Biologics drugs are complex molecules that are manufactured from living organisms or components of living organisms. Biologics include a wide variety of products derived from human, animal, or microorganisms by using biotechnological processes. Many biologics are produced using recombinant DNA technology. They are sometimes referred to as biopharmaceuticals or biological drugs. Various types of biologic drugs include monoclonal antibody, recombinant proteins/hormones, vaccines, cell and gene therapy and others. These biologics may contain proteins that control the action of other proteins and cellular processes, genes that control production of vital proteins, modified human hormones, or cells that produce substances that suppress or activate components of the immune system. Biologics are sometimes referred as referred to as biologic response modifiers, as they change the manner of operation of natural biologic intracellular and cellular actions.

The market for biologics is driven by increasing incidence of disease across the globe, increasing number of biologics approvals and emergence of next generation biologics such as cell and gene therapy. Strong pipelined products and huge number of ongoing clinical trials are providing market growth oppurtunity. Challenges associated with biologics production, high cost of the drug, increasing number of biologics going off patent and emergence of biosimilars are hampering market growth.

Market Analysis: The “Global Biologics market” is estimated to witness a CAGR of 9.9% during the forecast period 2018–2024. The global market is analyzed based on three segments – Product, Application and regions.

Regional Analysis: The regions covered in the report are the North America, Europe, Asia Pacific, and Rest of the World (ROW). North America is the major shareholder in the global biologics market, followed by Europe. North America dominates the biologics market due to increasing product approvals, increasing demand for the product to treat various disease conditions, and presence of established players in this region. Asia-Pacific region is expected to have the fastest growth rate during the forecasted period due to increasing research activities, flexible regulatory environment for clinical trials, growing awareness about biopharmaceutical therapeutics, and rising healthcare expenditure.

Product Analysis: The market by product is segmented into monoclonal antibodies, recombinant proteins/hormones, vaccines, cell and gene therapy and others. Monoclonal antibodies occupied major market share of global biologics market in 2017 and cell and gene therapy is expected to grow at high CAGR during the forecasted period. Wide application of monoclonal antibodies in treatment of various diseases makes this segment, a major shareholder of biologics products market.

Application Analysis: The market by application is segmented into cancer, infectious disease, immunological disorders, hematological disorders, cardiovascular disease and others. Among various application, cancer occupied the largest share in 2017 and is expected to grow at fastest rate during the forecasted period. Growing elderly population, changing lifestyle, increasing disease prevalence makes cancer, the fastest growing application segment during the forecasted period.

Key Players: F. Hoffmann-La Roche, Amgen, Inc., Sanofi S.A., Novo Nordisk A/S, Johnson and Johnson, AbbVie, Inc., Novartis AG, GlaxoSmithKline plc, Bristol-Myers Squibb, Merck & Co., Eli Lilly & Company Ltd., AstraZeneca PLC, Teva Pharmaceutical Industries Ltd., Takeda Pharmaceutical Company and other predominate and niche players.

Competitive Analysis: Currently cancer segment dominates the global biologics segment. Biologics are entering new therapeutic areas such as, asthma and allergy where they are not present historically. The key market players are taking the advantage of strategic deals and product approvals to increase their share in the market. For instance, in September 2017, GSK and AbCellera Biologics, Inc. entered an antibody discovery research collaboration, for the discovery of monoclonal antibodies against an undisclosed membrane protein target. In August 2017, Novartis received first FDA approval from FDA for CAR-T cell therapy, Kymriah to treat patients with B-cell precursor acute lymphoblastic leukemia (ALL) and in May 2018, Novartis received second FDA approval for Kymriah to treat patients with B-cell lymphoma.

Benefits: The report provides complete details about the usage and adoption rate of biologics in various therapeutic verticals and regions. With that, key stakeholders can know about the major trends, drivers, investments, and vertical player’s initiatives. Moreover, the report provides details about the major challenges that are going to impact on the market growth. Additionally, the report gives the complete details about the key business opportunities to key stakeholders to expand their business and capture the revenue in the specific verticals to analyze before investing or expanding the business in this market.

