Biologics

As Quoted In Drug Discovery & Development

Gains will be driven by dramatic shifts in production technology and an expansion in the number of targeted diseases, including cancer, diabetes and other serious medical conditions.

US demand to rise 6.5% annually through 2015

US demand for biologics is expected to grow 6.5 percent per year to $102 billion in 2015, driven by dramatic shifts in production technology and an expansion in the number of targeted diseases. New biologics are being developed for the treatment of cancer, diabetes and other serious medical conditions, many of which are seeing their incidence rise in the US population. While growth in market value will slow from the doubledigit advances registered during the past decade, this is primarily a function of restrained pricing, which will mask to some extent continued robust gains in market penetration.

Monoclonal antibodies to remain key segment

Biologics such as insulin, vaccines and various blood products have been available for many years. However, the more recent introduction of recombinant DNA technology has allowed manufacturers to develop a wide range of new products with very specific applications. For example, monoclonal antibodies that destroy targeted antigens -- such as cancer cells -- can now be purified, cloned and introduced into patients to instigate immune responses. Of more than 40 brand-named monoclonal antibodies currently available in the US, 26 have received FDA approval since 2000, and 15 of the 26 since 2005.

These products have quickly established themselves as effective therapies for many forms of cancer, macular degeneration, rheumatoid arthritis and other diseases. New antibodies are under intensive investigation, and are expected to be introduced to market during the forecast period.

US approval of biosimilars to spur new biologics

A growing global market for biosimilars (also known as follow-on biologics) is gaining momentum in response to the expiration of patents for a number of key biologics and consumer demand to reduce treatment costs. Europe has led the global regulatory process to make biosimilars available but to date US approvals have lagged behind those in the international community. The FDA has allowed only a few biosimilars for sale in the US, generally following procedures for small molecule generics. However, the FDA has announced plans to release new regulatory guidelines by the end of 2011 that will clarify the approval process for follow-on biologics.

Once biosimilars can be approved for US sale, they are expected to make lower-cost biologic treatments more widely available, presenting a challenge to some longstanding proprietary products. The push for approval of biosimilars is also expected to spur the creation of new biologic products and applications.

Study Scope

This study analyzes the $74.3 billion US biologics industry. It presents historical demand data for the years 2000, 2005 and 2010, and forecasts for 2015 and 2020 by product (e.g., monoclonal antibodies, vaccines and toxoids, hormones, growth factors, immunomodulators, blood and blood products, enzymes, coagulation factors) and application (e.g., human health care, animal health, research).

The study also considers market environment factors, details industry structure, evaluates company market share and profiles 44 industry competitors, including Roche, Amgen and Sanofi-Aventis.

