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. 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.
- By addressing these hurdles, Indian pharmaceutical firms can further enhance their contribution to global healthcare access.
- This commitment to quality ensures that patients worldwide can access affordable medicines without compromising safety or efficacy.
- Abbott Laboratories is a worldwide medical device and healthcare corporation based in Abbott Park, Illinois, United States.
- He holds a Bachelor’s degree in Pharmacy (Hons.) from BITS Pilani, one of India’s premier institutions.
- Their responsibilities include compliance with health, safety, and regulatory standards, and ensuring the efficacy and quality of the products.
- 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.
- Recent developments include advancements in oncology with drugs like Verzenio, as well as ongoing research into Alzheimer’s treatments.
Top 16 Generic Pharmaceuticals Companies
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.
The Rising Demand for Generic Drugs
The concept of digital health is having a big impact on healthcare, especially when it comes to improving … InFebruary 2023, a wholly owned subsidiary of Sun Pharma secured final approvalfrom the US Food and Drug Administration (FDA) for its Abbreviated New DrugApplication (ANDA) concerning generic lenalidomide Capsules in multiplestrengths. 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. To enhance oversight of bulk-buy medications, the administration said it is committed to conducting regular and random checks on drugmakers that win bids and will promptly address any issues. Additionally, anesthesiologists and hospital officials from various hospitals in Shanghai said the generic versions of the anesthetics they use produce the desired clinical outcomes.
Mylan N.V. [Annual Revenue: USD 11.5 Billion]
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.
Expanding Access to Medicines: The Role of Generics in Emerging Markets
The global generic drugs market is forecasted to generate $404.3 billion in revenue in 2022, with an estimated compound annual growth rate of 7.20% until 2030, reaching $705.1 billion. In the dynamic landscape of healthcare, the demand for accessible and cost-effective medications is more pronounced than ever before. A significant player in this realm is the global market for generic drugs — a sphere that has witnessed remarkable growth and transformation in recent years.
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The ongoing expansion of drugs available to China’s public health insurance fund will also promote growth in generics domestically. 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 global demand for generics will continue to rise, as the global burden of disease also increases. This research report on the global generic drugs market has been segmented and sub-segmented based on the type, application, and region. 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.
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Its generic offerings span various therapeuticdomains, including cardiovascular, central nervous system, oncology, infectiousdiseases, pain management, and respiratory ailments. Notably, Sandoz holds aleading global position in generic antibiotics, uniquely positioned with alarge-scale vertically integrated business headquartered in Europe. It offers an extensive portfolio comprising around 500 genericprescription products, spanning over 1,400 variations in dosage strengths,packaging sizes, and formulations. Its offerings encompass a diverse range oforal solid dosage forms, injectables, inhalants, transdermal patches, liquids,ointments, and creams.
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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. They specialize in pharmaceutical trading, contract development and manufacturing, and pharmacovigilance.
Driving Forces Behind Generic Drug Industry Growth
Under this initiative, the government has set up thousands of Janaushadhi Kendras (generic drug stores) to ensure that citizens have access to a wide range of medications at a fraction of the branded drug cost. However, maintaining stringent quality control standards remains a key focus to foster trust and sustained use of these generics. We’re able to make these medicines affordable because we manage the entire value chain – from producing the active ingredients to developing formulations abiraterone cost uk 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. Many people throughout the world do not have access to good health because they can’t afford expensive medicines.
Joint event with World Economic Forum on the evolving role of generics – Meeting Report
With risinghealthcare costs globally, patients and healthcare systems are increasinglyseeking cost-effective alternatives without compromising on quality. 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. Using a robust pipeline of drug candidates in development, the company offers affordable and accessible high-quality generic medicines and biosimilars through its subsidiary Sandoz. Novartis conducts research in various disease areas through The Novartis Institutes for BioMedical Research (NIBR).
- 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.
- 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.
- The Fresenius SE & Co. consists of the operating Companies Fresenius Kabi and Fresenius Helios and the Investment Companies Fresenius Medical Care and Fresenius Vamed.
- 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.
- 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.
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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.
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.
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In 2020, the company operated commercial activities with a global organization that included two businesses—Biopharma and Upjohn, which were each directed by a single manager until November 16, 2020. Pfizer concluded the spin-off and merging of the Upjohn Business with Mylan on November 16, 2020. 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. As a leading global medicines company, they use innovative science and digital technologies to create transformative treatments in areas of great medical need. In their quest to find new medicines, the company consistently rank among the world’s top companies investing in research and development.
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. Viatris is a global pharmaceutical company offering a wide range of therapeutic products and services. They focus on providing branded and generic medications, active pharmaceutical ingredients (APIs), and over-the-counter products. With a commitment to sustainability and corporate responsibility, Viatris aims to improve global healthcare and enhance patient outcomes.
