Specialty Enzymes Market

[306 Pages Report] According to MarketsandMarkets, the global Specialty enzymes market size is estimated to be valued at USD 6.1 billion in 2024 and is projected to reach USD 9.2 billion by 2029, recording a CAGR of 8.5%.

The growth of specialty enzymes is fueled by increasing demand for effective biocatalysts in pharmaceuticals and diagnostics drives innovation and market expansion. Advancements in biotechnology and genetic engineering enable the development of more efficient and specific enzymes, broadening their application scope. Additionally, investment in healthcare and biopharmaceuticals is increasing, supporting the use of specialty enzymes in developing new therapies and drug formulations.  As consumers become more health-conscious, the use of specialty enzymes in nutraceuticals and functional foods is also on the rise, further propelling market growth.

The expanding business has offered lucrative business opportunities to the players who are operating in the market segments. For instance, in February 2024, New England Biolabs (US) launched the NEBNext Enzymatic 5hmC-seq Kit (E5hmC-seq), an enzyme-based method for the specific detection of 5hmC sites, offering high yields and quality data from inputs ranging from 100 pg to 200 ng. By enabling the specific detection of 5hmC, NEB strengthens its position in the enzyme market, providing researchers with advanced tools for epigenetic studies and gene regulation research.

Other major players, such as Sekisui Diagnostics (US) announced a USD 16.4 million investment to expand cGMP microbial capacity at its Maidstone, Kent site, slated for completion in the second half of 2022. This followed a USD 1.9 million investment in a new Bioprocess Innovation Centre completed in October 2019. This strategic expansion significantly enhanced Sekisui's capabilities in the specialty enzyme market, enabling them to meet growing demand and solidify their position in the microbial biopharma CDMO sector.

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Specialty Enzymes Market Dynamics

Drivers: Supportive Government Policies and Funding

Public funding and incentives for biotechnological research can drive growth and innovation in the specialty enzymes market. The EU's Horizon Europe program, with a budget of USD 103.6 billion for 2021-2027, focuses on research and innovation, including biotechnology, supporting projects aimed at developing advanced biotechnological processes and products. In the United States, the National Institutes of Health (NIH) allocated over USD 42.0 billion for biomedical research in 2022, with part of this funding directed towards biotechnology research, including developing novel enzymes for medical and industrial applications. India's Biotechnology Industry Research Assistance Council (BIRAC) also provides funding and support for biotech startups and research institutions, fostering innovation in enzyme technology through initiatives like the Biotechnology Ignition Grant (BIG) scheme.

One noteworthy government initiative aimed at fostering innovation and growth in the specialty enzymes market, particularly within biotechnology and pharmaceuticals, is the Biotechnology Industry Research Assistance Council (BIRAC) in India. Established by the Department of Biotechnology (DBT), Government of India, BIRAC actively supports biotech startups and research institutions through various funding schemes. Among these initiatives is the Biotechnology Ignition Grant (BIG) scheme, which provides early-stage funding to startups and entrepreneurs with innovative ideas in biotechnology. In July 2020, BIRAC allocated Rs. 50 crores (USD 6.7 million approximately) under the BIG scheme to support approximately 100 startups and entrepreneurs in the biotechnology sector. This funding injection aims to catalyze innovation, encourage entrepreneurship, and accelerate the development of novel enzyme-based solutions for various applications in biotechnology and pharmaceuticals. By providing financial support and fostering a conducive ecosystem for research and development, initiatives like BIRAC's BIG scheme contribute to the growth and competitiveness of the enzyme market in India..

Restraints: High Costs Limiting Specialty Enzymes Market Adoption and Growth

The production of specialty enzymes often involves advanced biotechnological methods, such as recombinant DNA technology, protein engineering, and fermentation processes. These methods require state-of-the-art equipment and highly skilled personnel, which contribute to the overall cost. For example, the production of recombinant enzymes involves the use of genetically modified microorganisms, which must be carefully cultivated, maintained, and controlled to ensure consistent enzyme quality and activity.

The high production costs of specialty enzymes translate to higher prices for end-users in industries such as pharmaceuticals, food and beverages, and biotechnology. This price premium can be a significant barrier to adoption, especially for small and medium-sized enterprises (SMEs) that may not have the financial resources to invest in these high-cost inputs. In the pharmaceutical industry, enzymes are used in drug formulation and production processes. The high cost of these enzymes can significantly impact the overall cost of drug development and manufacturing. For instance, the cost of enzymes used in biocatalysis can account for up to 30% of the total production cost of certain pharmaceuticals. This cost factor can influence the pricing of the final pharmaceutical products, potentially making them less competitive in the market.

