Global Generic Drugs Market Report 2021: The New Generics Era - The Patent Cliff, Types of Generic Drugs, Simple Generics, Super Generics, Biosimilars, ANDA Approvals - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Global Generic Drugs Market 2020-2025" report has been added to ResearchAndMarkets.com's offering.

The global market for generic drugs should grow from $411.6 billion in 2020 to $650.3 billion by 2025, at a compound annual growth rate (CAGR) of 9.6% for the period of 2020-2025.

The nature and structure of the generic drug industry is discussed, with profiles of the leading 20+ generic drug companies and an update on M&A activity. Five-year sales forecasts are provided for the national markets and the major therapeutic categories of the products involved.

This report is being published at a time when the pharmaceutical industry faces challenges and changes more radical than any it has faced in the last half-century. The worldwide economic recession in 2008 has had a profound impact on an industry that is normally resilient to the usual ups and downs of commercial life. Apart from the sometimes painful process of cutting costs and restructuring, the industry has had to confront the fact that its trading environment has fundamentally changed because all its customers are now aware of prices.

At this critical time, the pharmaceutical world has also endured a phase for which the label "patent cliff" was coined. A stream of blockbuster drugs has begun losing their patent protection, and R&D pipelines have not been able to produce a satisfactory supply of replacements. The doors have been thrown open to generic drug producers to do what they do best: provide low-cost alternatives.

And there is an added complexity. Over the past two decades, advances in biotechnology have led to the introduction of a generation of biotherapeutic agents that are often more efficacious than traditional small-molecule drugs at treating their target diseases. The earliest of these biotherapeutics are now losing their patent protection, and this offers yet another opportunity for generic copies - although this is a technically fraught area, as will be seen. In fact, the challenges facing "originator" companies - the major purveyors of own-brand pharmaceuticals - are matched by those confronting generic drug suppliers.

Suppliers of generic drugs relied initially on low cost as their main market advantage. It became a potent argument, as the government health departments in most European countries operating national health schemes began to introduce measures designed to curb pharmaceutical expenditure. In the U.S., developments in managed care had a similar effect. Everywhere, these cost-cutting exercises favored generics.

However, the low-cost argument that had been the generic products' main rationale acted against the commercial promise of this industry sector. This occurred partly because the attractiveness (and thus high-volume sales potential) of blockbuster drugs remained in place after these drugs lost their patent cover. Generic drug companies vied with each other to introduce low-cost copies, and they were driven to undercut each other to the point where a year after patent expiry on the original brand, the mean price of copy products was merely 20% or less of the original.

Partly, too, generic price competition was fueled by government reimbursement measures, which favored low-cost drugs and thus tended to trigger further price cutting among the generic drug contenders.

This development had two far-reaching effects. First, it began to weed out the weaker generic drug companies in favor of companies that had the means and the resolve to exist in an environment where profit margins were severely cut, sometimes to less than 10%. One of the survival strategies adopted by these manufacturers has been to widen their appeal beyond mere cost-cutting, to include, for example, "super generics" products with added value, often in the form of special delivery formulations.

Company profiles of the leading players operating in the global generic drugs market including Aspen, Cipla, Lupin, Pfizer, Sanofi, Sun Pharmaceuticals and Teva Pharmaceuticals

Key Topics Covered:

Chapter 1 Introduction

Chapter 2 Summary and Highlights

Chapter 3 Market Overview

• Recent History of the Generic Drug Industry
• Roche-Bolar
• Generics Lobby
• ICH

Chapter 4 Impact of COVID-19

• Short-Term Impact on the Pharma Industry
• Long-Term Impact on the Pharma Industry
• Impact of COVID-19 on the Market for Generic Drugs
• Impact on the Supply Chain

Chapter 5 The New Generics Era

• The Patent Cliff
• Types of Generic Drugs
• Simple Generics
• Super Generics
• Biosimilars
• ANDA (Abbreviated New Drug Application) Approvals

Chapter 6 Major Issues Within the Market for Generic Drugs

• Regulatory Environment
• U.S.
• European Union
• Japan
• Regulation of Biosimilars
• EU Provisions
• Evolving Situation in the U.S.
• User Fees
• Defensive Strategies Used by Big Pharma
• Authorized Generic Drugs
• User Fees
• Changing Climate for Generics
• Situation in Europe
• Patents and IP
• Supplementary Protection Certificates

Chapter 7 Global Market for Generic Drugs

• Global Pharmaceutical Market: Brand Name and Generic Drugs
• Global Market for Generic Drugs
• Market Opportunities by Product Class
• Market Shares of Pharmaceutical Drugs by Therapeutic Area

Chapter 8 Market Breakdown by Region

Chapter 9 Industry Trends

• Competitive Landscape
• Market Trends
• Structure of the Generic Drug Industry
• Recent Mergers and Acquisitions
• Brand Name Company Involvement

Chapter 10 Company Profiles

• Aspen Holdings
• Cipla Inc.
• Fresenius Kabi
• Lupin Ltd.
• Mylan Inc.
• Pfizer Inc.
• Sandoz International Gmbh
• Sanofi
• Sun Pharmaceutical Industries Ltd.
• Teva Pharmaceutical Industries Ltd.

Chapter 11 Other International Companies

• Aurobindo Pharma Ltd.
• Dr. Reddy's Laboratories Ltd.
• Egis Pharmaceuticals Plc
• Krka
• Par Pharmaceutical Inc.
• Stada Arzneimittel
• Strides Shasun Ltd.
• Wockhardt Ltd.
• Zydus Cadila

For more information about this report visit https://www.researchandmarkets.com/r/59t8x