However, challenges such as patent litigations and strict regulations continue to shape the industry. Teva Pharmaceutical Industries Ltd. is a global leader in the generic drug market, with a history dating back to 1901. Specializing in affordable alternatives to brand-name medications, Teva offers a diverse portfolio covering various therapeutic areas. Despite facing challenges like pricing pressures, the company remains committed to accessibility and quality, continually optimizing its offerings through R&D and strategic initiatives.
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).
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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.
This strategic diversification strengthens India’s position in the global pharmaceutical market. Generic medications, being generally more economical than their branded counterparts, provide enhanced accessibility to a diverse patient demographic, notably benefiting those in low- and middle-income countries. These generic drugs present a financially prudent option, offering a cost-effective alternative for essential treatments, thereby expanding access to a wider population. This economic viability becomes particularly vital in regions where financial limitations frequently impede the availability of critical, life-saving medications. India excels in generic medicine production, commanding 20% of global supply and leading vaccine manufacturing.
As aleading global generic pharmaceutical enterprise, it facilitates access tomedical treatments through its extensive portfolio exceeding 1,000 productsspanning various therapeutic categories. Proactive implementation of quality control measures, including adherence to good manufacturing practices (GMP) and stringent quality checks, ensures the safety and efficacy of Indian generic medicines. As a key player in generic medicine supply, India consistently upholds high standards in pharmaceutical production. Generic medicines, synonymous with cost-effectiveness, emerge as pharmaceutical counterparts to brand-name drugs. Their crucial role lies in providing quality treatment at reduced costs, vital for the efficiency of healthcare systems. Efforts to educate patients and healthcare providers about the benefits of generic medicines can address the preference for branded medications and lack of knowledge, increasing their usage.
- TheNorth America Generics (NAG) segment stands as Dr. Reddy’s largest market andachieved a milestone by surpassing the USD 1 billion revenue mark for thesecond consecutive year in 2023.
- These companies have demonstrated exceptional growth, strategicforesight, and operational excellence, enabling them to navigate complexregulatory environments and fierce competition within the pharmaceuticalindustry.
- They are committed to providing affordable and high-quality healthcare solutions to improve the lives of people worldwide.
- 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.
- 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.
- 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.
He is committed to staying at the forefront of industry innovations, ensuring that his work consistently exceeds client expectations. Whether working with small start-ups or large enterprises, Anil consistently delivers high-quality research that supports informed decision-making and drives impactful results in the healthcare industry. Aurobindohas garnered approvals for sophisticated injectable suspension products,including generic versions of Kenalog®, Depot-Medrol®, and Depo-Provera®,typically characterized by an extended duration of action lasting up to severalweeks. Discover the top human resources software companies offering innovative solutions for workforce management, including Workday and BambooHR. The Nutritional Products segment encompasses a vast range of pediatric and adult nutritional items that are developed, marketed, and sold all over the world.
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.
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.
However, when a patent expires, manufacturers may ask the FDA for permission to produce generic drugs. Consequently, generic medications are less expensive than marketed drugs, and almost 80% of prescription drugs are generic. Metformin, metoprolol, amphetamine salt combo, acyclovir, bupropion HCL tablet, cholestyramine, ibuprofen tablet, letrozole, and verapamil are some examples of generic drugs.
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.
Additionally, certain Medicare Part D plans failed to cover generic Hepatitis C drugs in 2019, resulting in missed savings opportunities. The export of generic medicines enables countries to share their pharmaceutical resources and expertise with others. Disparities in disease prevalence between developed and developing countries can result in gaps in the utilization of specialty medicines. Generic medications emerge as a solution to bridge these discrepancies, offering more affordable and accessible treatment options. 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.
They boast a diverse portfolio of over 1,400 molecules and maintain a strong presence in over 160 countries. Viatris’ focus on affordability and accessibility aligns well with the growing demand for generic drugs worldwide. The Established Pharmaceutical Products segment encompasses a broad range of branded generic medications made around the world and marketed and sold in emerging markets outside of the United States. 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. Certain products are co-marketed or co-promoted with other companies or are licensed from them.
With over 3,000 pharmaceutical companies and 10,500 manufacturing facilities, India boasts a robust industry. Producing 60,000 generic brands across 60 categories, India meets substantial global demand and provides affordable HIV treatment. Generic drugs first appeared in 1984, when the Hatch-Waxman Act encouraged the manufacture of generic drugs and developed system regulation. In contrast to branded products, generic drugs have the same API pharmacokinetic and pharmacodynamic properties. It is also bioequivalent to currently available branded drugs but differs in fillers, preservatives, form, packaging, and flavor. Branded drug manufacturers spend money on research and development and ads for their new products, and they are granted a monopoly for a set period.
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. If you want to find more companies that specialize in producing affordable generic medications you can do so with Inven.