In the early 1980s, it was once predicted that "the 21st century will be the century of biology." This prediction has now become a reality. Among the top ten global scientific and technological breakthroughs selected by the American journal Science in 2014, half of the achievements came from the field of life sciences. In 2014, scientists made numerous breakthroughs in aging research, biological evolution, genetic disease gene analysis, stem cells, and brain and nerve cell research, which will help people uncover the secrets of human growth, development, aging, illness, and death, and ultimately help people overcome major diseases such as AIDS, cancer, and Ebola.

In China, as one of the seven strategic emerging industries listed in the "Decision of the State Council on Accelerating the Cultivation and Development of Strategic Emerging Industries," the bio-industry has become the focus of policy and capital attention in recent years. In 2014, in the 863 and 973 programs, the biological field remained the area with the most investment. The "Bio-industry Development Plan" set a development goal of an average annual growth rate of over 20% for the bio-industry's output value in the past three years, marking that China's bio-industry has entered a period of rapid development. Important areas of the bio-industry, such as biomedicine and bio-agriculture, will inevitably increase related production and R&D investment.

The development of the bio-industry will inevitably bring huge market opportunities to life science instruments, which are important tools in the field of life sciences. Relevant research reports show that in 2014, global life science instrument market sales exceeded 40 billion US dollars, growing at a rate of 6%. For the Chinese market, despite a slowdown in economic growth, increased national support and the huge procurement demand brought by the booming development of the bio-industry itself make the Chinese market still the strongest driving force for life science instruments.

The molecular diagnostics market remains one of the hot spots for development in the life sciences field. In 2014, the global molecular diagnostics market grew at a rate of over 10%, while the Chinese molecular diagnostics market grew by over 20%. In another life science hotspot, bio-breeding, with transgenic technology as its core, is the leader in the development of China's bio-agriculture. The rapid development of these hot areas has driven the procurement demand for related research tools, such as gene sequencers, PCR instruments, and other molecular and cell biology instruments.

Foreign media predict that in the next three years, with the booming development of molecular diagnostics, biomedicine, and other fields, genomics-related instruments such as fluorescence quantitative PCR instruments, next-generation sequencing (NGS)/third-generation sequencing (3GS), chips, PCR, CE sequencing, and digital PCR; proteomics instruments such as protein separation and analysis equipment, ELISA, blotting, and protein chips; and cell biology instruments such as flow cytometers and microscopes will generate a significant market size.

In response to the booming life science industry, major instrument companies have successively increased their efforts to transform towards the life sciences field. Agilent, through its spin-off, focuses more on the biomedical field to achieve greater development in life sciences and diagnostics; Merck and Danaher accelerate expansion into the life sciences field through acquisitions; Bruker's sale of its ICP-MS business is one of its important strategies to shift its focus to the life sciences field. It is clear that the life sciences field has become a battleground for major instrument companies.

Gene Sequencers: Rapid Development Amidst Policy Changes

Gene sequencing is a revolutionary technology with a wide range of applications. In recent years, with the advancement of gene sequencing technology, the gene sequencing industry has entered a period of rapid development.

Gene sequencing technology is an important technical means in life science research and an indispensable research tool for molecular diagnostics and biomedicine. The Sanger chain-termination sequencing method (first-generation sequencing technology) invented in 1977, combined with capillary electrophoresis, once became the mainstream method for gene sequencing due to its simplicity and speed, and was widely used in scientific research and clinical work. With the booming rise of personalized medicine, gene sequencing technology has played an increasingly important role in clinical, forensic, CDC, and other application areas.

The "Implementation Plan for Comprehensively Advancing Nucleic Acid Testing in Blood Stations (2013-2015)" was released on the website of the National Health and Family Planning Commission (NHFPC). It requires all regions to establish a reasonably laid out, efficiently resourced, and functionally complete network of nucleic acid testing laboratories for blood stations. By 2015, nucleic acid testing for blood screening will basically cover the whole country. This promoted the market demand for gene sequencers in 2014.

