Charting the development of biotechnology in the mid-1990s is, for any analyst or policymaker, a challenge defined as much by the boundaries of data as by the field’s scientific frontiers. By 1994, biotech had already proven itself as more than a passing trend, yet the industry’s true contours remained elusive. ISIC 7210—research and development on natural sciences and engineering—serves as the statistical starting point, but it casts a wide net. Within its coverage are classic biotech labs, pure-play startups, contract research organizations, and a fair number of research groups working in fields only tangentially related to biotechnology.
The first step is to build a roster of ISIC 7210-registered firms for the relevant geography—say, the United States, Canada, or the EU-15. The list can be obtained from business registries, innovation agency records, and, in some jurisdictions, industry associations with more detailed membership lists. A straightforward registry search, though, won’t separate the life science innovators from the physicists, material scientists, or engineering research shops sharing the same classification. Supplementary clues come from business descriptions, archived websites (if they exist), and, sometimes, the language of press releases and grant announcements. Firms referencing gene therapy, monoclonal antibodies, or recombinant technology are likelier to be engaged in biotech R&D than those describing general engineering or chemistry.
Once the population is refined, integrating firm-level research expense data becomes the next task. Larger, publicly traded biotech companies often broke out R&D expenses in their annual financial statements—sometimes even identifying spending on individual development programs. For smaller private firms, the trail is patchier. Venture funding announcements, NIH grant reports, or state/provincial innovation agency disclosures can help approximate research budgets, though the granularity is rarely perfect. In some cases, academic partnerships or collaborative R&D consortia reveal research spending through indirect sources—co-authored papers, shared patents, or project budgets.
A crucial link in measuring the sector’s impact is to match research activity to regulatory milestones. In the US, the FDA approval process stands as the chief marker of progress for any biotech firm aspiring to move from lab bench to commercial product. FDA records, published in the Federal Register and (later) online, provide details on investigational new drug applications (INDs), new drug approvals (NDAs), and biologics licenses (BLAs). Cross-referencing these approvals with ISIC 7210-registered companies helps identify which firms succeeded in translating R&D into regulatory advancement. Some approvals are joint ventures or the fruit of collaborations, so company affiliations can shift over time.
Analysts can construct a timeline, aligning research expenditures with FDA filings or approvals. In years when spending surges, does the number of INDs or NDAs rise? Are certain firms repeatedly successful, or is approval activity concentrated among a handful of players? The relationship is rarely linear—some programs require years of steady investment before reaching the FDA, while others are abandoned, redirected, or even spun out into new entities. Still, mapping approvals and expenses in parallel brings the sector’s momentum, and its volatility, into sharper relief.
Documentation of the process is essential at every turn. Assumptions about which firms “count” as biotech, estimates for unreported R&D expenses, and the linkage between approval records and corporate identity should all be logged. The boundaries of the sector are porous: some engineering and pharmaceutical companies shifted toward biotech in these years, while others diversified away after a single product cycle.
The resulting analysis is necessarily imperfect—patchy in places, often reliant on incomplete evidence. Yet, when firm-level research spending is layered with regulatory outcome data, a more vivid portrait of 1994’s biotechnology sector emerges. The signals of innovation, risk, and occasional breakthrough are all there, even if the details sometimes slip through the cracks. For those willing to look closely, it is possible to glimpse not just the science but the business of biotech, as it truly took shape in the closing years of the twentieth century.