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  1. Biologics

    $4,900.00

    1. 1 INTRODUCTION

      $99.00

    2. 2 EXECUTIVE SUMMARY

      $126.00

      1. Table | BIOLOGICS DEMAND BY TYPE (million dollars)

    3. 3 MARKET ENVIRONMENT

      $1,551.00

      1. 3.1 General

        $82.00

      2. 3.2 Demographic Patterns

        $156.00

        1. Table | POPULATION & HOUSEHOLDS (million persons)

      3. 3.3 Macroeconomic Outlook

        $158.00

        1. Table | MACROECONOMIC INDICATORS (billion 2005 dollars)

      4. 3.4 Healthcare Trends

        $301.00

        1. 3.4.1 National Health Expenditures

          $131.00

          1. Table | NATIONAL HEALTH EXPENDITURES BY TYPE & SOURCE OF PAYMENT (billion dollars)

        2. 3.4.2 Pharmaceutical Supply & Demand

          $82.00

          1. Table | PHARMACEUTICAL SUPPLY & DEMAND

        3. 3.4.3 Pharmaceutical Shipments by Therapeutic Class

          $84.00

          1. Table | PHARMACEUTICAL SHIPMENTS BY THERAPEUTIC CLASS (billion dollars)

      5. 3.5 Patient Activity

        $103.00

        1. Table | PATIENT ACTIVITY (million)

      6. 3.6 Medical Conditions

        $177.00

        1. Table | MEDICAL CONDITIONS (million)

        2. 3.6.1 Acute Conditions

          $82.00

        3. 3.6.2 Chronic Conditions

          $93.00

      7. 3.7 Animal Health Industry Outlook

        $93.00

        1. Table | ANIMAL POPULATION & VETERINARY HEALTH EXPENDITURES

      8. 3.8 Technological Overview of Biologics

        $249.00

        1. 3.8.1 Recombinant DNA Biologics

          $82.00

        2. 3.8.2 Biosimilars

          $147.00

      9. 3.9 Regulation

        $261.00

        1. 3.9.1 Regulation of Human Biologic Therapies

          $140.00

        2. 3.9.2 Regulation of Biosimilar Products

          $82.00

        3. 3.9.3 Regulation of Biologics Research & Testing Products

          $82.00

        4. 3.9.4 Regulation of Animal Biologics

          $82.00

    4. 4 PRODUCTS

      $2,732.00

      1. 4.1 General

        $82.00

      2. 4.2 Demand by Type

        $100.00

        1. Table | BIOLOGICS DEMAND BY TYPE (million dollars)

      3. 4.3 Monoclonal Antibodies

        $328.00

        1. Table | MONOCLONAL ANTIBODIES DEMAND (million dollars)

        2. 4.3.1 Cancer Treatment

          $82.00

        3. 4.3.2 Rheumatoid Arthritis

          $82.00

        4. 4.3.3 Macular Degeneration

          $82.00

        5. 4.3.4 Psoriasis

          $82.00

        6. 4.3.5 Infectious Disease

          $82.00

        7. 4.3.6 Other Applications

          $82.00

      4. 4.4 Vaccines & Toxoids

        $249.00

        1. Table | VACCINES DEMAND (million dollars)

        2. 4.4.1 Vaccines for Human Health

          $158.00

        3. 4.4.2 Animal Vaccines

          $82.00

      5. 4.5 Hormones

        $377.00

        1. Table | HORMONES DEMAND (million dollars)

        2. 4.5.1 Insulin

          $87.00

        3. 4.5.2 Human Growth Hormone

          $82.00

        4. 4.5.3 Teriparatide

          $82.00

        5. 4.5.4 Follicle-Stimulating Hormone

          $82.00

        6. 4.5.5 Estrogen

          $82.00

        7. 4.5.6 Calcitonin

          $82.00

        8. 4.5.7 Thyrotropin

          $82.00

        9. 4.5.8 Corticotropin

          $82.00

        10. 4.5.9 Other Hormones

          $82.00

      6. 4.6 Growth Factors

        $264.00

        1. Table | GROWTH FACTORS DEMAND (million dollars)

        2. 4.6.1 Erythropoietins

          $82.00

        3. 4.6.2 Colony-Stimulating Factors

          $82.00

        4. 4.6.3 Bone Morphogenetic Proteins

          $82.00

        5. 4.6.4 Other Growth Factors

          $82.00

      7. 4.7 Immunomodulators

        $239.00

        1. Table | IMMUNOMODULATORS DEMAND (million dollars)

        2. 4.7.1 Immunosuppressing Agents

          $82.00

        3. 4.7.2 Interferons

          $82.00

        4. 4.7.3 Other Immunomodulators

          $82.00

      8. 4.8 Blood & Blood Products

        $364.00

        1. Table | BLOOD & BLOOD PRODUCTS DEMAND (million dollars)

        2. 4.8.1 Plasma & Plasma Fractions

          $91.00

        3. 4.8.2 Whole Blood

          $82.00

        4. 4.8.3 Cellular Components

          $152.00

      9. 4.9 Enzymes

        $539.00

        1. Table | ENZYMES DEMAND (million dollars)

        2. 4.9.1 Enzyme Replacement Therapies

          $133.00

        3. 4.9.2 Neuromodulators

          $90.00

        4. 4.9.3 Digestive Enzymes

          $95.00

        5. 4.9.4 Thrombolytics

          $82.00

        6. 4.9.5 Diagnostics

          $82.00

        7. 4.9.6 Other Enzymes

          $82.00

      10. 4.10 Coagulation Factors

        $155.00

        1. Table | COAGULATION FACTORS DEMAND (million dollars)

        2. 4.10.1 Antihemophilics

          $82.00