Key Stakeholders:

 

Report Scope:

• Product Type
  
  
  • Monoclonal antibodies
  
  
  • Recombinant Proteins
  
  
  • Vaccines
  
  
  • Cell therapy
  
  
  • Gene therapy
  
  
  • Others
  
  
   


• Source
  
  
  • Microbial source
  
  
  • Mammalian source
  
  
   


• Application
  
  
  • Cancer
  
  
  • Infectious disease
  
  
  • Haematological disorder
  
  
  • Immunological disorder
  
  
  • Others
  
  
   


• Regions
  
  
  • North America
  
  
  • Europe
  
  
  • Asia Pacific
  
  
  • Rest of the World
  
  
   


 

1    Industry Outlook 

1.1      Industry Overview

1.2      Industry Trends

1.2.1     R&D Pipeline in the Pharmaceutical Industry

2    Report Outline 

2.1      Report Scope

2.2      Report Summary

2.3      Research Methodology

2.4      Report Assumptions

3    Market Snapshot

3.1      Market Definition – Infoholic Research

3.2      Segmented Addressable Market

3.3      Trends in the Biologics Market

3.4      Related Markets

3.4.1     Over-the-counter Drugs

3.4.2     Orphan Drugs

3.4.3     Human Insulin

4    Market Outlook 

4.1      Market segmentation

4.2      PEST Analysis

4.3      Porter 5(Five) Forces

5    Market Characteristics 

5.1      DRO Analysis – Market Dynamics

5.1.1     Drivers

5.1.1.1  Growing incidence of disease across the globe

5.1.1.2  Increasing number of biologics approvals

5.1.2     Opportunities

5.1.2.1  Strong portfolio of product pipeline and huge number of ongoing clinical trials

5.1.2.2  Increasing opportunities in emerging markets

5.1.3     Restraints

5.1.3.1  Challenges associated with biologics production

5.1.3.2  Increasing number of biologics going off patent and emergence of biosimilars

5.2      DRO – Impact Analysis

5.3      Key Stakeholders

6    Products: Market Size and Analysis 

6.1      Overview

6.2      Monoclonal Antibodies

6.3      Recombinant Proteins/Hormones

6.4      Vaccines

6.5      Cell & Gene Therapy

6.6      Others

7    Applications: Market Size and Analysis 

7.1      Overview

7.2      Cancer

7.3      Immunological Disorders

7.4      Infectious Disease

7.5      Hematologic Disorders

7.6      Cardiovascular Disease

7.7      Others

8    Regions: Market Size and Analysis 

8.1      Overview

8.2      North America

8.2.1     US

8.2.2     Canada

8.3      Europe

8.3.1     UK

8.3.2     Germany

8.3.3     France

8.3.4     Spain

8.4      Asia Pacific

8.4.1     India

8.4.2     China

8.4.3     Japan

8.5      Rest of the World

9    Competitive Landscape 

 

10   Vendors Profile 

10.1     F. Hoffmann-La Roche

10.1.1   Overview

10.1.2   Business Units

10.1.3   Geographic Presence

10.1.4   Business Focus

10.1.5   SWOT Analysis

10.1.6   Business Strategies

10.2     Sanofi S.A.

10.2.1   Overview

10.2.2   Business Units

10.2.3   Geographic Presence

10.2.4   Business Focus

10.2.5   SWOT Analysis

10.2.6   Business Strategies

10.3     Amgen Inc.

10.3.1   Overview

10.3.2   Geographic Presence

10.3.3   Business Focus

10.3.4   SWOT Analysis

10.3.5   Business Strategies

10.4     Novo Nordisk A/S

10.4.1   Overview

10.4.2   Business Units

10.4.3   Geographic Presence

10.4.4   Business Focus

10.4.5   SWOT Analysis

10.4.6   Business Strategies

10.5     AbbVie Inc.

10.5.1   Overview

10.5.2   Geographic Presence

10.5.3   Business Focus

10.5.4   SWOT Analysis

10.5.5   Business Strategies

10.6     Johnson & Johnson

10.6.1   Overview

10.6.2   Business Units

10.6.3   Geographic Revenue

10.6.4   Business Focus

10.6.5   SWOT Analysis

10.6.6   Business Strategies

10.7     Novartis AG

10.7.1   Overview

10.7.2   Business Units

10.7.3   Geographic Revenue

10.7.4   Business Focus

10.7.5   SWOT Analysis

10.7.6   Business Strategies

11   Companies to Watch for

11.1     Bristol–Myers Squibb

11.1.1   Overview

11.2     GlaxoSmithKline plc

11.2.1   Overview

11.3     Merck & Co.

11.3.1   Overview

11.4     Eli Lilly and Company Ltd.

11.4.1   Overview

11.5     Teva Pharmaceutical Industries Ltd.

11.5.1   Overview

11.6     AstraZeneca PLC

11.6.1   Overview

11.7     Takeda Pharmaceuticals

11.7.1   Overview

Annexure 

Abbreviations