Branded Generics Market by Product (Trade Named Generics, Value-Added), Drug Type (Alkylating Agents, Anti-depressants, Anti-epileptics), Route of Administration, Indication, Distribution Channel - Global Forecast 2024-2030

[191 Pages Report] The Branded Generics Market size was estimated at USD 432.30 billion in 2023 and expected to reach USD 494.29 billion in 2024, at a CAGR 14.66% to reach USD 1,126.43 billion by 2030.

Branded generic drugs refer to medications that are bioequivalent to the original innovator drug and are distributed under a different brand name by another company after patent expiration. These drugs are formulated using the same active pharmaceutical ingredients (APIs) as the innovator product and must meet similar regulatory requirements for manufacturing processes, safety profiles, and efficacy standards. However, branded generics may exhibit subtle differences in terms of excipients, packaging materials, or manufacturing techniques compared to their innovator counterparts. Increasing consumer awareness about accessible treatment options, rising healthcare expenditure, and increasing patent expirations on blockbuster drugs drive the growth of the branded generics market. However, stringent regulatory requirements for drug approval and quality control and price erosion resulting from intense competition among manufacturers may hinder market growth. Nevertheless, advancements in pharmaceutical research enabling the development of bioequivalent products create lucrative opportunities for the growth of the branded generics market.

In the Americas region, the branded generics market has a lucrative landscape due to its robust healthcare infrastructure and high per capita spending on pharmaceuticals. The government's initiatives to increase awareness about generic drugs have led to promising growth prospects for branded generics. Additionally, the investment in R&D by leading pharmaceutical companies has resulted in new product approvals and innovative therapeutics entering this market space. The European Union showcases a diverse landscape within the branded generics sector. There is considerable demand for cost-effective treatment options with increasing healthcare expenditure across EU countries and favorable pricing policies for generic medicines by national governments. Major players are investing heavily in research activities to develop novel drugs while maintaining competitiveness against low-cost alternatives from emerging markets. The Middle East and Africa offer notable potential for growth in the branded generics market as the government initiatives aimed at improving healthcare infrastructure and affordability of medicines are driving factors contributing to expanding market opportunities. The Asia-Pacific showcases immense potential for branded generics development owing to the rising research and development, supportive government initiatives, increasing demand for trade generics, and surging collaborations among international players to develop innovative therapies catering to global needs.

The market dynamics represent an ever-changing landscape of the Branded Generics Market by providing actionable insights into factors, including supply and demand levels. Accounting for these factors helps design strategies, make investments, and formulate developments to capitalize on future opportunities. In addition, these factors assist in avoiding potential pitfalls related to political, geographical, technical, social, and economic conditions, highlighting consumer behaviors and influencing manufacturing costs and purchasing decisions.

• Market Drivers
  • Prevalence of chronic diseases necessitating the use of generic medications
  • Increasing patent expiration for blockbuster drugs and the need for cost-effective alternatives
• Market Restraints
  • Concerns associated with quality variations in branded generic medications
• Market Opportunities
  • Novel bioequivalence studies and efforts by market players to expand branded generics business
• Market Challenges
  • Litigation issues and issues related to price erosion of innovator drugs

• Product: Significant adoption of value-added branded generics due to their additional advantages

  Ttrade-named generics are the pharmaceutical product that combines the trusted efficacy of an established generic drug with the recognition and reputation of a well-known brand name. These products offer the benefits of both generic and branded medicines, with high quality at an affordable price. Pharmaceutical manufacturers commonly use trade-named generics to penetrate competitive markets, providing patients and healthcare professionals with cost-effective alternatives that maintain trust in safety, effectiveness, and reliability. Value-added offerings represent a distinct category that differentiates itself from standard formulations by bringing additional benefits to the consumer. These value-added products may combine multiple active ingredients for enhanced therapeutic effects or adopt innovative dosage forms for improved convenience, such as extended-release formulations or easy-to-swallow tablets. In some cases, value-added trade-named generics can also include drugs reformulated to reduce side effects or improve patient adherence, such as Benitek A (Olmesatran in combination with Amlodipine), Nifedical (nifedipine), and Digitek (digoxin).

