According to McKinsey & Company “The opportunity in biopharmaceuticals is big and growing too rapidly to ignore. Today, biopharmaceuticals generate global revenues of $163 billion, making up about 20 percent of the pharma market. It is by far the fastest-growing part of the industry: biopharma’s current annual growth rate of more than 8 percent is double that of conventional pharma, and growth is expected to continue at that rate for the foreseeable future. The current biologics-development pipeline supports an outlook of continued healthy growth. The number of biotech patents applied for every year has been growing at 25 percent annually since 1995. There are currently more than 1,500 biomolecules undergoing clinical trials, and the success rate for biologics has so far been over twice that of small-molecule products, with 13 percent of biopharma products that enter the Phase I trial stage going on to launch. If anything, the emerging long-term picture is even more exciting, with disruptive innovations such as immunotherapies, antibody drug conjugates, and gene and cell therapies all making progress toward commercial launch in the next few years.
Quality functions are struggling to keep up with the rising demands of regulators, primarily the US Food and Drug Administration. The industry has received an unprecedented number of warning letters and remediation programs in the last five years, and scrutiny is unlikely to decrease. Furthermore, the increasing relevance of global markets (beyond the United States, European Union, and Japan) is adding the complexity of multiple quality standards and regulatory regimes. Compliance, robustness of processes, and efficiency will need to be squared in one equation.”
Worldwide biotechnology market (therapeutics and diagnostics, R&D services, other) consists of 14,000+ companies, with ~4,000 of them located in the United States.
Companies per sector (Worldwide)
Sector | Total companies | |
Biotechnology – Therapeutics and Diagnostics: | 3,862 | |
Biotechnology / R&D Services: | 6,493 | |
Biotechnology – other: | 3,717 | |
Pharma: | 2,299 | |
Medical Technology: | 5,125 | |
Investor: | 735 | |
Professional Services and Consulting: | 5,013 | |
Public / Non-Profit Organizations / Medical Facil: | 5,202 | |
Supplier & Engineering: | 8,890 | |
Media: | 171 | |
HealthTech: | 844 | |
Total: | 42,351 | |
Total Number of Biotech companies: | 14,072 |
Companies per sector (USA)
Sector | Total companies |
Biotechnology – Therapeutics and Diagnostics | 1,773 |
Biotechnology / R&D Services | 1,672 |
Biotechnology – other | 320 |
Pharma | 219 |
Medical Technology | 1,341 |
Investor | 248 |
Professional Services and Consulting | 1,260 |
Public / Non-Profit Organizations / Medical Facility | 862 |
Supplier & Engineering | 1,153 |
Media | 55 |
HealthTech | 135 |
Total | 9038 |