First Research US Industry Profile

Already a subscriber?  Login >>

View Sample
Biotechnology Product Manufacturing
SIC Codes: 2836
NAICS Codes: 325414
Last Quarterly Update: 9/21/2020
Companies in this industry manufacture drugs, therapies, vaccines, and other products based on genetically manipulated compounds. Major companies include Amgen, Bayer, Biogen, Genentech (owned by Switzerland-based Roche), and Gilead Sciences (all based in the US), as well as CSL (Australia), Merck KGaA (Germany), Novo Nordisk (Denmark), and the biotech research arms of major international pharmaceutical companies such as Sanofi (France).
The global biotechnology industry generates total revenue of about $400 billion, according to Global Market Insights. Top regions for biotechnology include the US and Europe. Emerging markets include Australia, Canada, China, India, Singapore, Japan, and Brazil.
The US biotechnology product manufacturing industry generates annual revenue of more than $100 billion. Because many drugs are now developed using biotechnology, the biotechnology and pharmaceutical industries overlap considerably. A separate industry report covers Pharmaceutical Manufacturing.
Competitive Landscape
Biotech firms face stiff competition from major pharmaceutical manufacturers and other companies seeking to be first with a new product or discovery. Development is often focused on high-demand, profitable markets such as cancer or rare disease treatment. Biopharmaceutical companies depend on gaining regulatory and insurance coverage approval for new treatments. They may also count on participation in government research or expedited approval programs.
Because the market for potential products is so large, small biotechnology companies can co-exist successfully with large ones if they have expertise in a particular line of research. Smaller companies often team up with larger manufacturers, financial backers, or marketing partners because R&D and commercialization processes are lengthy and costly. The US industry is highly concentrated: the largest 20 companies account for more than 80% of revenue.
The US is the largest biotechnology market. The Netherlands, Germany, Italy, Ireland, and Belgium are among the top export markets for US biotechnology products. Imports of drugs to the US, partly from foreign manufacturing plants of US companies, come primarily from Ireland, Germany, Switzerland, Korea, and Italy.
Competitive Advantages:
Effective Pricing Strategies - As pressure on companies to lower drug prices intensifies, biotech firms must explore ways to maximize efficiencies in operations, especially as biosimilars become more available. Adoption of digital and AI technologies could help boost efficiencies in the R&D lab, a major source of expenditures.
Innovation - Companies must keep up with scientific innovations to stay relevant in the research lab and ward off financial risk from patent expirations. Use of new biological techniques such as cell therapy and gene editing are driving innovation in cancer research and other disease fields.
Adjusting to Regulatory Changes - Potential ramifications of the UK's exit from the EU and the potential repeal of US Affordable Care Act are creating unease in the biotech industry. Negative implications include shifting drug pricing models and fundraising and dealmaking challenges.
Companies to Watch:
Amgen is one of the oldest and most successful global biotech companies, with offerings that fight infection, anemia, and other conditions in cancer and kidney disease patients, as well as rheumatoid arthritis and other ailments. The company is investing in biosimilar research to ward off impacts of patent loss on key products, and it has R&D programs in a wide range of specialties.
Gilead Sciences has climbed its way up the biotech ladder as a maker of infectious disease treatments. While the company's lucrative HIV franchise is losing some value due to increased competition, Gilead is experiencing growth in sales of newer antivirals including hepatitis medicine Epclusa and is strengthening its R&D programs in new fields such as oncology and inflammation.
Biogen is another long-time player in the relatively young industry. Despite a troubled regulatory history over one top selling drug, Tysabri, the company has built success through treatments for immune and neurological conditions such as multiple sclerosis and Crohn's disease. The company is widening its portfolio through R&D, acquisitions, and partnerships.
Products, Operations & Technology
Biotechnology is used to produce drugs, therapies, vaccines, and medical diagnostic tests. Medicines primarily target cancers, neurology, inflammation, ... plus:
Sales & Marketing
,
Finance & Regulation
,
Regional & International Issues
,
Human Resources
Also includes the following chapters:
Quarterly Industry Update
,
Industry Indicators
,
Business Challenges
,
Trends and Opportunities
,
Call Preparation Questions
,
Financial Information
,
Industry Forecast
,
Industry Websites
,
Glossary of Acronyms

Historical Profiles (PDF format)

12/02/2019
06/24/2019
03/18/2019
12/10/2018
09/10/2018
06/11/2018
03/12/2018
12/04/2017
09/04/2017
06/05/2017
03/06/2017
11/28/2016
08/29/2016
05/30/2016
02/22/2016
11/16/2015
08/24/2015
05/25/2015
02/23/2015
11/24/2014
09/01/2014
06/09/2014
03/10/2014
12/02/2013
09/09/2013
06/17/2013
03/25/2013
12/17/2012
09/24/2012
07/09/2012
04/16/2012
01/09/2012
10/03/2011
06/27/2011
03/14/2011
12/06/2010
09/13/2010
06/07/2010
03/01/2010