On February 9, 2014, the China Food and Drug Administration (CFDA) and the General Office of the National Health and Family Planning Commission (NHFPC) issued an urgent notice on their official websites, suspending the clinical use of gene sequencing-related products and technologies. The fundamental reason for the suspension of gene sequencing was the uneven quality of companies engaged in gene testing and a relatively chaotic market. Gene sequencing involves a series of issues such as ethics, privacy, protection of human genetic resources, biosafety, and the management, pricing, and quality supervision of gene diagnostic services carried out by medical institutions. The regulatory authorities need to regulate the industry, and it is not that gene sequencing technology itself has problems. On the contrary, due to the advantages of gene sequencing in prenatal diagnosis, with the relaxation of the "separate two-child" policy, the number of elderly pregnant women is gradually increasing, and the demand for gene sequencing is growing instead.

This is indeed the case. On July 2, the China Food and Drug Administration (CFDA) announced that, after review, it had approved the medical device registration of the BGISEQ-1000 gene sequencer, BGISEQ-100 gene sequencer, and fetal chromosomal aneuploidy (T21, T18, T13) detection kits (combined probe anchoring and ligation sequencing method), and fetal chromosomal aneuploidy (T21, T18, T13) detection kits (semiconductor sequencing method). The CFDA stated that this was China's first approved registration of second-generation gene sequencing diagnostic products. More than four months after gene sequencing was suspended, second-generation gene sequencing products ushered in a new dawn for re-opening in clinical medical applications. On November 5, Daan Gene Co., Ltd.'s gene sequencer and non-invasive Down syndrome detection kit also received CFDA production approval.

Recently, the NHFPC announced the first batch of pilot units for clinical application of high-throughput sequencing technology, approving clinical pilot projects for genetic disease diagnosis, prenatal screening and diagnosis, and preimplantation embryo genetic diagnosis. This means that gene sequencing and related申报单位 can officially apply this project to the medical system and truly use it clinically, which can be said to have a significant impact.

Affected by changes in instrument policies, the gene sequencer market in 2014 showed some fluctuations. Policies at the beginning of the year had a certain dampening effect on the market demand for gene sequencers in China. Although the market size of gene sequencers in China did not show a significant decline due to other policies promoting demand for gene sequencers and the investment and support of national projects, the growth momentum was not as significant as usual. However, with the approval of second-generation gene sequencers and the recent approval of pilot documents for the clinical application of gene sequencing technology, the market demand for gene sequencers may experience an explosive growth after a brief suppression.

Globally, innovations in sequencing technology have driven the market size of sequencers and even the entire genomics instrument market. DeciBio Life Science Market Research Company once published a report stating: "The next-generation gene sequencer market is expected to grow by 16% annually," and the market size of next-generation gene sequencers is estimated to reach 2.25 billion US dollars in 2016.

After Roche closed its 454 business, the market for next-generation sequencers was mainly dominated by Illumina and Life Technologies. According to data published by C&EN magazine, Illumina holds an absolute market share in the next-generation sequencer market, reaching 71%, while the third-generation sequencing technologies that have recently received widespread attention are mostly in the development stage or early commercialization, and are unlikely to threaten Illumina's leading position at present.

PCR Instruments: Multiple positive news drives steady growth

In 1985, Kary Mullis, a chemist at Cetus Corporation, invented PCR, a revolutionary technology that made the long-desired wish of infinitely amplifying nucleic acid fragments in vitro a reality. PCR technology is no longer limited to target gene amplification; quantitative fluorescence PCR technology makes nucleic acid detection and quantification more accurate and convenient, and also makes PCR instruments widely used in clinical diagnosis, biological breeding, food safety testing, forensic identification, and other fields.

Following quantitative fluorescence PCR, digital PCR is one of the most exciting innovations in the life sciences. Digital PCR can directly count the number of DNA molecules, providing absolute quantification of starting samples. It is particularly suitable for research areas such as copy number variation, mutation detection, gene relative expression studies, validation of next-generation sequencing results, miRNA expression analysis, and single-cell gene expression analysis. Companies like Life Technologies and Bio-Rad have successively launched digital PCR systems. It is foreseeable that with the development and popularization of PCR technology, digital PCR instruments will occupy the widest market in the future.

