A generic drug is a duplicate copy of original branded drug, which has same dosage form, active pharma ingredients (API), strength, route of administration, and also same intended use as the branded one. Regulatory authorities and governments have mandated that an authorized generic drug has to medicinally correspond to the branded drug and sanctioned as an Abbreviated New Drug Application (ANDA) by the Food and Drug Administration (FDA). An authorized generic is the branded company’s individual product, but repackaged and marketed as generic drug either via subsidiary or third party. These are already approved as a New Drug Application by the FDA, only they are promoted via private label. The authorized generics market grew rapidly in the past few years as these provide consumers with branded quality drugs at generic prices. Presently, there is a growing trend of original maker giving approvals to a subsidiary or a private label distribution company to sell its brand name drug as a generic drug at a subsequently low price.
An example of authorized generic drug is Azithromycin Pak which is sold under by the company name Greenstone. Pfizer’s original branded drug Z-pak was approved by the FDA. Before patent expiry of Z-pak, Pfizer allowed Greenstone to sell Z-pak using authorized generic name Azithromycin Pak. Greenstone is a wholly owned subsidiary of Pfizer.
The global authorized generics market is expected to witness strong growth. Authorized generic drugs are priced at significantly discounted rate i.e. 50% to 70% as compared to branded counterparts. Additionally, many of the popular branded drugs of pharma companies are losing patent protection rights, which is also termed as patent cliffs. This would pave the way for entry of new complex generics in the market. These factors are likely to drive the authorized generics market in the near future. Other factors driving the market are health care plans by governments across the world, rapidly increasing cost of branded drugs, and aging populations. On the other hand, possibility of side effects, and lack of regulatory awareness about products and quality management are factors likely to restrain the global authorized generics market.
The global authorized generics market can be classified based on product type, application, end-user, and region.
In terms of product type, the global authorized generics market can be segmented into biosimilars, simple generic, super generic, and others. Based on applications the market can be classified into cardiovascular, anti-infective, anti-arthritis, central nervous system, anti-cancer, respiratory, and others.
Geographically, the global authorized generics market can be divided into North America, Asia Pacific, Europe, Latin America, and Middle East & Africa. North America accounted for the largest share of the market, primarily due to technological advancements, rise in demand for generic drugs, increase in overall cost of branded drugs, and presence of key players. Europe held a significant share of the market attributed to advancements in generic drugs, rise in various types of cancer, and blood related disorders. Asia Pacific, however, has been exhibiting high growth rate on account of growing demand for generic drugs, rise in geriatric population, increase in disposable income, and government initiatives to support generic drugs. Rapidly rising population in the region has increased demand for better health care and induced both private and government players to meet the demand. Developing economies such as India and China have also made a significant contribution to the rise of the global authorized generics market by focusing on establishing a better health care infrastructure.
Key players in the market are Teva Pharmaceuticals, Sandoz, Allergan, Mylan, Sun Pharmaceuticals, and STADA Arzneimittel. Other prominent vendors in the market are Abbott, Amgen, Apotex, Aspen, AstraZeneca, Aurobindo Pharma, Baxter, Berlin-Chemie, Biocon, Biogen, Boehringer Ingelheim, Celltrion, Cipla, Coherus Biosciences, Dr. Reddy's Laboratories, Daiichi Sankyo, Eli Lilly and Company, Emcure Pharmaceuticals, Eurofarma Laboratories, Gedeon Richter, Gilead Sciences, and GlaxoSmithKline.
This study by TMR is all-encompassing framework of the dynamics of the market. It mainly comprises critical assessment of consumers' or customers' journeys, current and emerging avenues, and strategic framework to enable CXOs take effective decisions.
Our key underpinning is the 4-Quadrant Framework EIRS that offers detailed visualization of four elements:
- Customer Experience Maps
- Insights and Tools based on data-driven research
- Actionable Results to meet all the business priorities
- Strategic Frameworks to boost the growth journey
The study strives to evaluate the current and future growth prospects, untapped avenues, factors shaping their revenue potential, and demand and consumption patterns in the global market by breaking it into region-wise assessment.
The following regional segments are covered comprehensively:
- North America
- Asia Pacific
- Latin America
- The Middle East and Africa
The EIRS quadrant framework in the report sums up our wide spectrum of data-driven research and advisory for CXOs to help them make better decisions for their businesses and stay as leaders.
Below is a snapshot of these quadrants.
1. Customer Experience Map
The study offers an in-depth assessment of various customers’ journeys pertinent to the market and its segments. It offers various customer impressions about the products and service use. The analysis takes a closer look at their pain points and fears across various customer touchpoints. The consultation and business intelligence solutions will help interested stakeholders, including CXOs, define customer experience maps tailored to their needs. This will help them aim at boosting customer engagement with their brands.
2. Insights and Tools
The various insights in the study are based on elaborate cycles of primary and secondary research the analysts engage with during the course of research. The analysts and expert advisors at TMR adopt industry-wide, quantitative customer insights tools and market projection methodologies to arrive at results, which makes them reliable. The study not just offers estimations and projections, but also an uncluttered evaluation of these figures on the market dynamics. These insights merge data-driven research framework with qualitative consultations for business owners, CXOs, policy makers, and investors. The insights will also help their customers overcome their fears.
3. Actionable Results
The findings presented in this study by TMR are an indispensable guide for meeting all business priorities, including mission-critical ones. The results when implemented have shown tangible benefits to business stakeholders and industry entities to boost their performance. The results are tailored to fit the individual strategic framework. The study also illustrates some of the recent case studies on solving various problems by companies they faced in their consolidation journey.
4. Strategic Frameworks
The study equips businesses and anyone interested in the market to frame broad strategic frameworks. This has become more important than ever, given the current uncertainty due to COVID-19. The study deliberates on consultations to overcome various such past disruptions and foresees new ones to boost the preparedness. The frameworks help businesses plan their strategic alignments for recovery from such disruptive trends. Further, analysts at TMR helps you break down the complex scenario and bring resiliency in uncertain times.
The report sheds light on various aspects and answers pertinent questions on the market. Some of the important ones are:
1. What can be the best investment choices for venturing into new product and service lines?
2. What value propositions should businesses aim at while making new research and development funding?
3. Which regulations will be most helpful for stakeholders to boost their supply chain network?
4. Which regions might see the demand maturing in certain segments in near future?
5. What are the some of the best cost optimization strategies with vendors that some well-entrenched players have gained success with?
6. Which are the key perspectives that the C-suite are leveraging to move businesses to new growth trajectory?
7. Which government regulations might challenge the status of key regional markets?
8. How will the emerging political and economic scenario affect opportunities in key growth areas?
9. What are some of the value-grab opportunities in various segments?
10. What will be the barrier to entry for new players in the market?
Note: Although care has been taken to maintain the highest levels of accuracy in TMR’s reports, recent market/vendor-specific changes may take time to reflect in the analysis.