Generics/Biosimilars Collection - Report Bundle

  • October 2013
  • -
  • Firstword Pharma

Generics/Biosimilars Collection - Report Bundle consists of all 4 reports from our Generics/Biosimilars Report Series.

Reports Included

1. Charting the Biosimilar and Biobetter Development Pipeline (2013) (July 2013)
2. Biosimilar Defensive Plays -- assessing the options (June 2013)
3. Branded Generics: Strategies and Tactics for Winning in Latin America (April 2013)
4. Biosimilars in Emerging Markets (Volume 1 and Volume 2) (March 2013)

Charting the Biosimilar and Biobetter Development Pipeline (2013) (July 2013)

If you need to understand the important biosimilar and biobetter drug developments worldwide then this report is critical.

The promise of biosimilars has been great but beyond the first wave of products progress has been slow. With a number of high-value biologics, particularly monoclonal antibodies such as Herceptin, Avastin, Remicade and Humira, losing patent expiry in the coming years the potential for biosimilars remains high. With greater clarity on regulatory approval and the demand of health payers for low cost medicines, the drive to develop a viable biosimilar market will continue to grow.

Who are the companies involved? What does their portfolio look like? What stage are they at? Which products offer the best potential in terms of competitor development? Critical questions needing robust answers. That is where Charting the Biosimilar and Biobetter Development Pipeline (2013) comes in.

Charting the Biosimilar and Biobetter Development Pipeline (2013) will help you to:
Understand the landscape of biosimilar/biobetter development through pipeline analysis of all known biosimilar developers worldwide
Drill down to discover the levels of potential biosimilar and biobetter competition by therapy area, drug class, development status, and country
Establish the level of biosimilar/biobetter competition to leading brands
Learn which biosimilar developers are potential future competitors or collaborators
Interrogate the development portfolio of over 300 companies and discover which are the leaders in biosimilar/biobetter development
Identify development hotspots and know where research is taking place

Biosimilar Defensive Plays -- assessing the options (June 2013)

Although biological therapeutics have developed into an increasingly valuable segment of the pharmaceutical market, the commercial impact of biosimilar products has, to date, been fairly insignificant. However, that?s set to change.

Five of the world?s best-selling innovator drugs, with collective sales of $35 billion in 2012, will shortly lose patent protection, making them vulnerable to biosimilar competition. Developers of biosimilars will also benefit from the recent establishment of an abbreviated regulatory pathway for the approval of biosimilars in the United States.

With the biosimilar market on the brink of expansion, FirstWord Dossier has recognised the need for robust guidance on defensive strategies, focusing on two main areas: delaying approval of competing biosimilars; and sustaining product revenues in the face of the competitive challenge.

In creating this unique report, FirstWord sought expert opinions on factors that have influenced decisions to date and how these will impact further developments.

Biosimilar Defensive Plays -- assessing the options is an essential resource for biotechnology executives who need to understand the challenges and opportunities presented by biosimilars.

Branded Generics: Strategies and Tactics for Winning in Latin America (April 2013)

It’s a $66 billion market—and getting bigger every year. The time is ripe for action. Yet for all the appeal and potential returns of investing in Latin America’s burgeoning branded generics market, there are hurdles.

For pharma companies seeking entry into the diverse, complex and emerging Latin American market, challenges exist on all fronts. Consumers have an embedded preference for known brand names or cheap alternatives. The sector is increasingly becoming consolidated. Regulatory reforms continue to favour local manufacturers. And politics across borders are as diverse as official reimbursement policies.

Yet one thing remains constant: The moment to invest in the Latin American branded generics market has arrived.

Like a clear roadmap across complex terrain, Branded Generics: Strategies and Tactics for Winning in Latin America offers critical knowledge into how pharmaceutical companies can leverage their global experience into a region transitioning from sales to marketing models. Filled with on-point information and insights into everything from the importance of long-term commitment to building consumer loyalty amongst the rising middle class, the dossier lays bare the issues—and answers—to making profitable in-roads.

Biosimilars in Emerging Markets (Volume 1 and Volume 2) (March 2013)

There are few areas of the pharmaceutical market more hotly debated than biosimilars yet the pathway to developing a viable global product marketplace is not clear. Biosimilar interest is being driven by the potential offered by a range of high-value brands which will be subject to patent challenges in the next 5-10 years such as Roche’s Herceptin and Avastin.

The US market remains the big prize for biosimilars but is stalled with an untried regulatory process. Europe is more advanced but there are significant barriers to entry. It is no surprise, then, that biosimilar developers are turning to emerging markets as a preferred market entry point.

The fundamentals of biosimilars in emerging markets are sound: high unmet clinical need in large and expanding populations, growing GDP and health spending, increasing patient expectation and often amenable regulatory regimes all provide a fertile environment for biosimilar products. Many biosimilar companies in emerging markets are developing networks and alliances outside of the US and Europe which is providing valuable revenue and knowledge of international trade. Are we seeing a 2-speed biosimilars sector in which emerging markets and companies are taking a lead?

Understanding this complex market requires a detailed analysis of the trends which are shaping its development. Biosimilars in Emerging Markets is a 2-volume report which provides both a comprehensive overview of the biosimilars sector and highly-detailed expert analysis of the issues that are affecting developments on the ground in a range of emerging markets including Korea, India, China, Brazil, Russia and Turkey.

• VOLUME 1: Putting emerging markets and companies into global context
This detailed volume succinctly reviews the biosimilars sector and will ensure you have a complete working brief of the current state of emerging markets in their international context. It provides a review of regulations covering biosimilars, identifies sales and patent expiry of leading biological brands and looks at market value and biosimilar pricing. There are country-by-country appraisals of leading emerging economies which examine the biosimilar operating environment along with company profiles of 23 local biosimilar developers with pipeline analysis for leading organisations.

• VOLUME 2: Drilling down into emerging markets: local industry experts share their insights
What trends are driving biosimilars in emerging markets? Many countries have the need for biosimilars but do not have the development or manufacturing capacity to produce biosimilars for their own population. At the other end of the scale, a good deal of government interest and incentive for private companies has established the necessary framework for national/regional supply with long term ambitions for US/Europe. Even so, biosimilar companies may face challenges even with their own markets such as patient and clinical concerns over safety and quality. Volume 2 brings together highly-detailed market analysis with contributions from local industry experts whose clear insights provide a real world perspective of opportunities and challenges which must be overcome now and in the future.

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