gain high-quality drugs to be approved globally. Moreover, the FDA has taken a crucial step toward easing the entry of generic medicines into the market by introducing generic competition to the level of branded medicines known as complex drugs. The authorization of the first generic version of Advair Diskus in Jan 2019 for the treatment of asthma is an example of this, which creates future opportunities for the generic drug market. 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.

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.

In addition, increasing initiatives from the MEA countries favoring generic drugs support regional market growth. The APAC market held the second-largest worldwide market share in 2023, falling right behind North America. Countries such as India and China in the Asia-Pacific region dominated the global generic drugs business in volume. 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%.

Global Pharma is a leading generics partner in the region, specializing in the production of medicines and herbal remedies. With a manufacturing facility in Dubai Investment Park, the company has an extensive product range that covers various therapeutic areas. They work closely with healthcare professionals to understand their needs and offer support programs for better patient management. Almatica’s Gralise (gabapentin) is a medication primarily used to treat epilepsy and neuropathic pain, with patent set to expire in early 2024.

With a focus on affordability and accessibility, Mylan expanded its reach worldwide, particularly in emerging markets. 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.

Generic medicines play a crucial role in bridging healthcare gaps on a global scale by providing affordable and accessible healthcare solutions. This blog post will discuss the importance of generic medicines in addressing healthcare disparities and their potential to improve health outcomes worldwide. Alkem Labs is a pharmaceutical company that specializes in cardiovascular health, dyslipidemia, and hypertension. With a global presence in markets such as Africa, Philippines, and Kazakhstan, Alkem Labs aims to provide innovative healthcare solutions through their technologically advanced research facilities. Neo Química is a pharmaceutical company that offers a wide range of generic medicines and healthcare products. Another prominent Indian pharmaceutical company, Dr. Reddy’s Laboratories is a leading player in the global generics market.

• Hisun Pharmaceutical is a comprehensive pharmaceutical enterprise that specializes in the research, development, production, and sales of innovative drugs, biological drugs, and generic drugs.
• Today, it is the third-largest pharmaceutical market in terms of volume and ranks among the top 10 in terms of value.
• The Indian pharmaceutical industry has evolved significantly over the past few decades, transforming from primarily domestic to global.
• In this blog, we unveil the top 10 generic drug companies that are leading the charge in revolutionizing the industry.
• 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.
• Depending on the market covered, Abbott-owned distribution centers and public warehouses sell these items directly to wholesalers, distributors, government agencies, health care facilities, pharmacies, and independent retailers.
• Given their portfolios and footprints, these five companies – Cipla, Hikma, Sun Pharma, Teva and Viatris – can have a huge impact on access in LMICs.

Oxialfarm is a pharmaceutical company based in Ecuador that specializes in the production of retroviral medications. With over 10 years of experience, they are the first Ecuadorian company to produce retroviral drugs in the country. Their commitment to quality is evident in their efforts to provide top-notch products and services, excellent customer care, and responsible practices that mitigate environmental impact. Oxialfarm aims to contribute to the social and economic stability of its workforce and achieve significant growth in the local market. By producing bioequivalentversions of brand-name medications, generic drug companies dramatically reducecosts while maintaining the same therapeutic efficacy. This democratization ofmedicine ensures that essential treatments—from antibiotics to cardiovasculardrugs—are not reserved solely for the privileged few but are accessible to allwho need them.

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. Sandoz was the world’s leading generics manufacturer in 2020, with 9.5 Billion US dollars in revenue. Tablets, capsules, and tablets aren’t the only ways to get medicine into your body; injectables are another option. They’re considered the most effective because the drug’s bioavailability is higher through this route than the others. The market in the Middle East and Africa is expected to hold a moderate share of the worldwide market during the forecast period. The rising number of improvements in the healthcare infrastructure and healthcare system of MEA countries is favoring the generic drugs market in MEA.

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.

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 sofosbuvir price in germany 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.