Specialty Generics: Climbing the Value Chain
“Mighty things from small beginnings grow,” John Dryden once astutely noted.
Although the influential 17th century poet and literary critic knew nothing of medicine and marketing, his words ring true today, particularly when it comes to the specialty generics industry.
While conventional generics face market saturation globally, companies have increasingly turned to pharmerging markets such as Latin America, Central and Eastern Europe and Asia to breathe new life into the bottom line. Yet for those also eager to increase the value—not just the volume—of products and sales, the specialty generics and biosimilars market has definite appeal.
Relative to commodity generics, specialty generics commercialization is more challenging, with multi-party patent ownership, the need for promotion, and complex manufacturing processes all potentially contributing to higher barriers to market entry. However, these also mean higher returns. While competition and reimbursement policies have traditionally sunk generics company margins in the established markets of the UK, US and Germany, the specialty sector has gone from strength to strength. In 2009, for example, while the total US generics market grew by an estimated 2.8 percent, specialty generics products pole-vaulted growth to 11 percent. Overall, according to experts, the US specialty generics market was valued at $5.74 billion, or one-fifth of the overall generics landscape.
Already, major companies like Pfizer, GlaxoSmithKline and Merck & Co are jockeying for precedence through deals and acquisitions, or by refocusing their energies on specifics, such as injectibles or biosimilars. In fact, Pfizer recently indicated its interest in specialties, and intends to launch 100 generic injectible products by 2013.
The question is: How fast will the specialty market grow and who’s in place to take the lead?
Key insights from expert sources
FirstWord’s newest dossier, Specialty Generics: Climbing the pharmaceutical value chain , answers the question in an expertly and clearly-written report that draws together information from across the generics industry to offer readers an up-to-date overview of the specialty generics market. The report, which includes specialty generics deals and alliances, in addition to analysis of the specialty and commodity generics approvals and their correlation with number of generics entrants, therapy area, and company, gives readers insight into an emerging market—and where it’s potential lies.
The report reviews the emerging specialty generics market to discover:
The report
Although the influential 17th century poet and literary critic knew nothing of medicine and marketing, his words ring true today, particularly when it comes to the specialty generics industry.
While conventional generics face market saturation globally, companies have increasingly turned to pharmerging markets such as Latin America, Central and Eastern Europe and Asia to breathe new life into the bottom line. Yet for those also eager to increase the value—not just the volume—of products and sales, the specialty generics and biosimilars market has definite appeal.
Relative to commodity generics, specialty generics commercialization is more challenging, with multi-party patent ownership, the need for promotion, and complex manufacturing processes all potentially contributing to higher barriers to market entry. However, these also mean higher returns. While competition and reimbursement policies have traditionally sunk generics company margins in the established markets of the UK, US and Germany, the specialty sector has gone from strength to strength. In 2009, for example, while the total US generics market grew by an estimated 2.8 percent, specialty generics products pole-vaulted growth to 11 percent. Overall, according to experts, the US specialty generics market was valued at $5.74 billion, or one-fifth of the overall generics landscape.
Already, major companies like Pfizer, GlaxoSmithKline and Merck & Co are jockeying for precedence through deals and acquisitions, or by refocusing their energies on specifics, such as injectibles or biosimilars. In fact, Pfizer recently indicated its interest in specialties, and intends to launch 100 generic injectible products by 2013.
The question is: How fast will the specialty market grow and who’s in place to take the lead?
Key insights from expert sources
FirstWord’s newest dossier, Specialty Generics: Climbing the pharmaceutical value chain , answers the question in an expertly and clearly-written report that draws together information from across the generics industry to offer readers an up-to-date overview of the specialty generics market. The report, which includes specialty generics deals and alliances, in addition to analysis of the specialty and commodity generics approvals and their correlation with number of generics entrants, therapy area, and company, gives readers insight into an emerging market—and where it’s potential lies.
The report reviews the emerging specialty generics market to discover:
- Which major pharma companies are investing in its future
- Why specialty generics are of such interest outside of the generics industry
The report
- Examines the current trend towards developing specialty generics
- Overviews the considerable barriers to market entry and the higher returns
- Offers key information on acquisitions, alliances, approvals and therapy area correlations
- Reviews generics company associations with commodity and specialty products
- Includes access to charts and graphs illustrating the current state of the market
EXECUTIVE SUMMARY
SPECIALTY GENERICS OVERVIEW
What are specialty generics?
Why are specialty generics of interest?
Declining profitability of mature commodity generics markets
Climbing the pharmaceutical value-chain
A small but fast-growing market
Specialty generics deals and alliances
The shift in M&A focus
Product licensing deals
Biosimilars product licensing deals
SPECIALTY AND COMMODITY GENERIC DRUG APPROVALS IN THE US, 2006–10
The number of generic entrants per brand
A comparison of commodity and specialty generic ANDA approvals
Injectables formed the largest class within specialty generics
Therapy area correlations
Commodity generic approvals by therapy area
Specialty generic approvals by therapy area
Comparing the therapy area split for commodity and specialty generic drugs
Equivalent commodity/specialty generics split
Commodity generics bias
Specialty generics bias
Generics company associations with commodity and specialty products
Commodity generic approvals by corporation
Specialty generic approvals by corporation
The variation in specialty focus for the leading generics companies
Commodity focused companies
Specialty focused companies
Intermediate companies
BIBLIOGRAPHY
SPECIALTY GENERICS OVERVIEW
What are specialty generics?
Why are specialty generics of interest?
Declining profitability of mature commodity generics markets
Climbing the pharmaceutical value-chain
A small but fast-growing market
Specialty generics deals and alliances
The shift in M&A focus
Product licensing deals
Biosimilars product licensing deals
SPECIALTY AND COMMODITY GENERIC DRUG APPROVALS IN THE US, 2006–10
The number of generic entrants per brand
A comparison of commodity and specialty generic ANDA approvals
Injectables formed the largest class within specialty generics
Therapy area correlations
Commodity generic approvals by therapy area
Specialty generic approvals by therapy area
Comparing the therapy area split for commodity and specialty generic drugs
Equivalent commodity/specialty generics split
Commodity generics bias
Specialty generics bias
Generics company associations with commodity and specialty products
Commodity generic approvals by corporation
Specialty generic approvals by corporation
The variation in specialty focus for the leading generics companies
Commodity focused companies
Specialty focused companies
Intermediate companies
BIBLIOGRAPHY