Opportunities: Technological Innovations and Wide Industry Scope

A new number of specialty applications of enzymes are being developed to enhance production processes. Several companies in the pharmaceutical industry are incorporating the use of enzymes as an alternative to chemicals to produce drugs with negligible side effects. Gene modification in the existing enzyme has resulted in significant development to enable enzymes to be functional under varying temperatures and pH levels. Specialty enzymes have been commonly used in biotechnology developments to duplicate and insert DNA when required in genetic engineering techniques. Due to advancements in research & biotechnology, the time-efficient diagnosis of various chronic diseases such as cancer, cardiovascular diseases, and lysosomal abnormalities has been found. Research institutes are focusing on high investments in R&D and discovering new applications such as drug cloning and gene modifications.

Here are some examples:

• In November 2023, BRAIN Biotech's interdisciplinary project teams,s comprising experts in microbiology, molecular biology, and bioprocess development, optimized an Aspergillus Niger strain for efficient enzyme and alternative protein production, achieving yields in the double-digit gram-per-liter range. This innovation positions BRAIN Biotech AG to significantly advance in the specialty enzyme market by replacing a large proportion of animal proteins with sequence-identical, microbially produced proteins, enhancing sustainability and efficiency.
• In May 2023, Codexis, Inc. announced the launch of its Enzyme-Catalyzed Oligonucleotide (ECO) Synthesis technology, a new platform for manufacturing RNA oligonucleotide therapeutics at scale. This proprietary technology replaces traditional phosphoramidite chemistry with enzymatic methods, enabling scalable, sustainable production designed to overcome existing manufacturing challenges.

Challenges: High Research and Development Costs

High research and development (R&D) costs are a significant barrier for companies, especially smaller ones, looking to enter the specialty enzymes market. The development of new enzymes requires substantial investments in research, laboratory equipment, personnel, and clinical trials. These expenses can be prohibitive for smaller companies with limited financial resources, thus limiting innovation and competition within the market.

The Pharmaceutical Research and Manufacturers of America (PhRMA) indicates that the pharmaceutical industry's R&D spending reached approximately USD 83.0 billion in 2020 (source: PhRMA Annual Membership Survey, 2020).

Novozymes A/S (Denmark) is a global leader in the production of enzymes and microorganisms. The company invests heavily in R&D to drive innovation and develop new enzyme solutions tailored to various industries, including agriculture, food and beverages, bioenergy, and household care. As of their Annual Report 2023, Novozymes allocated approximately 11.27% of its revenue (approximately USD 290 million) to research and development activities. This substantial investment enables Novozymes to maintain its competitive edge by continuously introducing new products and improving existing ones.

The Specialty Enzymes Market Ecosystem

Proteases is projected to be the fastest-growing segment in the enzyme market during the forecast period.

Proteases have extensive applications in pharmaceuticals, biotechnology, and healthcare. In the pharmaceutical sector, they are crucial for drug formulation and therapeutic treatments, including anti-inflammatory and anticancer drugs, due to their ability to break down proteins into peptides and amino acids. In biotechnology, proteases are vital for protein sequencing, peptide synthesis, and various molecular biology applications, driven by the demand for precise tools in genetic research and biotechnological advancements. In healthcare, they play a significant role in wound care and digestive health products, improving patient outcomes through enzymatic debridement and digestive supplements. Advancements in genetic engineering have further enhanced the efficiency and specificity of proteases, making them indispensable across these sectors.

Microorganism-based specialty enzymes are projected to experience the fastest growth in the forecasted period

This trend is primarily driven by advancements in biotechnology and microbial fermentation techniques, which have significantly enhanced the production efficiency and diversity of enzymes derived from microorganisms. Microbial sources such as bacteria and fungi offer several advantages over traditional plant and animal sources, including higher enzyme yields, faster production times, and the ability to modify enzyme characteristics through genetic engineering. Moreover, the increasing demand for sustainable and eco-friendly manufacturing processes has boosted the adoption of microorganism-based enzymes. These enzymes are often more cost-effective and scalable, making them ideal for large-scale specialty applications in sectors such as research & biotechnology, biocatalysts, diagnostics, and pharmaceuticals. Their versatility allows for the development of enzymes tailored to specific industrial needs, such as thermostable enzymes for high-temperature processes or enzymes with enhanced substrate specificity.

Diagnostics is the fastest-growing application in the specialty enzymes market during the forecast period

One major factor contributing to this growth is the advancement in enzyme-based diagnostic technologies. Enzymes such as polymerases and ligases are essential in molecular diagnostics, including PCR (Polymerase Chain Reaction) and other nucleic acid amplification techniques. These technologies are crucial for the detection of infectious diseases, genetic disorders, and cancer. For example, in March  2023, Thermo Fisher Scientific launched a new line of high-performance enzymes designed to enhance the sensitivity and speed of PCR diagnostics, addressing the growing need for efficient diagnostic tools in clinical settings.

