Hundreds of businesses worldwide research, develop, and manufacture biopharmaceutical drugs — complex medicines generated from living cells or organisms. These drugs offer patients new treatment modalities and offer companies new revenue streams, but developing biopharmaceuticals require substantial resources, sophisticated facilities and multidisciplinary expertise. Previously untreatable diseases are now potentially curable making biologics and biopharmaceuticals industry game-changers. Companies — large and small, established and new — must adapt to these changes and be forward-thinking to compete in this massive and growing market. Here we describe the top five global biopharmaceutical companies and characteristics they have in common.
Top 5 Biopharmaceutical Companies in 2020
1. Samsung Biologics (KRX: 207940)
Samsung Biologics is a biopharmaceutical contract development and manufacturing organization (CDMO) headquartered in South Korea. It is recognized as a one-stop shop for development and manufacturing from discovery through commercialization. With a global presence, a reputation of reliability and comprehensive capabilities, as well as the world’s largest manufacturing facility at a single location, it is becoming a major figure in the biopharmaceutical industry.
Gilead Sciences is a US-based biopharmaceutical company with approximately 12,000 employees and operations in over 35 countries to research, develop and commercialize drugs. In 2019, its total revenue exceeded $22B with product sales in the United States accounting for $16.6B. It is predominantly focused on antiviral drugs for HIV, Hepatitis B, Hepatitis C and influenza, but has recently gotten massive attention for remdesivir, a COVID-19 treatment.
3. Amgen (NDX: AMGN)
Amgen is a US-based company with 23,000+ employees around the world. It is one of the world’s largest independent biotechnology companies and a worldwide leader in biologics manufacturing. Amgen has a robust clinical pipeline leveraging state-of-the-art science and molecular engineering with a focus on transformative medicine in six therapeutic areas: cardiovascular disease, oncology, bone health, neuroscience, nephrology and inflammation.
Genentech is a subsidiary of Roche headquartered in California with roughly 13,500 employees. It has 785K sq.ft. dedicated to research, over 40 medicines on the market, and over 20K patents. Recently, the FDA approved Genetech’s EnspryngTM – the first and only subcutaneous treatment for adult AQP4 antibody-positive neuromyelitis optica spectrum disorder. It can also be self-administered, which makes it more convenient for patients and could boost compliance.
5. Roche (SWK: RO)
Roche is a healthcare behemoth based in Switzerland that was founded in 1896. It is a leader in precision medicine and diagnostics, has 17 biopharmaceuticals on the market, and over half of its product pipeline are biopharmaceuticals. In 2019, it launched two new medicines and generated 72 new molecular entities (NMEs).
Trends of Top Biopharmaceutical Companies
With COVID-19 demanding immediate and constant attention from the biopharmaceutical and pharmaceutical industry, all top biopharmaceutical companies have devoted significant time and resources to fight the pandemic. There is an abundance of information and media coverage on the activities of these companies related to COVID-19. Here we discuss more general trends among the industry that have surfaced prior to the pandemic and have become even more apparent throughout the course of it.
Growth of Biopharma Facilities
Biopharma companies are expanding their facilities or building new ones to maximize operational efficiency and scale up development and manufacturing abilities to meet growing and changing production demands. Samsung Biologics broke ground in November 2020 on its fourth plant and also said that it is negotiating with the authorities at IFEZ (Incheon Free Economic Zone) to purchase additional land for its second bio complex. The two investments will cost roughly $2B and will expand its current facility to 620KL total capacity upon completion, which will make it the world’s largest biopharmaceutical contract manufacturing facility in the world.
Partnerships and collaborations have always been an important part of the pharmaceutical industry, but with drug discovery, research, development, and manufacturing becoming more complex, it requires a multidisciplinary approach and cost is increasing. External partnering bridges complementary skills and helps de-risk projects as both (or multiple) stakeholders are invested. Numerous partnerships and collaborations have formed surrounding COVID-19, such as Lilly and Amgen collaborating on manufacturing COVID-19 antibody therapies. Amgen is also a member of the COVID R&D Alliance and Quantum Leap Healthcare Collaborative, which will evaluate cenicriviroc, Otezla®, and Firazyr® on inflammatory response in COVID-19 patients in the I-SPY COVID Trial.
Throughout 2019 and 2020, there have been an abundance of partnerships surrounding other conditions and industry needs.
Gilead and Galapagos (a European-based company focused on inflammatory, fibrotic and other diseases such as rheumatoid arthritis) partnered in 2019 to expand and accelerate research and commercialization programs to support unmet medical needs. Additionally, Gilead’s External Innovation Center fosters close relationships with partners to facilitate knowledge transfer and achieve the aim of bringing 10+ new transformative therapies to patients in the next 10 years. In 2019, the company established 27 strategic partnerships and licensing deals
Samsung Biologics’ innovative, one-stop business model facilitates long-term partnerships with drugmakers for research, development, and manufacturing of biomedicines to reduce disruptions associated with having multiple vendors. In 2020, Samsung Biologics formed strategic partnerships with AstraZeneca, GSK, Eli Lilly and many others. Additionally, the company participates in enterprise-wide collaborations to improve the supply chain network.
Recently, the SMA (spinal muscular atrophy) Foundation, PTC Therapeutics and Roche have teamed up to develop innovative treatments for patients with SMA.
New Biological Products
New treatment modalities continue to emerge as innovation is a major priority of biopharmaceutical companies. As new drug classes enter the pipeline and market, companies are adopting new technologies to increase drug development capabilities and are acquiring smaller companies to diversify their portfolio. The market will continue to grow and companies are anticipating a continued focus on precision medicine, biologics, and rare diseases. To remain competitive, establishing capabilities in areas of high interest is critical.
In 2019, Roche invested roughly one fifth of the company’s sales to develop new tests and medicines for patients needing new options. It is now developing products for diseases with low incidence rates such as multiple sclerosis, haemophilia and neuroscience diseases. Genentech has had 33 FDA breakthrough therapy designations, which are designed to accelerate the development and review of medicines. Samsung Biologics is continuing to expand their contract research services to include cell bank manufacturing, cell line characterization and viral clearance studies.
Expansion of Biosimilars and Biogenerics
Over the next 5–10 years in the US, it is estimated that biosimilars can save the healthcare system approximately $150B.
Going Beyond Treatment
The industry is becoming more patient-centric to deliver comprehensive support and better medicine to patients. Major areas of focus include financial and emotional health, as well as boosting patient engagement. Genentech offers financial support programs to help patients pay for their medicines. The company explains insurance coverage, provides free medicine to certain individuals through its patient foundation, and offers co-pay services.
In addition to the trends listed above, the top five biopharmaceutical companies have dedicated resources and efforts towards increasing the ﬂexibility and capabilities of their development and manufacturing facilities; are transitioning away from high-cost stainless steel production equipment and moving towards single-use systems for research, clinical, and commercial scales; are boosting productivity by adopting automation, artificial intelligence, and cloud technology; and are increasing the use of continuous processing for both upstream and downstream manufacturing.
The biopharmaceutical industry is massive and the major players demonstrate exceptional agility, forward-thinking, and collaboration. As the market continues to grow and become more complex, all biopharmaceutical companies will need to consider adopting trends displayed by the top biopharmaceutical companies.