• Drug Type: High usage of anti-hypertensive for treating high blood pressure

  Alkylating agents are a class of drugs primarily used in cancer treatment, and they work by inhibiting DNA replication restricting the growth and multiplication of cancer cells, such as cyclophosphamide, melphalan, and cisplatin. Anti-depressant medications are used to treat various forms of depression and anxiety disorders as they restore the balance of neurotransmitters within the brain, particularly serotonin, norepinephrine, and dopamine, and commonly prescribed anti-depressants include fluoxetine, venlafaxine, and amitriptyline. Anti-epileptic drugs (AEDs) are medications designed to prevent or control epileptic seizures in individuals diagnosed with epilepsy. Anti-hypertensive medications lower blood pressure in individuals with hypertension, reducing the risk of heart disease, stroke, and other complications. Antipsychotic medications are primarily used to manage symptoms of psychotic diseases such as bipolar disorder and schizophrenia. Antimetabolites are a group of chemotherapeutic agents that interfere with cellular metabolism and DNA synthesis in cancer cells while they mimic essential building blocks for DNA replication or inhibit critical enzymes involved in these processes. Hormone-based medications are used in various medical conditions, including hormone imbalances, endocrine disorders, and certain cancers. Lipid-lowering medications are designed to reduce elevated levels of triglyceride and cholesterol in the blood, lowering the chance of cardiovascular disorders such as heart attacks.

The porter's five forces analysis offers a simple and powerful tool for understanding, identifying, and analyzing the position, situation, and power of the businesses in the Branded Generics Market. This model is helpful for companies to understand the strength of their current competitive position and the position they are considering repositioning into. With a clear understanding of where power lies, businesses can take advantage of a situation of strength, improve weaknesses, and avoid taking wrong steps. The tool identifies whether new products, services, or companies have the potential to be profitable. In addition, it can be very informative when used to understand the balance of power in exceptional use cases.

The value chain of the Branded Generics Market encompasses all intermediate value addition activities, including raw materials used, product inception, and final delivery, aiding in identifying competitive advantages and improvement areas. Critical path analysis of theBranded Generics Market identifies task sequences crucial for timely project completion, aiding resource allocation and bottleneck identification. Value chain and critical path analysis methods optimize efficiency, improve quality, enhance competitiveness, and increase profitability. Value chain analysis targets production inefficiencies, and critical path analysis ensures project timeliness. These analyses facilitate businesses in making informed decisions, responding to market demands swiftly, and achieving sustainable growth by optimizing operations and maximizing resource utilization.

The regulatory framework analysis for the Branded Generics Market is essential for ensuring legal compliance, managing risks, shaping business strategies, fostering innovation, protecting consumers, accessing markets, maintaining reputation, and managing stakeholder relations. Regulatory frameworks shape business strategies and expansion initiatives, guiding informed decision-making processes. Furthermore, this analysis uncovers avenues for innovation within existing regulations or by advocating for regulatory changes to foster innovation.

The market share analysis is a comprehensive tool that provides an insightful and in-depth assessment of the current state of vendors in the Branded Generics Market. By meticulously comparing and analyzing vendor contributions, companies are offered a greater understanding of their performance and the challenges they face when competing for market share. These contributions include overall revenue, customer base, and other vital metrics. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With these illustrative details, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

The FPNV positioning matrix is essential in evaluating the market positioning of the vendors in the Branded Generics Market. This matrix offers a comprehensive assessment of vendors, examining critical metrics related to business strategy and product satisfaction. This in-depth assessment empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success, namely Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

• Vyvanse Generics Approved by FDA

  The FDA has approved generic forms of Vyvanse - (Lisdexamfetamine Dimesylate) for the treatment option of ADHD in patients aged six years or older, as well as moderate-to-severe BED in adults. Takeda Pharmaceuticals' U.S. patent for Vyvanse expired, allowing companies to manufacture and sell generic versions of the medication. These generic versions may contain different binding agents, fillers, and colors. [Published On: September 05, 2023]

• Pharmaceutical Alliance, Generic Pharmaceutical Association Renew Generic Drug Pricing Agreement

  The pan-Canadian Pharmaceutical Alliance (pCPA) & the Canadian Generic Pharmaceutical Association (CGPA) have renewed a three-year pricing initiative for generic medicines. This initiative aims to effectively manage public drug plan costs while providing a stable and predictable environment for generics manufacturers to introduce new drugs. As a part of the new initiative, any new generics entering the pan-Canadian Tiered Pricing Framework automatically reduce their prices to 55% of the brand reference price after three months, provided that there is only one generic product available in Canada. [Published On: September 01, 2023]