Additionally, the growing emphasis on personalized medicine and early disease detection has spurred innovation in diagnostic technologies. Specialty enzymes are integral to the development of point-of-care (POC) diagnostic devices, which offer quick and reliable results at the patient’s bedside. These devices are increasingly used for managing chronic conditions such as diabetes, where timely and accurate diagnostics are crucial.

Moreover, government initiatives and funding for healthcare infrastructure are propelling the diagnostics sector. Governments worldwide are investing in healthcare systems to enhance diagnostic capabilities, thus driving the demand for specialty enzymes. In October 2021, the Indian government announced the PM Ayushman Bharat Health Infrastructure Mission, pledging approximately USD 8.6 billion over five years to enhance healthcare infrastructure, including the development of diagnostic facilities equipped with advanced enzyme-based technologies nationwide. This initiative aims to bolster healthcare accessibility and improve diagnostic capabilities across India.

Asia Pacific is poised to experience the highest CAGR in the Specialty enzymes market during the forecast period.

The region's pharmaceutical and biotechnology sectors are also expanding rapidly. According to the India Brand Equity Foundation, 2023, India's pharmaceutical industry, which contributes over 20% of the global generics market, relies heavily on enzymes for drug production.

Advancements in biotechnology and increased R&D investments enhance enzyme production capabilities. Japan and South Korea are at the forefront of biotechnological innovations, with South Korea investing over USD 2.5 billion annually in biotechnology R&D (OECD, 2023).

The growing awareness and implementation of sustainable and environmentally friendly practices have further driven the demand for specialty enzymes. Microbial enzymes, in particular, are preferred for their efficiency and eco-friendly nature, aligning with global sustainability goals. Additionally, the region benefits from a strong emphasis on research and development. Numerous academic and research institutions in the Asia Pacific are focused on biotechnology and enzyme research, leading to innovations and advancements in enzyme production and applications.

Asia Pacific: Specialty Enzymes Market Snapshot

Key Market Players

Key players in this market include BRAIN Biotech AG (Germany), Novozymes A/S (Denmark), Codexis, Inc. (US), Sanofi (France), Merck KGaA (Germany), Dyadic International Inc (US), Advanced Enzyme Technologies (India), Amano Enzyme Inc (Japan), F. Hoffmann-La Roche Ltd (Switzerland), New England Biolabs (US), BBI Solutions (UK), Creative Enzymes (US), Bioseutica (Netherland), and SEKISUI Diagnostics (US)

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Scope of the Report

Target Audience:

• Specialty enzyme raw material suppliers
• Specialty enzyme manufacturers
• Intermediate suppliers such as traders and distributors of enzymes
• Government and research organizations
• Associations, regulatory bodies, and other industry-related bodies

Report Scope:

Specialty Enzymes Market, By Source

• Microorganisms
• Plant
• Animal

Specialty Enzymes Market, By Type

• Carbohydrases
• Proteases
• Lipases
• Polymerases & Nucleases
• Other enzymes

Specialty Enzymes Market, By Application

• Pharmaceuticals
• Research & Biotechnology
• Diagnostics
• Biocatalysts

Specialty Enzymes Market, By Form

• Liquid
• Dry

Specialty Enzymes Market, By Region

• North America
• Europe
• Asia Pacific
• South America
• Rest of the World (RoW)

Recent Developments

• In March 2024, Biocatalysts, part of the BRAIN Biotech Group, enhanced its production capacity by adding a large-scale freeze-drying facility at its Cardiff site. This new facility would support the customization and precise formulation of enzymes for the food, beverage, and life sciences industries. By complying with kosher, halal, ISO9001:2015, and FSSC22000 standards, the facility ensured high-quality and flexible enzyme production..
• In March 2024, Sanofi India Limited (SIL) approved an agreement with Emcure Pharmaceuticals to exclusively distribute and promote SIL’s Cardiovascular products in India. While SIL retains ownership, import, and manufacturing, Emcure would enhance engagement with healthcare professionals and broaden the reach, benefiting patients nationwide and strengthening Sanofi’s market presence.
• In March 2024, Merck invested over USD 324.68 million in a new bioprocessing production center in Daejeon, South Korea, marking its largest life science investment in the Asia Pacific. This expansion, expected to create around 300 jobs by 2028, underscores Merck’s commitment to enhancing its capacity in this rapidly growing region.

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