Increasing Capital Investment by the Key Market Players
In 2016, biologics accounted for six of the top-eight drugs, in terms of revenue. AbbVie’s Humira (adalimumab) for rheumatoid arthritis, psoriasis, Crohn’s, and other autoimmune diseases led the way, with a total of USD 18.4 billion sales. The growing success rate of biologics drugs and their demand have led to huge capital investment for the expansion of commercial biologics manufacturing capacities, among CMO and big pharmaceutical companies. For instance, Novartis AG invested around USD 700 million in its biologics facility in Singapore, and Bristol-Myers Squibb invested nearly USD 900 million in an Irish large-scale biologics facility that is anticipated to be completed by 2019. In addition, the rise in the prevalence of chronic diseases, loss of patent exclusivity of the leading biologics drugs, and growing demand and higher acceptability for innovative therapies are the factors driving the global biologics market growth.
Stringent Regulatory Process and High Capital Investment
Biologics drugs are highly complex and require controlled conditions and maintenance, throughout the development and production process. Such regulated environment and quality-control procedures involve huge capital in the initial phase of process. Further, biologics are extremely susceptible to light, heat conditions, and need extremely favorable environment that is not available uniformly across the globe. In most emerging markets, biologics currently have little-to-no presence. Stringent regulatory policies and high-capital investment, coupled with limited patient access to affordable biologics, especially in the developing countries, owing to the rising control and cost for accessing biologics, are likely to impede the growth of the global biologics market.
North America to Dominate the Market
The biologics market has been segmented on the basis of product type, application, and geography. By geography, the market has been categorized into North America, Europe, Asia-Pacific, the Middle East & Africa, and South America.
Owing to the presence of well-established pharmaceuticals companies and increase in the number of biotech companies, being funded by venture capital, North America is dominating the biologics market. Asia-Pacific is also expected to grow at a great pace during forecast period, owing to factors, such as rise in the outsourcing of biologics contract manufacturing in emerging countries of the region, less stringent regulatory environment for clinical trials of drugs, and the growing awareness regarding the success of biologics for the treatment of chronic diseases.
Key Developments in the Market
- December 2017: The US Food and Drug Administration (US FDA) approved GlaxoSmithKline’s biologic Nucala for the treatment of a rare disease called eosinophilic granulomatosis, with polyangiitis (EPGA).
- October 2017: The US Food and Drug Administration (US FDA) accepted F. Hoffmann-La Roche Ltd’s supplemental Biologics License Application for Avastin as a front-line treatment for women, with advanced ovarian cancer.
Reasons to Purchase this Report
- Current and future global biologics market outlook in the developed and emerging markets
- Various perspectives of the market, with the help of Porter’s five forces analysis
- The segment expected to dominate the market
- The region expected to witness the fastest growth rate during the forecast period
- The latest developments, market shares, and strategies that are employed by the major market players
- 3 months analyst support, along with the Market Estimate sheet (in excel)
This report can be customized to meet your requirements.
1.1 Market Definition
2. Research Methodology
3. Executive Summary
4. Key Inferences
5. Market Overview
5.1 Current Market Scenario
5.2 Porter's Five Forces Analysis
5.2.1 Bargaining Power of Suppliers
5.2.2 Bargaining Power of Consumers
5.2.3 Threat of New Entrants
5.2.4 Threat of Substitute Product & Services
5.2.5 Competitive Rivalry within the Industry
6. Drivers, Restraints, Opportunities, and Challenges Analysis (DROC)
6.1 Market Drivers
6.1.1 Growing Capital Investment from Key Market Players
6.1.2 Rise in the Prevalence of Chronic Diseases
6.1.3 Loss of Patent Exclusivity of the Leading Biologics Drugs
6.1.4 Growing Demand and Higher Acceptability for Innovative Therapies
6.2 Market Restraints
6.2.1 Stringent Regulatory Process and Initial High Capital Investment
6.2.2 Rising Control and Cost for Accessing Biologics
6.4 Key Challenges
7. Market Segmentation
7.1 By Product
7.1.1 Monoclonal Antibodies
7.1.3 Recombinant Hormones/Proteins
7.1.4 Cell Therapy
7.1.5 Gene Therapy
7.2 By Application
7.2.2 Infectious Diseases
7.2.3 Rare Diseases
7.2.4 Autoimmune Diseases
7.3 By Geography
7.3.1 North America
126.96.36.199 United States
188.8.131.52 United Kingdom
184.108.40.206 Rest Of Europe
220.127.116.11 Australia & New Zealand
18.104.22.168 South Korea
22.214.171.124 Rest of Asia-Pacific
7.3.4 Middle East & Africa
126.96.36.199 South Africa
188.8.131.52 Rest of the Middle East & Africa
7.3.5 South America
184.108.40.206 Rest of South America
8. Competitive Landscape
8.1 Mergers and Acquisition Analysis
8.2 Agreements, Collaborations, and Partnerships
8.3 New Products Launches
9. Key Players
9.1 Abbvie Inc.
9.3 Eli Lilly and Company
9.4 F. Hoffmann-La Roche Ltd
9.5 Glaxosmithkline Plc.
9.6 Johnson & Johnson
9.7 Merck & Co
9.8 Novo Nordisk
9.9 Pfizer Inc.
10. Future of the Market