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

11 February, 2025

High-quality Generic Meds Globally

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. Their commitment to producing affordable medicines without compromising quality has reshaped the global pharmaceutical landscape. As these companies continue to innovate, collaborate, and expand their reach, the future promises a more accessible and equitable healthcare system worldwide.

Aspen Pharmacare Holdings Limited

High-quality Generic Meds Globally

With an extensive rangeof offerings, the company is focused on strengthening its presence in keydomestic markets such as India, alongside South Africa, North America, andother pivotal regulated and emerging markets. 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.

  • If you want to find more companies that specialize in producing affordable generic medications you can do so with Inven.
  • 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 increasing number of initiatives by the European governments favoring generic drugs is fuelling the European market growth.
  • 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.
  • Contributing significantly to India’s economy, the pharmaceutical industry is ranked 3rd worldwide in production volume and 14th by value.
  • It further underscores the company’saspiration to be recognized as the foremost global leader in biosimilars andgenerics, valued for its commitment and excellence.
  • 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.

Despite initiatives to strengthen manufacturing, further efforts needed to safeguard product availability

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.

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Headquartered in Israel, the company holds the top spot in revenue and maintains a robust presence in both developed and emerging markets. 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).

Industry

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. 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.

Top 23 Specialty and Generic Pharmaceuticals Providers

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.

Top 10 Generic Drugs Companies in the World

Viatris seeks to provide improved access to inexpensive, high-quality medications for patients worldwide, regardless of region or circumstance, by combining the assets of these two businesses. Laurus Labs is an innovative company with world-class research capabilities, specializing in the manufacturing and marketing of pharmaceutical products. Laurus Labs is committed to developing new cures, building a profitable business, and improving the quality of life through affordable medicines. The success of these top companies can be attributed to several shared elements and approaches. Firstly, they have invested heavily in research and development, constantly striving to bring new and improved generic drugs to the market. Secondly, they have built robust manufacturing capabilities, ensuring high-quality and cost-effective production.

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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. With the prevalence of T2D increasing globally, the demand for effective and affordable treatments is expected to rise, creating a sizeable market for generics. When it comes to expanding access to medicine, the power of the generics industry is often underestimated. It’s more than the transactional relationship of selling drugs at volume and competing on price. The cardiovascular segment is estimated to showcase a healthy CAGR during the forecast period.

Global Generic Drugs Market Size

The journey of Indian pharmaceutical companies exemplifies a synergistic blend of economic viability and social responsibility, positioning them as true leaders in the pursuit of global health equity. Baxter International Inc. is a leading healthcare company renowned for its diverse portfolio of generic drugs, encompassing injectables, oral solid formulations, and essential pharmaceuticals across various therapeutic areas. With a history dating back to 1931, Baxter has earned recognition for its commitment to quality, innovation, and affordability. 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. Beximco Pharmaceuticals Ltd. is a company that specializes in the manufacturing and marketing of generic pharmaceutical products.

The Indian pharmaceutical industry has invested significantly in research and development (R&D) activities, creating innovative generic drugs. This focus on innovation has resulted in the development of complex generics and biosimilars, addressing unmet medical needs globally. 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.

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. 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.

  • This commitment to quality ensures that patients worldwide can access affordable medicines without compromising safety or efficacy.
  • However, challenges such as patent litigations and strict regulations continue to shape the industry.
  • In low and middle-income countries (LMICs), generics make up 70-80% of the private sector market share.
  • The analysis reveals areas where companies can focus their attention as they step up efforts to expand access to their essential medicines.
  • The world’s leading producers of generic and biosimilar medicines – such as the five market leaders profiled in this report – occupy a central position in the global health landscape.

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.

Top 17 Leading Generic Drugs Companies Worldwide

  • Fresenius Kabi produces generic drugs as a subsidiary of the company, leading a major growth area in healthcare.
  • In March 1996, Ciba-Geigy and Sandoz merged, forming Novartis, a separate company with pharmaceutical and agrochemical operations.
  • Learn more about the BMI products and services that empower you to make critical business decisions with confidence.
  • Committed to health, Teva is a global leader in generic and specialty medicines across various therapeutic areas.
  • With over 27 years of experience, Ritedose has delivered more than 10 billion doses since 2012 without any interruptions, demonstrating a commitment to precision and reliability.
  • 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.
  • 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.

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.

AbbVie Inc. [Annual Revenue: USD 14.301 Billion]

  • 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.
  • One of the primary contributions of Indian pharmaceutical companies to global healthcare is the production of high-quality generic drugs.
  • AspenPharmacare has made substantial investments not only to align with contemporaryregulatory standards but also to address evolving patient needs by offeringcost-effective alternatives to newer, pricier innovative drugs.
  • Apotex is a global pharmaceutical company that offers a wide range of generic and over-the-counter medications.
  • Almatica’s Gralise (gabapentin) is a medication primarily used to treat epilepsy and neuropathic pain, with patent set to expire in early 2024.

Novartis AG is a Swiss pharmaceutical giant formed in 1996 through the merger of Ciba-Geigy and Sandoz, boasting a rich history in the industry. Its subsidiary Sandoz is a key player in the generic drug market, offering a diverse range of affordable pharmaceuticals across therapeutic areas. Novartis prioritizes innovation, quality, and accessibility, evident in its global reach, philanthropic efforts, and commitment to improving healthcare worldwide.

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. As these diverse initiatives unfold, they highlight a shared commitment to expanding the reach of high-quality generic medicines. Rivopharm is a global pharmaceutical company specializing in the development, production, and distribution of generic pharmaceutical products. They focus on providing high-quality, cost-effective solutions in various therapeutic areas, including antibiotics, antidepressants, anti-inflammatories, epilepsy, and angina. With a commitment to research and development, Rivopharm continuously reinvests its financial performance to expand laboratory and production facilities.

High-quality Generic Meds Globally

Hisun Pharmaceutical is a comprehensive pharmaceutical enterprise that specializes in the research, development, production, and sales of innovative drugs, biological drugs, and generic drugs. With a portfolio covering various therapeutic areas including anti-tumor, anti-infection, and cardiovascular, Hisun Pharmaceutical is dedicated to delivering world-class quality medications and making crucial contributions to human life and health. The generic drugs industry has a profound influence on various sectors, including healthcare, insurance, and consumer spending. By offering lower-cost alternatives to expensive medications, it helps reduce healthcare costs and improves accessibility for patients.

Discover the Top 17 Healthcare Diagnostics Companies revolutionizing healthcare with innovative diagnostic solutions. 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 harvoni price in malaysia 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.

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