Biobetters - Major Players and Market Prospects

On paper, the numbers look good: Worldwide, biological drugs generate more than $120 billion in revenue.

From monoclonal antibody therapies and glycoproteins to vaccines and blood factors, biopharmaceuticals seem to have a healthy—and expanding—bottom line, particularly in emerging and increasingly wealthy Asian and South American markets.

But beyond the ledger, there is a different story. As more and more of the earliest, first generation biologicals such as human insulin and early recombinant forms of human growth hormone become patent-expired, they are thrown into competition with biosimilars—generic versions of the same drug. The impact on the industry is undeniable: The rising cost of existing and expensive biopharmaceuticals contrasted with the lower price point and increasing availability of biosimilars are expected to hit the global market hard.

The solution may lie with ‘biobetters’. Already, innovation leaders like Novo Nordisk, Merck & Co and Roche are breaking ground and building on first generation biopharmaceuticals to create newer versions of expired-patent biologicals that do the job smarter, faster or with a better side-effect profile.

While most first generation biologicals are immediate-release and delivered subcutaneously or via infusion, for example, biobetters make a good thing even better. Modified by protein or glyco-engineering, they are more efficacious, require a lower dosing frequency and, most critically, reduce the risk of immunogenicity. Even better, they have lower early-stage R&D costs.

But the question remains: Will biobetters be competitive enough to strengthen pharma’s bottom line?

Key insights and strategies from innovators and thought leaders

FirstWord’s compelling investigation into the current state of play between biosimilars and biobetters sets the tone and informational basis upon which the industry must act. Based on solid analysis, research and interviews with key thought leaders, the report examines how biosimilar drugs are being received in Europe and Japan, reviews the developing American regulatory environment and identifies the key strategists and leaders in biobetter advances. The report includes a breakdown of commercial areas and a detailed analysis of new technology, novel formulations and innovative manufacturing methods that, along with an emerging biological pipeline, will keep the industry competitive and on track.

The report investigates the biological drug market to determine:

  • Key strategies for establishing a cutting-edge, competitive biobetter market
  • Which industry innovators are producing new bio-technologies, manufacturing and engineering advances

The report

  • Scans the current biological market environment to establish the impact of patent-expired biopharmaceuticals on future drug pricing, reimbursements, competition and R&D strategies
  • Offers a detailed analysis of biobetter strategies from innovation leaders
  • Identifies key marketing and development targets for biobetter advancement
  • Fully examines events in the most critical commercial biopharmaceutical areas, such as monoclonal antibodies, vaccines, glycoproteins, blood factors and insulin
  • Includes insights from industry thought leaders who identify key development opportunities
  • Offers critical observations regarding the need to substantively differentiate biobetters from biosimilars

Key industry leaders identified in this report

  • Novo Nordisk
  • Merck & Co.
  • Roche Group
  • Biogen Idec
  • Amgen
  • Sanofi-Aventis
  • Eli Lilly
  • GlaxoSmithKline
  • Novartis
  • AstraZeneca
  • Pfizer
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Publication date:
 December, 2009
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Content Highlights

  • Executive summary
  • Biosimilars and the High Demand for New Biological Drugs
    > Biological Drugs
    > Table 1: Commercially Important Biological Drug Types
    > Biological Drug Market Growth
    > Biosimilars
    > Definition of Biosimilars
    > Biosimilar Regulatory Update
    > Follow-On Protein Products in the US
    > The Biosimilar Market
  • Biobetters
    > Possible Repercussions of Biosimilars
    > Combating Biosimilars with Biobetters
    > What Are Biobetters?
    > Types of Biobetter
    > Table 2: Biobetter Drug Design Techniques
  • Challenges in Biobetter Development
    > Innovator Research and Development Strategies
    > Rise of the Biobetter
    > Current Biological Research and Development Climate
    > Difficult Financial Climate for Smaller Biotechnology Companies
    > The Need for Differentiation
    > Active Comparator Clinical Trials
    > Manufacturing Challenges
    > Biological Manufacturing
    > New Manufacturing Methods are Arriving …
    > …But Do Not Obviate the Need for Differentiation
    > Regulatory Hurdles for Biobetters
    > Patent Issues
    > Immunogenicity and Safety Fears
    > Data Exclusivity in the US
    > Marketing Challenges for Biobetters
    > The Challenge of Marketing Biobetter Drugs
    > Pricing and Reimbursement
    > Possible Increasing Biosimilar Competition
    > Biosimilar Price Reductions
  • Opinions of Thought Leaders on the Future of Biobetters
  • Biobetter Strategies
    > Monoclonal Antibodies
    > Biosimilar Monoclonal Antibodies
    > The Future for Biobetter Monoclonal Antibodies
    > Further Humanisation of Monoclonal Antibodies
    > Table 3: Biobetter Monoclonal Antibodies: Towards Fully human
    > Additional Antibody Targets
    > Table 4: Biobetter Monoclonal Antibodies: Additional Targets
    > Antibody-Drug Conjugates
    > Antibody Fragments
    > Table 5: Biobetter Monoclonal Antibodies: Antibody Fragments
    > Glycoproteins
    > Biobetter Pegylated Glycoproteins
    > Table 6: Biobetter Pegylated Glycoproteins
    > Biobetter Glycoproteins: New Technologies
    > Table 7: Biobetter Glycoproteins - New Technologies
    > Biobetter Glycoproteins: Improved Manufacturing
    > Erythropoietin Drugs
    > Granulocyte Colony-Stimulating Factor (G-CSF)
    > Interferons
    > Vaccines
    > The Vaccine Market
    > Biobetter Vaccines: New Delivery Methods
    > Table 8: Biobetter Vaccines - New Delivery Methods
    > Biobetter Vaccines: New Technologies
    > Table 9: Biobetter Vaccines - New Recombinant Technologies
    > Table 10: Biobetter Vaccines - New Adjuvants
    > Table 11 Biobetter Vaccines - New Manufacturing Technology
    > Biobetter Vaccines: More Strains
    > Table 12: Biobetter Vaccines - Broader Spectrum of Activity
    > Protein Hormones
    > The Insulin Market
    > Novel Formulations are the Key Biobetter Opportunity
    > New Insulin Delivery Methods
    > Dermatological Insulin
    > Oral Insulin
    > Inhaled Insulin
    > Table 13: Biobetter Insulin Devices
    > Biobetter Growth Hormones and other Hormones
    > Other Biological Drugs
    > Table 14: Other Biobetter Examples
  • Leading Biobetter Companies
    > Who are the Biobetter Leaders?
    > The Biobetter Strategists
    > Novo Nordisk
    > Merck & Co.
    > The Bioleaders
    > Roche Group
    > Biogen Idec
    > Amgen
    > Sanofi-Aventis
    > Eli Lilly
    > Other Large Pharmaceutical Companies
    > GlaxoSmithKline
    > Novartis
    > AstraZeneca
    > Pfizer
  • Conclusion
  • Abbreviations
  • Index