In recent years, despite the impact of economic downturns and monetary tightening policies in Europe and the United States, demand from industries such as biology, healthcare, and scientific research has declined. However, the molecular diagnostics industry and the bio-breeding industry, centered on transgenic technology, have seen great development. According to statistics, molecular diagnostics is the fastest-growing segment of the global in vitro diagnostics market. In 2014, the total demand for the global molecular diagnostics market reached 7 billion US dollars, and its proportion of in vitro diagnostics has grown from 2% in 1995 to 14%. The market growth rate will reach 11%, ranking first among various sub-segments. China's molecular diagnostics market is developing even more rapidly, with an annual growth rate twice that of the global average. Moreover, in the "12th Five-Year Plan for the Development of National Strategic Emerging Industries" compiled by China's National Development and Reform Commission, the bio-breeding industry was listed as one of the seven national strategic emerging industries. Transgenic technology is even more a strategic emerging industry related to national core competitiveness and long-term national development.

Quantitative fluorescence PCR instruments are indispensable research tools in the fields of molecular diagnostics and bio-breeding. In the next one to two years, the global market for quantitative fluorescence PCR instruments will grow by about 6%, with the market size steadily climbing to 2.95 billion US dollars in 2016. In China, the incremental growth of the quantitative fluorescence PCR instrument market is expected to reach about 10%. In the event of sudden incidents like epidemics, procurement demand can further increase. For example, in response to the 2014 West African Ebola virus outbreak, the General Office of the National Health and Family Planning Commission issued a notice on the "Diagnosis and Disposal Pathways for Ebola Hemorrhagic Fever Related Cases," which required the use of qPCR for blood sample testing of observation or suspected cases. This triggered a round of procurement demand for quantitative fluorescence PCR instruments.

It is worth noting that, with the future development of the molecular diagnostics industry, quantitative fluorescence PCR instruments will undoubtedly pay more attention to meeting the specific needs of clinical diagnostic laboratories, and users will be more concerned about whether the products have obtained In Vitro Diagnostic (IVD) medical device certification.

Similar to quantitative fluorescence PCR instruments, the market for conventional PCR instruments also saw favorable policies in 2014. On March 28, the official website of the National Pharmacopoeia Commission released a notice seeking public comments on the General Rules (Draft) of the 2015 edition of the Chinese Pharmacopoeia. The 2015 edition of the Chinese Pharmacopoeia's general rules catalog and the revised draft added various instruments and methods, such as DNA barcode molecular identification methods for traditional Chinese medicine and nucleic acid molecular identification methods, stipulating PCR instruments as verification instruments.

Regarding food safety, 91 food testing standards were implemented on August 1st, including standards for detecting genetically modified components in crops, viruses in aquatic products, and fruit variety identification, which specify PCR as a testing equipment. In 2014, the implementation of the above policies and related standards played a certain role in driving the demand for PCR instruments.

In the Chinese quantitative fluorescence PCR instrument market, a long-term tripartite dominance has been observed among Life Technologies, Bio-Rad, and Roche. The combined annual sales of these three major brands account for approximately 60% of the total annual market sales. While domestic quantitative fluorescence PCR instruments, after long-term accumulation, have generally reached or approached international mainstream levels, it still requires a considerable amount of time for them to be widely recognized by the market. In response to this market situation, domestic quantitative fluorescence PCR instrument manufacturers like Hangzhou Bioer currently focus mainly on exports.

The mainstream market for conventional PCR instruments is mainly dominated by brands such as Bio-Rad, Eppendorf, Life Technologies, and Analytik Jena. In recent two years, domestic manufacturers like Hangzhou Bioer and Hangzhou Longgene have seen rapid sales growth, and currently, the market share of domestic conventional PCR instrument brands can basically match that of imported brands.

Gene Chips: Market needs cultivation

As an important research tool in the field of life sciences, gene chips have been rapidly developed in recent years through the joint efforts of academia and relevant companies. Applying gene chips allows for the quantitative analysis of a large number of gene expressions simultaneously, possessing fast, precise, and low-cost bioanalytical testing capabilities, with immense market potential.

The application fields of gene chip technology mainly include disease diagnosis and prediction, new gene discovery, gene mutation and polymorphism analysis, drug screening, etc. Among them, gene chip-assisted diagnosis and treatment perform particularly well in cancer, infectious diseases, and some genetic diseases. Using gene chip diagnostic technology to analyze patient blood samples can determine whether some cancer-related genes have mutations or deletions, thereby clarifying the condition. The advantages of chips are further reflected in the rapid and high-throughput detection of pathogenic microorganisms. In the field of prenatal screening, it is currently known that over 600 genetic diseases are related to genes, and gene chips have been applied to the detection of genetic diseases such as hemophilia, Duchenne muscular dystrophy, thalassemia, abnormal hemoglobinopathies, and phenylketonuria.

