Pharmaceutical and biopharmaceutical companies both generate therapeutics but differ in the way the drugs are made. Pharmaceutical companies use chemicals and synthetic processes to make drugs, whereas biopharmaceutical companies use living organisms. Different types of organizations can be classified as a pharmaceutical or biopharmaceutical company, such as startups, contract manufacturing organizations, contract research organizations, and industry giants with a vast therapeutic pipeline. Companies with an abundance of capital, resources and expertise might have the capability of producing both pharmaceuticals and biopharmaceuticals.
In 2019, the world market for biopharmaceuticals was over $270 billion with recombinant protein therapeutics approaching $200 billion in sales alone. The global market is projected to reach over $446 billion by 2025, which is largely being driven by monoclonal antibodies (mAbs) (estimated at roughly $82 billion in 2018). In addition to mAbs, key product types include vaccines, recombinant human insulin, erythropoietin, granulocyte colony-stimulating factors, interferons, and human growth hormones. Cell and gene therapy, and precision medicine as a whole, are key areas with novel technologies shaping the industry and also allow for previously “untreatable” diseases to be treated — and potentially cured. For instance, biopharmaceutical company Spark Therapeutics’ developed Luxturna — a gene therapy for certain rare inherited retinal diseases such as Leber congenital amaurosis or retinitis pigmentosa that could cure the associated blindness. Because of its novelty, cost to manufacture, and value it is set at a hefty price of $850,000 for a one-time treatment. Generally, biologics are more expensive for the drugmakers and the patients compared with traditional pharmaceuticals. Like Luxturna, Novartis’ Zolgensma – a gene therapy for children with spinal muscular atrophy – has a price of $2.1 million.
According to The Science Times, the top 5 global biopharmaceutical companies in 2020 based on being “blockbuster” in size or having the highest potential of becoming notable globally are Gilead Sciences, Amgen, Samsung Biologics, Genentech, and Roche. Roche is also listed as a top 5 pharmaceutical company based on revenue. Major applications for biopharmaceuticals include oncology, autoimmune disorders, diabetes, inflammatory and infectious diseases, neurological diseases, cardiovascular diseases, and rare diseases.
Some key trends identified by Biosimilar Development in bioprocessing that are driving industry changes include:
- Increasing number of global biopharma facilities catalyzing growth in related bioprocessing supplies and services;
- New biological product classes;
- Expansion of biosimilars and biogenerics;
- Increased ﬂexibility and capabilities of development and manufacturing facilities;
- Transitioning away from high-cost stainless steel production equipment towards adoption of single-use systems for research to commercial scales;
- Boosting productivity with further automation, more robust process control, and improved bioprocessing efﬁciency with titers and yields continuing to increase; and
- Escalating use of continuous processing for both upstream and downstream manufacturing.
With anticipated market growth and the introduction of new drugs, product development and manufacturing must adapt to mitigate detrimental bottlenecks and produce high quality drugs in line with regulatory changes. Biopharmaceuticals can be life-changing for patients, but are complex and expensive to manufacture compared to traditional pharmaceuticals. Development and manufacturing costs, along with new pricing strategies for new classes of drugs can result in astronomical costs.
The pharmaceutical industry has grown significantly over the past two decades, being valued at $390.2B in 2001 and $1.25T in 2019. Continued growth is expected as top companies tackle COVID-19 and continue to introduce new drugs and technologies for wide-ranging illnesses. Oncologics, pain therapy, and antidiabetics are the top global pharmaceuticals based on revenues, generating roughly $100B, $79B, and $40B, respectively, in 2018
AbbVie’s Humira consistently ranks as the world’s top drug based on revenue, with it generating $19.2B in 2019, which was a modest decrease from nearly $20B in 2018. Humira is predominantly used for treating rheumatoid and psoriatic arthritis. However, it can be used for a wide-range of medical conditions such as Crohn’s disease, ankylosing spondylitis, ulcerative colitis, psoriasis, uveitis, and some other autoimmune diseases. Keytruda (Merck & Co.), Revlimid (Bristol Myers Squibb), Opdivo (Bristol Myers Squibb), Eliquis (Bristol Myers Squibb) and Eylea (Regeneron, Bayer) are among other top pharmaceutical drugs in 2019.
According to Pharmaceutical Technology, the top five pharmaceutical companies in 2020 by revenue are Johnson & Johnson ($56.1B), Pfizer ($51.7B), Roche ($49.23B), Novartis ($47.45B), and Merck & Co ($46.84B). J&J has a massive pharmaceutical and biopharmaceutical drug portfolio with some products being particularly successful, such as Stelara, Tremfya, Darzalex, and Imbruvia. J&J executives expect $85.8 billion to $86.6 billion in 2020 sales ($82.1 billion in sales in 2019).
As the pharmaceutical industry continues to evolve, companies must adapt to better fulfill patient needs and become more efficient and cost effective. Some key trends within the pharmaceutical industry include:
- Prioritizing patient engagement and closer patient connections;
- Innovative commercial strategies and models;
- Supporting patients beyond treatment to include emotional, financial, and other needs associated with their medical condition;
- Increasing operational efficiency by adopting cloud technology and AI capabilities; and
- Cross-industry and enterprise-wide collaborations.
Startups also play a major role in the (bio)pharmaceutical industry as they introduce ground-breaking innovations to the market. According to MedicalStartups, the top five pharmaceutical and drug discovery startups include Roivant Sciences (biopharmaceutical), Relay Therapeutics (allosteric drug-discovery), Recursion Pharmaceuticals (rare genetic diseases), Synergy Pharmaceuticals (gastrointestinal biopharmaceuticals), and Dicerna Pharmaceuticals (dicer substrate technology).
Pharmaceutical and biopharmaceutical companies frequently rely on contract research organizations (CROs), contract manufacturing organizations (CMOs), and contract development and manufacturing organizations (CDMOs) to accelerate drug development from preclinical research through commercialization. Partnering with these organizations enables companies to leverage facilities, equipment, and expertise that would be too costly to establish internally. Services can be hyper specific or wide-ranging within an individual CRO or CMO/CDMO, but ultimately they are all aiming to streamline workflow; reduce costs of research, development, and manufacturing; and de-risk projects. With the pharmaceutical and biopharmaceutical market becoming more complex in regards to pipeline diversity and regulatory guidelines, some outsourcing companies are adapting by offering more comprehensive services. For instance, Samsung Biologics is a biopharmaceutical CDMO and is marketed as a “one-stop shop” for biopharmaceutical companies. Samsung Biologics has extensive capabilities and expertise allowing their partners to eliminate delays associated with technology transfer between multiple vendors.
Therapeutics continue to evolve and become more diverse and personalized, increasing the complexity of drug discovery, development, and delivery. There are two general types of drugs based on the way they were made: pharmaceuticals (using chemical and synthetic methods) and biopharmaceuticals (using live organisms). Many companies identify as either pharmaceutical or biopharmaceutical, but some pharmaceutical giants and companies with robust capital develop both types of drugs through means of mergers and acquisitions, partnerships, or investing in new in-house capabilities.