        3. 4.10.2 Other Coagulation Factors

          $82.00

      11. 4.11 Other Biologics

        $82.00

        1. Table | OTHER BIOLOGICS DEMAND (million dollars)

    5. 5 APPLICATIONS

      $935.00

      1. 5.1 General

        $82.00

        1. Table | BIOLOGICS DEMAND BY APPLICATION (million dollars)

      2. 5.2 Human Healthcare

        $762.00

        1. Table | BIOLOGICS DEMAND FOR HUMAN HEALTHCARE BY CONDITION & USE (million dollars)

        2. 5.2.1 Cancer

          $208.00

          1. Table | CANCER BIOLOGICS DEMAND (million dollars)

        3. 5.2.2 Autoimmune Diseases

          $85.00

          1. Table | AUTOIMMUNE BIOLOGICS DEMAND (million dollars)

        4. 5.2.3 Infectious Diseases

          $95.00

          1. Table | INFECTIOUS DISEASES BIOLOGICS DEMAND (million dollars)

        5. 5.2.4 Blood Disorders

          $103.00

          1. Table | BLOOD DISORDERS BIOLOGICS DEMAND (million dollars)

        6. 5.2.5 Diabetes

          $82.00

          1. Table | DIABETES BIOLOGICS DEMAND (million dollars)

        7. 5.2.6 Other Conditions

          $99.00

          1. Table | OTHER HUMAN HEALTH BIOLOGICS DEMAND BY CONDITION & PRODUCT (million dollars)

      3. 5.3 Biologics for Other Uses

        $114.00

        1. Table | BIOLOGICS DEMAND FOR OTHER APPLICATIONS (million dollars)

        2. 5.3.1 Animal Health

          $82.00

        3. 5.3.2 Research & All Other Applications

          $82.00

    6. 6 INDUSTRY STRUCTURE

      $4,931.00

      1. 6.1 General

        $85.00

        1. Table | US BIOLOGICS SALES BY COMPANY, 2010 (million dollars)

      2. 6.2 Market Share

        $489.00

      3. 6.3 Competitive Strategies

        $87.00

      4. 6.4 Mergers & Acquisitions

        $160.00

        1. Table | SELECTED ACQUISITIONS & DIVESTITURES

      5. 6.5 Licensing & Related Agreements

        $462.00

        1. Table | SELECTED COOPERATIVE AGREEMENTS

      6. 6.6 Research & Development

        $82.00

      7. 6.7 Manufacturing

        $82.00

      8. 6.8 Marketing & Distribution

        $82.00

      9. 6.9 Company Profiles

        $4,931.00

        1. 6.9.1 Abbott Laboratories

          $188.00

        2. 6.9.2 Alere Incorporated

          $84.00

        3. 6.9.3 Alexion Pharmaceuticals Incorporated

          $82.00

        4. 6.9.4 Allergan Incorporated

          $82.00

        5. 6.9.5 American Red Cross

          $82.00

        6. 6.9.6 Amgen Incorporated

          $310.00

        7. 6.9.7 Aptalis Pharma Incorporated

          $82.00

        8. 6.9.8 AstraZeneca plc

          $142.00

        9. 6.9.9 Baxter International Incorporated

          $82.00

        10. 6.9.10 Bayer AG

          $88.00

        11. 6.9.11 Biogen Idec Incorporated

          $82.00

        12. 6.9.12 BioMarin Pharmaceutical Incorporated

          $89.00

        13. 6.9.13 Blood Systems Incorporated

          $82.00

        14. 6.9.14 Bristol-Myers Squibb Company

          $139.00

        15. 6.9.15 CSL Limited

          $184.00

        16. 6.9.16 EKR Therapeutics Incorporated

          $82.00

        17. 6.9.17 Eli Lilly & Company

          $213.00

        18. 6.9.18 Emergent BioSolutions Incorporated

          $290.00

        19. 6.9.19 GlaxoSmithKline plc

          $309.00

        20. 6.9.20 Halozyme Therapeutics Incorporated

          $170.00

        21. 6.9.21 Intercell AG

          $171.00

        22. 6.9.22 Ipsen

          $82.00

        23. 6.9.23 Johnson & Johnson

          $377.00

        24. 6.9.24 Lonza Group Limited

          $234.00

        25. 6.9.25 Lundbeck (H.) A/S

          $82.00

        26. 6.9.26 Massachusetts Biologic Laboratories

          $82.00

        27. 6.9.27 Medtronic Incorporated

          $82.00

        28. 6.9.28 Merck & Company Incorporated

          $406.00

        29. 6.9.29 Merck KGaA

          $82.00

        30. 6.9.30 New York Blood Center

          $82.00

        31. 6.9.31 Novartis AG

          $372.00

        32. 6.9.32 Novo Nordisk A/S

          $91.00

        33. 6.9.33 Pfizer Incorporated

          $388.00

        34. 6.9.34 Questcor Pharmaceuticals Incorporated

          $82.00

        35. 6.9.35 Roche Holding Limited

          $444.00

        36. 6.9.36 Sanofi-Aventis

          $548.00

        37. 6.9.37 Shire plc

          $118.00

        38. 6.9.38 sigma-tau Group

          $82.00

        39. 6.9.39 Solvay SA

          $82.00

        40. 6.9.40 Stryker Corporation

          $82.00

        41. 6.9.41 Teva Pharmaceutical Industries Limited

          $109.00

        42. 6.9.42 US WorldMeds LLC

          $82.00

        43. 6.9.43 ViaCyte Incorporated

          $82.00

        44. 6.9.44 WiCell Research Institute

          $82.00

      10. 6.10 Other Companies Mentioned in Study

        $128.00

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