However, regarding the domestic market, compared to gene sequencers and PCR instruments which have already entered a period of rapid development, gene chips' stimulation to the market is currently more of a "concept," and market demand still needs cultivation.

In the international market, biochip technology is developing rapidly and showing a peak in development. In 2014, the global gene chip industry's output value was approximately 7 billion US dollars, and it is expected to reach 20 billion US dollars by 2020. According to incomplete statistics, American company Affymetrix has the highest market share, reaching about 50%, while Agilent and Illumina, also based in the United States, rank second and third in market share, totaling 30%. Currently, the gene chip industry is mainly concentrated in developed markets in Europe and America, where it has gained widespread application in scientific research, biopharmaceuticals, and clinical diagnostics.

Compared to the rapid development of the gene chip industry in developed foreign countries, the domestic gene chip market is clearly in its nascent stage, not yet industrialized, and has not been widely applied in the field of molecular diagnostics. It is only used in scientific research areas such as bioinformatics, with a very small market size. The reasons are, first, insufficient development in domestic gene chip application areas, a small number of downstream target users, and slightly insufficient R&D efforts; second, the high cost of single gene chip diagnostics, which makes individual promotion unaffordable for patients. However, the advantage of chips lies in their high throughput. Once the large-scale application of chips is achieved, the advantages in price and accuracy compared to traditional methods will become prominent, and the domestic industry will usher in an explosive growth point.

Cell Biology Instruments: Stem Cell Industry Drives Rapid Development

Cell biology instruments are tools used to study cellular life activities at the whole cell, sub-microscopic, and molecular levels. These include cell sorting, microscopic imaging, cell counting, and cell culture, playing an important role in hot topics in life sciences such as stem cell research.

In recent years, stem cell research conducted worldwide is driving a new round of medical revolution. The widespread clinical application of stem cells and their derived tissues and organs will lead to a completely new clinical technology, which is the regeneration of normal, and even younger, human tissues and organs. Currently, the use of hematopoietic stem cell transplantation technology has gradually become an important means for treating leukemia, various malignant tumors, and hematopoietic and immune system dysfunctions caused by radiotherapy and chemotherapy.

Although the stem cell industry has enormous market potential, its clinical application remains in a regulatory gray area, with a mix of companies and institutions involved, hindering the healthy development of the industry. The stem cell industry regulatory policies, including the "Management Measures for Stem Cell Clinical Trial Research", "Management Measures for Stem Cell Clinical Trial Research Bases", and "Guiding Principles for Quality Control and Pre-clinical Research of Stem Cell Preparations", have undergone multiple deliberations in 2014 and are expected to be introduced soon. These policies aim to fill the gap in domestic stem cell industry regulation, and the establishment of clinical rules will pave the way for the development of the domestic stem cell industry.

With the relaxation of stem cell therapy policies and breakthroughs in stem cell technology, the scientific research process in cell biology will be further advanced. This will trigger rapid growth in the market for cell biology research tools – particularly cell biology instruments in China. Authoritative media predict that driven by the development of cell biology technology, cell discovery services, basic cell biology reagents, flow cytometers, transfection and electroporation, media and sera, microscopes, cell culture equipment, whole-cell analysis, cells and tissues, and imaging equipment will generate impressive market scale and technological progress in recent years.

The mainstream cell biology instrument market is primarily dominated by foreign manufacturers such as BD, Beckman Coulter, and Life Technologies. However, it is noteworthy that Danaher's Beckman Coulter announced the acquisition of Xitogen Technologies (Saijing Biotechnology) in April 2014. The technology and patents held by Chinese flow cytometry companies have significantly impressed the world's flow cytometer giants. For a long time, flow cytometry technology has been monopolized by foreign manufacturers. Only in recent years have some domestic manufacturers gradually started to develop their own flow cytometers. Saijing's technology becoming part of Beckman Coulter's product line will greatly boost the confidence of domestic flow cytometry manufacturers. It is believed that with the growth of new players like ACEA Biosciences and Mindray Medical, and more technical and returned overseas talents joining the local instrument R&D teams, domestic cell biology instrument enterprises will break the monopoly of foreign manufacturers in the future.