• Amneal Launches Authorized Generic for Xyrem (sodium oxybate) and Receives FDA Approval for Five Complex Generics

  Amneal Pharmaceuticals, Inc. introduced its authorized generic version of Xyrem1 (Sodium Oxybate) oral solution CIII in the United States. This medication is commonly prescribed to address cataplexy or excessive daytime sleepiness (EDS) by acting as a central nervous system depressant. In addition to this launch, Amneal has obtained Abbreviated New Drug Application (ANDA) approvals from the U.S. FDA for five complex generic products. [Published On: July 03, 2023]

The report delves into recent significant developments in the Branded Generics Market, highlighting leading vendors and their innovative profiles. These include Dr. Reddy’s Laboratories Ltd., Lupin Limited, Viatris Inc., Sandoz International GmbH by Novartis AG, Bausch Health Companies Inc., GlaxoSmithKline PLC, Amneal Pharmaceuticals LLC, Eris Lifesciences Limited, Alkem Laboratories Ltd., Cipla Limited, Zentiva Group, a.s., Nichi-Iko Pharmaceutical Co., Ltd., Endo International PLC, Aurobindo Pharma Limited, AstraZeneca PLC, Eva Pharma, Hetero Drugs Limited, Abbott Laboratories, Glenmark Pharmaceuticals Limited, Fresenius Kabi AG, Pfizer Inc., Aspen Pharmacare Holdings Limited, Sun Pharmaceutical Industries Ltd., Ajanta Pharma Ltd., Apotex Inc., Bristol-Myers Squibb Company, Sanofi S.A., Micro Labs Limited, Torrent Pharmaceuticals Ltd., and Teva Pharmaceutical Industries Ltd..

This research report categorizes the Branded Generics Market to forecast the revenues and analyze trends in each of the following sub-markets:

• Product
  • Trade Named Generics
  • Value-Added
• Drug Type
  • Alkylating Agents
  • Anti-depressants
  • Anti-epileptics
  • Anti-hypertensive
  • Anti-psychotics
  • Antimetabolites
  • Hormones
  • Lipid Lowering Drugs
• Route of Administration
  • Oral
  • Parenteral
  • Topical
• Indication
  • Acute & Chronic Pain
  • Cardiovascular Diseases
  • Dermatological Diseases
  • Gastrointestinal Diseases
  • Neurological Diseases
  • Oncology
• Distribution Channel
  • Offline
    • Hospital Pharmacy
    • Retail Pharmacy
  • Online

• Region
  • Americas
    • Argentina
    • Brazil
    • Canada
    • Mexico
    • United States
      • California
      • Florida
      • Illinois
      • New York
      • Ohio
      • Pennsylvania
      • Texas
  • Asia-Pacific
    • Australia
    • China
    • India
    • Indonesia
    • Japan
    • Malaysia
    • Philippines
    • Singapore
    • South Korea
    • Taiwan
    • Thailand
    • Vietnam
  • Europe, Middle East & Africa
    • Denmark
    • Egypt
    • Finland
    • France
    • Germany
    • Israel
    • Italy
    • Netherlands
    • Nigeria
    • Norway
    • Poland
    • Qatar
    • Russia
    • Saudi Arabia
    • South Africa
    • Spain
    • Sweden
    • Switzerland
    • Turkey
    • United Arab Emirates
    • United Kingdom

1. Market Penetration: This section thoroughly overviews the current market landscape, incorporating detailed data from key industry players.
2. Market Development: The report examines potential growth prospects in emerging markets and assesses expansion opportunities in mature segments.
3. Market Diversification: This includes detailed information on recent product launches, untapped geographic regions, recent industry developments, and strategic investments.
4. Competitive Assessment & Intelligence: An in-depth analysis of the competitive landscape is conducted, covering market share, strategic approaches, product range, certifications, regulatory approvals, patent analysis, technology developments, and advancements in the manufacturing capabilities of leading market players.
5. Product Development & Innovation: This section offers insights into upcoming technologies, research and development efforts, and notable advancements in product innovation.

1. What is the current market size and projected growth?
2. Which products, segments, applications, and regions offer promising investment opportunities?
3. What are the prevailing technology trends and regulatory frameworks?
4. What is the market share and positioning of the leading vendors?
5. What revenue sources and strategic opportunities do vendors in the market consider when deciding to enter or exit?